LG-octaplas solution for infusion
*Company:
Octapharma 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 09 February 2023
File name
LG-octaplas IE SPC - 20210301.pdf
Reasons for updating
- Document format updated
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 March 2021
File name
LG-octaplas IE SPC - 20210301.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 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 March 2021
File name
LG-octaplas IE PIL March 2021 - 20210111.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
Updated on 26 March 2020
File name
LG-octaplas PIL - 20191031.pdf
Reasons for updating
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - use in children/adolescents
- Change to section 6 - manufacturer
Updated on 26 March 2020
File name
LG-octaplas SPC 20191031.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 20 May 2019
File name
LG-octaplas PIL - May 2019 - 20190327.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to information for healthcare professionals
Updated on 20 May 2019
File name
LG-octaplas SPC - May 2019 - 20190327.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 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 4.2.: Updated citrate toxicity information
- Section 4.4: Updated serological testing information
Updated on 15 August 2018
File name
LG-octaplas SPC IE - June 2018.pdf
Reasons for updating
- File format updated to PDF
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 June 2018
File name
LG-octaplas SPC IE - June 2018.docx
Reasons for updating
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 29 May 2018
File name
LG-octaplas SPC IE - May 2018.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 22 May 2018
File name
20180115_spc_952_IE_22_17_en.docx
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 6.3 - Shelf life
- Change to section 8 - Marketing authorisation number(s)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Summary of changes:
- Section 4.4 - Addition of sodium content
- Section 6.3 - Extension of post-thaw shelf life at +2-8°C from 24 hours to 5 days
Updated on 21 May 2018
File name
LG-octaplas PIL - May 2018 - 20180308.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 5 - how to store or dispose
- Change to section 6 - marketing authorisation holder
Updated on 12 June 2017
File name
PIL_16317_267.pdf
Reasons for updating
- New PIL for new product
Updated on 12 June 2017
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 07 June 2017
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 07 June 2017
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- 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 12 July 2016
Reasons for updating
- Change to section 6.3 - Shelf life
- 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
Updated on 11 July 2016
Reasons for updating
- Change to storage instructions
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to how the medicine works
- Change to date of revision
Updated on 01 June 2016
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
- Improved electronic presentation
Updated on 20 April 2016
Reasons for updating
- 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)
Free text change information supplied by the pharmaceutical company
Updated on 08 May 2015
Reasons for updating
- New PIL for medicines.ie
Updated on 17 April 2015
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may not be renewed (A)