Novoeight



Novoeight

Product Specs Novoeight
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
  • Refrigerated at 36°F to 46°F or (2°C to 8°C) for up to 30 months from date of manufacture until expiration date stated on carton or room temperature up to 86°F (30°C) up to 12 months or up to 104°F (40°F) up to 3 months
  • Use within 4 hours after reconstitution if at room temperature < 86°F (30°C) or use within 2 hours when stored between 86°F (30°C) to 104°F (40°C)
  • Protect from light.
  • Do not freeze.
    		•
    Shelf Life 30 months from manufactured date 12 months at room temperature up to 86°F (30°C) or 3 months up 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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