Human prothrombin complex
Each vial of lyophilized powder contains the following active pharmaceutical ingredients:
Octaplex 500: (280 – 760) IU of Factor II, (180 – 480) IU of Factor VII, 500 IU of Factor IX, (360 – 600) IU of Factor X, (260 – 620) IU of protein C, (240 – 640) IU of protein S.
Prophylaxis, perioperative replacement and bleeding treatment in patients with congenital or acquired deficiency of clotting factors II, VII, IX and / or X.
- Hypersensitivity (allergy) to the components of this product.
- Type II heparin induced thrombocytopenia.
- Recent myocardial infarction, pectoris angina or high risk of thrombosis. Exception: life-threatening bleeding caused by an overdose of anticoagulants, and before starting a fibrinolytic therapy.
- High risk of disseminated intravascular coagulation. Protrombinic complex concentrates should be administered after the treatment of the cause of disseminated intravascular coagulation.
Octaplex 500: box containing one vial with the lyophilized powder + one vial with 20 mL of the solvent + one transfer set for administration.