Country: Indonesia
Bahasa: Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
NONACOG ALFA
PFIZER INDONESIA - Indonesia
NONACOG ALFA
250 IU
SERBUK INJEKSI LIOFILISASI
DUS, 1 VIAL @ 250 IU + 1 PRE-FILLED SYRINGE @ 5 ML + 1 VIAL ADAPT...
WYETH FARMA, S.A. - Spain
2021-12-27
Generic Name: Nonacog alfa Trade Name: BeneFIX CDS Effective Date: December 22, 2017 Supersedes: NA Approved by BPOM: 2020-0066233 Page 1 of 17 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Nonacog alfa Trade Name: BeneFIX CDS Effective Date: December 22, 2017 Supersedes: NA 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 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE INGREDIENTS, ACTIVE MOIETIES Nonacog alfa (INN) (recombinant coagulation factor IX). PHYSICAL CHARACTERISTICS BeneFIX is formulated as a sterile, nonpyrogenic, lyophilized powder preparation. It is a clear, colorless solution after reconstitution. Each single-use vial contains nominally 250, 500, or 1000 international units (IU). 3. PHARMACEUTICAL FORM Powder for reconstitution and intravenous (IV) injection 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS BeneFIX is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE Treatment should be initiated under the supervision of a physician experienced in the treatment of hemophilia B. Treatment with all factor IX products, including BeneFIX, requires individualized dosage adjustment. The dosage and duration of treatment for all factor IX products depend on the severity of the factor IX deficiency, the location and extent of bleeding, and the patient's clinical condition. Dosing of BeneFIX may differ from that of plasma-derived factor IX products. To ensure that the desired factor IX activity level has been achieved, precise monitoring using the factor IX activity assay is advised, in particular for surgical interventions. In order to adjust the dose as appropriate, do Baca dokumen lengkap