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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-pt-873a1a47330e628770640f9c96c0761e
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      v: B. FOLHETO INFORMATIVO
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        v: Karvea 300 mg comprimidos irbesartan Leia com atenção todo este folheto antes de começar a tomar este medicamento, pois contém informação importante para si. Conserve este folheto. Pode ter necessidade de o ler novamente. Caso ainda tenha dúvidas, fale com o seu médico ou farmacêutico. Este medicamento foi receitado apenas para si. Não deve dá-lo a outros; o medicamento pode serlhes prejudicial mesmo que apresentem os mesmos sinais de doença. Se tiver quaisquer efeitos secundários, incluindo efeitos secundários não indicados neste folheto, fale com o seu médico ou farmacêutico.
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      v: O que contém este folheto
    code:
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        v: O que contém este folheto
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        v: O que contém este folheto: O que é Karvea e para que é utilizado O que precisa de saber antes de tomar Karvea Como tomar Karvea Efeitos secundários possíveis Como conservar Karvea Conteúdo da embalagem e outras informações
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      v: 1. O que é Karvea e para que é utilizado
    code:
      text:
        v: 1. O que é Karvea e para que é utilizado
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        v: Karvea pertence a um grupo de medicamentos conhecidos como antagonistas dos recetores da angiotensina-II. A angiotensina-II é uma substância produzida no organismo que se liga a recetores nos vasos sanguíneos, provocando o seu estreitamento, o que conduz ao aumento da pressão arterial. Karvea impede a ligação da angiotensina-II a estes recetores, fazendo com que os vasos sanguíneos se relaxem e a pressão arterial baixe. Karvea atrasa a diminuição da função renal nos doentes com pressão arterial elevada e diabetes do tipo 2. Karvea é usado em doentes adultos para tratar a pressão arterial elevada (hipertensão essencial) para proteger os rins nos doentes com pressão arterial elevada, diabetes do tipo 2 e evidência laboratorial de insuficiência dos rins.
  section:
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      v: 2. O que precisa de saber antes de tomar Karvea
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        v: 2. O que precisa de saber antes de tomar Karvea
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        v: Não tome Karvea se tem alergia ao irbesartan ou a qualquer outro componente deste medicamento (indicados na secção 6). se tiver mais do que três meses de gravidez. (Também é preferível não tomar Karvea no início da gravidez - ver secção Gravidez se tem diabetes ou função renal diminuída e está a ser tratado com um medicamento que contém aliscireno para diminuir a pressão arterial Advertências e precauções Fale com o seu médico antes de tomar Karvea e se alguma das seguintes situações se aplicar a si: se tiver vómitos ou diarreia prolongados se sofrer de problemas nos rins se sofre de problemas do coração se receber Karvea para doença nos rins diabética. Neste caso, o seu médico pode efetuar-lhe análises ao sangue com regularidade, especialmente para medir os níveis sanguíneos de potássio em caso de insuficiência dos rins se desenvolver baixos níveis de açúcar no sangue (os sintomas podem incluir sudação, fraqueza, fome, tonturas, tremores, dor de cabeça, rubor ou palidez, dormência, batimento cardíaco acelerado e palpitante), especialmente se estiver a ser tratado para a diabetes. se vai ser submetido a uma operação (cirurgia) ou se lhe vão ser administrados anestésicos se está a tomar algum dos seguintes medicamentos para tratar a pressão arterial elevada: um inibidor da ECA (por exemplo enalapril, lisinopril, ramipril), em particular se tiver problemas nos rins relacionados com diabetes. aliscireno O seu médico pode verificar a sua função renal, pressão arterial e a quantidade de eletrólitos (por exemplo, o potássio) no seu sangue em intervalos regulares. Ver também a informação sob o título “Não tome Karvea” Deve informar o seu médico se pensa que está (ou pode vir a estar) grávida. Karvea não está recomendado no início da gravidez e não pode ser tomado após o terceiro mês de gravidez, uma vez que pode ser gravemente prejudicial para o bebé se utilizado a partir desta altura (ver secção Gravidez). Crianças e adolescentes Este medicamento não deve ser utilizado em…
  section:
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      v: 3. Como tomar Karvea
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        v: 3. Como tomar Karvea
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        v: Tomar este medicamento exatamente como indicado pelo seu médico. Fale com o seu médico ou farmacêutico se tiver dúvidas. Modo de administração Karvea destina-se à via oral. Engolir os comprimidos com uma quantidade suficiente de líquidos (por exemplo um copo com água). Pode tomar Karvea com ou sem alimentos. Tente tomar a dose diária sempre à mesma hora. É importante que continue a tomar Karvea até que o seu médico lhe dê outra indicação. Doentes com pressão arterial elevada A dose habitual é 150 mg uma vez ao dia. Em função da resposta da pressão arterial, a dose pode ser aumentada para 300 mg, uma vez ao dia. Doentes com pressão arterial elevada e diabetes do tipo 2 com doença nos rins Nos doentes com pressão arterial elevada e diabetes do tipo 2, a dose de manutenção preferível para o tratamento da doença renal associada é de 300 mg uma vez por dia. O