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)”

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

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:
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