| Product Specs | Description |
|---|---|
| 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/Shelf Life |
|
| Nominal Vial Size & Diluent Volume | 250 IU/5 mL 500 IU/5 mL 1000 IU/10 mL |