médico pode receitar uma dose mais baixa, sobretudo quando se inicia o tratamento em certos doentes, como sejam os que estão em hemodiálise ou os que têm mais de 75 anos. O efeito hipotensor máximo deve obter-se às 4 a 6 semanas após o início do tratamento. Utilização em crianças e adolescentes Karvea não deve ser administrado a crianças com idade idade inferior a 18 anos. Se uma criança engolir alguns comprimidos, deve contactar o médico imediatamente. Se tomar mais Karvea do que deveria Se, acidentalmente, tomar demasiados comprimidos, contacte o médico imediatamente. Caso se tenha esquecido de tomar Karvea Se, acidentalmente, não tomar uma dose diária, tome a dose seguinte como planeado. Não tome uma dose a dobrar para compensar uma dose que se esqueceu de tomar. Caso ainda tenha dúvidas sobre a utilização deste medicamento, fale com o seu médico ou farmacêutico.
  section:
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      v: 4. Efeitos indesejáveis possíveis
    code:
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        v: 4. Efeitos indesejáveis possíveis
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        v: Como todos os medicamentos, este medicamento pode causar efeitos secundários, embora estes não se manifestem em todas as pessoas. Alguns destes efeitos podem ser graves e requerer cuidados médicos. Tal como acontece com medicamentos semelhantes, em doentes a tomar irbesartan foram notificados casos raros de reações alérgicas na pele (erupção na pele, erupção na pele com comichão), assim como inchaço localizado da face, lábios e/ou língua. Se tiver algum destes sintomas, ou se tiver dificuldade em respirar, pare de tomar Karvea e contacte o médico imediatamente. A frequência dos efeitos adversos listados abaixo é definida utilizando a seguinte convenção: Muito frequentes: podem afetar mais de 1 em 10 pessoas Frequentes: podem afetar até 1 em 10 pessoas Pouco frequentes: podem afetar até 1 em 100 pessoas Os efeitos secundários notificados em estudos clínicos para os doentes tratados com Karvea foram: Muito frequentes (podem afetar mais de 1 em 10 pessoas): se tiver pressão arterial elevada e diabetes do tipo 2 com doença nos rins, as análises ao sangue podem mostrar níveis de potássio aumentados. Frequentes (podem afetar até 1 em 10 pessoas): tonturas, mal estar/vómitos, fadiga e as análises ao sangue podem mostrar níveis de uma enzima que avalia a função muscular e cardíaca (enzima creatina cinase) aumentados. Em doentes com pressão arterial elevada e diabetes do tipo 2 com doença nos rins foram também notificados tonturas quando se passa da posição deitada ou sentada para a posição de pé, pressão arterial baixa quando se passa da posição deitada ou sentada para a posição de pé, dor nas articulações ou músculos e níveis de uma proteína nos glóbulos vermelhos (hemoglobina) diminuídos. Pouco frequentes (podem afetar até 1 em 100 pessoas): ritmo cardíaco rápido, rubor (vermelhidão), tosse, diarreia, indigestão/pirose (azia), disfunção sexual (problemas com o desempenho sexual) e dor torácica. Alguns efeitos indesejáveis foram notificados desde a comercialização de Karve…
  section:
    title:
      v: 5. Como conservar Karvea
    code:
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        v: 5. Como conservar Karvea
    text:
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        v: Manter este medicamento fora da vista e do alcance das crianças. Não utilize este medicamento após o prazo de validade impresso na embalagem exterior e no blister, após VAL. O prazo de validade corresponde ao último dia do mês indicado. Não conservar acima de 30ºC. Não deite fora quaisquer medicamentos na canalização ou no lixo doméstico. Pergunte ao seu farmacêutico como deitar fora os medicamentos que já não necessita. Estas medidas ajudarão a proteger o ambiente.
  section:
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      v: 6. Conteúdo da embalagem e outras informações
    code:
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        v: 6. Conteúdo da embalagem e outras informações
    text:
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      div:
        v: Qual a composição de Karvea A substância ativa é o irbesartan. Cada comprimido de Karvea 300 mg contém 300 mg de irbesartan. Os outros componentes são celulose microcristalina, croscarmelose sódica, lactose monohidratada, estearato de magnésio, sílica coloidal hidratada, amido de milho pré-gelificado e poloxamero 188. Por favor ver a secção 2 “Karvea contém lactose”. Qual o aspeto de Karvea e conteúdo da embalagem Os comprimidos de Karvea 300 mg são de cor branca a esbranquiçada, biconvexos, de forma oval, com um coração marcado numa das faces e o número 2773 gravado na outra face. Os comprimidos de Karvea a 300 mg são fornecidos em embalagens de 14, 28, 56 ou 98 comprimidos acondicionados em blister. Estão também disponíveis, para uso hospitalar, embalagens de 56 x 1 comprimido em blister para dose unitária. É possível que não sejam comercializadas todas as apresentações. Titular da Autorização de Introdução no Mercado Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly França Fabricante SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex - França SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - França Para quaisquer informações sobre este medicamento, queira contactar o representante local do Titular da Autorização de Introdução no Mercado. België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111 Magyarország SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S.r.l.. Tel: +39 02 39394275 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131 Nederland Sanofi B.V. Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge san…

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    v: Generated Narrative: Ingredient ingredient-for-karvea-hypromellose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/3NXW29V3WO (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Hypromellose
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 3NXW29V3WO
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-macrogol3000
type: Ingredient
id:
  v: ingredient-for-karvea-macrogol3000
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-macrogol3000 Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/SA1B764746 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Macrogol 3000
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: SA1B764746
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-lactosemonohydrate
type: Ingredient
id:
  v: ingredient-for-karvea-lactosemonohydrate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-lactosemonohydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/EWQ57Q8I5X (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Lactose Monohydrate
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: EWQ57Q8I5X
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-silicondioxide
type: Ingredient
id:
  v: ingredient-for-karvea-silicondioxide
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-silicondioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/ETJ7Z6XBU4 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Silicon dioxide
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: ETJ7Z6XBU4
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-titaniumdioxide
type: Ingredient
id:
  v: ingredient-for-karvea-titaniumdioxide
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-titaniumdioxide Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/15FIX9V2JP (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Titanium Dioxide
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 15FIX9V2JP
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-irbesartan
type: Ingredient
id:
  v: ingredient-for-karvea-irbesartan
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-irbesartan Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/J0E2756Z7N (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: active substance Codes - Concept * irbesartan Strengths - Presentation[x] Basis * 75 mg (Details: UCUM codemg = 'mg') active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: J0E2756Z7N
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072072
    display:
      v: active
substance:
  strength:
    presentation: Quantity
      value:
        v: 75
      system:
        v: http://unitsofmeasure.org
        l: unitsofmeasure.org
      code:
        v: mg

