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http://hl7.eu/fhir/ig/gravitate-health/Composition/composition-da-873a1a47330e628770640f9c96c0761e
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        v: B. INDLÆGSSEDDEL Indlægsseddel: Information til brugeren Karvea 75 mg tabletter irbesartan Læs denne indlægsseddel grundigt, inden du begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger. - Gem indlægssedlen. Du kan få brug for at læse den igen. - Spørg lægen eller apotekspersonalet, hvis der er mere, du vil vide. - Lægen har ordineret Karvea til dig personligt. Lad derfor være med at give medicinen til andre. Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har. - Kontakt lægen eller apotekspersonalet, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her. Se punkt 4. Se den nyeste indlægsseddel på www.indlaegsseddel.dk.
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      v: Oversigt over indlægssedlen
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        v: Oversigt over indlægssedlen
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        v: Oversigt over indlægssedlen: 1. Virkning og anvendelse 2. Det skal du vide, før du begynder at tage Karvea 3. Sådan skal du tage Karvea 4. Bivirkninger 5. Opbevaring 6. Pakningsstørrelser og yderligere oplysninger
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      v: 1. Virkning og anvendelse
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        v: 1. Virkning og anvendelse
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        v: Karvea tilhører en medicingruppe, der kaldes angiotensin-II receptorantagonister. Angiotensin-II er et stof, der produceres i kroppen, og som binder sig til receptorer i blodårerne og får dem til at trække sig sammen. Dette medfører, at blodtrykket øges. Karvea forebygger at angiotensin-II binder sig til disse receptorer. Derved afslappes blodårerne, og blodtrykket falder. Karvea mindsker faldende nyrefunktion hos patienter med forhøjet blodtryk og type 2 diabetes (sukkersyge). Karvea anvendes til voksne patienter til at behandle forhøjet blodtryk (hypertension) til at beskytte nyrerne hos patienter med for højt blodtryk, type 2 diabetes og blodprøver, der viser nedsat nyrefunktion.
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      v: 2. Det skal du vide, før du begynder at tage Karvea
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        v: Tag ikke Karvea: hvis du er overfølsom (allergisk) over for irbesartan eller et af de øvrige indholdsstoffer i Karvea (angivet i punkt 6). hvis du er længere end 3 måneder henne i din graviditet. (Det er også bedre at lade være med at tage Karvea i begyndelsen af graviditeten – se afsnittet om graviditet) hvis du har diabetes eller nedsat nyrefunktion, og du bliver behandlet med et lægemiddel, der sænker blodtrykket, som indeholder aliskiren Advarsler og forsigtighedsregler Kontakt lægen, før du tager Karvea, hvis noget af det følgende gælder for dig: hvis du får hyppig opkastning eller diarré hvis du lider af nyreproblemer hvis du lider af hjerteproblemer hvis du får Karvea for diabetisk nyresygdom. I dette tilfælde kan lægen tage regelmæssige blodprøver med særlig henblik på at måle kaliumniveauet i blodet, hvis nyrefunktionen er nedsat hvis du udvikler lavt blodsukkerniveau (symptomerne kan inkludere svedtendens, svaghed, sult, svimmelhed, skælven, hovedpine, rødmen eller bleghed, følelsesløshed, hurtige og hamrende hjerteslag), især hvis du er i behandling for diabetes hvis du skal opereres eller bedøves hvis du tager en af følgende lægemidler, der anvendes til at behandle forhøjet blodtryk: * en ACE-hæmmer (f.eks. enalapril, lisinopril, remipril) især hvis du har nyreproblemer, der skyldes diabetes. * Aliskiren. Din læge vil måske regelmæssigt kontrollere din nyrefunktion, dit blodtryk og mængden af elektrolytter (f.eks. kalium) i dit blod. Se også information under ”Tag ikke Karvea”. Du skal fortælle det til din læge, hvis du tror du er gravid eller planlægger at blive gravid. Karvea bør ikke bruges tidligt i graviditeten og du må ikke tage Karvea, hvis du er længere end 3 måneder henne i din graviditet, da det kan skade dit barn alvorligt, hvis det bruges i den periode (se afsnittet om graviditet). Børn og unge Dette lægemiddel bør ikke anvendes til børn og unge, da sikkerhed og virkning ikke er blevet fuldstændig klarlagt. Brug af anden medicin sammen med Ka…
