From be0acb650ff93789bc010abc5e13f0df718e19a4 Mon Sep 17 00:00:00 2001 From: Jens Kristian Villadsen Date: Sun, 23 Apr 2023 14:43:26 +0200 Subject: [PATCH] Revert "Merging (#79)" This reverts commit 6416642e8b45a76688c224f31b422ce8d244d027. --- .gitignore | 3 +- FHIR-uv-emedicinal-product-info.xml | 123 +- ePICreator/Biktarvy.xlsx | Bin 29605 -> 0 bytes ePICreator/Calcio_Vitamina D.xlsx | Bin 28310 -> 0 bytes ePICreator/Dovato.xlsx | Bin 30882 -> 0 bytes ePICreator/Flucelvax.xlsx | Bin 27816 -> 0 bytes ePICreator/Humalog.xlsx | Bin 29949 -> 0 bytes ePICreator/Humira.xlsx | Bin 31099 -> 0 bytes ePICreator/Karvea.xlsx | Bin 28961 -> 0 bytes ePICreator/Mirtazapine.xlsx | Bin 28945 -> 0 bytes ePICreator/Paracetamol.xlsx | Bin 20804 -> 0 bytes ePICreator/Pentasa.xlsx | Bin 22473 -> 0 bytes ePICreator/Remsima.xlsx | Bin 35836 -> 0 bytes ePICreator/Suliqua.xlsx | Bin 23663 -> 0 bytes ePICreator/acmeDrug.xlsx | Bin 27564 -> 0 bytes ePICreator/cinitrapide.xlsx | Bin 20930 -> 0 bytes ePICreator/createAll.py | 27 - ePICreator/creator.py | 152 -- ePICreator/empty-template.xlsx | Bin 21049 -> 0 bytes ePICreator/instructions.md | 26 - .../AdministrableProductDefinition.fsh | 35 - ePICreator/templates/Bundle.fsh | 43 - .../templates/ClinicalUseDefinition.fsh | 43 - ePICreator/templates/Composition.fsh | 193 -- ePICreator/templates/Ingredient.fsh | 71 - .../templates/ManufacturedItemDefinition.fsh | 38 - .../templates/MedicinalProductDefinition.fsh | 68 - ePICreator/templates/Organization.fsh | 41 - .../templates/PackagedProductDefinition.fsh | 61 - .../templates/RegulatedAuthorization.fsh | 64 - ePICreator/templates/Substance.fsh | 47 - ePICreator/validator.py | 108 -- input/fsh/aliases.fsh | 2 +- .../acmedrug-ema-automatic/Bundle.fsh | 2 +- .../acmedrug-ema-automatic/Composition.fsh | 89 +- .../AdministrableProductDefinition.fsh | 26 + .../adalimumab-ema-automatic/Bundle.fsh | 91 + .../ClinicalUseDefinition.fsh | 0 .../adalimumab-ema-automatic/Composition.fsh | 154 ++ .../adalimumab-ema-automatic/Ingredient.fsh | 104 ++ .../ManufacturedItemDefinition.fsh | 26 + .../MedicinalProductDefinition.fsh | 34 +- .../adalimumab-ema-automatic/Organization.fsh | 117 ++ .../PackagedProductDefinition.fsh | 40 + .../RegulatedAuthorization.fsh | 20 +- .../Substance.fsh | 0 .../AdministrableProductDefinition.fsh | 26 - .../biktarvy-ema-automatic/Bundle.fsh | 96 - .../biktarvy-ema-automatic/Composition.fsh | 425 ----- .../biktarvy-ema-automatic/Ingredient.fsh | 192 -- .../ManufacturedItemDefinition.fsh | 24 - .../MedicinalProductDefinition.fsh | 54 - .../biktarvy-ema-automatic/Organization.fsh | 59 - .../PackagedProductDefinition.fsh | 40 - .../fsh/examples}/biktarvy.fsh | 308 ++++ .../Bundle.fsh | 2 +- .../Composition.fsh | 89 +- input/fsh/examples/cava-ema/BundlecavaEpi.fsh | 103 ++ ...ClinicalUseDefinition-contraindication.fsh | 18 + .../ClinicalUseDefinition-indication.fsh | 18 + .../ClinicalUseDefinition-interaction.fsh | 19 + .../ClinicalUseDefinition-interaction2.fsh | 19 + ...linicalUseDefinition-undesirableeffect.fsh | 16 + .../ClinicalUseDefinition-warning.fsh | 17 + .../administrableproductdefinition.fsh | 29 + .../examples/cava-ema/composition75-en.fsh | 458 +++++ .../cava-ema/ingredient-carnaubawax.fsh | 23 + .../ingredient-croscarmellosesodium.fsh | 23 + .../cava-ema/ingredient-hypromellose.fsh | 23 + .../cava-ema/ingredient-irbesartan75.fsh | 28 + .../ingredient-lactosemonohydrate.fsh | 23 + .../examples/cava-ema/ingredient-macrogol.fsh | 23 + .../cava-ema/ingredient-magnesiumstearate.fsh | 23 + .../ingredient-microcrystallinecellulose.fsh | 23 + .../cava-ema/ingredient-silicondioxide.fsh | 23 + .../cava-ema/ingredient-titaniumdioxide.fsh | 23 + .../manufactureditemdefinition-karvea75.fsh | 21 + .../cava-ema/medicinalproductdefinition.fsh | 50 + .../examples/cava-ema/organization-mah.fsh | 25 + .../cava-ema/packagedproductdefinition.fsh | 34 + .../cava-ema/regulatedauthorization75.fsh | 27 + .../examples/cava-ema/substanceirbesartan.fsh | 28 + .../cinitrapide-ema-automatic/Bundle.fsh | 2 +- .../cinitrapide-ema-automatic/Composition.fsh | 435 ++++- .../MedicinalProductDefinition.fsh | 5 +- .../Organization.fsh | 1 - .../examples/dovato-ema-automatic/Bundle.fsh | 2 +- .../AdministrableProductDefinition.fsh | 26 - .../flucelvax-ema-automatic/Bundle.fsh | 131 -- .../ClinicalUseDefinition.fsh | 0 .../flucelvax-ema-automatic/Composition.fsh | 195 -- .../flucelvax-ema-automatic/Ingredient.fsh | 396 ---- .../ManufacturedItemDefinition.fsh | 26 - .../MedicinalProductDefinition.fsh | 55 - .../flucelvax-ema-automatic/Organization.fsh | 32 - .../PackagedProductDefinition.fsh | 48 - .../RegulatedAuthorization.fsh | 38 - .../flucelvax-ema-automatic/Substance.fsh | 108 -- .../AdministrableProductDefinition.fsh | 10 +- .../examples/humalog-ema-automatic/Bundle.fsh | 18 +- .../humalog-ema-automatic/Composition.fsh | 180 +- .../humalog-ema-automatic/Ingredient.fsh | 48 +- .../ManufacturedItemDefinition.fsh | 6 +- .../MedicinalProductDefinition.fsh | 16 +- .../PackagedProductDefinition.fsh | 10 +- .../RegulatedAuthorization.fsh | 2 +- .../examples/humira-ema-automatic/Bundle.fsh | 2 +- .../humira-ema-automatic/Composition.fsh | 50 +- .../MedicinalProductDefinition.fsh | 4 +- .../examples/karvea-ema-automatic/Bundle.fsh | 10 +- .../ClinicalUseDefinition.fsh | 8 +- .../karvea-ema-automatic/Composition.fsh | 89 +- .../MedicinalProductDefinition.fsh | 10 +- .../mirtazapine-ema-automatic/Bundle.fsh | 2 +- .../mirtazapine-ema-automatic/Composition.fsh | 89 +- .../paracetamol-ema-automatic/Bundle.fsh | 2 +- .../paracetamol-ema-automatic/Composition.fsh | 433 ++++- .../MedicinalProductDefinition.fsh | 6 +- .../examples/pentasa-ema-automatic/Bundle.fsh | 2 +- .../pentasa-ema-automatic/Composition.fsh | 433 ++++- .../MedicinalProductDefinition.fsh | 11 +- .../AdministrableProductDefinition.fsh | 26 - .../examples/remsima-ema-automatic/Bundle.fsh | 96 - .../ClinicalUseDefinition.fsh | 0 .../remsima-ema-automatic/Composition.fsh | 636 ------- .../remsima-ema-automatic/Ingredient.fsh | 154 -- .../ManufacturedItemDefinition.fsh | 24 - .../remsima-ema-automatic/Organization.fsh | 59 - .../PackagedProductDefinition.fsh | 40 - .../RegulatedAuthorization.fsh | 37 - .../remsima-ema-automatic/Substance.fsh | 28 - .../examples/suliqua-ema-automatic/Bundle.fsh | 2 +- .../ClinicalUseDefinition.fsh | 4 +- .../suliqua-ema-automatic/Composition.fsh | 113 +- parkingLot/Flucelvax CAP ENG (1).xml | 1615 ----------------- parkingLot/flucelvax -eng.json | 1432 --------------- sushi-config.yaml | 5 +- 137 files changed, 3652 insertions(+), 7840 deletions(-) delete mode 100644 ePICreator/Biktarvy.xlsx delete mode 100644 ePICreator/Calcio_Vitamina D.xlsx delete mode 100644 ePICreator/Dovato.xlsx delete mode 100644 ePICreator/Flucelvax.xlsx delete mode 100644 ePICreator/Humalog.xlsx delete mode 100644 ePICreator/Humira.xlsx delete mode 100644 ePICreator/Karvea.xlsx delete mode 100644 ePICreator/Mirtazapine.xlsx delete mode 100644 ePICreator/Paracetamol.xlsx delete mode 100644 ePICreator/Pentasa.xlsx delete mode 100644 ePICreator/Remsima.xlsx delete mode 100644 ePICreator/Suliqua.xlsx delete mode 100644 ePICreator/acmeDrug.xlsx delete mode 100644 ePICreator/cinitrapide.xlsx delete mode 100644 ePICreator/createAll.py delete mode 100644 ePICreator/creator.py delete mode 100644 ePICreator/empty-template.xlsx delete mode 100644 ePICreator/instructions.md delete mode 100644 ePICreator/templates/AdministrableProductDefinition.fsh delete mode 100644 ePICreator/templates/Bundle.fsh delete mode 100644 ePICreator/templates/ClinicalUseDefinition.fsh delete mode 100644 ePICreator/templates/Composition.fsh delete mode 100644 ePICreator/templates/Ingredient.fsh delete mode 100644 ePICreator/templates/ManufacturedItemDefinition.fsh delete mode 100644 ePICreator/templates/MedicinalProductDefinition.fsh delete mode 100644 ePICreator/templates/Organization.fsh delete mode 100644 ePICreator/templates/PackagedProductDefinition.fsh delete mode 100644 ePICreator/templates/RegulatedAuthorization.fsh delete mode 100644 ePICreator/templates/Substance.fsh delete mode 100644 ePICreator/validator.py create mode 100644 input/fsh/examples/adalimumab-ema-automatic/AdministrableProductDefinition.fsh create mode 100644 input/fsh/examples/adalimumab-ema-automatic/Bundle.fsh rename input/fsh/examples/{biktarvy-ema-automatic => adalimumab-ema-automatic}/ClinicalUseDefinition.fsh (100%) create mode 100644 input/fsh/examples/adalimumab-ema-automatic/Composition.fsh create mode 100644 input/fsh/examples/adalimumab-ema-automatic/Ingredient.fsh create mode 100644 input/fsh/examples/adalimumab-ema-automatic/ManufacturedItemDefinition.fsh rename input/fsh/examples/{remsima-ema-automatic => adalimumab-ema-automatic}/MedicinalProductDefinition.fsh (52%) create mode 100644 input/fsh/examples/adalimumab-ema-automatic/Organization.fsh create mode 100644 input/fsh/examples/adalimumab-ema-automatic/PackagedProductDefinition.fsh rename input/fsh/examples/{biktarvy-ema-automatic => adalimumab-ema-automatic}/RegulatedAuthorization.fsh (51%) rename input/fsh/examples/{biktarvy-ema-automatic => adalimumab-ema-automatic}/Substance.fsh (100%) delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/AdministrableProductDefinition.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/Bundle.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/Composition.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/Ingredient.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/ManufacturedItemDefinition.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/MedicinalProductDefinition.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/Organization.fsh delete mode 100644 input/fsh/examples/biktarvy-ema-automatic/PackagedProductDefinition.fsh rename {parkingLot => input/fsh/examples}/biktarvy.fsh (50%) create mode 100644 input/fsh/examples/cava-ema/BundlecavaEpi.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-contraindication.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-indication.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction2.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-undesirableeffect.fsh create mode 100644 input/fsh/examples/cava-ema/ClinicalUseDefinition-warning.fsh create mode 100644 input/fsh/examples/cava-ema/administrableproductdefinition.fsh create mode 100644 input/fsh/examples/cava-ema/composition75-en.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-carnaubawax.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-croscarmellosesodium.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-hypromellose.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-irbesartan75.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-lactosemonohydrate.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-macrogol.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-magnesiumstearate.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-microcrystallinecellulose.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-silicondioxide.fsh create mode 100644 input/fsh/examples/cava-ema/ingredient-titaniumdioxide.fsh create mode 100644 input/fsh/examples/cava-ema/manufactureditemdefinition-karvea75.fsh create mode 100644 input/fsh/examples/cava-ema/medicinalproductdefinition.fsh create mode 100644 input/fsh/examples/cava-ema/organization-mah.fsh create mode 100644 input/fsh/examples/cava-ema/packagedproductdefinition.fsh create mode 100644 input/fsh/examples/cava-ema/regulatedauthorization75.fsh create mode 100644 input/fsh/examples/cava-ema/substanceirbesartan.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/AdministrableProductDefinition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/Bundle.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/ClinicalUseDefinition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/Composition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/Ingredient.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/ManufacturedItemDefinition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/MedicinalProductDefinition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/Organization.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/PackagedProductDefinition.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/RegulatedAuthorization.fsh delete mode 100644 input/fsh/examples/flucelvax-ema-automatic/Substance.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/AdministrableProductDefinition.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/Bundle.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/ClinicalUseDefinition.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/Composition.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/Ingredient.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/ManufacturedItemDefinition.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/Organization.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/PackagedProductDefinition.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/RegulatedAuthorization.fsh delete mode 100644 input/fsh/examples/remsima-ema-automatic/Substance.fsh delete mode 100644 parkingLot/Flucelvax CAP ENG (1).xml delete mode 100644 parkingLot/flucelvax -eng.json diff --git a/.gitignore b/.gitignore index a3efc45b10..679eab7f38 100644 --- a/.gitignore +++ b/.gitignore @@ -24,5 +24,4 @@ _updatePublisher.sh log.txt .gitignore .vscode/* -__pycache__/ -~$*.xlsx \ No newline at end of file +__pycache__/ \ No newline at end of file diff --git a/FHIR-uv-emedicinal-product-info.xml b/FHIR-uv-emedicinal-product-info.xml index 9b6e393713..f9be84bd67 100644 --- a/FHIR-uv-emedicinal-product-info.xml +++ b/FHIR-uv-emedicinal-product-info.xml @@ -10,20 +10,20 @@ - + - + - + @@ -31,7 +31,6 @@ - @@ -44,15 +43,13 @@ - - - - + + @@ -61,7 +58,7 @@ - + @@ -70,7 +67,7 @@ - + @@ -78,9 +75,10 @@ - + + @@ -98,18 +96,23 @@ + - + + + + + @@ -119,9 +122,9 @@ + - @@ -139,20 +142,20 @@ + - - + - + @@ -162,26 +165,25 @@ - + - - + - - + + @@ -192,16 +194,16 @@ - + - - + + @@ -212,7 +214,7 @@ - + @@ -231,18 +233,20 @@ - - + + - + + + @@ -261,26 +265,57 @@ + + + - + + + + + + + + + + + + + + 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zn)STN{kI8Tak$u@(w+G-4H2mb3JF#kO85Ri)f=ObZ$$NBw4k6%do03Yse=X?A< z`1eitzXqQH8bE*J{rkBk|96z%ceegQ*+BVQl%M-te@FR!Bj7KTZ|HxE@^f3@?-?u~jLUG6cTa=%hBYsEu-4Oi?rHlA)QGVK^e@FS=(>A)!)PXTp|As^Sf2&7tB4)Pnh40JHG?`-emj*;KTA0;8)A> z_o2TxCVmYKX8&{O?`?|T5q>X|{X*d2{o9A|vuO4^%J0>MUnt@Ne~a?BPxAMb*Dn+Y z;lD-sxeojNZ~51J^cMyYP`(%t(C^vl@1y@!iT`=@q2xb}{!5n?q`?8P>5r}u8W0~K LqT0&*@!S6c6%h}x diff --git a/ePICreator/createAll.py b/ePICreator/createAll.py deleted file mode 100644 index e589857d35..0000000000 --- a/ePICreator/createAll.py +++ /dev/null @@ -1,27 +0,0 @@ -import sys -from os import listdir, getcwd, mkdir, rmdir -from creator import create_from_template - -# total arguments -n = len(sys.argv) -if n < 3: - raise Exception( - "Please provide the path to the input file and the path to the output file" - ) - - -DATA_FOLDER = sys.argv[1] -TEMPLATE_FOLDER = sys.argv[2] -OUTPUT_FOLDER = sys.argv[3] - - -for file in listdir(DATA_FOLDER): - - if ( - file.endswith(".xlsx") - and not file.startswith("~$") - and not file.startswith("empty") - ): - print(file) - print("**" * 50) - create_from_template(file, TEMPLATE_FOLDER, OUTPUT_FOLDER) diff --git a/ePICreator/creator.py b/ePICreator/creator.py deleted file mode 100644 index 3d7e254e69..0000000000 --- a/ePICreator/creator.py +++ /dev/null @@ -1,152 +0,0 @@ -from os import listdir, getcwd, mkdir -from os.path import exists -from jinja2 import Environment, FileSystemLoader -import pandas as pd -import sys -import uuid -import re -from datetime import datetime -from validator import pre_validation -import hashlib - -context = {"now": datetime.now().strftime("%Y-%m-%dT%H:%M:%SZ")} - - -# total arguments -n = len(sys.argv) -if n < 3: - raise Exception( - "Please provide the path to the input file and the path to the output file" - ) - - -# Custom filter method -def regex_replace(s, find, replace): - """A non-optimal implementation of a regex filter""" - return re.sub(find, replace, s) - - -DATA_FILE = sys.argv[1] -TEMPLATE_FOLDER = sys.argv[2] -OUTPUT_FOLDER = sys.argv[3] - -env = Environment(loader=FileSystemLoader(TEMPLATE_FOLDER), trim_blocks=True) -env.filters["regex_replace"] = regex_replace - - -def hash_id(string): - hash_object = hashlib.md5(bytes(string, "utf-8")) - return str(hash_object.hexdigest()) - - -env.filters["create_hash_id"] = hash_id - - -def create_from_template(DATA_FILE, TEMPLATE_FOLDER, OUTPUT_FOLDER): - elements = [ - "AdministrableProductDefinition", - "Substance", - "RegulatedAuthorization", - "Organization", - "ClinicalUseDefinition", - "Composition", - "Ingredient", - "MedicinalProductDefinition", - "ManufacturedItemDefinition", - "PackagedProductDefinition", - "Bundle", - ] - - # create temp_folder: - print(DATA_FILE, TEMPLATE_FOLDER, OUTPUT_FOLDER) - - if TEMPLATE_FOLDER[-1] != "/": - TEMPLATE_FOLDER += "/" - if OUTPUT_FOLDER[-1] != "/": - OUTPUT_FOLDER += "/" - - temp_folder = getcwd() + "/temp/" - - if not exists(temp_folder): - mkdir(temp_folder) - major_name = DATA_FILE.lower().split("/")[-1].split(".")[0].replace(" ", "_") - real_output_folder = OUTPUT_FOLDER + major_name + "-ema-automatic/" - print(real_output_folder) - if not exists(real_output_folder): - mkdir(real_output_folder) - for sheet in elements: - # read an excel file and convert - # into a dataframe object - df = pd.DataFrame(pd.read_excel(DATA_FILE, sheet_name=sheet)) - # pre_validation(df, sheet) - df["id_hash"] = df["id"].apply(lambda x: uuid.uuid4()) - df["id"].fillna(df["id_hash"], inplace=True) - # show the dataframe - # print(df) - df.to_csv(temp_folder + sheet + ".csv", index=True) - - data_dict = {"MajorName": major_name} # if needed - data = {"dictionary": data_dict, "turn": "1"} - - # multiple elementsa - for file in listdir(temp_folder): - print(file) - n_file = file.split(".")[0] - # with open(TEMPLATE_FOLDER + n_file + ".fsh", "r") as file: - - # templateString = env.get_template(file.read()) - - t = env.get_template(n_file + ".fsh") - # t = Template(templateString, trim_blocks=True) - - df = pd.read_csv(temp_folder + n_file + ".csv", index_col=0) - - df = df.astype(str) - data["data"] = df - t.stream(data=data, **context).dump(real_output_folder + n_file + ".fsh") - - # get ids: - ## goes for all, checks for ID and adds to list - ## then creates again with references - object_ids = {} - for file in listdir(real_output_folder): - # print(file) - # n_file = file.split(".")[0] - with open(real_output_folder + file, "r") as file1: - Lines = file1.readlines() - instances = [] - ids = [] - for line in Lines: - - if "Instance: " in line: - # print(line) - instances.append(line.replace("Instance: ", "").strip()) - # if "* id = " in line: - # print(line) - ids.append(line.replace("Instance: ", "").strip()) - - object_ids[file.split(".")[0]] = [(i, j) for i, j in zip(instances, ids)] - - print("ob", object_ids) - data["references"] = object_ids - - print("newline" + " ---" * 30) - # multiple elementsa - for file in listdir(temp_folder): - # print(file) - n_file = file.split(".")[0] - # with open(TEMPLATE_FOLDER + n_file + ".fsh", "r") as f: - # templateString = f.read() - # t = Template(templateString, trim_blocks=True) - t = env.get_template(n_file + ".fsh") - - df = pd.read_csv(temp_folder + file, index_col=0) - # print(df) - df = df.astype(str) - data["data"] = df - data["turn"] = "2" - t.stream(data=data, **context).dump(real_output_folder + n_file + ".fsh") - - -if __name__ == "__main__": - create_from_template(DATA_FILE, TEMPLATE_FOLDER, OUTPUT_FOLDER) diff --git a/ePICreator/empty-template.xlsx b/ePICreator/empty-template.xlsx deleted file mode 100644 index bdf0c5bc3a8b6b29a433704d58f9653055471db2..0000000000000000000000000000000000000000 GIT binary patch literal 0 HcmV?d00001 literal 21049 zcmeIab9AKbmOdQYHaa#tw#|;sj&0kvZFFpOY$qK%>DYF@ynW_OpXqtepYvPaS~K-W z)vA@cuT(wHz4x_o?ORR~7z70X3;+TE0DurccU)K_7!Uwp8xjBj82|!EL(tmF!N|%% z=ZmY2k-ZkJi=_oY9taS54gk={=l}2VzxWD_C27g_(4z#MOTWNNT942BhM8b!KG>EL 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") %} - * text.div = """{{row['package_leaflet']}}""" - -{% else %} - * text.div = """
{{row['package_leaflet']}}
""" -{%- endif %} - - - -* section[=].section[+] - * title = "Package leaflet: Information for the user" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "Package leaflet: Information for the user" - * text.status = #additional -{% if row["information_user"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["information_user"].startswith("
") %} - * text.div = """{{row['information_user']}}""" - -{% else %} - * text.div = """
{{row['information_user']}}
""" -{%- endif %} - - - -* section[=].section[+] - * title = "What is in this leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "What is in this leaflet" - * text.status = #additional -{% if row["what_in_leaflet"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["what_in_leaflet"].startswith("
") %} - * text.div = """{{row['what_in_leaflet']}}""" - -{% else %} - * text.div = """
{{row['what_in_leaflet']}}
""" -{%- endif %} - - -* section[=].section[+] - * title = "1. What {{row['name']}} is and what it is used for" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "1. What {{row['name']}} is and what it is used for" - * text.status = #additional -{% if row["what_product_is"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - -{%- elif row["what_product_is"].startswith("
") %} - * text.div = """{{row['what_product_is']}}""" - -{% else %} - * text.div = """
{{row['what_product_is']}}
""" -{%- endif %} - - - -* section[=].section[+] - * title = "2. What you need to know before you take {{row['name']}}" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "2. What you need to know before you take {{row['name']}}" - * text.status = #additional -{% if row["before_take"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["before_take"].startswith("
") %} - * text.div = """{{row['before_take']}}""" - -{% else %} - * text.div = """
{{row['before_take']}}
""" -{%- endif %} - -* section[=].section[+] - * title = "3. How to take {{row['name']}}" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "3. How to take {{row['name']}}" - * text.status = #additional -{% if row["how_to_take"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["how_to_take"].startswith("
") %} - * text.div = """{{row['how_to_take']}}""" - -{% else %} - * text.div = """
{{row['how_to_take']}}
""" -{%- endif %} - - -* section[=].section[+] - * title = "4. Possible side effects" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "4. Possible side effects" - * text.status = #additional -{% if row["side_effects"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["side_effects"].startswith("
") %} - * text.div = """{{row['side_effects']}}""" - -{% else %} - * text.div = """
{{row['side_effects']}}
""" -{%- endif %} - -* section[=].section[+] - * title = "5. How to store {{row['name']}}" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "5. How to store {{row['name']}}" - * text.status = #additional -{% if row["how_to_store"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["how_to_store"].startswith("
") %} - * text.div = """{{row['how_to_store']}}""" - -{% else %} - * text.div = """
{{row['how_to_store']}}
""" -{%- endif %} - - -* section[=].section[+] - * title = "6. Contents of the pack and other information" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "6. Contents of the pack and other information" - * text.status = #additional -{% if row["other_info"]|string == "nan" %} - - * text.div = """
unavailable
""" - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable -{%- elif row["other_info"].startswith("
") %} - * text.div = """{{row['other_info']}}""" - -{% else %} - * text.div = """
{{row['other_info']}}
""" -{%- endif %} - -{% endif %} -{% endfor %} \ No newline at end of file diff --git a/ePICreator/templates/Ingredient.fsh b/ePICreator/templates/Ingredient.fsh deleted file mode 100644 index 57c1d6cd1e..0000000000 --- a/ePICreator/templates/Ingredient.fsh +++ /dev/null @@ -1,71 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -{% set ns = namespace() %} -{% set ns.one = data["dictionary"]["MajorName"]|lower|regex_replace('[^A-Za-z0-9]+', '') %} -{% set ns.two = row["name"]| lower | regex_replace('[^A-Za-z0-9]+', '') %} -{% set ns.name_to_has= ns.one ~ ns.two %} - - - -{% if ns.name_to_has|length > 48 %} - -Instance: ingredient-for-{{ns.name_to_has| create_hash_id}} - - -{% else %} - -Instance: ingredient-for-{{ data["dictionary"]["MajorName"]|lower|regex_replace('[^A-Za-z0-9]+', '')}}-{{ row["name"]| lower | regex_replace('[^A-Za-z0-9]+', '') }} - -{% endif %} - -InstanceOf: IngredientUvEpi -Title: "Ingredient-{{row["role"]| lower}} {{ row["name"] }}" -Description: "{{ row["name"] }}" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - -* role = $spor-rms#{{ row["roleID"] }} "{{ row["role"] }}" - -* status = #{{ row["status"] }} - -* substance.code.concept.coding = $ginas#{{ row["identifier"] }} "{{ row["name"] }}" - -{% if row["quantity"]|string !="nan" %} - -* substance.strength.presentationQuantity = {{ row["quantity"] | replace (",",".") }} '{{ row["quantity unit"] }}' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#{{row["StrengthBasis"]}} "{{row["StrengthBasisText"]|trim }}" -{% endif %} - - -{% if data["turn"] != "1" %} -// Reference to products -* for = Reference({{data["references"]["ManufacturedItemDefinition"][0][0]}}) -* for[+] = Reference({{data["references"]["MedicinalProductDefinition"][0][0]}}) -* for[+] = Reference({{data["references"]["AdministrableProductDefinition"][0][0]}}) - -{%- endif %} - -// Reference to Organization: Reference to MAH - -{% set ns = namespace(referenced=False) -%} -{% if data["turn"] != "1" %} -{% for refs in data["references"]["Organization"] %} -{% if refs[0].startswith("manufacturerapi") %} -{% set ns.referenced=True -%} - -* manufacturer.manufacturer = Reference({{refs[0]}}) -{%- endif %} -{%- endfor %} - -{% if not ns.referenced %} - -* manufacturer.manufacturer = Reference({{data["references"]["Organization"][0][0]}}) -{% endif %} -{% endif %} -{% endif %} -{% endfor %} \ No newline at end of file diff --git a/ePICreator/templates/ManufacturedItemDefinition.fsh b/ePICreator/templates/ManufacturedItemDefinition.fsh deleted file mode 100644 index 18c08a9ee8..0000000000 --- a/ePICreator/templates/ManufacturedItemDefinition.fsh +++ /dev/null @@ -1,38 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -Instance: mid-{{ row["name"] | lower | regex_replace('[^A-Za-z0-9]+', '') | create_hash_id }} -InstanceOf: ManufacturedItemDefinitionUvEpi -Title: "Manufactured item {{ row["name"] }}" -Description: "{{ row["name"] }}" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - -* status = #{{ row["status"] }} -* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#{{row["doseFormID"]}} "{{ row["doseForm"] }}" - -* unitOfPresentation = $spor-rms#{{row["unit_presentationID"]}} "{{ row["unit_presentation"] }}" - - - - -{% set ns = namespace(referenced=False) -%} -{% if data["turn"] != "1" %} -{% for refs in data["references"]["Organization"] %} -{% if refs[0].startswith("manufacturer") and "manufacturerapi" not in refs[0] %} -{% set ns.referenced=True -%} - -* manufacturer = Reference({{refs[0]}}) -{%- endif %} -{%- endfor %} - -{% if not ns.referenced %} - -* manufacturer = Reference({{data["references"]["Organization"][0][0]}}) -{%- endif %} -{%- endif %} -{%- endif %} -{%- endfor %} \ No newline at end of file diff --git a/ePICreator/templates/MedicinalProductDefinition.fsh b/ePICreator/templates/MedicinalProductDefinition.fsh deleted file mode 100644 index 7552710f99..0000000000 --- a/ePICreator/templates/MedicinalProductDefinition.fsh +++ /dev/null @@ -1,68 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -Instance: mp{{ row["productname"]| regex_replace('[^A-Za-z0-9]+', '') | create_hash_id }} -InstanceOf: MedicinalProductDefinitionUvEpi -Title: "Medicinal Product {{ row["productname"]}}" -Description: "{{ row["productname"]}}" -Usage: #example - -{% if row["identifier_system"]|string != 'nan' %} -{% for idx in range(0,row["identifier_system"].count("|")+1) %} -* identifier[+].system = "{{ row["identifier_system"].split("|")[idx]}}" -* identifier[=].value = "{{ row["identifier_value"].split("|")[idx]}}" -{%- endfor %} -{%- endif %} - -* type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" - -* domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" - -* status = http://hl7.org/fhir/publication-status#active "active" - - -{{ "* indication = \"{}\"".format(row.indication) if row.indication|string !="nan"}} - - -* legalStatusOfSupply = $spor-rms#{{row['statusSuplyID']}} "{{row['statusSuply']}}" - -{% if row["classification_ids"]|string != 'nan' %} -{% for idx in range(0,row["classification_ids"].count("|")+1) %} - -* classification[+] = $atc#{{ row["classification_ids"].split("|")[idx]}} "{{ row["classification_texts"].split("|")[idx]}}" - -{%- endfor %} -{%- endif %} - -* name - * productName = "{{ row["productname"]|trim }}" - * type = $spor-productNamePartType-cs#220000000001 - * text = "Full name" - - * part[0] - * part = "{{ row["inventedNamePart"]|trim }}" - * type = $spor-productNamePartType-cs#220000000002 - * type.text = "Invented name part" - - * part[+] - * part = "{{ row["ScientificNamePart"] |trim }}" - * type = $spor-productNamePartType-cs#220000000003 - * type.text = "Scientific name part" - - * part[+] - * part = "{{ row["StrengthPart"] |trim }}" - * type = $spor-productNamePartType-cs#220000000004 - * type.text = "Strength part" - - * part[+] - * part = "{{ row["PharmaceuticalDosePart"]|trim }}" - * type = $spor-productNamePartType-cs#220000000005 - * type.text = "Pharmaceutical dose form part" - - * usage - * country = urn:iso:std:iso:3166#{{ row["countryCode"] }} "{{ row["country"] }}" - * jurisdiction = urn:iso:std:iso:3166#{{ row["countryCode"] }} "{{ row["country"] }}" - * language = urn:ietf:bcp:47#{{ row["languageID"] }} "{{ row["language"] }}" - -{%- endif %} -{%- endfor %} \ No newline at end of file diff --git a/ePICreator/templates/Organization.fsh b/ePICreator/templates/Organization.fsh deleted file mode 100644 index 8c6eed39e4..0000000000 --- a/ePICreator/templates/Organization.fsh +++ /dev/null @@ -1,41 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -{% set ns = namespace() %} -{% set ns.one = row['type'] %} -{% set ns.two = row['name'] %} -{% set ns.three= data["dictionary"]["MajorName"] %} -{% set ns.name_to_has= ns.one ~ ns.two ~ns.three %} - - - -Instance: org-{{ns.name_to_has| create_hash_id}} - -InstanceOf: OrganizationUvEpi -Title: "{{ row["name"] }} as {{ row["type"] }}" -Description: "{{ row["name"] }} as {{ row["type"] }}" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - -* active = {{ row["active"]|lower }} - -* type = $spor-rms#{{row["typeID"]}} "{{ row["type"] }}" -* type.text = "{{ row["type"] }}" -* name = "{{ row["name"] }}" - -* contact - * address - * text = "{{ row["address_line"] }} {{ row["address_city"] }} {{ row["address_country"] }}" - * use = #{{ row["address_use"] }} - * type = #{{ row["address_type"] }} - * line = "{{ row["address_line"]|trim }}" - * city = "{{ row["address_city"]|trim }}" - * country = "{{ row["address_country"]|trim }}" - {{ "* postalCode = \"{}\"".format(row.address_postalCode|trim) if row.address_postalCode|string !="nan"}} - - -{%- endif %} -{%- endfor %} \ No newline at end of file diff --git a/ePICreator/templates/PackagedProductDefinition.fsh b/ePICreator/templates/PackagedProductDefinition.fsh deleted file mode 100644 index 78ad490dc8..0000000000 --- a/ePICreator/templates/PackagedProductDefinition.fsh +++ /dev/null @@ -1,61 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -Instance: ppd-{{ row["name"]| lower | regex_replace('[^A-Za-z0-9]+', '') | create_hash_id}} -InstanceOf: PackagedProductDefinitionUvEpi -Title: "{{ row["name"] }}" -Description: "{{ row["name"] }}" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - -* name = "{{ row["name"] }}" - -* type = $spor-rms#{{ row["typeID"] }} "{{ row["type"] }}" -//* type = $spor-rms#100000155527 - - -* status = http://hl7.org/fhir/publication-status#active "Active" -* statusDate = "{{ row["statusDate"]}}" - -{% if row["quantity"]|string !="nan" %} - -* containedItemQuantity = {{ row["quantity"].split(' ')[0] }} '{{ row["quantity"].split(' ')[1] }}' -{% endif %} - -{{ "* description = \"{}\"".format(row.description) if row.description|string !="nan"}} -{{ "* copackagedIndicator = {}".format(row.copackagedIndicator|lower) if row.copackagedIndicator|string !="nan"}} - - -* packaging - * identifier.system = $spor-prod - * identifier.value = "{{ row["packaging_identifier"] }}" - * type = $spor-rms#{{ row["Packaging_typeID"] }} "{{ row["Packaging_type"] }}" - * quantity = {{ row["packaging_quantity"] }} - * material = $spor-rms#{{ row["packaging_materialID"] }} "{{ row["packaging_material"] }}" - -{% if row["inside_packaging_type"]|string != "nan" %} - - * packaging.type = $spor-rms#{{ row["inside_packaging_typeID"] }} "{{ row["inside_packaging_type"] }}" - * packaging.quantity = {{ row["inside_packaging_quantity"] }} -{% for idx in range(0,row["inside_packaging_materialID"].count("|")+1) %} - - * packaging.material[+] = $spor-rms#{{ row["inside_packaging_materialID"].split("|")[idx] }} "{{ row["inside_packaging_material"].split("|")[idx] }}" - -{%- endfor %} -{%- endif %} - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -{% if data["turn"] != "1" %} -* packageFor = Reference({{data["references"]["MedicinalProductDefinition"][0][0]}}) -{% endif %} - // Reference to Organization: MAH -{% if data["turn"] != "1" %} -* manufacturer = Reference({{data["references"]["Organization"][0][0]}}) -{% endif %} - -{%- endif %} -{%- endfor %} \ No newline at end of file diff --git a/ePICreator/templates/RegulatedAuthorization.fsh b/ePICreator/templates/RegulatedAuthorization.fsh deleted file mode 100644 index 312aabf99f..0000000000 --- a/ePICreator/templates/RegulatedAuthorization.fsh +++ /dev/null @@ -1,64 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -Instance: authorization{{ row["name"]| lower | regex_replace('[^A-Za-z0-9]+', '') | create_hash_id }} -InstanceOf: RegulatedAuthorizationUvEpi -Title: "Regulated Authorization for {{ row["name"] }}" -Description: "Regulated Authorization for {{ row["name"] }}" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - - // Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet - {% if data["turn"] != "1" %} -//* subject = Reference(karvea75mgblisterx28) -* subject = Reference({{data["references"]["MedicinalProductDefinition"][0][0]}}) -{% endif %} -* type = $spor-rms#{{ row["typeID"] }} "{{ row["type"] }}" - -//* type = $spor-rms#100000072062 -//* type.text = "Marketing Authorisation" - -* region = urn:iso:std:iso:3166#{{ row["regionID"] }} "{{ row["region"] }}" - - -* status = http://hl7.org/fhir/publication-status#{{ row["statusID"] }} "{{ row["status"] }}" - - -* statusDate = "{{ row["statusDate"] }}" -{% set ns = namespace(referenced=False) -%} - -// * holder = Reference(sanofiaventisgroupe) -{% if data["turn"] != "1" %} -{% for refs in data["references"]["Organization"] %} -{% if refs[0].startswith("marketingauthorisationholder") %} -{% set ns.referenced=True -%} - -* holder = Reference({{refs[0]}}) -{%- endif %} -{%- endfor %} - -{% if not ns.referenced %} - -* holder = Reference({{data["references"]["Organization"][0][0]}}) -{%- endif %} - -{%- endif %} - -{%- endif %} -{%- endfor %} - - - -{% if data["turn"] != "1" %} -{% for refs in data["references"]["Organization"] %} -{% if refs[0].startswith("medicinesregulatoryauthority") %} - // Reference to Organization: EMA -* regulator = Reference({{refs[0]}}) -{%- endif %} -{%- endfor %} -{%- endif %} - - diff --git a/ePICreator/templates/Substance.fsh b/ePICreator/templates/Substance.fsh deleted file mode 100644 index f104e4b240..0000000000 --- a/ePICreator/templates/Substance.fsh +++ /dev/null @@ -1,47 +0,0 @@ -{% for index,row in data["data"].iterrows() %} -{% if row["skip"] not in ['y', 'Y', 'x', 'X'] %} - -Instance: substance-{{ row["name"]| lower | regex_replace('[^A-Za-z0-9]+', '') }} -InstanceOf: SubstanceDefinitionUvEpi -Description: "{{ row["name"] }}" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "{{ row["identifier"] }}" -* identifier.use = #official - -* version = "{{ row["version"] }}" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#{{ row["statusID"] }} "{{ row["status"] }}" - -//* description = "{{ row["description"] }}" -{{ "* description = \"{}\"".format(row.description) if row.description|string !="nan"}} - - // Reference to Organization: MAH - {% if data["turn"] != "1" %} - -* manufacturer = Reference({{data["references"]["Organization"][0][0]}}) - -{%- endif %} - -{% if row["moleclularWeigth"]|string != "nan" %} - -{% for idx in range(0,row["moleclularWeigth"].count("|")+1) %} - -* molecularWeight[+].type.text = "{{ row["moleclularWeigthType"].split("|")[idx] }}" -* molecularWeight[=].amount.value = {{ row["moleclularWeigth"].split("|")[idx] | replace (",",".")}} - -{%- endfor %} -{%- endif %} - -* structure.molecularFormula = "{{ row["molecularFormula"] }}" - -//* name.name = "{{ row["name_name"] }}" -{{ "* name.name = \"{}\"".format(row.name_name) if row.name_name|string !="nan"}} - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#{{ row["name_typeID"] }} "{{ row["name_type"] }}" -{{ "* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#{} \"{}\"".format(row.name_typeID,row.name_type) if row.name_type|string !="nan"}} - - -{%- endif %} -{%- endfor %} \ No newline at end of file diff --git a/ePICreator/validator.py b/ePICreator/validator.py deleted file mode 100644 index 07f55c7476..0000000000 --- a/ePICreator/validator.py +++ /dev/null @@ -1,108 +0,0 @@ -import pandas as pd - - -def pre_validation(df, sheet): - """Pre-validation of the input data""" - - def if_has_spaces(df, col): - if df[col].str.strip().str.contains(" ").any(): - raise Exception(str(col) + " cannot contain spaces") - - def if_has_spaces_or_null(df, col): - for item in df[col]: - if not pd.isna(item): - if " " in item: - raise Exception(str(col) + " cannot contain spaces") - - def if_numeric_or_null(df, col): - if not ( - pd.to_numeric(df[col], errors="coerce").notnull() | df[col].isnull() - ).all(): - raise Exception(str(col) + " must be numeric or null") - - def if_numeric(df, col): - if not pd.to_numeric(df[col], errors="coerce").notnull().all(): - raise Exception(str(col) + " must be numeric") - - def if_has_newline(df, col): - if df[col].str.contains("\n").any(): - raise Exception(str(col) + " cannot contain new lines (enters)") - - def validate_AdministrableProductDefinition(df): - """Validate the ingredient sheet""" - if_has_spaces(df, "status") - if_numeric(df, "unit_presentationID") - if_numeric(df, "routeID") - if_numeric(df, "doseFormID") - if_has_newline(df, "name") - return "ok" - - def validate_ingredient(df): - """Validate the ingredient sheet""" - if_has_spaces(df, "identifier") - if_has_spaces(df, "StrengthBasis") - if_numeric_or_null(df, "quantity") - if_numeric(df, "roleID") - if_has_newline(df, "name") - return "ok" - - def validate_ManufacturedItemDefinition(df): - """Validate the ingredient sheet""" - if_has_spaces(df, "status") - if_numeric(df, "unit_presentationID") - if_numeric(df, "doseFormID") - if_has_newline(df, "name") - if_has_spaces(df, "identifier") - - return "ok" - - def validate_MedicinalProductDefinition(df): - """Validate the ingredient sheet""" - if_has_newline(df, "productname") - if_has_spaces(df, "status") - if_has_spaces(df, "countryCode") - - if_numeric(df, "statusSuplyID") - if_has_newline(df, "inventedNamePart") - if_has_newline(df, "ScientificNamePart") - if_has_newline(df, "StrengthPart") - if_has_newline(df, "PharmaceuticalDosePart") - - return "ok" - - def validate_Organization(df): - """Validate the ingredient sheet""" - if_has_spaces(df, "identifier") - if_numeric_or_null(df, "address_postalCode") - if_numeric(df, "typeID") - if_has_newline(df, "name") - return "ok" - - def validate_PackagedProductDefinition(df): - """Validate the ingredient sheet""" - if_has_spaces_or_null(df, "identifier") - if_numeric_or_null(df, "inside_packaging_typeID") - if_numeric_or_null(df, "inside_packaging_quantity") - if_numeric_or_null(df, "packaging_quantity") - if_numeric_or_null(df, "Packaging_typeID") - if_numeric_or_null(df, "packaging_materialID") - if_numeric_or_null(df, "packaging_quantity") - - if_numeric(df, "typeID") - - if_has_newline(df, "name") - return "ok" - - if sheet == "Ingredient": - return validate_ingredient(df) - - if sheet == "AdministrableProductDefinition": - return validate_AdministrableProductDefinition(df) - if sheet == "ManufacturedItemDefinition": - return validate_ManufacturedItemDefinition(df) - if sheet == "MedicinalProductDefinition": - return validate_MedicinalProductDefinition(df) - if sheet == "Organization": - return validate_Organization(df) - if sheet == "PackagedProductDefinition": - return validate_PackagedProductDefinition(df) diff --git a/input/fsh/aliases.fsh b/input/fsh/aliases.fsh index d0f456b20e..ddad89e038 100644 --- a/input/fsh/aliases.fsh +++ b/input/fsh/aliases.fsh @@ -16,7 +16,7 @@ Alias: $allergyintolerance-verification = http://terminology.hl7.org/CodeSystem/ Alias: $condition-clinical = http://terminology.hl7.org/CodeSystem/condition-clinical Alias: $list-order = http://terminology.hl7.org/CodeSystem/list-order Alias: $example-org = http://example.org -Alias: $snomed = http://snomed.info/sct + // SPOR Code systems (lists) Alias: $spor-precautionsForStorage-cs = https://spor.ema.europa.eu/lists/100000073344 diff --git a/input/fsh/examples/acmedrug-ema-automatic/Bundle.fsh b/input/fsh/examples/acmedrug-ema-automatic/Bundle.fsh index d7b32c74bf..4854d67c08 100644 --- a/input/fsh/examples/acmedrug-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/acmedrug-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/96/007/035" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/composition5aa8042f9b2bea12d814ccaf27f6d64e" diff --git a/input/fsh/examples/acmedrug-ema-automatic/Composition.fsh b/input/fsh/examples/acmedrug-ema-automatic/Composition.fsh index 1b68b3b8b9..831e2dfda4 100644 --- a/input/fsh/examples/acmedrug-ema-automatic/Composition.fsh +++ b/input/fsh/examples/acmedrug-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-2aff7154a8d952c895e8a03849a25108) * title = "TEST PURPOSES ONLY - acmedrug" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
unavailable
""" * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,8 +42,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
+ + * text.div = """

