Composition

Each vial contains: Activated recombinant coagulation factor VIIa (eptacog alfa) 1 mg (corresponds to 50 KIU). 1 KIU equals 1,000 IU (International Units). Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology. After reconstitution, the product contains 1 mg/mL eptacog alfa (activated) when reconstituted with solvent  

ATC Code/ATCvet Code

B02BD08  

Product Category

Vaccines and Biologics

Marketing Category

Prescription-only Medicine (POM)  

Packsize

1 mg (50 KIU) x 1's (in clear glass vial) + 1 mL Histidine solvent (in clear glass pre-filled syringe)  

Product Description

Powder and solvent for solution for injection. White lyophilised powder. Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0.

Manufacturer Name

Novo Nordisk A/S

Manufacturer Country

DENMARK  

Approval Date

2019-10-31  

Expiry Date

2024-10-30