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


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