Xyntha
Xyntha
| Product Specs | Xyntha |
|---|---|
| Manufacturer Name | Pfizer |
| Indications | XYNTHA® Antihemophilic Factor (Recombinant) is an injectable medicine that is used to help control and prevent bleeding in people with hemophilia A. |
| 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 manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including hamster proteins. |
| Stabilizer in Final Formulation | Sucrose |
| Viral Safety Process | Chromatography, affinity chromatography; solvent/detergent nanofiltration |
| Product Half-Life | Initial Visit (n=30): 11.2 ± 5.0 hours Month 6 (n=25): 11.8 ± 6.2 hours Pre-surgery (n=8): 16.7 ± 5.4 hours |
| Product Recovery Percentage Mean incremental recovery IR (IU/dL per IU/kg) | Initial Visit (n=30): 2.15 ± 0.44 Month 6 (n=25): 2.47 ± 0.84 Pre-surgery (n=8): 2.17 ± 0.47 |
| Storage Requirements |
|
| Shelf Life | 36 months from manufactured date 3 months at room temperature |
| Nominal Vial Size & Diluent Volume | 250, 500, 1000, 2000 IU/4 mL |
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