diff --git a/ePICreator/data/calchichew-d3f.xlsx b/ePICreator/data/calchichew-d3f.xlsx new file mode 100644 index 000000000..58e413280 Binary files /dev/null and b/ePICreator/data/calchichew-d3f.xlsx differ diff --git a/ePICreator/data/domperidone.xlsx b/ePICreator/data/domperidone.xlsx new file mode 100644 index 000000000..30b02c851 Binary files /dev/null and b/ePICreator/data/domperidone.xlsx differ diff --git a/ePICreator/pdf-to-html/parser.py b/ePICreator/pdf-to-html/parser.py index 0e632e116..1f5f2b45d 100644 --- a/ePICreator/pdf-to-html/parser.py +++ b/ePICreator/pdf-to-html/parser.py @@ -5,7 +5,7 @@ from os.path import exists -LANGUAGE = "pt" +LANGUAGE = "uk" if LANGUAGE == "dk": @@ -18,6 +18,8 @@ from parser_fr import parse_html, cleanhtml, split_parts if LANGUAGE == "en": from parser_en import parse_html, cleanhtml, split_parts +if LANGUAGE == "uk": + from parser_uk import parse_html, cleanhtml, split_parts # Define the path to the PDF file pdf_path = "../../source-data/epi/karvea-epar-product-information_da.pdf" @@ -25,6 +27,9 @@ pdf_path = "/Users/joaoalmeida/Downloads/humalog-epar-product-information_da.pdf" pdf_path = "/Users/joaoalmeida/Downloads/dovato-epar-product-information_da.pdf" pdf_path = "/Users/joaoalmeida/Downloads/dovato-epar-product-information_pt.pdf" +pdf_path = "/Users/joaoalmeida/Downloads/pil.12844.pdf" +pdf_path = "/Users/joaoalmeida/Downloads/pil.4177.pdf" + html_folder = "../temp_html/" if not exists(html_folder): diff --git a/ePICreator/pdf-to-html/parser_uk.py b/ePICreator/pdf-to-html/parser_uk.py new file mode 100644 index 000000000..d730fe776 --- /dev/null +++ b/ePICreator/pdf-to-html/parser_uk.py @@ -0,0 +1,58 @@ +import re + + +# Open the PDF file +def replace_unicode_character(input_string, character_to_replace, replacement_char): + return input_string.replace(character_to_replace, replacement_char) + + +def parse_html(html_content): + new_html_content = [] + endidx = -1 + startidx = 0 + pasr = html_content.split("\n") + for idx, line in enumerate(pasr): + line = replace_unicode_character(line, chr(61607) + " ", "*") + line = replace_unicode_character(line, "• \n", "*") + + new_html_content.append(line) + if "PATIENT INFORMATION LEAFLET" in line: # ema and UK + # print(line) + startidx = idx + if ( + "Detailed information on this medicine is available on the European Medicines Agency web site: " + in line + ): + # print(line) + endidx = idx + 5 + break + print(startidx, endidx) + return "\n".join(new_html_content[startidx:endidx]) + + +def cleanhtml(raw_html): + raw_html = re.sub(r"\*\n", "* ", raw_html) + raw_html = re.sub(r"\d{2,3}\s\n", "", raw_html) + + raw_html = re.sub(r"(\d\.)\s\n", r"\1 ", raw_html) + # raw_html = re.sub(r"\so\s", "* ", raw_html) + raw_html = re.sub(r"-\s\n", "- ", raw_html) + raw_html = re.sub(r"•\s\n", "* ", raw_html) + + return raw_html + + +def split_parts(clean_content): + second_part = re.findall( + r"What is in this leaflet\S?\s{0,2}\n{1,2}\s{0,2}1. .+\n2. .+\n3. .+\n4. .+\n5. .+\n6. .+\n", + clean_content, + )[0] + first_part = re.split( + r"What is in this leaflet\S?\s{0,2}\n{1,2}\s{0,2}1. .+\n2. .+\n3. .+\n4. .+\n5. .+\n6. .+\n", + clean_content, + )[0] + third_part = re.split( + r"What is in this leaflet\S?\s{0,2}\n{1,2}\s{0,2}1. .+\n2. .+\n3. .+\n4. .+\n5. .+\n6. .+\n", + clean_content, + )[1] + return first_part, second_part, third_part diff --git a/input/fsh/examples/rawEPI/acmedrug-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/acmedrug-ema-automatic/Bundle.fsh index a57b52897..fe73c1017 100644 --- a/input/fsh/examples/rawEPI/acmedrug-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/acmedrug-ema-automatic/Bundle.fsh @@ -42,9 +42,7 @@ RuleSet: 5aa8042f9b2bea12d814ccaf27f6d64eBundleRuleset * entry[=].resource = mah-2aff7154a8d952c895e8a03849a25108 -// composition-en-534e209eb0a3ff60437639cb2015316f -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-534e209eb0a3ff60437639cb2015316f/composition-en-534e209eb0a3ff60437639cb2015316f" -* entry[=].resource = composition-en-534e209eb0a3ff60437639cb2015316f + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/amox-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/amox-ema-automatic/Bundle.fsh index 90c9cabf2..e99bd8cf0 100644 --- a/input/fsh/examples/rawEPI/amox-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/amox-ema-automatic/Bundle.fsh @@ -77,9 +77,7 @@ RuleSet: 2d6b74860092f2b27363e070e7cc20eaBundleRuleset * entry[=].resource = mah-0880223fada9f23e0f3760dee80fc7a3 -// composition-en-b62cc095c7be2116a8a65157286376a3 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-b62cc095c7be2116a8a65157286376a3/composition-en-b62cc095c7be2116a8a65157286376a3" -* entry[=].resource = composition-en-b62cc095c7be2116a8a65157286376a3 + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/aquilea-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/aquilea-ema-automatic/Bundle.fsh index af2213a38..739d39077 100644 --- a/input/fsh/examples/rawEPI/aquilea-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/aquilea-ema-automatic/Bundle.fsh @@ -4,9 +4,7 @@ RuleSet: 49bbaf88ca82da246f516eabbf90d54eBundleRuleset -// composition-es-3b8585822d27945de47423af5de9824d -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-3b8585822d27945de47423af5de9824d/composition-es-3b8585822d27945de47423af5de9824d" -* entry[=].resource = composition-es-3b8585822d27945de47423af5de9824d + diff --git a/input/fsh/examples/rawEPI/biktarvy-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/biktarvy-ema-automatic/Bundle.fsh index 63e329d8c..d6799bc85 100644 --- a/input/fsh/examples/rawEPI/biktarvy-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/biktarvy-ema-automatic/Bundle.fsh @@ -9,9 +9,7 @@ RuleSet: 63b15a3bb9d18a00ecd0962bc011c765BundleRuleset * entry[=].resource = cud-d79af6e660f456c6c7091803d6bd1a92 -// composition-es-2a9c4333cfd126f2e7b73ad3cafd6949 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-2a9c4333cfd126f2e7b73ad3cafd6949/composition-es-2a9c4333cfd126f2e7b73ad3cafd6949" -* entry[=].resource = composition-es-2a9c4333cfd126f2e7b73ad3cafd6949 + @@ -76,14 +74,10 @@ RuleSet: 63b15a3bb9d18a00ecd0962bc011c765BundleRuleset * entry[=].resource = mra-1133a7374c78f1d40f41885344f06a5a -// composition-en-2a9c4333cfd126f2e7b73ad3cafd6949 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-2a9c4333cfd126f2e7b73ad3cafd6949/composition-en-2a9c4333cfd126f2e7b73ad3cafd6949" -* entry[=].resource = composition-en-2a9c4333cfd126f2e7b73ad3cafd6949 + -// composition-dk-2a9c4333cfd126f2e7b73ad3cafd6949 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-dk-2a9c4333cfd126f2e7b73ad3cafd6949/composition-dk-2a9c4333cfd126f2e7b73ad3cafd6949" -* entry[=].resource = composition-dk-2a9c4333cfd126f2e7b73ad3cafd6949 + // PackagedProductDefinition @@ -96,9 +90,7 @@ RuleSet: 63b15a3bb9d18a00ecd0962bc011c765BundleRuleset * entry[=].resource = ppd-6d93344139a7793e7b9bd0f5e32b6c91 -// composition-pt-2a9c4333cfd126f2e7b73ad3cafd6949 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-pt-2a9c4333cfd126f2e7b73ad3cafd6949/composition-pt-2a9c4333cfd126f2e7b73ad3cafd6949" -* entry[=].resource = composition-pt-2a9c4333cfd126f2e7b73ad3cafd6949 + // MedicinalProductDefinition diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/AdministrableProductDefinition.fsh new file mode 100644 index 000000000..31357fc9c --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/AdministrableProductDefinition.fsh @@ -0,0 +1,24 @@ + +Instance: ap-a64c0ccb066e7fdf6ba2d86dcd8bda5e +InstanceOf: AdministrableProductDefinitionUvEpi +Title: "Administrable product Calcichew-D3 Forte" +Description: "Administrable product Calcichew-D3 Forte" +Usage: #inline + +* identifier.system = "https://spor.ema.europa.eu/pmswi" +* identifier.value = "gh-1" + +* status = #active + +* formOf = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) +* administrableDoseForm = $spor-rms#100000073684 "Chewable tablet" +* unitOfPresentation = $spor-rms#200000002152 "Tablet" + + + +* producedFrom = Reference(mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e) + + +* routeOfAdministration.code = $spor-rms#100000073619 "Oral use" + +* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Bundle.fsh new file mode 100644 index 000000000..a01e16b32 --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Bundle.fsh @@ -0,0 +1,79 @@ + + + +RuleSet: 9e23fbe86c1f883dff598a2d9fed332eBundleRuleset + + + + + +// Ingredient +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calchichewd3f-calciumcarbonate" +* entry[=].resource = ingredient-for-calchichewd3f-calciumcarbonate + + +// Ingredient +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-calchichewd3f-cholecalciferol" +* entry[=].resource = ingredient-for-calchichewd3f-cholecalciferol + + +// AdministrableProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-a64c0ccb066e7fdf6ba2d86dcd8bda5e" +* entry[=].resource = ap-a64c0ccb066e7fdf6ba2d86dcd8bda5e + + +// RegulatedAuthorization +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationa64c0ccb066e7fdf6ba2d86dcd8bda5e0" +* entry[=].resource = authorizationa64c0ccb066e7fdf6ba2d86dcd8bda5e0 + + +// Organization +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-d21dfe8c15312e8b8bf0b7774b510a9d" +* entry[=].resource = mah-d21dfe8c15312e8b8bf0b7774b510a9d + + +// PackagedProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-a46ff5cb1a9568d59a1669fd597f58bf" +* entry[=].resource = ppd-a46ff5cb1a9568d59a1669fd597f58bf + + +// MedicinalProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp04c5df8b1b688f62331c672bbd9ffa97" +* entry[=].resource = mp04c5df8b1b688f62331c672bbd9ffa97 + + + + + +// ManufacturedItemDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e" +* entry[=].resource = mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e + + + + + +Instance: bundlepackageleaflet-en-a64c0ccb066e7fdf6ba2d86dcd8bda5e +InstanceOf: BundleUvEpi +Title: "ePI document Bundle for Calcichew-D3 Forte Package Leaflet for language en" +Description: "ePI document Bundle for Calcichew-D3 Forte Package Leaflet for language en" +Usage: #example + + + + +* identifier.system = "https://www.gravitatehealth.eu/sid/doc" +* identifier.value = "gh-1" +* type = #document +* timestamp = "2023-06-27T10:09:22Z" +* language = #en + + + + + +// Composition +* entry[0].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-04c5df8b1b688f62331c672bbd9ffa97" +* entry[0].resource = composition-en-04c5df8b1b688f62331c672bbd9ffa97 + +* insert 9e23fbe86c1f883dff598a2d9fed332eBundleRuleset \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/ClinicalUseDefinition.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Ingredient.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Ingredient.fsh new file mode 100644 index 000000000..c93059300 --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Ingredient.fsh @@ -0,0 +1,66 @@ + + +Instance: ingredient-for-calchichewd3f-calciumcarbonate + +InstanceOf: IngredientUvEpi +Title: "Ingredient-active Calcium Carbonate" +Description: "Calcium Carbonate" +Usage: #inline + +* identifier.system = $ginas +* identifier.value = "H0G9379FGK" +* identifier.use = #official + +* role = $spor-rms#100000072072 "Active" + +* status = #active + +* substance.code.concept.coding = $ginas#H0G9379FGK "Calcium Carbonate" + + +* substance.strength.presentationQuantity = 2500 'mg' + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" + + +// Reference to products +* for = Reference(mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e) +* for[+] = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) +* for[+] = Reference(ap-a64c0ccb066e7fdf6ba2d86dcd8bda5e) + + + +//* manufacturer.manufacturer = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) + + +Instance: ingredient-for-calchichewd3f-cholecalciferol + +InstanceOf: IngredientUvEpi +Title: "Ingredient-active cholecalciferol" +Description: "cholecalciferol" +Usage: #inline + +* identifier.system = $ginas +* identifier.value = "1C6V77QF41" +* identifier.use = #official + +* role = $spor-rms#100000072072 "Active" + +* status = #active + +* substance.code.concept.coding = $ginas#1C6V77QF41 "cholecalciferol" + + +* substance.strength.presentationQuantity = 22 'ug' + +* substance.strength.basis = http://terminology.hl7.org/CodeSystem/v3-RoleClass#ACTIB "active ingredient - basis of strength" + + +// Reference to products +* for = Reference(mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e) +* for[+] = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) +* for[+] = Reference(ap-a64c0ccb066e7fdf6ba2d86dcd8bda5e) + + + +//* manufacturer.manufacturer = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/List.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/List.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/ManufacturedItemDefinition.fsh new file mode 100644 index 000000000..54ba4decb --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/ManufacturedItemDefinition.fsh @@ -0,0 +1,21 @@ + +Instance: mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e +InstanceOf: ManufacturedItemDefinitionUvEpi +Title: "Manufactured item Calcichew-D3 Forte" +Description: "Manufactured item Calcichew-D3 Forte" +Usage: #inline + +* identifier.system = "https://spor.ema.europa.eu/pmswi" +* identifier.value = "gh-1" +* identifier.use = #official + +* status = #active +* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000073684 "Chewable tablet" + +* unitOfPresentation = $spor-rms#200000002152 "Tablet" + + + + + +//* manufacturer = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/MedicinalProductDefinition.fsh new file mode 100644 index 000000000..0d0f34d4d --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/MedicinalProductDefinition.fsh @@ -0,0 +1,48 @@ + +Instance: mp04c5df8b1b688f62331c672bbd9ffa97 +InstanceOf: MedicinalProductDefinitionUvEpi +Title: "Medicinal Product Calcichew-D3 Forte" +Description: "Calcichew-D3 Forte" +Usage: #inline + + +* identifier[+].system = "http://fakesys.com/ids" +* identifier[=].value = "gh-1" +* 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 = "Calcichew-D3 Forte" + * type = $spor-productNamePartType-cs#220000000001 "Full name" + + * part[0] + * part = "Calcichew-D3 Forte" + * type = $spor-productNamePartType-cs#220000000002 "Invented name part" + + * part[+] + * part = "calcium/colecalciferol" + * type = $spor-productNamePartType-cs#220000000003 "Scientific name part" + + * part[+] + * part = "500 mg/400 IU" + * type = $spor-productNamePartType-cs#220000000004 "Strength part" + + * part[+] + * part = "CHEWABLE TABLETS" + * type = $spor-productNamePartType-cs#220000000005 "Pharmaceutical dose form part" + + * usage + * country = urn:iso:std:iso:3166#UK "United Kingdom" + * jurisdiction = urn:iso:std:iso:3166#UK "United Kingdom" + * language = urn:ietf:bcp:47#en "English" + diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Organization.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Organization.fsh new file mode 100644 index 000000000..fe08a2cbe --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Organization.fsh @@ -0,0 +1,32 @@ + + +//Marketing authorisation holder + + + + +Instance: mah-d21dfe8c15312e8b8bf0b7774b510a9d + +InstanceOf: OrganizationUvEpi +Title: "Neon Healthcare Ltd as Marketing authorisation holder" +Description: "Neon Healthcare Ltd as Marketing authorisation holder" +Usage: #inline + +* identifier.system = $spor-org +* identifier.value = "xx" +* identifier.use = #official +* active = true +* type = $spor-rms#220000000034 "Marketing authorisation holder" +//* type.text = "Marketing authorisation holder" +* name = "Neon Healthcare Ltd" + + +* contact + * address + * text = "8 The Chase, John Tate Road, Foxholes Business Park, Hertford Hertfordshire UK" + * use = #work + * type = #physical + * line = "8 The Chase, John Tate Road, Foxholes Business Park, Hertford" + * city = "Hertfordshire" + * country = "UK" + \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/PackagedProductDefinition.fsh new file mode 100644 index 000000000..fb2f1bb50 --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/PackagedProductDefinition.fsh @@ -0,0 +1,50 @@ + + + +Instance: ppd-a46ff5cb1a9568d59a1669fd597f58bf +InstanceOf: PackagedProductDefinitionUvEpi +Title: "Packaged Product Definition: Calcichew-D3 Forte 28" +Description: "Packaged Product Definition: Calcichew-D3 Forte 28" +Usage: #inline + +* identifier.system = $spor-prod +* identifier.value = "gh-1" +* identifier.use = #official + +* name = "Calcichew-D3 Forte 28" + +* type = $spor-rms#100000155527 "Chemical Medicinal Product" +//* type = $spor-rms#100000155527 + + +* status = http://hl7.org/fhir/publication-status#active "Active" +* statusDate = "2015-02-07T13:28:17Z" + + + + + +* packaging +// * identifier.system = $spor-prod +// * identifier.value = "mock-id" + * quantity = 1 + * type = $spor-rms#100000073498 "Box" + * material = $spor-rms#200000003529 "Cardboard" + + * packaging + + * identifier.system = $spor-prod + * identifier.value = "123456" + * containedItem.item.reference = Reference(mid-a64c0ccb066e7fdf6ba2d86dcd8bda5e) + * type = $spor-rms#100000073496 "Blister" + + * quantity = 28 + * material = $spor-rms#200000003222 "PolyVinyl Chloride" + + +//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet +* packageFor = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) + + + +//* manufacturer = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/RegulatedAuthorization.fsh new file mode 100644 index 000000000..2ab48e320 --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/RegulatedAuthorization.fsh @@ -0,0 +1,34 @@ + +Instance: authorizationa64c0ccb066e7fdf6ba2d86dcd8bda5e0 +InstanceOf: RegulatedAuthorizationUvEpi +Title: "Regulated Authorization for Calcichew-D3 Forte 0" +Description: "Regulated Authorization for Calcichew-D3 Forte 0" +Usage: #inline + +* identifier.system = $spor-prod +* identifier.value = "gh-1" +* identifier.use = #official + + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet + +* subject = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) + +* type = $spor-rms#220000000061 "Marketing Authorisation" + +//* type = $spor-rms#100000072062 +//* type.text = "Marketing Authorisation"* region = urn:iso:std:iso:3166#UK "United Kingdom" + + +* status = http://hl7.org/fhir/publication-status#active "Active" + + +* statusDate = "2015-02-07T13:28:17Z" +// * holder = Reference(sanofiaventisgroupe) + +* holder = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) + + + + + diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Substance.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/Substance.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/composition-en-04c5df8b1b688f62331c672bbd9ffa97.fsh b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/composition-en-04c5df8b1b688f62331c672bbd9ffa97.fsh new file mode 100644 index 000000000..c7c65b8e7 --- /dev/null +++ b/input/fsh/examples/rawEPI/calchichew-d3f-ema-automatic/composition-en-04c5df8b1b688f62331c672bbd9ffa97.fsh @@ -0,0 +1,312 @@ +Instance: composition-en-04c5df8b1b688f62331c672bbd9ffa97 +InstanceOf: CompositionUvEpi +Title: "Composition for Calcichew-D3 Forte Package Leaflet" +Description: "Composition for Calcichew-D3 Forte Package Leaflet" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/rmswi/" + + +* identifier.value = "462b3fc5470f43286799c472a0c8554e" + +* status = #final + + + + + +* type = https://spor.ema.europa.eu/rmswi/#100000155538 +* type.text = "Package Leaflet" + +* subject = Reference(mp04c5df8b1b688f62331c672bbd9ffa97) +* date = "2022-02-16T13:28:17Z" + + + // Reference to Organization: MAH +* author = Reference(mah-d21dfe8c15312e8b8bf0b7774b510a9d) + + +* title = "TEST PURPOSES ONLY - Calcichew-D3 Forte" +* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official +* attester.time = "2022-02-16T13:28:17Z" +* language = #en +* category = epicategory-cs#R "Raw" + + +* 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 = """

