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Human Albumin Baxalta 50 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):

    Human Albumin

    *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

The change involves an editorial quality change affecting the SmPC sections 2 and 6.1. 
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

In section 6.1 - Change in the expression of the sodium content of the drug product in the list of excipients

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

Section 4.8 - "Baxter-sponsored clinical trials" amended to "company-sponsored clinical trials"

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)

Free text change information supplied by the pharmaceutical company

None provided