ADVATE 250 IU, 500 IU, 1000 IU and 1500 IU powder and solvent for solution for injection 2 ml solvent - Baxject III

  • Name:

    ADVATE 250 IU, 500 IU, 1000 IU and 1500 IU powder and solvent for solution for injection 2 ml solvent - Baxject III

  • Company:
    info
  • Active Ingredients:

    Octocog Alfa

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/08/18

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Summary of Product Characteristics last updated on medicines.ie: 17/9/2018

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Shire Pharmaceuticals Limited

Shire_Logo_Blue_rgb

Address: Shire Pharmaceuticals Ireland Limited, Block 2, Miesian Plaza, 50-58 Baggot St, Dublin 2, Ireland

Medical Information E-mail: medinfoEMEA@shire.com

Customer Care direct line: 01800837470

Company Products

Medicine NameActive Ingredients
Medicine Name ADVATE 2000 IU and 3000 IU powder and solvent for solution for injection 5 ml water - Baxject III Active Ingredients Octocog Alfa
Medicine Name ADVATE 250 IU, 500 IU, 1000 IU and 1500 IU powder and solvent for solution for injection 2 ml solvent - Baxject III Active Ingredients Octocog Alfa
Medicine Name CEPROTIN 1000 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name CEPROTIN 500 IU powder and solvent for solution for injection Active Ingredients Protein C
Medicine Name Cuvitru 200 mg/ml solution for subcutaneous injection Active Ingredients Human Normal Immunoglobulin
Medicine Name FEIBA 25 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name FEIBA 50 U/ml powder and solvent for solution for infusion Active Ingredients Factor VIII Inhibitor Bypassing Fraction
Medicine Name Flexbumin 200 g/l solution for infusion Active Ingredients Human Albumin
Medicine Name GAMMAGARD S/D Human Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Human Albumin Baxalta 50 g/l Solution for Infusion Active Ingredients Human Albumin
Medicine Name HyQvia 100 mg/ml solution for infusion for subcutaneous use Active Ingredients Human Normal Immunoglobulin
Medicine Name KIOVIG 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name OBIZUR 500 U powder and solvent for solution for injection Active Ingredients
Medicine Name Prothromplex TOTAL 600 IU powder and solvent for solution for injection Active Ingredients Human Prothrombin Complex
Medicine Name Revestive 1.25 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name Revestive 5 mg powder and solvent for solution for injection Active Ingredients Teduglutide
Medicine Name SUBCUVIA 160 g/l Solution for injection Active Ingredients Human Normal Immunoglobulin
Medicine Name VEYVONDI 650 IU and 1300 IU powder and solvent for solution for injection Active Ingredients Vonicog alfa
1 - 0 of 18 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 17 September 2018 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 5.1 (Pharmacodynamic properties), updated with the rewording of information regarding Immune Tolerance Induction (ITI)

Updated on 15 August 2018 PIL

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 14 August 2018 PIL

Reasons for updating

  • Change to section 3 - use in children/adolescents

Updated on 14 August 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 (Posology and method of administration), deletion of specific information that the use of 2 ml presentations has not been documented for paediatric subjects below 2 years of age.

Updated on 19 December 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

  • In section 4.4 (Special warnings and precautions for use), updated with scientific information on inhibitors.
  • In section 4.8 (undesirable effects), updated with scientific information on inhibitors.
  • In section 5.1 (Pharmacodynamic properties), removed scientific information on inhibitor development.
  • In section 9 (DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION), updated with the latest renewal date.

Updated on 19 December 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 14 December 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects

Updated on 14 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 July 2017 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided