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
  • Refrigerate 36°F to 46°F (2°C to 8°C) for up to 30 months from date of manufacture until expiration date stated on carton or may be stored at room temperature up to 86°F (30°C) up to 12 months or may be stored up to 104°F (40°C) up to 3 months.
  • Protect from light.
  • Do not freeze.
  • Use within 4 hours after reconstitution when stored ≤86°F° (30°C) or within 24 hours when stored in refrigerator.
    		•
    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 500, 1000, 1500, 2000, 3000 IU/4mL of saline diluent


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