Lomexin cream for vaginal and external use

देश: आर्मेनिया

भाषा: अंग्रेज़ी

स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

सक्रिय संघटक:

fenticonazole (fenticonazole nitrate)

थमां उपलब्ध:

Recordati Industria Chimica e Farmaceutica S.p.A.

ए.टी.सी कोड:

G01AC12, D01AF12

INN (इंटरनेशनल नाम):

fenticonazole (fenticonazole nitrate)

डोज़:

20mg/g

फार्मास्यूटिकल फॉर्म:

cream for vaginal and external use

पैकेज में यूनिट:

30g aluminium tube, 78g aluminium tube and dispenser

प्रिस्क्रिप्शन प्रकार:

Prescription

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2016-04-02

सूचना पत्रक

MINISTRY
OF
HEALTI.I
OF
THE
RUSSIAN
TEDERATION
PATTENT
INFORMATION
LEAFI"ET
cln
the
drug
for
nedicai
use
LOMEXIN@
i
Registration
number:
Trade
nams
of
the
drug:
Lomexin
INN:
Fenticonazole
Chemical
n&me!
1-[(2RS)-2-(2,4-dic]rlorophenyl)-2-[[4-(phenylsulfanyl)
berizyl]
oxyl
ethyll-1H-
inridazole
nitrate
Dosnge
form:
cream
for
vaginal
and
external
use
Composition per
100
g
of
the
cream
Active
subslance'.
Fentieonazole
nitate
2.00
g
Excipients:
Water
60.50
g
Glyceryl
monostearate
.....................,......
3,
00
g
Disodium
edetate
0"50
g
Fatty
acids
and
macrogol
ether
15.00
g
Hydrogenated
lanolin
1.00
g
Ahnoncloil
.............
10.00
g
Propylene
glycol
5.00
g
Cetyl
alcohol
..............
..........3.00
g
Description
White
honrogeueous
crearn.
Fharmacother:l
peutic
group
Anti{ungal
agerit
/;P
,"
q
",{/''r{eyy
irgr
rr
i
(A.*OJ./f
ATC
code:
G01AFl2.
D01AC12
Fh
nrmacological
properf
ies
Pharmacodynamics
Lome'rin
is
an
antiftlngal
cirug
of
broad
spectrum
of
action
for
externa]
and
topical
admi*istration.
Fenticonazole
(active
substance
of
Lomexin)
is
a
synthetic
derivative
of
imidazole
(its
racernic
ntixture
in
the
fo|m
of
nifrate
sait
of fbnticonazole),
it
provides
local
fungicidal
and
fiurgistatic
action'
[t
also
has
an
antibacteriai
effect,
The
rnechanism
of action
is
inhibirion
of
t]re
synthesis
of
etgosterol
which
regulates
the
Permeability
of
cell
niembrane
of
fungi,
It
is
active
against
dcrrrratophyles'fr|'allaryhytorz
sp2t.,
MicrosporLtnz
spp..
Epidet'ntoplzyton
spp..
pit.vrtssporr{il.t
ttrbicttlare
and
P
rsvole,
yeast
lungi
Cctndida
Eryr.
(includ
ing
Canclicla
albiccuts')ar-icl
Gram-positive
bacteria
(staphllococcus
aureus,
streptor:oc€t,ts
spp.),
as
wellas
against
Tiichomoncts
vaginali,s.
Unlike
other
knou"rr
azole
compounds
(in
particular,
econaz'ole,
miconazole.
ancl
ketoconazoie),
lbnticonazole
inhibits
biosynthesi
s
of
Cctnc{idct.spp.
proteases
in
concentrations
less
tSan
tlrc
nrinimltnt
inhibitory
concentration
-
from
0.25
to
16
ptg
linl,
Tliis
action
is
independe't
of
tlre
mtifiingalactivity
and
due
to

उत्पाद विशेषताएं

RECORDATI Industria Chimica e Farmaceutica S.p.A.
1
Summary of Product Characteristic
Dermatological Fenticonazole – January 2015
SAMMARY OF PRODUCTS CHARACTERISTICS
DERMATOLOGICAL FENTICONAZOLE
1.
TRADE NAME OF THE MEDICINAL PRODUCT
LOMEXIN 2% CREAM
LOMEXIN 2% GEL
LOMEXIN 2% CUTANEOUS SOLUTION,
LOMEXIN 2% CUTANEOUS SPRAY, SOLUTION
LOMEXIN 2% CUTANEOUS POWDER
LOMEXIN 2% SHAMPOO
LOMEXIN 2% CUTANEOUS FOAM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_2% CREAM: _
100 g of cream contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_2% GEL: _
100 g of gel contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_2% CUTANEOUS SOLUTION: _
100 g of solution contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_ _
_2% CUTANEOUS SPRAY, SOLUTION: _
100 g of solution contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_2% CUTANEOUS POWDER: _
100 g of powder contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_2% SHAMPOO: _
100 g of solution contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
_2% CUTANEOUS FOAM: _
RECORDATI Industria Chimica e Farmaceutica S.p.A.
2
Summary of Product Characteristic
Dermatological Fenticonazole – January 2015
100 g of solution contain:
_Active ingredient: _
Fenticonazole nitrate 2 g (equal to 1.757 g Fenticonazole)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
Gel
Cutaneous solution
Cutaneous spray, solution
Cutaneous powder
Shampoo
Cutaneous foam
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Dermatomycoses from dermatophytes (_Tricophyton, Microsporum,
Epidermophyton_) in different
locations: tinea capitis, tinea corporis, tinea cruris, tinea pedis
(athletes foot), tinea manuum,
tinea faciei, tinea barbae, tinea unguium.
-
Skin candidiasis (intertrigo, perleche, facial candidiasis,
“diaper” candidiasis, perineal and scrotal
ca