PATIENT INFORMATION LEAFLET

+

CALCICHEW*-D3 FORTE 500 mg/400 IU CHEWABLE TABLETS +calcium/colecalciferol

+

Read all of this leaflet carefully before you start taking this medicine because it contains +important information for you. +- Always take this medicine exactly as described in this leaflet or as your pharmacist has +told you.
+- Keep this leaflet. You may need to read it again. +- Ask your pharmacist if you need more information or advice. +- You must talk to a doctor if you do not feel better or if you feel worse after two weeks. +- If you get any side effects talk to your 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 is in this leaflet:
+1. What Calcichew-D3 Forte is and what it is used for +2. What you need to know before you take Calcichew-D3 Forte
+3. How to take Calcichew-D3 Forte
+4. Possible side effects +5. How to store Calcichew-D3 Forte
+6. Contents of the pack and other information

""" + + +* section[=].section[+] + * title = "1. What Calcichew-D3 Forte is and what it is used for" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "1. What Calcichew-D3 Forte is and what it is used for" + * text.status = #additional + * text.div = """

WHAT CALCICHEW- D3 FORTE IS AND WHAT IT IS USED FOR

+

Calcichew-D3 Forte Chewable Tablets are lemon flavoured chewable tablets containing +calcium and vitamin D3 which are both important substances in bone formation. Both are +found in the diet and vitamin D is also produced in the skin after exposure to the sun.

+

Calcichew-D3 Forte is used to treat and prevent vitamin D/calcium deficiency, which may +occur when your diet or lifestyle does not provide enough, or when body requirements are +increased. This medicine may also be prescribed or recommended for certain bone +conditions, for example osteoporosis, or during pregnancy.

