Prothromplex Description

Prothromplex TOTAL 600 IU is a powder for solution for intravenous application. Each vial nominally contains the following IU of human coagulation factors. (See Table 1.)

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The total protein content per vial is 300 - 750 mg. The specific activity of the product is at least 0.6 IU/mg, in relation to the factor IX activity.
One vial contains at least 400 IU Protein C co-purified with the blood coagulation factors.
The activity (IU) of factor IX was determined by the one-step coagulation test described in the European Pharmacopoeia, which is calibrated against the International Standard for Factor IX Concentrates of the World Health Organisation (WHO).
The activity (IU) of factor II, factor VII and factor X was determined by the chromogenic assay described in the European Pharmacopoeia, which is calibrated against the International Standards for Factor II, Factor VII and Factor X Concentrates of the World Health Organisation (WHO).
The activity (IU) of protein C was determined by the chromogenic assay described in the European Pharmacopoeia, which is calibrated against the International Standard for Protein C Concentrates of the World Health Organisation (WHO).
Solvent: Sterilized water for injections.
After reconstitution, the pH value of the solution is 6.5 to 7.5 and the osmolality does not lie below 240 mosm/kg. The solution is clear or slightly opalescent.
Excipients with known effect: Prothromplex TOTAL 600 IU contains 81.7 mg sodium per vial. Furthermore, each vial contains heparin sodium (max. 0.5 IU/IU factor IX).
Excipients/Inactive Ingredients: Powder: Sodium chloride, Sodium citrate dihydrate, Heparin sodium 0.2 - 0.5 IU/IU FIX, Antithrombin III 15 - 30 IU per vial (0.75 - 1.5 IU/ml).
Solvent: Sterilized water for injections.