Kovaltry

Product Specs	Description
Manufacturer Name	Bayer
Indications
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 history of hypersensitivity reactions to the active substance, mouse or hamster protein, or other constituents of the product.
Stabilizer in Final Formulation	Glycine, sucrose, sodium chloride, calcium chloride, histidine, polysorbate 80
Viral Safety Process	20 nm filtration, detergent treatment
Product Half-Life	Half-life (± SD) in hours >18yrs: 14.3 ± 3.7 12-17yrs: 11.7 ± 1.11 6-12yrs: 12.0 ± 2.1 0-6yrs: 12.1 ± 2.7
Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg)	2
Storage Requirements/Shelf Life	Store at +2°C to +8°C (36°F to 46°F) for up to 30 months from the date of manufacture. Do not freeze. May be stored for a single period of up to 12 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 12 months, or after the expiration date on the product. 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 not, store at room temperature for no longer than 3 hours. Do not use if the reconstituted solution is cloudy or has particulate matter.
Nominal Vial Size & Diluent Volume	250, 500, 1000 IU/2.5 mL 2000, 3000 IU/5 mL