""" + + + +* section[=].section[+] + * title = "2. What you need to know before you take Calcichew-D3 Forte" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "2. What you need to know before you take Calcichew-D3 Forte" + * text.status = #additional + * text.div = """

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALCICHEW- D3 +FORTE

+

Do not take Calcichew- D3 Forte if you: +• are allergic to calcium, vitamin D, or any of the other ingredients of this medicine +(listed in section 6)
+• have severe kidney problems
+• have a condition that causes excessive amounts of calcium in your blood or urine
+(hypercalcaemia or hypercalciuria) e.g. +o renal (kidney) failure +o cancer that has affected your bones +• have excessive amounts of vitamin D in your blood +• have kidney stones.

+

Warnings and precautions +Talk to your doctor or pharmacist before taking Calcichew- D3 Forte: +• if you have osteoporosis (brittle bones) and are also unable to move around +• if you are on long term treatment, especially if you are taking medicines for a heart +disorder (cardiac glycosides), or diuretics (used in the treatment of high blood +pressure or oedema) +• if you have signs of impaired kidney function or a high tendency to kidney stone +(calculus) formation +• if you have cancer or any other conditions that may have affected your bones +• if you have sarcoidosis (an immune system disorder which may cause increased +levels of vitamin D in the body).

+

If you have any of the following conditions your serum calcium or phosphate levels, or +urinary calcium excretion must be monitored. Calcichew should be taken under close medical +supervision. +• sarcoidosis (an immune system disorder which may affect your liver, lungs, skin or +lymph nodes) +• kidney problems
+• you are on long-term treatment with Calcichew +• you are already taking additional doses of calcium or vitamin D.

+

If you have increased calcium levels in the blood or develop signs of kidney problems, the +dose of Calcichew-D3 Forte should be reduced or the treatment discontinued.

+

Other medicines and Calcichew- D3 Forte +Tell your pharmacist if you are taking, have recently taken or might take any other medicines.

+

In particular, the following medicines may interact with Calcichew-D3 Forte chewable tablets: +* thiazide diuretics (water tablets); your serum calcium levels should be monitored +regularly. +* cardiac glycosides (heart medicines); you should be monitored by +electrocardiogram (ECG) and your serum calcium levels measured. +* tetracycline antibiotics; these should be taken at least two hours before, or four to +six hours afterwards. Calcium carbonate may interfere with the absorption of +tetracycline preparations if taken at the same time.
+ levothyroxine (hormone used to treat thyroid deficiency); these should be taken +at least four hours before or after taking Calcichew- D3 Forte
+ quinolone antibiotics (ciprofloxacin, lomefloxacin, norfloxacin, sparfloxacin): +the effect of these medicines may be reduced if taken at the same time as calcium. +Take quinolone antibiotics two hours before or six hours after taking Calcichew- +D3 Forte. +* bisphosphonates; should be taken at least one hour before Calcichew-D3 Forte +* Calcium salts may decrease the absorption of iron, zinc and strontium ranelate. +Consequently iron, zinc or strontium ranelate preparations should be taken at least +two hours before or after Calcichew-D3 Forte
+* Orlistat (used to treat obesity) may disturb the absorption of fat-soluble vitamins, +e.g. vitamin D3.

+

If you are taking any of the above-mentioned medicines, your pharmacist will give you further +instructions.

+

Taking Calcichew-D3 Forte with food and drink +Calcichew-D3 Forte can be taken with or without food and drink.

+

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 pharmacist for advice before taking Calcichew-D3 Forte.

+

If you are pregnant, you may use Calcichew-D3 Forte in case of a calcium and vitamin D +deficiency. During pregnancy you should not take more than 2500 mg calcium and 4000 IU +vitamin D per day, as overdoses may harm the unborn child.

+

Calcichew-D3 Forte can be used during breast-feeding. Calcium and vitamin D3 pass into +breast milk. This should be considered when giving additional vitamin D to the child.

+

Driving and using machines +Calcichew- D3 Forte has no known influence on the ability to drive or use machines.

+

Calcichew- D3 Forte contains isomalt and sucrose.
+Calcichew-D3 Forte contains isomalt (E953) and sucrose (E420): if you have been told by +your doctor that you have an intolerance to some sugars, contact your doctor before taking +this medicine. May be harmful to teeth.

""" + +* section[=].section[+] + * title = "3. How to take Calcichew-D3 Forte" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "3. How to take Calcichew-D3 Forte" + * text.status = #additional + * text.div = """

HOW TO TAKE CALCICHEW- D3 FORTE

+

Always take Calcichew- D3 Forte Tablets exactly as described in this leaflet or as your pharmacist +has told you. Check with your pharmacist if you are not sure.

+

Dosage +The recommended dose is two tablets a day, preferably one tablet in the morning and one +tablet in the evening. The tablet may be chewed or sucked.

+

Children +Calcichew-D3 Forte chewable tablets are not recommended for use in children

+

If you take more than you should +If you have taken more Calcichew- D3 Forte than you should, talk to your pharmacist +immediately.

+

If you forget to take Calcichew- D3 Forte Chewable Tablets +Do not take a double dose to make up for a forgotten tablet.

+

If you have any further questions on the use of this medicine, ask your 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 = """

POSSIBLE SIDE EFFECTS

+

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

+

Stop taking your medicine and see a doctor immediately if you experience: +•
+Frequent urge to urinate +* Headache +•
+Loss of appetite, nausea or vomiting +•
+Unusual tiredness or weakness, along with elevated levels of calcium in the blood and +kidney impairment

+

Side effects may include:

+

Uncommon side effects (may affect up to 1 in 100 people): +* excessive amounts of calcium in your blood (hypercalcaemia) or in your urine +(hypercalcuria) may occur with large doses

+

Rare side effects (may affect up to 1 in 1,000 people): +* nausea +* stomach ache +* constipation +* heartburn (dyspepsia) +* diarrhoea +* wind (flatulence) +* rash +* hives +* itching

+

Very rare side effects (may affect up to 1 in 10,000 people): +* Milk alkali syndrome (also called Burnett’s Syndrome and usually only seen when +excessive amounts of calcium have been ingested), symptoms are frequent urge to +urinate, headache, loss of appetite, nausea or vomiting, unusual tiredness or weakness, +along with elevated levels of calcium in the blood and kidney impairment.

+

Not known (frequency cannot be estimated from the available data):
+* Hypersensitivity reactions such as swelling of the face, tongue, lips (angioedema) or +swelling of the throat (laryngeal oedema). +* If you have impaired renal function, you may be at risk of increased amounts of +phosphate in the blood, renal stone formation and increased amounts of calcium in the +kidneys.

+

Reporting of side effects +If you get any side effects, talk to your pharmacist. This includes any possible side effects not listed +in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: +www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App +Store. By reporting side effects you can help provide more information on the safety of this medicine.

""" + +* section[=].section[+] + * title = "5. How to store Calcichew-D3 Forte" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "5. How to store Calcichew-D3 Forte" + * text.status = #additional + * text.div = """

HOW TO STORE CALCICHEW-D3 FORTE

+

Keep out of the sight and reach of children.

+

Store in the original package. Keep the container tightly closed to protect from moisture. Do +not store above 30°C

+

Do not use Calcichew- D3 Forte Tablets after the expiry date which is stated on the label after +EXP. The expiry date refers to the last day of that month. If the tablets have changed shape +or colour do not use.

+

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 = """

CONTENTS OF THE PACK AND OTHER INFORMATION

+

What Calcichew-D3 Forte Chewable Tablets contain +The active ingredients in each tablet are: +• 1250mg calcium carbonate (equivalent to 500mg calcium) +• 400IU colecalciferol (equivalent to 10 micrograms vitamin D3)

+

The other ingredients are: xylitol (E967), povidone, isomalt (E953), fatty acid mono- and di- +glycerides, magnesium stearate, lemon flavour, sucralose (E955), sucrose, tocopherol, modified +maize starch, medium-chain triglycerides, sodium ascorbate and anhydrous colloidal silica (see +also end of Section 2 “Calcichew-D3 Forte contains isomalt and sucrose”).

+

What Calcichew-D3 Forte look like and contents of the pack +The tablets are round, white, uncoated, convex and lemon flavoured; they may have small specks. +The tablets are packed in white, plastic bottles of 60 and 100 tablets. Not all pack sizes may be +marketed.

+

Marketing Authorisation Holder
+Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, UK

+

Manufacturer +Asker Contract Manufacturing AS, Drammensveien 852, N-1385 Asker, Norway.

+

This leaflet was last revised in March 2023.
+Additional Information
+Calcichew-D3 Forte are a combination of calcium and vitamin D designed to keep bones +healthy. Calcium is an essential component of bones while vitamin D plays an important role +in the absorption of calcium from food.

+

Requirements for calcium increase with age and, although many people obtain enough +calcium from their diet, some people may require a supplement in order that their body has +all the calcium it needs to maintain healthy bones. Vitamin D is produced largely from the +action of sunlight. Certain foodstuffs do contain vitamin D in reasonable amounts but it is +not always possible to obtain all the vitamin D you need from your diet. People who do not +get out and about, for instance those who are housebound or people living in nursing and +residential homes, may not receive all the vitamin D they need.

+

People with diets and lifestyles that mean they will obtain less than the recommended intake +of calcium and vitamin D are at risk of weakened bones. Prolonged lack of adequate calcium +and vitamin D intake can lead to the development of osteoporosis, a condition where bones +become weak to a level that minimal trauma (for example, a fall) can result in a fracture, +most typically at the hip, spine or wrist.

+

Calcichew-D3 Forte have been designed to give people whose intakes of calcium and vitamin +D are low a boost to the recommended amounts.

+

Maintaining healthy bones and helping to avoid osteoporosis is an important issue for many +people. There are many ways that people can help themselves: regular exercise, a balanced +diet with an adequate intake of calcium and vitamin D and, for some people, advice on how +to prevent falls which may lead to fracture.

+

The Royal Osteoporosis Society is a national charity dedicated to improving the diagnosis, prevention +and treatment of osteoporosis. The Royal Osteoporosis Society offers support to people with +osteoporosis and raises awareness of the importance of healthy bones.

