Product Name: Helixate FS

Formulation & Concentration: Antihemophilic Factor (Recombinant) Formulated with Sucrose

Manufacturer: CSL

Indications
For control and prevention of bleeding episodes in adults and children with Hemophilia A; peri-operative management in adults and children and routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with Hemophilia A with no pre-existing joint damage

Vial Size NDC # Size
250 IU 0053-8131-02 2.5ml
500 IU 0053-8132-02 2.5ml
1000 IU 0053-8133-02 5ml
2000 IU 0053-8134-02 5ml
3000 IU 0053-8135-02 5ml

Shelf Life
24 months under refrigeration

Storage
Store in refrigerator at 2-8°C (36-46°F) for period indicated by the expiration date on the label. Within this period, Helixate® FS may also be stored at room temperature, not to exceed 25°C (77°F), for up to 12 months, such as in home treatment situations. Do not freeze. Protect from extreme exposure to light and store the lyophilized powder in the carton prior to use.

Full Prescribing Information:
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