Jivi



Jivi

Product Specs Jivi
Manufacturer Name Bayer
Indications JIVI is a recombinant DNA derived, Factor VIII 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 (>12yrs of age)

Perioperative Management

 Yes (>12yrs of age)

Routine Prophylaxis to Prevent or Reduce the Frequency of Bleeding Episodes

 Yes (>12yrs of age)
Contraindications Nutrient in Cell Culture Do not use in patients who have a history of hypersensitivity reactions to the active substance, polyethylene glycol (PEG), mouse or hamster proteins, or other constituents of the product.
Stabilizer in Final Formulation Glycine, sucrose, histidine, sodium chloride, calcium chloride, polysorbate 80
Viral Safety Process Chromatography, 20 nm viral filtration
Product Half-Life Terminal* half-life is 18.6 ± 4.6 hours
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) The incremental recovery using a chromogenic assay following a 60 IU/kg dose is 2.53 ± 0.43
Storage Requirements
  • Refrigerated at 2°C to 8°C (36°F to 46°F) for up to 24 months or at room temperature, for up to 6 months, up to 25°C (77°F).
  • Do not freeze.
  • Use within 3 hours of reconstitution.
    		•
    Shelf Life 24 months from manufactured date 6 months at room temperature
    Nominal Vial Size & Diluent Volume 500, 1000, 2000, or 3000 IU/2.5 mL

    *Note: Terminal half-life is the time required to divide the plasma concentration by two after reaching pseudo-equilibrium, and not the time required to eliminate half the administered dose. (Toutain PL, et al. J Vet Pharmacoll Ther. 2004.)


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