+

If you are concerned about osteoporosis, please contact the Royal Osteoporosis Society, Camerton, +Bath BA2 0PJ. Tel: 01761 471 771 or email: info@theros.org.uk.
+*Registered Trademark

""" + diff --git a/input/fsh/examples/rawEPI/calcio_vitamina_d-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/calcio_vitamina_d-ema-automatic/Bundle.fsh index d734396ed..e81b1e0ba 100644 --- a/input/fsh/examples/rawEPI/calcio_vitamina_d-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/calcio_vitamina_d-ema-automatic/Bundle.fsh @@ -82,9 +82,7 @@ RuleSet: bdfe699962879d1b1d2adb6ccf20a5cbBundleRuleset * entry[=].resource = authorization925dad38f0afbba36223a82b3a7664380 -// composition-es-d4bcbbaec04bf6aceb2f71162205967e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-d4bcbbaec04bf6aceb2f71162205967e/composition-es-d4bcbbaec04bf6aceb2f71162205967e" -* entry[=].resource = composition-es-d4bcbbaec04bf6aceb2f71162205967e + // Organization diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/administrableproductdefinition.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/administrableproductdefinition.fsh index bb70a9d08..d652db3fd 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/administrableproductdefinition.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/administrableproductdefinition.fsh @@ -2,7 +2,7 @@ Instance: adminprodcarbamazepine200 InstanceOf: AdministrableProductDefinitionUvEpi Title: "Administrable Product - Tegretol (carbamazepine) 200 mg for tablet" Description: "Administrable Product - Tegretol (carbamazepine) 200 mg for tablet" -Usage: #example +Usage: #inline * identifier.system = $phpid * identifier.value = "FB9808F4FED210183F412F9998622287" //PHPID diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/ingredients.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/ingredients.fsh index d137fee3e..3d216c1fe 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/ingredients.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/ingredients.fsh @@ -2,7 +2,7 @@ Instance: carbamazepine InstanceOf: IngredientUvEpi Title: "Ingredient - carbamazepine" Description: "Ingredient - carbamazepine" -Usage: #example +Usage: #inline * identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" * identifier.value = "33CM23913M" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/manufactureditemdefinition.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/manufactureditemdefinition.fsh index 85b4513a3..da42b913b 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/manufactureditemdefinition.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/manufactureditemdefinition.fsh @@ -1,7 +1,7 @@ Instance: manitemcarbamazepine200 InstanceOf: ManufacturedItemDefinitionUvEpi Description: "Manufactured Item - Tegretol (carbamazepine) 200 mg for tablet" -Usage: #example +Usage: #inline * identifier.system = "https://pmda-sccj" * identifier.value = "placeholder" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/medicinalproductdefinition.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/medicinalproductdefinition.fsh index e9fe64c96..9ecc5954f 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/medicinalproductdefinition.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/medicinalproductdefinition.fsh @@ -2,7 +2,7 @@ Instance: medprodcarbamazepine200 InstanceOf: MedicinalProductDefinitionUvEpi Title: "Medicinal Product - Tegretol (carbamazepine) 200 mg for tablet" Description: "Medicinal Product - Tegretol (carbamazepine) 200 mg for tablet" -Usage: #example +Usage: #inline * identifier[+].system = "http://iyaku.info/medicine" * identifier[=].value = "1139002F1070" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/organization.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/organization.fsh index e4a8d7c60..d50b3e586 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/organization.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/organization.fsh @@ -2,7 +2,7 @@ Instance: orgfujinaga InstanceOf: OrganizationUvEpi Title: "Marketing Authorization Holder - Fujinaga Pharmaceutical Co., Ltd." Description: "Marketing Authorization Holder - Fujinaga Pharmaceutical Co., Ltd." -Usage: #example +Usage: #inline * identifier.system = "https://pmda-org-id" * identifier.value = "fujinaga" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/packaging.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/packaging.fsh index 1e5ae5b3d..32149aab5 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/packaging.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/packaging.fsh @@ -2,7 +2,7 @@ Instance: packcarbamazepine200 InstanceOf: PackagedProductDefinitionUvEpi Title: "28 tablets in bottle" Description: "28 tablets in bottle" -Usage: #example +Usage: #inline * identifier.system = "https://pmda-packinsertno/" * identifier.value = "placeholder2" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/regulatedauthorization.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/regulatedauthorization.fsh index 501f322c0..36935b3d5 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/regulatedauthorization.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/regulatedauthorization.fsh @@ -2,7 +2,7 @@ Instance: authcarbamazepine200 InstanceOf: RegulatedAuthorizationUvEpi Title: "Regulated Authorization - Tegretol (carbamazepine) 200 mg for tablet" Description: "Regulated Authorization - Tegretol (carbamazepine) 200 mg for tablet" -Usage: #example +Usage: #inline * identifier.system = "https://pmda-approvalandlicenseno/" * identifier.value = "22700AMX00173" diff --git a/input/fsh/examples/rawEPI/carbamazepine-jp/substance.fsh b/input/fsh/examples/rawEPI/carbamazepine-jp/substance.fsh index 3ecb5f441..71f30984f 100644 --- a/input/fsh/examples/rawEPI/carbamazepine-jp/substance.fsh +++ b/input/fsh/examples/rawEPI/carbamazepine-jp/substance.fsh @@ -2,7 +2,7 @@ Instance: subcarbamazepine200 InstanceOf: SubstanceDefinitionUvEpi Title: "Substance - carbamazepine" Description: "Substance - carbamazepine" -Usage: #example +Usage: #inline * identifier.system = "https://gsrs.ncats.nih.gov/ginas/app/beta/" * identifier.value = "33CM23913M" diff --git a/input/fsh/examples/rawEPI/cinitrapide-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/cinitrapide-ema-automatic/Bundle.fsh index d96a0cccd..bf3e49e9a 100644 --- a/input/fsh/examples/rawEPI/cinitrapide-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/cinitrapide-ema-automatic/Bundle.fsh @@ -37,9 +37,7 @@ RuleSet: af8224f8c853d17daf5ea6782cb5a097BundleRuleset * entry[=].resource = ingredient-for-cinitrapide-starchcorn -// composition-es-1453e0f16ff6c1d3106ed737a7857578 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-1453e0f16ff6c1d3106ed737a7857578/composition-es-1453e0f16ff6c1d3106ed737a7857578" -* entry[=].resource = composition-es-1453e0f16ff6c1d3106ed737a7857578 + // Substance diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/AdministrableProductDefinition.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/AdministrableProductDefinition.fsh new file mode 100644 index 000000000..31895be11 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/AdministrableProductDefinition.fsh @@ -0,0 +1,24 @@ + +Instance: ap-27c9d5187cd283f8d160ec1ed2b5ac89 +InstanceOf: AdministrableProductDefinitionUvEpi +Title: "Administrable product Mo" +Description: "Administrable product Mo" +Usage: #inline + +* identifier.system = "https://spor.ema.europa.eu/pmswi" +* identifier.value = "gh-2" + +* status = #active + +* formOf = Reference(mpc08df9bb5fb44242a6291b1eee5d09ad) +* administrableDoseForm = $spor-rms#100000073664 "Tablet" +* unitOfPresentation = $spor-rms#200000002152 "Tablet" + + + +* producedFrom = Reference(mid-27c9d5187cd283f8d160ec1ed2b5ac89) + + +* routeOfAdministration.code = $spor-rms#100000073619 "Oral use" + +* routeOfAdministration.targetSpecies.code = $spor-rms#100000109093 "Human" \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Bundle.fsh new file mode 100644 index 000000000..6101f77ab --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Bundle.fsh @@ -0,0 +1,74 @@ + + + +RuleSet: 78599bc1ba0ed00b25c5531cce99cd04BundleRuleset + + + + + + + + +// Ingredient +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-domperidone-domperidone" +* entry[=].resource = ingredient-for-domperidone-domperidone + + +// AdministrableProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-27c9d5187cd283f8d160ec1ed2b5ac89" +* entry[=].resource = ap-27c9d5187cd283f8d160ec1ed2b5ac89 + + +// RegulatedAuthorization +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorization27c9d5187cd283f8d160ec1ed2b5ac890" +* entry[=].resource = authorization27c9d5187cd283f8d160ec1ed2b5ac890 + + +// Organization +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-3ba8fc4ba9a20220f5e2470c283f7ae3" +* entry[=].resource = mah-3ba8fc4ba9a20220f5e2470c283f7ae3 + + +// PackagedProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-c40decbddc475d768d3f1dad1c6f77a4" +* entry[=].resource = ppd-c40decbddc475d768d3f1dad1c6f77a4 + + +// MedicinalProductDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mpc08df9bb5fb44242a6291b1eee5d09ad" +* entry[=].resource = mpc08df9bb5fb44242a6291b1eee5d09ad + + +// ManufacturedItemDefinition +* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-27c9d5187cd283f8d160ec1ed2b5ac89" +* entry[=].resource = mid-27c9d5187cd283f8d160ec1ed2b5ac89 + + + + + +Instance: bundlepackageleaflet-en-27c9d5187cd283f8d160ec1ed2b5ac89 +InstanceOf: BundleUvEpi +Title: "ePI document Bundle for Mo Package Leaflet for language en" +Description: "ePI document Bundle for Mo Package Leaflet for language en" +Usage: #example + + + + +* identifier.system = "https://www.gravitatehealth.eu/sid/doc" +* identifier.value = "gh-2" +* type = #document +* timestamp = "2023-06-27T10:09:22Z" +* language = #en + + + + + +// Composition +* entry[0].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-en-c08df9bb5fb44242a6291b1eee5d09ad" +* entry[0].resource = composition-en-c08df9bb5fb44242a6291b1eee5d09ad + +* insert 78599bc1ba0ed00b25c5531cce99cd04BundleRuleset \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/ClinicalUseDefinition.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/ClinicalUseDefinition.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/Ingredient.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Ingredient.fsh new file mode 100644 index 000000000..a39865247 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Ingredient.fsh @@ -0,0 +1,29 @@ + + +Instance: ingredient-for-domperidone-domperidone + +InstanceOf: IngredientUvEpi +Title: "Ingredient-active DOMPERIDONE" +Description: "DOMPERIDONE" +Usage: #inline + +* identifier.system = $ginas +* identifier.value = "5587267Z69" +* identifier.use = #official + +* role = $spor-rms#100000072072 "Active" + +* status = #active + +* substance.code.concept.coding = $ginas#5587267Z69 "DOMPERIDONE" + + + +// Reference to products +* for = Reference(mid-27c9d5187cd283f8d160ec1ed2b5ac89) +* for[+] = Reference(mpc08df9bb5fb44242a6291b1eee5d09ad) +* for[+] = Reference(ap-27c9d5187cd283f8d160ec1ed2b5ac89) + + + +//* manufacturer.manufacturer = Reference(mah-3ba8fc4ba9a20220f5e2470c283f7ae3) diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/List.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/List.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/ManufacturedItemDefinition.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/ManufacturedItemDefinition.fsh new file mode 100644 index 000000000..3dab2046a --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/ManufacturedItemDefinition.fsh @@ -0,0 +1,21 @@ + +Instance: mid-27c9d5187cd283f8d160ec1ed2b5ac89 +InstanceOf: ManufacturedItemDefinitionUvEpi +Title: "Manufactured item Mo" +Description: "Manufactured item Mo" +Usage: #inline + +* identifier.system = "https://spor.ema.europa.eu/pmswi" +* identifier.value = "gh-2" +* identifier.use = #official + +* status = #active +* manufacturedDoseForm = https://spor.ema.europa.eu/rmswi/#100000073665 "Film-coated tablet" + +* unitOfPresentation = $spor-rms#200000002152 "Tablet" + + + + + +//* manufacturer = Reference(mah-3ba8fc4ba9a20220f5e2470c283f7ae3) \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/MedicinalProductDefinition.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/MedicinalProductDefinition.fsh new file mode 100644 index 000000000..37e879df8 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/MedicinalProductDefinition.fsh @@ -0,0 +1,48 @@ + +Instance: mpc08df9bb5fb44242a6291b1eee5d09ad +InstanceOf: MedicinalProductDefinitionUvEpi +Title: "Medicinal Product Mo" +Description: "Mo" +Usage: #inline + + +* identifier[+].system = "http://fakesys.com/ids" +* identifier[=].value = "gh-2" +* 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 = "Mo" + * type = $spor-productNamePartType-cs#220000000001 "Full name" + + * part[0] + * part = "Motillium" + * type = $spor-productNamePartType-cs#220000000002 "Invented name part" + + * part[+] + * part = "Domperidone" + * type = $spor-productNamePartType-cs#220000000003 "Scientific name part" + + * part[+] + * part = "10 mg" + * type = $spor-productNamePartType-cs#220000000004 "Strength part" + + * part[+] + * part = "tablet" + * type = $spor-productNamePartType-cs#220000000005 "Pharmaceutical dose form part" + + * usage + * country = urn:iso:std:iso:3166#UK "United Kingdom" + * jurisdiction = urn:iso:std:iso:3166#UK "United Kingdom" + * language = urn:ietf:bcp:47#en "English" + diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/Organization.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Organization.fsh new file mode 100644 index 000000000..ad00af612 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Organization.fsh @@ -0,0 +1,32 @@ + + +//Marketing authorisation holder + + + + +Instance: mah-3ba8fc4ba9a20220f5e2470c283f7ae3 + +InstanceOf: OrganizationUvEpi +Title: "Zentiva as Marketing authorisation holder" +Description: "Zentiva as Marketing authorisation holder" +Usage: #inline + +* identifier.system = $spor-org +* identifier.value = "xx" +* identifier.use = #official +* active = true +* type = $spor-rms#220000000034 "Marketing authorisation holder" +//* type.text = "Marketing authorisation holder" +* name = "Zentiva" + + +* contact + * address + * text = "First Floor, Andrews House, College Road, Guildford, Surrey UK" + * use = #work + * type = #physical + * line = "First Floor, Andrews House, College Road, Guildford," + * city = "Surrey" + * country = "UK" + \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/PackagedProductDefinition.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/PackagedProductDefinition.fsh new file mode 100644 index 000000000..3ab89bf3d --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/PackagedProductDefinition.fsh @@ -0,0 +1,53 @@ + + + +Instance: ppd-c40decbddc475d768d3f1dad1c6f77a4 +InstanceOf: PackagedProductDefinitionUvEpi +Title: "Packaged Product Definition: Mo 28" +Description: "Packaged Product Definition: Mo 28" +Usage: #inline + +* identifier.system = $spor-prod +* identifier.value = "dd" +* identifier.use = #official + +* name = "Mo 28" + +* type = $spor-rms#100000155527 "Chemical Medicinal Product" +//* type = $spor-rms#100000155527 + + +* status = http://hl7.org/fhir/publication-status#active "Active" +* statusDate = "2015-02-07T13:28:17Z" + + +* containedItemQuantity = 10 'mg' + + + + + +* packaging +// * identifier.system = $spor-prod +// * identifier.value = "mock-id" + * quantity = 1 + * type = $spor-rms#100000073498 "Box" + * material = $spor-rms#200000003529 "Cardboard" + + * packaging + + * identifier.system = $spor-prod + * identifier.value = "123456" + * containedItem.item.reference = Reference(mid-27c9d5187cd283f8d160ec1ed2b5ac89) + * type = $spor-rms#100000073496 "Blister" + + * quantity = 28 + * material = $spor-rms#200000003222 "PolyVinyl Chloride" + + +//reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet +* packageFor = Reference(mpc08df9bb5fb44242a6291b1eee5d09ad) + + + +//* manufacturer = Reference(mah-3ba8fc4ba9a20220f5e2470c283f7ae3) \ No newline at end of file diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/RegulatedAuthorization.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/RegulatedAuthorization.fsh new file mode 100644 index 000000000..cd8d637b8 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/RegulatedAuthorization.fsh @@ -0,0 +1,34 @@ + +Instance: authorization27c9d5187cd283f8d160ec1ed2b5ac890 +InstanceOf: RegulatedAuthorizationUvEpi +Title: "Regulated Authorization for Mo 0" +Description: "Regulated Authorization for Mo 0" +Usage: #inline + +* identifier.system = $spor-prod +* identifier.value = "4177" +* identifier.use = #official + + +// Reference to MedicinalProductDefinition: EU/1/97/049/001 Karvea 75 mg tablet + +* subject = Reference(mpc08df9bb5fb44242a6291b1eee5d09ad) + +* type = $spor-rms#220000000061 "Marketing Authorisation" + +//* type = $spor-rms#100000072062 +//* type.text = "Marketing Authorisation"* region = urn:iso:std:iso:3166#UK "United Kingdom" + + +* status = http://hl7.org/fhir/publication-status#active "Active" + + +* statusDate = "2015-02-07T13:28:17Z" +// * holder = Reference(sanofiaventisgroupe) + +* holder = Reference(mah-3ba8fc4ba9a20220f5e2470c283f7ae3) + + + + + diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/Substance.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/Substance.fsh new file mode 100644 index 000000000..e69de29bb diff --git a/input/fsh/examples/rawEPI/domperidone-ema-automatic/composition-en-c08df9bb5fb44242a6291b1eee5d09ad.fsh b/input/fsh/examples/rawEPI/domperidone-ema-automatic/composition-en-c08df9bb5fb44242a6291b1eee5d09ad.fsh new file mode 100644 index 000000000..e2e0bb365 --- /dev/null +++ b/input/fsh/examples/rawEPI/domperidone-ema-automatic/composition-en-c08df9bb5fb44242a6291b1eee5d09ad.fsh @@ -0,0 +1,311 @@ +Instance: composition-en-c08df9bb5fb44242a6291b1eee5d09ad +InstanceOf: CompositionUvEpi +Title: "Composition for Mo Package Leaflet" +Description: "Composition for Mo Package Leaflet" +Usage: #example + +* identifier.system = "https://spor.ema.europa.eu/rmswi/" + + +* identifier.value = "beed2bb9992ec6835c69d1ba0554b00f" + +* status = #final + + + + + +* type = https://spor.ema.europa.eu/rmswi/#100000155538 +* type.text = "Package Leaflet" + +* subject = Reference(mpc08df9bb5fb44242a6291b1eee5d09ad) +* date = "2022-02-16T13:28:17Z" + + + // Reference to Organization: MAH +* author = Reference(mah-3ba8fc4ba9a20220f5e2470c283f7ae3) + + +* title = "TEST PURPOSES ONLY - Mo" +* attester.mode = http://hl7.org/fhir/composition-attestation-mode#official +* attester.time = "2022-02-16T13:28:17Z" +* language = #en +* category = epicategory-cs#R "Raw" + + +* 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 = """

