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/Shelf Life	Store at +2°C to +8°C (36°F to 46°F) for up to 24 months from the date of manufacture. Do not freeze. May be stored for a single period of up to 6 months at temperatures up to +25°C or 77°F. Once stored at room temperature, do not return the product to the refrigerator. The shelf life then expires after storage at room temperature for 6 months, or after the expiration date on the product vial. Do not use after the expiration date indicated on the vial. Protect from extreme exposure to light and store the vial with the lyophilized powder in the carton prior to use. After Reconstitution, administer as soon as possible. If you do not administer the reconstituted immediately, then store at room temperature for no longer than 3 hours. Do not use Jivi if the reconstituted solution is cloudy or has particulate matter.
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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