BENEFIX

البلد: أندونيسيا

اللغة: الإندونيسية

المصدر: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

العنصر النشط:

NONACOG ALFA

متاح من:

PFIZER INDONESIA - Indonesia

INN (الاسم الدولي):

NONACOG ALFA

جرعة:

250 IU

الشكل الصيدلاني:

SERBUK INJEKSI LIOFILISASI

الوحدات في الحزمة:

DUS, 1 VIAL @ 250 IU + 1 PRE-FILLED SYRINGE @ 5 ML + 1 VIAL ADAPT...

المصنعة من قبل:

WYETH FARMA, S.A. - Spain

تاريخ الترخيص:

2021-12-27

خصائص المنتج

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