Profilnine

Product Specs	Profilnine
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	Stored at temperatures between 2°C-8°C (36°F-46°F) May be stored at room temperature not to exceed 30 °C for up to 3 months. Do not freeze.
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