ALPHANINE SD FOR INJECTION 1000 IU/VIAL [SIN08963P]
Active ingredients: FACTOR IX (HUMAN)
Last updated on 9 October 2026
Product Info
ALPHANINE SD FOR INJECTION 1000 IU/VIAL
[SIN08963P]
Product information
Active Ingredient and Strength | FACTOR IX (HUMAN) - 1,000 INTERNATIONAL UNITS PER 10 ML VIAL |
Dosage Form | INJECTION, POWDER, FOR SOLUTION |
Manufacturer and Country | GRIFOLS BIOLOGICALS LLC. - UNITED STATES |
Registration Number | SIN08963P |
Licence Holder | GRIFOLS ASIA PACIFIC PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B02BD04 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
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 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.
Dosing
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.
Contraindications
CONTRAINDICATIONS
None known.