Formula & Concentration
Coagulation Factor IX (Human)
Mononine® is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease.
Limitation of Use
Mononine® is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII.
Mononine® contains non-detectable levels of Factors II, VII and X (<0.0025 IU per Factor IX unit using stan- dard coagulation assays) and is, therefore, not indicated for replacement therapy of these clotting factors. Mononine® is also not indicated in the treatment or reversal of coumarin-induced anticoagulation or in a hemorrhagic state caused by hepatitis-induced lack of production of liver dependent coagulation factors.
Shelf Life and Storage
When stored at refrigerator temperature, 2-8°C (36-46°F), Mononine® is stable for the period indicated by the expiration date on its label. Within this period, Mononine® may be stored at room temperature not to exceed 25°C (77°F), for up to one month. Avoid freezing, which may damage container for the diluent.