Flexbumin 200 g/l solution for infusion
*Company:
Takeda Products Ireland LtdStatus:
No Recent UpdateLegal 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
Updated on 23 November 2023
File name
ie-spc-flexbumin-November 2023-clean.pdf
Reasons for updating
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Shelf life updated
Updated on 15 February 2022
File name
ie-pl-flexbumin-TIA-082-Dec 2021-clean.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Correction of spelling/typing errors
- Change to improve clarity and readability
Updated on 21 June 2020
File name
ie-spc-flexbumin-TIB-072-June 2020-clean.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.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)