enhancedddbundlekarvea
type: Bundle
node role: treeRoot
id:
  v: enhancedddbundlekarvea
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi
    l: Bundle-uv-epi
language:
  v: en
identifier:
  system:
    v: https://www.gravitatehealth.eu/sid/doc
    l: doc
  value:
    v: EU/1/97/049/001
type:
  v: document
timestamp:
  v: 2023-04-25T11:55:27Z
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Composition/enhanced-compositionf4d45353edcb21af3718d3a0df94a4d8
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-a40c2367ed3c1c715eacd432105752a0
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-585e364c14debe29f6c6b564138aa400
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-4fce9d5258f70f7d605059f97c24efa8
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-hypromellose
    l: ingredient-for-karvea-hypromellose
  resource: ingredient-for-karvea-hypromellose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-macrogol3000
    l: ingredient-for-karvea-macrogol3000
  resource: ingredient-for-karvea-macrogol3000
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-lactosemonohydrate
    l: ingredient-for-karvea-lactosemonohydrate
  resource: ingredient-for-karvea-lactosemonohydrate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-silicondioxide
    l: ingredient-for-karvea-silicondioxide
  resource: ingredient-for-karvea-silicondioxide
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-titaniumdioxide
    l: ingredient-for-karvea-titaniumdioxide
  resource: ingredient-for-karvea-titaniumdioxide
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-irbesartan
    l: ingredient-for-karvea-irbesartan
  resource: ingredient-for-karvea-irbesartan
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-croscarmellosesodium
    l: ingredient-for-karvea-croscarmellosesodium
  resource: ingredient-for-karvea-croscarmellosesodium
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-microcrystallinecellulose
    l: ingredient-for-karvea-microcrystallinecellulose
  resource: ingredient-for-karvea-microcrystallinecellulose
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-magnesiumstearate
    l: ingredient-for-karvea-magnesiumstearate
  resource: ingredient-for-karvea-magnesiumstearate
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Ingredient/ingredient-for-karvea-carnaubawax
    l: ingredient-for-karvea-carnaubawax
  resource: ingredient-for-karvea-carnaubawax
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-irbesartan
    l: substance-irbesartan
  resource: substance-irbesartan
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-dcaa4d32aa6658a8df831551503e52ee
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee0
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee1
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee2
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/RegulatedAuthorization/authorizationdcaa4d32aa6658a8df831551503e52ee3
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/mah-511671db37e83e520b00f8a0d817dc96
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/Organization/man-4bb7a752921434fd5f9921b5b9473eda
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-d91b269b209aaa5538a1bfafd1a7434d
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-f3f2f89544dfc5d20216861bcf90c0c5
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-5763619e2b501aeeab53677bd09d5cbf
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-9b1d5d261d22694685deb35714ec08ea
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp873a1a47330e628770640f9c96c0761e
    l: mp873a1a47330e628770640f9c96c0761e
  resource: mp873a1a47330e628770640f9c96c0761e
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-dcaa4d32aa6658a8df831551503e52ee
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/contraindication-kidney
    l: contraindication-kidney
  resource: contraindication-kidney
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/contraindication-diabetes-mellitus
    l: contraindication-diabetes-mellitus
  resource: contraindication-diabetes-mellitus
entry:
  full url:
    v: http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/contraindication-pregnancy
    l: contraindication-pregnancy
  resource: contraindication-pregnancy

