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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-es-873a1a47330e628770640f9c96c0761e
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        v: PROSPECTO: INFORMACIÓN PARA EL USUARIO
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        v: Prospecto: información para el usuario Biktarvy 50 mg/200 mg/25 mg comprimidos recubiertos con película bictegravir/emtricitabina/tenofovir alafenamida Lea todo el prospecto detenidamente antes de empezar a tomar este medicamento, porque contiene información importante para usted. Conserve este prospecto, ya que puede tener que volver a leerlo. Si tiene alguna duda, consulte a su médico o farmacéutico. Este medicamento se le ha recetado solamente a usted, y no debe dárselo a otras personas aunque tengan los mismos síntomas que usted, ya que puede perjudicarles. Si experimenta efectos adversos, consulte a su médico o farmacéutico, incluso si se trata de efectos adversos que no aparecen en este prospecto. Ver sección 4.
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    code:
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        v: Contenido del prospecto Qué es Biktarvy y para qué se utiliza Qué necesita saber antes de empezar a tomar Biktarvy Cómo tomar Biktarvy Posibles efectos adversos Conservación de Biktarvy Contenido del envase e información adicional
  section:
    title:
      v: 1. Qué es Karvea y para qué se utiliza
    code:
      text:
        v: 1. Qué es Karvea y para qué se utiliza
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        v: Biktarvy contiene tres principios activos: bictegravir, un medicamento antirretroviral conocido como inhibidor de la transferencia de las hebras de la integrasa (INI) emtricitabina, un medicamento antirretroviral de un tipo conocido como nucleósido inhibidor de la transcriptasa inversa (ITIAN) tenofovir alafenamida, un medicamento antirretroviral de un tipo conocido como nucleótido inhibidor de la transcriptasa inversa (ITIANt) Biktarvy es un comprimido único para el tratamiento de la infección por el virus de la inmunodeficiencia humana 1 (VIH-1) en adultos. Biktarvy reduce la cantidad de VIH presente en el organismo. Esto mejora el sistema inmunitario y disminuye el riesgo de desarrollar enfermedades asociadas con la infección por el VIH.
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      v: 2. Qué necesita saber antes de empezar a tomar Karvea
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        v: 2. Qué necesita saber antes de empezar a tomar Karvea
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        v: No tome Biktarvy Si es alérgico a bictegravir, emtricitabina, tenofovir alafenamida o a alguno de los demás componentes de este medicamento (incluidos en la sección 6 de este prospecto). Si actualmente está tomando alguno de los siguientes medicamentos: rifampicina utilizada para tratar algunas infecciones bacterianas como la tuberculosis hierba de San Juan (Hypericum perforatum, hipérico), un medicamento a base de plantas utilizado para la depresión y la ansiedad, o productos que la contengan. Si está tomando alguno de estos medicamentos, no tome Biktarvy y consulte a su médico inmediatamente. Advertencias y precauciones Consulte a su médico antes de empezar a tomar Biktarvy: Si tiene problemas hepáticos o antecedentes de enfermedad hepática, incluida la hepatitis. Los pacientes que padecen de enfermedades hepáticas, como la hepatitis B o C crónica, y están en tratamiento con antirretrovirales tienen más riesgo de presentar complicaciones hepáticas graves y potencialmente mortales. Si tiene infección por el virus de la hepatitis B, su médico evaluará detenidamente la mejor pauta terapéutica para usted. Si tiene hepatitis B. Los problemas hepáticos pueden empeorar después de dejar de tomar Biktarvy. No deje de tomar Biktarvy si tiene hepatitis B. Hable antes con su médico. Puede consultar más detalles en la sección 3, No interrumpa el tratamiento con Biktarvy. Mientras esté tomando Biktarvy Una vez que empiece a tomar Biktarvy, esté atento a: Signos de inflamación o infección Dolor articular, rigidez o problemas óseos Si nota cualquiera de estos síntomas, informe a su médico inmediatamente. Puede consultar más información en la sección 4, Posibles efectos adversos. Aunque no se han observado problemas renales con Biktarvy, existe la posibilidad de que pueda experimentar problemas renales si toma Biktarvy durante un periodo de tiempo prolongado. Mientras esté tomando este medicamento aún puede transmitir el VIH a los demás, aunque un tratamiento antirretroviral efica…
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        v: 3. Cómo tomar Karvea
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        v: Siga exactamente las instrucciones de administración de este medicamento indicadas por su médico. En caso de duda, consulte de nuevo a su médico o farmacéutico. La dosis recomendada es: Adultos: un comprimido al día, con o sin alimentos No mastique, triture ni divida el comprimido. Consulte a su médico o farmacéutico si está tomando: antiácidos para tratar úlceras estomacales, acidez estomacal o reflujo ácido, que contengan hidróxido de aluminio y/o de magnesio suplementos de minerales o vitaminas que contengan magnesio o hierro Vea la sección 2 para más información sobre cómo tomar estos medicamentos con Biktarvy. Si toma más Biktarvy del que debe Si toma más cantidad de la dosis recomendada de Biktarvy puede correr mayor riesgo de experimentar posibles efectos adversos con este medicamento (ver sección 4, Posibles efectos adversos). Consulte inmediatamente a su médico o acuda al servicio de urgencias más cercano. Lleve consigo el frasco de comprimidos para que pueda describir fácilmente qué ha tomado. Si olvidó tomar Biktarvy Es importante que no olvide una dosis de Biktarvy. Si olvida una dosis: Si se da cuenta en las 18 horas posteriores a la hora a la que normalmente toma Biktarvy, debe tomar el comprimido tan pronto como sea posible. Luego tome la dosis siguiente de la forma habitual. Si se da cuenta después de 18 horas o más de la hora a la que normalmente toma Biktarvy, no tome la dosis olvidada. Espere y tome la siguiente dosis a la hora habitual. Si vomita antes de que transcurra 1 hora tras haber tomado Biktarvy, tome otro comprimido. Si vomita transcurrida 1 hora de haber tomado Biktarvy, no necesita tomar otro comprimido hasta el momento de la hora habitual. No interrumpa el tratamiento con Biktarvy No interrumpa el tratamiento con Biktarvy sin hablar antes con su médico. Interrumpir Biktarvy puede afectar gravemente el funcionamiento de tratamientos futuros. Si se interrumpe Biktarvy por algún motivo, consulte con su médico antes de reiniciar la toma d…
