KIOVIG 100 mg/ml solution for infusion

  • Name:

    KIOVIG 100 mg/ml solution for infusion

  • 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: 20/11/19

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Summary of Product Characteristics last updated on medicines.ie: 20/11/2019

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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 20 November 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Free text change information supplied by the pharmaceutical company

The telephone number in the Patient Leaflet (Annex IIIB under “Marketing authorization holder”) has been updated from a UK number (+44(0)1256 894 959) to the International number + 800 66838470.

Updated on 20 November 2019 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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

Free text change information supplied by the pharmaceutical company

Approval of the Transfer of Marketing Authorization Holder (MAH) from Baxter AG to Takeda Manufacturing Austria AG.

Updated on 6 September 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 23 August 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 4 - how to report a side effect

Updated on 23 July 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 12 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 6 March 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for

Updated on 21 February 2019 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 6 - date of revision

Updated on 21 February 2019 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • 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

Update to SmPC and Patient Leaflet (PL) to comply with the issuance by EMA of the new core SmPC for IVIgs that comes into effect on 1 January 2019.
This current SmPC revision includes also the inclusion of a new indication, chronic demyelinating polyradiculoneuropathy (CIDP).
Some misspelled words in English have also been corrected and make some minor editorial changes in several languages have been rectified.

Updated on 2 November 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Update of SmPC to implement a PRAC recommendation to include the lupus-like syndrome safety signal under 4.8. in the SmPC. Since clinical symptoms of cutaneous lupus erythematosus are already captured in the Patient Information Leaflet (PIL), section 4 of the package leaflet has not been updated.

Updated on 16 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 June 2017 PIL

Reasons for updating

  • Change to section 6 - date of revision

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)