http://hl7.eu/fhir/ig/gravitate-health/Composition/enhanced-compositionf4d45353edcb21af3718d3a0df94a4d8
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi
    l: Composition-uv-epi
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition enhanced-compositionf4d45353edcb21af3718d3a0df94a4d8 Language: en Profile: Composition (ePI) eu/fhir/ig/gravitate-health/StructureDefinition/Lenses: mock-lib HtmlElementLink elementClass: pregnancyCategory concept: Pregnancy HtmlElementLink elementClass: breastfeedingCategory concept: Normal breast feeding (finding) HtmlElementLink elementClass: indication concept: ClinicalUseDefinition: type = indication HtmlElementLink elementClass: contraindication concept: Contraindicated (qualifier value) HtmlElementLink elementClass: contra-indication-pregancy concept: ClinicalUseDefinition: identifier = https://spor.ema.europa.eu/rmswi/#/#pregnancy (use: official, ); type = contraindication HtmlElementLink elementClass: contra-indication-kidney concept: ClinicalUseDefinition: identifier = https://spor.ema.europa.eu/rmswi/#/#kidney function (use: official, ); type = contraindication HtmlElementLink elementClass: contra-indication-diabetes-mellitus concept: ClinicalUseDefinition: identifier = https://spor.ema.europa.eu/rmswi/#/#diabetes-mellitus (use: official, ); type = contraindication HtmlElementLink elementClass: lactose concept: Primary lactose intolerance identifier: https://spor.ema.europa.eu/rmswi//0d69fdcb-33cf-407f-8209-a6529856ab4f status: Final type: Package Leaflet category: Focused date: 2022-02-16 13:28:17+0000 author: Organization Sanofi Winthrop Industrie title: TEST PURPOSES ONLY - Karvea
extension:
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/Lenses
    l: Lenses
  value: Reference
    l: mock-lib
    reference:
      v: mock-lib
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: pregnancyCategory
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/77386006
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: breastfeedingCategory
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/69840006
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: indication
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: contraindication
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/410536001
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: contra-indication-pregancy
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      reference:
        l: contraindication-pregnancy
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: contra-indication-kidney
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      reference:
        l: contraindication-kidney
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: contra-indication-diabetes-mellitus
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      reference:
        l: contraindication-diabetes-mellitus
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
extension:
  extension:
    url:
      v: elementClass
      l: elementClass
    value: String
      v: lactose
  extension:
    url:
      v: concept
      l: concept
    value: CodeableReference
      concept:
        coding: http://snomed.info/id/190751001
  url:
    v: http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink
    l: HtmlElementLink
identifier:
  system:
    v: https://spor.ema.europa.eu/rmswi/
    l: rmswi
status:
  v: final
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000155538
  text:
    v: Package Leaflet
category:
  coding:
    system:
      v: http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs
      l: epicategory-cs
    code:
      v: F
    display:
      v: Focused
subject:
  l: mp873a1a47330e628770640f9c96c0761e
date:
  v: 2022-02-16T13:28:17Z
title:
  v: TEST PURPOSES ONLY - Karvea
section:
  title:
    v: B. Package Leaflet
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi/
        l: rmswi
      code:
        v: 100000155538
    text:
      v: B. PACKAGE LEAFLET
  text:
    status:
      v: additional
    div:
      v: unavailable

http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-a40c2367ed3c1c715eacd432105752a0
type: ClinicalUseDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-contraindication-uv-epi
    l: ClinicalUseDefinition-contraindication-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition cud-a40c2367ed3c1c715eacd432105752a0 Profile: ClinicalUseDefinition Contraindication (ePI) type: Contraindication subject: 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 contraindication DiseaseSymptomProcedures - Concept * Diabetis Mellitus
type:
  v: contraindication
subject:
  l: mp873a1a47330e628770640f9c96c0761e

http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-585e364c14debe29f6c6b564138aa400
type: ClinicalUseDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-indication-uv-epi
    l: ClinicalUseDefinition-indication-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition cud-585e364c14debe29f6c6b564138aa400 Profile: ClinicalUseDefinition Indication (ePI) type: Indication subject: 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 indication DiseaseSymptomProcedures - Concept * Hypertension
type:
  v: indication
subject:
  l: mp873a1a47330e628770640f9c96c0761e

http://hl7.eu/fhir/ig/gravitate-health/ClinicalUseDefinition/cud-4fce9d5258f70f7d605059f97c24efa8
type: ClinicalUseDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ClinicalUseDefinition-interaction-uv-epi
    l: ClinicalUseDefinition-interaction-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ClinicalUseDefinition cud-4fce9d5258f70f7d605059f97c24efa8 Profile: ClinicalUseDefinition Interaction (ePI) type: Interaction subject: 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 interaction Interactants - Item[x] * METHOTREXATE
type:
  v: interaction
subject:
  l: mp873a1a47330e628770640f9c96c0761e
interaction:
  interactant:
    item: CodeableConcept

ingredient-for-karvea-hypromellose
type: Ingredient
id:
  v: ingredient-for-karvea-hypromellose
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-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:
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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:
    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/authorizationdcaa4d32aa6658a8df831551503e52ee2
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 authorizationdcaa4d32aa6658a8df831551503e52ee2 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/97/049/002 (use: official, ) subject: PackagedProductDefinition Karvea 75 mg tablet 56 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/1/97/049/002
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/authorizationdcaa4d32aa6658a8df831551503e52ee3
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 authorizationdcaa4d32aa6658a8df831551503e52ee3 Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/EU/1/97/049/003 (use: official, ) subject: PackagedProductDefinition Karvea 75 mg tablet 98 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/1/97/049/003
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/Organization/mah-511671db37e83e520b00f8a0d817dc96
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization mah-511671db37e83e520b00f8a0d817dc96 Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100011564 (use: official, ) active: true type: Marketing authorisation holder name: Sanofi Winthrop Industrie Contacts - Address * 82 avenue Raspail Gentilly FR(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100011564
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000034
    display:
      v: Marketing authorisation holder
name:
  v: Sanofi Winthrop Industrie
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: 82 avenue Raspail Gentilly FR
    line:
      v: 82 avenue Raspail
    city:
      v: Gentilly
    postal code:
      v: 94250
    country:
      v: FR