Karvea 75 mg tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. @@ -54,19 +53,15 @@ Usage: #example
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
    • -
    """ - - - - +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    + + * text.div = """
    • What Karvea is and what it is used for
    • What you need to know before you take Karvea
      • @@ -75,18 +70,15 @@ Usage: #example
    • How to store Karvea
    • Contents of the pack and other information
    -
    """ - - - +
    """ * section[=].section[+] * title = "1. What acmedrug is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What acmedrug is and what it is used for" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

    @@ -96,19 +88,15 @@ Usage: #example
  • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
    • -
    """ - - - - - +
    """ * section[=].section[+] * title = "2. What you need to know before you take acmedrug" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take acmedrug" * text.status = #additional - - * text.div = """
    + + + * text.div = """
    Do not take Karvea
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • @@ -171,17 +159,14 @@ Usage: #example Karvea contains sodium.

      This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

      -
    """ - - - +
    """ * section[=].section[+] * title = "3. How to take acmedrug" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take acmedrug" * text.status = #additional - - * text.div = """
    + + * text.div = """
    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration @@ -210,9 +195,7 @@ Usage: #example If you forget to take Karvea

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    -
    """ - - +
    """ * section[=].section[+] @@ -220,8 +203,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    The frequency of the side effects listed below is defined using the following convention:

    @@ -241,17 +224,15 @@ Usage: #example Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

    -
    """ - - +
    """ * section[=].section[+] * title = "5. How to store acmedrug" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store acmedrug" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. @@ -259,18 +240,15 @@ Usage: #example

    Do not store above 30°C.

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

    -
    """ - - - +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    + + * text.div = """
    What Karvea contains
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • @@ -493,7 +471,4 @@ Usage: #example

      This leaflet was last revised in

      Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

      -
    """ - - - +
    """ \ No newline at end of file diff --git a/input/fsh/examples/adalimumab-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/adalimumab-ema-automatic/AdministrableProductDefinition.fsh new file mode 100644 index 0000000000..517c972fe3 --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/AdministrableProductDefinition.fsh @@ -0,0 +1,26 @@ + +Instance: ap-2e8a8b1c9142de3ac8de0723812d3fef +InstanceOf: AdministrableProductDefinitionUvEpi +Title: "Administrable product adalimumab" +Description: "adalimumab" +Usage: #example + +* identifier.system = $phpid +* identifier.value = "TBD" + +* status = #active + +* formOf = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) +* administrableDoseForm = $spor-rms#100000073863 "Solution for injection" +* unitOfPresentation = $spor-rms#200000002135 "Pen" + +//this is just manufactured with extra steps? + + +//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet +* producedFrom = Reference(mid-2e8a8b1c9142de3ac8de0723812d3fef) + + +* routeOfAdministration.code = $spor-rms#100000073633 "Subcutaneous use" + +* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/adalimumab-ema-automatic/Bundle.fsh b/input/fsh/examples/adalimumab-ema-automatic/Bundle.fsh new file mode 100644 index 0000000000..b50e1a9c23 --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/Bundle.fsh @@ -0,0 +1,91 @@ + +Instance: bundlepackageleaflet-2e8a8b1c9142de3ac8de0723812d3fef +InstanceOf: BundleUvEpi +Title: "ePI document Bundle for adalimumab Package Leaflet" +Description: "Bundle for adalimumab Package Leaflet ePI document" +Usage: #example + +* identifier.system = "https://www.gravitatehealth.eu/sid/doc" +* identifier.value = "EU/1/16/1157/003" +* type = #document +* timestamp = "2023-01-20T17:19:33Z" + +// Composition +* entry[0].fullUrl = "Composition/composition2e8a8b1c9142de3ac8de0723812d3fef" +* entry[0].resource = composition2e8a8b1c9142de3ac8de0723812d3fef + + + + + + + + +// Ingredient + +* entry[+].fullUrl = "Ingredient/ingredient-for-adalimumab-insulinglargine" +* entry[=].resource = ingredient-for-adalimumab-insulinglargine + +// Ingredient + +* entry[+].fullUrl = "Ingredient/ingredient-for-adalimumab-lixisenatide" +* entry[=].resource = ingredient-for-adalimumab-lixisenatide + +// Ingredient + +* entry[+].fullUrl = "Ingredient/ingredient-for-adalimumab-glycerol85whodd" +* entry[=].resource = ingredient-for-adalimumab-glycerol85whodd + + + +// AdministrableProductDefinition + +* entry[+].fullUrl = "AdministrableProductDefinition/ap-2e8a8b1c9142de3ac8de0723812d3fef" +* entry[=].resource = ap-2e8a8b1c9142de3ac8de0723812d3fef + + +// RegulatedAuthorization + +* entry[+].fullUrl = "RegulatedAuthorization/authorization2e8a8b1c9142de3ac8de0723812d3fef" +* entry[=].resource = authorization2e8a8b1c9142de3ac8de0723812d3fef + + +// Organization + +* entry[+].fullUrl = "Organization/org-b4249a5180d23ad521b23e06e99b7afd" +* entry[=].resource = org-b4249a5180d23ad521b23e06e99b7afd + +// Organization + +* entry[+].fullUrl = "Organization/org-90385ec6a39a5d293a77ef9f7095bd30" +* entry[=].resource = org-90385ec6a39a5d293a77ef9f7095bd30 + +// Organization + +* entry[+].fullUrl = "Organization/org-591fe9c5de748b22eace6d084f2f041a" +* entry[=].resource = org-591fe9c5de748b22eace6d084f2f041a + +// Organization + +* entry[+].fullUrl = "Organization/org-bcc70233ff79453d8ddfc13faa4dfb4e" +* entry[=].resource = org-bcc70233ff79453d8ddfc13faa4dfb4e + + +// PackagedProductDefinition + +* entry[+].fullUrl = "PackagedProductDefinition/ppd-2e8a8b1c9142de3ac8de0723812d3fef" +* entry[=].resource = ppd-2e8a8b1c9142de3ac8de0723812d3fef + + +// MedicinalProductDefinition + +* entry[+].fullUrl = "MedicinalProductDefinition/mp2e8a8b1c9142de3ac8de0723812d3fef" +* entry[=].resource = mp2e8a8b1c9142de3ac8de0723812d3fef + + +// ManufacturedItemDefinition + +* entry[+].fullUrl = "ManufacturedItemDefinition/mid-2e8a8b1c9142de3ac8de0723812d3fef" +* entry[=].resource = mid-2e8a8b1c9142de3ac8de0723812d3fef + + diff --git a/input/fsh/examples/biktarvy-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/adalimumab-ema-automatic/ClinicalUseDefinition.fsh similarity index 100% rename from input/fsh/examples/biktarvy-ema-automatic/ClinicalUseDefinition.fsh rename to input/fsh/examples/adalimumab-ema-automatic/ClinicalUseDefinition.fsh diff --git a/input/fsh/examples/adalimumab-ema-automatic/Composition.fsh b/input/fsh/examples/adalimumab-ema-automatic/Composition.fsh new file mode 100644 index 0000000000..3eb2e770c1 --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/Composition.fsh @@ -0,0 +1,154 @@ + +Instance: composition2e8a8b1c9142de3ac8de0723812d3fef +InstanceOf: CompositionUvEpi +Title: "Composition for adalimumab Package Leaflet" +Description: "Composition for adalimumab Package Leaflet" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/rmswi/" +* identifier.value = "0d69fdcb-33cf-407f-8209-a6529856ab4f" + +* status = #final + +* type = https://spor.ema.europa.eu/rmswi/#100000155538 +* type.text = "Package Leaflet" + +* subject = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) +* date = "2022-02-16T13:28:17Z" +* author = Reference(org-b4249a5180d23ad521b23e06e99b7afd) + +* title = "TEST PURPOSES ONLY - adalimumab" + + + + + + + + +* section[+]. + * title = "B. Package Leaflet" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "B. PACKAGE LEAFLET" + * text.status = #additional + + * text.div = """
    unavailable
    """ + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + + +* section[=].section[+] + * title = "Package leaflet: Information for the user" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "Package leaflet: Information for the user" + * text.status = #additional + + * text.div = """
    +PACKAGE LEAFLET: INFORMATION FOR THE USER +Humalog Mix50 100 units/ml suspension for injection in cartridge +insulin lispro +Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ + +* section[=].section[+] + * title = "What is in this leaflet" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "What is in this leaflet" + * text.status = #additional + + * text.div = """
    +What in this leaflet +
      +
    1. What Humalog Mix50 is and what it is used for
      2. +
    2. What you need to know before you take Humalog Mix50
      3. +
    3. How to take Humalog Mix50
      4. +
    4. Possible side effects
      5. +
    5. How to store Humalog Mix50
      6. +
    6. Contents of the pack and other information
      7. +
    +
    """ + +* section[=].section[+] + * title = "1. What adalimumab is and what it is used for" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "1. What adalimumab is and what it is used for" + * text.status = #additional + + * text.div = """
    unavailable
    """ + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable +* section[=].section[+] + * title = "2. What you need to know before you take adalimumab" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "2. What you need to know before you take adalimumab" + * text.status = #additional + + + * text.div = """
    +2. What you need to know before you use Humalog Mix50 +Do NOT use Humalog Mix50 if you +
    """ +* section[=].section[+] + * title = "3. How to take adalimumab" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "3. How to take adalimumab" + * text.status = #additional + + * text.div = """
    +3. How to use Humalog Mix50 +The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens. +

    Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor +if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by +you only, even if the needle on the delivery device is changed.

    +
    """ + + +* section[=].section[+] + * title = "4. Possible side effects" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "4. Possible side effects" + * text.status = #additional + + * text.div = """
    +

    4. Possible side effects

    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    +
    """ + +* section[=].section[+] + * title = "5. How to store adalimumab" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "5. How to store adalimumab" + * text.status = #additional + + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ + +* section[=].section[+] + * title = "6. Contents of the pack and other information" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "6. Contents of the pack and other information" + * text.status = #additional + + * text.div = """
    +6. Contents of the pack and other information +What Humalog Mix50 100 units/ml suspension for injection in cartridge contains +

    The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant +DNA technology’ process. It is a changed form of human insulin and so is different from other +human and animal insulins. Insulin lispro is closely related to human insulin which is a natural +hormone made by the pancreas. +The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium +phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid +may have been used to adjust the acidity.

    +
    """ \ No newline at end of file diff --git a/input/fsh/examples/adalimumab-ema-automatic/Ingredient.fsh b/input/fsh/examples/adalimumab-ema-automatic/Ingredient.fsh new file mode 100644 index 0000000000..e2d86799c2 --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/Ingredient.fsh @@ -0,0 +1,104 @@ + +Instance: ingredient-for-adalimumab-insulinglargine +InstanceOf: IngredientUvEpi +Title: "Ingredient-active Insulin glargine" +Description: "Insulin glargine" +Usage: #example + +* identifier.system = $ginas +* identifier.value = "2ZM8CX04RZ" +* identifier.use = #official + +* role = $spor-rms#72072 "active" + +* status = #active + +* substance.code.concept.coding = $ginas#2ZM8CX04RZ "Insulin glargine" + + +* substance.strength.presentationQuantity = 100.0 'U/ml' + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" + + +// Reference to products +* for = Reference(mid-2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(ap-2e8a8b1c9142de3ac8de0723812d3fef) +// Reference to Organization: Reference to MAH + + + + + + + +* manufacturer.manufacturer = Reference(org-b4249a5180d23ad521b23e06e99b7afd) + +Instance: ingredient-for-adalimumab-lixisenatide +InstanceOf: IngredientUvEpi +Title: "Ingredient-active Lixisenatide" +Description: "Lixisenatide" +Usage: #example + +* identifier.system = $ginas +* identifier.value = "74O62BB01U" +* identifier.use = #official + +* role = $spor-rms#72072 "active" + +* status = #active + +* substance.code.concept.coding = $ginas#74O62BB01U "Lixisenatide" + + +* substance.strength.presentationQuantity = 50.0 'ug/ml' + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" + + +// Reference to products +* for = Reference(mid-2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(ap-2e8a8b1c9142de3ac8de0723812d3fef) +// Reference to Organization: Reference to MAH + + + + + + + +* manufacturer.manufacturer = Reference(org-b4249a5180d23ad521b23e06e99b7afd) + +Instance: ingredient-for-adalimumab-glycerol85whodd +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient GLYCEROL 85% [WHO-DD]" +Description: "GLYCEROL 85% [WHO-DD]" +Usage: #example + +* identifier.system = $ginas +* identifier.value = "PDC6A3C0OX" +* identifier.use = #official + +* role = $spor-rms#100000072082 "Excipient" + +* status = #active + +* substance.code.concept.coding = $ginas#PDC6A3C0OX "GLYCEROL 85% [WHO-DD]" + + + +// Reference to products +* for = Reference(mid-2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) +* for[+] = Reference(ap-2e8a8b1c9142de3ac8de0723812d3fef) +// Reference to Organization: Reference to MAH + + + + + + + +* manufacturer.manufacturer = Reference(org-b4249a5180d23ad521b23e06e99b7afd) diff --git a/input/fsh/examples/adalimumab-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/adalimumab-ema-automatic/ManufacturedItemDefinition.fsh new file mode 100644 index 0000000000..9390b85efe --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/ManufacturedItemDefinition.fsh @@ -0,0 +1,26 @@ + +Instance: mid-2e8a8b1c9142de3ac8de0723812d3fef +InstanceOf: ManufacturedItemDefinitionUvEpi +Title: "Manufactured item adalimumab" +Description: "adalimumab" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" +* identifier.value = "EU/1/16/1157/003" +* identifier.use = #official + +* status = #active +* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#200000002007 "Solution" + +* unitOfPresentation = $spor-rms#200000002135 "Pen" + + + + + + + + + + +* manufacturer = Reference(org-b4249a5180d23ad521b23e06e99b7afd) \ No newline at end of file diff --git a/input/fsh/examples/remsima-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/adalimumab-ema-automatic/MedicinalProductDefinition.fsh similarity index 52% rename from input/fsh/examples/remsima-ema-automatic/MedicinalProductDefinition.fsh rename to input/fsh/examples/adalimumab-ema-automatic/MedicinalProductDefinition.fsh index a8fa541b34..bc1cf272d1 100644 --- a/input/fsh/examples/remsima-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/adalimumab-ema-automatic/MedicinalProductDefinition.fsh @@ -1,15 +1,13 @@ -Instance: mpbe76bdf784deea6950583b234f789db2 +Instance: mp2e8a8b1c9142de3ac8de0723812d3fef InstanceOf: MedicinalProductDefinitionUvEpi -Title: "Medicinal Product Remsima 100 mg powder for concentrate for solution for infusion" -Description: "EU/1/97/049/001 Remsima 100 mg powder for concentrate for solution for infusion" +Title: "Medicinal Product adalimumab" +Description: "EU/1/97/049/001 adalimumab" Usage: #example - -* identifier[+].system = "https://spor.ema.europa.eu/pmswi" -* identifier[=].value = "EU/1/13/853/001" -* identifier[+].system = "https://www.who-umc.org/phpid" -* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E82718" +* identifier.system = $spor-prod +* identifier.value = "EU/1/16/1157/002" + * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" * domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" @@ -17,38 +15,40 @@ Usage: #example * status = http://hl7.org/fhir/publication-status#active "active" - +* indication = "Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors." * legalStatusOfSupply = $spor-rms#100000072084 "Medicinal product subject to medical prescription" + +* classification[+] = $atc#A10AE54 "insulin glargine and lixisenatide" * name - * productName = "Remsima 100 mg powder for concentrate for solution for infusion" + * productName = "adalimumab" * type = $spor-productNamePartType-cs#220000000001 * text = "Full name" * part[0] - * part = "Remsima" + * part = "Suliqua" * type = $spor-productNamePartType-cs#220000000002 * type.text = "Invented name part" * part[+] - * part = "Infliximab" + * part = "Insulin glargine, Lixisenatide" * type = $spor-productNamePartType-cs#220000000003 * type.text = "Scientific name part" * part[+] - * part = "100 mg" + * part = "100 units/ml + 50 ug/ml" * type = $spor-productNamePartType-cs#220000000004 * type.text = "Strength part" * part[+] - * part = "powder for concentrate for solution for infusion" + * part = "Solution for injection" * type = $spor-productNamePartType-cs#220000000005 * type.text = "Pharmaceutical dose form part" * usage - * country = urn:iso:std:iso:3166#eu "" - * jurisdiction = urn:iso:std:iso:3166#eu "" - * language = urn:ietf:bcp:47#eu "English" \ No newline at end of file + * country = urn:iso:std:iso:3166#DK "Denmark" + * jurisdiction = urn:iso:std:iso:3166#DK "Denmark" + * language = urn:ietf:bcp:47#en "English" \ No newline at end of file diff --git a/input/fsh/examples/adalimumab-ema-automatic/Organization.fsh b/input/fsh/examples/adalimumab-ema-automatic/Organization.fsh new file mode 100644 index 0000000000..68026b1652 --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/Organization.fsh @@ -0,0 +1,117 @@ + + + + +Instance: org-b4249a5180d23ad521b23e06e99b7afd + +InstanceOf: OrganizationUvEpi +Title: "Sanofi-Aventis Groupe as Marketing authorisation holder" +Description: "Sanofi-Aventis Groupe as Marketing authorisation holder" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100000789" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000034 "Marketing authorisation holder" +* type.text = "Marketing authorisation holder" +* name = "Sanofi-Aventis Groupe" + +* contact + * address + * text = "54, rue La Boétie F-75008 Paris FR" + * use = #work + * type = #physical + * line = "54, rue La Boétie F-75008" + * city = "Paris" + * country = "FR" + + + + +Instance: org-90385ec6a39a5d293a77ef9f7095bd30 + +InstanceOf: OrganizationUvEpi +Title: "Sanofi-Aventis Deutschland GmbH as Manufacturer API" +Description: "Sanofi-Aventis Deutschland GmbH as Manufacturer API" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100001175" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000033 "Manufacturer API" +* type.text = "Manufacturer API" +* name = "Sanofi-Aventis Deutschland GmbH" + +* contact + * address + * text = "Brueningstrasse 50, Industriepark Höchst Frankfurt am Main de" + * use = #work + * type = #physical + * line = "Brueningstrasse 50, Industriepark Höchst" + * city = "Frankfurt am Main" + * country = "de" + * postalCode = "65926" + + + +Instance: org-591fe9c5de748b22eace6d084f2f041a + +InstanceOf: OrganizationUvEpi +Title: "Sanofi-Aventis Deutschland GmbH as Manufacturer Batch release" +Description: "Sanofi-Aventis Deutschland GmbH as Manufacturer Batch release" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100001175" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000033 "Manufacturer Batch release" +* type.text = "Manufacturer Batch release" +* name = "Sanofi-Aventis Deutschland GmbH" + +* contact + * address + * text = "Brueningstrasse 50, Industriepark Höchst Frankfurt am Main de" + * use = #work + * type = #physical + * line = "Brueningstrasse 50, Industriepark Höchst" + * city = "Frankfurt am Main" + * country = "de" + * postalCode = "65927" + + + +Instance: org-bcc70233ff79453d8ddfc13faa4dfb4e + +InstanceOf: OrganizationUvEpi +Title: "European Medicines Agency as Medicines Regulatory Authority" +Description: "European Medicines Agency as Medicines Regulatory Authority" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100013412" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000033 "Medicines Regulatory Authority" +* type.text = "Medicines Regulatory Authority" +* name = "European Medicines Agency" + +* contact + * address + * text = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam nl" + * use = #work + * type = #physical + * line = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est" + * city = "Amsterdam" + * country = "nl" + * postalCode = "1083 HS" \ No newline at end of file diff --git a/input/fsh/examples/adalimumab-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/adalimumab-ema-automatic/PackagedProductDefinition.fsh new file mode 100644 index 0000000000..beff330d8a --- /dev/null +++ b/input/fsh/examples/adalimumab-ema-automatic/PackagedProductDefinition.fsh @@ -0,0 +1,40 @@ + +Instance: ppd-2e8a8b1c9142de3ac8de0723812d3fef +InstanceOf: PackagedProductDefinitionUvEpi +Title: "adalimumab" +Description: "adalimumab" +Usage: #example + +* identifier.system = $spor-prod +* identifier.value = "EU/1/16/1157/002" +* identifier.use = #official + +* name = "adalimumab" + +* type = $spor-rms#100000155527 "Chemical Medicinal Prodcut" +//* type = $spor-rms#100000155527 + + +* status = http://hl7.org/fhir/publication-status#active "Active" +* statusDate = "2015-02-07T13:28:17Z" + + +* containedItemQuantity = 3 'ml' + +* description = "Type I colourless glass cartridge with a black plunger (bromobutyl rubber) and a flanged cap (aluminium) with inserted laminated sealing disks (bromobutyl rubber on the medicinal product side and polyisoprene on the outside) containing 3 ml of solution. Each cartridge is assembled into a disposable pen." +* copackagedIndicator = false + + +* packaging + * identifier.system = $spor-prod + * identifier.value = "EU/1/16/1157/002" + * type = $spor-rms#100000073543 "Pre-filled pen" + * quantity = 5 + * material = $spor-rms#200000003204 "Glass type 1" + + + +//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet +* packageFor = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) + // Reference to Organization: MAH +* manufacturer = Reference(org-b4249a5180d23ad521b23e06e99b7afd) diff --git a/input/fsh/examples/biktarvy-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/adalimumab-ema-automatic/RegulatedAuthorization.fsh similarity index 51% rename from input/fsh/examples/biktarvy-ema-automatic/RegulatedAuthorization.fsh rename to input/fsh/examples/adalimumab-ema-automatic/RegulatedAuthorization.fsh index 2627385e0b..08255c5200 100644 --- a/input/fsh/examples/biktarvy-ema-automatic/RegulatedAuthorization.fsh +++ b/input/fsh/examples/adalimumab-ema-automatic/RegulatedAuthorization.fsh @@ -1,37 +1,41 @@ -Instance: authorization14ba4cb05b11f838919ef39edd3e0cdf +Instance: authorization2e8a8b1c9142de3ac8de0723812d3fef InstanceOf: RegulatedAuthorizationUvEpi -Title: "Regulated Authorization for Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -Description: "Regulated Authorization for Biktarvy 50 mg/200 mg/25 mg film-coated tablets" +Title: "Regulated Authorization for adalimumab" +Description: "Regulated Authorization for adalimumab" Usage: #example * identifier.system = $spor-prod -* identifier.value = "EU/1/18/1289/001" +* identifier.value = "EU/1/16/1157/002" * identifier.use = #official // Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet //* subject = Reference(karvea75mgblisterx28) -* subject = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) +* subject = Reference(mp2e8a8b1c9142de3ac8de0723812d3fef) * type = $spor-rms#100000072062 "Marketing Authorisation" //* type = $spor-rms#100000072062 //* type.text = "Marketing Authorisation" -* region = urn:iso:std:iso:3166#eu "European Union" +* region = urn:iso:std:iso:3166#DK "Denmark" * status = http://hl7.org/fhir/publication-status#active "Active" -* statusDate = "2018-06-21T13:28:17Z" +* statusDate = "2017-01-11T13:28:17Z" // * holder = Reference(sanofiaventisgroupe) + + -* holder = Reference(org-715f8a161ed438d0584510e5b4512caa) +* holder = Reference(org-b4249a5180d23ad521b23e06e99b7afd) + + diff --git a/input/fsh/examples/biktarvy-ema-automatic/Substance.fsh b/input/fsh/examples/adalimumab-ema-automatic/Substance.fsh similarity index 100% rename from input/fsh/examples/biktarvy-ema-automatic/Substance.fsh rename to input/fsh/examples/adalimumab-ema-automatic/Substance.fsh diff --git a/input/fsh/examples/biktarvy-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/biktarvy-ema-automatic/AdministrableProductDefinition.fsh deleted file mode 100644 index 5e3910da82..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/AdministrableProductDefinition.fsh +++ /dev/null @@ -1,26 +0,0 @@ - -Instance: ap-14ba4cb05b11f838919ef39edd3e0cdf -InstanceOf: AdministrableProductDefinitionUvEpi -Title: "Administrable product Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -Description: "Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -Usage: #example - -* identifier.system = $phpid -* identifier.value = "EU/1/18/1289/001" - -* status = #active - -* formOf = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* administrableDoseForm = $spor-rms#10219000 "Tablet" -* unitOfPresentation = $spor-rms#nan "nan" - -//this is just manufactured with extra steps? - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* producedFrom = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) - - -* routeOfAdministration.code = $spor-rms#20053000 "Oral use" - -* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/biktarvy-ema-automatic/Bundle.fsh b/input/fsh/examples/biktarvy-ema-automatic/Bundle.fsh deleted file mode 100644 index d71132fa19..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/Bundle.fsh +++ /dev/null @@ -1,96 +0,0 @@ - -Instance: bundlepackageleaflet-63b15a3bb9d18a00ecd0962bc011c765 -InstanceOf: BundleUvEpi -Title: "ePI document Bundle for biktarvy Package Leaflet" -Description: "Bundle for biktarvy Package Leaflet ePI document" -Usage: #example - -* identifier.system = "https://www.gravitatehealth.eu/sid/doc" -* identifier.value = "EU/1/18/1289/001" -* type = #document -* timestamp = "2023-04-18T13:34:01Z" - -// Composition -* entry[0].fullUrl = "Composition/composition1846d2b12fecbbb0310cd8c196c98a58" -* entry[0].resource = composition1846d2b12fecbbb0310cd8c196c98a58 - - - - - - - - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-bictegravirsodium" -* entry[=].resource = ingredient-for-biktarvy-bictegravirsodium - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-emtricitabine" -* entry[=].resource = ingredient-for-biktarvy-emtricitabine - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-tenofoviralafenamide" -* entry[=].resource = ingredient-for-biktarvy-tenofoviralafenamide - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-microcrystallinecellulose" -* entry[=].resource = ingredient-for-biktarvy-microcrystallinecellulose - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-croscarmellosesodium" -* entry[=].resource = ingredient-for-biktarvy-croscarmellosesodium - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-biktarvy-magnesiumstearate" -* entry[=].resource = ingredient-for-biktarvy-magnesiumstearate - - - -// AdministrableProductDefinition - -* entry[+].fullUrl = "AdministrableProductDefinition/ap-14ba4cb05b11f838919ef39edd3e0cdf" -* entry[=].resource = ap-14ba4cb05b11f838919ef39edd3e0cdf - - -// RegulatedAuthorization - -* entry[+].fullUrl = "RegulatedAuthorization/authorization14ba4cb05b11f838919ef39edd3e0cdf" -* entry[=].resource = authorization14ba4cb05b11f838919ef39edd3e0cdf - - -// Organization - -* entry[+].fullUrl = "Organization/org-715f8a161ed438d0584510e5b4512caa" -* entry[=].resource = org-715f8a161ed438d0584510e5b4512caa - -// Organization - -* entry[+].fullUrl = "Organization/org-1133a7374c78f1d40f41885344f06a5a" -* entry[=].resource = org-1133a7374c78f1d40f41885344f06a5a - - -// PackagedProductDefinition - -* entry[+].fullUrl = "PackagedProductDefinition/ppd-bb925abf9dc1f2dd024210a50c0ee14b" -* entry[=].resource = ppd-bb925abf9dc1f2dd024210a50c0ee14b - - -// MedicinalProductDefinition - -* entry[+].fullUrl = "MedicinalProductDefinition/mp5fb1761a0a38bea0a9b49f146371c68b" -* entry[=].resource = mp5fb1761a0a38bea0a9b49f146371c68b - - -// ManufacturedItemDefinition - -* entry[+].fullUrl = "ManufacturedItemDefinition/mid-14ba4cb05b11f838919ef39edd3e0cdf" -* entry[=].resource = mid-14ba4cb05b11f838919ef39edd3e0cdf - - diff --git a/input/fsh/examples/biktarvy-ema-automatic/Composition.fsh b/input/fsh/examples/biktarvy-ema-automatic/Composition.fsh deleted file mode 100644 index d61136048e..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/Composition.fsh +++ /dev/null @@ -1,425 +0,0 @@ - -Instance: composition1846d2b12fecbbb0310cd8c196c98a58 -InstanceOf: CompositionUvEpi -Title: "Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet" -Description: "Composition for Biktarvy 50 mg/200 mg/25 mg film-coated tablets Package Leaflet" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/rmswi/" -* identifier.value = "EU/1/18/1289/001" - -* status = #final - - - - - -* type = https://spor.ema.europa.eu/rmswi/#100000155538 -* type.text = "Package Leaflet" - -* subject = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* date = "2022-02-16T13:28:17Z" -* author = Reference(org-715f8a161ed438d0584510e5b4512caa) - -* title = "TEST PURPOSES ONLY - Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en - - -* section[+]. - * title = "B. Package Leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "B. PACKAGE LEAFLET" - * text.status = #additional - * text.div = """

    Read all of this leaflet carefully before you start taking this medicine because it contains -important information for you.

    -
      -
    • Keep this leaflet. You may need to read it again.
      • -
    • If you have any further questions, ask your doctor or pharmacist.
      • -
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, -even if their signs of illness are the same as yours.
      • -
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side -effects not listed in this leaflet. See section 4.
      • -
    -

    If Biktarvy has been prescribed for your child, please note that all the information in this leaflet -is addressed to your child (in this case please read “your child” instead of “you”).

    """ - - - -* section[=].section[+] - * title = "Package leaflet: Information for the user" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "Package leaflet: Information for the user" - * text.status = #additional - * text.div = """

    Read all of this leaflet carefully before you start taking this medicine because it contains -important information for you.

    -
      -
    • Keep this leaflet. You may need to read it again.
      • -
    • If you have any further questions, ask your doctor or pharmacist.
      • -
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, -even if their signs of illness are the same as yours.
      • -
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side -effects not listed in this leaflet. See section 4.
      • -
    -

    If Biktarvy has been prescribed for your child, please note that all the information in this leaflet -is addressed to your child (in this case please read “your child” instead of “you”).

    """ - - - -* section[=].section[+] - * title = "What is in this leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "What is in this leaflet" - * text.status = #additional - * text.div = """

    What is in this leaflet

    -
      -
    1. What Biktarvy is and what it is used for
      2. -
    2. What you need to know before you take Biktarvy
      3. -
    3. How to take Biktarvy
      4. -
    4. Possible side effects
      5. -
    5. How to store Biktarvy
      6. -
    6. Contents of the pack and other information
      7. -
    """ - - -* section[=].section[+] - * title = "1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "1. What Biktarvy 50 mg/200 mg/25 mg film-coated tablets is and what it is used for" - * text.status = #additional - * text.div = """

    Biktarvy contains three active substances:

    -
      -
    • bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)
      • -
    • emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase -inhibitor (NRTI)
      • -
    • tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse -transcriptase inhibitor (NtRTI)
      • -
    -

    Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in -adults, adolescents and children 2 years of age and older, who weigh at least 14 kg.

    -

    Biktarvy reduces the amount of HIV in your body. This will improve your immune system and reduce -the risk of developing illnesses linked to HIV infection.

    """ - - - -* section[=].section[+] - * title = "2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "2. What you need to know before you take Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * text.status = #additional - * text.div = """

    Do not take Biktarvy

    -
      -
    • If you are allergic to bictegravir, emtricitabine, tenofovir alafenamide or any of the other -ingredients of this medicine (listed in section 6).
      • -

    • If you are currently taking any of the following medicines:

      -
        -
      • rifampicin used to treat some bacterial infections such as tuberculosis
        • -
      • St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and -anxiety, or products that contain it.
        • -
      -
      • -

    • If any of these apply to you, do not take Biktarvy and tell your doctor immediately.

      -
      • -
    -

    Warnings and precautions

    -

    Talk to your doctor before taking Biktarvy:

    -
      -
    • If you have liver problems or a history of liver disease, including hepatitis. Patients with -liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a -higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, -your doctor will carefully consider the best treatment regimen for you.
      • -

    • If you have hepatitis B infection. Liver problems may become worse after you stop taking -Biktarvy.

      -
      • -

    • Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first. For more details, see -section 3, Do not stop taking Biktarvy.

      -
      • -

    • If you have had kidney disease or if tests have shown problems with your kidneys. Your -doctor may order blood tests to monitor how your kidneys work when starting and during -treatment with Biktarvy.

      -
      • -
    -

    While you are taking Biktarvy

    -

    Once you start taking Biktarvy, look out for:

    -
      -
    • Signs of inflammation or infection
      • -
    • Joint pain, stiffness or bone problems
      • -
    -

    If you notice any of these symptoms, tell your doctor immediately. For more information see -section 4, Possible side effects.

    -

    There is a possibility that you may experience kidney problems when taking Biktarvy over a long -period of time (see Warnings and precautions).

    -

    This medicine is not a cure for HIV infection. While taking Biktarvy you may still develop infections -or other illnesses associated with HIV infection.

    -

    Children and adolescents

    -

    Do not give this medicine to children under 2 years of age, or weighing less than 14 kg regardless -of age. The use of Biktarvy in children under 2 years of age, or weighing less than 14 kg has not yet -been studied. For children and adolescents who weigh 25 kg or more, Biktarvy 50 mg/200 mg/25 mg -film-coated tablets are available.

    -

    Loss of bone mass has been reported in some children from 3 to less than 12 years of age who -received one of the medicinal products (tenofovir alafenamide) contained in Biktarvy. The effects on -long term bone health and future fracture risk in children is uncertain. Your doctor will monitor your -child’s bone health as needed.

    -

    Other medicines and Biktarvy

    -

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other -medicines. Biktarvy may interact with other medicines. As a result, the amounts of Biktarvy or other -medicines in your blood may change. This may stop your medicines from working properly, or may -make any side effects worse. In some cases, your doctor may need to adjust your dose or check your -blood levels.

    -

    Medicines that must never be taken with Biktarvy:

    -
      -
    • rifampicin used to treat some bacterial infections such as tuberculosis
      • -
    • St. John’s wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or -products that contain it.
      • -
    • If you are taking any of these medicines, do not take Biktarvy and tell your doctor immediately.
      • -
    -

    Talk to your doctor if you are taking:

    -
      -
    • medicines used for treating HIV and/or hepatitis B, containing:
        -
      • adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir -alafenamide, or tenofovir disoproxil
        • -
      -
      • -
    • antibiotics used to treat bacterial infections, containing:
        -
      • azithromycin, clarithromycin, rifabutin or rifapentine
        • -
      -
      • -
    • anticonvulsants used to treat epilepsy, containing:
        -
      • carbamazepine, oxcarbazepine, phenobarbital or phenytoin
        • -
      -
      • -
    • immunosuppressants used to control your body’s immune response after a transplant, -containing ciclosporin
      • -

    • ulcer-healing medicines containing sucralfate

      -
      • -

    • Tell your doctor if you are taking any of these medicines. Do not stop your treatment without -contacting your doctor.

      -
      • -
    -

    Get advice from a doctor or pharmacist if you are taking:

    -
      -
    • antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or -magnesium hydroxide
      • -
    • mineral supplements or vitamins containing magnesium or iron
      • -
    • Get advice from your doctor or pharmacist before taking Biktarvy if you are taking any of -these medicines.
      • -
    -

    Antacids and magnesium supplements: you will need to take Biktarvy at least 2 hours before -antacids or supplements containing aluminium and/or magnesium. Or you can take Biktarvy with -food at least 2 hours after.

    -

    Iron supplements: you will need to take Biktarvy at least 2 hours before iron supplements, or you -can take them together with food.

    -

    Pregnancy and breast-feeding

    -
      -
    • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, -ask your doctor or pharmacist for advice before taking this medicine.
      • -
    • Tell your doctor immediately if you become pregnant and ask about the potential benefits and -risks of your antiretroviral therapy to you and your child.
      • -
    -

    If you have taken Biktarvy during your pregnancy, your doctor may request regular blood tests and -other diagnostic tests to monitor the development of your child. In children whose mothers took -nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection -against HIV outweighed the risk of side effects.

    -

    Do not breast-feed during treatment with Biktarvy. This is because some of the active substances -in this medicine pass into human breast milk. Breast-feeding is not recommended in women living -with HIV because HIV infection can be passed on to the baby in breast milk. If you are -breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as -possible.

    -

    Driving and using machines

    -

    Biktarvy can cause dizziness. If you feel dizzy when taking Biktarvy, do not drive or ride a bicycle -and do not use any tools or machines.

    -

    Biktarvy contains sodium

    -

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially -‘sodium-free’.

    """ - -* section[=].section[+] - * title = "3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "3. How to take Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * text.status = #additional - * text.div = """

    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist -if you are not sure.

    -

    There are two strengths of Biktarvy tablets. Your doctor will prescribe the appropriate tablet for your -age and weight.

    -

    The recommended dose is:

    -

    Children 2 years of age and older, who weigh at least 14 kg but less than 25 kg: one tablet each -day with or without food (one 30 mg/120 mg/15 mg tablet).

    -

    Due to the bitter taste, it is recommended not to chew or crush the tablet. -If you have difficulty swallowing the tablet whole, you can split it in half. Take both halves of the -tablet one after the other to get the full dose. Do not store the split tablet.

    -

    The score line on the tablet is only there to help you break the tablet if your child has difficulty -swallowing it whole.

    -

    The 90-day multipack contains three 30-day packs together.

    -
      -
    • Get advice from a doctor or pharmacist if you are taking:
      • -
    • antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or -magnesium hydroxide
      • -
    • mineral supplements or vitamins containing magnesium or iron
      • -
    • See section 2 for more information on taking these medicines with Biktarvy.
      • -
    -

    If you are on dialysis, take your daily dose of Biktarvy following completion of dialysis.

    -

    If you take more Biktarvy than you should

    -

    If you take more than the recommended dose of Biktarvy you may be at higher risk of side effects of -this medicine (see section 4, Possible side effects). -Contact your doctor or nearest emergency department immediately for advice. Keep or take the tablet -bottle or carton with you so that you can easily describe what you have taken.

    -

    If you forget to take Biktarvy

    -

    It is important not to miss a dose of Biktarvy.

    -

    If you miss a dose:

    -
      -
    • If you notice within 18 hours of the time you usually take Biktarvy, you must take the tablet as -soon as possible. Then take the next dose as usual.
      • -
    • If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the -missed dose. Wait and take the next dose at your usual time.
      • -
    -

    If you vomit less than 1 hour after taking Biktarvy, take another tablet. If you vomit more than 1 hour -after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.

    -

    Do not stop taking Biktarvy

    -

    Do not stop taking Biktarvy without talking to your doctor. Stopping Biktarvy can seriously affect -how future treatment works. If Biktarvy is stopped for any reason, speak to your doctor before you -restart taking Biktarvy tablets.

    -

    When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist. This is -very important because the amount of virus may start to increase if the medicine is stopped for even a -short time. The disease may then become harder to treat.

    -

    If you have both HIV infection and hepatitis B, it is especially important not to stop your Biktarvy -treatment without talking to your doctor first. You may require blood tests for several months after -stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is -not recommended as this may lead to worsening of your hepatitis, which may be life-threatening.

    -
      -
    • Tell your doctor immediately about new or unusual symptoms after you stop treatment, -particularly symptoms you associate with hepatitis B infection. -If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
      • -
    """ - - -* section[=].section[+] - * title = "4. Possible side effects" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "4. Possible side effects" - * text.status = #additional - * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    -

    Possible side effects: tell a doctor immediately

    -
      -
    • Any signs of inflammation or infection. In some patients with advanced HIV infection -(AIDS) and a history of opportunistic infections (infections that occur in people with a weak -immune system), signs and symptoms of inflammation from previous infections may occur soon -after HIV treatment is started. It is thought that these symptoms are due to an improvement in -the body’s immune response, enabling the body to fight infections that may have been present -with no obvious symptoms.
      • -
    • Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur -after you start taking medicines for HIV infection. Autoimmune disorders may occur many -months after the start of treatment. Look out for any symptoms of infection or other symptoms -such as:
        -
      • muscle weakness
        • -
      • weakness beginning in the hands and feet and moving up towards the trunk of the body
        • -
      • palpitations, tremor or hyperactivity
        • -
      -
      • -
    • If you notice these or any symptoms of inflammation or infection, tell your doctor -immediately.
      • -
    -

    Common side effects -(may affect up to 1 in 10 people)

    -
      -
    • depression
      • -
    • abnormal dreams
      • -
    • headache
      • -
    • dizziness
      • -
    • diarrhoea
      • -
    • feeling sick (nausea)
      • -
    • tiredness (fatigue)
      • -
    -

    Uncommon side effects

    -

    (may affect up to 1 in 100 people)

    -
      -
    • anaemia
      • -
    • vomiting
      • -
    • stomach pain
      • -
    • problems with digestion resulting in discomfort after meals (dyspepsia)
      • -
    • wind (flatulence)
      • -
    • swelling of the face, lips, tongue or throat (angioedema)
      • -
    • itching (pruritus)
      • -
    • rash
      • -
    • hives (urticaria)
      • -
    • joint pain (arthralgia)
      • -
    • suicidal thoughts and suicide attempt (particularly in patients who have had depression or -mental health problems before)
      • -
    • anxiety
      • -
    • sleep disorders -Blood tests may also show:
      • -
    • higher levels of substances called bilirubin and/or serum creatinine in the blood
      • -
    -

    Rare side effects

    -

    (may affect up to 1 in 1000 people)

    -
      -
    • Stevens-Johnson syndrome (SJS) is a serious life-threatening condition which usually starts -with flu- like symptoms. A few days later other symptoms appear including:
        -
      • Painful red or purple skin that looks burned and peels off
        • -
      • Blisters on your skin, mouth, nose, and genitals
        • -
      • Red, painful, watery eyes
        • -
      -
      • -
    • If you have any of these symptoms, stop your medicine immediately and tell your doctor -straight away.
      • -
    • If any of the side effects get serious, tell your doctor.
      • -
    -

    Other effects that may be seen during HIV treatment

    -

    The frequency of the following side effects is not known (frequency cannot be estimated from the -available data).

    -
      -
    • Bone problems. Some patients taking combination antiretroviral medicines such as Biktarvy -may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood -supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, -drinking alcohol, having a very weak immune system, and being overweight, may be some of -the many risk factors for developing this disease. Signs of osteonecrosis are:
        -
      • joint stiffness
        • -
      • joint aches and pains (especially of the hip, knee and shoulder)
        • -
      • difficulty with movement
        • -
      -
      • -
    • If you notice any of these symptoms tell your doctor.
      • -
    -

    During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This -is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV -medicines themselves. Your doctor will test for these changes.

    -

    Reporting of side effects -If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects -not listed in this leaflet. You can also report side effects directly via the national reporting system -listed in Appendix V. By reporting side effects you can help provide more information on the safety -of this medicine.

    """ - -* section[=].section[+] - * title = "5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "5. How to store Biktarvy 50 mg/200 mg/25 mg film-coated tablets" - * text.status = #additional - * text.div = """

    Keep this medicine out of the sight and reach of children.

    -

    Do not use this medicine after the expiry date which is stated on the carton and bottle or blister strips -after {EXP}. The expiry date refers to the last day of that month.

    -

    Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not -use if the seal over the bottle opening is broken or missing.

    -

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to -throw away medicines you no longer use. These measures will help protect the environment.

    """ - - -* section[=].section[+] - * title = "6. Contents of the pack and other information" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "6. Contents of the pack and other information" - * text.status = #additional - * text.div = """

    What Biktarvy contains

    -

    The active substances are bictegravir, emtricitabine and tenofovir alafenamide. Each Biktarvy tablet -contains bictegravir sodium equivalent to 30 mg of bictegravir, 120 mg of emtricitabine and tenofovir -alafenamide fumarate equivalent to 15 mg of tenofovir alafenamide.

    -

    The other ingredients areTablet coreMicrocrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E470b).

    -

    Film-coatingPolyvinyl alcohol (E203), titanium dioxide (E171), macrogol (E1521), talc (E553b), iron oxide red -(E172), iron oxide black (E172).

    -

    What Biktarvy looks like and contents of the pack

    -

    Biktarvy 30 mg/120 mg/15 mg film-coated tablets are pink, capsule-shaped, film-coated tablets, -debossed with “BVY” on one side and a score line on the other side of the tablet.

    -

    The tablets are supplied in a bottle. Not all pack sizes may be marketed.

    -

    Biktarvy comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets. -Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. -The silica gel desiccant is contained in a separate sachet or canister and should not be swallowed.

    """ - diff --git a/input/fsh/examples/biktarvy-ema-automatic/Ingredient.fsh b/input/fsh/examples/biktarvy-ema-automatic/Ingredient.fsh deleted file mode 100644 index 85799077e3..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/Ingredient.fsh +++ /dev/null @@ -1,192 +0,0 @@ - -Instance: ingredient-for-biktarvy-bictegravirsodium -InstanceOf: IngredientUvEpi -Title: "Ingredient-active BICTEGRAVIR SODIUM" -Description: "BICTEGRAVIR SODIUM" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "4L5MP1Y7W7" -* identifier.use = #official - -* role = $spor-rms#72072 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#4L5MP1Y7W7 "BICTEGRAVIR SODIUM" - - -* substance.strength.presentationQuantity = 50.0 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) - -Instance: ingredient-for-biktarvy-emtricitabine -InstanceOf: IngredientUvEpi -Title: "Ingredient-active Emtricitabine" -Description: "Emtricitabine" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "G70B4ETF4S" -* identifier.use = #official - -* role = $spor-rms#72072 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#G70B4ETF4S "Emtricitabine" - - -* substance.strength.presentationQuantity = 200.0 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) - -Instance: ingredient-for-biktarvy-tenofoviralafenamide -InstanceOf: IngredientUvEpi -Title: "Ingredient-active tenofovir alafenamide" -Description: "tenofovir alafenamide" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "EL9943AG5J" -* identifier.use = #official - -* role = $spor-rms#72072 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#EL9943AG5J "tenofovir alafenamide" - - -* substance.strength.presentationQuantity = 25.0 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) - -Instance: ingredient-for-biktarvy-microcrystallinecellulose -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Microcrystalline cellulose" -Description: "Microcrystalline cellulose" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "OP1R32D61U" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#OP1R32D61U "Microcrystalline cellulose" - - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) - -Instance: ingredient-for-biktarvy-croscarmellosesodium -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Croscarmellose sodium" -Description: "Croscarmellose sodium" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "M28OL1HH48" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#M28OL1HH48 "Croscarmellose sodium" - - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) - -Instance: ingredient-for-biktarvy-magnesiumstearate -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Magnesium stearate" -Description: "Magnesium stearate" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "70097M6I30" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#70097M6I30 "Magnesium stearate" - - - -// Reference to products -* for = Reference(mid-14ba4cb05b11f838919ef39edd3e0cdf) -* for[+] = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) -* for[+] = Reference(ap-14ba4cb05b11f838919ef39edd3e0cdf) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) diff --git a/input/fsh/examples/biktarvy-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/biktarvy-ema-automatic/ManufacturedItemDefinition.fsh deleted file mode 100644 index 6d69d222f9..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/ManufacturedItemDefinition.fsh +++ /dev/null @@ -1,24 +0,0 @@ - -Instance: mid-14ba4cb05b11f838919ef39edd3e0cdf -InstanceOf: ManufacturedItemDefinitionUvEpi -Title: "Manufactured item Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -Description: "Biktarvy 50 mg/200 mg/25 mg film-coated tablets" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" -* identifier.value = "EU/1/18/1289/001" -* identifier.use = #official - -* status = #active -* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000073665 "tablet" - -* unitOfPresentation = $spor-rms#200000002152 "Tablet" - - - - - - - - -* manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) \ No newline at end of file diff --git a/input/fsh/examples/biktarvy-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/biktarvy-ema-automatic/MedicinalProductDefinition.fsh deleted file mode 100644 index 94828ce158..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/MedicinalProductDefinition.fsh +++ /dev/null @@ -1,54 +0,0 @@ - -Instance: mp5fb1761a0a38bea0a9b49f146371c68b -InstanceOf: MedicinalProductDefinitionUvEpi -Title: "Medicinal Product Remsima 100 Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion" -Description: "Remsima 100 Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion" -Usage: #example - - -* identifier[+].system = "https://spor.ema.europa.eu/pmswi" -* identifier[=].value = "EU/1/18/1289/001" -* identifier[+].system = "https://www.who-umc.org/phpid" -* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E827gy" -* type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" - -* domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" - -* status = http://hl7.org/fhir/publication-status#active "active" - - - - - -* legalStatusOfSupply = $spor-rms#100000072084 "Medicinal product subject to medical prescription" - - -* name - * productName = "Remsima 100 Biktarvy 50 mg/200 mg/25 mg film-coated tabletsmg powder for concentrate for solution for infusion" - * type = $spor-productNamePartType-cs#220000000001 - * text = "Full name" - - * part[0] - * part = "Biktarvy" - * type = $spor-productNamePartType-cs#220000000002 - * type.text = "Invented name part" - - * part[+] - * part = "bictegravir/emtricitabine/tenofovir alafenamide" - * type = $spor-productNamePartType-cs#220000000003 - * type.text = "Scientific name part" - - * part[+] - * part = "50 mg/200 mg/25 mg" - * type = $spor-productNamePartType-cs#220000000004 - * type.text = "Strength part" - - * part[+] - * part = "film-coated tablets" - * type = $spor-productNamePartType-cs#220000000005 - * type.text = "Pharmaceutical dose form part" - - * usage - * country = urn:iso:std:iso:3166#eu "" - * jurisdiction = urn:iso:std:iso:3166#eu "" - * language = urn:ietf:bcp:47#eu "English" \ No newline at end of file diff --git a/input/fsh/examples/biktarvy-ema-automatic/Organization.fsh b/input/fsh/examples/biktarvy-ema-automatic/Organization.fsh deleted file mode 100644 index 11a9446539..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/Organization.fsh +++ /dev/null @@ -1,59 +0,0 @@ - - - - -Instance: org-715f8a161ed438d0584510e5b4512caa - -InstanceOf: OrganizationUvEpi -Title: "Gilead Sciences Ireland UC as Marketing authorisation holder" -Description: "Gilead Sciences Ireland UC as Marketing authorisation holder" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "ORG-100008368" -* identifier.use = #official - -* active = true - -* type = $spor-rms#220000000034 "Marketing authorisation holder" -* type.text = "Marketing authorisation holder" -* name = "Gilead Sciences Ireland UC" - -* contact - * address - * text = "Carrigtohill, County Cork, T45 County Cork IR" - * use = #work - * type = #physical - * line = "Carrigtohill, County Cork, T45" - * city = "County Cork" - * country = "IR" - - - - -Instance: org-1133a7374c78f1d40f41885344f06a5a - -InstanceOf: OrganizationUvEpi -Title: "European Medicines Agency as Medicines Regulatory Authority" -Description: "European Medicines Agency as Medicines Regulatory Authority" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "ORG-100013412" -* identifier.use = #official - -* active = true - -* type = $spor-rms#220000000032 "Medicines Regulatory Authority" -* type.text = "Medicines Regulatory Authority" -* name = "European Medicines Agency" - -* contact - * address - * text = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL" - * use = #work - * type = #physical - * line = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est" - * city = "Amsterdam" - * country = "NL" - * postalCode = "1083 HS" \ No newline at end of file diff --git a/input/fsh/examples/biktarvy-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/biktarvy-ema-automatic/PackagedProductDefinition.fsh deleted file mode 100644 index cb07e27c44..0000000000 --- a/input/fsh/examples/biktarvy-ema-automatic/PackagedProductDefinition.fsh +++ /dev/null @@ -1,40 +0,0 @@ - -Instance: ppd-bb925abf9dc1f2dd024210a50c0ee14b -InstanceOf: PackagedProductDefinitionUvEpi -Title: "Biktarvy 50 mg/200 mg/25 mg film-coated tablets 90 (3 bottles of 30) film-coated tablets" -Description: "Biktarvy 50 mg/200 mg/25 mg film-coated tablets 90 (3 bottles of 30) film-coated tablets" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "EU/1/18/1289/001" -* identifier.use = #official - -* name = "Biktarvy 50 mg/200 mg/25 mg film-coated tablets 90 (3 bottles of 30) film-coated tablets" - -* type = $spor-rms#100000155527 "Chemical Medicinal Prodcut" -//* type = $spor-rms#100000155527 - - -* status = http://hl7.org/fhir/publication-status#active "Active" -* statusDate = "2012-02-07T13:28:17Z" - - -* containedItemQuantity = 90 'tablets' - - - - - -* packaging - * identifier.system = $spor-prod - * identifier.value = "654321" - * type = $spor-rms#100000073504 "Child-resistant closure" - * quantity = 1 - * material = $spor-rms#200000003529 "Cardboard" - - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* packageFor = Reference(mp5fb1761a0a38bea0a9b49f146371c68b) - // Reference to Organization: MAH -* manufacturer = Reference(org-715f8a161ed438d0584510e5b4512caa) diff --git a/parkingLot/biktarvy.fsh b/input/fsh/examples/biktarvy.fsh similarity index 50% rename from parkingLot/biktarvy.fsh rename to input/fsh/examples/biktarvy.fsh index cfb36bb7ca..5a676d57be 100644 --- a/parkingLot/biktarvy.fsh +++ b/input/fsh/examples/biktarvy.fsh @@ -2,6 +2,175 @@ // Project: Biktarvy V2 (id1665505010977) // View: Initial view +Instance: cfsb1665505019066 +InstanceOf: RegulatedAuthorization +Description: "RegulatedAuthorization1" +Usage: #example + +* identifier.system = "$spor-prod" +* identifier.value = "EU/1/18/1289/001" +* identifier.use = #official + +* type = $spor-rms#100000072062 +* type.text = "Marketing Authorisation" + +* region = urn:iso:std:iso:3166#eu +* region.text = "European Union" + +* status = http://hl7.org/fhir/publication-status#active +* status.text = "Active" + +* statusDate = "2018-06-21T13:28:17Z" +//reference to Marketing Authorization Holder +* holder = Reference(cfsb1665505132093) + +//reference to Regulator +* regulator = Reference(cfsb1665505181936) + + +Instance: cfsb1665505132093 +InstanceOf: Organization +Description: "Marketing Authorization Holder" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100008368" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000034 "Marketing authorisation holder" +* type.text = "Marketing authorisation holder" +* name = "Gilead Sciences Ireland UC" + +* contact.address.text = "Carrigtohill, County Cork, T45 DP77 Ireland" +* contact.address.use = #work +* contact.address.type = #physical +* contact.address.line = "Carrigtohill, County Cork, T45" +* contact.address.city = "County Cork" +* contact.address.country = "IR" + +Instance: cfsb1665505181936 +InstanceOf: Organization +Description: "Regulator" +Usage: #example + +* identifier.system = $spor-org +* identifier.value = "ORG-100013412" +* identifier.use = #official + +* identifier[1].system = $spor-org +* identifier[1].value = "LOC-100020264" +* identifier[1].use = #official + + + +* active = true + + +* type = https://spor.ema.europa.eu/rmswi/#/#220000000032 +* type.text = "Medicines Regulatory Authority" + +* name = "European Medicines Agency" +* contact.address.text = "Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands" +* contact.address.use = #work +* contact.address.type = #physical +* contact.address.line = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est" +* contact.address.postalCode = "1083 HS" +* contact.address.city = "Amsterdam" +* contact.address.country = "nl" + +Instance: cfsb1665505232916 +InstanceOf: Ingredient +Description: "Bictegravir" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "4L5MP1Y7W7" +* identifier.use = #official + +* status = #active + +* role = https://spor.ema.europa.eu/rmswi/#00000072072 +* role.text = "active" + + + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#4L5MP1Y7W7 "BICTEGRAVIR SODIUM" + +* substance.strength.presentationQuantity.value = 50 + +* substance.strength.presentationQuantity.unit = "mg" + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB + +* substance.strength.basis.text = "active ingredient - basis of strength" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1665505279685 +InstanceOf: Ingredient +Description: "Embtricitabine" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "G70B4ETF4S" +* identifier.use = #official + +* status = #active + +* role = https://spor.ema.europa.eu/rmswi/#100000072072 "active" + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#G70B4ETF4S "Emtricitabine" + +* substance.strength.presentationQuantity = 200 'mg' +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB + +* substance.strength.basis.text = "active ingredient - basis of strength" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1665505991728 +InstanceOf: MedicinalProductDefinition +Description: "EU/1/18/1289/001" +Usage: #example + +* identifier.system = "$spor-prod" +* identifier.value = "11102022" + +* type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" + +* domain = http://hl7.org/fhir/medicinal-product-domain#Human +* domain.text = "Human use" + +* status = http://hl7.org/fhir/publication-status#active "Active" + +* legalStatusOfSupply = $spor-rms#100000072084 +* legalStatusOfSupply.text = "Medicinal product subject to medical prescription" + +* name.productName = "Biktarvy 50 mg/200 mg/25 mg film-coated tablets" +* name.type = $spor-rms#220000000001 "Full name" +* name.usage.country = urn:iso:std:iso:3166#eu "European Union" + +* name.usage.jurisdiction = urn:iso:std:iso:3166#eu "European Union" + +* name.usage.language = urn:ietf:bcp:47#en "English" + +* name.part[+].part = "Biktarvy" +* name.part[=].type = $spor-rms#220000000002 "Invented name part" + +* name.part[+].part = "bictegravir/emtricitabine/tenofovir alafenamide" +* name.part[=].type = $spor-rms#220000000003 "Scientific name part" + +* name.part[+].part = "50 mg/200 mg/25 mg" +* name.part[=].type = $spor-rms#220000000004 "Strength part" + +* name.part[+].part = "film-coated tablets" +* name.part[=].type = $spor-rms#220000000005 "Pharmaceutical dose form part" Instance: cfsb1665507846505 InstanceOf: AdministrableProductDefinition @@ -32,8 +201,147 @@ Usage: #example +Instance: cfsb1666195266647 +InstanceOf: Ingredient +Description: "tenofovir alafenamide" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "EL9943AG5J" +* identifier.use = #official + +* status = #active + +* role = https://spor.ema.europa.eu/rmswi/#100000072072 "active" + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#EL9943AG5J "tenofovir alafenamide" + +* substance.strength.presentationQuantity.value = 25 + +* substance.strength.presentationQuantity.unit = "mg" + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB + +* substance.strength.basis.text = "active ingredient - basis of strength" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1666197397224 +InstanceOf: Ingredient +Description: "Microcrystalline cellulose" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "OP1R32D61U" +* identifier.use = #official + +* role = https://spor.ema.europa.eu/rmswi/#100000072082 +* role.text = "Excipient" + +* status = #active + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#OP1R32D61U "Microcrystalline cellulose" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1666197441225 +InstanceOf: Ingredient +Description: "Croscarmellose sodium" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "M28OL1HH48" +* identifier.use = #official + +* role = https://spor.ema.europa.eu/rmswi/#100000072082 +* role.text = "Excipient" + +* status = #active + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#M28OL1HH48 "Croscarmellose sodium" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1666197470356 +InstanceOf: Ingredient +Description: "Magnesium stearate" +Usage: #example + +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" +* identifier.value = "70097M6I30" +* identifier.use = #official + +* role = https://spor.ema.europa.eu/rmswi/#100000072082 +* role.text = "Excipient" + +* status = #active + +* substance.code.concept.coding = https://gsrs.ncats.nih.gov/ginas/app/beta/#70097M6I30 "Magnesium stearate" + +//reference to EU/1/18/1289/001 +* for = Reference(cfsb1665505991728) + + +Instance: cfsb1667576615115 +InstanceOf: ManufacturedItemDefinition +Description: "Biktarvy 50 mg/200 mg/25 mg film-coated tablets" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" +* identifier.value = "EU/1/18/1289/001" +* identifier.use = #official + +* status = #active +* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000073665 +* manufacturedDoseForm.text = "tablet" + +* unitOfPresentation = $spor-rms#200000002152 +* unitOfPresentation.text = "Tablet" + +//reference to Marketing Authorization Holder +* manufacturer = Reference(cfsb1665505132093) + + + + +Instance: cfsb1667580052450 +InstanceOf: PackagedProductDefinition +Description: "90 (3 bottles of 30) film-coated tablets" +Usage: #example + +* identifier.system = $spor-prod +* identifier.value = "EU/1/18/1289/001" +* identifier.use = #official + +* name = "Biktarvy 50 mg/200 mg/25 mg film-coated tablets" + +* type = $spor-rms#100000155527 +* type.text = "Chemical Medicinal Prodcut" + +* status = http://hl7.org/fhir/publication-status#active "Active" +* statusDate = "2012-02-07T13:28:17Z" + +* containedItemQuantity.value = 90 +* containedItemQuantity.unit = "tablets" + +* packaging.identifier.system = $spor-prod +* packaging.identifier.value = "654321" +* packaging.type = $spor-rms#100000073504 "Child-resistant closure" +* packaging.quantity = 1 +* packaging.material = $spor-rms#200000003529 "Cardboard" + +// Reference to Organization: Marketing Authorization Holder +* manufacturer = Reference(cfsb1665505132093) +//reference to EU/1/18/1289/001 +* packageFor = Reference(cfsb1665505991728) diff --git a/input/fsh/examples/calcio_vitamina_d-ema-automatic/Bundle.fsh b/input/fsh/examples/calcio_vitamina_d-ema-automatic/Bundle.fsh index 7c35f379cf..c46c2b1c00 100644 --- a/input/fsh/examples/calcio_vitamina_d-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/calcio_vitamina_d-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "xx" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/composition02e928f15b7b861b4b44915d9f1330ec" diff --git a/input/fsh/examples/calcio_vitamina_d-ema-automatic/Composition.fsh b/input/fsh/examples/calcio_vitamina_d-ema-automatic/Composition.fsh index 6c2668ca97..358553a01a 100644 --- a/input/fsh/examples/calcio_vitamina_d-ema-automatic/Composition.fsh +++ b/input/fsh/examples/calcio_vitamina_d-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-b7afabe350ac415f70e662ba6c703030) * title = "TEST PURPOSES ONLY - CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #es + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,8 +42,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Prospecto: información para el usuario

     

    Calcio/Vitamina D3 ROVI 1000 mg / 880 UI comprimidos efervescentes

    @@ -56,19 +55,15 @@ Usage: #example

    -Si tiene alguna duda, consulte a su médico o farmacéutico.

    -Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles.

    -Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.

    -
    """ - - - - +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Contenido del prospecto

    1. Qué es Calcio/Vitamina D3 ROVI y para qué se utiliza
      2. @@ -78,33 +73,26 @@ Usage: #example
    2. Conservación de Calcio/Vitamina D3 ROVI
    3. Contenido del envase e información adicional
    -
    """ - - - +
    """ * section[=].section[+] * title = "1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES is and what it is used for" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Calcio/Vitamina D3 ROVI son comprimidos efervescentes. Se presentan en envases con 30 comprimidos.

    Este medicamento es una asociación de calcio y vitamina D que está indicada para la corrección de la deficiencia combinada de vitamina D y calcio en pacientes de edad avanzada así como suplemento de vitamina D y calcio como coadyuvante a la terapia específica para el tratamiento de la osteoporosis en pacientes con deficiencia o con alto riesgo de deficiencia combinada de vitamina D y calcio.

    -
    """ - - - - - +
    """ * section[=].section[+] * title = "2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * text.status = #additional - - * text.div = """

    No tome Calcio/Vitamina D3 ROVI:

    + + + * text.div = """

    No tome Calcio/Vitamina D3 ROVI:

     

      @@ -168,17 +156,14 @@ Usage: #example

      Este medicamento contiene lactosa. Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

       

      Este medicamento contiene glucosa (en maltodextrina procedente de maíz). Si su médico le ha indicado que padece una intolerancia a ciertos azúcares, consulte con él antes de tomar este medicamento.

      -
    """ - - - +
    """ * section[=].section[+] * title = "3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Siga exactamente las instrucciones de administración de este medicamento  indicadas por su médico o farmacéutico. En caso de duda, consulte de nuevo a su médico o farmacéutico.

     

    Dosis

    @@ -210,9 +195,7 @@ Usage: #example

    Si interrumpe el tratamiento con Calcio/Vitamina D3 ROVI

     

    Si tiene cualquier otra duda sobre el uso de este medicamento, pregunte a su médico o farmacéutico.

    -
    """ - - +
    """ * section[=].section[+] @@ -220,8 +203,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran.

     

    -Poco frecuentes (pueden afectar a entre 1 y 10 de cada 1.000 pacientes ):

    @@ -248,17 +231,15 @@ Usage: #example

     

    Comunicación de efectos adversos

    Si experimenta cualquier tipo de efecto adverso, consulte a su médico o farmacéutico, incluso si se trata de posibles efectos adversos que no aparecen en este prospecto. También puede comunicarlos directamente a través Sistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. Mediante la comunicación de efectos adversos usted puede contribuir a proporcionar más información sobre la seguridad de este medicamento.

    -
    """ - - +
    """ * section[=].section[+] * title = "5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store CALCIO/VITAMINA D3 ROVI 1000 mg/880 UI COMPRIMIDOS EFERVESCENTES" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Mantener este medicamento fuera de la vista y del alcance de los niños.

     

    Conservar en el envase original para protegerlo de la humedad.

    @@ -266,18 +247,15 @@ Usage: #example

    No utilice este medicamento después de la fecha de caducidad que aparece en el envase después de CAD. La fecha de caducidad es el último día del mes que se indica.

     

    Los medicamentos no se deben tirar por los desagües ni a la basura. Deposite los envases y los medicamentos que no necesita en el Punto SIGRE de la farmacia. En caso de duda pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que no necesita. De esta forma, ayudará a proteger el medio ambiente

    -
    """ - - - +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Composición de Calcio/Vitamina D3 ROVI

     

    -Los principios activos son: carbonato de calcio y concentrado de colecalciferol (en forma de polvo). Cada comprimido contiene 2500 mg de carbonato de calcio (equivalente a 1.000 mg de calcio) y 22 microgramos de concentrado de colecalciferol en forma de polvo (equivalente a 880 UI de colecalciferol = vitamina D3).

    @@ -306,7 +284,4 @@ Usage: #example

    La información detallada de este medicamento está disponible en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) (https://www.aemps.gob.es/)

    -
    """ - - - +
    """ \ No newline at end of file diff --git a/input/fsh/examples/cava-ema/BundlecavaEpi.fsh b/input/fsh/examples/cava-ema/BundlecavaEpi.fsh new file mode 100644 index 0000000000..d4d32b9c94 --- /dev/null +++ b/input/fsh/examples/cava-ema/BundlecavaEpi.fsh @@ -0,0 +1,103 @@ +Instance: bundlepackageleaflet75 +InstanceOf: BundleUvEpi +Title: "ePI document Bundle for cava 75 mg Package Leaflet" +Description: "Bundle for cava Package Leaflet ePI document" +Usage: #example + +* identifier.system = "https://www.gravitatehealth.eu/sid/doc" +* identifier.value = "EU/1/96/007/035" +* type = #document +* timestamp = "2018-06-23T08:38:00+02:00" + +// Composition 0 +* entry[0].fullUrl = "urn:uuid:e63f72b2-993f-48b1-b7cb-539b1ed71571" +* entry[0].resource = compositioncava75 + +// Organizations +* entry[+].fullUrl = "urn:uuid:d71bf884-90eb-47f9-81b7-fa81ecec7e75" +* entry[=].resource = acmeinc + +// authorizations +* entry[+].fullUrl = "urn:uuid:297e405a-b6f9-4273-bc01-ae031efe47f8" +* entry[=].resource = authorizationcava75 + +// medicinal products 3 +* entry[+].fullUrl = "urn:uuid:800a51a2-d81d-49a4-a4eb-f2417d301837" +* entry[=].resource = cava75mgblisterx28 + +// packaged product 4 +* entry[+].fullUrl = "urn:uuid:eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d" +* entry[=].resource = packagebottlex28 + +// administrable product 5 +* entry[+].fullUrl = "urn:uuid:373b9bf3-1fae-47a1-a7cd-230106def069" +* entry[=].resource = adminproductcava75 + +// manufactured items 6 +* entry[+].fullUrl = "urn:uuid:3214f286-b8ec-4ef5-bc8d-0aec39d97468" +* entry[=].resource = manitemcava75 + +// ingredients 7 +* entry[+].fullUrl = "urn:uuid:09c13040-8fd5-4818-972d-f01d4ee169b6" +* entry[=].resource = Silicondioxide + +// 8 +* entry[+].fullUrl = "urn:uuid:745c01bc-936e-45ca-9880-57e97608f43e" +* entry[=].resource = irbesartan + +// 9 +* entry[+].fullUrl = "urn:uuid:a4b7b60c-998f-4f93-89c7-860396af0fe3" +* entry[=].resource = carnaubawax + +//10 +* entry[+].fullUrl = "urn:uuid:fbf58407-83d3-42db-be3d-506b2006d431" +* entry[=].resource = Croscarmellosesodium + +// 11 +* entry[+].fullUrl = "urn:uuid:1c10b441-6bd3-40b8-b14b-514e7c2f79d0" +* entry[=].resource = Hypromellose + +// 12 +* entry[+].fullUrl = "urn:uuid:7a3c0b14-2473-4541-9e45-a24d24cceddf" +* entry[=].resource = lactosemonohydrate + +// 13 +* entry[+].fullUrl = "urn:uuid:ceba5cd1-321f-4bc3-b203-92d97fcf472e" +* entry[=].resource = Macrogol3000 + +// 14 +* entry[+].fullUrl = "urn:uuid:eee155e8-e442-491d-9a82-7af3cefac57f" +* entry[=].resource = Magnesiumstearate + +// 15 +* entry[+].fullUrl = "urn:uuid:1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd" +* entry[=].resource = Microcrystallinecellulose + +// 16 +* entry[+].fullUrl = "urn:uuid:a88891dc-7e9e-4d84-b462-95e53de3b6a6" +* entry[=].resource = titaniumdioxide + +// 17 +// Clinical Use Definition - Indication +* entry[+].fullUrl = "urn:uuid:4e922ec1-a398-4a78-8381-3729422b7602" +* entry[=].resource = indication + +// 18 +// Clinical Use Definition - Contraindication +* entry[+].fullUrl = "urn:uuid:83f4a22f-9e5e-4941-9fdb-339a0f1f2055" +* entry[=].resource = contraindication + +// Clinical Use Definition - Interaction +* entry[+].fullUrl = "urn:uuid:e60575aa-e7b3-4461-a456-d310514f4041" +* entry[=].resource = interactionmethotrexate + +* entry[+].fullUrl = "urn:uuid:f7d8f2a0-27eb-4e37-8036-58f3d5aa6537" +* entry[=].resource = interactiongrapefruitjuice + +// Clinical Use Definition - Warning +* entry[+].fullUrl = "urn:uuid:ac21a804-cafa-41ff-b644-a14c8003edeb" +* entry[=].resource = warninghypotension + +// Substance +* entry[+].fullUrl = "urn:uuid:da33bd51-a726-4232-aaa0-4168b9bfe249" +* entry[=].resource = substanceirbesartan diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-contraindication.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-contraindication.fsh new file mode 100644 index 0000000000..f066b9e25e --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-contraindication.fsh @@ -0,0 +1,18 @@ +Instance: contraindication +InstanceOf: ClinicalUseDefinition-contraindication-uv-epi +Description: "Contraindication - Gastrointestinal disorders" +Usage: #example + +* id = "83f4a22f-9e5e-4941-9fdb-339a0f1f2055" + +* identifier.system = "https://spor.ema.europa.eu/rmswi#" +* identifier.value = "Gastrointestinal disorders" +* identifier.use = #official + +* type = #contraindication + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* contraindication + * diseaseSymptomProcedure.concept.coding = $meddra#10012601 "Diabetis Mellitus" \ No newline at end of file diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-indication.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-indication.fsh new file mode 100644 index 0000000000..16410b1a9e --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-indication.fsh @@ -0,0 +1,18 @@ +Instance: indication +InstanceOf: ClinicalUseDefinitionIndicationUvEpi +Description: "Indication" +Usage: #example + +* id = "4e922ec1-a398-4a78-8381-3729422b7602" + +* identifier.system = "https://spor.ema.europa.eu/rmswi#" +* identifier.value = "Psoriasis" +* identifier.use = #official + +* type = #indication + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* indication + * diseaseSymptomProcedure.concept.coding = $meddra#10020772 "Hypertension" diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction.fsh new file mode 100644 index 0000000000..6f907925ca --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction.fsh @@ -0,0 +1,19 @@ +Instance: interactionmethotrexate +InstanceOf: ClinicalUseDefinitionInteractionUvEpi +Description: "Interaction - METHOTREXATE" +Usage: #example + +* id = "e60575aa-e7b3-4461-a456-d310514f4041" +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta" +* identifier.value = "YL5FZ2Y5U1" +* identifier.use = #official + +* type = #interaction + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* interaction.interactant.itemCodeableConcept = https://gsrs.ncats.nih.gov/ginas/app/beta/#YL5FZ2Y5U1 + +* interaction.interactant.itemCodeableConcept.text = "METHOTREXATE" + diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction2.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction2.fsh new file mode 100644 index 0000000000..98691dd7e4 --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-interaction2.fsh @@ -0,0 +1,19 @@ +Instance: interactiongrapefruitjuice +InstanceOf: ClinicalUseDefinitionInteractionUvEpi +Description: "Interaction - GRAPEFRUIT JUICE" +Usage: #example + +* id = "f7d8f2a0-27eb-4e37-8036-58f3d5aa6537" +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta" +* identifier.value = "JQ9EK2H6BG" +* identifier.use = #official + +* type = #interaction + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* interaction.interactant.itemCodeableConcept = https://gsrs.ncats.nih.gov/ginas/app/beta/#JQ9EK2H6BG + +* interaction.interactant.itemCodeableConcept.text = "GRAPEFRUIT JUICE" + diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-undesirableeffect.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-undesirableeffect.fsh new file mode 100644 index 0000000000..c0af07d6fc --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-undesirableeffect.fsh @@ -0,0 +1,16 @@ +Instance: undesirableEffectanemia +InstanceOf: ClinicalUseDefinition-undesirableEffect-uv-epi +Description: "Undesirable Effect - anemia" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/rmswi#" +* identifier.value = "anemia" +* identifier.use = #official + +* type = #undesirable-effect + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* undesirableEffect + * symptomConditionEffect.concept.coding = $meddra#10002272 "Anemia" diff --git a/input/fsh/examples/cava-ema/ClinicalUseDefinition-warning.fsh b/input/fsh/examples/cava-ema/ClinicalUseDefinition-warning.fsh new file mode 100644 index 0000000000..29e55f52f2 --- /dev/null +++ b/input/fsh/examples/cava-ema/ClinicalUseDefinition-warning.fsh @@ -0,0 +1,17 @@ +Instance: warninghypotension +InstanceOf: ClinicalUseDefinition-warning-uv-epi +Description: "Warning - hypotension" +Usage: #example +* id = "ac21a804-cafa-41ff-b644-a14c8003edeb" +* identifier.system = "https://spor.ema.europa.eu/rmswi#" +* identifier.value = "hypotension" +* identifier.use = #official + +* type = #warning + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet blister x28 +* subject = Reference(cava75mgblisterx28) + +* warning + * description = "Intravascular volume depletion: symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of cava." + diff --git a/input/fsh/examples/cava-ema/administrableproductdefinition.fsh b/input/fsh/examples/cava-ema/administrableproductdefinition.fsh new file mode 100644 index 0000000000..22e12ff30d --- /dev/null +++ b/input/fsh/examples/cava-ema/administrableproductdefinition.fsh @@ -0,0 +1,29 @@ +Instance: adminproductcava75 +InstanceOf: AdministrableProductDefinitionUvEpi +Title: "cava 75mg tablet administrable product" +Description: "cava 75 mg tablet" +Usage: #example + +* id = "373b9bf3-1fae-47a1-a7cd-230106def069" + +* identifier.system = $phpid +* identifier.value = "adminproductcava75" + +* status = #active + +//reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet +* formOf = Reference(cava75mgblisterx28) + +* administrableDoseForm = $spor-combinedPharmaceuticalDoseForm-cs#200000002152 +* administrableDoseForm.text = "Tablet" + +* unitOfPresentation = $spor-rms#200000002152 +* unitOfPresentation.text = "Tablet" + + // Reference to ManufacturedItemDefinition: Manufactured Item +* producedFrom = Reference(manitemcava75) + +* routeOfAdministration.code = $spor-route-cs#100000073619 +* routeOfAdministration.code.text = "Oral use" +* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 +* routeOfAdministration.targetSpecies.code.text = "Human" diff --git a/input/fsh/examples/cava-ema/composition75-en.fsh b/input/fsh/examples/cava-ema/composition75-en.fsh new file mode 100644 index 0000000000..1bfb7e4bdc --- /dev/null +++ b/input/fsh/examples/cava-ema/composition75-en.fsh @@ -0,0 +1,458 @@ +Instance: compositioncava75 +InstanceOf: CompositionUvEpi +Title: "Composition for cava 75 mg Package Leaflet" +Description: "Package Leaflet" +Usage: #example + +* id = "e63f72b2-993f-48b1-b7cb-539b1ed71571" +* identifier.system = "https://spor.ema.europa.eu/rmswi" +* identifier.value = "0d69fdcb-33cf-407f-8209-a6529856ab4f" + +* status = #final + +* type = https://spor.ema.europa.eu/rmswi#100000155538 +* type.text = "Package Leaflet" + +* subject = Reference(cava75mgblisterx28) //reference to the medicinal product + +* date = "2022-02-16T13:28:17Z" + +* author = Reference(acmeinc) // Reference to Organization: Marketing Authorization Holder + +* title = "TEST PURPOSES ONLY - cava (irbesartan) 75 mg tablets" + +* section[+]. + * title = "B. Package Leaflet" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "B. PACKAGE LEAFLET" + * text.status = #additional + * text.div = """
    unavailable
    """ + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + +* section[+]. + * title = "B. Package Leaflet" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "B. PACKAGE LEAFLET" + * text.status = #additional + * text.div = """
    unavailable
    """ + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + +* section[=].section[+] + * title = "Package leaflet: Information for the user" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "Package leaflet: Information for the user" + * text.status = #additional + * text.div = """
    +

