|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.
|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|
|Shelf Life||3 months at room temperature|
|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
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