ALPHANINE SD FOR INJECTION 500 iu/vial

GRIFOLS ASIA PACIFIC PTE. LTD.

GRIFOLS ASIA PACIFIC PTE. LTD.

Therapeutic

Prescription Only

INJECTION, POWDER, FOR SOLUTION

**DOSAGE AND ADMINISTRATION** For adult usage: AlphaNine® SD should be administered intravenously promptly following reconstitution. Administration of AlphaNine® SD within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Discard any unused contents into the appropriate safety container. The amount of AlphaNine® SD required to establish hemostasis will vary with each patient and depend upon the circumstances. The following formula may be used as a guide in determining the number of units to be administered.16  In clinical practice there is variability between patients and their clinical response. Therefore, the Factor IX level of each patient should be monitored frequently during replacement therapy. **Treatment Guidelines for Hemorrhagic Events and Surgery in Patients Diagnosed with Hemophilia B**  Dosing requirements and frequency of dosing is calculated on the basis of an initial response of 1% FIX increase achieved per international units of FIX infused per kg body weight and an average half-life for FIX of 18 hours. If dosing studies have revealed that a particular patient exhibits a lower response, the dose should be adjusted accordingly. **For pediatric usage:** See PRECAUTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. * * * 16.Zauber, N.P. & Levine, J. Factor IX Levels in Patients with Hemophilia B (Christmas Disease) Following Transfusion with Concentrates of Factor IX or Fresh Frozen Plasma (FFP). _Medicine_ 56:213–224, 1977. 17\. Nilson, I.M. Hemorrhagic and Thrombotic Diseases: London, John Wiley and Sons, 1974. 18\. Roberts, H.R. and Eberst, M.E. Current Management of Hemophilia B. _Hematology/Oncology Clinics of North America_ 7(6): 1269–1280, 1993. 19\. Roberts, H.R. and Gray, T.F. Clinical Aspects of Hemophilia B. In Hematology: Basic Principles and Practice, 2nd: Edition, pp 1678–1685, Churchill Livingston. 20\. Hedner, U. and Davie, E.W. In “Hemostasis and Thrombosis: Basic Principles and Clinical Practice”, eds. Colman, R.W., Hirsh, J., Marder, V.J., Salzman, E.W., 2nd Edition, Philadelphia, J.B. Lippincot Co, 1987. 21\. Levin, P.H. In “Hemostasis and Thrombosis: Basic Principles and Clinical Practice”, eds. Colman, R.W., Hirsh, J., Marder, V.J., Salzman, E.W., 2nd Edition, Philadelphia, J.B., Lippincot Co, 1987.