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About octaplex®
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octaplex® replaces pro-coagulant prothrombin factors and inhibitory proteins
octaplex® is a plasma-derived, virally inactivated four-factor prothrombin complex concentrate (4F-PCC) containing coagulation factors II, VII, IX and X. It also contains the naturally occurring anticoagulants protein C and protein S.1
It exerts its effects by elevating plasma concentrations of essential coagulation factors and proteins, which play a critical role in blood clot formation. This mechanism helps to stop or prevent bleeding and contributes to the restoration of haemostasis..1
octaplex® composition
Active substances | Octaplex® 500 IU | Octaplex® 1000 IU | Quantity after reconstitution |
|---|---|---|---|
Human coagulation factor II | 280–760 IU | 560–1520 IU | 14–38 IU/mL |
Human coagulation factor VII | 180–480 IU | 360–960 IU | 9–24 IU/mL |
Human coagulation factor IXa | 500 IU | 1000 IU | 25 IU/mL |
Human coagulation factor X | 360–600 IU | 720–1200 IU | 18–30 IU/mL |
Protein C | 260–620 IU | 520–1240 IU | 13–31 IU/mL |
Protein S | 240–640 IU | 480–1280 IU | 12–32 IU/mL |
Excipients | |||
|---|---|---|---|
Heparin | 100–250 IU | 200–500 IU | 0.2–0.5 IU/IU FIX |
Sodium | 75–125 mg | 150–250 mg | 17.0–27.0 mmol/L |
A robust, efficient, and gentle manufacturing process ensures a product of consistent quality and safety.2
The plasma used for the manufacture of octaplex® is sourced from donation centres inspected by national health authorities and audited by Octapharma. These centres follow strict procedures for donor selection, plasma testing, storage, and documentation.3 Only donations testing negative for hepatitis B surface antigen, antibodies against hepatitis C virus and HIV-1/2, as well as those that pass PCR tests for HIV and HCV are utilised.
Each octaplex® batch is produced from cryo-poor plasma, with additional testing for parvovirus B19 depending on the donation center. The plasma pool is further tested for HCV, parvovirus B19, HBsAg, and anti-HIV-1/2.3 octaplex® undergoes two pathogen inactivation/removal steps (solvent/detergent treatment and nanofiltration) to ensure the removal of both enveloped and non-enveloped viruses.1-3
References
SPC
Hoffer L WV, Weinberger J, Roemisch J. Consistent manufacturing of 50 consecutive octaplex® 500 lots: biochemical characteristics of a prothrombin complex concentrate. J Thromb Haem. 2005;3(Suppl 1): P0656.
octaplex® Product Monograph Canada 2017.
