Human Albumin Baxalta 50 g/l Solution for Infusion * Pharmacy Only: Prescription
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 10 February 2022
File name
ie-pl-human-albumin-50gl-TIA081-clean_1644501272.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 18 August 2021
File name
ie-spc-human-albumin-50gl-TIB064-clean-Nov-19_1629291895.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- 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 06 February 2020
File name
ie-pl-human-albumin-50gl-TIAIN066-clean_1581000878.pdf
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 05 December 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 05 December 2017
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 6.1 - List of excipients
- 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
In section 2 the excipient with known effect has been updated to Sodium 13 - 160 mmol/l.
In section 6.1, the excipient Sodium has been amended to Sodium Chloride q.s and a "Total sodium content 130 - 160 mmol/l" has been added.
The date of revision (section 10) has been updated to November 2017.
Updated on 16 November 2016
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
Updated on 21 July 2016
File name
PIL_16635_600.pdf
Reasons for updating
- New PIL for new product
Updated on 21 July 2016
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
Updated on 21 July 2016
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 15 February 2016
Reasons for updating
- New PIL for medicines.ie
Updated on 12 February 2016
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)