País: Armènia
Idioma: anglès
Font: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
imiquimod
3M Health Care Limited
D06BB10
imiquimod
50mg/g
cream for local use
(12) sachets 250mg
Prescription
Registered
2016-08-01
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 Llegiu el document complet