Cuvitru 200 mg/ml solution for subcutaneous injection

  • Name:

    Cuvitru 200 mg/ml solution for subcutaneous injection

  • Company:
    info
  • Active Ingredients:

    Human Normal Immunoglobulin

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/12/19

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Summary of Product Characteristics last updated on medicines.ie: 3/12/2019
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions.

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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 3 December 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Free text change information supplied by the pharmaceutical company

The pack size has changed and not all pack sizes may be marketed now 

Updated on 3 December 2019 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change in pack size 

Updated on 29 May 2019 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 29 May 2019 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Section 2 (QUALITATIVE AND QUANTITATIVE COMPOSITION): To inclue 50 ml/ 10g

Section 6.5 (Nature and contents of container): to include 50ml to the pack size list

Updated on 15 August 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use

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

Free text change information supplied by the pharmaceutical company

  1. In Section 4.2 (posology and method of administration) an update to the "method of administration" has been made that the infusion of Cuvitru must be started immediately upon transfer into the syringe to prevent particulate formation including what to do if an administration shorter than 2 hours is not possible.
  2. In section 4.4 (special warnings and precautions for use) a warning regarding particulate formation if Cuvitru remains in a siliconized syringe for more than 2 hours has been added.
  3. Accordingly, the date of revision (section 10) has been updated.

Updated on 15 August 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 8 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 8 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 28 April 2017 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Free text change information supplied by the pharmaceutical company

In section 5.2, typographical error with the units has been correct from ‘mg’ to ‘g’. The text should now read 0.3 to 1.0 g/kg body weight/4 weeks.

Updated on 8 February 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 8 February 2017 SmPC

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided