ALDARA 5 %

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

IMIQUIMOD

Dostopno od:

MEGAPHARM LTD

Koda artikla:

D06BB10

Farmacevtska oblika:

CREAM

Sestava:

IMIQUIMOD 5 %

Pot uporabe:

DERMAL, PERIANAL, GENITAL

Tip zastaranja:

Required

Izdeluje:

3M HEALTH CARE LTD., UK

Terapevtska skupina:

IMIQUIMOD

Terapevtsko območje:

IMIQUIMOD

Terapevtske indikacije:

Indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients. For the treatment of actinic keratoses in adults with normal immune systems. For the treatment of superficial basal cell carcinoma in adults with normal immune systems when surgical methods are less appropriate.

Datum dovoljenje:

2019-10-31

Navodilo za uporabo

07
Product
Aldara 5%
Size
350 x 355 mm
(W) x (H)
Product spec
Solution
Tech ref
Font
(type
& min.
size /
language)
Arial 7p (Heb, Arb, Eng)
Aldara-Cream-
Leaflet-05.indd
Color
BLACK
Type
LEAFLET
Date
20/09/2023
Artwork operator
Nurit Assayag
Job no.
SO23000513
1986 - )تار
َ
ضحتسم( ةلدايصلا ةمظنأ بجومب كلهتسملل
ةرشن
طقف بيبط ةفصو قفو ءاودلا ق
ّ
وس
ُ
ي
ميرك ،5% ارادلأ
:ةلاعف ةدام
Imiquimod 5% زيكرتب دوميوكيمإ
تامولعم" دنبلا 2 لصفلا رظنا :رضحتسملا
يف ة
ّ
يساسحلل ةريثمو ةلا
ّ
عف ريغ داوم
."ة
ّ
يفاضإ تامولعم" 6 لصفلاو "ءاودلا تابكرم
نم مسق نع ةمهم
هذه يوتحت .ءاودلا لامعتساب ءدبلا لبق
كلذو اهتياهن ىتح ن
ّ
عمتب ةرشنلا أرقا
ىلإ ه
ّ
جوتف ة
ّ
يفاضإ ةلئسأ كيدل تناك اذإ .ءاودلا نع
ةزجوم تامولعم ىلع ةرشنلا
.
ّ
يلديصلا ىلإ وأ بيبطلا
ادب ول ىتح ،مهب
ّ
رضي دق ه
ّ
نلأ ؛نيرخلآل ه
ِ
طعت لا .كضرم جلاعل فصو ءاودلا اذه
.مهضرمو كضرم نيب هباشت كل
.1
؟ءاو
ّ
دلا اذه
ّ
دعأ
َ
مل
صصخم اهلجأ نم يتلا ةثلاثلا
تابابطتسلاا يف ارادلأ ميركب جلاعلا
ةقيرط فلتخت
:جلاعل ارادلأ بيبطلا كل فصي دق
.رضحتسملا
ف
ّ
نؤملا لولؤثلا( جرشلا ةحتف ةقطنم يف وأ
ةيلسانتلا ءاضعلأا ىلع ليلآثلا
.نيغلابلا ىدل )_condyloma acuminata_
.ميلس يعانم زاهج يوذ نيغلابلا ىدل )
_actinic keratosis_ (
يعفسلا نارقتلا
_ Superficial Basal Cell_( دلجلا يف ةيحطسلا
ةيدعاقلا ايلاخلا ناطرس
اهيف حصني لا يتلا تلااحلا يف ،ميلس
ةعانم زاهج يوذ ىدل )_Carcinoma_
.يحارج ءارجإب
ىلع م

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ALDARA 5%
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Each sachet contains 12.5 mg of imiquimod in 250 mg cream (5 %).
100 mg of cream contains 5 mg of imiquimod.
Excipients with known effects:
Methyl hydroxybenzoate (E218)
Propyl hydroxybenzoate (E216)
Cetyl alcohol
Stearyl alcohol
Benzyl alcohol
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Cream.
White to slightly yellow cream with uniform appearance.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imiquimod cream is indicated for the topical treatment of :
External genital and perianal warts (condylomata acuminata) in adults.
superficial basal cell carcinoma in adults with normal immune systems
when
surgical methods are less appropriate.
actinic keratoses in adults with normal immune systems.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Posology _
The application frequency and duration of treatment with imiquimod
cream is different for each
indication.
External genital warts in adults:
Imiquimod cream should be applied 3 times per week (example: Monday,
Wednesday, and
Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping
hours, and should remain
on the skin for 6 to 10 hours. Imiquimod cream treatment should
continue until the clearance of
visible genital or perianal warts for a maximum of 16 weeks per
episode of warts.
For quantity to be applied see 4.2 Method of administration.
Superficial basal cell carcinoma in adults:
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday
to Friday) prior to
normal sleeping hours, and leave on the skin for approximately 8
hours.
For quantity to be applied see 4.2 Method of administration.
Actinic keratosis in adults
Treatment should be initiated and monitored by a physician. Imiquimod
cream should be applied
3 times per week (example: Monday, Wednesday and Friday) for four
weeks prior to normal
sleeping hours, and left on the skin for approximately 8 hours.
Sufficient cream sho