Koate

Product Specs	Koate
Manufacturer Name	Kedrion
Indications	Indicated for the control and prevention of bleeding episodes or in order to perform emergency and elective surgery in patients with hemophilia A (hereditary Factor VIII deficiency).
Contraindications	Do not use in patients who have known hypersensitivity reactions, including anaphylaxis, to KOĀTE or its components.
Ratio of VWF: RCO to FVIII	1:1
Viral Safety Process	Solvent/detergent, TNBP/polysorbate 80 treatment and dry heat treatment (80°C heat, 72 hours)
Product Half-Life	Mean: 16.12 (Koate-HP 16.13) hours
Product Recovery Percentage	1.90% IU/kg (Koate-HP 1.82% IU/kg) 10 minutes postinfusion
Manufacturing Methods	Pooled fresh-frozen human plasma
Storage Requirements	Refrigerated at 2°C-8°C (36°F-46°F), or room temperature (up to 25°C or 77°F). Do not freeze.
Shelf Life	6 months from manufactured date
Nominal Vial Size & Diluent Volume	250 IU/5 mL 500 IU/5 mL 1000 IU/10 mL