VFEND

Land: Indonesien

Sprog: indonesisk

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

Aktiv bestanddel:

VORICONAZOLE

Tilgængelig fra:

PFIZER INDONESIA - Indonesia

INN (International Name):

VORICONAZOLE

Dosering:

200 MG

Lægemiddelform:

SERBUK INJEKSI

Enheder i pakken:

DUS, 1 VIAL @ 200 MG

Fremstillet af:

FAREVA AMBOISE - France

Autorisation dato:

2019-06-12

Produktets egenskaber

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