Aldara cream for local use

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

imiquimod

Beschikbaar vanaf:

3M Health Care Limited

ATC-code:

D06BB10

INN (Algemene Internationale Benaming):

imiquimod

Dosering:

50mg/g

farmaceutische vorm:

cream for local use

Eenheden in pakket:

(12) sachets 250mg

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2016-08-01

Productkenmerken

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
1.
NAME OF THE MEDICINAL PRODUCT
ALDARA 5% cream
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
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 (E 218) 2.0 mg/g cream
Propyl hydroxybenzoate (E 216) 0.2 mg/g cream
Cetyl alcohol 22.0 mg/g cream
Stearyl alcohol 31.0 mg/g cream
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Cream.
White to slightly yellow cream.
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.
•
Small superficial basal cell carcinomas (sBCCs) in adults.
•
Clinically typical, nonhyperkeratotic, nonhypertrophic actinic
keratoses (AKs) on the face or
scalp in immunocompetent adult patients when size or number of lesions
limit the efficacy
and/or acceptability of cryotherapy and other topical treatment
options are contraindicated or
less appropriate.
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 or for a maximum of 16 weeks per episode of warts.
For quantity to be applied see section 4.2 Method of administration.
_ _
2
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 initia