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        v: 4. Posibles efectos adversos
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        v: Al igual que todos los medicamentos, este medicamento puede producir efectos adversos, aunque no todas las personas los sufran. Posibles efectos adversos: informe a un médico inmediatamente Cualquier signo de inflamación o de infección. En algunos pacientes con infección avanzada por el VIH (sida) y antecedentes de infecciones oportunistas (infecciones que ocurren en personas con un sistema inmunitario débil), se pueden producir signos y síntomas de inflamación por infecciones previas poco después de iniciar el tratamiento contra el VIH. Se cree que estos síntomas se deben a una mejoría de la respuesta inmunitaria del organismo, que le permite combatir infecciones que podrían haber estado presentes sin síntomas obvios. Se pueden producir también trastornos autoinmunitarios, en los que el sistema inmunitario ataca a los tejidos sanos del organismo, después de que empiece a tomar medicamentos para la infección por el VIH. Los trastornos autoinmunitarios se pueden producir muchos meses después del inicio del tratamiento. Esté atento a cualquier síntoma de infección u otros síntomas, como: debilidad muscular debilidad que se inicia en las manos y los pies y se desplaza hacia el tronco palpitaciones, temblor o hiperactividad Si nota cualquiera de estos síntomas o cualquier síntoma de inflamación o infección, informe a su médico inmediatamente. Efectos adversos frecuentes (pueden afectar hasta 1 de cada 10 personas) depresión sueños anormales dolor de cabeza mareo diarrea ganas de vomitar (náuseas) cansancio (fatiga) Efectos adversos poco frecuentes (pueden afectar hasta 1 de cada 100 personas) anemia vómitos dolor de estómago problemas digestivos que generan molestias después de las comidas (dispepsia) gases (flatulencia) hinchazón de la cara, labios, lengua o garganta (angioedema) picazón (prurito) erupción habones (urticaria) dolor en las articulaciones (artralgia) comportamiento suicida ansiedad trastornos del sueño Los análisis de sangre también pueden mostrar: Conce…
  section:
    title:
      v: 5. Conservación de Karvea
    code:
      text:
        v: 5. Conservación de Karvea
    text:
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        v: Mantener este medicamento fuera de la vista y del alcance de los niños. No utilice este medicamento después de la fecha de caducidad que aparece en la caja y en el frasco después de {CAD}. La fecha de caducidad es el último día del mes que se indica. Conservar en el embalaje original para protegerlo de la humedad. Mantener el frasco perfectamente cerrado. No utilizar si falta el sello del frasco o está roto. Los medicamentos no se deben tirar por los desagües ni a la basura. Pregunte a su farmacéutico cómo deshacerse de los envases y de los medicamentos que ya no necesita. De esta forma, ayudará a proteger el medio ambiente.
  section:
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      v: 6. Contenido del envase e información adicional
    code:
      text:
        v: 6. Contenido del envase e información adicional
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        v: Karvea indeholder: Aktivt stof: irbesartan. Hver Karvea-tablet 75 mg indeholder 75 mg irbesartan. Øvrige indholdsstoffer: lactosemonohydrat, mikrokrystallinsk cellulose, croscarmellosenatrium, magnesiumstearat, kolloid silica, prægelatineret majsstivelse, poloaxamer 188. Se punkt 2 ”Aprovel indeholder lactose” Udseende og pakningstørrelser Karvea 75 mg tabletter er hvide til mathvide, bikonvekse og ovale med et hjerte præget på den ene side og nummeret 2771 på den anden side. Karvea 75 mg tabletter leveres i blisterpakninger af 14, 28, 56 eller 98 tabletter. Der fås også enkeltdosisblisterpakninger med 56 x 1 tablet til hospitalsbrug. Ikke alle pakningsstørrelser er nødvendigvis markedsført. Indehaveren af markedsføringstilladelsen: Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly Frankrig Fremstiller: SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc Cedex - Frankrig SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7F-37071 Tours Cedex 2 - Frankrig Hvis du vil have yderligere oplysninger om Karvea, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen: België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 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 Magyarország SANOFI-AVENTIS Zrt. Tel.: +36 1 505 0 Danmark Sanofi A/S Tlf: +45 45 16 70 Malta Sanofi S.r.l. Tel: +39 02 39394 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 Tel. aus dem Ausland: +49 69 305 21 Nederland Sanofi B.V. Tel: +31 20 245 4 Eesti Swixx Biopharma OÜ Tel: +372 640 10 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 Ελλάδα Sanofi-Aventis Μονοπρόσωπη AEBE Τηλ: +30 210 900 16 Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0 España sanofi-aventis, S.A. Tel: +34 93 485 94 Polska sanofi-aventis S…

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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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