Profilnine
| Product Specs | Description |
|---|---|
| Manufacturer Name | Grifols |
| Indications | Profilnine, Factor IX Complex, is indicated for the prevention and control of bleeding in patients with factor IX deficiency (hemophilia B). Profilnine contains non-therapeutic levels of factor VII and is not indicated for use in the treatment of factor VII deficiency. |
| Contraindications | None known. |
| Viral Safety Process | DEAE chromatography and nanofiltration; solvent/detergent treatment with a mixture of Tri (n-butyl) phosphate (TNBP) and Polysorbate 80 |
| Product Half-Life | 24.68 ± 8.29 hours |
| Product Recovery Percentage | 1.15 ± 0.16 IU/dL per IU infused per kg body weight |
| Manufacturing Method | Plasma Derived |
| Storage Requirements/Shelf Life |
|
| Nominal Vial Size & Diluent Volume | 500 IU FIX/5 mL single dose vial 1000 IU FIX/10 mL single dose vial 1500 IU FIX/10 mL single dose vial |