PATIENT INFORMATION LEAFLET +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 is in this leaflet: +1. What Motilium is and what it is used for +2. What you need to know before you take Motilium +3. How to take Motilium +4. Possible side effects +5. How to store Motilium +6. Contents of the pack and other information

""" + + +* section[=].section[+] + * title = "1. What Domperidone is and what it is used for" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "1. What Domperidone is and what it is used for" + * text.status = #additional + * text.div = """
"
    +
  1. WHAT MOTILIUM IS AND WHAT IT IS USED FOR +The name of your medicine is Motilium 10mg Film-Coated Tablets (called Motilium in this leaflet). Motilium +contains a medicine called domperidone. This belongs to a group of medicines called ‘dopamine antagonists’. +This medicine is used to treat nausea (feeling sick) and vomiting (being sick) in adults and adolescents (years of age and older weighting 35 kg or more).
    2. +
"
""" + + + +* section[=].section[+] + * title = "2. What you need to know before you take Domperidone" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "2. What you need to know before you take Domperidone" + * text.status = #additional + * text.div = """

Do not take Motilium tablets if: +• You are allergic to domperidone or any of the other ingredients of Motilium 10mg Film-Coated Tablets (listed +in section 6). +Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, +throat or tongue. +• You have a tumour of the pituitary gland (prolactinoma) +• You have a blockage or tear in your intestines +• You have black, tarry bowel motions (stools) or notice blood in your bowel motions. This could be a sign of +bleeding in the stomach or intestines. +• You have a moderate or severe liver disease. +• Your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval”. +• You have or had a problem where your heart cannot pump the blood round your body as well as it should +(condition called heart failure). +• You have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in +your blood. +• You are taking certain medicines (see “Other medicines and Motilium”) +Do not take Motilium if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist +before taking Motilium. +Warnings and precautions +Before taking this medicine contact your doctor if: +• You suffer from liver problems (liver function impairment or failure) (see “Do not take Motilium tablets if”) +• You suffer from kidney problems (kidney function impairment or failure). It is advisable to ask your doctor +for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less +often, and your doctor may want to examine you regularly. +If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Motilium. +Do this even if they have applied in the past. +Motilium may be associated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may +be more likely in those over 60 years old or taking doses higher than 30 mg per day. The risk also increases +when Motilium is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to +treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see +“Other medicines and Motilium). +Motilium should be used at the lowest effective dose. +While taking Motilium, contact your doctor if you experience heart rhythm disorders such as palpitations, +trouble breathing, loss of consciousness. Treatment with Motilium should be stopped. +Adolescents weighing less than 35 kg and children +Motilium should not be given to adolescents 12 years of age and older weighing less than 35 kg, or in any +children less than 12 years of age, as it is not effective in these age groups. +Other medicines and Motilium +Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes +medicines you can buy without a prescription, including herbal medicines. This is because Motilium can affect +the way some other medicines work. Also, some medicines can affect the way Motilium works. +Do not take Motilium if you are taking medicine to treat: +• Fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole. +• Bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine +(these are antibiotics) +• Heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, +sotalol, diltiazem, verapamil) +• Psychoses (e.g., haloperidol, pimozide, sertindole) +• Depression (e.g., citalopram, escitalopram) +• Gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride) +• Allergy (e.g., mequitazine, mizolastine) +• Malaria (in particular halofantrine) +• AIDS/HIV (protease inhibitors) +• Cancer (e.g., toremifene, vandetanib, vincamine) +Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems, AIDS/HIV or Parkinson’s +disease. +Motilium and apomorphine +Before you use Motilium and apomorphine, your doctor will ensure that you tolerate both medicines when used +simultaneously. Ask your doctor or specialist for a personalised advice. Please refer to the apomorphine leaflet. +It is important to ask your doctor or pharmacist if Motilium is safe for you when you are taking any other +medicines, including medicines obtained without prescription. +Taking Motilium with food and drink +It is recommended to take Motilium before meals, as when taken after meals the absorption of the medicine is +slightly delayed. +Pregnancy and breast-feeding +Talk to your doctor or pharmacist before taking Motilium if: +• You are pregnant, might become pregnant or think you may be pregnant +• You are breast-feeding. It is best not to take Motilium if you are breast-feeding. +Small amounts of Motilium have been detected in breast-milk. Motilium may cause unwanted side effects +affecting the heart in a breast-fed baby. Motilium should be used during breast feeding only if your physician +considers this clearly necessary. Ask your doctor for advice before taking this medicine. +Driving and using machines: +Motilium can affect your ability to drive or use machinery as it may make you sleepy. Do not drive while taking +this medicine until you know how it affects you. +Motilium tablets contain lactose. +This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some +sugars, contact your doctor before taking this medicinal product. +fold here +25,5mm +420 mm +148 mm +25,5mm +25,5mm +25,5mm +fold here +3380 +3380 +3380 +3380 +fold here +fold here

""" + +* section[=].section[+] + * title = "3. How to take Domperidone" + * code = https://spor.ema.europa.eu/rmswi/#100000155538 + * code.text = "3. How to take Domperidone" + * text.status = #additional + * text.div = """

Follow these instructions closely unless your doctor has advised you otherwise. You should check with your +doctor or pharmacist if you are not sure. +Duration of treatment +Your doctor will decide how long you will need to take this medicine.
+Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Motilium for longer than 7 days +without consulting your doctor. +Taking this medicine +• Swallow the tablets whole with a drink of water. +• Take the tablets 15 to 30 minutes before a meal. +• Do not crush or chew them. +The usual dose is: +• Adults and adolescents 12 years of age and older with a body weight of 35kg or more +The usual dose is one tablet taken up to three times per day, if possible before meals. Do not take more +than three tablets per day. +• This product is not suitable for children under 12 years of age and older with a body weight of +less than 35 kg. +People with kidney problems +Your doctor may tell you to take a lower dose or to take the medicine less often. +If you take more Motilium than you should: +• If you have used or taken too many Motilium tablets contact your doctor, pharmacist or the poisons centre +at your nearest hospital casualty department immediately. Take the carton and any tablets left with you. This +is so the doctors know what you have taken. +In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring could be +undertaken, because of the possibility of a heart problem called prolonged QT interval. +• The signs of taking more than you should include feeling sleepy, confused, uncontrolled movements which +include unusual eye movements, unusual movements of the tongue or abnormal posture (such as a twisted +neck). +If you forget to take Motilium: +• If you forget to take Motilium, take it as soon as you remember. +• However if it is almost time for the next dose, wait until that is due and then continue as normal. +• Do not take a double dose to make up for a forgotten dose.

""" + + +* 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, Motilium can have side effects, although not everybody gets them. +Stop taking Motilium and see your doctor or go to a hospital straightaway if: +• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or +breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria). This may mean you are +having an allergic reaction to Motilium. +• You notice any uncontrolled movements. These include irregular eye movements, unusual movements of +the tongue, and abnormal posture such as a twisted neck, trembling and muscle stiffness. These symptoms +should stop once you stop taking Motilium. +• You have a very fast or unusual heartbeat. This could be a sign of a life-threatening heart problem. +• You have a fit (seizure). +Other side effects include: +Common (affects less than 1 in 10 people) +• Dry mouth +Uncommon (affects less than 1 in 100 people) +• Lowering of sexual drive (libido) in men +• Feeling anxious +• Feeling agitated or irritable +• Feeling more nervous than usual +• Feeling drowsy +• Headaches +• Diarrhoea +• Itchy skin. You may also have a rash +• Unusual production of breast milk in men and women +• Painful or tender breasts +• A general feeling of weakness +Not known (Frequency cannot be estimated from the available data) +• Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heart beat) have +been reported; if this happens, you should stop the treatment immediately. Motilium may be associ- +ated with an increased risk of heart rhythm disorder and cardiac arrest. This risk may be more likely +in those over 60 years old or taking doses higher than 30 mg per day. Motilium should be used at the +lowest effective dose. +• Abnormal eye movements +• Feeling the urge to move your legs, arms or other parts of your body (restless legs syndrome). These +symptoms may become worse in patients suffering from Parkinson’s disease. +• Inability to urinate +• Breast enlargement in men +• In women, menstrual periods may be irregular or stop +• A blood test shows changes in the way your liver is working. +Some patients who have used Motilium for conditions and dosages requiring longer term medical supervision +have experienced the following unwanted effects: +Restlessness; swollen or enlarged breasts, unusual discharge from breasts, irregular menstrual periods in +women, difficulty breastfeeding, depression, hypersensitivity. +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 Yellow card Scheme at: www.mhra.gov.uk/ +yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, +you can help provide more information on the safety of this medicine.

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

• Keep out of the sight and reach of children. +• Do not store above 25°C. +• Do not use this medicine after the expiry date which is stated on the pack. +• Do not throw away any medicines via wastewater or household water. Ask your pharmacist how to throw +away medicines you no longer use. These medicines 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 Motilium 10mg Film-Coated Tablets contain +• The active ingredient is domperidone. Each tablet contains 10 mg of domperidone. +• It also contains lactose, maize starch, microcrystalline cellulose, hypromellose, pregelatinised starch, povi- +done, propylene glycol, magnesium stearate, silica colloidal hydrated and polysorbate 20. +What Motilium 10mg Film-Coated Tablets look like and contents of the pack +Each pack contains 30 or 100 white to cream coloured, film-coated tablets with Motilium stamped on one side. +Marketing Authorisation Holder: +Zentiva Pharma UK Limited, 12 New Fetter Lane, London EC4A 1JP, United Kingdom +Manufacturer: +S.C. Zentiva S.A., 50 Theodor Pallady Blvd, District 3, Bucharest, 032266, Romania. +This leaflet was last revised in: November 2023 +Motilium® is a registered Trademark of Johnson & Johnson Inc. +‘Zentiva is a registered trademark © 2023 Zentiva. +942329

