Rebinyn



REBINYN

Product Specs REBINYN
Manufacturer Name Novo Nordisk
Description REBINYN is a recombinant DNAderived coagulation Factor IX concentrate
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 known hypersensitivity to REBINYN or its components, including hamster proteins
Viral Safety Process Chromatography, detergent treatment, nanofiltration
Product Half-Life Children ≤6 years : 69.6 (15.8 hours)
Children 7-12 years : 76.3 (25.5 hours)
Adolescents 13-17 years : 89.4 (24.1 hours)
Adults ≥18 years : 83.0 (22.5 hours)
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) Children ≤6 years : 1.51 (7.31)
Children 7-12 years : 1.59 (16.2)
Adolescents 13-17 years : 1.96 (14.7)
Adults ≥18 years : 2.34 (11.3)
Manufacturing Method Recombinant DNA technology
Storage Requirements/Shelf Life
  • Store in the original package in order to protect from light.
  • Store at a temperature of 36°F-46°F (2°C – 8°C) for up to 24 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 6 months within the 24-month time period.
  • The total time of storage at room temperature should not exceed 6 months. Do not return the product to the refrigerator.
  • Do not use after the end of the 6-month period at room temperature storage, or after the expiration date stated on the vial.
  • Do not freeze.
  • Use within 4 hours after reconstitution when stored at room temperature. Store the reconstituted product in the vial.
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    Nominal Vial Size & Diluent Volume 500, 1000, 2000, or 3000 IU/4mL of histidine solution


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