ingredient-for-karvea-croscarmellosesodium
type: Ingredient
id:
  v: ingredient-for-karvea-croscarmellosesodium
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-croscarmellosesodium Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/M28OL1HH48 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Croscarmellose sodium
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: M28OL1HH48
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-microcrystallinecellulose
type: Ingredient
id:
  v: ingredient-for-karvea-microcrystallinecellulose
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-microcrystallinecellulose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/OP1R32D61U (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Microcrystalline cellulose
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: OP1R32D61U
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-magnesiumstearate
type: Ingredient
id:
  v: ingredient-for-karvea-magnesiumstearate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-magnesiumstearate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/70097M6I30 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Magnesium stearate
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 70097M6I30
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

ingredient-for-karvea-carnaubawax
type: Ingredient
id:
  v: ingredient-for-karvea-carnaubawax
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredient-for-karvea-carnaubawax Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/R12CBM0EIZ (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription AdministrableProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001; status = active; administrableDoseForm = Tablet; unitOfPresentation = Tablet role: Excipient substance Codes - Concept * Carnauba wax
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: R12CBM0EIZ
status:
  v: active
for:
  l: mp873a1a47330e628770640f9c96c0761e
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient

substance-irbesartan
type: SubstanceDefinition
id:
  v: substance-irbesartan
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition substance-irbesartan Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//J0E2756Z7N (use: official, ) version: 1 status: Active description: White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. manufacturer: Organization Sanofi Winthrop Industrie MolecularWeights - Type Amount * exact 428.53 Structures - MolecularFormula * C25H28N6O Names - Name Type * (+)-6-methyleneandrosta-1,4-diene-3,17-dione Chemical Name
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: J0E2756Z7N
version:
  v: 1
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
description:
  v: White to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.
molecular weight:
  type:
    text:
      v: exact
  amount:
    value:
      v: 428.53
structure:
  molecular formula:
    v: C25H28N6O
name:
  name:
    v: (+)-6-methyleneandrosta-1,4-diene-3,17-dione
  type:
    coding:
      system:
        v: https://gsrs.ncats.nih.gov/ginas/app/beta/
        l: beta
      code:
        v: x
      display:
        v: Chemical Name

http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-dcaa4d32aa6658a8df831551503e52ee
type: AdministrableProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition ap-dcaa4d32aa6658a8df831551503e52ee Profile: AdministrableProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/97/049/001 status: Active formOf: MedicinalProductDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001,https://www.who-umc.org/phpid#0xF79CABF272B6A7EEF104DDDA44E82719; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Tablet unitOfPresentation: Tablet producedFrom: ManufacturedItemDefinition: identifier = https://spor.ema.europa.eu/pmswi#EU/1/97/049/001 (use: official, ); status = active; manufacturedDoseForm = Tablet; unitOfPresentation = Tablet routeOfAdministration code: Oral use TargetSpecies - Code * Human
identifier:
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/97/049/001
status:
  v: active
form of:
  l: mp873a1a47330e628770640f9c96c0761e
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073664
    display:
      v: Tablet
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002152
    display:
      v: Tablet
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073619
      display:
        v: Oral use

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee0
type: RegulatedAuthorization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authorizationdcaa4d32aa6658a8df831551503e52ee0 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/97/049/010 (use: official, ) subject: PackagedProductDefinition Karvea 75 mg tablet 14 type: Marketing Authorisation status: Active statusDate: 2015-02-07 13:28:17+0000 holder: Organization Sanofi Winthrop Industrie
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/97/049/010
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
status:
  coding:
    system:
      v: http://hl7.org/fhir/publication-status
      l: publication-status
    code:
      v: active
    display:
      v: Active
status date:
  v: 2015-02-07T13:28:17Z

http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee1
type: RegulatedAuthorization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authorizationdcaa4d32aa6658a8df831551503e52ee1 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/97/049/001 (use: official, ) subject: PackagedProductDefinition Karvea 75 mg tablet 28 type: Marketing Authorisation status: Active statusDate: 2015-02-07 13:28:17+0000 holder: Organization Sanofi Winthrop Industrie
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
  value:
    v: EU/1/97/049/001
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
status:
  coding:
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v: Macrogol 3000

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