Flexbumin 200 g/l solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Takeda Products Ireland Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 21 June 2020

File name

ie-spc-flexbumin-TIB-072-June 2020-clean_1592775123.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • 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 21 June 2020

File name

ie-pl-flexbumin-TIB-072-June 2020-clean_1592774962.pdf

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 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to information for healthcare professionals

Updated on 12 February 2016

File name

PIL_16626_165.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 February 2016

Reasons for updating

  • New SPC for new product

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