Formula & Concentration

Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified.

Manufacturer

CSL Behring

Indications

Monoclate-P® is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately- dosed pre-surgical IV bolus of Monoclate-P® followed by intermittent maintenance doses (see DOSAGE AND ADMINISTRATION).

Monoclate-P® is not effective in controlling the bleeding of patients with von Willebrand’s disease.

Product Options

Package Size

NDC #

Presentation

1000 IU

00053-7633-02

Vial

1500 IU

00053-7634-02

Vial

Shelf Life and Storage

24 Months

When stored at refrigerator temperature, 2-8°C (36-46°F), Monoclate-P® is stable for the period indicated by the expiration date on its label. Within this period, Monoclate-P® may be stored at room temperature not to exceed 25°C (77°F), for up to 6 months. Avoid freezing which may damage container for the diluent.