Formula & Concentration

Coagulation Factor IX (Human)

Manufacturer

Grifols

Indications

AlphaNine SD is indicated for the prevention and control of bleeding in patients with Factor IX deficiency due to hemophilia B. AlphaNine SD contains low, non-therapeutic levels of Factors II, VII, and X, and, therefore, is not indicated for the treatment of Factor II, VII or X deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.

Product Options

Package Size

NDC #

Presentation

500 IU

68516-3610-02

Vial

1000 IU

68516-3611-02

Vial

1500 IU

68516-3612-02

Vial

Shelf Life and Storage

Three years, up to the date printed on the label.

AlphaNine SD is stable for three years, up to the expiration date printed on its label, provided that the storage temperature is between 2 and 8 °C (36 and 46 °F). Do not freeze to prevent damage to diluent vial. May be stored at room temperature not to exceed 30 °C for 1 month. When removed from refrigeration, record the date removed on the space provided on the carton.