""" + diff --git a/input/fsh/examples/rawEPI/dovato-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/dovato-ema-automatic/Bundle.fsh index 02b59aa74..89eac70c9 100644 --- a/input/fsh/examples/rawEPI/dovato-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/dovato-ema-automatic/Bundle.fsh @@ -4,6 +4,19 @@ RuleSet: 6eb523b7a88cd6dcee848368833cbd08BundleRuleset + + + + + + + + + + + + + // Ingredient @@ -51,9 +64,7 @@ RuleSet: 6eb523b7a88cd6dcee848368833cbd08BundleRuleset * entry[=].resource = ap-49178f16170ee8a6bc2a4361c1748d5f -// composition-en-16598f252d07b4784b82ba43cf9e847e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-16598f252d07b4784b82ba43cf9e847e/composition-en-16598f252d07b4784b82ba43cf9e847e" -* entry[=].resource = composition-en-16598f252d07b4784b82ba43cf9e847e + // RegulatedAuthorization @@ -76,14 +87,10 @@ RuleSet: 6eb523b7a88cd6dcee848368833cbd08BundleRuleset * entry[=].resource = mra-7c9b97127f73ff3605a10eb1c2cc24d1 -// composition-pt-16598f252d07b4784b82ba43cf9e847e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-pt-16598f252d07b4784b82ba43cf9e847e/composition-pt-16598f252d07b4784b82ba43cf9e847e" -* entry[=].resource = composition-pt-16598f252d07b4784b82ba43cf9e847e + -// composition-dk-16598f252d07b4784b82ba43cf9e847e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-dk-16598f252d07b4784b82ba43cf9e847e/composition-dk-16598f252d07b4784b82ba43cf9e847e" -* entry[=].resource = composition-dk-16598f252d07b4784b82ba43cf9e847e + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/enbrel-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/enbrel-ema-automatic/Bundle.fsh index 2b0f4810f..01542388c 100644 --- a/input/fsh/examples/rawEPI/enbrel-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/enbrel-ema-automatic/Bundle.fsh @@ -47,9 +47,7 @@ RuleSet: f2c90821a14dbdb924eb4be01de36427BundleRuleset * entry[=].resource = mah-9800de324c3962f6f767647a95e0c17e -// composition-en-25bbfa948f4a0b224f9baa1fe481efa8 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-25bbfa948f4a0b224f9baa1fe481efa8/composition-en-25bbfa948f4a0b224f9baa1fe481efa8" -* entry[=].resource = composition-en-25bbfa948f4a0b224f9baa1fe481efa8 + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/flucelvax-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/flucelvax-ema-automatic/Bundle.fsh index 8468b8959..20e53d923 100644 --- a/input/fsh/examples/rawEPI/flucelvax-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/flucelvax-ema-automatic/Bundle.fsh @@ -4,9 +4,7 @@ RuleSet: 56a32a5ee239fc834b47c10db1faa3fdBundleRuleset -// composition-en-b6ced64d25ea2c8da6c6099386f14db1 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-b6ced64d25ea2c8da6c6099386f14db1/composition-en-b6ced64d25ea2c8da6c6099386f14db1" -* entry[=].resource = composition-en-b6ced64d25ea2c8da6c6099386f14db1 + @@ -90,9 +88,7 @@ RuleSet: 56a32a5ee239fc834b47c10db1faa3fdBundleRuleset * entry[=].resource = ap-04c9bd6fb89d38b2d83eced2460c4dc1 -// composition-es-b6ced64d25ea2c8da6c6099386f14db1 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-b6ced64d25ea2c8da6c6099386f14db1/composition-es-b6ced64d25ea2c8da6c6099386f14db1" -* entry[=].resource = composition-es-b6ced64d25ea2c8da6c6099386f14db1 + // RegulatedAuthorization diff --git "a/input/fsh/examples/rawEPI/hip\303\251rico_arkopharma-ema-automatic/Bundle.fsh" "b/input/fsh/examples/rawEPI/hip\303\251rico_arkopharma-ema-automatic/Bundle.fsh" index 66e50f603..525e50162 100644 --- "a/input/fsh/examples/rawEPI/hip\303\251rico_arkopharma-ema-automatic/Bundle.fsh" +++ "b/input/fsh/examples/rawEPI/hip\303\251rico_arkopharma-ema-automatic/Bundle.fsh" @@ -4,9 +4,7 @@ RuleSet: 2e9b255d9b94b05d362748d5716e558cBundleRuleset -// composition-es-af8d2f6e4772c29a8ef9fbb165e80d28 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-af8d2f6e4772c29a8ef9fbb165e80d28/composition-es-af8d2f6e4772c29a8ef9fbb165e80d28" -* entry[=].resource = composition-es-af8d2f6e4772c29a8ef9fbb165e80d28 + diff --git a/input/fsh/examples/rawEPI/humalog-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/humalog-ema-automatic/Bundle.fsh index 31fa2de1d..a7721ca03 100644 --- a/input/fsh/examples/rawEPI/humalog-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/humalog-ema-automatic/Bundle.fsh @@ -4,9 +4,7 @@ RuleSet: 35570a7ffa4ad1ddf8a920b1728d4cd2BundleRuleset -// composition-en-d33868162d255ced115cecbbf188aab4 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-d33868162d255ced115cecbbf188aab4/composition-en-d33868162d255ced115cecbbf188aab4" -* entry[=].resource = composition-en-d33868162d255ced115cecbbf188aab4 + @@ -90,9 +88,7 @@ RuleSet: 35570a7ffa4ad1ddf8a920b1728d4cd2BundleRuleset * entry[=].resource = ppd-03a3a81da9e0b9a5bb33d75251bb5234 -// composition-dk-d33868162d255ced115cecbbf188aab4 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-dk-d33868162d255ced115cecbbf188aab4/composition-dk-d33868162d255ced115cecbbf188aab4" -* entry[=].resource = composition-dk-d33868162d255ced115cecbbf188aab4 + // MedicinalProductDefinition diff --git a/input/fsh/examples/rawEPI/humira-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/humira-ema-automatic/Bundle.fsh index f36a072e1..99c57c164 100644 --- a/input/fsh/examples/rawEPI/humira-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/humira-ema-automatic/Bundle.fsh @@ -7,9 +7,7 @@ RuleSet: 3a3583227b4c5b0887f1e0d38269b469BundleRuleset -// composition-en-f97db27e6330f77484eb8425ad2913cd -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-f97db27e6330f77484eb8425ad2913cd/composition-en-f97db27e6330f77484eb8425ad2913cd" -* entry[=].resource = composition-en-f97db27e6330f77484eb8425ad2913cd + // Ingredient diff --git a/input/fsh/examples/rawEPI/ibuprofen-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/ibuprofen-ema-automatic/Bundle.fsh index 7fb2558c0..bb7cdf9b1 100644 --- a/input/fsh/examples/rawEPI/ibuprofen-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/ibuprofen-ema-automatic/Bundle.fsh @@ -52,9 +52,7 @@ RuleSet: 10daca0041c9b151561aea3f8524ae71BundleRuleset * entry[=].resource = ppd-1f1356f6a8c19d66c5c3f4e40da7536c -// composition-en-01eaaf0a81574efda98a52449788e7a2 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-01eaaf0a81574efda98a52449788e7a2/composition-en-01eaaf0a81574efda98a52449788e7a2" -* entry[=].resource = composition-en-01eaaf0a81574efda98a52449788e7a2 + // MedicinalProductDefinition diff --git a/input/fsh/examples/rawEPI/karvea-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/karvea-ema-automatic/Bundle.fsh index ab8f00cbd..93cfbb9cc 100644 --- a/input/fsh/examples/rawEPI/karvea-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/karvea-ema-automatic/Bundle.fsh @@ -19,9 +19,7 @@ RuleSet: d99852efa4d4976d99a584078a2ca48cBundleRuleset * entry[=].resource = cud-4fce9d5258f70f7d605059f97c24efa8 -// composition-en-873a1a47330e628770640f9c96c0761e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-873a1a47330e628770640f9c96c0761e/composition-en-873a1a47330e628770640f9c96c0761e" -* entry[=].resource = composition-en-873a1a47330e628770640f9c96c0761e + @@ -126,9 +124,7 @@ RuleSet: d99852efa4d4976d99a584078a2ca48cBundleRuleset * entry[=].resource = man-4bb7a752921434fd5f9921b5b9473eda -// composition-es-873a1a47330e628770640f9c96c0761e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-873a1a47330e628770640f9c96c0761e/composition-es-873a1a47330e628770640f9c96c0761e" -* entry[=].resource = composition-es-873a1a47330e628770640f9c96c0761e + // PackagedProductDefinition @@ -151,9 +147,7 @@ RuleSet: d99852efa4d4976d99a584078a2ca48cBundleRuleset * entry[=].resource = ppd-9b1d5d261d22694685deb35714ec08ea -// composition-dk-873a1a47330e628770640f9c96c0761e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-dk-873a1a47330e628770640f9c96c0761e/composition-dk-873a1a47330e628770640f9c96c0761e" -* entry[=].resource = composition-dk-873a1a47330e628770640f9c96c0761e + // MedicinalProductDefinition @@ -161,9 +155,7 @@ RuleSet: d99852efa4d4976d99a584078a2ca48cBundleRuleset * entry[=].resource = mp873a1a47330e628770640f9c96c0761e -// composition-pt-873a1a47330e628770640f9c96c0761e -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-pt-873a1a47330e628770640f9c96c0761e/composition-pt-873a1a47330e628770640f9c96c0761e" -* entry[=].resource = composition-pt-873a1a47330e628770640f9c96c0761e + // ManufacturedItemDefinition diff --git a/input/fsh/examples/rawEPI/mirtazapine-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/mirtazapine-ema-automatic/Bundle.fsh index 07ad66e3a..6ee45c904 100644 --- a/input/fsh/examples/rawEPI/mirtazapine-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/mirtazapine-ema-automatic/Bundle.fsh @@ -37,9 +37,7 @@ RuleSet: a91e68f5f39edd2d60f8aeca00ff2a3cBundleRuleset * entry[=].resource = ingredient-for-mirtazapine-cornstarch -// composition-es-7a7ff0f4e1993c2fdabba6c8d9931a52 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-7a7ff0f4e1993c2fdabba6c8d9931a52/composition-es-7a7ff0f4e1993c2fdabba6c8d9931a52" -* entry[=].resource = composition-es-7a7ff0f4e1993c2fdabba6c8d9931a52 + // Substance diff --git a/input/fsh/examples/rawEPI/naturesplus-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/naturesplus-ema-automatic/Bundle.fsh index b95eb4eaf..eb48d6c0d 100644 --- a/input/fsh/examples/rawEPI/naturesplus-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/naturesplus-ema-automatic/Bundle.fsh @@ -4,9 +4,7 @@ RuleSet: 9aabab1dccc46a284a817edc09bfaddaBundleRuleset -// composition-es-96d7b1b575aa8164c8c2b4cbe70f252a -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-96d7b1b575aa8164c8c2b4cbe70f252a/composition-es-96d7b1b575aa8164c8c2b4cbe70f252a" -* entry[=].resource = composition-es-96d7b1b575aa8164c8c2b4cbe70f252a + diff --git a/input/fsh/examples/rawEPI/paracetamol-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/paracetamol-ema-automatic/Bundle.fsh index 2a04d6e64..4420b54e6 100644 --- a/input/fsh/examples/rawEPI/paracetamol-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/paracetamol-ema-automatic/Bundle.fsh @@ -57,9 +57,7 @@ RuleSet: 34060417eeae4622c4674a9c4100d2edBundleRuleset * entry[=].resource = mah-65db33d6be47a433e6e9e9c2980ea7a4 -// composition-es-a975b7e209ea5c4c3bf8040a42b86fbd -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-a975b7e209ea5c4c3bf8040a42b86fbd/composition-es-a975b7e209ea5c4c3bf8040a42b86fbd" -* entry[=].resource = composition-es-a975b7e209ea5c4c3bf8040a42b86fbd + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/pentasa-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/pentasa-ema-automatic/Bundle.fsh index 35694bc4a..f16069ad4 100644 --- a/input/fsh/examples/rawEPI/pentasa-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/pentasa-ema-automatic/Bundle.fsh @@ -37,9 +37,7 @@ RuleSet: 87263ad77afb6e39aa59e421ea0b6b37BundleRuleset * entry[=].resource = ingredient-for-pentasa-microcrystallinecellulose -// composition-es-b3a8d58c709a2281d8ad2a590fe81663 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-b3a8d58c709a2281d8ad2a590fe81663/composition-es-b3a8d58c709a2281d8ad2a590fe81663" -* entry[=].resource = composition-es-b3a8d58c709a2281d8ad2a590fe81663 + // Substance diff --git a/input/fsh/examples/rawEPI/remsima-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/remsima-ema-automatic/Bundle.fsh index 1b1d6e12a..06ef34c15 100644 --- a/input/fsh/examples/rawEPI/remsima-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/remsima-ema-automatic/Bundle.fsh @@ -67,9 +67,7 @@ RuleSet: c29ba23bb04c16ab758f150fe41d6513BundleRuleset * entry[=].resource = mpbe76bdf784deea6950583b234f789db2 -// composition-en-be76bdf784deea6950583b234f789db2 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-be76bdf784deea6950583b234f789db2/composition-en-be76bdf784deea6950583b234f789db2" -* entry[=].resource = composition-en-be76bdf784deea6950583b234f789db2 + // ManufacturedItemDefinition diff --git a/input/fsh/examples/rawEPI/simvastatine-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/simvastatine-ema-automatic/Bundle.fsh index a8c57ca72..8dca272d1 100644 --- a/input/fsh/examples/rawEPI/simvastatine-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/simvastatine-ema-automatic/Bundle.fsh @@ -52,9 +52,7 @@ RuleSet: b225abac985fe47fe0c881943c7381c0BundleRuleset * entry[=].resource = mp245a2b4a9e3ee4304e5e6cf2b1a252b4 -// composition-en-245a2b4a9e3ee4304e5e6cf2b1a252b4 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-245a2b4a9e3ee4304e5e6cf2b1a252b4/composition-en-245a2b4a9e3ee4304e5e6cf2b1a252b4" -* entry[=].resource = composition-en-245a2b4a9e3ee4304e5e6cf2b1a252b4 + // ManufacturedItemDefinition diff --git a/input/fsh/examples/rawEPI/skilarence-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/skilarence-ema-automatic/Bundle.fsh index 5e36c74ef..694ca50cc 100644 --- a/input/fsh/examples/rawEPI/skilarence-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/skilarence-ema-automatic/Bundle.fsh @@ -60,9 +60,7 @@ RuleSet: 040bd687344f34655b854f4b67248074BundleRuleset -// composition-en-284ddecbce6fb138483090d5e55bafac -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-284ddecbce6fb138483090d5e55bafac/composition-en-284ddecbce6fb138483090d5e55bafac" -* entry[=].resource = composition-en-284ddecbce6fb138483090d5e55bafac + Instance: bundlepackageleaflet-en-6a3c9768548036f502739419bacb2482 diff --git a/input/fsh/examples/rawEPI/soria-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/soria-ema-automatic/Bundle.fsh index 1cb29ccdc..fb0892d20 100644 --- a/input/fsh/examples/rawEPI/soria-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/soria-ema-automatic/Bundle.fsh @@ -32,9 +32,7 @@ RuleSet: 1c7aee423a757a868580dc7fca4c9316BundleRuleset * entry[=].resource = mah-26a803db094176fea72396f24bb6b37d -// composition-es-5aea2ea50d47a8b479a61aec209c957f -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-5aea2ea50d47a8b479a61aec209c957f/composition-es-5aea2ea50d47a8b479a61aec209c957f" -* entry[=].resource = composition-es-5aea2ea50d47a8b479a61aec209c957f + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/suliqua-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/suliqua-ema-automatic/Bundle.fsh index f75cfe7ab..ca43a4402 100644 --- a/input/fsh/examples/rawEPI/suliqua-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/suliqua-ema-automatic/Bundle.fsh @@ -107,9 +107,7 @@ RuleSet: 9150fcc2bde4114d1671dc57e6fd4ca7BundleRuleset * entry[=].resource = mra-ff74c5498eb163c2fb470e9fd175a0c1 -// composition-en-367b9089c0743a2330f4c6e82b40ee41 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-367b9089c0743a2330f4c6e82b40ee41/composition-en-367b9089c0743a2330f4c6e82b40ee41" -* entry[=].resource = composition-en-367b9089c0743a2330f4c6e82b40ee41 + // PackagedProductDefinition diff --git a/input/fsh/examples/rawEPI/tegretol-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/tegretol-ema-automatic/Bundle.fsh index ba7692d59..a45013398 100644 --- a/input/fsh/examples/rawEPI/tegretol-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/tegretol-ema-automatic/Bundle.fsh @@ -57,9 +57,7 @@ RuleSet: 38fbd67f0d3e64f32230141d1621df57BundleRuleset * entry[=].resource = mid-2f37d696067eeb6daf1111cfc3272672 -// composition-es-ac2bb08bb4cc3f51f8c4e3513034c019 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-ac2bb08bb4cc3f51f8c4e3513034c019/composition-es-ac2bb08bb4cc3f51f8c4e3513034c019" -* entry[=].resource = composition-es-ac2bb08bb4cc3f51f8c4e3513034c019 + diff --git a/input/fsh/examples/rawEPI/trastuzumab-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/trastuzumab-ema-automatic/Bundle.fsh index aa863f763..efde50811 100644 --- a/input/fsh/examples/rawEPI/trastuzumab-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/trastuzumab-ema-automatic/Bundle.fsh @@ -52,9 +52,7 @@ RuleSet: 094b29cee867407552635ebcaf13f8c8BundleRuleset * entry[=].resource = mid-5af3df1132d20d744a88dab06e924e5e -// composition-en-aae8d931abe2f2d9085b87555b9bb088 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-aae8d931abe2f2d9085b87555b9bb088/composition-en-aae8d931abe2f2d9085b87555b9bb088" -* entry[=].resource = composition-en-aae8d931abe2f2d9085b87555b9bb088 + diff --git a/input/fsh/examples/rawEPI/vaxigriptetra-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/vaxigriptetra-ema-automatic/Bundle.fsh index b1eb4e9ec..ea84fdbd8 100644 --- a/input/fsh/examples/rawEPI/vaxigriptetra-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/vaxigriptetra-ema-automatic/Bundle.fsh @@ -97,9 +97,7 @@ RuleSet: e9513387532dad14223da3d260adb3d7BundleRuleset * entry[=].resource = ppd-533038a0a634e664ced4f999f6a95f85 -// composition-en-822aeee7cf35efce0583ec39919328fb -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-822aeee7cf35efce0583ec39919328fb/composition-en-822aeee7cf35efce0583ec39919328fb" -* entry[=].resource = composition-en-822aeee7cf35efce0583ec39919328fb + // MedicinalProductDefinition diff --git a/input/fsh/examples/rawEPI/xenical-ema-automatic/Bundle.fsh b/input/fsh/examples/rawEPI/xenical-ema-automatic/Bundle.fsh index b5d3259d1..ef41acdbc 100644 --- a/input/fsh/examples/rawEPI/xenical-ema-automatic/Bundle.fsh +++ b/input/fsh/examples/rawEPI/xenical-ema-automatic/Bundle.fsh @@ -70,9 +70,7 @@ RuleSet: 37d610f9c96d541562699215b0864126BundleRuleset * entry[=].resource = ppd-352d83277f894aa6147981b6a4f36c07 -// composition-es-bc60fa1aa0bfe774d11ee13c0c131622 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-es-bc60fa1aa0bfe774d11ee13c0c131622/composition-es-bc60fa1aa0bfe774d11ee13c0c131622" -* entry[=].resource = composition-es-bc60fa1aa0bfe774d11ee13c0c131622 + // MedicinalProductDefinition @@ -80,9 +78,7 @@ RuleSet: 37d610f9c96d541562699215b0864126BundleRuleset * entry[=].resource = mpbc60fa1aa0bfe774d11ee13c0c131622 -// composition-en-bc60fa1aa0bfe774d11ee13c0c131622 -* entry[+].fullUrl = "http://hl7.eu/fhir/ig/gravitate-health/composition-en-bc60fa1aa0bfe774d11ee13c0c131622/composition-en-bc60fa1aa0bfe774d11ee13c0c131622" -* entry[=].resource = composition-en-bc60fa1aa0bfe774d11ee13c0c131622 + // ManufacturedItemDefinition diff --git a/input/fsh/examples/rawEPI/xyntha-pm/binary.fsh b/input/fsh/examples/rawEPI/xyntha-pm/binary.fsh index 529b34277..c59d13f61 100644 --- a/input/fsh/examples/rawEPI/xyntha-pm/binary.fsh +++ b/input/fsh/examples/rawEPI/xyntha-pm/binary.fsh @@ -1,7 +1,7 @@ Instance: binaryimage003-1537998405 InstanceOf: Binary Description: "image003_1537998405" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -10,7 +10,7 @@ Usage: #example Instance: binaryimage004-124372563 InstanceOf: Binary Description: "binaryimage004_124372563" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -19,7 +19,7 @@ Usage: #example Instance: binaryimage006-1085115419 InstanceOf: Binary Description: "binaryimage006_1085115419" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -28,7 +28,7 @@ Usage: #example Instance: binaryimage007-1887834135 InstanceOf: Binary Description: "binaryimage007_1887834135" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -37,7 +37,7 @@ Usage: #example Instance: binaryimage008-1358253692 InstanceOf: Binary Description: "binaryimage008_1358253692" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -46,7 +46,7 @@ Usage: #example Instance: binaryimage010-240412440 InstanceOf: Binary Description: "binaryimage010_240412440" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -55,7 +55,7 @@ Usage: #example Instance: binaryimage012-1035983834 InstanceOf: Binary Description: "binaryimage012_1035983834" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -64,7 +64,7 @@ Usage: #example Instance: binaryimage012-251481591 InstanceOf: Binary Description: "binaryimage012_251481591" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -73,7 +73,7 @@ Usage: #example Instance: binaryimage013-244659630 InstanceOf: Binary Description: "binaryimage013_244659630" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -82,7 +82,7 @@ Usage: #example Instance: binaryimage014-39753133 InstanceOf: Binary Description: "binaryimage014_39753133" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -91,7 +91,7 @@ Usage: #example Instance: binaryimage016-646543884 InstanceOf: Binary Description: "binaryimage016_646543884" -Usage: #example +Usage: #inline * contentType = #image/jpeg diff --git a/input/fsh/examples/rawEPI/xyntha-pmi/Organizationpfizercanada.fsh b/input/fsh/examples/rawEPI/xyntha-pmi/Organizationpfizercanada.fsh index 91b8eddab..4eb31c00a 100644 --- a/input/fsh/examples/rawEPI/xyntha-pmi/Organizationpfizercanada.fsh +++ b/input/fsh/examples/rawEPI/xyntha-pmi/Organizationpfizercanada.fsh @@ -2,7 +2,7 @@ Instance: organizationpfizercanada InstanceOf: OrganizationUvEpi Title: "Marketing authorisation holder - Pfizer Canada ULC." Description: "Pfizer Limited as Marketing authorisation holder" -Usage: #example +Usage: #inline * identifier.system = $spor-org * identifier.value = "placeholder" diff --git a/input/fsh/examples/rawEPI/xyntha-pmi/Organizationwyeth.fsh b/input/fsh/examples/rawEPI/xyntha-pmi/Organizationwyeth.fsh index f79ca3744..4ab84e6e9 100644 --- a/input/fsh/examples/rawEPI/xyntha-pmi/Organizationwyeth.fsh +++ b/input/fsh/examples/rawEPI/xyntha-pmi/Organizationwyeth.fsh @@ -2,7 +2,7 @@ Instance: organizationwyeth InstanceOf: OrganizationUvEpi Title: "Manufactured, Packaged and Released By Wyeth Farma S.A" Description: "Manufactured, Packaged and Released By Wyeth Farma S.A" -Usage: #example +Usage: #inline * identifier.system = $spor-org * identifier.value = "placeholder" diff --git a/input/fsh/examples/rawEPI/xyntha-pmi/binary.fsh b/input/fsh/examples/rawEPI/xyntha-pmi/binary.fsh index b63d7fbcb..7db6a1893 100644 --- a/input/fsh/examples/rawEPI/xyntha-pmi/binary.fsh +++ b/input/fsh/examples/rawEPI/xyntha-pmi/binary.fsh @@ -1,7 +1,7 @@ Instance: binarypfizerlogo InstanceOf: Binary Description: "Pfizer Logo" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -11,7 +11,7 @@ Usage: #example Instance: binaryimage003 InstanceOf: Binary Description: "clip_image003_-1584181510.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -20,7 +20,7 @@ Usage: #example Instance: binaryimage004 InstanceOf: Binary Description: "clip_image004_128978964.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -29,7 +29,7 @@ Usage: #example Instance: binaryimage006 InstanceOf: Binary Description: "clip_image006_1402751276.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -38,7 +38,7 @@ Usage: #example Instance: binaryimage007 InstanceOf: Binary Description: "clip_image007_1848870172.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -47,7 +47,7 @@ Usage: #example Instance: binaryimage008 InstanceOf: Binary Description: "clip_image008_-1930407291.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -56,7 +56,7 @@ Usage: #example Instance: binaryimage010 InstanceOf: Binary Description: "clip_image010_524367703.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -65,7 +65,7 @@ Usage: #example Instance: binaryimage012a InstanceOf: Binary Description: "clip_image012_583978923.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -74,7 +74,7 @@ Usage: #example Instance: binaryimage012b InstanceOf: Binary Description: "clip_image012_-1646958650.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -83,7 +83,7 @@ Usage: #example Instance: binaryimage013 InstanceOf: Binary Description: "clip_image013_1472120925.png" -Usage: #example +Usage: #inline * contentType = #image/jpeg @@ -92,7 +92,7 @@ Usage: #example Instance: binaryimage0014 InstanceOf: Binary Description: "clip_image014_-861669482.jpg" -Usage: #example +Usage: #inline * contentType = #image/jpeg diff --git a/input/fsh/examples/rawEPI/zithromax/zithromax-ar-medicinalproduct.fsh b/input/fsh/examples/rawEPI/zithromax/zithromax-ar-medicinalproduct.fsh index 37305a871..e45dc5353 100644 --- a/input/fsh/examples/rawEPI/zithromax/zithromax-ar-medicinalproduct.fsh +++ b/input/fsh/examples/rawEPI/zithromax/zithromax-ar-medicinalproduct.fsh @@ -3,7 +3,7 @@ Instance: zi6fb1761a0a38bea0a9b49f146371c68b InstanceOf: MedicinalProductDefinitionUvEpi Title: "Medicinal Product zithromax (azithromycin) 250 mg capsules - النشرة الداخلية: معلومات للمريض - كبسولات زيثروماكس® 250 مجم" Description: "zithromax (azithromycin) 250 mg capsules - النشرة الداخلية: معلومات للمريض - كبسولات زيثروماكس® 250 مجم" -Usage: #example +Usage: #inline * identifier[+].system = "https://jfda.jo" * identifier[=].value = "placeholder" diff --git a/input/fsh/examples/rawEPI/zithromax/zithromax-en-medicinalproduct.fsh b/input/fsh/examples/rawEPI/zithromax/zithromax-en-medicinalproduct.fsh index 257f03f0c..e6746da82 100644 --- a/input/fsh/examples/rawEPI/zithromax/zithromax-en-medicinalproduct.fsh +++ b/input/fsh/examples/rawEPI/zithromax/zithromax-en-medicinalproduct.fsh @@ -3,7 +3,7 @@ Instance: zi5fb1761a0a38bea0a9b49f146371c68b InstanceOf: MedicinalProductDefinitionUvEpi Title: "Medicinal Product zithromax (azithromycin) 250 mg capsules" Description: "zithromax (azithromycin) 250 mg capsules" -Usage: #example +Usage: #inline * identifier[+].system = "https://jfda.jo" * identifier[=].value = "placeholder" diff --git a/input/fsh/examples/rawEPI/zithromax/zithromax-en-organization.fsh b/input/fsh/examples/rawEPI/zithromax/zithromax-en-organization.fsh index 2332d85f4..d2419e82c 100644 --- a/input/fsh/examples/rawEPI/zithromax/zithromax-en-organization.fsh +++ b/input/fsh/examples/rawEPI/zithromax/zithromax-en-organization.fsh @@ -2,7 +2,7 @@ Instance: org-1134a7374c78f1d40f41885344f06a5a InstanceOf: OrganizationUvEpi Title: "Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom" Description: "Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom" -Usage: #example +Usage: #inline * identifier.system = $spor-org * identifier.value = "ORG-100008368"