AlphanineSD
AlphaNine SD
| Product Specs | AlphaNine SD |
|---|---|
| Manufacturer Name | Grifols |
| Indications | The prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, nontherapeutic levels of Factors II, VII and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII. |
| Contraindications | None known. |
| Viral Safety Process | DEAE chromatography, dual affinity chromatography and nanofiltration; screening of plasma donors, column chromatography, solvent/detergent treatment |
| Product Half-Life | 21 hours |
| Product Recovery Percentage | 48-51% |
| Manufacturing Method | The ability of the manufacturing process to inactivate and eliminate virus from the Coagulation Factor IX (Human) products was evaluated at key stages in the process. The ability of the AlphaNine SD process to eliminate virus, by physically partitioning virus from product, was evaluated at key stages of the manufacturing process. The studies mentioned above indicate that the manufacturing process of AlphaNine SD is capable of reducing viruses by approximately 6 logs, in addition to virus reduction achieved by the solvent detergent process. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as column chromatography, solvent/ detergent treatment and nanofiltration in the manufacturing process. |
| Storage Requirements/Shelf Life |
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| Nominal Vial Size & Diluent Volume | 500 IU FIX/10 mL single dose vial 1000 IU FIX/10 mL single dose vial 1500 IU FIX/10 mL single dose vial |
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