Duac gel for external use

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

clindamycin (clindamycin phosphate), benzoyl peroxide

Dostępny od:

Glaxo Operations UK Limited

Kod ATC:

D10AF51

INN (International Nazwa):

clindamycin (clindamycin phosphate), benzoyl peroxide

Dawkowanie:

10mg/g+ 50mg/g

Forma farmaceutyczna:

gel for external use

Sztuk w opakowaniu:

15g aluminium tube

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2015-10-20

Charakterystyka produktu

Summary of Product
Characteristics
Updated 26-Jan-201S
I
Stiefel
I.
Name of the medicinal
product
I
g of gel contains:
DuacQl)
Once Daily 10 mg/g
+
50 mg/g Gel
2.
Qualitative and quantitative
composition
10 mg c\indamycin
as clindamycin
phosphate
50 mg anhydrous
benzoyl
peroxide
as hydrous
benzoyl
peroxide
For the fu 1\ list of excipients,
see section 6.1.
3.
Pharmaceutical
form
Gel
White to slightly yellow homogeneous
gel
4.
Clinical
particulars
4.1 Therapeutic
indications
Duac Once Daily Gel
is indicated for the topical
treatment
of mild to moderate
acne vulgaris,
particularly
inflammatory
lesions,
in adults
and adolescents
aged 12 years and above (see
sections 4.41and 5.1).
Consideration
should be given to official
guidance on the appropriate
use of antibacterial
agents.
4.2 Posology and method of administration
For cutaneous
use only.
Posology
_Adults_
_and Adolescents_
_(aged_
12
_years and above)_
Duac Once Daily Gel
should be applied once daily in the evening,
to the entire affected area.
Patients
should be advised that
excessive
application will
not
im-6fove-effrcacy,
but-may increase
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the risk of skin irritation.
If excessive
dryness
or peeling occurseJrfn uen~
J
M-
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be reduced or application
temporarily
interrupted (see section;4;:~)",
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An effect
on inflammatory
and non-inflammatory
lesions may be seen as early as week 2-5 of
treatment
(see section 5.1).
The safety and efficacy of Duac Once Daily Gel
has not been studied beyond
12
weeks in acne
vulgaris clinical
trials.
Treatment
with Duac Once Daily Gel
should not
exceed more than
12
weeks of continuous
use.
_Paediatric_
_population_
The safety and efficacy ofDuac
Once Daily Gel
has not
been established
in children under
12
years of age,
therefore
Duac Once Daily Gel
is not
recommended
for use in this p