DIFLUCAN

Valsts: Indonēzija

Valoda: indonēziešu

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

Aktīvā sastāvdaļa:

FLUCONAZOLE

Pieejams no:

PFIZER INDONESIA - Indonesia

SNN (starptautisko nepatentēto nosaukumu):

FLUCONAZOLE

Deva:

2.00 MG/ML

Zāļu forma:

INJEKSI

Vienības iepakojumā:

DUS, VIAL @ 100 ML

Ražojis:

FAREVA AMBOISE - France

Autorizācija datums:

2021-09-21

Produkta apraksts

Generic Name: Fluconazole
Trade Name: Diflucan
CDS Effective Date: January 15, 2021
Supersedes: April 16, 2020
Approved by BPOM:
2020-0061279, 2020-0066398
Page 1 of 18
PT. PFIZER INDONESIA
LOCAL PRODUCT DOCUMENT
Generic Name: Fluconazole
Trade Name: Diflucan
CDS Effective Date: January 15, 2021
Supersedes: April 16, 2020
DESCRIPTION
Fluconazole is a bis-triazole: 2-(2,4-difluorophenyl)-1,3-bis
(1H-1,2,4-triazol-1yl)-2 propanol.
It has the following structural formula:
Fluconazole is a white to off-white crystalline powder which is
sparingly soluble in water and saline. It has
a molecular weight of 306.3.
Diflucan capsules contain 50 mg and 150 mg of fluconazole and the
following inactive ingredients: hard
gelatin capsules (which may contain Blue 5 and other inert
ingredients), lactose, corn starch, silicon
dioxide, magnesium stearate and sodium lauryl sulfate.
Diflucan for injection is an iso-osmotic, sterile, non-pyrogenic
solution of fluconazole in a sodium chloride
diluent. Each ml contains 2 mg of fluconazole and 9 mg of sodium
chloride. The pH ranges from 4.0 to 8.6.
Injection volumes of 100 ml are packaged in glass infusion vials.
N
N
N
N
N
N
CH
2
CH
2
C
F
F
OH
DISETUJUI OLEH BPOM: 02/09/2021
ID: EREG10024112100167-169
EREG10024112100361
Generic Name: Fluconazole
Trade Name: Diflucan
CDS Effective Date: January 15, 2021
Supersedes: April 16, 2020
Approved by BPOM:
2020-0061279, 2020-0066398
Page 2 of 18
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Antimycotics for systemic use, triazole
derivatives, ATC code J02AC01.
Mode of Action
Fluconazole, a triazole antifungal agent, is a potent and specific
inhibitor of fungal sterol synthesis.
Its primary mode of action is the inhibition of fungal cytochrome
P-450-mediated 14-alpha-lanosterol
demethylation, an essential step in fungal ergosterol biosynthesis.
The accumulation of 14-alpha-methyl
sterols
correlates
with
the
subsequent
loss
of
ergosterol
in
the
fungal
cell
membrane
and
may
be
responsible for the antifungal activity