Country: Singapor
Lingwa: Ingliż
Sors: HSA (Health Sciences Authority)
Nonacog Alfa
PFIZER PRIVATE LIMITED
B02BD04
2000IU/vial(550IU/mL)
INJECTION, POWDER, FOR SOLUTION
Nonacog Alfa 2000IU/vial(550IU/mL)
INTRAVENOUS
Prescription Only
(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG
ACTIVE
2010-05-20
1. NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection. BeneFIX 500 IU powder and solvent for solution for injection. BeneFIX 1000 IU powder and solvent for solution for injection. BeneFIX 2000 IU powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 200 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 400 IU nonacog alfa. Excipients: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM White/ almost white powder and clear and colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4. Aqra d-dokument sħiħ
1. NAME OF THE MEDICINAL PRODUCT BeneFIX 250 IU powder and solvent for solution for injection. BeneFIX 500 IU powder and solvent for solution for injection. BeneFIX 1000 IU powder and solvent for solution for injection. BeneFIX 2000 IU powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BeneFIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 50 IU nonacog alfa. BeneFIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 100 IU nonacog alfa. BeneFIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 200 IU nonacog alfa. BeneFIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog alfa (recombinant coagulation factor IX). After reconstitution with the accompanying 5 ml (0.234%) sodium chloride solution for injection, each ml of the solution contains approximately 400 IU nonacog alfa. EXCIPIENTS: For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM White/almost white powder and clear and colorless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Treatment should be initiated under the supervision of a physician experienced Aqra d-dokument sħiħ