CEPROTIN 1000 IU powder and solvent for solution for injection

  • Name:

    CEPROTIN 1000 IU powder and solvent for solution for injection

  • Company:
    info
  • Active Ingredients:

    Protein C

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/10/18

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Summary of Product Characteristics last updated on medicines.ie: 2/10/2018

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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
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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 2 October 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 October 2018 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 10 - Date of revision of the text

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

Free text change information supplied by the pharmaceutical company



Following issuance of an update of the Company Core Safety Information (CCSI) the SmPC and PIL of Ceprotin are revised: The section 4.8 of the SmPC is revised with regard to information on adverse events and it is also modified with regard to moving the paragraph on the development of inhibitors into section 4.4. Summary of the changes are given below:

- In section 4.4, a warning regarding use in patients with severe congenital protein C deficiency has been added.

- In section 4.8, the ADRs have been updated and also tabulated in line with MedDRA.

- The date of revision of the text in section 10 has been updated in line with the CHMP opinion date (i.e. variation approval date).

Updated on 4 December 2017 PIL

Reasons for updating

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

Updated on 4 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 19 September 2017 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 February 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 12 February 2016 SmPC

Reasons for updating

  • New SmPC for new product

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