Pharmacological properties : תכונות פרמקולוגיות

Pharmacodynamic Properties

5.1.    Pharmacodynamic properties
Pharmacotherapeutic Group: antihaemorrhagics: blood coagulation factor VIII. ATC code: B02BD02.
The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
When infused into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient’s circulation.


Recombinate Powder for Solution for Injection- BAXIJET ll,   26 2. 2015, RH 
Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Recombinate has been studied in 71 previously untreated children (PUP’s). Median age of the cohort at the time of first Recombinate infusion was 10 months (range: 2 days to 50 months). The product was well tolerated and not associated with significant short-term adverse effects. Its clinical efficacy was comparable to other full-length FVIII molecules in both the treatment of acute haemorrhage and for surgical prophylaxis (10 subjects had undergone surgical interventions). Long-term follow-up of the cohort revealed an incidence of product-related adverse events of 0.86/1000 infusions, none serious or life-threatening.

Pharmacokinetic Properties