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        v: Tag altid Karvea nøjagtigt efter lægen anvisning. Er du i tvivl, så spørg lægen eller på apoteket. Sådan tages tabletterne Karvea skal tages gennem munden. Tabletterne skal synkes med en tilstrækkelig mængde væske (for eksempel 1 glas vand). Du kan tage Karvea med eller uden mad. Prøv at tage medicinen på ca. samme tidspunkt hver dag. Det er vigtigt, at du fortsætter med at tage Karvea, indtil lægen siger du kan stoppe. Patienter med højt blodtryk Den sædvanlige dosis er 150 mg 1 gang dagligt (to tabletter dagligt). Dosis kan senere øges til 300 mg 1 gang dagligt (fire tabletter dagligt) afhængig af blodtryksmålingerne. Patienter med højt blodtryk og type 2 diabetes med nyresygom Hos patienter med højt blodtryk og type 2 diabetes er 300 mg 1 gang dagligt (fire tabletter dagligt) den foretrukne vedligeholdelsesdosis til behandling af ledsagende nyresygdom. Lægen kan anbefale en lavere dosis, specielt til patienter, som bliver behandlet med hæmodialyse eller til ældre patienter over 75 år. Den maksimale blodtryksnedsættende virkning skal være nået 4-6 uger efter behandlingsstart. Børn og unge må ikke få Karvea Karvea må ikke gives til børn under 18 år. Hvis et barn sluger en eller flere tabletter, skal du straks kontakte lægen. Hvis du har taget for mange Karvea Hvis du ved et uheld har taget for mange tabletter, skal du omgående kontakte lægen. Hvis du har glemt at tage Karvea Hvis du har glemt at tage en dosis, skal du blot tage den næste til sædvanlig tid. Tag ikke dobbeltdosis som erstatning for den glemte dosis. Spørg lægen eller apotekspersonalet, hvis der er noget, du er i tvivl om.
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        v: Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. Nogle af disse bivirkninger kan være alvorlige og kan kræve medicinsk behandling. Som ved anden medicin af samme type, er der hos patienter, der har modtaget behandling med irbesartan, rapporteret sjældne tilfælde af allergiske hudreaktioner (udslæt, nældefeber) samt opsvulmet ansigt, læber og/eller tunge. Hvis du får et eller flere af disse symptomer eller får åndenød, skal du holde op med at tage Karvea og straks søge lægehjælp. Hyppigheden af nedenstående bivirkninger er angivet på følgende måde: Meget almindelig: kan påvirke flere end 1 ud af 10 patienter Almindelig: kan påvirke op til 1 ud af 10 patienter Ikke almindelig: kan påvirke op til 1 ud af 100 patienter Følgende bivirkninger blev indberettet i kliniske forsøg med patienter, der fik Karvea: Meget almindelig (kan påvirke flere end 1 ud af 10 patienter): hvis du har højt blodtryk og type 2 diabetes med nyresygdom, kan blodprøver vise, at du har for meget kalium i blodet. Almindelig (kan påvirke op til 1 ud af 10 patienter): svimmelhed, kvalme/opkastning, træthed og blodprøver, der viser en forhøjet mængde af et enzym, der måler muskel- og hjertefunktionen (kreatinin-kinase-enzym).Der er hos patienter med forhøjet blodtryk og type 2 diabetes med nyresygdom også indberettet svimmelhed, når man rejser sig op fra liggende eller siddende stilling, lavt blodtryk når man rejser sig op fra liggende eller siddende stilling, led- og muskelsmerter og en nedsat mængde protein i de røde blodlegemer (hæmoglobin). Ikke almindelig (kan påvirke op til 1 ud af 100 patienter): hurtig hjerterytme, rødme, hoste, diarré, fordøjelsesbesvær/halsbrand, seksuelle problemer, brystsmerter. Der er indberettet bivirkninger efter markedsføring af Karvea. Bivirkninger, hvor hyppigheden ikke er kendt, er: følelse af, at omgivelserne kører rundt, hovedpine, smagsforstyrrelser, ringen for ørerne, muskelkramper, led- og muskelsmerter, nedsat antal r…
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        v: Opbevar lægemidlet utilgængeligt for børn. Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisterpakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned. Må ikke opbevares ved temperaturer over 30°C. Spørg på apoteket, hvordan du skal bortskaffe medicinrester. Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
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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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interaction:
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    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:
    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:
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v: Scientific name part

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v: Strength part

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v: Pharmaceutical dose form part

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v: en

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