Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health and changes regularly. See the Directory of published versions

Example Bundle: ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en

Composition category: Raw
Composition status: final

Narrative Text


B. Package Leaflet

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Package leaflet: Information for the user

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What is in this leaflet

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1. What Enbrel 25 mg powder for solution for injection is and what it is used for

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2. What you need to know before you take Enbrel 25 mg powder for solution for injection

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3. How to take Enbrel 25 mg powder for solution for injection

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4. Possible side effects

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5. How to store Enbrel 25 mg powder for solution for injection

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6. Contents of the pack and other information

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Product Information

Enbrel 25 mg powder for solution for injection

IDS: zz

Full name: Enbrel 25 mg powder for solution for injection

- Invented name part: Enbrel

- Scientific name part: Etanercept

- Strength part: 25 mg

- Pharmaceutical dose form part: powder for solution for injection

Name usage: English (Norway)

Authorised dose form:

Legal status of supply: Medicinal product subject to medical prescription

Domain: Human use

Resource status: active

Product classification:

Marketing Authorisation 1 of 1

Authorisation number: EU/1/99/126/003

Region:

Marketing authorisation holder: Pfizer Europe MA EEIG

Identifier:

  • ORG-100011459

Status: Active (2009-11-26T13:28:17Z)

Package 1 of 1

PMSWI: EU/1/99/126/003

Description:

Marketing status:

Pack size:

  • 25

    Package: 1 Box (Cardboard)

    Containing:

    Package: 28 Blister (PolyVinyl Chloride)

    Containing:

    Manufactured Item

    Dose form: Powder for solution for injection

    Unit of presentation: Vial

    Ingredient

    Role: Excipient

    Substance: SUCROSE

    Ingredient

    Role: Excipient

    Substance: MANNITOL

    Ingredient

    Role: Active

    Substance: Etanercept

    Ingredient

    Role: Excipient

    Substance: TROMETHAMINE

    Administrable Product (1 of 1)

    Dose form: Powder for solution for injection

    Unit of presentation: Vial

    Route of administration:

    • Subcutaneous use

    Ingredients:

    Ingredient

    Role: Excipient

    Substance: SUCROSE

    Ingredient

    Role: Excipient

    Substance: MANNITOL

    Ingredient

    Role: Active

    Substance: Etanercept

    Ingredient

    Role: Excipient

    Substance: TROMETHAMINE