    cava 75 mg tablets

    +

    irbesartan

    + Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ + +* section[=].section[+] + * title = "What is in this leaflet" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "What is in this leaflet" + * text.status = #additional + * text.div = """
    +
      +
    • What cava is and what it is used for
      • +
    • What you need to know before you take cava
      • +
    • How to take cava
      • +
    • Possible side effects
      • +
    • How to store cava
      • +
    • Contents of the pack and other information
      • +
    +
    """ + +* section[=].section[+] + * title = "1. What cava is and what it is used for" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "1. What cava is and what it is used for" + * text.status = #additional + * text.div = """
    +

    + cava belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. cava prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. cava slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. +

    +

    cava is used in adult patients

    +
      +
    • to treat high blood pressure (essential hypertension)
      • +
    • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory + evidence of impaired kidney function.
      • +
    +
    """ + +* section[=].section[+] + * title = "2. What you need to know before you take cava" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "2. What you need to know before you take cava" + * text.status = #additional + * text.div = """
    + Do not take cava +
      +
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • +
    • if you are more than 3 months pregnant. (It is also better to avoid cava in early pregnancy – + see pregnancy section)
      • +
    • if you have diabetes or impaired kidney function and you are treated with a blood pressure + lowering medicine containing aliskiren.
      • +
    + Warning and precautions +

    Talk to your doctor before taking cava and if any of the following apply to you:

    +
      +
    • if you get excessive vomiting or diarrhoea
      • +
    • if you suffer from kidney problems
      • +
    • if you suffer from heart problems
      • +
    • if you receive cava for diabetic kidney disease. In this case your doctor may perform regular + blood tests, especially for measuring blood potassium levels in case of poor kidney function
      • +
    • if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, + dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart + beat), particularly if you are being treated for diabetes.
      • +
    • if you are going to have an operation (surgery) or be given anaesthetics
      • +
    • +
        +
      • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
        • +
      • aliskiren
        • +
      +
      • +
    +

    Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

    +

    See also information under the heading “Do not take cava”.

    +

    You must tell your doctor if you think you are (or might become) pregnant. cava is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

    + Children and adolescents +

    This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

    + Other medicines and cava +

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

    +

    Your doctor may need to change your dose and/or to take other precautions: + If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take + cava” and “Warnings and precautions”).

    + You may need to have blood checks if you take: +
      +
    • potassium supplements
      • +
    • salt substitutes containing potassium
      • +
    • potassium-sparing medicines (such as certain diuretics)
      • +
    • medicines containing lithium
      • +
    • repaglinide (medication used for lowering blood sugar levels)
      • +
    +

    If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

    + cava with food and drink +

    cava can be taken with or without food.

    + Pregnancy and breast-feeding + Pregnancy +

    You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking cava before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of cava. cava is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

    + Breast-feeding +

    Tell your doctor if you are breast-feeding or about to start breast-feeding. cava is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

    + Driving and using machines +

    cava is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. +

    + + cava contains lactose. +

    If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

    + + cava contains sodium. +

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

    +
    """ + +* section[=].section[+] + * title = "3. How to take cava" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "3. How to take cava" + * text.status = #additional + * text.div = """
    + Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. + + Method of administration +

    cava is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take cava with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take cava until your doctor tells you otherwise.

    +
      +
    • + Patients with high blood pressure +

      The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

      +
      • +
    • + Patients with high blood pressure and type 2 diabetes with kidney disease +

      In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

      +
      • +
    + +

    The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. +

    +

    The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

    + + Use in children and adolescents +

    cava should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

    + + If you take more cava than you should +

    If you accidentally take too many tablets, contact your doctor immediately.

    + + If you forget to take cava +

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    +

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    +
    """ + +* section[=].section[+] + * title = "4. Possible side effects" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "4. Possible side effects" + * text.status = #additional + * text.div = """
    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    +

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking cava and contact your doctor immediately.

    +

    The frequency of the side effects listed below is defined using the following convention:

    +

    Very common: may affect more than 1 in 10 people

    +

    Common: may affect up to 1 in 10 people

    +

    Uncommon: may affect up to 1 in 100 people

    +

    Side effects reported in clinical studies for patients treated with cava were:

    +
      +
    • Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and + type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
      • +
    • Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. +
      • +
    • Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
      • +
    +

    Some undesirable effects have been reported since marketing of cava. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. +

    + Reporting of side effects +

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. +

    +
    """ + +* section[=].section[+] + * title = "5. How to store cava" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "5. How to store cava" + * text.status = #additional + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ + +* section[=].section[+] + * title = "6. Contents of the pack and other information" + * code = https://spor.ema.europa.eu/rmswi#100000155538 + * code.text = "6. Contents of the pack and other information" + * text.status = #additional + * text.div = """
    + What cava contains +
      +
    • The active substance is irbesartan. Each tablet of cava 75 mg contains 75 mg irbesartan.
      • +
    • The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose + monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “cava contains lactose”.
      • +
    + What cava looks like and contents of the pack +

    cava 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

    +

    cava 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

    +

    Not all pack sizes may be marketed.

    + Marketing Authorisation Holder: +

    Acme inc

    +

    For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

    + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
    +

    België/Belgique/Belgien

    +

    Acme Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00

    +     		+

    Lietuva

    +

    Swixx Biopharma UAB

    +

    Tel: +370 5 236 91 40

    +
    +

    България

    +

    Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

    +     		+

    Luxembourg/Luxemburg

    +

    Acme Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

    +
    +

    Česká republika

    +

    Acme inc, s.r.o. Tel: +420 233 086 111

    +     		+

    Magyarország

    +

    Acme-A VENTIS Zrt. Tel.: +36 1 505 0050

    +
    +

    Danmark

    +

    Acme A/S

    +

    Tlf: +45 45 16 70 00

    +     		+

    Malta

    +

    Acme S.r.l.

    +

    Tel: +39 02 39394275

    +
    +

    Deutschland

    +

    Acme inc Deutschland GmbH

    +

    Tel: 0800 52 52 010

    +

    Tel. aus dem Ausland: +49 69 305 21 131

    +     		+

    Norge

    +

    Acme inc Norge AS Tlf: +47 67 10 71 00

    +
    +

    Eesti

    +

    Swixx Biopharma OÜ Tel: +372 640 10 30

    +     		+

    Österreich

    +

    Acme inc GmbH Tel: +43 1 80 185 - 0

    +
    +

    Ελλάδα

    +

    Acme inc AEBE Τηλ: +30 210 900 16 00

    +     		+

    Polska

    +

    Acme inc Sp. z o.o. Tel.: +48 22 280 00 00

    +
    +

    España

    +

    Acme inc, S.A. Tel: +34 93 485 94 00

    +
    +

    France

    +

    Acme inc France

    +

    Tél: 0 800 222 555

    +

    Appel depuis l'étranger : +33 1 57 63 23 23

    +     		+

    Portugal

    +

    Acme - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

    +
    +

    Hrvatska

    +

    Swixx Biopharma d.o.o. Tel: +385 1 2078 500

    +     		+

    România

    +

    Acme Romania SRL Tel: +40 (0) 21 317 31 36

    +
    +

    Ireland

    +

    Acme inc Ireland Ltd. T/A Acme Tel: +353 (0) 1 403 56 00

    +     		+

    Slovenija

    +

    Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

    +
    +

    Ísland

    +

    Vistor hf.

    +

    Sími: +354 535 7000

    +     		+

    Slovenská republika

    +

    Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

    +
    +

    Italia

    +

    Acme S.r.l. Tel: 800 536389

    +     		+

    Suomi/Finland

    +

    Acme Oy

    +

    Puh/Tel: +358 (0) 201 200 300

    +
    +

    Κύπρος

    +

    C.A. Papaellinas Ltd. Τηλ: +357 22 741741

    +     		+

    Sverige

    +

    Acme AB

    +

    Tel: +46 (0)8 634 50 00

    +
    +

    Latvija

    +

    Swixx Biopharma SIA Tel: +371 6 616 47 50

    +     		+

    United Kingdom (Northern Ireland)

    +

    Acme inc Ireland Ltd. T/A Acme Tel: +44 (0) 800 035 2525

    +
    +

    This leaflet was last revised in

    +

    Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

    +
    """ \ No newline at end of file diff --git a/input/fsh/examples/cava-ema/ingredient-carnaubawax.fsh b/input/fsh/examples/cava-ema/ingredient-carnaubawax.fsh new file mode 100644 index 0000000000..afad3add15 --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-carnaubawax.fsh @@ -0,0 +1,23 @@ +Instance: carnaubawax +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient carnauba wax" +Description: "Carnauba wax" +Usage: #example + +* id = "a4b7b60c-998f-4f93-89c7-860396af0fe3" +* identifier.system = $ginas +* identifier.value = "R12CBM0EIZ" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#R12CBM0EIZ "Carnauba wax" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-croscarmellosesodium.fsh b/input/fsh/examples/cava-ema/ingredient-croscarmellosesodium.fsh new file mode 100644 index 0000000000..e9e39063f4 --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-croscarmellosesodium.fsh @@ -0,0 +1,23 @@ +Instance: Croscarmellosesodium +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Croscarmellose sodium" +Description: "Croscarmellose sodium" +Usage: #example + +* id = "fbf58407-83d3-42db-be3d-506b2006d431" +* identifier.system = $ginas +* identifier.value = "M28OL1HH48" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#M28OL1HH48 "Croscarmellose sodium" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-hypromellose.fsh b/input/fsh/examples/cava-ema/ingredient-hypromellose.fsh new file mode 100644 index 0000000000..0f5beddbdd --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-hypromellose.fsh @@ -0,0 +1,23 @@ +Instance: Hypromellose +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Hypromellose" +Description: "Hypromellose" +Usage: #example + +* id = "1c10b441-6bd3-40b8-b14b-514e7c2f79d0" +* identifier.system = $ginas +* identifier.value = "3NXW29V3WO" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#3NXW29V3WO "Hypromellose" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) \ No newline at end of file diff --git a/input/fsh/examples/cava-ema/ingredient-irbesartan75.fsh b/input/fsh/examples/cava-ema/ingredient-irbesartan75.fsh new file mode 100644 index 0000000000..cb6d119efc --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-irbesartan75.fsh @@ -0,0 +1,28 @@ +Instance: irbesartan +InstanceOf: IngredientUvEpi +Title: "Irbesartan – Example of Ingredient with basis for strength" +Description: "irbesartan" +Usage: #example + +* id = "745c01bc-936e-45ca-9880-57e97608f43e" +* identifier.system = $ginas +* identifier.value = "J0E2756Z7N" +* identifier.use = #official + +* status = #active + +* role = $roleclass#ACTIB +* role.text = "active ingredient - basis of strength" + +* substance.code.concept.coding = $ginas#J0E2756Z7N "irbesartan" +* substance.strength.presentationQuantity.value = 75 +* substance.strength.presentationQuantity.unit = "mg" + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB +* substance.strength.basis.text = "active ingredient - basis of strength" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-lactosemonohydrate.fsh b/input/fsh/examples/cava-ema/ingredient-lactosemonohydrate.fsh new file mode 100644 index 0000000000..29e3841fb0 --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-lactosemonohydrate.fsh @@ -0,0 +1,23 @@ +Instance: lactosemonohydrate +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Lactose Monohydrate" +Description: "Lactose Monohydrate" +Usage: #example + +* id = "7a3c0b14-2473-4541-9e45-a24d24cceddf" +* identifier.system = $ginas +* identifier.value = "EWQ57Q8I5X" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#EWQ57Q8I5X "Lactose Monohydrate" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-macrogol.fsh b/input/fsh/examples/cava-ema/ingredient-macrogol.fsh new file mode 100644 index 0000000000..63788c641f --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-macrogol.fsh @@ -0,0 +1,23 @@ +Instance: Macrogol3000 +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Macrogol 3000" +Description: "Macrogol 3000" +Usage: #example + +* id = "ceba5cd1-321f-4bc3-b203-92d97fcf472e" +* identifier.system = $ginas +* identifier.value = "SA1B764746" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#SA1B764746 "Macrogol 3000" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-magnesiumstearate.fsh b/input/fsh/examples/cava-ema/ingredient-magnesiumstearate.fsh new file mode 100644 index 0000000000..cb47f4d92d --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-magnesiumstearate.fsh @@ -0,0 +1,23 @@ +Instance: Magnesiumstearate +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Magnesium stearate" +Description: "Magnesium stearate" +Usage: #example + +* id = "eee155e8-e442-491d-9a82-7af3cefac57f" +* identifier.system = $ginas +* identifier.value = "70097M6I30" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#70097M6I30 "Magnesium stearate" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-microcrystallinecellulose.fsh b/input/fsh/examples/cava-ema/ingredient-microcrystallinecellulose.fsh new file mode 100644 index 0000000000..ff325551ad --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-microcrystallinecellulose.fsh @@ -0,0 +1,23 @@ +Instance: Microcrystallinecellulose +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Microcrystalline cellulose" +Description: "Microcrystalline cellulose" +Usage: #example + +* id = "1cdfb0bc-55f0-43ff-b750-8f3a0d9970bd" +* identifier.system = $ginas +* identifier.value = "OP1R32D61U" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#OP1R32D61U "Microcrystalline cellulose" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-silicondioxide.fsh b/input/fsh/examples/cava-ema/ingredient-silicondioxide.fsh new file mode 100644 index 0000000000..f0d825584b --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-silicondioxide.fsh @@ -0,0 +1,23 @@ +Instance: Silicondioxide +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Silicon dioxide" +Description: "Silicon dioxide" +Usage: #example + +* id = "09c13040-8fd5-4818-972d-f01d4ee169b6" +* identifier.system = $ginas +* identifier.value = "ETJ7Z6XBU4" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#ETJ7Z6XBU4 "Silicon dioxide" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/ingredient-titaniumdioxide.fsh b/input/fsh/examples/cava-ema/ingredient-titaniumdioxide.fsh new file mode 100644 index 0000000000..8e02ee53d0 --- /dev/null +++ b/input/fsh/examples/cava-ema/ingredient-titaniumdioxide.fsh @@ -0,0 +1,23 @@ +Instance: titaniumdioxide +InstanceOf: IngredientUvEpi +Title: "Ingredient-excipient Titanium Dioxide" +Description: "Titanium Dioxide" +Usage: #example +* id = "a88891dc-7e9e-4d84-b462-95e53de3b6a6" + +* identifier.system = $ginas +* identifier.value = "15FIX9V2JP" +* identifier.use = #official + +* role = $roleclass#IACT +* role.text = "inactive ingredient" + +* status = #active + +* substance.code.concept.coding = $ginas#15FIX9V2JP "Titanium Dioxide" + +// Reference to manufactured item +* for = Reference(manitemcava75) + +// Reference to Organization: Reference to MAH +* manufacturer.manufacturer = Reference(acmeinc) \ No newline at end of file diff --git a/input/fsh/examples/cava-ema/manufactureditemdefinition-karvea75.fsh b/input/fsh/examples/cava-ema/manufactureditemdefinition-karvea75.fsh new file mode 100644 index 0000000000..03d3ec9273 --- /dev/null +++ b/input/fsh/examples/cava-ema/manufactureditemdefinition-karvea75.fsh @@ -0,0 +1,21 @@ +Instance: manitemcava75 +InstanceOf: ManufacturedItemDefinitionUvEpi +Title: "Manufactured item cava 75 mg tabelt" +Description: "cava 75 mg tablet" +Usage: #example + +* id = "3214f286-b8ec-4ef5-bc8d-0aec39d97468" +* identifier.system = "https://spor.ema.europa.eu/pmswi/#" +* identifier.value = "EU/1/96/007/035" +* identifier.use = #official + +* status = #active + +* manufacturedDoseForm = $spor-combinedPharmaceuticalDoseForm-cs#10219000 +* manufacturedDoseForm.text = "tablet" + +* unitOfPresentation = $spor-rms#200000002152 +* unitOfPresentation.text = "Tablet" + + // Reference to Organization: Manufacturer +* manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/medicinalproductdefinition.fsh b/input/fsh/examples/cava-ema/medicinalproductdefinition.fsh new file mode 100644 index 0000000000..d74bacbce1 --- /dev/null +++ b/input/fsh/examples/cava-ema/medicinalproductdefinition.fsh @@ -0,0 +1,50 @@ +Instance: cava75mgblisterx28 +InstanceOf: MedicinalProductDefinitionUvEpi +Title: "Medicinal Product cava 75 mg tablet in blister pack of 28 tablets" +Description: "EU/1/97/049/001 cava 75 mg tablet blister x28" +Usage: #example + +* id = "800a51a2-d81d-49a4-a4eb-f2417d301837" +* identifier.system = $spor-prod +* identifier.value = "4471bb15-7f52-4fcd-b615-8674ce6eb91e" + +* type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct +* type.text = "Medicinal Product" + +* domain = http://hl7.org/fhir/medicinal-product-domain#Human +* domain.text = "Human use" + +* status = http://hl7.org/fhir/publication-status#active "Active" + +* legalStatusOfSupply = $spor-rms#100000072084 +* legalStatusOfSupply.text = "Medicinal product subject to medical prescription" + +* name + * productName = "cava 75 mg tablet blister x28" + * type = $spor-productNamePartType-cs#220000000001 + * text = "Full name" + + * part[0] + * part = "cava" + * type = $spor-productNamePartType-cs#220000000002 + * type.text = "Invented name part" + + * part[+] + * part = "irbesartan" + * type = $spor-productNamePartType-cs#220000000003 + * type.text = "Scientific name part" + + * part[+] + * part = "75 mg" + * type = $spor-productNamePartType-cs#220000000004 + * type.text = "Strength part" + + * part[+] + * part = "tablet" + * type = $spor-productNamePartType-cs#220000000005 + * type.text = "Pharmaceutical dose form part" + + * usage + * country = urn:iso:std:iso:3166#DK + * jurisdiction = urn:iso:std:iso:3166#DK + * language = urn:ietf:bcp:47#en diff --git a/input/fsh/examples/cava-ema/organization-mah.fsh b/input/fsh/examples/cava-ema/organization-mah.fsh new file mode 100644 index 0000000000..9e7e2d6aa7 --- /dev/null +++ b/input/fsh/examples/cava-ema/organization-mah.fsh @@ -0,0 +1,25 @@ +Instance: acmeinc +InstanceOf: OrganizationUvEpi +Title: "Acme Inc. as Marketing Authorization Holder" +Description: "Marketing Authorization Holder" +Usage: #example + +* id = "d71bf884-90eb-47f9-81b7-fa81ecec7e75" +* identifier.system = $spor-org +* identifier.value = "ORG-100000789" +* identifier.use = #official + +* active = true + +* type = $spor-rms#220000000034 "Marketing authorisation holder" +* type.text = "Marketing authorisation holder" +* name = "Acme Inc" + +* contact + * address + * text = "60, rue La Boétie F-75008 Paris - France" + * use = #work + * type = #physical + * line = "60, rue La Boétie F-75008" + * city = "Lion" + * country = "FR" diff --git a/input/fsh/examples/cava-ema/packagedproductdefinition.fsh b/input/fsh/examples/cava-ema/packagedproductdefinition.fsh new file mode 100644 index 0000000000..7fff7aca14 --- /dev/null +++ b/input/fsh/examples/cava-ema/packagedproductdefinition.fsh @@ -0,0 +1,34 @@ +Instance: packagebottlex28 +InstanceOf: PackagedProductDefinitionUvEpi +Title: "Packaging Blister x28 75 mg tablets" +Description: "Blister x28 tablets" +Usage: #example + +* id = "eb8392a6-2cec-4ff3-9d9e-7c5f4ae3786d" +* identifier.system = $spor-prod +* identifier.value = "EU/1/97/049/001" +* identifier.use = #official + +* name = "cava 75 mg tablet blister x28 tablets" + +* type = $spor-rms#100000155527 +* type.text = "Chemical Medicinal Prodcut" + +* status = http://hl7.org/fhir/publication-status#active "Active" +* statusDate = "2015-02-07T13:28:17Z" + +* containedItemQuantity.value = 75 +* containedItemQuantity.unit = "mg" + +* packaging + * identifier.system = $spor-prod + * identifier.value = "123456" + * type = $spor-rms#100000073496 "Blister" + * quantity = 28 + * material = $spor-rms#200000003222 "PolyVinyl Chloride" + +//reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet +* packageFor = Reference(cava75mgblisterx28) + + // Reference to Organization: MAH +* manufacturer = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/regulatedauthorization75.fsh b/input/fsh/examples/cava-ema/regulatedauthorization75.fsh new file mode 100644 index 0000000000..7c82f81d4f --- /dev/null +++ b/input/fsh/examples/cava-ema/regulatedauthorization75.fsh @@ -0,0 +1,27 @@ +Instance: authorizationcava75 +InstanceOf: RegulatedAuthorizationUvEpi +Title: "Regulated Authorization for cava 75 mg tablets" +Description: "Regulated Authorization" +Usage: #example + +* identifier.system = $spor-prod +* identifier.value = "EU/1/96/007/035" +* identifier.use = #official + +* id = "297e405a-b6f9-4273-bc01-ae031efe47f8" + // Reference to MedicinalProductDefinition: EU/1/97/049/001 cava 75 mg tablet +* subject = Reference(cava75mgblisterx28) + +* type = $spor-rms#100000072062 +* type.text = "Marketing Authorisation" + +* region = urn:iso:std:iso:3166#DK +* region.text = "Denmark" + +* status = http://hl7.org/fhir/publication-status#active +* status.text = "Active" + +* statusDate = "2015-02-07T13:28:17Z" + + // Reference to Organization: Marketing Authorization Holder +* holder = Reference(acmeinc) diff --git a/input/fsh/examples/cava-ema/substanceirbesartan.fsh b/input/fsh/examples/cava-ema/substanceirbesartan.fsh new file mode 100644 index 0000000000..781c34cf64 --- /dev/null +++ b/input/fsh/examples/cava-ema/substanceirbesartan.fsh @@ -0,0 +1,28 @@ +Instance: substanceirbesartan +InstanceOf: SubstanceDefinitionUvEpi +Description: "irbesartan" +Usage: #example + +* id = "da33bd51-a726-4232-aaa0-4168b9bfe249" +* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta" +* identifier.value = "J0E2756Z7N" +* identifier.use = #official + +* version = "1" + +* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 +* status.text = "Validated (UNII)" + +* description = "White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 1234 engraved on the other side." + + // Reference to Organization: MAH +* manufacturer = Reference(acmeinc) + +* molecularWeight.type.text = "exact" +* molecularWeight.amount.value = 428.53 + +* structure.molecularFormula = "C25H28N6O" + +* name.name = "(+)-6-methyleneandrosta-1,4-diene-3,17-dione" +* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 +* name.type.text = "Chemical Name" diff --git a/input/fsh/examples/cinitrapide-ema-automatic/Bundle.fsh b/input/fsh/examples/cinitrapide-ema-automatic/Bundle.fsh index 885102cd1e..b4de924f45 100644 --- a/input/fsh/examples/cinitrapide-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/cinitrapide-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/96/007/035" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/compositionaf8224f8c853d17daf5ea6782cb5a097" diff --git a/input/fsh/examples/cinitrapide-ema-automatic/Composition.fsh b/input/fsh/examples/cinitrapide-ema-automatic/Composition.fsh index 49a25e250f..5721bdc3d0 100644 --- a/input/fsh/examples/cinitrapide-ema-automatic/Composition.fsh +++ b/input/fsh/examples/cinitrapide-ema-automatic/Composition.fsh @@ -6,14 +6,10 @@ Description: "Composition for cinitrapide Package Leaflet" Usage: #example * identifier.system = "https://spor.ema.europa.eu/rmswi/" -* identifier.value = "nan" +* identifier.value = "xx" * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-94f8082c22713e050c3f2b55ea9d53ff) * title = "TEST PURPOSES ONLY - cinitrapide" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,50 +42,160 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - + + * text.div = """
    +

    Karvea 75 mg tablets

    +

    irbesartan

    + Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +
      +
    • What Karvea is and what it is used for
      • +
    • What you need to know before you take Karvea
      • +
    • How to take Karvea
      • +
    • Possible side effects
      • +
    • How to store Karvea
      • +
    • Contents of the pack and other information
      • +
    +
    """ * section[=].section[+] * title = "1. What cinitrapide is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What cinitrapide is and what it is used for" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - + + * text.div = """
    +

    + Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. +

    +

    Karvea is used in adult patients

    +
      +
    • to treat high blood pressure (essential hypertension)
      • +
    • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory + evidence of impaired kidney function.
      • +
    +
    """ * section[=].section[+] * title = "2. What you need to know before you take cinitrapide" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take cinitrapide" * text.status = #additional + - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + * text.div = """
    + Do not take Karvea +
      +
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • +
    • if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – + see pregnancy section)
      • +
    • if you have diabetes or impaired kidney function and you are treated with a blood pressure + lowering medicine containing aliskiren.
      • +
    + Warning and precautions +

    Talk to your doctor before taking Karvea and if any of the following apply to you:

    +
      +
    • if you get excessive vomiting or diarrhoea
      • +
    • if you suffer from kidney problems
      • +
    • if you suffer from heart problems
      • +
    • if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular + blood tests, especially for measuring blood potassium levels in case of poor kidney function
      • +
    • if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, + dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart + beat), particularly if you are being treated for diabetes.
      • +
    • if you are going to have an operation (surgery) or be given anaesthetics
      • +
    • +
        +
      • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
        • +
      • aliskiren
        • +
      +
      • +
    +

    Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

    +

    See also information under the heading “Do not take Karvea”.

    +

    You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

    + Children and adolescents +

    This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

    + Other medicines and Karvea +

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

    +

    Your doctor may need to change your dose and/or to take other precautions: + If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take + Karvea” and “Warnings and precautions”).

    + You may need to have blood checks if you take: +
      +
    • potassium supplements
      • +
    • salt substitutes containing potassium
      • +
    • potassium-sparing medicines (such as certain diuretics)
      • +
    • medicines containing lithium
      • +
    • repaglinide (medication used for lowering blood sugar levels)
      • +
    +

    If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

    + Karvea with food and drink +

    Karvea can be taken with or without food.

    + Pregnancy and breast-feeding + Pregnancy +

    You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

    + Breast-feeding +

    Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

    + Driving and using machines +

    Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. +

    + + Karvea contains lactose. +

    If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

    + + Karvea contains sodium. +

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

    +
    """ * section[=].section[+] * title = "3. How to take cinitrapide" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take cinitrapide" * text.status = #additional + + * text.div = """
    + Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. + + Method of administration +

    Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

    +
      +
    • + Patients with high blood pressure +

      The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

      +
      • +
    • + Patients with high blood pressure and type 2 diabetes with kidney disease +

      In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

      +
      • +
    + +

    The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. +

    +

    The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

    - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + Use in children and adolescents +

    Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

    + + If you take more Karvea than you should +

    If you accidentally take too many tablets, contact your doctor immediately.

    + + If you forget to take Karvea +

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    +

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    +
    """ * section[=].section[+] @@ -94,26 +203,272 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + * text.div = """
    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    +

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    +

    The frequency of the side effects listed below is defined using the following convention:

    +

    Very common: may affect more than 1 in 10 people

    +

    Common: may affect up to 1 in 10 people

    +

    Uncommon: may affect up to 1 in 100 people

    +

    Side effects reported in clinical studies for patients treated with Karvea were:

    +
      +
    • Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and + type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
      • +
    • Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. +
      • +
    • Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
      • +
    +

    Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. +

    + Reporting of side effects +

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. +

    +
    """ * section[=].section[+] * title = "5. How to store cinitrapide" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store cinitrapide" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    + What Karvea contains +
      +
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • +
    • The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose + monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.
      • +
    + What Karvea looks like and contents of the pack +

    Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

    +

    Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

    +

    Not all pack sizes may be marketed.

    + Marketing Authorisation Holder: +

    sanofi-aventis groupe

    +

    54, rue La Boétie

    +

    F-75008 Paris - France

    +

    Manufacturer:

    +

    SANOFI WINTHROP INDUSTRIE

    +

    1, rue de la Vierge

    +

    Ambarès and Lagrave

    +

    F-33565 Carbon Blanc Cedex - France

    +

    SANOFI WINTHROP INDUSTRIE

    +

    30-36 Avenue Gustave Eiffel, BP 7166

    +

    F-37071 Tours Cedex 2 - France

    +

    For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

    + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
    +

    België/Belgique/Belgien

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00

    +     		+

    Lietuva

    +

    Swixx Biopharma UAB

    +

    Tel: +370 5 236 91 40

    +
    +

    България

    +

    Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

    +     		+

    Luxembourg/Luxemburg

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

    +
    +

    Česká republika

    +

    sanofi-aventis, s.r.o. Tel: +420 233 086 111

    +     		+

    Magyarország

    +

    SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

    +
    +

    Danmark

    +

    Sanofi A/S

    +

    Tlf: +45 45 16 70 00

    +     		+

    Malta

    +

    Sanofi S.r.l.

    +

    Tel: +39 02 39394275

    +
    +

    Deutschland

    +

    Sanofi-Aventis Deutschland GmbH

    +

    Tel: 0800 52 52 010

    +

    Tel. aus dem Ausland: +49 69 305 21 131

    +     		+

    Norge

    +

    sanofi-aventis Norge AS Tlf: +47 67 10 71 00

    +
    +

    Eesti

    +

    Swixx Biopharma OÜ Tel: +372 640 10 30

    +     		+

    Österreich

    +

    sanofi-aventis GmbH Tel: +43 1 80 185 – 0

    +
    +

    Ελλάδα

    +

    sanofi-aventis AEBE Τηλ: +30 210 900 16 00

    +     		+

    Polska

    +

    sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

    +
    +

    España

    +

    sanofi-aventis, S.A. Tel: +34 93 485 94 00

    +
    +

    France

    +

    sanofi-aventis France

    +

    Tél: 0 800 222 555

    +

    Appel depuis l’étranger : +33 1 57 63 23 23

    +     		+

    Portugal

    +

    Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

    +
    +

    Hrvatska

    +

    Swixx Biopharma d.o.o. Tel: +385 1 2078 500

    +     		+

    România

    +

    Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

    +
    +

    Ireland

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

    +     		+

    Slovenija

    +

    Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

    +
    +

    Ísland

    +

    Vistor hf.

