LG-octaplas solution for infusion *
Pharmacy Only: Prescription

  • Company:

    Octapharma Ltd
  • Status:

    No Recent Update
  • Legal 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 17 March 2021

File name

LG-octaplas IE SPC - 20210301_1615990364.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_1615990094.pdf

Reasons for updating

  • Change to section 2 - use in children and adolescents

Updated on 26 March 2020

File name

LG-octaplas PIL - 20191031_1585226903.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_1585226240.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_1558357346.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_1558357178.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_1534339165.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