Rx Item-Alphanine Sd 500 (+ ) Vial 10ml By ASD Healthcare

ALPHANINE SD coagulation factor ix (human)
Grifols Biologicals Inc.
DESCRIPTION
Coagulation Factor IX (Human), AlphaNine? SD, is purified, solvent detergent treated, virus filtered preparation of Factor IX derived from human plasma.1 It contains minimum of 150 IU Factor IX/mg protein; levels of Factor VII (proconvertin), Factor II (prothrombin) and Factor (Stuart-Prower Factor) which are below the limit of detection (less than 0.04 Factor VII unit, less than 0.05 Factor II unit, and less than 0.05 Factor unit per IU Factor IX). AlphaNine SD is sterile, lyophilized preparation intended for intravenous administration only. Each vial is single dose container.
CLINICAL PHARMACOLOGY
AlphaNine SD is purified formulation of Factor IX containing not less than 150 IU Factor IX activity/mg of total protein.2 AlphaNine SD contains non-therapeutic levels of Factor II, Factor VII and Factor X.
INDICATIONS AND USAGE
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 deficiencies. This product is also not indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia patients with inhibitors to Factor VIII
WARNINGS
Because Coagulation Factor IX (Human), AlphaNine SD is made from pooled human plasma, it may carry risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma to the application of viral elimination/reduction steps such as column chromatography, solvent detergent treatment and nanofiltration in the manufacturing process. Despite these measures, such product can potentially transmit disease, therefore the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient.
Pregnancy Category C

Rx Item-Alphanine Sd 500 (+ ) Vial 10ml
NDC No.68516-3601-02 UPC/GTIN No. MPN No. 36214 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA, Physical Thera

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FACTOR IX AL 5
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