    +

    Sími: +354 535 7000

    +     		+

    Slovenská republika

    +

    Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

    +
    +

    Italia

    +

    Sanofi S.r.l. Tel: 800 536389

    +     		+

    Suomi/Finland

    +

    Sanofi Oy

    +

    Puh/Tel: +358 (0) 201 200 300

    +
    +

    Κύπρος

    +

    C.A. Papaellinas Ltd. Τηλ: +357 22 741741

    +     		+

    Sverige

    +

    Sanofi AB

    +

    Tel: +46 (0)8 634 50 00

    +
    +

    Latvija

    +

    Swixx Biopharma SIA Tel: +371 6 616 47 50

    +     		+

    United Kingdom (Northern Ireland)

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

    +
    +

    This leaflet was last revised in

    +

    Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

    +
    """ \ No newline at end of file diff --git a/input/fsh/examples/cinitrapide-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/cinitrapide-ema-automatic/MedicinalProductDefinition.fsh index c6d0b54a89..b37c0dd7b2 100644 --- a/input/fsh/examples/cinitrapide-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/cinitrapide-ema-automatic/MedicinalProductDefinition.fsh @@ -6,7 +6,10 @@ Description: "EU/1/97/049/001 BLASTON 1 mg tablets" Usage: #example * identifier.system = $spor-prod -* identifier.value = "ss" +* identifier.value = "59.032" + +* identifier[+].system = $phpid +* identifier[=].value = "0x9982CA8A825D4561506CE808982E3B9E" * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" diff --git a/input/fsh/examples/cinitrapide-ema-automatic/Organization.fsh b/input/fsh/examples/cinitrapide-ema-automatic/Organization.fsh index eb24490f27..f61ae288ec 100644 --- a/input/fsh/examples/cinitrapide-ema-automatic/Organization.fsh +++ b/input/fsh/examples/cinitrapide-ema-automatic/Organization.fsh @@ -3,7 +3,6 @@ Instance: org-94f8082c22713e050c3f2b55ea9d53ff - InstanceOf: OrganizationUvEpi Title: "Lacer, S.A. - Boters, 5 as Marketing authorisation holder" Description: "Lacer, S.A. - Boters, 5 as Marketing authorisation holder" diff --git a/input/fsh/examples/dovato-ema-automatic/Bundle.fsh b/input/fsh/examples/dovato-ema-automatic/Bundle.fsh index 612fbe98f9..bd31daf634 100644 --- a/input/fsh/examples/dovato-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/dovato-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/19/1370/001" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-04-05T13:17:13Z" // Composition * entry[0].fullUrl = "Composition/composition16598f252d07b4784b82ba43cf9e847e" diff --git a/input/fsh/examples/flucelvax-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/flucelvax-ema-automatic/AdministrableProductDefinition.fsh deleted file mode 100644 index 22368adce5..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/AdministrableProductDefinition.fsh +++ /dev/null @@ -1,26 +0,0 @@ - -Instance: ap-04c9bd6fb89d38b2d83eced2460c4dc1 -InstanceOf: AdministrableProductDefinitionUvEpi -Title: "Administrable product Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Description: "Flucelvax Tetra - suspension for injection in pre-filled syringe Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Usage: #example - -* identifier.system = $phpid -* identifier.value = "xx" - -* status = #active - -* formOf = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* administrableDoseForm = $spor-rms#100000074063 "suspension for injection in pre-filled syringe" -* unitOfPresentation = $spor-rms#200000002150 "Syringe" - -//this is just manufactured with extra steps? - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* producedFrom = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) - - -* routeOfAdministration.code = $spor-rms#100000073633 "Subcutaneous use" - -* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/flucelvax-ema-automatic/Bundle.fsh b/input/fsh/examples/flucelvax-ema-automatic/Bundle.fsh deleted file mode 100644 index eec28be110..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/Bundle.fsh +++ /dev/null @@ -1,131 +0,0 @@ - -Instance: bundlepackageleaflet-56a32a5ee239fc834b47c10db1faa3fd -InstanceOf: BundleUvEpi -Title: "ePI document Bundle for flucelvax Package Leaflet" -Description: "Bundle for flucelvax Package Leaflet ePI document" -Usage: #example - -* identifier.system = "https://www.gravitatehealth.eu/sid/doc" -* identifier.value = "flucelvax-1" -* type = #document -* timestamp = "2023-04-22T15:49:34Z" - -// Composition -* entry[0].fullUrl = "Composition/composition056f32ee5cf49404607e368bd8d3f2af" -* entry[0].resource = composition056f32ee5cf49404607e368bd8d3f2af - - - - - - - - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-2e8cb2387c664fb619f6b8914767d38f" -* entry[=].resource = ingredient-for-2e8cb2387c664fb619f6b8914767d38f - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole" -* entry[=].resource = ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-f4e520e2974f4acb8abe26b607ea5a46" -* entry[=].resource = ingredient-for-f4e520e2974f4acb8abe26b607ea5a46 - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-2c0c197a41a706fb2549601e635da1f3" -* entry[=].resource = ingredient-for-2c0c197a41a706fb2549601e635da1f3 - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-sodiumchloride" -* entry[=].resource = ingredient-for-flucelvax-sodiumchloride - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-potassiumchloride" -* entry[=].resource = ingredient-for-flucelvax-potassiumchloride - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-magnesiumchloride" -* entry[=].resource = ingredient-for-flucelvax-magnesiumchloride - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate" -* entry[=].resource = ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-potassiumdihydrogenphosphate" -* entry[=].resource = ingredient-for-flucelvax-potassiumdihydrogenphosphate - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-flucelvax-waterforinjections" -* entry[=].resource = ingredient-for-flucelvax-waterforinjections - - -// Substance - -* entry[+].fullUrl = "SubstanceDefinition/substance-influenzaavirusadelaware552019cvr45h1n1whole" -* entry[=].resource = substance-influenzaavirusadelaware552019cvr45h1n1whole - -// Substance - -* entry[+].fullUrl = "SubstanceDefinition/substance-influenzaavirusadarwin112021h3n2whole" -* entry[=].resource = substance-influenzaavirusadarwin112021h3n2whole - -// Substance - -* entry[+].fullUrl = "SubstanceDefinition/substance-influenzabvirusbsingaporewuh46182021whole" -* entry[=].resource = substance-influenzabvirusbsingaporewuh46182021whole - -// Substance - -* entry[+].fullUrl = "SubstanceDefinition/substance-influenzabvirusbsingaporeinftt1606102016whole" -* entry[=].resource = substance-influenzabvirusbsingaporeinftt1606102016whole - - -// AdministrableProductDefinition - -* entry[+].fullUrl = "AdministrableProductDefinition/ap-04c9bd6fb89d38b2d83eced2460c4dc1" -* entry[=].resource = ap-04c9bd6fb89d38b2d83eced2460c4dc1 - - -// RegulatedAuthorization - -* entry[+].fullUrl = "RegulatedAuthorization/authorization04c9bd6fb89d38b2d83eced2460c4dc1" -* entry[=].resource = authorization04c9bd6fb89d38b2d83eced2460c4dc1 - - -// Organization - -* entry[+].fullUrl = "Organization/org-45fe50eae508b5755dd140ab2093eb5e" -* entry[=].resource = org-45fe50eae508b5755dd140ab2093eb5e - - -// PackagedProductDefinition - -* entry[+].fullUrl = "PackagedProductDefinition/ppd-04c9bd6fb89d38b2d83eced2460c4dc1" -* entry[=].resource = ppd-04c9bd6fb89d38b2d83eced2460c4dc1 - - -// MedicinalProductDefinition - -* entry[+].fullUrl = "MedicinalProductDefinition/mpb6ced64d25ea2c8da6c6099386f14db1" -* entry[=].resource = mpb6ced64d25ea2c8da6c6099386f14db1 - - -// ManufacturedItemDefinition - -* entry[+].fullUrl = "ManufacturedItemDefinition/mid-04c9bd6fb89d38b2d83eced2460c4dc1" -* entry[=].resource = mid-04c9bd6fb89d38b2d83eced2460c4dc1 - - diff --git a/input/fsh/examples/flucelvax-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/flucelvax-ema-automatic/ClinicalUseDefinition.fsh deleted file mode 100644 index e69de29bb2..0000000000 diff --git a/input/fsh/examples/flucelvax-ema-automatic/Composition.fsh b/input/fsh/examples/flucelvax-ema-automatic/Composition.fsh deleted file mode 100644 index 4e14c64a15..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/Composition.fsh +++ /dev/null @@ -1,195 +0,0 @@ - -Instance: composition056f32ee5cf49404607e368bd8d3f2af -InstanceOf: CompositionUvEpi -Title: "Composition for asdad Package Leaflet" -Description: "Composition for asdad Package Leaflet" -Usage: #example - -* identifier.system = "asdas" -* identifier.value = "asdasd" - -* status = #final - - - - - -* type = https://spor.ema.europa.eu/rmswi/#100000155538 -* type.text = "Package Leaflet" - -* subject = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* date = "2023-04-22T15:15:46Z" -* author = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - -* title = "TEST PURPOSES ONLY - asdad" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2023-04-22T15:15:46Z" -* language = #en - - -* section[+]. - * title = "B. Package Leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "B. PACKAGE LEAFLET" - * text.status = #additional - * text.div = """
    <p class="MsoNormal" style="text-align: center;" align="center"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Package leaflet: Information for the user</span></strong></p> -<p class="MsoNormal" style="text-align: center; line-height: normal; mso-list: skip; tab-stops: 36.0pt; background: white;" align="center"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="SmPC-PLtext" style="text-align: center;" align="center"><strong style="mso-bidi-font-weight: normal;"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span></strong><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;"> - suspension for injection in pre-filled syringe</span></strong></p> -<p class="SmPC-PLtext" style="text-align: center;" align="center"><span lang="EN-GB" style="color: windowtext;">Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)</span></p> -<p class="MsoNormal" style="line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-no-proof: yes;"><img src="data:image/png;base64,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" annotationsrc="~/_entity/annotation/76a10366-26e0-ed11-a7c6-000d3aaa0403" />This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</span></p> -<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></strong></p> -<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</span></strong></p> -<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this leaflet. You may need to read it again. </span></p> -<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you have any further questions, ask your doctor, pharmacist or nurse.</span></p> -<p class="MsoNormal" style="margin-left: 1.0cm; text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; color: red;"> </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">This includes any possible side effects not listed in this leaflet. See section 4.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">What is in this leaflet</span></strong></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">1.<span style="mso-tab-count: 1;">    </span>What </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">is and what it is used for </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">2.<span style="mso-tab-count: 1;">    </span>What you need to know before you <span class="SmPC-PLtextChar">receive </span></span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">3.<span style="mso-tab-count: 1;">    </span>How </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span class="SmPC-PLtextChar"><span lang="EN-GB">is given</span></span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">4.<span style="mso-tab-count: 1;">    </span>Possible side effects </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">5.<span style="mso-tab-count: 1;">    </span>How to store </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-spacerun: yes;"> </span></span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">6.<span style="mso-tab-count: 1;">    </span>Contents of the pack and other information</span></p>
    -
    """ - - - -* section[=].section[+] - * title = "Package leaflet: Information for the user" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "Package leaflet: Information for the user" - * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - -* section[=].section[+] - * title = "What is in this leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "What is in this leaflet" - * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - -* section[=].section[+] - * title = "1. What asdad is and what it is used for" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "1. What asdad is and what it is used for" - * text.status = #additional - * text.div = """
    <p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a vaccine against flu (influenza). </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span class="SmPC-PLtextChar"><span lang="EN-GB" style="color: windowtext;">is prepared in cell cultures, and, therefore, is egg-free.</span></span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is used to prevent flu in adults and children from 2 years of age.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</span></p>
    -
    """ - - - -* section[=].section[+] - * title = "2. What you need to know before you take asdad" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "2. What you need to know before you take asdad" - * text.status = #additional - * text.div = """
    <p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt;"><span lang="EN-GB" style="color: windowtext;">If you are allergic to:</span></p> -<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">the active ingredients or any of the other ingredients of this medicine (listed in section 6)</span></p> -<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.</span></p>
    -
    """ - -* section[=].section[+] - * title = "3. How to take asdad" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "3. How to take asdad" - * text.status = #additional - * text.div = """
    <p class="MsoNormal" style="line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Talk to your doctor, pharmacist or nurse before <span class="SmPC-PLtextChar">receiving</span> </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span lang="EN-GB">.</span></span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span><u><span style="color: windowtext; mso-ansi-language: EN-US;">BEFORE receiving the vaccine</span></u></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Your <span style="mso-bidi-font-weight: bold;">doctor or nurse</span> will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span style="color: windowtext;"> </span></span><span style="color: windowtext; mso-ansi-language: EN-US;">as with all vaccines that are injected.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US; mso-bidi-font-weight: bold;">You</span><span style="color: windowtext; mso-ansi-language: EN-US;"> should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have a bleeding problem or bruise easily.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</span></p> -<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span style="color: windowtext; mso-ansi-language: EN-US;"> </span><span style="color: windowtext; mso-ansi-language: EN-US;">As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</span></p>
    -
    """ - - -* section[=].section[+] - * title = "4. Possible side effects" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "4. Possible side effects" - * text.status = #additional - * text.div = """
    <p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Like all medicines, this medicine can cause side effects, although not everybody gets them.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The following side effects have been reported during clinical trials and during general use:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Very serious side effects</span></strong></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</span></p> -<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Serious side effects</span></strong></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of <span style="mso-spacerun: yes;"> </span>Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Extensive swelling of injected limb</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Mild side effects</span></strong></p> -<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Very common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect more than 1 in 10 people):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Headache</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Muscle pain <span style="mso-spacerun: yes;"> </span></span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Tiredness </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Loss of appetite</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Irritability (only reported in children from 2 to < 6 years)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Sleepiness (only reported in children 2 to < 6 years)</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Headache was common in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Loss of appetite was common in adults, eldery and children 9 to < 18 years.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><u><span lang="EN-GB" style="color: windowtext;">Common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect up to 1 in 10 people):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Nausea, vomiting, diarrhoea </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Joint pain</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Shivering</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Change in eating habits (only reported in children from 2 to < 6 years)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Fever (<u>></u> 38°C)</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Vomiting was uncommon in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Fever was uncommon in adults and the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Not known</span></u><span lang="EN-GB" style="color: windowtext;"> (frequency cannot be estimated from the available data):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Numbness and tingling sensation (paraesthesia)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash </span></p>
    -
    """ - -* section[=].section[+] - * title = "5. How to store asdad" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "5. How to store asdad" - * text.status = #additional - * text.div = """
    <p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this <span class="SmPC-PLtextChar">vaccine</span> out of the sight and reach of children.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Store in a refrigerator (2 °C to 8 °C). Do not freeze.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Keep the pre-filled syringe in the outer carton in order to protect from light.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not use this <span class="SmPC-PLtextChar">vaccine</span> after the expiry date which is stated on the label and carton after <span class="SmPC-PLtextChar">EXP</span>. The expiry date refers to the last day of that month.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</span></p>
    -
    """ - - -* section[=].section[+] - * title = "6. Contents of the pack and other information" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "6. Contents of the pack and other information" - * text.status = #additional - * text.div = """
    <p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a suspension for injection in a pre-filled syringe (ready to use syringe). <br /></span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a clear to slightly opalescent suspension.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">A single syringe contains 0.5 ml of suspension for injection.</span></p> -<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Not all pack sizes may be marketed.</span></p>
    -
    """ - diff --git a/input/fsh/examples/flucelvax-ema-automatic/Ingredient.fsh b/input/fsh/examples/flucelvax-ema-automatic/Ingredient.fsh deleted file mode 100644 index 7da3815fb2..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/Ingredient.fsh +++ /dev/null @@ -1,396 +0,0 @@ - - - - - -Instance: ingredient-for-2e8cb2387c664fb619f6b8914767d38f - - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-active INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE" -Description: "INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "9V4SVN4JQV" -* identifier.use = #official - -* role = $spor-rms#100000072072 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#9V4SVN4JQV "INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE" - - -* substance.strength.presentationQuantity = 15.0 'mcg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-influenzaavirusadarwin112021h3n2whole - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-active INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE" -Description: "INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "JS7E5ZZ3AC" -* identifier.use = #official - -* role = $spor-rms#100000072082 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#JS7E5ZZ3AC "INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE" - - -* substance.strength.presentationQuantity = 15.0 'mcg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-f4e520e2974f4acb8abe26b607ea5a46 - - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-active INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE" -Description: "INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "BFA4LSE5QQ" -* identifier.use = #official - -* role = $spor-rms#100000072082 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#BFA4LSE5QQ "INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE" - - -* substance.strength.presentationQuantity = 15.0 'mcg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-2c0c197a41a706fb2549601e635da1f3 - - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-active INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE" -Description: "INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "B3EV5T8SUF" -* identifier.use = #official - -* role = $spor-rms#100000072082 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#B3EV5T8SUF "INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE" - - -* substance.strength.presentationQuantity = 15.0 'mcg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-sodiumchloride - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Sodium chloride" -Description: "Sodium chloride" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "451W47IQ8X" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#451W47IQ8X "Sodium chloride" - - -* substance.strength.presentationQuantity = 1.0 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-potassiumchloride - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Potassium chloride" -Description: "Potassium chloride" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "660YQ98I10" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#660YQ98I10 "Potassium chloride" - - -* substance.strength.presentationQuantity = 0.5 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-magnesiumchloride - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient MAGNESIUM CHLORIDE" -Description: "MAGNESIUM CHLORIDE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "02F3473H9O" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#02F3473H9O "MAGNESIUM CHLORIDE" - - -* substance.strength.presentationQuantity = 0.2 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-sodiumphosphatedibasicdihydrate - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient SODIUM PHOSPHATE, DIBASIC, DIHYDRATE" -Description: "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "94255I6E2T" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#94255I6E2T "SODIUM PHOSPHATE, DIBASIC, DIHYDRATE" - - -* substance.strength.presentationQuantity = 0.2 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-potassiumdihydrogenphosphate - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Potassium dihydrogen phosphate -" -Description: "Potassium dihydrogen phosphate -" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "4J9FJ0HL51" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#4J9FJ0HL51 "Potassium dihydrogen phosphate -" - - -* substance.strength.presentationQuantity = 0.2 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - - -Instance: ingredient-for-flucelvax-waterforinjections - - -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Water for injections" -Description: "Water for injections" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "059QF0KO0R" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #nan - -* substance.code.concept.coding = $ginas#059QF0KO0R "Water for injections" - - -* substance.strength.presentationQuantity = 0.01 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#nan "nan" - - -// Reference to products -* for = Reference(mid-04c9bd6fb89d38b2d83eced2460c4dc1) -* for[+] = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* for[+] = Reference(ap-04c9bd6fb89d38b2d83eced2460c4dc1) -// Reference to Organization: Reference to MAH - - - - -* manufacturer.manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) diff --git a/input/fsh/examples/flucelvax-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/flucelvax-ema-automatic/ManufacturedItemDefinition.fsh deleted file mode 100644 index 1dbd672e73..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/ManufacturedItemDefinition.fsh +++ /dev/null @@ -1,26 +0,0 @@ - -Instance: mid-04c9bd6fb89d38b2d83eced2460c4dc1 -InstanceOf: ManufacturedItemDefinitionUvEpi -Title: "Manufactured item Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Description: "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" -* identifier.value = "EU/1/18/1326/001 -" -* identifier.use = #official - -* status = #active -* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000074063 "suspension for injection in pre-filled syringe" - -* unitOfPresentation = $spor-rms#200000002150 "Syringe" - - - - - - - -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) \ No newline at end of file diff --git a/input/fsh/examples/flucelvax-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/flucelvax-ema-automatic/MedicinalProductDefinition.fsh deleted file mode 100644 index 9d39b30019..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/MedicinalProductDefinition.fsh +++ /dev/null @@ -1,55 +0,0 @@ - -Instance: mpb6ced64d25ea2c8da6c6099386f14db1 -InstanceOf: MedicinalProductDefinitionUvEpi -Title: "Medicinal Product Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Description: "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Usage: #example - - -* identifier[+].system = "hhtttp://asdsadad.com" -* identifier[=].value = "x" -* type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" - -* domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" - -* status = http://hl7.org/fhir/publication-status#active "active" - - - - - -* legalStatusOfSupply = $spor-rms#100000000000 "Medicinal product subject to medical prescription" - - -* name - * productName = "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" - * type = $spor-productNamePartType-cs#220000000001 - * text = "Full name" - - * part[0] - * part = "Flucelvax Tetra" - * type = $spor-productNamePartType-cs#220000000002 - * type.text = "Invented name part" - - * part[+] - * part = "Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" - * type = $spor-productNamePartType-cs#220000000003 - * type.text = "Scientific name part" - - * part[+] - * part = "15 mg" - * type = $spor-productNamePartType-cs#220000000004 - * type.text = "Strength part" - - * part[+] - * part = "Solution for injection" - * type = $spor-productNamePartType-cs#220000000005 - * type.text = "Pharmaceutical dose form part" - - * usage - * country = urn:iso:std:iso:3166#ES "" - * jurisdiction = urn:iso:std:iso:3166#ES "" - * language = urn:ietf:bcp:47#en "English" \ No newline at end of file diff --git a/input/fsh/examples/flucelvax-ema-automatic/Organization.fsh b/input/fsh/examples/flucelvax-ema-automatic/Organization.fsh deleted file mode 100644 index 645829dcd7..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/Organization.fsh +++ /dev/null @@ -1,32 +0,0 @@ - - - - -Instance: org-45fe50eae508b5755dd140ab2093eb5e - -InstanceOf: OrganizationUvEpi -Title: "Seqirus Netherlands B.V. as Marketing authorisation holder" -Description: "Seqirus Netherlands B.V. as Marketing authorisation holder" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "ORG-100013715" -* identifier.use = #official - -* active = true - -* type = $spor-rms#220000000034 "Marketing authorisation holder" -* type.text = "Marketing authorisation holder" -* name = "Seqirus Netherlands B.V." - -* contact - * address - * text = "Paasheuvelweg 28 - 1105BJ Amsterdam - Netherlands" - * use = #work - * type = #physical - * line = "Paasheuvelweg 28" - * city = "1105BJ Amsterdam" - * country = "Netherlands" - * postalCode = "367061" \ No newline at end of file diff --git a/input/fsh/examples/flucelvax-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/flucelvax-ema-automatic/PackagedProductDefinition.fsh deleted file mode 100644 index 8d41a509df..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/PackagedProductDefinition.fsh +++ /dev/null @@ -1,48 +0,0 @@ - -Instance: ppd-04c9bd6fb89d38b2d83eced2460c4dc1 -InstanceOf: PackagedProductDefinitionUvEpi -Title: "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Description: "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "nan" -* identifier.use = #official - -* name = "Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" - -* type = $spor-rms#100000155527 "" -//* type = $spor-rms#100000155527 - - -* status = http://hl7.org/fhir/publication-status#active "Active" -* statusDate = "2019-01-01" - - -* containedItemQuantity = 15 'mcg' - - -* copackagedIndicator = true - - -* packaging - * identifier.system = $spor-prod - * identifier.value = "xxxx" - * type = $spor-rms#100000073498 "100000073498" - * quantity = 1 - * material = $spor-rms#200000003529 "Cardboard" - - - * packaging.type = $spor-rms#30051000 "Pre-filled syringe" - * packaging.quantity = 2 - - - * packaging.material[+] = $spor-rms#200000003204 "Glass type I" - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* packageFor = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) - // Reference to Organization: MAH -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) diff --git a/input/fsh/examples/flucelvax-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/flucelvax-ema-automatic/RegulatedAuthorization.fsh deleted file mode 100644 index e871ac70f2..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/RegulatedAuthorization.fsh +++ /dev/null @@ -1,38 +0,0 @@ - -Instance: authorization04c9bd6fb89d38b2d83eced2460c4dc1 -InstanceOf: RegulatedAuthorizationUvEpi -Title: "Regulated Authorization for Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Description: "Regulated Authorization for Flucelvax Tetra - suspension for injection in pre-filled syringe -Influenza vaccine (surface antigen, inactivated, prepared in cell cultures)" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "EU/1/18/1326/001 -" -* identifier.use = #official - - // Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet - //* subject = Reference(karvea75mgblisterx28) -* subject = Reference(mpb6ced64d25ea2c8da6c6099386f14db1) -* type = $spor-rms#100000072062 "Marketing Authorisation" - -//* type = $spor-rms#100000072062 -//* type.text = "Marketing Authorisation" - -* region = urn:iso:std:iso:3166#EU "European Union" - - -* status = http://hl7.org/fhir/publication-status#active "Active" - - -* statusDate = "2019-01-01" -// * holder = Reference(sanofiaventisgroupe) - - - -* holder = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - - - - diff --git a/input/fsh/examples/flucelvax-ema-automatic/Substance.fsh b/input/fsh/examples/flucelvax-ema-automatic/Substance.fsh deleted file mode 100644 index 4793372078..0000000000 --- a/input/fsh/examples/flucelvax-ema-automatic/Substance.fsh +++ /dev/null @@ -1,108 +0,0 @@ - -Instance: substance-influenzaavirusadelaware552019cvr45h1n1whole -InstanceOf: SubstanceDefinitionUvEpi -Description: "INFLUENZA A VIRUS A/Delaware/55/2019 CVR-45 (H1N1) WHOLE" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "9V4SVN4JQV" -* identifier.use = #official - -* version = "1.0" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 "Validated (UNII)" - -//* description = "nan" - - - // Reference to Organization: MAH - -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - -* structure.molecularFormula = "nan" - -//* name.name = "nan" - - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#nan "nan" - -Instance: substance-influenzaavirusadarwin112021h3n2whole -InstanceOf: SubstanceDefinitionUvEpi -Description: "INFLUENZA A VIRUS A/Darwin/11/2021 (H3N2) WHOLE" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "JS7E5ZZ3AC" -* identifier.use = #official - -* version = "nan" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 "Validated (UNII)" - -//* description = "nan" - - - // Reference to Organization: MAH - -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - -* structure.molecularFormula = "nan" - -//* name.name = "nan" - - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#nan "nan" - -Instance: substance-influenzabvirusbsingaporewuh46182021whole -InstanceOf: SubstanceDefinitionUvEpi -Description: "INFLUENZA B VIRUS B/Singapore/WUH4618/2021 WHOLE" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "BFA4LSE5QQ" -* identifier.use = #official - -* version = "nan" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 "Validated (UNII)" - -//* description = "nan" - - - // Reference to Organization: MAH - -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - -* structure.molecularFormula = "nan" - -//* name.name = "nan" - - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#nan "nan" - -Instance: substance-influenzabvirusbsingaporeinftt1606102016whole -InstanceOf: SubstanceDefinitionUvEpi -Description: "INFLUENZA B VIRUS B/SINGAPORE/INFTT-16-0610/2016 WHOLE" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "B3EV5T8SUF" -* identifier.use = #official - -* version = "nan" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 "Validated (UNII)" - -//* description = "nan" - - - // Reference to Organization: MAH - -* manufacturer = Reference(org-45fe50eae508b5755dd140ab2093eb5e) - -* structure.molecularFormula = "nan" - -//* name.name = "nan" - - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#nan "nan" diff --git a/input/fsh/examples/humalog-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/humalog-ema-automatic/AdministrableProductDefinition.fsh index 1eb16558ee..6009b2e7e5 100644 --- a/input/fsh/examples/humalog-ema-automatic/AdministrableProductDefinition.fsh +++ b/input/fsh/examples/humalog-ema-automatic/AdministrableProductDefinition.fsh @@ -1,8 +1,8 @@ -Instance: ap-a38f06714db0c27b2ba704652e3f08c5 +Instance: ap-fa2090b7ce9bdf87e24a9d05bbb51677 InstanceOf: AdministrableProductDefinitionUvEpi -Title: "Administrable product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" -Description: "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" +Title: "Administrable product Humalog 100 U/ml 5 pre-filled pen" +Description: "Humalog 100 U/ml 5 pre-filled pen" Usage: #example * identifier.system = $phpid @@ -10,7 +10,7 @@ Usage: #example * status = #active -* formOf = Reference(mpd33868162d255ced115cecbbf188aab4) +* formOf = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) * administrableDoseForm = $spor-rms#100000073864 "Suspension for injection" * unitOfPresentation = $spor-rms#200000002135 "Pen" @@ -18,7 +18,7 @@ Usage: #example //reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* producedFrom = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) +* producedFrom = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) * routeOfAdministration.code = $spor-rms#100000073633 "Subcutaneous use" diff --git a/input/fsh/examples/humalog-ema-automatic/Bundle.fsh b/input/fsh/examples/humalog-ema-automatic/Bundle.fsh index 252dea60f4..aabf285e67 100644 --- a/input/fsh/examples/humalog-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/humalog-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "xx" * type = #document -* timestamp = "2023-04-17T13:20:24Z" +* timestamp = "2023-04-05T10:36:35Z" // Composition * entry[0].fullUrl = "Composition/composition45f3604d61f93f5f026bea5d5824af10" @@ -70,8 +70,8 @@ Usage: #example // AdministrableProductDefinition -* entry[+].fullUrl = "AdministrableProductDefinition/ap-a38f06714db0c27b2ba704652e3f08c5" -* entry[=].resource = ap-a38f06714db0c27b2ba704652e3f08c5 +* entry[+].fullUrl = "AdministrableProductDefinition/ap-fa2090b7ce9bdf87e24a9d05bbb51677" +* entry[=].resource = ap-fa2090b7ce9bdf87e24a9d05bbb51677 // RegulatedAuthorization @@ -98,19 +98,19 @@ Usage: #example // PackagedProductDefinition -* entry[+].fullUrl = "PackagedProductDefinition/ppd-a38f06714db0c27b2ba704652e3f08c5" -* entry[=].resource = ppd-a38f06714db0c27b2ba704652e3f08c5 +* entry[+].fullUrl = "PackagedProductDefinition/ppd-a9955d128989ce310e64a9fb99c8a9ac" +* entry[=].resource = ppd-a9955d128989ce310e64a9fb99c8a9ac // MedicinalProductDefinition -* entry[+].fullUrl = "MedicinalProductDefinition/mpd33868162d255ced115cecbbf188aab4" -* entry[=].resource = mpd33868162d255ced115cecbbf188aab4 +* entry[+].fullUrl = "MedicinalProductDefinition/mpf6b4fcaaf21ddd70f011f383780f7bf3" +* entry[=].resource = mpf6b4fcaaf21ddd70f011f383780f7bf3 // ManufacturedItemDefinition -* entry[+].fullUrl = "ManufacturedItemDefinition/mid-a38f06714db0c27b2ba704652e3f08c5" -* entry[=].resource = mid-a38f06714db0c27b2ba704652e3f08c5 +* entry[+].fullUrl = "ManufacturedItemDefinition/mid-fa2090b7ce9bdf87e24a9d05bbb51677" +* entry[=].resource = mid-fa2090b7ce9bdf87e24a9d05bbb51677 diff --git a/input/fsh/examples/humalog-ema-automatic/Composition.fsh b/input/fsh/examples/humalog-ema-automatic/Composition.fsh index e4ca0f6d5c..9520aeec08 100644 --- a/input/fsh/examples/humalog-ema-automatic/Composition.fsh +++ b/input/fsh/examples/humalog-ema-automatic/Composition.fsh @@ -10,21 +10,20 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" -* subject = Reference(mpd33868162d255ced115cecbbf188aab4) +* subject = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) * date = "2022-02-16T13:28:17Z" * author = Reference(org-3fdc76794516d7826890ab9f893e99c1) * title = "TEST PURPOSES ONLY - Humalog" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,8 +42,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    + + * text.div = """
    PACKAGE LEAFLET: INFORMATION FOR THE USER Humalog Mix50 100 units/ml suspension for injection in cartridge insulin lispro @@ -55,19 +54,15 @@ Read all of this leaflet carefully before you start taking this medicine because
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
    • -
    """ - - - - +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    + + * text.div = """
    What in this leaflet
    1. What Humalog Mix50 is and what it is used for
      2. @@ -77,36 +72,38 @@ What in this leaflet
    2. How to store Humalog Mix50
    3. Contents of the pack and other information
    -
    """ - - - +
    """ * section[=].section[+] * title = "1. What Humalog is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What Humalog is and what it is used for" * text.status = #additional - * text.div = """

    Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because -the insulin molecule has been changed slightly.

    -

    You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your -blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It -works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally -use Humalog within 15 minutes of a meal.

    -

    Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin -comes with another patient information leaflet to tell you about it. Do not change your insulin unless -your doctor tells you to. Be very careful if you do change insulin.

    -

    Humalog is suitable for use in adults and children.

    """ - - - + + * text.div = """
    +1.What Humalog Mix50 is and what it is used for +Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active +substance is insulin lispro. 50% of the insulin lispro in Humalog Mix50 is dissolved in water and it +works more quickly than normal human insulin because the insulin molecule has been changed +slightly. 50% of the insulin lispro in Humalog Mix50 is available in a suspension together with +protamine sulphate, so that its action is prolonged. +You get diabetes if your pancreas does not make enough insulin to control the level of glucose in +your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the +long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should +normally use Humalog Mix50 within 15 minutes of a meal. +Your doctor may tell you to use Humalog Mix50 as well as a longer-acting insulin. Each kind of +insulin comes with another patient information leaflet to tell you about it. Do not change your +insulin unless your doctor tells you to. Be very careful if you do change insulin. +
    """ * section[=].section[+] * title = "2. What you need to know before you take Humalog" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take Humalog" * text.status = #additional - - * text.div = """
    + + + * text.div = """
    +2. What you need to know before you use Humalog Mix50

    Do NOT use Humalog Mix50

    • if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to @@ -182,17 +179,14 @@ have:

      Humalog Mix50 contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
    -
    """ - - - +
    """ * section[=].section[+] * title = "3. How to take Humalog" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take Humalog" * text.status = #additional - - * text.div = """
    + + * text.div = """
    3. How to use Humalog Mix50

    Dose

      @@ -277,9 +271,7 @@ damaged.

      If you stop using Humalog Mix50.

      If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your insulin unless your doctor tells you to.

      -

      If you have any further questions on the use of this product, ask your doctor or pharmacist

    """ - - +

    If you have any further questions on the use of this product, ask your doctor or pharmacist

    """ * section[=].section[+] @@ -287,85 +279,20 @@ insulin unless your doctor tells you to.

    * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them. -Systemic allergy is rare (≥ 1/10,000 to <1/1,000). The symptoms are as follows:

    -
      -
    • rash over the whole body
      • -
    • blood pressure dropping
      • -
    • difficulty in breathing
      • -
    • heart beating fast
      • -
    • wheezing
      • -
    • sweating
      • -
    -

    If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once.

    -

    Local allergy is common (≥ 1/100 to <1/10). Some people get redness, swelling or itching around the -area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this -happens to you, tell your doctor.

    -

    Lipodystrophy is uncommon (≥ 1/1,000 to <1/100). If you inject insulin too often at the same place, -the fatty tissue may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin -may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may -not work very well if you inject into a lumpy area. Change the injection site with each injection to help -prevent these skin changes.

    -

    Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of -insulin therapy or during a change in therapy to improve control of your blood glucose.

    -

    Reporting of side effects

    -

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects -not listed in this leaflet. You can also report side effects directly via the national reporting system -listed in Appendix V. By reporting side effects you can help provide more information on the safety of -this medicine.

    -

    Common problems of diabetes

    -

    A. Hypoglycaemia

    -

    Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if:

    -
      -
    • you take too much Humalog or other insulin;
      • -
    • you miss or delay meals or change your diet;
      • -
    • you exercise or work too hard just before or after a meal;
      • -
    • you have an infection or illness (especially diarrhoea or vomiting);
      • -
    • there is a change in your need for insulin; or
      • -
    • you have trouble with your kidneys or liver which gets worse. -Alcohol and some medicines can affect your blood sugar levels. -The first symptoms of low blood sugar usually come on quickly and include the following:
      • -
    • tiredness
      • -
    • rapid heartbeat
      • -
    • nervousness or shakiness
      • -
    • feeling sick
      • -
    • headache
      • -
    • cold sweat. -While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a -car, in which you or others would be put at risk by hypoglycaemia.
      • -
    -

    B. Hyperglycaemia and diabetic ketoacidosis

    -

    Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. -Hyperglycaemia can be brought about by:

    -
      -
    • not taking your Humalog or other insulin;
      • -
    • taking less insulin than your doctor tells you to;
      • -
    • eating a lot more than your diet allows; or
      • -
    • fever, infection or emotional stress.
      • -
    -

    Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many -hours or days. The symptoms include the following:

    -
      -
    • feeling sleepy
      • -
    • no appetite
      • -
    • flushed face
      • -
    • fruity smell on the breath
      • -
    • thirst
      • -
    • feeling or being sick -Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately.
      • -
    -

    C. Illness

    -

    If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even -when you are not eating normally, you still need insulin. Test your urine or blood, follow your -‘sick rules’, and tell your doctor.

    """ + + * text.div = """
    +

    4. Possible side effects

    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    +
    """ * section[=].section[+] * title = "5. How to store Humalog" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store Humalog" * text.status = #additional - - * text.div = """
    + + * text.div = """
    +

    5. How to store Humalog Mix50

    Before the first use store your Humalog Mix50 in a refrigerator (2°C – 8°C). Do not freeze. Keep your cartridge in use at room temperature (below 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen @@ -376,18 +303,16 @@ date refers to the last day of that month. Do not use this medicine if you notice clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to -dispose of medicines no longer required. These measures will help to protect the environment.

    """ - - - +dispose of medicines no longer required. These measures will help to protect the environment.

    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    + + * text.div = """
    +6. Contents of the pack and other information What Humalog Mix50 100 units/ml suspension for injection in cartridge contains

    The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other @@ -396,7 +321,4 @@ hormone made by the pancreas. The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

    -
    """ - - - +
    """ \ No newline at end of file diff --git a/input/fsh/examples/humalog-ema-automatic/Ingredient.fsh b/input/fsh/examples/humalog-ema-automatic/Ingredient.fsh index bb8d497997..71f082432e 100644 --- a/input/fsh/examples/humalog-ema-automatic/Ingredient.fsh +++ b/input/fsh/examples/humalog-ema-automatic/Ingredient.fsh @@ -18,9 +18,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -49,9 +49,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -80,9 +80,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -111,9 +111,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -146,9 +146,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -177,9 +177,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -208,9 +208,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH @@ -239,9 +239,9 @@ Usage: #example // Reference to products -* for = Reference(mid-a38f06714db0c27b2ba704652e3f08c5) -* for[+] = Reference(mpd33868162d255ced115cecbbf188aab4) -* for[+] = Reference(ap-a38f06714db0c27b2ba704652e3f08c5) +* for = Reference(mid-fa2090b7ce9bdf87e24a9d05bbb51677) +* for[+] = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) +* for[+] = Reference(ap-fa2090b7ce9bdf87e24a9d05bbb51677) // Reference to Organization: Reference to MAH diff --git a/input/fsh/examples/humalog-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/humalog-ema-automatic/ManufacturedItemDefinition.fsh index 7a265fb43f..0d8f9b31f7 100644 --- a/input/fsh/examples/humalog-ema-automatic/ManufacturedItemDefinition.fsh +++ b/input/fsh/examples/humalog-ema-automatic/ManufacturedItemDefinition.fsh @@ -1,8 +1,8 @@ -Instance: mid-a38f06714db0c27b2ba704652e3f08c5 +Instance: mid-fa2090b7ce9bdf87e24a9d05bbb51677 InstanceOf: ManufacturedItemDefinitionUvEpi -Title: "Manufactured item Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" -Description: "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" +Title: "Manufactured item Humalog 100 U/ml 5 pre-filled pen" +Description: "Humalog 100 U/ml 5 pre-filled pen" Usage: #example * identifier.system = "https://spor.ema.europa.eu/pmswi/#/" diff --git a/input/fsh/examples/humalog-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/humalog-ema-automatic/MedicinalProductDefinition.fsh index 8b6945016a..4b8ceada4c 100644 --- a/input/fsh/examples/humalog-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/humalog-ema-automatic/MedicinalProductDefinition.fsh @@ -1,15 +1,13 @@ -Instance: mpd33868162d255ced115cecbbf188aab4 +Instance: mpf6b4fcaaf21ddd70f011f383780f7bf3 InstanceOf: MedicinalProductDefinitionUvEpi -Title: "Medicinal Product Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" -Description: "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" +Title: "Medicinal Product Humalog Mix50 Insulin KwikPen, 3ml pre-fill" +Description: "EU/1/97/049/001 Humalog Mix50 Insulin KwikPen, 3ml pre-fill" Usage: #example - -* identifier[+].system = "https://spor.ema.europa.eu/pmswi" -* identifier[=].value = "EU/1/96/007/035" -* identifier[+].system = "https://www.who-umc.org/phpid" -* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E82717" +* identifier.system = $spor-prod +* identifier.value = "EU/1/96/007/035" + * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" * domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" @@ -26,7 +24,7 @@ Usage: #example * classification[+] = $atc#A10AB04 "insulin lispro" * name - * productName = "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" + * productName = "Humalog Mix50 Insulin KwikPen, 3ml pre-fill" * type = $spor-productNamePartType-cs#220000000001 * text = "Full name" diff --git a/input/fsh/examples/humalog-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/humalog-ema-automatic/PackagedProductDefinition.fsh index 3edd505d02..bbd99e728e 100644 --- a/input/fsh/examples/humalog-ema-automatic/PackagedProductDefinition.fsh +++ b/input/fsh/examples/humalog-ema-automatic/PackagedProductDefinition.fsh @@ -1,15 +1,15 @@ -Instance: ppd-a38f06714db0c27b2ba704652e3f08c5 +Instance: ppd-a9955d128989ce310e64a9fb99c8a9ac InstanceOf: PackagedProductDefinitionUvEpi -Title: "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" -Description: "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" +Title: "Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen" +Description: "Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen" Usage: #example * identifier.system = $spor-prod * identifier.value = "EU/1/96/007/035" * identifier.use = #official -* name = "Humalog Mix50 Insulin KwikPen, 100 U/ml, Suspension for injection 3ml pre-fill" +* name = "Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen" * type = $spor-rms#100000155527 "Chemical Medicinal Prodcut" //* type = $spor-rms#100000155527 @@ -35,6 +35,6 @@ Usage: #example //reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* packageFor = Reference(mpd33868162d255ced115cecbbf188aab4) +* packageFor = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) // Reference to Organization: MAH * manufacturer = Reference(org-3fdc76794516d7826890ab9f893e99c1) diff --git a/input/fsh/examples/humalog-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/humalog-ema-automatic/RegulatedAuthorization.fsh index a839469803..6f3d9c47bc 100644 --- a/input/fsh/examples/humalog-ema-automatic/RegulatedAuthorization.fsh +++ b/input/fsh/examples/humalog-ema-automatic/RegulatedAuthorization.fsh @@ -11,7 +11,7 @@ Usage: #example // Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet //* subject = Reference(karvea75mgblisterx28) -* subject = Reference(mpd33868162d255ced115cecbbf188aab4) +* subject = Reference(mpf6b4fcaaf21ddd70f011f383780f7bf3) * type = $spor-rms#100000072062 "Marketing Authorisation" //* type = $spor-rms#100000072062 diff --git a/input/fsh/examples/humira-ema-automatic/Bundle.fsh b/input/fsh/examples/humira-ema-automatic/Bundle.fsh index 28d1512f89..b6de82db43 100644 --- a/input/fsh/examples/humira-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/humira-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "nan" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/composition3a3583227b4c5b0887f1e0d38269b469" diff --git a/input/fsh/examples/humira-ema-automatic/Composition.fsh b/input/fsh/examples/humira-ema-automatic/Composition.fsh index 600cab5620..7b7dfbe5b0 100644 --- a/input/fsh/examples/humira-ema-automatic/Composition.fsh +++ b/input/fsh/examples/humira-ema-automatic/Composition.fsh @@ -6,14 +6,10 @@ Description: "Composition for humira Package Leaflet" Usage: #example * identifier.system = "https://spor.ema.europa.eu/rmswi/" -* identifier.value = "nan" +* identifier.value = "EU/1/96/007/035" * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-fda7514c0dcb7b5f0176cb5af274235f) * title = "TEST PURPOSES ONLY - humira" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,6 +42,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional + * text.div = """

    Humira 40 mg solution for injection in pre-filled syringe adalimumab

    Read all of this leaflet carefully before your child starts using this medicine because it contains important information.

