Human Prothrombin Complex Concentrate
Octaplex® is a human four factor prothrombin complex concentrate (4F-PCC) containing Factors II, VII, IX and X, as well as inhibitor protein C and its cofactor protein S. It is an effective and convenient treatment to restore the levels of prothrombin complex coagulation factors in cases of congenital deficiency (of factor II or X, when an individual factor concentrate is not available) or acquired deficiency, such as deficiency provoked by the use of vitamin K antagonists (VKA) for anticoagulation therapy.
Octaplex® undergoes two specific pathogen inactivation/removal steps:
The Solvent/detergent the gold standard for inactivation of lipid enveloped viruses – inactivates these viruses rapidly and reliably;
A nanofiltration step for removal of both enveloped and non-enveloped viruses.
Octaplex® is indicated for the 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.
It can also be used in the 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.
Octaplex® is presented in vials containing 500 IU and 1000 IU of human prothrombin complex. The total protein content per vial is 260–820 mg (500 IU vial)/ 520–1640 mg (1000 IU vial). The specific activity of the product is ≥ 0.6 IU/mg proteins, expressed as factor IX activity.
Do not store above 25°C, do not freeze. Store in the original package in order to protect from light. The shelf life is three years.
1. Octaplex® - Summary of Product Characteristics (EU)
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