RET-AVIT GEL 0.025 %

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

TRETINOIN

MAH:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

ATC_code:

D10AD01

pharmaceutical_form:

GEL

composition:

TRETINOIN 0.025 %W/W

administration_route:

DERMAL

prescription_type:

Required

manufactured_by:

CTS CHEMICAL INDUSTRIES LTD, ISRAEL

therapeutic_group:

TRETINOIN

therapeutic_area:

TRETINOIN

therapeutic_indication:

Treatment of acne vulgaris.

authorization_date:

2023-05-31

PIL

:ة
ّ
يبناجلا ضارعلأا .4
ة
ّ
يبناج ضارعأ ءوشن ىلإ تيڤأ-تير لامعتسا
ي
ّ
دؤي دق ،ءاود
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لك لثم
لا دق .ة
ّ
يبناجلا ضارعلأا ةمئاق ةءارق دنع قلقت
لا .نيلمعتسملا ضعب دنع
.اهنم دحاو
ّ
يأ نم يناعت ضارعلأا ترهظ اذإ بيبطلا ىلإ ا
ً
روف ه
ّ
جوتلاو لامعتسلاا فاقيإ بجي
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يبناجلا
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.ة
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داح ضارعأ
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ىرخأ ة
ّ
يبناج ضارعأ
10 - 1 دنع رهظت ضارعأ - )common( ةعئاش ة
ّ
يبناج ضارعأ
:100 نيب نم نيلمعتسم
•
.دلجلا خفتني دقو ة
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يدلج روشق ،ر
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شقت ،رارمحا
•
.ة
ّ
كحلل ريثم ،
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فاج دلج
•
.دلجلا يف عذللاب روعش وأ ةنوخسلاب روعش
•
.
ّ
يدلج حفط
•
.زخولاب روعش وأ ملأ
•
.دلجلا غ
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بصت يف )ضافخنا وأ دايدزا( ةت
ّ
قؤم تار
ّ
يغت
دنع رهظت ضارعأ - )uncommon( ةعئاش ريغ ة
ّ
يبناج ضارعأ
:1٫000 نيب نم نيلمعتسم 10 - 1
•
.خافتناو نيعلا يف ج
ّ
يهت
•
.ة
ّ
يدلج ب
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جو تلاصيوح
نم
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لقأ دنع رهظت ضارعأ - )very rare( ا
ً
ّ
دج ةردان ة
ّ
يبناج ضارعأ
:10٫000 نيب نم دحاو لمعتسم
•
ىلع يوتحت ةيودلأ هتسملامل
ً
ةجيتن دلجلا )ة
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يجرأ( ة
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يساسح نع غ
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ل
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ب
.نيونيتيرت تنك اذإ وأ ،ة
ّ
يبناجلا ضارعلأا دحأ مقافت اذإ ،
ّ
يبناج ض
َ
رع رهظ اذإ
.بيبطلا ةراشتسا كيلعف ،ةرشنلا يف ركذ
ُ
ي مل
ّ
يبناج ض
َ
رع نم يناعت
ىلع طغضلا ةطساوب ة
ّ
حصلا ةرازول ة
ّ
يبناج ضارعأ نع غيلبتل

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
RET-AVIT GEL 0.05%, 0.025%
RET-AVIT CREAM 0.05%, 0.025%
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tretinoin 0.05% w/w.
Tretinoin 0.025% w/w.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
RET-AVIT GEL: Pale yellow clear gel, characteristic odour.
RET-AVIT CREAM: Pale yellow, homogeneous emulsion, characteristic
odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acne vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
RET-AVIT is for cutaneous use only.
The generally accepted dosage is: lightly apply to the entire affected
area once
a day in the evening before bedtime. For people with light or
sensitive skin, it is
recommended to apply the preparation once a day or every other day,
depending on how the skin reacts.
DO NOT EXCEED THE RECOMMENDED DOSE
Do not swallow. For external use only.
Before treatment, you should clean the skin with lukewarm water and/or
gentle
soap, dry the skin gently without rubbing it and wait for 20-30
minutes before
applying the medicine. Do not wash the treated area more than twice
per day.
Wash your hands after the treatment.
Apply a small amount of RET-AVIT and cover only the affected areas.
You can
use cotton wool or clean cotton swabs. Avoid accumulation of too much
RET-
AVIT in skin folds, such as the area where the nose meets the face. Do
not
apply to a cracked or eczematous area, to the eyes, eyelids, nostrils
or mouth.
If RET-AVIT comes into contact with these areas, wash them thoroughly
with
water.
Duration of treatment – the results of the treatment are visible
after two to three
weeks, but it may take six to eight weeks to achieve maximum results.
The
minimal duration of treatment is three months.
After applying of RET-AVIT, the skin may feel warm or sting slightly
for a while.
If these sensations continue or become worse, consult your doctor.
A transitory feeling of warmth or slight stinging may be noted on
application.
Patients treated with RET-AVIT may use cosmet