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
  • Refrigerate at 36°F to 46°F (2°C to 8°C) up to 24 months or at room temperature (up to 86°F (30°C)), for up to 6 months.
  • Do not freeze.
  • Use within 4 hours of reconstitution if at room temperature.
    		•
    Shelf Life 24 months from manufactured date 6 months if stored at room temperature up to 86°F (30°C)
    Nominal Vial Size & Diluent Volume 500, 1000, 2000, or 3000 IU/4mL of histidine solution


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