http://hl7.eu/fhir/ig/gravitate-health/Organization/man-4bb7a752921434fd5f9921b5b9473eda
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Organization-uv-epi
    l: Organization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Organization man-4bb7a752921434fd5f9921b5b9473eda Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/ORG-100011564 (use: official, ) active: true type: Manufacturer name: Sanofi Winthrop Industrie Contacts - Address * 1, rue de la Vierge Ambarès & Lagrave FR(work)
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/omswi
    l: omswi
  value:
    v: ORG-100011564
active:
  v: true
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000033
    display:
      v: Manufacturer
name:
  v: Sanofi Winthrop Industrie
contact:
  address:
    use:
      v: work
    type:
      v: physical
    text:
      v: 1, rue de la Vierge Ambarès & Lagrave FR
    line:
      v: 1, rue de la Vierge
    city:
      v: Ambarès & Lagrave
    postal code:
      v: 33565
    country:
      v: FR

http://hl7.eu/fhir/ig/gravitate-health/PackagedProductDefinition/ppd-d91b269b209aaa5538a1bfafd1a7434d
type: PackagedProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi
    l: PackagedProductDefinition-uv-epi
text:
  status:
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    v: Karvea 75 mg tablets irbesartan Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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    v: Do not take Karvea if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6) if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section) if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. Warning and precautions Talk to your doctor before taking Karvea and if any of the following apply to you: if you get excessive vomiting or diarrhoea if you suffer from kidney problems if you suffer from heart problems if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes. if you are going to have an operation (surgery) or be given anaesthetics an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems. aliskiren Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading “Do not take Karvea”. You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). Children and adolescents This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established. Other medicines and Karvea Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your…

title:
  v: 3. How to take Karvea
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    v: 3. How to take Karvea
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    v: additional
  div:
    v: Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise. Patients with high blood pressure The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response. Patients with high blood pressure and type 2 diabetes with kidney disease In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease. The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years. The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment. Use in children and adolescents Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately. If you take more Karvea than you should If you accidentally take too many tablets, contact your doctor immediately. If you forget to take Karvea If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

title:
  v: 4. Possible side effects
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    v: 4. Possible side effects
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    v: additional
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    v: Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention. As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately. The frequency of the side effects listed below is defined using the following convention: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Side effects reported in clinical studies for patients treated with Karvea were: Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium. Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported. Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain. Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, heada…

title:
  v: 5. How to store Karvea
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    v: 5. How to store Karvea
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    v: additional
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    v: Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month. Do not store above 30°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

title:
  v: 6. Contents of the pack and other information
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    v: 6. Contents of the pack and other information
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    v: What Karvea contains The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan. The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”. What Karvea looks like and contents of the pack Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side. Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available. Not all pack sizes may be marketed. Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris - France Manufacturer: SANOFI WINTHROP INDUSTRIE 1, rue de la Vierge Ambarès and Lagrave F-33565 Carbon Blanc Cedex - France SANOFI WINTHROP INDUSTRIE 30-36 Avenue Gustave Eiffel, BP 7166 F-37071 Tours Cedex 2 - France For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder. België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien) Česká republika sanofi-aventis, s.r.o. Tel: +420 233 086 111 Magyarország SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050 Danmark Sanofi A/S Tlf: +45 45 16 70 00 Malta Sanofi S.r.l. Tel: +39 02 39394275 Deutschland Sanofi-Aventis Deutschland GmbH Tel: 0800 52 52 010 Tel. aus dem Ausland: +49 69 305 21 131 Norge sanofi-aventis Norge AS Tlf: +47 67 10 71 00 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Österreich sanofi-aventis GmbH Tel: +43 1 80 185 – 0 Ελλάδα sanofi-aventis AEBE Τηλ: +30 210 900 16 00 Polska sanofi-aventis Sp. z o.o. Tel.: +48 22 2…

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