    @@ -55,13 +55,12 @@ adalimumab

    """ - - * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional + * text.div = """

    What is in this leaflet

    1. What Humira is and what it is used for
      2. @@ -71,14 +70,14 @@ adalimumab

    2. How to store Humira
    3. Contents of the pack and other information
    4. Injecting Humira
      5. -
    """ - +
    """ * section[=].section[+] * title = "1. What humira is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What humira is and what it is used for" * text.status = #additional + * text.div = """

    What Humira is and what it is used for Humira contains the active substance adalimumab. Humira is intended for the treatment of the inflammatory diseases described below:

    @@ -126,15 +125,14 @@ affecting the front of the eye This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation. Your child may first be given other medicines. If these medicines do not work well enough, your child -will be given Humira to reduce the signs and symptoms of his/her disease.

    """ - - - +will be given Humira to reduce the signs and symptoms of his/her disease.

    """ * section[=].section[+] * title = "2. What you need to know before you take humira" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take humira" * text.status = #additional + + * text.div = """

    Warnings and precautions

    Talk to your doctor or pharmacist before using Humira. Allergic reactions

    @@ -246,13 +244,13 @@ treatment with a TNF blocker is appropriate for your child.
  • On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
    • -
    """ - +
    """ * section[=].section[+] * title = "3. How to take humira" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take humira" * text.status = #additional + * text.div = """

    How to use Humira

    Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. @@ -272,7 +270,7 @@ not forgotten a dose. If you stop using Humira The decision to stop using Humira should be discussed with your doctor. Your child’s symptoms may return if you stop using Humira. -If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    """ +If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    """ * section[=].section[+] @@ -280,6 +278,7 @@ If you have any further questions on the use of this medicine, ask your doctor o * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional + * text.div = """

    Possible side effects

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur @@ -462,13 +461,14 @@ blood tests. These include: If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of -this medicine.

    """ +this medicine.

    """ * section[=].section[+] * title = "5. How to store humira" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store humira" * text.status = #additional + * text.div = """

    How to store Humira

    Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label/blister/carton after EXP. @@ -482,15 +482,13 @@ discarded, even if it is returned to the refrigerator. You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded. Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how -to throw away medicines you no longer use. These measures will help protect the environment.

    """ - +to throw away medicines you no longer use. These measures will help protect the environment.

    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - + * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable \ No newline at end of file diff --git a/input/fsh/examples/humira-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/humira-ema-automatic/MedicinalProductDefinition.fsh index a60996c30e..a917e1ea48 100644 --- a/input/fsh/examples/humira-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/humira-ema-automatic/MedicinalProductDefinition.fsh @@ -6,7 +6,9 @@ Description: "EU/1/97/049/001 Humira 40 mg Solution for injection Subcutaneous u Usage: #example * identifier.system = $spor-prod -* identifier.value = "nan" +* identifier.value = "EU/1/03/256/022" +* identifier[+].system = $phpid +* identifier[=].value = "0x9982CA8A825D4561506CE808982E3B9E" * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" diff --git a/input/fsh/examples/karvea-ema-automatic/Bundle.fsh b/input/fsh/examples/karvea-ema-automatic/Bundle.fsh index c96785b312..833c69ac93 100644 --- a/input/fsh/examples/karvea-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/karvea-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/96/007/035" * type = #document -* timestamp = "2023-04-16T11:17:59Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/compositionf4d45353edcb21af3718d3a0df94a4d8" @@ -19,13 +19,13 @@ Usage: #example // ClinicalUseDefinition -* entry[+].fullUrl = "ClinicalUseDefinition/contraindication-diabetismellitus" -* entry[=].resource = contraindication-diabetismellitus +* entry[+].fullUrl = "ClinicalUseDefinition/contraindication-gastrointestinaldisorders" +* entry[=].resource = contraindication-gastrointestinaldisorders // ClinicalUseDefinition -* entry[+].fullUrl = "ClinicalUseDefinition/indication-hypertension" -* entry[=].resource = indication-hypertension +* entry[+].fullUrl = "ClinicalUseDefinition/indication-psoriasis" +* entry[=].resource = indication-psoriasis // ClinicalUseDefinition diff --git a/input/fsh/examples/karvea-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/karvea-ema-automatic/ClinicalUseDefinition.fsh index 80d3179ccd..b5c32ccf48 100644 --- a/input/fsh/examples/karvea-ema-automatic/ClinicalUseDefinition.fsh +++ b/input/fsh/examples/karvea-ema-automatic/ClinicalUseDefinition.fsh @@ -1,7 +1,7 @@ -Instance: contraindication-diabetismellitus +Instance: contraindication-gastrointestinaldisorders InstanceOf: ClinicalUseDefinition-contraindication-uv-epi -Description: "contraindication - Diabetis Mellitus" +Description: "contraindication - Gastrointestinal disorders" Usage: #example * identifier.system = "https://spor.ema.europa.eu/rmswi/#/" @@ -19,9 +19,9 @@ Usage: #example -Instance: indication-hypertension +Instance: indication-psoriasis InstanceOf: ClinicalUseDefinition-indication-uv-epi -Description: "indication - Hypertension" +Description: "indication - Psoriasis" Usage: #example * identifier.system = "https://spor.ema.europa.eu/rmswi/#/" diff --git a/input/fsh/examples/karvea-ema-automatic/Composition.fsh b/input/fsh/examples/karvea-ema-automatic/Composition.fsh index 6cdba6de71..080d6cea44 100644 --- a/input/fsh/examples/karvea-ema-automatic/Composition.fsh +++ b/input/fsh/examples/karvea-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-fe4fee458a4f24fccb770d311350f67c) * title = "TEST PURPOSES ONLY - Karvea" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,8 +42,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Karvea 75 mg tablets

    irbesartan

    Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. @@ -54,19 +53,15 @@ Usage: #example
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
    • -
    """ - - - - +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    + + * text.div = """
    • What Karvea is and what it is used for
    • What you need to know before you take Karvea
      • @@ -75,18 +70,15 @@ Usage: #example
    • How to store Karvea
    • Contents of the pack and other information
    -
    """ - - - +
    """ * section[=].section[+] * title = "1. What Karvea is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What Karvea is and what it is used for" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

    @@ -96,19 +88,15 @@ Usage: #example
  • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
    • -
    """ - - - - - +
    """ * section[=].section[+] * title = "2. What you need to know before you take Karvea" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take Karvea" * text.status = #additional - - * text.div = """
    + + + * text.div = """
    Do not take Karvea
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • @@ -171,17 +159,14 @@ Usage: #example Karvea contains sodium.

      This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

      -
    """ - - - +
    """ * section[=].section[+] * title = "3. How to take Karvea" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take Karvea" * text.status = #additional - - * text.div = """
    + + * text.div = """
    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration @@ -210,9 +195,7 @@ Usage: #example If you forget to take Karvea

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    -
    """ - - +
    """ * section[=].section[+] @@ -220,8 +203,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    The frequency of the side effects listed below is defined using the following convention:

    @@ -241,17 +224,15 @@ Usage: #example Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

    -
    """ - - +
    """ * section[=].section[+] * title = "5. How to store Karvea" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store Karvea" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. @@ -259,18 +240,15 @@ Usage: #example

    Do not store above 30°C.

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

    -
    """ - - - +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    + + * text.div = """
    What Karvea contains
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • @@ -493,7 +471,4 @@ Usage: #example

      This leaflet was last revised in

      Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

      -
    """ - - - +
    """ \ No newline at end of file diff --git a/input/fsh/examples/karvea-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/karvea-ema-automatic/MedicinalProductDefinition.fsh index 509b280a42..dd7d3afb4b 100644 --- a/input/fsh/examples/karvea-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/karvea-ema-automatic/MedicinalProductDefinition.fsh @@ -5,10 +5,12 @@ Title: "Medicinal Product Karvea 75 mg tablet blister x28" Description: "EU/1/97/049/001 Karvea 75 mg tablet blister x28" Usage: #example -* identifier[+].system = "https://spor.ema.europa.eu/pmswi" -* identifier[=].value = "EU/1/97/049/001" -* identifier[+].system = "https://www.who-umc.org/phpid" -* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E82719" +* identifier.system = $spor-prod +* identifier.value = "EMEA/H/C/000142" +* identifier[+].system = $phpid +* identifier[=].value = "0x8DFB446EDB3B8AE508AE493827A704E4" + + * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" * domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" diff --git a/input/fsh/examples/mirtazapine-ema-automatic/Bundle.fsh b/input/fsh/examples/mirtazapine-ema-automatic/Bundle.fsh index 3faa7a4a42..5bd9fdc5df 100644 --- a/input/fsh/examples/mirtazapine-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/mirtazapine-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "x" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/composition7a7ff0f4e1993c2fdabba6c8d9931a52" diff --git a/input/fsh/examples/mirtazapine-ema-automatic/Composition.fsh b/input/fsh/examples/mirtazapine-ema-automatic/Composition.fsh index b41f0c98ea..a9225d352f 100644 --- a/input/fsh/examples/mirtazapine-ema-automatic/Composition.fsh +++ b/input/fsh/examples/mirtazapine-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-dbf32c7ed470ffbeb6060201f32edb29) * title = "TEST PURPOSES ONLY - MIRTAZAPINA CINFA 30 mg Coated Tablet" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,8 +42,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Karvea 75 mg tablets

    irbesartan

    Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. @@ -54,19 +53,15 @@ Usage: #example
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
    • -
    """ - - - - +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    + + * text.div = """
    • What Karvea is and what it is used for
    • What you need to know before you take Karvea
      • @@ -75,18 +70,15 @@ Usage: #example
    • How to store Karvea
    • Contents of the pack and other information
    -
    """ - - - +
    """ * section[=].section[+] * title = "1. What MIRTAZAPINA CINFA 30 mg Coated Tablet is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What MIRTAZAPINA CINFA 30 mg Coated Tablet is and what it is used for" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

    @@ -96,19 +88,15 @@ Usage: #example
  • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
    • -
    """ - - - - - +
    """ * section[=].section[+] * title = "2. What you need to know before you take MIRTAZAPINA CINFA 30 mg Coated Tablet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take MIRTAZAPINA CINFA 30 mg Coated Tablet" * text.status = #additional - - * text.div = """
    + + + * text.div = """
    Do not take Karvea
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • @@ -171,17 +159,14 @@ Usage: #example Karvea contains sodium.

      This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

      -
    """ - - - +
    """ * section[=].section[+] * title = "3. How to take MIRTAZAPINA CINFA 30 mg Coated Tablet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take MIRTAZAPINA CINFA 30 mg Coated Tablet" * text.status = #additional - - * text.div = """
    + + * text.div = """
    Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration @@ -210,9 +195,7 @@ Usage: #example If you forget to take Karvea

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    -
    """ - - +
    """ * section[=].section[+] @@ -220,8 +203,8 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    The frequency of the side effects listed below is defined using the following convention:

    @@ -241,17 +224,15 @@ Usage: #example Reporting of side effects

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

    -
    """ - - +
    """ * section[=].section[+] * title = "5. How to store MIRTAZAPINA CINFA 30 mg Coated Tablet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store MIRTAZAPINA CINFA 30 mg Coated Tablet" * text.status = #additional - - * text.div = """
    + + * text.div = """

    Keep this medicine out of the sight and reach of children.

    Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. @@ -259,18 +240,15 @@ Usage: #example

    Do not store above 30°C.

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

    -
    """ - - - +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    + + * text.div = """
    What Karvea contains
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • @@ -493,7 +471,4 @@ Usage: #example

      This leaflet was last revised in

      Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

      -
    """ - - - +
    """ \ No newline at end of file diff --git a/input/fsh/examples/paracetamol-ema-automatic/Bundle.fsh b/input/fsh/examples/paracetamol-ema-automatic/Bundle.fsh index 759fb17462..7ea379babf 100644 --- a/input/fsh/examples/paracetamol-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/paracetamol-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/96/007/035" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/composition34060417eeae4622c4674a9c4100d2ed" diff --git a/input/fsh/examples/paracetamol-ema-automatic/Composition.fsh b/input/fsh/examples/paracetamol-ema-automatic/Composition.fsh index 8f744c23a4..c21954e747 100644 --- a/input/fsh/examples/paracetamol-ema-automatic/Composition.fsh +++ b/input/fsh/examples/paracetamol-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-65db33d6be47a433e6e9e9c2980ea7a4) * title = "TEST PURPOSES ONLY - paracetamol" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #es + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,50 +42,160 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - + + * text.div = """
    +

    Karvea 75 mg tablets

    +

    irbesartan

    + Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +
      +
    • What Karvea is and what it is used for
      • +
    • What you need to know before you take Karvea
      • +
    • How to take Karvea
      • +
    • Possible side effects
      • +
    • How to store Karvea
      • +
    • Contents of the pack and other information
      • +
    +
    """ * section[=].section[+] * title = "1. What paracetamol is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What paracetamol is and what it is used for" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - + + * text.div = """
    +

    + Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. +

    +

    Karvea is used in adult patients

    +
      +
    • to treat high blood pressure (essential hypertension)
      • +
    • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory + evidence of impaired kidney function.
      • +
    +
    """ * section[=].section[+] * title = "2. What you need to know before you take paracetamol" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take paracetamol" * text.status = #additional + - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + * text.div = """
    + Do not take Karvea +
      +
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • +
    • if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – + see pregnancy section)
      • +
    • if you have diabetes or impaired kidney function and you are treated with a blood pressure + lowering medicine containing aliskiren.
      • +
    + Warning and precautions +

    Talk to your doctor before taking Karvea and if any of the following apply to you:

    +
      +
    • if you get excessive vomiting or diarrhoea
      • +
    • if you suffer from kidney problems
      • +
    • if you suffer from heart problems
      • +
    • if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular + blood tests, especially for measuring blood potassium levels in case of poor kidney function
      • +
    • if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, + dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart + beat), particularly if you are being treated for diabetes.
      • +
    • if you are going to have an operation (surgery) or be given anaesthetics
      • +
    • +
        +
      • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
        • +
      • aliskiren
        • +
      +
      • +
    +

    Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

    +

    See also information under the heading “Do not take Karvea”.

    +

    You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

    + Children and adolescents +

    This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

    + Other medicines and Karvea +

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

    +

    Your doctor may need to change your dose and/or to take other precautions: + If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take + Karvea” and “Warnings and precautions”).

    + You may need to have blood checks if you take: +
      +
    • potassium supplements
      • +
    • salt substitutes containing potassium
      • +
    • potassium-sparing medicines (such as certain diuretics)
      • +
    • medicines containing lithium
      • +
    • repaglinide (medication used for lowering blood sugar levels)
      • +
    +

    If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

    + Karvea with food and drink +

    Karvea can be taken with or without food.

    + Pregnancy and breast-feeding + Pregnancy +

    You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

    + Breast-feeding +

    Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

    + Driving and using machines +

    Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. +

    + + Karvea contains lactose. +

    If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

    + + Karvea contains sodium. +

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

    +
    """ * section[=].section[+] * title = "3. How to take paracetamol" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take paracetamol" * text.status = #additional + + * text.div = """
    + Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. + + Method of administration +

    Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

    +
      +
    • + Patients with high blood pressure +

      The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

      +
      • +
    • + Patients with high blood pressure and type 2 diabetes with kidney disease +

      In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

      +
      • +
    + +

    The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. +

    +

    The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

    - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + Use in children and adolescents +

    Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

    + + If you take more Karvea than you should +

    If you accidentally take too many tablets, contact your doctor immediately.

    + + If you forget to take Karvea +

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    +

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    +
    """ * section[=].section[+] @@ -94,26 +203,272 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + * text.div = """
    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    +

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    +

    The frequency of the side effects listed below is defined using the following convention:

    +

    Very common: may affect more than 1 in 10 people

    +

    Common: may affect up to 1 in 10 people

    +

    Uncommon: may affect up to 1 in 100 people

    +

    Side effects reported in clinical studies for patients treated with Karvea were:

    +
      +
    • Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and + type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
      • +
    • Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. +
      • +
    • Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
      • +
    +

    Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. +

    + Reporting of side effects +

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. +

    +
    """ * section[=].section[+] * title = "5. How to store paracetamol" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store paracetamol" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    + What Karvea contains +
      +
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • +
    • The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose + monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.
      • +
    + What Karvea looks like and contents of the pack +

    Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

    +

    Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

    +

    Not all pack sizes may be marketed.

    + Marketing Authorisation Holder: +

    sanofi-aventis groupe

    +

    54, rue La Boétie

    +

    F-75008 Paris - France

    +

    Manufacturer:

    +

    SANOFI WINTHROP INDUSTRIE

    +

    1, rue de la Vierge

    +

    Ambarès and Lagrave

    +

    F-33565 Carbon Blanc Cedex - France

    +

    SANOFI WINTHROP INDUSTRIE

    +

    30-36 Avenue Gustave Eiffel, BP 7166

    +

    F-37071 Tours Cedex 2 - France

    +

    For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

    + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
    +

    België/Belgique/Belgien

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00

    +     		+

    Lietuva

    +

    Swixx Biopharma UAB

    +

    Tel: +370 5 236 91 40

    +
    +

    България

    +

    Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

    +     		+

    Luxembourg/Luxemburg

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

    +
    +

    Česká republika

    +

    sanofi-aventis, s.r.o. Tel: +420 233 086 111

    +     		+

    Magyarország

    +

    SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

    +
    +

    Danmark

    +

    Sanofi A/S

    +

    Tlf: +45 45 16 70 00

    +     		+

    Malta

    +

    Sanofi S.r.l.

    +

    Tel: +39 02 39394275

    +
    +

    Deutschland

    +

    Sanofi-Aventis Deutschland GmbH

    +

    Tel: 0800 52 52 010

    +

    Tel. aus dem Ausland: +49 69 305 21 131

    +     		+

    Norge

    +

    sanofi-aventis Norge AS Tlf: +47 67 10 71 00

    +
    +

    Eesti

    +

    Swixx Biopharma OÜ Tel: +372 640 10 30

    +     		+

    Österreich

    +

    sanofi-aventis GmbH Tel: +43 1 80 185 – 0

    +
    +

    Ελλάδα

    +

    sanofi-aventis AEBE Τηλ: +30 210 900 16 00

    +     		+

    Polska

    +

    sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

    +
    +

    España

    +

    sanofi-aventis, S.A. Tel: +34 93 485 94 00

    +
    +

    France

    +

    sanofi-aventis France

    +

    Tél: 0 800 222 555

    +

    Appel depuis l’étranger : +33 1 57 63 23 23

    +     		+

    Portugal

    +

    Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

    +
    +

    Hrvatska

    +

    Swixx Biopharma d.o.o. Tel: +385 1 2078 500

    +     		+

    România

    +

    Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

    +
    +

    Ireland

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

    +     		+

    Slovenija

    +

    Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

    +
    +

    Ísland

    +

    Vistor hf.

    +

    Sími: +354 535 7000

    +     		+

    Slovenská republika

    +

    Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

    +
    +

    Italia

    +

    Sanofi S.r.l. Tel: 800 536389

    +     		+

    Suomi/Finland

    +

    Sanofi Oy

    +

    Puh/Tel: +358 (0) 201 200 300

    +
    +

    Κύπρος

    +

    C.A. Papaellinas Ltd. Τηλ: +357 22 741741

    +     		+

    Sverige

    +

    Sanofi AB

    +

    Tel: +46 (0)8 634 50 00

    +
    +

    Latvija

    +

    Swixx Biopharma SIA Tel: +371 6 616 47 50

    +     		+

    United Kingdom (Northern Ireland)

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

    +
    +

    This leaflet was last revised in

    +

    Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

    +
    """ \ No newline at end of file diff --git a/input/fsh/examples/paracetamol-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/paracetamol-ema-automatic/MedicinalProductDefinition.fsh index 48abfaf564..28d01f4786 100644 --- a/input/fsh/examples/paracetamol-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/paracetamol-ema-automatic/MedicinalProductDefinition.fsh @@ -5,9 +5,11 @@ Title: "Medicinal Product DOLOCATIL 1 g tablets" Description: "EU/1/97/049/001 DOLOCATIL 1 g tablets" Usage: #example -* identifier.system = $spor-prod -* identifier.value = "cc" +* identifier.system = $spor-prod +* identifier.value = "EMEA/H/C/000142" +* identifier[+].system = $phpid +* identifier[=].value = "0x8DFB446EDB3B8AE508AE493827A704E4" * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" * domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" diff --git a/input/fsh/examples/pentasa-ema-automatic/Bundle.fsh b/input/fsh/examples/pentasa-ema-automatic/Bundle.fsh index 52ec173d92..2438cd6748 100644 --- a/input/fsh/examples/pentasa-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/pentasa-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "xx" * type = #document -* timestamp = "2023-04-16T10:48:28Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/compositionb3a8d58c709a2281d8ad2a590fe81663" diff --git a/input/fsh/examples/pentasa-ema-automatic/Composition.fsh b/input/fsh/examples/pentasa-ema-automatic/Composition.fsh index d9a5fb7c3c..7a885f49f3 100644 --- a/input/fsh/examples/pentasa-ema-automatic/Composition.fsh +++ b/input/fsh/examples/pentasa-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-6ade044addd6563de0baefebb1cceb8e) * title = "TEST PURPOSES ONLY - Pentasa Slow Release Tablets 1g" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,50 +42,160 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - + + * text.div = """
    +

    Karvea 75 mg tablets

    +

    irbesartan

    + Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +
      +
    • What Karvea is and what it is used for
      • +
    • What you need to know before you take Karvea
      • +
    • How to take Karvea
      • +
    • Possible side effects
      • +
    • How to store Karvea
      • +
    • Contents of the pack and other information
      • +
    +
    """ * section[=].section[+] * title = "1. What Pentasa Slow Release Tablets 1g is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What Pentasa Slow Release Tablets 1g is and what it is used for" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - + + * text.div = """
    +

    + Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes. +

    +

    Karvea is used in adult patients

    +
      +
    • to treat high blood pressure (essential hypertension)
      • +
    • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory + evidence of impaired kidney function.
      • +
    +
    """ * section[=].section[+] * title = "2. What you need to know before you take Pentasa Slow Release Tablets 1g" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take Pentasa Slow Release Tablets 1g" * text.status = #additional + - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + * text.div = """
    + Do not take Karvea +
      +
    • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
      • +
    • if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – + see pregnancy section)
      • +
    • if you have diabetes or impaired kidney function and you are treated with a blood pressure + lowering medicine containing aliskiren.
      • +
    + Warning and precautions +

    Talk to your doctor before taking Karvea and if any of the following apply to you:

    +
      +
    • if you get excessive vomiting or diarrhoea
      • +
    • if you suffer from kidney problems
      • +
    • if you suffer from heart problems
      • +
    • if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular + blood tests, especially for measuring blood potassium levels in case of poor kidney function
      • +
    • if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, + dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart + beat), particularly if you are being treated for diabetes.
      • +
    • if you are going to have an operation (surgery) or be given anaesthetics
      • +
    • +
        +
      • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
        • +
      • aliskiren
        • +
      +
      • +
    +

    Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

    +

    See also information under the heading “Do not take Karvea”.

    +

    You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

    + Children and adolescents +

    This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

    + Other medicines and Karvea +

    Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

    +

    Your doctor may need to change your dose and/or to take other precautions: + If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take + Karvea” and “Warnings and precautions”).

    + You may need to have blood checks if you take: +
      +
    • potassium supplements
      • +
    • salt substitutes containing potassium
      • +
    • potassium-sparing medicines (such as certain diuretics)
      • +
    • medicines containing lithium
      • +
    • repaglinide (medication used for lowering blood sugar levels)
      • +
    +

    If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

    + Karvea with food and drink +

    Karvea can be taken with or without food.

    + Pregnancy and breast-feeding + Pregnancy +

    You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

    + Breast-feeding +

    Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

    + Driving and using machines +

    Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines. +

    + + Karvea contains lactose. +

    If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

    + + Karvea contains sodium. +

    This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

    +
    """ * section[=].section[+] * title = "3. How to take Pentasa Slow Release Tablets 1g" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take Pentasa Slow Release Tablets 1g" * text.status = #additional + + * text.div = """
    + Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. + + Method of administration +

    Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

    +
      +
    • + Patients with high blood pressure +

      The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

      +
      • +
    • + Patients with high blood pressure and type 2 diabetes with kidney disease +

      In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

      +
      • +
    + +

    The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. +

    +

    The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

    - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + Use in children and adolescents +

    Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

    + + If you take more Karvea than you should +

    If you accidentally take too many tablets, contact your doctor immediately.

    + + If you forget to take Karvea +

    If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

    +

    If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

    +
    """ * section[=].section[+] @@ -94,26 +203,272 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + * text.div = """
    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

    +

    As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

    +

    The frequency of the side effects listed below is defined using the following convention:

    +

    Very common: may affect more than 1 in 10 people

    +

    Common: may affect up to 1 in 10 people

    +

    Uncommon: may affect up to 1 in 100 people

    +

    Side effects reported in clinical studies for patients treated with Karvea were:

    +
      +
    • Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and + type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
      • +
    • Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. +
      • +
    • Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.
      • +
    +

    Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported. +

    + Reporting of side effects +

    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine. +

    +
    """ * section[=].section[+] * title = "5. How to store Pentasa Slow Release Tablets 1g" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store Pentasa Slow Release Tablets 1g" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    + What Karvea contains +
      +
    • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
      • +
    • The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose + monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.
      • +
    + What Karvea looks like and contents of the pack +

    Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

    +

    Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

    +

    Not all pack sizes may be marketed.

    + Marketing Authorisation Holder: +

    sanofi-aventis groupe

    +

    54, rue La Boétie

    +

    F-75008 Paris - France

    +

    Manufacturer:

    +

    SANOFI WINTHROP INDUSTRIE

    +

    1, rue de la Vierge

    +

    Ambarès and Lagrave

    +

    F-33565 Carbon Blanc Cedex - France

    +

    SANOFI WINTHROP INDUSTRIE

    +

    30-36 Avenue Gustave Eiffel, BP 7166

    +

    F-37071 Tours Cedex 2 - France

    +

    For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

    + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + +
    +

    België/Belgique/Belgien

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00

    +     		+

    Lietuva

    +

    Swixx Biopharma UAB

    +

    Tel: +370 5 236 91 40

    +
    +

    България

    +

    Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

    +     		+

    Luxembourg/Luxemburg

    +

    Sanofi Belgium

    +

    Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

    +
    +

    Česká republika

    +

    sanofi-aventis, s.r.o. Tel: +420 233 086 111

    +     		+

    Magyarország

    +

    SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

    +
    +

    Danmark

    +

    Sanofi A/S

    +

    Tlf: +45 45 16 70 00

    +     		+

    Malta

    +

    Sanofi S.r.l.

    +

    Tel: +39 02 39394275

    +
    +

    Deutschland

    +

    Sanofi-Aventis Deutschland GmbH

    +

    Tel: 0800 52 52 010

    +

    Tel. aus dem Ausland: +49 69 305 21 131

    +     		+

    Norge

    +

    sanofi-aventis Norge AS Tlf: +47 67 10 71 00

    +
    +

    Eesti

    +

    Swixx Biopharma OÜ Tel: +372 640 10 30

    +     		+

    Österreich

    +

    sanofi-aventis GmbH Tel: +43 1 80 185 – 0

    +
    +

    Ελλάδα

    +

    sanofi-aventis AEBE Τηλ: +30 210 900 16 00

    +     		+

    Polska

    +

    sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

    +
    +

    España

    +

    sanofi-aventis, S.A. Tel: +34 93 485 94 00

    +
    +

    France

    +

    sanofi-aventis France

    +

    Tél: 0 800 222 555

    +

    Appel depuis l’étranger : +33 1 57 63 23 23

    +     		+

    Portugal

    +

    Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

    +
    +

    Hrvatska

    +

    Swixx Biopharma d.o.o. Tel: +385 1 2078 500

    +     		+

    România

    +

    Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

    +
    +

    Ireland

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

    +     		+

    Slovenija

    +

    Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

    +
    +

    Ísland

    +

    Vistor hf.

    +

    Sími: +354 535 7000

    +     		+

    Slovenská republika

    +

    Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

    +
    +

    Italia

    +

    Sanofi S.r.l. Tel: 800 536389

    +     		+

    Suomi/Finland

    +

    Sanofi Oy

    +

    Puh/Tel: +358 (0) 201 200 300

    +
    +

    Κύπρος

    +

    C.A. Papaellinas Ltd. Τηλ: +357 22 741741

    +     		+

    Sverige

    +

    Sanofi AB

    +

    Tel: +46 (0)8 634 50 00

    +
    +

    Latvija

    +

    Swixx Biopharma SIA Tel: +371 6 616 47 50

    +     		+

    United Kingdom (Northern Ireland)

    +

    sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

    +
    +

    This leaflet was last revised in

    +

    Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

    +
    """ \ No newline at end of file diff --git a/input/fsh/examples/pentasa-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/pentasa-ema-automatic/MedicinalProductDefinition.fsh index d8eac75246..57eb950732 100644 --- a/input/fsh/examples/pentasa-ema-automatic/MedicinalProductDefinition.fsh +++ b/input/fsh/examples/pentasa-ema-automatic/MedicinalProductDefinition.fsh @@ -5,11 +5,12 @@ Title: "Medicinal Product Pentasa Slow Release Tablets 1g" Description: "EU/1/97/049/001 Pentasa Slow Release Tablets 1g" Usage: #example - -* identifier[+].system = "https://spor.ema.europa.eu/pmswi" -* identifier[=].value = "xx" -* identifier[+].system = "https://www.who-umc.org/phpid" -* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E8271xx" +* identifier.system = $spor-prod +* identifier.value = "EU/1/97/049/001" +* identifier[+].system = $phpid +* identifier[=].value = "0xF79CABF272B6A7EEF104DDDA44E82717" + + * type = http://hl7.org/fhir/medicinal-product-type#MedicinalProduct "Medicinal Product" * domain = http://hl7.org/fhir/medicinal-product-domain#Human "Human use" diff --git a/input/fsh/examples/remsima-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/remsima-ema-automatic/AdministrableProductDefinition.fsh deleted file mode 100644 index b8bfc0c911..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/AdministrableProductDefinition.fsh +++ /dev/null @@ -1,26 +0,0 @@ - -Instance: ap-e3e5e78d4e002ed9e15b925cd546e20b -InstanceOf: AdministrableProductDefinitionUvEpi -Title: "Administrable product Remsima 100 mg powder for concentrate for solution for infusion" -Description: "Remsima 100 mg powder for concentrate for solution for infusion" -Usage: #example - -* identifier.system = $phpid -* identifier.value = "EU/1/13/853/001" - -* status = #active - -* formOf = Reference(mpbe76bdf784deea6950583b234f789db2) -* administrableDoseForm = $spor-rms#100000074029 "Powder for concentrate for solution for infusion" -* unitOfPresentation = $spor-rms#200000002158 "Vial" - -//this is just manufactured with extra steps? - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* producedFrom = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) - - -* routeOfAdministration.code = $spor-rms#100000073611 "Intravenous use" - -* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/remsima-ema-automatic/Bundle.fsh b/input/fsh/examples/remsima-ema-automatic/Bundle.fsh deleted file mode 100644 index 17dc819549..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/Bundle.fsh +++ /dev/null @@ -1,96 +0,0 @@ - -Instance: bundlepackageleaflet-c29ba23bb04c16ab758f150fe41d6513 -InstanceOf: BundleUvEpi -Title: "ePI document Bundle for remsima Package Leaflet" -Description: "Bundle for remsima Package Leaflet ePI document" -Usage: #example - -* identifier.system = "https://www.gravitatehealth.eu/sid/doc" -* identifier.value = "EU/1/13/853/001" -* type = #document -* timestamp = "2023-04-16T10:58:41Z" - -// Composition -* entry[0].fullUrl = "Composition/compositionbe76bdf784deea6950583b234f789db2" -* entry[0].resource = compositionbe76bdf784deea6950583b234f789db2 - - - - - - - - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-remsima-infliximab" -* entry[=].resource = ingredient-for-remsima-infliximab - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-remsima-disodiumphosphatedihydrate" -* entry[=].resource = ingredient-for-remsima-disodiumphosphatedihydrate - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-remsima-sodiumdihydrogenphosphatemonohydrate" -* entry[=].resource = ingredient-for-remsima-sodiumdihydrogenphosphatemonohydrate - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-remsima-polysorbate80" -* entry[=].resource = ingredient-for-remsima-polysorbate80 - -// Ingredient - -* entry[+].fullUrl = "Ingredient/ingredient-for-remsima-sucrose" -* entry[=].resource = ingredient-for-remsima-sucrose - - -// Substance - -* entry[+].fullUrl = "SubstanceDefinition/substance-infliximab" -* entry[=].resource = substance-infliximab - - -// AdministrableProductDefinition - -* entry[+].fullUrl = "AdministrableProductDefinition/ap-e3e5e78d4e002ed9e15b925cd546e20b" -* entry[=].resource = ap-e3e5e78d4e002ed9e15b925cd546e20b - - -// RegulatedAuthorization - -* entry[+].fullUrl = "RegulatedAuthorization/authorizatione3e5e78d4e002ed9e15b925cd546e20b" -* entry[=].resource = authorizatione3e5e78d4e002ed9e15b925cd546e20b - - -// Organization - -* entry[+].fullUrl = "Organization/org-3c850a69e5187931f2198c5e63f933fe" -* entry[=].resource = org-3c850a69e5187931f2198c5e63f933fe - -// Organization - -* entry[+].fullUrl = "Organization/org-e3da03c458d6c0f3c5f1c39a2c6a1084" -* entry[=].resource = org-e3da03c458d6c0f3c5f1c39a2c6a1084 - - -// PackagedProductDefinition - -* entry[+].fullUrl = "PackagedProductDefinition/ppd-e3e5e78d4e002ed9e15b925cd546e20b" -* entry[=].resource = ppd-e3e5e78d4e002ed9e15b925cd546e20b - - -// MedicinalProductDefinition - -* entry[+].fullUrl = "MedicinalProductDefinition/mpbe76bdf784deea6950583b234f789db2" -* entry[=].resource = mpbe76bdf784deea6950583b234f789db2 - - -// ManufacturedItemDefinition - -* entry[+].fullUrl = "ManufacturedItemDefinition/mid-e3e5e78d4e002ed9e15b925cd546e20b" -* entry[=].resource = mid-e3e5e78d4e002ed9e15b925cd546e20b - - diff --git a/input/fsh/examples/remsima-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/remsima-ema-automatic/ClinicalUseDefinition.fsh deleted file mode 100644 index e69de29bb2..0000000000 diff --git a/input/fsh/examples/remsima-ema-automatic/Composition.fsh b/input/fsh/examples/remsima-ema-automatic/Composition.fsh deleted file mode 100644 index 89ab443e83..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/Composition.fsh +++ /dev/null @@ -1,636 +0,0 @@ - -Instance: compositionbe76bdf784deea6950583b234f789db2 -InstanceOf: CompositionUvEpi -Title: "Composition for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet" -Description: "Composition for Remsima 100 mg powder for concentrate for solution for infusion Package Leaflet" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/rmswi/" -* identifier.value = "EU/1/13/853/001" - -* status = #final - - - - - -* type = https://spor.ema.europa.eu/rmswi/#100000155538 -* type.text = "Package Leaflet" - -* subject = Reference(mpbe76bdf784deea6950583b234f789db2) -* date = "2022-02-16T13:28:17Z" -* author = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -* title = "TEST PURPOSES ONLY - Remsima 100 mg powder for concentrate for solution for infusion" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en - - -* section[+]. - * title = "B. Package Leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "B. PACKAGE LEAFLET" - * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - -* section[=].section[+] - * title = "Package leaflet: Information for the user" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "Package leaflet: Information for the user" - * text.status = #additional - * text.div = """

    Read all of this leaflet carefully before you start using this medicine because it contains -important information for you.

    -
      -
    • Keep this leaflet. You may need to read it again.
      • -
    • Your doctor will also give you a patient reminder card, which contains important safety -information you need to be aware of before and during your treatment with Remsima.
      • -
    • When starting a new card, keep this card as a reference for 4 months after your last dose of -Remsima.
      • -
    • If you have any further questions, ask your doctor, pharmacist or nurse.
      • -
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • -
    • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side efects not listed in this leaflet. See section 4.
      • -
    """ - - - -* section[=].section[+] - * title = "What is in this leaflet" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "What is in this leaflet" - * text.status = #additional - * text.div = """

    What is in this leaflet

    -
      -
    1. What Remsima is and what it is used for
      2. -
    2. What you need to know before you use Remsima
      3. -
    3. How to use Remsima
      4. -
    4. Possible side effects
      5. -
    5. How to store Remsima
      6. -
    6. Contents of the pack and other information
      7. -
    7. Instructions for use
      8. -
    """ - - -* section[=].section[+] - * title = "1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for" - * text.status = #additional - - * text.div = """

    Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody - a type of -protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha. -Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:

    -
      -
    • Rheumatoid arthritis
      • -
    • Psoriatic arthritis
      • -
    • Ankylosing spondylitis (Bechterew’s disease)
      • -
    • Psoriasis
      • -
    • Crohn’s disease
      • -
    • Ulcerative colitis.
      • -
    -

    Remsima works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved -in inflammatory processes of the body so blocking it can reduce the inflammation in your body.

    -

    Rheumatoid arthritisRheumatoid arthritis is an inflammatory disease of the joints. -If you have active rheumatoid arthritis -you will first be given other medicines. If these medicines do not work well enough, you will be given -Remsima which you will take with another medicine called methotrexate to:

    -
      -
    • reduce the signs and symptoms of your disease,
      • -
    • slow down the damage in your joints,
      • -
    • improve your physical function.
      • -
    -

    Psoriatic arthritisPsoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you -have active psoriatic arthritis you will first be given other medicines. If these medicines do not work -well enough, you will be given Remsima to:

    -
      -
    • reduce the signs and symptoms of your disease,
      • -
    • slow down the damage in your joints,
      • -
    • improve your physical function.
      • -
    -

    Ankylosing spondylitis (Bechterew’s disease)Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis -you will first be given other medicines. If these medicines do not work well enough, you will be given -Remsima to:

    -
      -
    • reduce the signs and symptoms of your disease,
      • -
    • improve your physical function.
      • -
    -

    PsoriasisPsoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you -will first be given other medicines or treatments, such as phototherapy. If these medicines or -treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of -your disease. -Ulcerative colitis -Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first -be given other medicines. If these medicines do not work well enough, you will be given Remsima to -treat your disease.

