Novoeight

Product Specs	Description
Manufacturer Name	Novo Nordisk
Indications	Antihemophilic Factor (Recombinant)
Indications for Adults:
Control and Prevention of Bleeding Episodes	Yes
Perioperative Management	Yes
Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes	Yes
Indications for Children:
Control and Prevention of Bleeding Episodes	Yes
Perioperative Management	Yes
Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes	Yes
Contraindications Nutrient in Cell Culture	Do not use in patients who have had lifethreatening hypersensitivity reactions, including anaphylaxis, to NovoEight or its components, including hamster proteins.
Stabilizer in Final Formulation	sodium chloride, L-histidine, sucrose, polysorbate 80, methionine, calcium chloride dihydrate
Viral Safety Process	20 nm filtration, detergent treatment
Product Half-Life	Children: 10.8 hours Adults: 12 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	Children (0-<6 years): 0.022 (0.006) Children (6-<12 years): 0.025 (0.006) Adults: 0.028 (0.006)
Storage Requirements/Shelf Life	Store in the original package to protect from light. Store refrigerated at a temperature of 36°F to 46°F (2°C to 8°C) for up to 30 months from the date of manufacture until the expiration date on the carton. May be kept at room temperature up to 86°F (≤30°C) for no longer than 12 months or up to 104°F(≤40°C) for no longer than 3 months. Do not return the product to the refrigerator. Do not freeze. Use within 4 hours after reconstitution when stored at <86°F (30°C) or within 2 hours when stored between 86°F (30°C) to 104°F (40°C).
Nominal Vial Size & Diluent Volume	250, 500, 1000, 1500, 2000, 3000 IU/4mL of 0.9% Sodium Chloride Solution