Skinoren cream for external use

국가: 아르메니아

언어: 영어

출처: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Download 제품 특성 요약 (SPC)
23-10-2018

유효 성분:

azelaic acid

제공처:

Bayer Healthcare Manufacturing S.r.l.

ATC 코드:

D10AX03

INN (International Name):

azelaic acid

복용량:

200mg/g

약제 형태:

cream for external use

패키지 단위:

30g aluminium tube

처방전 유형:

OTC

승인 상태:

Registered

승인 날짜:

2018-10-23

제품 특성 요약

                                Page 1 of 5
Summary of Product Characteristics
Skinoren cream
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Skinoren
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g Skinoren cream contains 200 mg (20%) azelaic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acne (acne vulgaris) in its various expressions,
characterised by the
presence of comedones, papules, pustules and small nodules.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Skinoren cream should be applied twice daily (morning and evening) to
the affected
skin areas and rubbed carefully into the skin. Approximately 2.5 cm of
cream is
sufficient for the entire facial area.
Method of administration
For cutaneous use
Before Skinoren cream is used, the skin must be carefully cleaned with
clear water and
dried. A mild skin cleanser can be used.
It is important to apply Skinoren cream regularly throughout the
entire treatment period.
For Skinoren cream, the duration of administration can vary
individually and is also
determined by the severity of the acne. A significant improvement in
the clinical picture
can generally be noted after about 4 weeks. To achieve optimum
results, Skinoren cream
should be used continuously over several months, if required. Clinical
experience has
been obtained with a continuous administration period of up to one
year.
Should
it
be
necessary,
due
to
pronounced
skin
irritation
(see
section 4.8
Undesirable effects), to reduce the amount of cream per application,
the frequency of
application
to
once
daily
or
to
discontinue
treatment
briefly,
the
frequency
of
application must again be increased to twice daily and the treatment
continued
regularly once the symptoms of irritation have resolved.
_Paediatric population _
No dose adjustment is required for the use of Skinoren cream in
adolescents aged
12-18 years. The safety and efficacy of using Skinoren cream in
children under
12 years have not been sufficiently stu
                                
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