octaplex® (Human prothrombin complex concentrate)

United Kingdom

UK 500 IU Summary of Product Characteristics

UK 1000 IU Summary of Product Characteristics

Patient Infomation Leaflet

United Kingdom: 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

UK/P/UKOPX/C/V2 August 2020

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

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Octapharma by telephoning 0845 1300 522.

Product Information

UK 500 IU Summary of Product Characteristics

UK 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 +25°C.

From a microbiological point of view, unless the method of opening/reconstitution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Vial Sizes

Our licensed vial sizes are listed below:

  • 500 IU

  • 1000 IU

For questions about availability please contact customer services.


Legal classification: Prescription-only Medicine

Pack size and basic NHS cost:
£0.49p per IU for 500 IU vial
£0.42p per IU for 1000 IU vial


Materials

UK & Ireland reconstitution video coming soon

UK/P/UKOPXHCP/C/V4 August 2020