Fluconazole-Inta 150mg capsules

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

fluconazole

Available from:

Incepta Pharmaceuticals Limited

ATC code:

J02AC01

INN (International Name):

fluconazole

Dosage:

150mg

Pharmaceutical form:

capsules

Units in package:

(10/1x10/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-04-22

Summary of Product characteristics

а{"
The
ýчшmеrу
of
the
рrоduсt
characteristics
(Appendix
1,9)
1.
Nаше
of
the
drug
2.
Qualitative
composition
3.
Quantitative
composition
:
Each
Capsule
Fluconazole-INTA
50
contains:
Active
ingredient:
Fluconazole
50mg
Еасh
Capsule
Fluconazole-INTA
150
contains:
Active
ingredient:
Fluconazole
150ш9
Fоr
list
of
excipients,
pleise
see
section
7,1,
:
Flцconazole-Inta
50
Fluconazole-Inta
150
ýPECIFICATION
ITEM
DESCRIPTION
Active
I
ВР-2003,
Vol-l,
Page,389-392
ВР-2003,
Vol-l,
Р
age,541
-548
ВР-
2003,
Vо1-2,
Page-1704-1705
USNF-22,
Page,2928
Colloidal
Silicon
Dioxide
ВР-2003,
v
o1-2,
Page-
l
|'l
3,1
4
Hard
Gelatin
Capsule
Sheý,#3,
4.
Dosage
fоrm
:
Ншd
Gelatin
Capsule
'.4+{qt
{rпэр.ri€
INCEPTA
PHARMACEUTICALS
LTD.
DHAKA,
BANGLADESH
5.
Clinical
characteristics
:
5.1
Indications
:
Fluconazole
is indicated
for
the
treatment
of:
1.
Vaginal
Candidiasis
(vaginal
yeast
infections
due to
Candida).
2.
Oropharyngeal
and esophageal
candidiasis.
In open
noncomparative
studies
of
relatively
small
numbers
of
patients,
fluconazole
was also
effective
for
the
treatment
of
Candida
urinary'tract
infections,
peritonitis,
and
systemic
Candida
infections
including
candidemia,
disseminated
candidiasis,
and
pneumonia.
3.
Cryptococcal
meningitis. Before
prescribing
fluconazole
fоr
AIDS
patients
with
cryptococcal
meningitis,
please
see
CLINICAL
STUDIES.
Stцdies
comparing
fluconazole to
amphotericin
В
in
поп-НIV
infected
patients
have
not
been
conducted.
,.,
Prophylaxis., Fluconazole
is
also
indicated
to
decrease
the incidence
of
candidiasis
in
patients
undergoing Ьопе
wmаrrоw transplantation who receive
cytotoxic
chemotherapy
and/or
radiation
therapy.
Specimens
fоr
fungal
culture
and
other
relevant laboratory studies
(serology,
histopathology)
should
Ье
obtained
рriоr
to
thеrару
to
isolate and
identify
causative
organisms.
Тhеrару
may Ье
instituted Ьеfоrе
the results
of
the
cultures
and
other
lаЬоrаtоrу
studies are
known;
however,
once
these
results Ьесоmе
available