Kovaltry



Kovaltry

Product Specs Kovaltry
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
  • Refrigerated at 2°C to 8°C (36°F to 46°F), or room temperature up to 25°C or 77°F.
    		•
    Shelf Life 30 months from manufactured date 12 months at room temperature
    Nominal Vial Size & Diluent Volume 250, 500, 1000 IU/2.5 mL
    2000, 3000 IU/5 mL


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