Eptacog alfa (activated) 1 mg/vial (corresponds to 50 KIU/vial), 1 mg/ml after reconstitution.
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.
Solvent: clear colourless solution. The reconstituted solution has a pH of approximately 6.0
Excipients/Inactive Ingredients: Powder: Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid (for pH-adjustment) and sodium hydroxide (for pH-adjustment).
Solvent: Histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections.