Država: Indonezija
Jezik: indonezijščina
Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
VORICONAZOLE
PFIZER INDONESIA - Indonesia
VORICONAZOLE
200 MG
SERBUK INJEKSI
DUS, 1 VIAL @ 200 MG
FAREVA AMBOISE - France
2019-06-12
Generic Name: Voriconazole Trade Name: VFEND ® CDS Effective Date: March 23, 2021 Supersedes: July 14, 2020 Approved by BPOM: 2021-0067528, 2020-0065736, 2020-0065737 Page 1 of 46 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Voriconazole Trade Name: VFEND ® CDS Effective Date: March 23, 2021 Supersedes: July 14, 2020 DESCRIPTION VFEND ® (voriconazole), a triazole antifungal agent, is available as film-coated tablets for oral administration, and as a lyophilized powder for solution for intravenous infusion. The structural formula is: VFEND is designated chemically as (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoro-4- pyrimidinyl)-1-(1_H_-1,2,4-triazol-1-yl)-2-butanol with an empirical formula of C 16 H 14 F 3 N 5 O and a molecular weight of 349.3. VFEND drug substance is a white to light-colored powder. VFEND Tablets contain 200 mg of voriconazole. The inactive ingredients include lactose monohydrate, pre-gelatinized starch, croscarmellose sodium, povidone, magnesium stearate and a coating containing hydroxypropyl methylcellulose, titanium dioxide, lactose monohydrate and triacetin. VFEND I.V. is a white lyophilized powder containing nominally 200 mg voriconazole and 3200 mg sulfobutyl ether beta-cyclodextrin sodium in a 30 mL Type I clear glass vial._ _ VFEND I.V. is intended for administration by intravenous infusion. It is a single dose, unpreserved product. Vials containing 200 mg lyophilized VFEND are intended for reconstitution with Water for Injection to produce a solution containing 10 mg/mL VFEND and 160 mg/mL of sulfobutyl ether beta-cyclodextrin sodium. The resultant solution is further diluted prior to administration as an intravenous infusion (see Section DOSAGE AND ADMINISTRATION). F F CH 3 N N F OH N N N DISETUJUI OLEH BPOM: 31/01/2022 ID: EREG10024112100372 EREG10024112100373 Generic Name: Voriconazole Trade Name: VFEND ® CDS Effective Date: March 23, 2021 Supersedes: July 14, 2020 Approved by BPOM: 2021-0067528, 2020-0065736, 2020-0065737 Page 2 of 46 CLINICAL PHARMACOLOGY PHARMACOKINE Preberite celoten dokument