Esperoct



Esperoct

Product Specs Esperoct
Manufacturer Name Novo Nordisk
Description Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant analogue of human coagulation FVIII conjugated with a 40-kDa polyethylene glycol (PEG) molecule.
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 You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
Stabilizer in Final Formulation Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, and calcium chloride
Viral Safety Process 20 nm filtration, detergent treatment
Product Half-Life Children (1-<6 years): 14.7 (27) hours
Children (6-<12 years): 13.8 (32) hours
Adolescents (12-<18 years): 17.4 (39) hours
Adults (>18 years): 21.7 (33) hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Children (1-<6 years): 1.82 (32)
Children (6-<12 years): 1.67 (22)
Adolescents (12-<18 years): 2.45 (16)
Adults (>18 years): 2.53 (24)
Storage Requirements/Shelf Life
  • Store in the original package to protect from light.
  • Store in a powder form under refrigeration at 36°F to 46°F (2°C to 8°C) for up to 30 months from the date of manufacture until the expiration date stated on the label.
  • May be stored at room temperature [not to exceed 86°F(30°C)] for up to 12 months within the 30-month time period.
  • The total time of storage at room temperature should not exceed 12 months. Do not return the product to the refrigerator after room temperature storage.
  • Do not use beyond the expiration date printed on the vial or 12 months after the date it was removed from refrigeration (whichever is earlier).
  • Do not freeze.
  • Use within 4 hours after reconstitution when stored at room temperature, or within 24 hours when stored in the refrigerator.
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    Nominal Vial Size & Diluent Volume 500, 1000, 1500, 2000, 3000 IU/4mL of saline diluent


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