Product Name: Monoclate P

Formulation & Concentration: Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified

Manufacturer: CSL

Indications
Treatment of classical hemophilia (hemophilia A).

Vial Size NDC # Size
250 IU 0053-7656-01 2.5ml
500 IU 0053-7656-02 5ml
1000 IU 0053-7656-04 10ml
1500 IU 0053-7656-05 10ml

Shelf Life
24 Months

Storage
“Store in refrigerator, 2-8°C (36-46°F) through expiration date on 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.”

Full Prescribing Information:
Mononine P Full Prescribing Information.