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LG-octaplas solution for infusion

*
Pharmacy Only: Prescription

  • Company:

    Octapharma Ltd

  • Status:

    Updated

  • Legal Category:

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

  • Active Ingredient(s):

    Human Plasma Proteins

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

Updated on 10 January 2025

File name

20241122_pil_952_IE_31.28_en.pdf

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

Inclusion of TRALI in Table. Added as 'acute breathing problems' under 'Not Known'

Updated on 10 January 2025

File name

20241213_spc_952_IE_32.29_en.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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

Free text change information supplied by the pharmaceutical company

Inclusion of TRALI in Table 1: Adverse reactions that have been identified for Octaplas. Added under 'Not Known'

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

Section 4.4: subsection headers added$0Section 4.8: specific warning of hypersensitivity added, updated ADR table$0$0Section 4.9: added warning of circulatory overload$0$0Section 10: date of revision updated$0$0

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

Improved clarity within wording of many sections within SPC.$0$0$0$0Section 6.3: Update to Post thaw stability to include in use shelf life.$0$0Section 10: updated Date of revision of text$0

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

Section 6.6: Updated thawing instructions

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)

Free text change information supplied by the pharmaceutical company

None provided