octaplex®(Human Prothrombin Complex Concentrate)

Ireland

Ireland 500 IU Summary of Product Characteristics

Ireland 1000 IU Summary of Product Characteristics

Ireland 500 IU Patient Information Leaflet

Ireland 1000 IU Patient Information Leaflet

Republic of Ireland: Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the HPRA website at www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/IROPX/C/V2 August 2020

This site is intended for Ireland healthcare professionals and may contain promotional information.

Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Octapharma in the United Kingdom by telephoning 1890 920 522.

Product Information

Ireland 500 IU Summary of Product Characteristics

Ireland 1000 IU Summary of Product Characteristics

Therapeutic Indications

Treatment of bleeding and perioperative prophylaxis of bleeding in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.

Treatment of bleeding and perioperative prophylaxis in congenital deficiency of the vitamin K dependent coagulation factors II and X when purified specific coagulation factor product is not available.

Shelf Life & Storage

Shelf life is three years. Chemical and physical in-use stability has been demonstrated for up to 8 hours at +2°C to +25°C.From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Vial Sizes

Our licensed vial sizes are listed below:

  • 500 IU

  • 1000 IU

For questions about availability please contact customer services.

Materials

UK & Ireland reconstitution video coming soon

ROI Reconstitution Guide

ROI Does Calculator

UK/P/IROPXHCP/C/V4 August 2020