Travogen cream for external use

Country: Armenia

Bahasa: Inggeris

Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ciri produk Ciri produk (SPC)
11-09-2015

Bahan aktif:

isoconazole (isoconazole nitrate)

Boleh didapati daripada:

Bayer Healthcare Manufacturing S.r.l.

Kod ATC:

D01AC05

INN (Nama Antarabangsa):

isoconazole (isoconazole nitrate)

Dos:

10mg/g

Borang farmaseutikal:

cream for external use

Unit dalam pakej:

20g aluminium tube

Jenis preskripsi:

Prescription

Status kebenaran:

Registered

Tarikh kebenaran:

2015-09-04

Ciri produk

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Summary
of
Product
Characteristics
Travogen
cream
Isoconazole
nitrate
TABLE
OF
CONTEN'TS
t.
I
NAME
oF
THE
MEDICINAL
PRODUCT
""""""""""""""""""""""
"""""""
4
OUALITATIVE
AND
QUANTITATIVE
COMPOSITION
IN
TERMS
OF
inr
lcrtvB
suBSTANCE(s)"
""""""'
4
3.
PHARMACEUTICAL
FORM
4.
CLINICALPARTICULARS
4
4,4
Special
warnings
aDd
precautions
for
usc"""""""'
"""
""""'
4
4.5
Interaction
with
other
mediciral
Products
and
other
forms
of
intercction
""""'
5
4.6
Pregnancy
and
lactation""""'
{
4.t
Indication(s)
""""
L
4.2
l)osage
and
method
of
administration
"""""""""'
4,3
Contraindications
4,9
Overdose
5
4,6.1
Pregnancy
'
4.6.2
Lactation.'.
"""""""""
5
4.1
Effects
on
sbility
to
drive
or
use
machines"""""""""""""""""""""""""""""""
5
4.8
Undesirable
eflects""""""""""
"""""""""
5
5
5.
PHARMACOLOGICA1',
PROPERTIES"""""""
"""""""""'
5
5.1
Pharmacodynamic
propertles""""""
'
"
"
""""""""
"""""""'
5
5.2
Pharmacokinetic
properties"""'
""""""""
5
5.3
Pl'eclinical
safety
data
""""""""""""'
"""""""""""
""""""""
6
6.
PHARMACEUTICAL
PAIITICULARS
""""""""'
""""
""'6
6.1
6.2
6.3
6.4
o.:t
6,6
1
Nature
and
contents
of
container
Instructions
for
use
/
handling
OWNER
OF
TEE
PRODUCT
..........6
:
I.
NAME
OF TTIE
MEDICINAL
PRODUCT
Travogen
2.
QUALITATIVE
AND
QUANTITATryE
COMPOSITION
IN
TERMS OF THE
ACTIVE
SUBSTANCE(S)
I
g
Travogen
cream
contains
l0
mg
(l%)
isoconazole nitrate.
For
a
full
list
ofexcipients,
see
section
6.1.
3,
PHARMACEUTICAL
FORM
Cream
1olo
CLINICAL
PARTICULARS
4,1
Indications
Superficial fungal infections
ofthe
skin:
-
ringworm
of
the
body
including
interdigital
spaces and
genital
regions localization,
-
skin
candidamycosis,
-
pityriasis
versicolor,
and
.
erythnsma.
4.2
Dosage
and
method
of administration
Thin layer
ofTravogen
cream should be applied once
a
day
topically
to
the diseased
areas
of
skin and
rubbed
in
gently.
Usual
length
oftreahnent
is
2
to
3
weeks
(up
to
4
weeks
in
case
of
interdigital
spaces
mycosis).
Longer
periods
of
trcatment
are
also
possible.
To
avoid
recuuence,
treatment should
be
contirued

                                
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