    -

    Crohn’s disease

    -

    Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be -given other medicines. If these medicines do not work well enough, you will be given Remsima to:

    -
      -
    • treat active Crohn’s disease,
      • -
    • reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery
      • -
    """ - - - - - -* section[=].section[+] - * title = "2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion" - * text.status = #additional - * text.div = """

    You must not use Remsima if

    -
      -
    • you are allergic to infliximab or any of the other ingredients of this medicine (listed in -section 6),
      • -
    • you are allergic to proteins that come from mice,
      • -
    • you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious -bacterial infection of the blood),
      • -
    • you have heart failure that is moderate or severe. -Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before -you are given Remsima.
      • -
    -

    Warnings and precautions

    -

    Talk to your doctor before or during treatment with Remsima if you have:

    -

    Had treatment with any medicine containing infliximab before

    -
      -
    • Tell your doctor if you have had treatment with medicines containing infliximab in the past and -are now starting Remsima treatment again.
      • -
    • If you have had a break in your treatment with infliximab of more than 16 weeks, there is a -higher risk for allergic reactions when you start the treatment again.
      • -
    -

    Local injection site reactions

    -
      -
    • Some patients receiving infliximab via injection under the skin have experienced local injection -site reactions. Signs of a local injection site reaction can include redness, pain, itching, swelling, -hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, -blisters and scab on the skin of the injection site.
      • -
    • Most of these reactions are mild to moderate and mostly resolve on their own within a day.
      • -
    -

    Infections

    -
      -
    • Tell your doctor before you are given Remsima if you have an infection even if it is a very -minor one.
      • -
    • Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area -where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. -These infections are caused by specific types of fungi that can affect the lungs or other parts of -your body.
      • -
    • You may get infections more easily when you are being treated with Remsima. If you are 65 -years of age or older, you have a greater risk.
      • -
    • These infections may be serious and include tuberculosis, infections caused by viruses, fungi, -bacteria or other organisms in the environment and sepsis that may be life-threatening. -Tell your doctor straight away if you get signs of infection during treatment with Remsima. Signs -include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems. Your -doctor may recommend temporarily stopping Remsima.
      • -
    -

    Tuberculosis (TB)

    -
      -
    • It is very important that you tell your doctor if you have ever had TB or if you have been in -close contact with someone who has had or has TB.
      • -
    • Your doctor will test you to see if you have TB. Cases of TB have been reported in patients -treated with infliximab, even in patients who have already been treated with medicines for TB. -Your doctor will record these tests on your patient reminder card.
      • -
    • If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before -you are given Remsima. -Tell your doctor straight away if you get signs of TB during treatment with Remsima. Signs include -persistent cough, weight loss, feeling tired, fever, night sweats.
      • -
    -

    Hepatitis B virus

    -
      -
    • Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever -had it.
      • -
    • Tell your doctor if you think you might be at risk of contracting hepatitis B.
      • -
    • Your doctor should test you for hepatitis B virus.
      • -
    • Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in -patients who carry this virus, which can be life-threatening in some cases.
      • -
    • If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and -may give you medicines such as effective antiviral therapy with supportive treatment.
      • -
    -

    Heart problems

    -
      -
    • Tell your doctor if you have any heart problems, such as mild heart failure.
      • -
    • Your doctor will want to closely monitor your heart. -Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with -Remsima. Signs include shortness of breath or swelling of your feet.
      • -
    -

    Cancer and lymphoma

    -
      -
    • Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type -of blood cancer) or any other cancer.
      • -
    • Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at -higher risk of developing lymphoma.
      • -
    • Patients taking Remsima may have an increased risk of developing lymphoma or another cancer.
      • -
    • Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Of these patients, most were teenage boys or young men and most had either Crohn’s disease or ulcerative colitis. This type of cancer has -usually resulted in death. Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
      • -
    • Some patients treated with infliximab have developed certain kinds of skin cancer. If there are -any changes in your skin or growths on the skin during or after therapy, tell your doctor.
      • -
    • Some women being treated for rheumatoid arthritis with infliximab have developed cervical -cancer. For women taking Remsima including those over 60 years of age, your doctor may -recommend regular screening for cervical cancer.
      • -
    -

    Lung disease or heavy smoking

    -
      -
    • Tell your doctor before you are given Remsima if you have a lung disease called chronic -obstructive pulmonary disease (COPD) or if you are a heavy smoker.
      • -
    • Patients with COPD and patients who are heavy smokers may have a higher risk of developing -cancer with Remsima treatment.
      • -
    -

    Nervous system disease

    -
      -
    • Tell your doctor before you are given Remsima if you have or have ever had a problem that -affects your nervous system. This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis’.
      • -
    -

    Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima. -Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part -of your body.

    -

    Abnormal skin openings

    -
      -
    • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given -Remsima.
      • -
    -

    Vaccinations

    -
      -
    • Talk to your doctor if you recently have had or are due to have a vaccine.
      • -
    • You should receive recommended vaccinations before starting Remsima treatment. You may -receive some vaccines during treatment with Remsima but you should not receive live vaccines -(vaccines that contain a living but weakened infectious agent) while using Remsima because -they may cause infections.
      • -
    • If you received Remsima while you were pregnant, your baby may also be at higher risk for -getting an infection as a result of receiving a live vaccine during the first year of life. It is -important that you tell your baby's doctors and other health care professionals about your -Remsima use so they can decide when your baby should receive any vaccine, including live -vaccines such as the BCG vaccine (used to prevent tuberculosis).
      • -
    • If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare -professionals about your Remsima use before your baby is given any vaccine. For more -information see section on Pregnancy and breast-feeding.
      • -
    -

    Therapeutic infectious agents

    -
      -
    • Talk to your doctor if you have recently received or are scheduled to receive treatment with a -therapeutic infectious agent (such as BCG instillation used for the treatment of cancer)
      • -
    -

    Operations or dental procedures

    -
      -
    • Tell your doctor if you are going to have any operations or dental procedures.
      • -
    • Tell your surgeon or dentist that you are having treatment with Remsima by showing them your -patient reminder card.
      • -
    -

    Liver problems

    -
      -
    • Some patients receiving infliximab have developed serious liver problems.
      • -
    • Tell your doctor straight away if you get symptoms of liver problems during treatment with -Remsima. Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or -swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
      • -
    -

    Low blood counts

    -
      -
    • In some patients receiving infliximab, the body may not make enough of the blood cells that -help fight infections or help stop bleeding.
      • -
    • Tell your doctor straight away if you get symptoms of low blood counts during treatment with -Remsima. Signs include persistent fever, bleeding or bruising more easily, small red or purple -spots caused by bleeding under the skin, or looking pale.
      • -
    -

    Immune system disorder

    -
      -
    • Some patients receiving infliximab have developed symptoms of an immune system disorder -called lupus.
      • -
    • Tell your doctor straight away if you develop symptoms of lupus during treatment with -Remsima. Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
      • -
    -

    Children and adolescents

    -

    Do not give this medicine to children and adolescents under 18 years of age because there are no data -that show that this medicine is safe and works in this age group.

    -

    Other medicines and Remsima

    -

    Patients who have inflammatory diseases already take medicines to treat their problem. These -medicines may cause side effects. Your doctor will advise you what other medicines you must keep -using while you are having Remsima.

    -

    Tell your doctor if you are using, have recently used or might use any other medicines, including any -other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing -spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as -vitamins and herbal medicines.

    -

    In particular, tell your doctor if you are using any of the following medicines:

    -
      -
    • Medicines that affect your immune system.
      • -
    • Kineret (which contains anakinra). Remsima and Kineret should not be used together.
      • -
    • Orencia (which contains abatacept). Remsima and Orencia should not be used together. -While using Remsima you should not receive live vaccines. If you were using Remsima during pregnancy or if you are receiving Remsima while breast-feeding, tell your baby’s doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
      • -
    -

    If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before -using Remsima.

    -

    Pregnancy, breast-feeding and fertility

    -
      -
    • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, -ask your doctor for advice before taking this medicine. Remsima should only be used during -pregnancy or while breast-feeding if your doctor feels it is necessary for you.
      • -
    • You should avoid getting pregnant when you are being treated with Remsima and for 6 months -after you stop being treated with it. Discuss the use of contraception during this time with your -doctor.
      • -
    • If you received Remsima during your pregnancy, your baby may have a higher risk for getting -an infection.
      • -
    • It is important that you tell your baby’s doctors and other healthcare professionals about your -Remsima use before your baby is given any vaccine. If you received Remsima while pregnant, -giving BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth -may result in infection with serious complications, including death. Live vaccines such as the -BCG vaccine should not be given to your baby within 12 months after birth, unless your baby’s -doctor recommends otherwise. For more information see section on vaccination.
      • -
    • If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare -professionals about your Remsima use before your baby is given any vaccine. Live vaccines -should not be given to your baby while you are breast-feeding unless your baby’s doctor -recommends otherwise.
      • -
    • Severely decreased numbers of white blood cells have been reported in infants born to women -treated with infliximab during pregnancy. If your baby has continual fevers or infections, -contact your baby’s doctor immediately.
      • -
    -

    Driving and using machines

    -

    Remsima is not likely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or -unwell after having Remsima, do not drive or use any tools or machines.

    -

    Remsima contains sodium and sorbitol

    -

    This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’ and 45 mg sorbitol in each 120 mg dose.

    """ - -* section[=].section[+] - * title = "3. How to take Remsima 100 mg powder for concentrate for solution for infusion" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "3. How to take Remsima 100 mg powder for concentrate for solution for infusion" - * text.status = #additional - * text.div = """

    Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

    -

    Rheumatoid arthritis

    -

    Your doctor will start your treatment with or without two Remsima intravenous infusion doses of 3 mg -for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). If -Remsima intravenous infusion doses are given to start the treatment, they are administered 2 weeks -apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given -Remsima via injection under the skin (subcutaneous injection). -The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.

    -

    Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease) and psoriasis

    -

    Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every -kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are -administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, -you will be given Remsima via injection under the skin (subcutaneous injection). -The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks -regardless of weight.

    -

    Crohn’s disease and ulcerative colitis

    -

    Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every -kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are -administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, -you will be given Remsima via injection under the skin (subcutaneous injection). -The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks -regardless of weight.

    -

    How Remsima is given

    -
      -
    • Remsima 120 mg solution for injection is administered by injection under the skin -(subcutaneous use) only. It is important to check the product labels to ensure that the correct -formulation is being given as prescribed.
      • -
    • For patients with rheumatoid arthritis, your doctor may start your Remsima treatment with or -without two Remsima intravenous infusion doses. For patients with Crohn’s disease, ulcerative -colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis, two Remsima infusion doses will -be given to start your Remsima treatment.
      • -

    • If Remsima treatment is initiated without two Remsima intravenous infusion doses, the table -below shows how often you will usually have this medicine after your first dose.

      -
      • -

    • If two Remsima intravenous infusion doses are given by your doctor or nurse to start the -treatment, they will be given 2 weeks apart and the first Remsima subcutaneous injection will -be given 4 weeks after the last intravenous infusion followed by Remsima subcutaneous -injections given every 2 weeks.

      -
      • -
    • The first subcutaneous injection of Remsima will be administered under the supervision of your -doctor.
      • -
    • After proper training, if you feel you are well-trained and confident to inject Remsima yourself, -your doctor may allow you to inject subsequent doses of Remsima yourself at home.
      • -
    • Talk to your doctor if you have any questions about giving yourself an injection. You will find -detailed “Instructions for Use” at the end of this leaflet.
      • -
    -

    If you use more Remsima than you should

    -

    If you have used more Remsima than you should (either by injecting too much on a single occasion or -by using it too frequently), talk to a doctor, pharmacist or nurse immediately. Always have the outer -carton of the medicine with you, even if it is empty.

    -

    If you forget to use Remsima

    -

    Missed dose for up to 7 days

    -

    If you miss a dose of Remsima for up to 7 days, after the original scheduled dose, you should take the -missed dose immediately. Take your next dose on the next originally planned date and then follow the -original dosing schedule.

    -

    Missed dose for 8 days or more

    -

    If you miss a dose of Remsima for 8 days or more, after the original scheduled dose, you should not take -the missed dose. Take your next dose on the next originally planned date and then follow the original -dosing schedule. -If you are not sure when to inject Remsima, call your doctor.

    -

    If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

    """ - - -* section[=].section[+] - * title = "4. Possible side effects" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "4. Possible side effects" - * text.status = #additional - * text.div = """

    Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side -effects are mild to moderate. However some patients may experience serious side effects and may -require treatment. Side effects may also occur after your treatment with Remsima has stopped.

    -

    Tell your doctor straight away if you notice any of the following:

    -
      -
    • Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may -cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or -ankles. Some of these reactions may be serious or life-threatening. An allergic reaction could -happen within 2 hours of your injection or later. More signs of allergic side effects that may -happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, -sore throat or headache.
      • -
    • Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, -bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and -scab.
      • -
    • Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness -of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), -vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your -feet.
      • -
    • Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, -shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection -of pus in the gut or around the anus (abscess), dental problems or burning sensation when -urinating.
      • -
    • Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, -fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
      • -
    • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest.
      • -
    • Signs of a nervous system problem (including eye problems) such as signs of a stroke -(sudden numbness or weakness of your face, arm or leg, especially on one side of your body; -sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble -walking, dizziness, loss of balance or coordination or a severe headache), fits, -tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight -such as double vision or other eye problems.
      • -
    • Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the -past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the -upper right side of the stomach area, joint pain, skin rashes, or fever.
      • -
    • Signs of an immune system disorder called lupus such as joint pain or a rash on cheeks or -arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash -(sarcoidosis).
      • -
    • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red -or purple spots caused by bleeding under the skin, or looking pale.
      • -
    • Signs of serious skin problems such as reddish-target-like spots or circular patches often with -central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of -mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body. -These skin reactions can be accompanied by fever. -Tell your doctor straight away if you notice any of the above. -The following side effects have been observed with Remsima:
      • -
    -

    Very common: may affect more than 1 in 10 people

    -
      -
    • Stomach pain, feeling sick -Viral infections such as herpes or flu
      • -
    • Upper respiratory infections such as sinusitis
      • -
    • Headache
      • -
    • Side effect due to an injection
      • -
    • Pain.
      • -
    -

    Common: may affect up to 1 in 10 people

    -
      -
    • Changes in how your liver works, increase in liver enzymes (shown in blood tests)
      • -
    • Lung or chest infections such as bronchitis or pneumonia
      • -
    • Difficult or painful breathing, chest pain
      • -
    • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
      • -
    • Nettle-type rash (hives), itchy rash or dry skin
      • -
    • Balance problems or feeling dizzy
      • -
    • Fever, increased sweating
      • -
    • Circulation problems such as low or high blood pressure
      • -
    • Bruising, hot flush or nosebleed, warm, red skin (flushing)
      • -
    • Feeling tired or weak
      • -
    • Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
      • -
    • Infection of the skin due to a fungus
      • -
    • Blood problems such as anaemia or low white blood cell count
      • -
    • Swollen lymph nodes
      • -
    • Depression, problems sleeping
      • -
    • Eye problems, including red eyes and infections
      • -
    • Fast heart beat (tachycardia) or palpitations
      • -
    • Pain in the joints, muscles or back
      • -
    • Urinary tract infection
      • -
    • Psoriasis, skin problems such as eczema and hair loss
      • -
    • Reactions at the injection site such as pain, swelling, redness or itching
      • -
    • Chills, a build-up of fluid under the skin causing swelling
      • -
    • Feeling numb or having a tingling feeling.
      • -
    -

    Uncommon: may affect up to 1 in 100 people

    -
      -
    • Shortage of blood supply, swelling of a vein
      • -
    • Collection of blood outside the blood vessels (haematoma) or bruising
      • -
    • Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen -lips, or thickening of the skin, or red, scaly, and flaky skin
      • -
    • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic -reactions to foreign proteins
      • -
    • Wounds taking longer to heal
      • -
    • Swelling of the liver (hepatitis) or gall bladder, liver damage
      • -
    • Feeling forgetful, irritable, confused, nervous
      • -
    • Eye problems including blurred or reduced vision, puffy eyes or sties
      • -
    • New or worsening heart failure, slow heart rate
      • -
    • Fainting
      • -
    • Convulsions, nerve problems
      • -
    • A hole in the bowel or blockage of the intestine, stomach pain or cramps
      • -
    • Swelling of your pancreas (pancreatitis)
      • -
    • Fungal infections such as yeast infection, or fungal infection of the nails
      • -
    • Lung problems (such as oedema)
      • -
    • Fluid around the lungs (pleural effusion)
      • -
    • Narrowed airway in the lungs, causing difficulty breathing
      • -
    • Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
      • -
    • Tuberculosis
      • -
    • Kidney infections -Low platelet count, too many white blood cells
      • -
    • Infections of the vagina
      • -
    • Blood test result showing ‘antibodies’ against your own body
      • -
    • Changes in cholesterol and fat levels in the blood.
      • -
    -

    Rare: may affect up to 1 in 1,000 people

    -
      -
    • A type of blood cancer (lymphoma)
      • -
    • Your blood not supplying enough oxygen to your body, circulation problems such as narrowing -of a blood vessel
      • -
    • Inflammation of the lining of the brain (meningitis)
      • -
    • Infections due to a weakened immune system
      • -
    • Hepatitis B infection when you have had hepatitis B in the past
      • -
    • Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
      • -
    • Liver problem that causes yellowing of the skin or eyes (jaundice)
      • -
    • Abnormal tissue swelling or growth
      • -
    • Severe allergic reaction that may cause loss of consciousness and could be life-threatening -(anaphylactic shock)
      • -
    • Swelling of small blood vessels (vasculitis)
      • -
    • Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
      • -
    • Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
      • -
    • Lack of interest or emotion
      • -
    • Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute -generalised exanthematous pustulosis
      • -
    • Other skin problems such as erythema multiforme, blisters and peeling skin, or boils -(furunculosis)
      • -
    • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, -optic neuritis and Guillain-Barré syndrome
      • -
    • Inflammation in the eye that may cause changes in the vision, including blindness
      • -
    • Fluid in the lining of the heart (pericardial effusion)
      • -
    • Serious lung problems (such as interstitial lung disease)
      • -
    • Melanoma (a type of skin cancer)
      • -
    • Cervical cancer
      • -
    • Low blood counts, including a severely decreased number of white blood cells
      • -
    • Small red or purple spots caused by bleeding under the skin
      • -
    • Abnormal values of a blood protein called ‘complement factor’ which is part of the immune -system
      • -
    • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on -mucous membranes).
      • -
    -

    Not known: frequency cannot be estimated from the available data

    -
      -
    • Cancer
      • -
    • A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
      • -
    • Liver failure
      • -
    • Merkel cell carcinoma (a type of skin cancer)
      • -
    • Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s -sarcoma most commonly appears as purple lesions on the skin.
      • -
    • Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle -weakness)
      • -
    • Heart attack
      • -
    • Stroke
      • -
    • Temporary loss of sight during or within 2 hours of infusion
      • -
    • Infection due to a live vaccine because of a weakened immune system.
      • -
    • Reporting of side effects
      • -
    -

    If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side -effects not listed in this leaflet. You can also report side effects directly via the national reporting -system listed in Appendix V. By reporting side effects you can help provide more information on the -safety of this medicine.

    """ - -* section[=].section[+] - * title = "5. How to store Remsima 100 mg powder for concentrate for solution for infusion" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "5. How to store Remsima 100 mg powder for concentrate for solution for infusion" - * text.status = #additional - * text.div = """
      -
    • Keep this medicine out of the sight and reach of children.
      • -
    • Do not use this medicine after the expiry date which is stated on the label and the carton after -“EXP”. The expiry date refers to the last day of that month.
      • -
    • Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the medicinal product in its outer carton -to protect from light.
      • -
    • This medicine can also be stored in the original carton outside of refrigerated storage up to a -maximum of 25°C for a single period of up to 28 days, but not beyond the original expiry date. -In this situation, do not return to refrigerated storage again. Write the new expiry date on the -carton including day/month/year. Discard this medicine if not used by the new expiry date or -the expiry date printed on the carton, whichever is earlier.
      • -
    • Do not throw away any medicines via wastewater or household waste. Ask your pharmacist -how to throw away medicines you no longer use. These measures will help protect the -environment.
      • -
    """ - - -* section[=].section[+] - * title = "6. Contents of the pack and other information" - * code = https://spor.ema.europa.eu/rmswi/#100000155538 - * code.text = "6. Contents of the pack and other information" - * text.status = #additional - * text.div = """

    What Remsima contains

    -
      -
    • The active substance is infliximab. Each 1 ml single dose pre-filled syringe contains 120 mg of -infliximab.
      • -
    • The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and -water for injections.
      • -
    -

    What Remsima looks like and contents of the pack

    -

    Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use -pre-filled syringe.

    -

    Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads, -4 pre-filled syringes with 4 alcohol pads or 6 pre-filled syringes with 6 alcohol pads.

    -

    Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled -syringes with automatic needle guard with 2 alcohol pads, 4 pre-filled syringes with automatic needle -guard with 4 alcohol pads or 6 pre-filled syringes with automatic needle guard with 6 alcohol pads.

    -

    Not all pack sizes may be marketed

    """ - diff --git a/input/fsh/examples/remsima-ema-automatic/Ingredient.fsh b/input/fsh/examples/remsima-ema-automatic/Ingredient.fsh deleted file mode 100644 index 4dd16204dc..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/Ingredient.fsh +++ /dev/null @@ -1,154 +0,0 @@ - -Instance: ingredient-for-remsima-infliximab -InstanceOf: IngredientUvEpi -Title: "Ingredient-active INFLIXIMAB" -Description: "INFLIXIMAB" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "B72HH48FLU" -* identifier.use = #official - -* role = $spor-rms#72072 "active" - -* status = #active - -* substance.code.concept.coding = $ginas#B72HH48FLU "INFLIXIMAB" - - -* substance.strength.presentationQuantity = 100.0 'mg' - -* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" - - -// Reference to products -* for = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) -* for[+] = Reference(mpbe76bdf784deea6950583b234f789db2) -* for[+] = Reference(ap-e3e5e78d4e002ed9e15b925cd546e20b) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -Instance: ingredient-for-remsima-disodiumphosphatedihydrate -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Disodium phosphate dihydrate" -Description: "Disodium phosphate dihydrate" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "94255I6E2T" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#94255I6E2T "Disodium phosphate dihydrate" - - - -// Reference to products -* for = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) -* for[+] = Reference(mpbe76bdf784deea6950583b234f789db2) -* for[+] = Reference(ap-e3e5e78d4e002ed9e15b925cd546e20b) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -Instance: ingredient-for-remsima-sodiumdihydrogenphosphatemonohydrate -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Sodium dihydrogen phosphate monohydrate" -Description: "Sodium dihydrogen phosphate monohydrate" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "593YOG76RN" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#593YOG76RN "Sodium dihydrogen phosphate monohydrate" - - - -// Reference to products -* for = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) -* for[+] = Reference(mpbe76bdf784deea6950583b234f789db2) -* for[+] = Reference(ap-e3e5e78d4e002ed9e15b925cd546e20b) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -Instance: ingredient-for-remsima-polysorbate80 -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient POLYSORBATE 80" -Description: "POLYSORBATE 80" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "6OZP39ZG8H" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#6OZP39ZG8H "POLYSORBATE 80" - - - -// Reference to products -* for = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) -* for[+] = Reference(mpbe76bdf784deea6950583b234f789db2) -* for[+] = Reference(ap-e3e5e78d4e002ed9e15b925cd546e20b) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -Instance: ingredient-for-remsima-sucrose -InstanceOf: IngredientUvEpi -Title: "Ingredient-excipient Sucrose" -Description: "Sucrose" -Usage: #example - -* identifier.system = $ginas -* identifier.value = "C151H8M554" -* identifier.use = #official - -* role = $spor-rms#100000072082 "Excipient" - -* status = #active - -* substance.code.concept.coding = $ginas#C151H8M554 "Sucrose" - - - -// Reference to products -* for = Reference(mid-e3e5e78d4e002ed9e15b925cd546e20b) -* for[+] = Reference(mpbe76bdf784deea6950583b234f789db2) -* for[+] = Reference(ap-e3e5e78d4e002ed9e15b925cd546e20b) -// Reference to Organization: Reference to MAH - - - - - -* manufacturer.manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) diff --git a/input/fsh/examples/remsima-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/remsima-ema-automatic/ManufacturedItemDefinition.fsh deleted file mode 100644 index c928a0c5ef..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/ManufacturedItemDefinition.fsh +++ /dev/null @@ -1,24 +0,0 @@ - -Instance: mid-e3e5e78d4e002ed9e15b925cd546e20b -InstanceOf: ManufacturedItemDefinitionUvEpi -Title: "Manufactured item Remsima 100 mg powder for concentrate for solution for infusion" -Description: "Remsima 100 mg powder for concentrate for solution for infusion" -Usage: #example - -* identifier.system = "https://spor.ema.europa.eu/pmswi/#/" -* identifier.value = "EU/1/13/853/001" -* identifier.use = #official - -* status = #active -* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000074029 "Powder for concentrate for solution for infusion" - -* unitOfPresentation = $spor-rms#200000002158 "Vial" - - - - - - - - -* manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) \ No newline at end of file diff --git a/input/fsh/examples/remsima-ema-automatic/Organization.fsh b/input/fsh/examples/remsima-ema-automatic/Organization.fsh deleted file mode 100644 index 5d82bdbaa4..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/Organization.fsh +++ /dev/null @@ -1,59 +0,0 @@ - - - - -Instance: org-3c850a69e5187931f2198c5e63f933fe - -InstanceOf: OrganizationUvEpi -Title: "Celltrion Healthcare Hungary Kft. as Marketing authorisation holder" -Description: "Celltrion Healthcare Hungary Kft. as Marketing authorisation holder" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "ORG-100000826" -* identifier.use = #official - -* active = true - -* type = $spor-rms#220000000034.0 "Marketing authorisation holder" -* type.text = "Marketing authorisation holder" -* name = "Celltrion Healthcare Hungary Kft." - -* contact - * address - * text = "Váci út 1-3. WestEnd Office Building B torony Budapest HU" - * use = #work - * type = #physical - * line = "Váci út 1-3. WestEnd Office Building B torony" - * city = "Budapest" - * country = "HU" - * postalCode = "1062" - - - -Instance: org-e3da03c458d6c0f3c5f1c39a2c6a1084 - -InstanceOf: OrganizationUvEpi -Title: "European Medicines Agency as Medicines Regulatory Authority" -Description: "European Medicines Agency as Medicines Regulatory Authority" -Usage: #example - -* identifier.system = $spor-org -* identifier.value = "ORG-100013412" -* identifier.use = #official - -* active = true - -* type = $spor-rms#nan "Medicines Regulatory Authority" -* type.text = "Medicines Regulatory Authority" -* name = "European Medicines Agency" - -* contact - * address - * text = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est Amsterdam NL" - * use = #work - * type = #physical - * line = "Carretera De Martorell 41 61, Poligono Industrial Nord-Est" - * city = "Amsterdam" - * country = "NL" - * postalCode = "1083 HS" \ No newline at end of file diff --git a/input/fsh/examples/remsima-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/remsima-ema-automatic/PackagedProductDefinition.fsh deleted file mode 100644 index 481a1a2949..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/PackagedProductDefinition.fsh +++ /dev/null @@ -1,40 +0,0 @@ - -Instance: ppd-e3e5e78d4e002ed9e15b925cd546e20b -InstanceOf: PackagedProductDefinitionUvEpi -Title: "Remsima 100 mg powder for concentrate for solution for infusion" -Description: "Remsima 100 mg powder for concentrate for solution for infusion" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "EU/1/13/853/001" -* identifier.use = #official - -* name = "Remsima 100 mg powder for concentrate for solution for infusion" - -* type = $spor-rms#100000155527 "Chemical Medicinal Prodcut" -//* type = $spor-rms#100000155527 - - -* status = http://hl7.org/fhir/publication-status#active "Active" -* statusDate = "2012-02-07T13:28:17Z" - - -* containedItemQuantity = 1 'vial' - - - - - -* packaging - * identifier.system = $spor-prod - * identifier.value = "654321" - * type = $spor-rms#100000073504 "Child-resistant closure" - * quantity = 1 - * material = $spor-rms#200000003529 "Cardboard" - - - -//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet -* packageFor = Reference(mpbe76bdf784deea6950583b234f789db2) - // Reference to Organization: MAH -* manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) diff --git a/input/fsh/examples/remsima-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/remsima-ema-automatic/RegulatedAuthorization.fsh deleted file mode 100644 index d3e184968a..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/RegulatedAuthorization.fsh +++ /dev/null @@ -1,37 +0,0 @@ - -Instance: authorizatione3e5e78d4e002ed9e15b925cd546e20b -InstanceOf: RegulatedAuthorizationUvEpi -Title: "Regulated Authorization for Remsima 100 mg powder for concentrate for solution for infusion" -Description: "Regulated Authorization for Remsima 100 mg powder for concentrate for solution for infusion" -Usage: #example - -* identifier.system = $spor-prod -* identifier.value = "EU/1/13/853/001" -* identifier.use = #official - - // Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet - //* subject = Reference(karvea75mgblisterx28) -* subject = Reference(mpbe76bdf784deea6950583b234f789db2) -* type = $spor-rms#100000072062 "Marketing Authorisation" - -//* type = $spor-rms#100000072062 -//* type.text = "Marketing Authorisation" - -* region = urn:iso:std:iso:3166#eu "European Union" - - -* status = http://hl7.org/fhir/publication-status#active "Active" - - -* statusDate = "2018-06-21" -// * holder = Reference(sanofiaventisgroupe) - - - - -* holder = Reference(org-3c850a69e5187931f2198c5e63f933fe) - - - - - diff --git a/input/fsh/examples/remsima-ema-automatic/Substance.fsh b/input/fsh/examples/remsima-ema-automatic/Substance.fsh deleted file mode 100644 index 0e23ead796..0000000000 --- a/input/fsh/examples/remsima-ema-automatic/Substance.fsh +++ /dev/null @@ -1,28 +0,0 @@ - -Instance: substance-infliximab -InstanceOf: SubstanceDefinitionUvEpi -Description: "INFLIXIMAB" -Usage: #example - -* identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" -* identifier.value = "B72HH48FLU" -* identifier.use = #official - -* version = "1" - -* status = https://gsrs.ncats.nih.gov/ginas/app/beta/#1 "Validated (UNII)" - -//* description = "nan" - - - // Reference to Organization: MAH - -* manufacturer = Reference(org-3c850a69e5187931f2198c5e63f933fe) - -* structure.molecularFormula = "C6458H9934N1728O2040S44" - -//* name.name = "IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER" -* name.name = "IMMUNOGLOBULIN G (HUMAN-MOUSE MONOCLONAL CA2 HEAVY CHAIN ANTI-HUMAN TUMOR NECROSIS FACTOR), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL CA2 LIGHT CHAIN, DIMER" - -//* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#x "Chemical Name" -* name.type = https://gsrs.ncats.nih.gov/ginas/app/beta/#x "Chemical Name" \ No newline at end of file diff --git a/input/fsh/examples/suliqua-ema-automatic/Bundle.fsh b/input/fsh/examples/suliqua-ema-automatic/Bundle.fsh index c9d87b2da9..cf1758a99f 100644 --- a/input/fsh/examples/suliqua-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/suliqua-ema-automatic/Bundle.fsh @@ -8,7 +8,7 @@ Usage: #example * identifier.system = "https://www.gravitatehealth.eu/sid/doc" * identifier.value = "EU/1/16/1157/003" * type = #document -* timestamp = "2023-04-15T19:56:26Z" +* timestamp = "2023-01-20T17:19:33Z" // Composition * entry[0].fullUrl = "Composition/compositionb4adca48035e7857c0e645892ad2c66e" diff --git a/input/fsh/examples/suliqua-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/suliqua-ema-automatic/ClinicalUseDefinition.fsh index d663c5ad85..7f6b154f72 100644 --- a/input/fsh/examples/suliqua-ema-automatic/ClinicalUseDefinition.fsh +++ b/input/fsh/examples/suliqua-ema-automatic/ClinicalUseDefinition.fsh @@ -19,9 +19,9 @@ Usage: #example -Instance: indication-diabetes +Instance: indication-hypertension InstanceOf: ClinicalUseDefinition-indication-uv-epi -Description: "indication - Diabetes" +Description: "indication - Hypertension" Usage: #example * identifier.system = "https://spor.ema.europa.eu/rmswi/#/" diff --git a/input/fsh/examples/suliqua-ema-automatic/Composition.fsh b/input/fsh/examples/suliqua-ema-automatic/Composition.fsh index 8e032b2ce6..33140ae9fc 100644 --- a/input/fsh/examples/suliqua-ema-automatic/Composition.fsh +++ b/input/fsh/examples/suliqua-ema-automatic/Composition.fsh @@ -10,10 +10,6 @@ Usage: #example * status = #final - - - - * type = https://spor.ema.europa.eu/rmswi/#100000155538 * type.text = "Package Leaflet" @@ -22,9 +18,12 @@ Usage: #example * author = Reference(org-16019cea3a857659d2c5a2018c2260df) * title = "TEST PURPOSES ONLY - Suliqua" -* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official -* attester.time = "2022-02-16T13:28:17Z" -* language = #en + + + + + + * section[+]. @@ -32,7 +31,7 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "B. PACKAGE LEAFLET" * text.status = #additional - + * text.div = """
    unavailable
    """ * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable @@ -43,50 +42,70 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "Package leaflet: Information for the user" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - + + * text.div = """
    +PACKAGE LEAFLET: INFORMATION FOR THE USER +Humalog Mix50 100 units/ml suspension for injection in cartridge +insulin lispro +Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. +
      +
    • Keep this leaflet. You may need to read it again.
      • +
    • If you have any further questions, ask your doctor or pharmacist.
      • +
    • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
      • +
    • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
      • +
    +
    """ * section[=].section[+] * title = "What is in this leaflet" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "What is in this leaflet" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +What in this leaflet +
      +
    1. What Humalog Mix50 is and what it is used for
      2. +
    2. What you need to know before you take Humalog Mix50
      3. +
    3. How to take Humalog Mix50
      4. +
    4. Possible side effects
      5. +
    5. How to store Humalog Mix50
      6. +
    6. Contents of the pack and other information
      7. +
    +
    """ * section[=].section[+] * title = "1. What Suliqua is and what it is used for" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "1. What Suliqua is and what it is used for" * text.status = #additional - + * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - - - + * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable * section[=].section[+] * title = "2. What you need to know before you take Suliqua" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "2. What you need to know before you take Suliqua" * text.status = #additional + - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + * text.div = """
    +2. What you need to know before you use Humalog Mix50 +Do NOT use Humalog Mix50 if you +
    """ * section[=].section[+] * title = "3. How to take Suliqua" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "3. How to take Suliqua" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + * text.div = """
    +3. How to use Humalog Mix50 +The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens. +

    Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor +if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by +you only, even if the needle on the delivery device is changed.

    +
    """ * section[=].section[+] @@ -94,26 +113,42 @@ Usage: #example * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "4. Possible side effects" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable + + * text.div = """
    +

    4. Possible side effects

    +

    Like all medicines, this medicine can cause side effects, although not everybody gets them.

    +
    """ * section[=].section[+] * title = "5. How to store Suliqua" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "5. How to store Suliqua" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +

    Keep this medicine out of the sight and reach of children.

    +

    + Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. +

    +

    Do not store above 30°C.

    +

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment. +

    +
    """ * section[=].section[+] * title = "6. Contents of the pack and other information" * code = https://spor.ema.europa.eu/rmswi/#100000155538 * code.text = "6. Contents of the pack and other information" * text.status = #additional - - * text.div = """
    unavailable
    """ - * emptyReason = http://terminology.hl7.org/CodeSystem/list-empty-reason#unavailable - + + * text.div = """
    +6. Contents of the pack and other information +What Humalog Mix50 100 units/ml suspension for injection in cartridge contains +

    The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant +DNA technology’ process. It is a changed form of human insulin and so is different from other +human and animal insulins. Insulin lispro is closely related to human insulin which is a natural +hormone made by the pancreas. +The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium +phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid +may have been used to adjust the acidity.

