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gammanorm

  • Name:

    gammanorm

  • 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: 23/10/20

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Summary of Product Characteristics last updated on medicines.ie: 23/10/2020

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Octapharma Ltd

octapharma

Company Products

Medicine NameActive Ingredients
Medicine Name albunorm 20% Active Ingredients Human Albumin
Medicine Name albunorm 5% Active Ingredients Human Albumin
Medicine Name Fibryga, 1 g, powder and solvent for solution for injection/infusion Active Ingredients Human Fibrinogen
Medicine Name gammanorm Active Ingredients Human Normal Immunoglobulin
Medicine Name LG-octaplas solution for infusion Active Ingredients Human Plasma Proteins
Medicine Name Nuwiq powder and solvent for solution for injection Active Ingredients simoctocog alfa
Medicine Name Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Panzyga 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Wilate powder and solvent for solution for injection Active Ingredients Factor VIII, von Willebrand factor
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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 23 October 2020 SPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 10 - Date of revision of the text

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

Updated on 23 October 2020 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 6 - date of revision

Updated on 15 August 2018 SPC

Reasons for updating

  • File format updated to PDF

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

Updated on 11 June 2018 SPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

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

Updated on 11 June 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 7 February 2018 SPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.1 - Therapeutic indications

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

Free text change information supplied by the pharmaceutical company

- Section 4.1: More detail given regarding therapeutic indications$0- Section 4.2: Rapid push has been added as a method of administration (i.e. subcutaneous infusion using a syringe)$0$0- Section 4.4: More detail has been given regarding Contraindications $0$0- Section 4.6: Crosses the placenta increasingly during third trimester$0$0- Section 4.7: May impair ability to drive$0$0- Section 4.8: Undesirable effects has been re-written, with addition of new tabulated list of adverse reactions$0$0- Section 5.1: Addition of a new clinical study$0

Updated on 7 February 2018 SPC

Reasons for updating

  • New SPC for new product

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

Updated on 7 February 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - driving and using machines
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 7 February 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 March 2016 PIL

Reasons for updating

  • Change of manufacturer

Updated on 10 November 2015 SPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to improve clarity and readability

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

Free text change information supplied by the pharmaceutical company

4.8 - change of wording to one side effect$04.8 - updated HPRA contact information$0$010 - Updated date of revision of text$0

Updated on 11 February 2015 SPC

Reasons for updating

  • 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

Section 4.8: Inclusion of Thromboembolic events as Vary rare ADR

Section 10: Updated revision of text.

Updated on 11 February 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 14 March 2014 SPC

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