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ALPHANINE SD FOR INJECTION 1000 IU/VIAL [SIN08963P]

Active ingredients: ALPHANINE SD FOR INJECTION 1000 IU/VIAL

Last updated 26 October 2025

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Product Info
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
CONTRAINDICATIONS

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
INSTITUTO GRIFOLS, S.A. (MANUFACTURER FOR WFI) - SPAIN
ROVI PHARMA INDUSTRIAL SERVICES, S.A. (ALTERNATE MANUFACTURER FOR WFI) - SPAIN

Registration Number

SIN08963P

Licence Holder

GRIFOLS ASIA PACIFIC PTE. LTD.

Forensic Classification

PRESCRIPTION ONLY MEDICINES

Anatomical Therapeutic Chemical (ATC) code

B02BD04

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.

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

Alphanine SD Dosage Formula 1



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

Alphanine SD Dosage Table 1



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

None known.