Mononine®

Manufacturer: CSL Behring
Generic Name: Coagulation Factor IX (Human) - Monoclonal

Indications: Mononine®, is indicated for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas Disease.

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 standard 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.

Mononine® Product Inserts

How Supplied: Factor products are supplied in vials sizes of varying International Units (iu). Vial sizes (iu sizes) may change with each new lot of product manufactured. Vial sizes may range from approximately 200 - 1500 iu per vial.

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