VEYVONDI Powder and solvent for solution for injection Ref.[27668] Active ingredients: Von Willebrand factor

VEYVONDI 650 IU powder and solvent for solution for injection:

Each vial of powder contains nominally 650 International Units (IU) vonicog alfa. After reconstitution with the 5 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.

VEYVONDI 1 300 IU powder and solvent for solution for injection:

Each vial of powder contains nominally 1 300 International Units (IU) vonicog alfa. After reconstitution with the 10 mL solvent provided, VEYVONDI contains approximately 130 IU/mL vonicog alfa.

The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg protein. The potency of VWF (IU) is measured using the European Pharmacopeia ristocetin cofactor activity assay (VWF:RCo). The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO).

Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF). It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation.

The product contains only trace amounts of human recombinant coagulation factor VIII (≤0.01 IU FVIII/IU VWF:RCo) as determined using the European Pharmacopoeia chromogenic assay for factor VIII (FVIII).

Excipients with known effect:

Each 650 IU powder vial contains 5.2 mg sodium and 0.5 mg of polysorbate 80.

Each 1 300 IU powder vial contains 10.4 mg sodium and 1.0 mg of polysorbate 80.

For the full list of excipients, see section 6.1.