- Approval Id
- a52870ba171a5970
- Drug Name
- ALPHANINE SD FOR INJECTION 1500 IU/VIAL
- Product Name
- ALPHANINE SD FOR INJECTION 1500 IU/VIAL
- Approval Number
- SIN08962P
- Approval Date
- 1996-10-07
- Registrant
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Licence Holder
- GRIFOLS ASIA PACIFIC PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong></p>
<p>For adult usage:<br>
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.<br>
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.<sup>16</sup></p>
<img src="/TGIF/AlphanineSD-Formula1.png" alt="Alphanine SD Dosage Formula 1" /><br><br>
<p>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.<br>
<strong>Treatment Guidelines for Hemorrhagic Events and Surgery in Patients Diagnosed with Hemophilia B</strong></p>
<img src="/TGIF/AlphanineSD-Table1.png" alt="Alphanine SD Dosage Table 1" /><br><br>
<p>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.<br>
<strong>For pediatric usage:</strong> See PRECAUTIONS – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<hr>
<p>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). <em>Medicine</em> 56:213–224, 1977.<br>
17. Nilson, I.M. Hemorrhagic and Thrombotic Diseases: London, John Wiley and Sons, 1974.<br>
18. Roberts, H.R. and Eberst, M.E. Current Management of Hemophilia B. <em>Hematology/Oncology Clinics of North America</em> 7(6): 1269–1280, 1993.<br>
19. Roberts, H.R. and Gray, T.F. Clinical Aspects of Hemophilia B. In Hematology: Basic Principles and Practice, 2<sub>nd</sub>: Edition, pp 1678–1685, Churchill Livingston.<br>
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., 2<sub>nd</sub> Edition, Philadelphia, J.B. Lippincot Co, 1987.<br>
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., 2<sub>nd</sub> Edition, Philadelphia, J.B., Lippincot Co, 1987.
</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong></p>
<p>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 <em>not</em> indicated for the treatment of Factor II, VII or X deficiencies. This product is also <em>not</em> indicated for the reversal of coumarin anticoagulant-induced hemorrhage, nor in the treatment of hemophilia A patients with inhibitors to Factor VIII.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>None known.</p>
- Atc Code
- B02BD04
- Atc Item Name
- coagulation factor IX
- Pharma Manufacturer Name
- GRIFOLS ASIA PACIFIC PTE. LTD.