    +
    """ \ No newline at end of file diff --git a/parkingLot/Flucelvax CAP ENG (1).xml b/parkingLot/Flucelvax CAP ENG (1).xml deleted file mode 100644 index ecd5c05f43..0000000000 --- a/parkingLot/Flucelvax CAP ENG (1).xml +++ /dev/null @@ -1,1615 +0,0 @@ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - <section id="12dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="SUMMARY OF PRODUCT CHARACTERISTICS" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029791" /> - <code value="200000029791" /> - <display value="SUMMARY OF PRODUCT CHARACTERISTICS" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="19dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="1. NAME OF THE MEDICINAL PRODUCT" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029792" /> - <code value="200000029792" /> - <display value="1. NAME OF THE MEDICINAL PRODUCT" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="2adccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029793" /> - <code value="200000029793" /> - <display value="2. QUALITATIVE AND QUANTITATIVE COMPOSITION" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="5ddccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="3. PHARMACEUTICAL FORM" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029797" /> - <code value="200000029797" /> - <display value="3. PHARMACEUTICAL FORM" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="65dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4. CLINICAL PARTICULARS" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029798" /> - <code value="200000029798" /> - <display value="4. CLINICAL PARTICULARS" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="80dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.1 Therapeutic indications" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029799" /> - <code value="200000029799" /> - <display value="4.1 Therapeutic indications" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="8adccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.2 Posology and method of administration" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029800" /> - <code value="200000029800" /> - <display value="4.2 Posology and method of administration" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="91dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Posology" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029801" /> - <code value="200000029801" /> - <display value="Posology" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="9bdccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Paediatric population" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029802" /> - <code value="200000029802" /> - <display value="Paediatric population" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - </section> - <section id="acdccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Method of administration" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029803" /> - <code value="200000029803" /> - <display value="Method of administration" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - </section> - <section id="c2dccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.3 Contraindications" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029805" /> - <code value="200000029805" /> - <display value="4.3 Contraindications" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="cbdccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.4 Special warnings and precautions for use" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029806" /> - <code value="200000029806" /> - <display value="4.4 Special warnings and precautions for use" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="ebdccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.5 Interaction with other medicinal products and other forms of interaction" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029809" /> - <code value="200000029809" /> - <display value="4.5 Interaction with other medicinal products and other forms of interaction" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="fadccaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.6 Fertility, pregnancy and lactation" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029811" /> - <code value="200000029811" /> - <display value="4.6 Fertility, pregnancy and lactation" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="20ddcaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.7 Effects on ability to drive and use machines" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029815" /> - <code value="200000029815" /> - <display value="4.7 Effects on ability to drive and use machines" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="28ddcaba-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4.8 Undesirable effects" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029816" /> - <code value="200000029816" /> - <display value="4.8 Undesirable effects" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="41ddcaba-25e0-ed11-a7c7-000d3aaa0c5f"> - 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This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</span></p> -<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></strong></p> -<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</span></strong></p> -<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this leaflet. You may need to read it again. </span></p> -<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you have any further questions, ask your doctor, pharmacist or nurse.</span></p> -<p class="MsoNormal" style="margin-left: 1.0cm; text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">              </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; color: red;"> </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">This includes any possible side effects not listed in this leaflet. See section 4.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">What is in this leaflet</span></strong></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">1.<span style="mso-tab-count: 1;">    </span>What </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">is and what it is used for </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">2.<span style="mso-tab-count: 1;">    </span>What you need to know before you <span class="SmPC-PLtextChar">receive </span></span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">3.<span style="mso-tab-count: 1;">    </span>How </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span class="SmPC-PLtextChar"><span lang="EN-GB">is given</span></span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">4.<span style="mso-tab-count: 1;">    </span>Possible side effects </span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">5.<span style="mso-tab-count: 1;">    </span>How to store </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-spacerun: yes;"> </span></span></p> -<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">6.<span style="mso-tab-count: 1;">    </span>Contents of the pack and other information</span></p></div> - </text> - <section id="c285c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="1. What Flucelvax Tetra is and what it is used for" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029895" /> - <code value="200000029895" /> - <display value="1. What X is and what it is used for" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a vaccine against flu (influenza). </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span class="SmPC-PLtextChar"><span lang="EN-GB" style="color: windowtext;">is prepared in cell cultures, and, therefore, is egg-free.</span></span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is used to prevent flu in adults and children from 2 years of age.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</span></p></div> - </text> - </section> - <section id="ca85c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="2. What you need to know before you receive Flucelvax Tetra" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029896" /> - <code value="200000029896" /> - <display value="2. What you need to know before you <take> <use> X" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="d285c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="You should not receive Flucelvax Tetra:" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029897" /> - <code value="200000029897" /> - <display value="Do not <take> <use> X" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt;"><span lang="EN-GB" style="color: windowtext;">If you are allergic to:</span></p> -<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">the active ingredients or any of the other ingredients of this medicine (listed in section 6)</span></p> -<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate 80, which are trace residues from the manufacturing process.</span></p></div> - </text> - </section> - <section id="db85c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Warnings and precautions" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029898" /> - <code value="200000029898" /> - <display value="Warnings and precautions" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Talk to your doctor, pharmacist or nurse before <span class="SmPC-PLtextChar">receiving</span> </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span lang="EN-GB">.</span></span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span><u><span style="color: windowtext; mso-ansi-language: EN-US;">BEFORE receiving the vaccine</span></u></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Your <span style="mso-bidi-font-weight: bold;">doctor or nurse</span> will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span style="color: windowtext;"> </span></span><span style="color: windowtext; mso-ansi-language: EN-US;">as with all vaccines that are injected.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US; mso-bidi-font-weight: bold;">You</span><span style="color: windowtext; mso-ansi-language: EN-US;"> should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have a bleeding problem or bruise easily.</span></p> -<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">        </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</span></p> -<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span style="color: windowtext; mso-ansi-language: EN-US;"> </span><span style="color: windowtext; mso-ansi-language: EN-US;">As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</span></p></div> - </text> - </section> - <section id="ea85c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Children <and adolescents>" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029899" /> - <code value="200000029899" /> - <display value="Children <and adolescents>" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="f385c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Other medicines and Flucelvax Tetra" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029900" /> - <code value="200000029900" /> - <display value="Other medicines and X" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Tell your doctor or <span class="SmPC-PLtextChar">nurse</span> if you are using, have recently <span style="mso-no-proof: yes;">used or might use any other medicines, <span class="SmPC-PLtextChar">including medicines obtained without a prescription or if you have recently received any other vaccine.</span></span></span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">may be given at the same time as other vaccines.</span></p></div> - </text> - </section> - <section id="fc85c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="X with <food> <and> <,> <drink> <and> <alcohol>" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029901" /> - <code value="200000029901" /> - <display value="X with <food> <and> <,> <drink> <and> <alcohol>" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="0686c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Pregnancy and breast-feeding" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029902" /> - <code value="200000029902" /> - <display value="Pregnancy <and> <,> breast-feeding <and fertility>" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Pregnancy:</span></u></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy. </span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Breast-feeding:</span></u></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Use of </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.</span></p></div> - </text> - </section> - <section id="1086c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Driving and using machines" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029903" /> - <code value="200000029903" /> - <display value="Driving and using machines" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">has no or negligible effect on your ability to drive and use machines.</span></p></div> - </text> - </section> - <section id="1a86c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="X contains {name the excipient(s)}" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029904" /> - <code value="200000029904" /> - <display value="X contains {name the excipient(s)}" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - </section> - <section id="4486c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="3. How Flucelvax Tetra is given" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029905" /> - <code value="200000029905" /> - <display value="3. How to <take> <use> X" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span><u><span lang="EN-GB" style="color: windowtext;">Adults and children from 2 years of age:</span></u></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">One dose of 0.5 ml</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.</span></p></div> - </text> - <section id="5686c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Use in children <and adolescents>" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029906" /> - <code value="200000029906" /> - <display value="Use in children <and adolescents>" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - </section> - <section id="8286c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4. Possible side effects" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029910" /> - <code value="200000029910" /> - <display value="4. Possible side effects" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Like all medicines, this medicine can cause side effects, although not everybody gets them.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The following side effects have been reported during clinical trials and during general use:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Very serious side effects</span></strong></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</span></p> -<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Serious side effects</span></strong></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of <span style="mso-spacerun: yes;"> </span>Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Extensive swelling of injected limb</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Mild side effects</span></strong></p> -<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Very common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect more than 1 in 10 people):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Headache</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Muscle pain <span style="mso-spacerun: yes;"> </span></span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Tiredness </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Loss of appetite</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Irritability (only reported in children from 2 to < 6 years)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Sleepiness (only reported in children 2 to < 6 years)</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Headache was common in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Loss of appetite was common in adults, eldery and children 9 to < 18 years.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="page-break-after: avoid;"><u><span lang="EN-GB" style="color: windowtext;">Common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect up to 1 in 10 people):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Nausea, vomiting, diarrhoea </span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Joint pain</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Shivering</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Change in eating habits (only reported in children from 2 to < 6 years)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Fever (<u>></u> 38°C)</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Vomiting was uncommon in the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Fever was uncommon in adults and the elderly.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Not known</span></u><span lang="EN-GB" style="color: windowtext;"> (frequency cannot be estimated from the available data):</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Numbness and tingling sensation (paraesthesia)</span></p> -<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">      </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash </span></p></div> - </text> - <section id="9d86c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Reporting of side effects" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029912" /> - <code value="200000029912" /> - <display value="Reporting of side effects" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="BodytextAgency" style="margin-bottom: 0cm; line-height: normal;"><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-no-proof: yes;">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;"> This includes any possible <span style="mso-no-proof: yes;">side effects not listed in this leaflet.</span></span><span lang="EN-GB" style="font-size: 11.0pt;"> </span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;">You can also report side effects directly via </span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-bidi-font-family: Verdana; background: lightgrey; mso-highlight: lightgrey;">the national reporting system listed in </span><span lang="EN-GB"><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc"><span style="font-size: 11.0pt; font-family: 'Times New Roman',serif; background: lightgrey; mso-highlight: lightgrey;">Appendix V</span></a></span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;">.</span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-bidi-font-family: Verdana;">* By reporting side effects, you can help provide more information on the safety of this medicine.</span></p></div> - </text> - </section> - </section> - <section id="a886c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="5. How to store Flucelvax Tetra" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029913" /> - <code value="200000029913" /> - <display value="5. How to store X" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this <span class="SmPC-PLtextChar">vaccine</span> out of the sight and reach of children.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Store in a refrigerator (2 °C to 8 °C). Do not freeze.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Keep the pre-filled syringe in the outer carton in order to protect from light.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not use this <span class="SmPC-PLtextChar">vaccine</span> after the expiry date which is stated on the label and carton after <span class="SmPC-PLtextChar">EXP</span>. The expiry date refers to the last day of that month.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</span></p></div> - </text> - </section> - <section id="b486c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="6. Contents of the pack and other information" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029914" /> - <code value="200000029914" /> - <display value="6. Contents of the pack and other information" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="c086c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="What Flucelvax Tetra contains" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029915" /> - <code value="200000029915" /> - <display value="What X contains" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; page-break-after: avoid; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">The active substances are</span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;"> </span><span class="SmPC-PLtextChar"><span lang="EN-GB">influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:</span></span></p> -<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;"> </span></p> -<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB" style="mso-fareast-language: DE;">A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15 micrograms HA**</span></p> -<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB" style="mso-fareast-language: DE;">A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15 micrograms HA**</span></p> -<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB">B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15 micrograms HA**</span></p> -<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="mso-bidi-font-size: 10.0pt; color: windowtext; mso-no-proof: no;">B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15 micrograms HA**</span></p> -<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="color: windowtext;"> </span></p> -<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="color: windowtext;">per 0.5 ml dose</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">……………………………………….</span></p> -<p class="SmPC-PLtext" style="margin-left: 1.0cm; text-indent: -1.0cm;"><span style="color: windowtext; mso-ansi-language: EN-US;">*<span style="mso-tab-count: 1;">        </span>propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown); </span></p> -<p class="SmPC-PLtext" style="margin-left: 1.0cm; text-indent: -1.0cm;"><span style="color: windowtext; mso-ansi-language: EN-US;">**<span style="mso-tab-count: 1;">      </span>haemagglutinin</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">The other ingredients are: </span><span class="SmPC-PLtextChar"><span lang="EN-GB">sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.</span></span></p></div> - </text> - </section> - <section id="c586c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="What Flucelvax Tetra looks like and contents of the pack" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029916" /> - <code value="200000029916" /> - <display value="What X looks like and contents of the pack" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a suspension for injection in a pre-filled syringe (ready to use syringe). <br /></span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a clear to slightly opalescent suspension.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">A single syringe contains 0.5 ml of suspension for injection.</span></p> -<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.</span></p> -<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Not all pack sizes may be marketed.</span></p></div> - </text> - </section> - <section id="cb86c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Marketing Authorisation Holder and Manufacturer" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029917" /> - <code value="200000029917" /> - <display value="Marketing Authorisation Holder and Manufacturer" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Marketing Authorisation Holder </span></strong></p> -<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;">Seqirus Netherlands B.V.</span></p> -<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Paasheuvelweg 28</span></p> -<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">1105BJ Amsterdam</span></p> -<p class="SmPC-PLtext"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Netherlands</span></p> -<p class="SmPC-PLtext"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;"> </span></p> -<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Manufacturer</span></strong></p> -<p class="MsoNormal" style="line-height: normal; page-break-after: avoid;"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Seqirus Netherlands B.V.</span></p> -<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Paasheuvelweg 28</span></p> -<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span style="color: windowtext; mso-ansi-language: EN-US;">1105BJ Amsterdam</span></p> -<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US; mso-no-proof: no;">Netherlands</span></p> -<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;"> </span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<table class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-border-insideh: none; mso-border-insidev: none;" border="0" cellspacing="0" cellpadding="0"> -<tbody> -<tr style="mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: yes;"> -<td style="width: 230.25pt; padding: 0cm 5.4pt 0cm 5.4pt;" valign="top" width="307"> -<p class="MsoNormal"><strong><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">België/Belgique/Belgien</span></strong></p> -<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V.</span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Nederland/Netherlands</span></p> -<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">България</span></strong></p> -<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Нидерландия</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Тел</span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">.: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">Česká republika</span></strong></p> -<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V. </span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Nizozemsko</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Danmark</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Holland</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tlf: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Deutschland</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus GmbH Marburg</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Tel: 08003601010</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Eesti</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Holland</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Ελλάδα</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="EN-GB">Ολλανδία</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Τηλ</span><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;">: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;">España</span></strong></p> -<p class="MsoNormal"><span lang="ES-TRAD" style="mso-ansi-language: ES-TRAD;">Seqirus Spain, S.L., Barcelona</span></p> -<p class="MsoNormal"><span lang="EN-GB">Tel: 937 817 884</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">France</span></strong></p> -<p class="MsoNormal" style="line-height: normal; page-break-after: avoid;"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Netherlands</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tél: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Hrvatska</span></strong></p> -<p class="MsoNormal"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Nizozemska</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Ireland</span></strong></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Seqirus UK Limited Maidenhead</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +44 1628 641 500</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Ísland</span></strong></p> -<p class="MsoNormal"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Holland</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Sími: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Italia</span></strong></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Seqirus S.r.l. Siena</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Tel: +39 0577 096400</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Κύπρος</span></strong></p> -<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="EN-GB">Ολλανδία</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Τηλ: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Latvija</span></strong></p> -<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT;">Nīderlande</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -</td> -<td style="width: 230.3pt; padding: 0cm 5.4pt 0cm 5.4pt;" valign="top" width="307"> -<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Lietuva</span></strong></p> -<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT;">Nyderlandai</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Luxembourg/Luxemburg</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Netherlands</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tél/Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Magyarország</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Hollandia</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel.: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Malta</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">In-Netherlands</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Nederland</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. Amsterdam</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Norge</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Nederland</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tlf: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Österreich</span></strong></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Valneva Austria GmbH, Wien</span></p> -<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Tel: +43 1 20620 </span></p> -<p class="MsoNormal"><span lang="DE" style="color: #1f497d; mso-ansi-language: DE;"> </span></p> -<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Polska</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Holandia</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel.: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Portugal</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Países Baixos</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">România</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Olanda</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Slovenija</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Nizozemska</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Slovenská republika</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="SK" style="mso-ansi-language: SK;">Holandsko</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Suomi/Finland</span></strong></p> -<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Alankomaat</span></p> -<p class="MsoNormal"><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;">Puh/Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><strong><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;">Sverige</span></strong></p> -<p class="MsoNormal"><span lang="SV" style="mso-ansi-language: SV;">Seqirus Netherlands B.V. </span><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV;">Nederländerna</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -</td> -</tr> -</tbody> -</table></div> - </text> - </section> - <section id="d486c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="This leaflet was last revised on 07/2022" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029919" /> - <code value="200000029919" /> - <display value="This leaflet was last revised in <{MM/YYYY}><{month YYYY}>." /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="de86c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="Other sources of information" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029920" /> - <code value="200000029920" /> - <display value="Other sources of information" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Detailed information on this medicine is available on the European Medicines Agency web site: </span><span lang="EN-GB"><span style="mso-field-code: ' HYPERLINK ';"><span class="MsoHyperlink"><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">http://www.ema.europa.eu</span></span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">. </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">---------------------------------------------------------------------------------------------------------------------------</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">The following information is intended for healthcare professionals only:</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Shake before use. After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.</span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p> -<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.</span></p></div> - </text> - </section> - </section> - </section> - </Composition> - </resource> - </entry> - </Bundle> - </resource> - </entry> - <entry> - <fullUrl value="urn:uuid:ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" /> - <resource> - <Bundle> - <id value="ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" /> - <meta> - <versionId value="1" /> - <lastUpdated value="2023-04-21T12:41:28.269+00:00" /> - </meta> - <identifier> - <system value="http://ema.europa.eu/fhir" /> - <value value="ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" /> - </identifier> - <type value="document" /> - <timestamp value="2023-04-21T12:41:28.269+00:00" /> - <entry> - <fullUrl value="urn:uuid:ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" /> - <resource> - <Composition> - <id value="ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" /> - <language value="en" /> - <status value="final" /> - <type> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/100000155531/terms/100000155535" /> - <code value="100000155535" /> - <display value="Labelling" /> - </coding> - </type> - <date value="2023-04-21" /> - <author> - <identifier> - <value value="systemuser" /> - </identifier> - </author> - <title value="Labelling" /> - <section id="0087c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="LABELLING" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029861" /> - <code value="200000029861" /> - <display value="LABELLING" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="0887c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029862" /> - <code value="200000029862" /> - <display value="PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - <section id="1287c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="1. NAME OF THE MEDICINAL PRODUCT" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029863" /> - <code value="200000029863" /> - <display value="1. NAME OF THE MEDICINAL PRODUCT" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="1987c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="2. STATEMENT OF ACTIVE SUBSTANCE(S)" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029864" /> - <code value="200000029864" /> - <display value="2. STATEMENT OF ACTIVE SUBSTANCE(S)" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="3087c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="3. LIST OF EXCIPIENTS" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029865" /> - <code value="200000029865" /> - <display value="3. LIST OF EXCIPIENTS" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="3c87c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="4. PHARMACEUTICAL FORM AND CONTENTS" /> - <code> - <coding> - <system value="https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029866" /> - <code value="200000029866" /> - <display value="4. PHARMACEUTICAL FORM AND CONTENTS" /> - </coding> - </code> - <text> - <status value="generated" /> - <div xmlns="http://www.w3.org/1999/xhtml" /> - </text> - </section> - <section id="4787c5c0-25e0-ed11-a7c7-000d3aaa0c5f"> - <title value="5. 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This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</span></p>\n<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></strong></p>\n<p class="MsoNormal" style="line-height: normal; mso-hyphenate: none; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Read all of this leaflet carefully before you receive this medicine because it contains important information for you.</span></strong></p>\n<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this leaflet. You may need to read it again. </span></p>\n<p class="MsoNormal" style="text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1; tab-stops: 36.0pt; margin: 0cm -.1pt .0001pt 1.0cm;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you have any further questions, ask your doctor, pharmacist or nurse.</span></p>\n<p class="MsoNormal" style="margin-left: 1.0cm; text-indent: -1.0cm; line-height: normal; mso-list: l0 level1 lfo1;"><!-- [if !supportLists]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;"><span style="mso-list: Ignore;">-<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; color: red;"> </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">This includes any possible side effects not listed in this leaflet. See section 4.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">What is in this leaflet</span></strong></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">1.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>What </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">is and what it is used for </span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">2.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>What you need to know before you <span class="SmPC-PLtextChar">receive </span></span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">3.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>How </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span class="SmPC-PLtextChar"><span lang="EN-GB">is given</span></span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"> </span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">4.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>Possible side effects </span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">5.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>How to store </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra </span><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;"><span style="mso-spacerun: yes;">\u00a0</span></span></p>\n<p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; tab-stops: 21.3pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">6.<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0 </span>Contents of the pack and other information</span></p></div>" - }, - "section" : [{ - "id" : "c285c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "1. What Flucelvax Tetra is and what it is used for", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029895", - "code" : "200000029895", - "display" : "1. What X is and what it is used for" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a vaccine against flu (influenza). </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span class="SmPC-PLtextChar"><span lang="EN-GB" style="color: windowtext;">is prepared in cell cultures, and, therefore, is egg-free.</span></span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">When a person is given the vaccine, the immune system (the body’s natural defence system) will produce its own protection against the influenza virus. None of the ingredients in the vaccine can cause flu.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is used to prevent flu in adults and children from 2 years of age.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The vaccine targets four strains of influenza virus following the recommendations by the World Health Organisation for the 2022/2023 SEASON.</span></p></div>" - } - }, - { - "id" : "ca85c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "2. What you need to know before you receive Flucelvax Tetra", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029896", - "code" : "200000029896", - "display" : "2. What you need to know before you <take> <use> X" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - }, - "section" : [{ - "id" : "d285c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "You should not receive Flucelvax Tetra:", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029897", - "code" : "200000029897", - "display" : "Do not <take> <use> X" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt;"><span lang="EN-GB" style="color: windowtext;">If you are allergic to:</span></p>\n<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">the active ingredients or any of the other ingredients of this medicine (listed in section\u00a06)</span></p>\n<p class="SmPC-PLtext" style="margin-left: 36.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 42.55pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">beta-propiolactone, cetyltrimethylammonium bromide, or polysorbate\u00a080, which are trace residues from the manufacturing process.</span></p></div>" - } - }, - { - "id" : "db85c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Warnings and precautions", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029898", - "code" : "200000029898", - "display" : "Warnings and precautions" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Talk to your doctor, pharmacist or nurse before <span class="SmPC-PLtextChar">receiving</span> </span><span style="mso-bidi-font-size: 11.0pt; mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span lang="EN-GB">.</span></span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span><u><span style="color: windowtext; mso-ansi-language: EN-US;">BEFORE receiving the vaccine</span></u></p>\n<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Your <span style="mso-bidi-font-weight: bold;">doctor or nurse</span> will make sure that appropriate medical treatment and supervision is readily available in case of a rare anaphylactic reaction (a very severe allergic reaction with symptoms such as difficulty in breathing, dizziness, a weak and rapid pulse and skin rash) following the administration. This reaction may occur with </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span class="SmPC-PLtextChar"><span style="color: windowtext;"> </span></span><span style="color: windowtext; mso-ansi-language: EN-US;">as with all vaccines that are injected.</span></p>\n<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have an acute illness associated with fever. Your doctor may decide to delay your vaccination until your fever is gone.</span></p>\n<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US; mso-bidi-font-weight: bold;">You</span><span style="color: windowtext; mso-ansi-language: EN-US;"> should tell your doctor if your immune system is impaired, or if you are undergoing treatment which affects the immune system, e.g. with medicine against cancer (chemotherapy) or corticosteroid medicines (see section “Other medicines and Flucelvax Tetra”).</span></p>\n<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">You should tell your doctor if you have a bleeding problem or bruise easily.</span></p>\n<p class="SmPC-PLtext" style="margin-left: 18.0pt; text-indent: -18.0pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span style="font-family: Symbol; mso-fareast-font-family: Symbol; mso-bidi-font-family: Symbol; color: windowtext; mso-ansi-language: EN-US;"><span style="mso-list: Ignore;">·<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span style="color: windowtext; mso-ansi-language: EN-US;">Fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if you fainted with a previous injection.</span></p>\n<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span style="color: windowtext; mso-ansi-language: EN-US;">\u00a0</span><span style="color: windowtext; mso-ansi-language: EN-US;">As with all vaccines, Flucelvax Tetra may not fully protect all persons who are vaccinated.</span></p></div>" - } - }, - { - "id" : "ea85c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Children <and adolescents>", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029899", - "code" : "200000029899", - "display" : "Children <and adolescents>" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - } - }, - { - "id" : "f385c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Other medicines and Flucelvax Tetra", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029900", - "code" : "200000029900", - "display" : "Other medicines and X" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Tell your doctor or\u00a0<span class="SmPC-PLtextChar">nurse</span> if you are using, have recently <span style="mso-no-proof: yes;">used or might use any other medicines, <span class="SmPC-PLtextChar">including medicines obtained without a prescription or if you have recently received any other vaccine.</span></span></span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">may be given at the same time as other vaccines.</span></p></div>" - } - }, - { - "id" : "fc85c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "X with <food> <and> <,> <drink> <and> <alcohol>", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029901", - "code" : "200000029901", - "display" : "X with <food> <and> <,> <drink> <and> <alcohol>" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - } - }, - { - "id" : "0686c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Pregnancy and breast-feeding", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029902", - "code" : "200000029902", - "display" : "Pregnancy <and> <,> breast-feeding <and fertility>" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Pregnancy:</span></u></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. Influenza vaccines may be given in any trimester of pregnancy. </span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Breast-feeding:</span></u></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Use of </span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">during breast-feeding has not been studied. Flucelvax Tetra may be given during breast-feeding.</span></p></div>" - } - }, - { - "id" : "1086c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Driving and using machines", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029903", - "code" : "200000029903", - "display" : "Driving and using machines" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">has no or negligible effect on your ability to drive and use machines.</span></p></div>" - } - }, - { - "id" : "1a86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "X contains {name the excipient(s)}", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029904", - "code" : "200000029904", - "display" : "X contains {name the excipient(s)}" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - } - }] - }, - { - "id" : "4486c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "3. How Flucelvax Tetra is given", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029905", - "code" : "200000029905", - "display" : "3. How to <take> <use> X" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is given to you by your doctor or nurse as an injection into the muscle at the top of the upper arm (deltoid muscle).</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span><u><span lang="EN-GB" style="color: windowtext;">Adults and children from 2 years of age:</span></u></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">One dose of 0.5 ml</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">If your child is younger than 9 years of age and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.</span></p></div>" - }, - "section" : [{ - "id" : "5686c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Use in children <and adolescents>", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029906", - "code" : "200000029906", - "display" : "Use in children <and adolescents>" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - } - }] - }, - { - "id" : "8286c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "4. Possible side effects", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029910", - "code" : "200000029910", - "display" : "4. Possible side effects" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -1.45pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Like all medicines, this medicine can cause side effects, although not everybody gets them.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">The following side effects have been reported during clinical trials and during general use:</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Very serious side effects</span></strong></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately or go to the casualty department at your nearest hospital if you experience the following side effect – you may need urgent medical attention or hospitalisation:</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Difficulty in breathing, dizziness, a weak and rapid pulse and skin rash which are symptoms of an anaphylactic reaction (a very severe allergic reaction)</span></p>\n<p class="SmPC-PLtext" style="tab-stops: 36.0pt;"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Serious side effects</span></strong></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Tell your doctor immediately if you experience any of the following side effects – you may need medical attention:</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">You feel weak, you have difficulty moving around or you experience numbness or tingling in your limbs. These can be symptoms of <span style="mso-spacerun: yes;">\u00a0</span>Guillain-Barré syndrome (GBS), an autoimmune disease caused by your body’s own immune system.</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Extensive swelling of injected limb</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="color: windowtext;">Mild side effects</span></strong></p>\n<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Very common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect more than 1 in 10 people):</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Injection site pain, bruising, reddening and hardening or swelling at the site of the injection</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Headache</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Muscle pain <span style="mso-spacerun: yes;">\u00a0</span></span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Tiredness </span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Loss of appetite</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Irritability (only reported in children from 2 to < 6 years)</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Sleepiness (only reported in children 2 to < 6 years)</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Hardening or swelling at the site of the injection, headache, muscle pain, and tiredness were common in the elderly.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Bruising at the site of the injection was common in adults, eldery and children 9 to < 18 years.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Headache was common in the elderly.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Loss of appetite was common in adults, eldery and children 9 to < 18 years.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="page-break-after: avoid;"><u><span lang="EN-GB" style="color: windowtext;">Common</span></u><span lang="EN-GB" style="color: windowtext;"> (may affect up to 1 in 10 people):</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Nausea, vomiting, diarrhoea </span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Joint pain</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Shivering</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Change in eating habits (only reported in children from 2 to < 6 years)</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Fever (<u>></u> 38°C)</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Vomiting was uncommon in the elderly.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Fever was uncommon in adults and the elderly.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext"><u><span lang="EN-GB" style="color: windowtext;">Not known</span></u><span lang="EN-GB" style="color: windowtext;"> (frequency cannot be estimated from the available data):</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Numbness and tingling sensation (paraesthesia)</span></p>\n<p class="SmPC-PLtext" style="margin-left: 14.2pt; text-indent: -14.2pt; mso-list: l0 level1 lfo1; tab-stops: 36.0pt;"><!-- [if !supportLists]--><span lang="EN-GB" style="color: windowtext;"><span style="mso-list: Ignore;">•<span style="font: 7.0pt 'Times New Roman';">\u00a0\u00a0\u00a0\u00a0\u00a0 </span></span></span><!--[endif]--><span lang="EN-GB" style="color: windowtext;">Generalised skin reactions including itching, bumps on the skin (pruritis, urticaria) or non-specific rash </span></p></div>" - }, - "section" : [{ - "id" : "9d86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Reporting of side effects", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029912", - "code" : "200000029912", - "display" : "Reporting of side effects" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="BodytextAgency" style="margin-bottom: 0cm; line-height: normal;"><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-no-proof: yes;">If you get any side effects, talk to your doctor, pharmacist or nurse.</span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;"> This includes any possible <span style="mso-no-proof: yes;">side effects not listed in this leaflet.</span></span><span lang="EN-GB" style="font-size: 11.0pt;"> </span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;">You can also report side effects directly via </span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-bidi-font-family: Verdana; background: lightgrey; mso-highlight: lightgrey;">the national reporting system listed in </span><span lang="EN-GB"><a href="http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc"><span style="font-size: 11.0pt; font-family: 'Times New Roman',serif; background: lightgrey; mso-highlight: lightgrey;">Appendix V</span></a></span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif;">.</span><span lang="EN-GB" style="font-size: 11.0pt; font-family: 'Times New Roman',serif; mso-bidi-font-family: Verdana;">* By reporting side effects, you can help provide more information on the safety of this medicine.</span></p></div>" - } - }] - }, - { - "id" : "a886c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "5. How to store Flucelvax Tetra", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029913", - "code" : "200000029913", - "display" : "5. How to store X" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Keep this\u00a0<span class="SmPC-PLtextChar">vaccine</span> out of the sight and reach of children.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Store in a refrigerator (2 °C\u00a0to\u00a08 °C). Do not freeze.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Keep the pre-filled syringe in the outer carton in order to protect from light.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not use this <span class="SmPC-PLtextChar">vaccine</span> after the expiry date which is stated on the label and carton after <span class="SmPC-PLtextChar">EXP</span>. The expiry date refers to the last day of that month.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</span></p></div>" - } - }, - { - "id" : "b486c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "6. Contents of the pack and other information", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029914", - "code" : "200000029914", - "display" : "6. Contents of the pack and other information" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - }, - "section" : [{ - "id" : "c086c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "What Flucelvax Tetra contains", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029915", - "code" : "200000029915", - "display" : "What X contains" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; page-break-after: avoid; tab-stops: 36.0pt;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">The active substances are</span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;"> </span><span class="SmPC-PLtextChar"><span lang="EN-GB">influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:</span></span></p>\n<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB" style="mso-fareast-language: DE;">A/Wisconsin/588/2019 (H1N1)pdm09-like strain (A/Delaware/55/2019 CVR-45) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15\u00a0micrograms HA**</span></p>\n<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB" style="mso-fareast-language: DE;">A/Darwin/6/2021 (H3N2)-like strain (A/Darwin/11/2021, wild type) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15\u00a0micrograms HA**</span></p>\n<p class="MsoNormal" style="margin-bottom: 6.0pt; line-height: normal; tab-stops: 10.0cm;"><span lang="EN-GB">B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-fareast-language: DE;">15\u00a0micrograms HA**</span></p>\n<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="mso-bidi-font-size: 10.0pt; color: windowtext; mso-no-proof: no;">B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type) 15\u00a0micrograms HA**</span></p>\n<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="color: windowtext;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="tab-stops: 1.0cm 326.05pt;"><span lang="EN-GB" style="color: windowtext;">per\u00a00.5\u00a0ml dose</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">……………………………………….</span></p>\n<p class="SmPC-PLtext" style="margin-left: 1.0cm; text-indent: -1.0cm;"><span style="color: windowtext; mso-ansi-language: EN-US;">*<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 </span>propagated in Madin Darby Canine Kidney (MDCK) cells (this is the special cell culture in which the influenza virus is grown); </span></p>\n<p class="SmPC-PLtext" style="margin-left: 1.0cm; text-indent: -1.0cm;"><span style="color: windowtext; mso-ansi-language: EN-US;">**<span style="mso-tab-count: 1;">\u00a0\u00a0\u00a0\u00a0\u00a0 </span>haemagglutinin</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">This vaccine complies with the World Health Organisation (WHO) recommendation (northern hemisphere) and EU recommendation for the 2022/2023 SEASON.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><span style="mso-bidi-font-size: 11.0pt; mso-ansi-language: EN-US; mso-no-proof: yes;">The other ingredients are: </span><span class="SmPC-PLtextChar"><span lang="EN-GB">sodium chloride, potassium chloride, magnesium chloride hexahydrate, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.</span></span></p></div>" - } - }, - { - "id" : "c586c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "What Flucelvax Tetra looks like and contents of the pack", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029916", - "code" : "200000029916", - "display" : "What X looks like and contents of the pack" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a suspension for injection in a pre-filled syringe (ready to use syringe). <br /></span><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is a clear to slightly opalescent suspension.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">A single syringe contains 0.5\u00a0ml of suspension for injection.</span></p>\n<p class="SmPC-PLtext"><span style="mso-fareast-font-family: 'MS Mincho'; color: windowtext; mso-ansi-language: EN-US;">Flucelvax Tetra</span><span style="mso-fareast-font-family: 'MS Mincho'; mso-ansi-language: EN-US;"> </span><span lang="EN-GB" style="color: windowtext;">is available in packs containing 1 pre-filled syringe with or without needle or 10 pre-filled syringes with or without needles.</span></p>\n<p class="SmPC-PLtext"><span lang="EN-GB" style="color: windowtext;">Not all pack sizes may be marketed.</span></p></div>" - } - }, - { - "id" : "cb86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Marketing Authorisation Holder and Manufacturer", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029917", - "code" : "200000029917", - "display" : "Marketing Authorisation Holder and Manufacturer" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip; tab-stops: 36.0pt;"><strong style="mso-bidi-font-weight: normal;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Marketing Authorisation Holder </span></strong></p>\n<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;">Seqirus Netherlands B.V.</span></p>\n<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Paasheuvelweg 28</span></p>\n<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">1105BJ Amsterdam</span></p>\n<p class="SmPC-PLtext"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Netherlands</span></p>\n<p class="SmPC-PLtext"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">\u00a0</span></p>\n<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><strong style="mso-bidi-font-weight: normal;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Manufacturer</span></strong></p>\n<p class="MsoNormal" style="line-height: normal; page-break-after: avoid;"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Seqirus Netherlands B.V.</span></p>\n<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span lang="NL" style="color: windowtext; mso-ansi-language: NL;">Paasheuvelweg 28</span></p>\n<p class="SmPC-PLtext" style="mso-pagination: widow-orphan lines-together; page-break-after: avoid;"><span style="color: windowtext; mso-ansi-language: EN-US;">1105BJ Amsterdam</span></p>\n<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US; mso-no-proof: no;">Netherlands</span></p>\n<p class="SmPC-PLtext"><span style="color: windowtext; mso-ansi-language: EN-US;">\u00a0</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<table class="MsoTableGrid" style="border-collapse: collapse; border: none; mso-yfti-tbllook: 1184; mso-padding-alt: 0cm 5.4pt 0cm 5.4pt; mso-border-insideh: none; mso-border-insidev: none;" border="0" cellspacing="0" cellpadding="0">\n<tbody>\n<tr style="mso-yfti-irow: 0; mso-yfti-firstrow: yes; mso-yfti-lastrow: yes;">\n<td style="width: 230.25pt; padding: 0cm 5.4pt 0cm 5.4pt;" valign="top" width="307">\n<p class="MsoNormal"><strong><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">België/Belgique/Belgien</span></strong></p>\n<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V.</span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Nederland/Netherlands</span></p>\n<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">България</span></strong></p>\n<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Нидерландия</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Тел</span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">.: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL; mso-no-proof: yes;">Česká republika</span></strong></p>\n<p class="MsoNormal"><span lang="NL" style="mso-ansi-language: NL;">Seqirus Netherlands B.V. </span><span lang="NL" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: NL;">Nizozemsko</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Danmark</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Holland</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tlf: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Deutschland</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus GmbH Marburg</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Tel: 08003601010</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Eesti</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Holland</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Ελλάδα</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="EN-GB">Ολλανδία</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Τηλ</span><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;">: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="ES-TRAD" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: ES-TRAD; mso-no-proof: yes;">España</span></strong></p>\n<p class="MsoNormal"><span lang="ES-TRAD" style="mso-ansi-language: ES-TRAD;">Seqirus Spain, S.L., Barcelona</span></p>\n<p class="MsoNormal"><span lang="EN-GB">Tel: 937 817 884</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">France</span></strong></p>\n<p class="MsoNormal" style="line-height: normal; page-break-after: avoid;"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Netherlands</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tél: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Hrvatska</span></strong></p>\n<p class="MsoNormal"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Nizozemska</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Ireland</span></strong></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Seqirus UK Limited Maidenhead</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +44 1628 641 500</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Ísland</span></strong></p>\n<p class="MsoNormal"><span lang="EN-GB">Seqirus Netherlands B.V. </span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Holland</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Sími: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Italia</span></strong></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Seqirus S.r.l. Siena</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Tel: +39 0577 096400</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Κύπρος</span></strong></p>\n<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="EN-GB">Ολλανδία</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Τηλ: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Latvija</span></strong></p>\n<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT;">Nīderlande</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n</td>\n<td style="width: 230.3pt; padding: 0cm 5.4pt 0cm 5.4pt;" valign="top" width="307">\n<p class="MsoNormal"><strong><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT; mso-no-proof: yes;">Lietuva</span></strong></p>\n<p class="MsoNormal"><span lang="IT" style="mso-ansi-language: IT;">Seqirus Netherlands B.V. </span><span lang="IT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: IT;">Nyderlandai</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Luxembourg/Luxemburg</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Netherlands</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tél/Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Magyarország</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Hollandia</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel.: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Malta</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">In-Netherlands</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Nederland</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. Amsterdam</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Norge</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Seqirus Netherlands B.V. </span><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE;">Nederland</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Tlf: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Österreich</span></strong></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Valneva Austria GmbH, Wien</span></p>\n<p class="MsoNormal"><span lang="DE" style="mso-ansi-language: DE;">Tel: +43 1 20620 </span></p>\n<p class="MsoNormal"><span lang="DE" style="color: #1f497d; mso-ansi-language: DE;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="DE" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: DE; mso-no-proof: yes;">Polska</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Holandia</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel.: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Portugal</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Países Baixos</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">România</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Olanda</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Slovenija</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Nizozemska</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Slovenská republika</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="SK" style="mso-ansi-language: SK;">Holandsko</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT; mso-no-proof: yes;">Suomi/Finland</span></strong></p>\n<p class="MsoNormal"><span lang="PT" style="mso-ansi-language: PT;">Seqirus Netherlands B.V. </span><span lang="PT" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: PT;">Alankomaat</span></p>\n<p class="MsoNormal"><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;">Puh/Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><strong><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV; mso-no-proof: yes;">Sverige</span></strong></p>\n<p class="MsoNormal"><span lang="SV" style="mso-ansi-language: SV;">Seqirus Netherlands B.V. </span><span lang="SV" style="mso-bidi-font-size: 11.0pt; mso-ansi-language: SV;">Nederländerna</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Tel: +31 (0) 20 204 6900</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n</td>\n</tr>\n</tbody>\n</table></div>" - } - }, - { - "id" : "d486c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "This leaflet was last revised on 07/2022", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029919", - "code" : "200000029919", - "display" : "This leaflet was last revised in <{MM/YYYY}><{month YYYY}>." - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - } - }, - { - "id" : "de86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "Other sources of information", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029920", - "code" : "200000029920", - "display" : "Other sources of information" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt;">Detailed information on this medicine is available on the European Medicines Agency web site: </span><span lang="EN-GB"><span style="mso-field-code: ' HYPERLINK ';"><span class="MsoHyperlink"><span style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">http://www.ema.europa.eu</span></span></span></span><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">. </span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">---------------------------------------------------------------------------------------------------------------------------</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">The following information is intended for healthcare professionals only:</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">Shake before use. After shaking, the normal appearance of the vaccine is a clear to slightly opalescent suspension.</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">\u00a0</span></p>\n<p class="MsoNormal" style="margin-right: -.1pt; line-height: normal; mso-list: skip;"><span lang="EN-GB" style="mso-bidi-font-size: 11.0pt; mso-no-proof: yes;">The vaccine should be visually inspected for particulate matter and discoloration prior to administration. In the event of any foreign particulate matter and/or variation of physical aspect being observed, do not administer the vaccine.</span></p></div>" - } - }] - }] - }] - } - }] - } - }, - { - "fullUrl" : "urn:uuid:ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "resource" : { - "resourceType" : "Bundle", - "id" : "ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "meta" : { - "versionId" : "1", - "lastUpdated" : "2023-04-21T12:41:28.269+00:00" - }, - "identifier" : { - "system" : "http://ema.europa.eu/fhir", - "value" : "ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f" - }, - "type" : "document", - "timestamp" : "2023-04-21T12:41:28.269+00:00", - "entry" : [{ - "fullUrl" : "urn:uuid:ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "resource" : { - "resourceType" : "Composition", - "id" : "ec86c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "language" : "en", - "status" : "final", - "type" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/100000155531/terms/100000155535", - "code" : "100000155535", - "display" : "Labelling" - }] - }, - "date" : "2023-04-21", - "author" : [{ - "identifier" : { - "value" : "systemuser" - } - }], - "title" : "Labelling", - "section" : [{ - "id" : "0087c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "LABELLING", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029861", - "code" : "200000029861", - "display" : "LABELLING" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - }, - "section" : [{ - "id" : "0887c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}", - "code" : { - "coding" : [{ - "system" : "https://spor.ema.europa.eu/rmswi/#/lists/200000029659/terms/200000029862", - "code" : "200000029862", - "display" : "PARTICULARS TO APPEAR ON <THE OUTER PACKAGING> <AND> <THE IMMEDIATE PACKAGING> {NATURE/TYPE}" - }] - }, - "text" : { - "status" : "generated", - "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"/>" - }, - "section" : [{ - "id" : "1287c5c0-25e0-ed11-a7c7-000d3aaa0c5f", - "title" : "1. 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