Generic Name and Formulations:
Antihemophilic Factor VIII:C (human) 250 IU, 500IU, 1000 IU, 1500 IU; per vial; lyophilized concentrate for IV infusion after reconstitution; contains albumin.

Company:
CSL Behring, LLC
Indications for MONOCLATE-P:
Treatment and surgical prophylaxis for Hemophilia A.

Adults and Children:
Dosage Required (IU) = Body Weight (kg) × Desired % Factor VIII Increase × 0.5. Individualize. Infusion rate: 2mL/min if tolerated. Mild hemorrhages: single infusion to attain 30% FVIII increase. Moderate hemorrhage or minor surgery: initially 15–25 IU/kg, then 10–15 IU/kg every 8–12hrs if needed. Severe hemorrhage: initially 40–50 IU/kg, then 20–25 IU/kg every 8–12hrs. Major surgery: give first dose 1 hour pre-op to attain 80–100% FVIII increase, then give a ½ dose 5 hours after first dose; maintain daily at ≥30% FVIII increase for 10–14 days post-op.

Contraindications:
Mouse protein sensitivity.

Warnings/Precautions:
Not for von Willebrand's disease. Confirm Factor VIII deficiency prior to treatment. Contains human plasma; monitor for possible infection transmission. Large or frequent dosing: monitor hematocrit for signs of progressive anemia. Monitor for development of Factor VIII inhibitors. Pregnancy (Cat.C).

Pharmacological Class:
Clotting factor.

Adverse Reactions:
Allergic reactions, chills, GI upset, inj site reactions, antibody formation.

Note:
Report any infections suspected to be transmitted by Monoclate-P to (800) 504-5434.

How Supplied:
Single-dose vial—1 (w. diluent, supplies)