Recombinate
| Product Specs | Description |
|---|---|
| Manufacturer Name | Takeda |
| Indications | RECOMBINATE is recombinant Factor VIII, a clotting factor that is deficient in people with hemophilia A. RECOMBINATE is used to help control bleeds when they occur and prevent future bleeds. |
| 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 | Contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including bovine, mouse or hamster proteins. |
| Stabilizer in Final Formulation | Albumin (Human), calcium, polyethylene glycol,sodium, histidine, polysorbate 80 |
| Viral Safety Process | Immunoaffinity chromatography |
| Product Half-Life | 14.6 ± 4.9 hours |
| Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) | 123.9 ± 47.7 |
| Storage Requirements/Shelf Life |
|
| Nominal Vial Size & Diluent Volume | 250, 500, 1000, 1500, and 2000 IU/5mL |