Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
imiquimod
Viatris Healthcare Limited
D06BB10
imiquimod
Antibiotics and chemotherapeutics for dermatological use
Condylomata Acuminata; Keratosis; Keratosis, Actinic; Carcinoma, Basal Cell
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.
Revision: 31
Authorised
1998-09-18
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE USER ALDARA 5% CREAM IMIQUIMOD READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If any get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Aldara cream is and what it is used for 2. What you need to know before you use Aldara cream 3. How to use Aldara cream 4. Possible side effects 5. How to store Aldara cream 6. Contents of the pack and other information 1. WHAT ALDARA CREAM IS AND WHAT IT IS USED FOR Aldara cream may be used for three different conditions. Your doctor may prescribe Aldara cream for the treatment of: • Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage) • Superficial basal cell carcinoma. This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body. It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure. If left untreated, basal cell carcinoma can disfigure, especially on the face – therefore early recognition and treatment are important. • Actinic keratosis Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty. Aldara should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Aldara সম্পূর্ণ নথি পড়ুন
1 _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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 Benzyl alcohol 20.0 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. _ _ 3 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 সম্পূর্ণ নথি পড়ুন