LG-octaplas solution for infusion

  • Name:

    LG-octaplas solution for infusion

  • Company:
    info
  • Active Ingredients:

    Human Plasma Proteins

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 26/03/20

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Summary of Product Characteristics last updated on medicines.ie: 26/3/2020

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Octapharma Ltd

octapharma

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Medicine Name gammanorm Active Ingredients Human Normal Immunoglobulin
Medicine Name LG-octaplas solution for infusion Active Ingredients Human Plasma Proteins
Medicine Name Nuwiq powder and solvent for solution for injection Active Ingredients simoctocog alfa
Medicine Name Octaplex 1000 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Octaplex 500 IU coagulation factor IX per vial, powder and solvent for solution for infusion Active Ingredients Human Prothrombin Complex
Medicine Name Panzyga 100 mg/ml solution for infusion Active Ingredients Human Normal Immunoglobulin
Medicine Name Wilate powder and solvent for solution for injection Active Ingredients Factor VIII, von Willebrand factor
1 - 0 of 10 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 26 March 2020 PIL

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

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Updated on 20 May 2019 PIL

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

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

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

Reasons for updating

  • File format updated to PDF

Updated on 22 June 2018

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

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

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 PIL

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 PIL

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 12 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 7 June 2017

Reasons for updating

  • New SmPC for new product

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

Updated on 7 June 2017 SPC

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 SPC

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 PIL

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 1 June 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Improved electronic presentation

Updated on 20 April 2016 SPC

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 8 May 2015 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 April 2015 SPC

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