Factor VIIa


NovoSeven

PRODUCT NAME: Novoseven RT

FORMULATION & CONCENTRATION: (Coagulation Factor VIIa [Recombinant] Room Temperature Stable)

MANUFACTURER: Novo Nordisk

INDICATIONS:
Treatment of bleeding episodes in hemophilia A or B with inhibitors and in acquired hemophilia (1.1)
Prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B with inhibitors and in acquired hemophilia (1.2)
Treatment of bleeding episodes in congenital FVII deficiency (1.3)

SHELF LIFE:
36 Months

STORAGE:
Prior to reconstitution, keep refrigerated or store between 2-25°C/36- 77°F. Do not freeze. Store protected from light. Do not use past the expiration date.

After reconstitution, NovoSeven® RT may be stored either at room temperature or refrigerated for up to 3 hours. Do not freeze reconstituted NovoSeven® RT or store it in syringes.

Full Prescribing Information for Novoseven RT

Vial Size NDC # Size
1.0 mg 0169-7010-01 1.1ml Histidine diluent
2.0 mg 0169-7020-01 2.1ml Histidine diluent
5.0 mg 0169-7050-01 5.2ml Histidine diluent
8.0 mg 0169-7040-01 8.1ml Histidine diluent