Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Pimecrolimus
Mawdsley-Brooks & Company Ltd
D11AH02
Pimecrolimus
10mg/1gram
Cutaneous cream
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13050300
148 mm 594 mm 50 mm Sens de Sens de lecture 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT ELIDEL CREAM CONTAINS • The active substance is pimecrolimus. 1 gram of Elidel cream contains 10mg of pimecrolimus. • The other ingredients are: medium chain triglycerides, oleyl alcohol, propylene glycol (E 1520), stearyl alcohol, cetyl alcohol, mono-and di-glycerides, sodium cetostearyl sulphate, benzyl alcohol, citric acid anhydrous, sodium hydroxide, purified water. • This medicine contains 10 mg benzyl alcohol and 50 mg propylene glycol (E 1520), in 1 g of cream. See section 2. WHAT ELIDEL LOOKS LIKE AND CONTENTS OF THE PACK Elidel is a whitish, odourless, non-staining and easily spreadable cream. The cream is available in tubes of 5g, 15 g, 30 g, 60 g and 100 g. Not all pack sizes are necessarily available in your country. MARKETING AUTHORISATION HOLDER Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK MANUFACTURER Meda Pharma GmBH & Co. KG. Benzstrasse 1, 61352 Bad Homburg, Germany MEDA Manufacturing, Avenue J. F. Kennedy, 33700 Merignac, France THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Austria: Elidel 10 mg/g Creme Belgium: Elidel 10 mg/g crème Bulgaria Елидел 10 mg/g крем Croatia: Elidel 10 mg/g krema Cyprus: Elidel cream 10 mg/g Czech Republic: Elidel 10 mg/g krém Denmark: Elidel 10 mg/g Creme Estonia: Elidel 10 mg/g kreem Finland: Elidel 10 mg/g emulsiovoide Germany Elidel 10mg/g Creme Greece: Elidel , κρέµα 10 mg/g Hungary: Elidel 10 mg/g krém Iceland: Elidel 10 mg/g krém Italy: Elidel 10 mg/g crema Latvia: Elidel 10 mg/g krēms Lithuania: Elidel 10 mg/g kremas Luxembourg: Elidel 10 mg/g Creme Malta: Elidel 10 mg/g cream Netherlands: Elidel, 10 mg/g crème Norway: Elidel 10 mg/g krem Poland: Elidel 10 mg/g krem Portugal: Elidel 10 mg/g creme Romania: Elidel 10 mg/g cremă Slovakia: Elidel 10 mg/g krém Slovenia: Elidel 10 mg/g krema Spain: Elidel 10 mg/g crema Sweden: Elidel 10 mg/g kräm United Kingdom: E Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Elidel 10 mg/g cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g of cream contains 10 mg of pimecrolimus. Excipients with known effect 10 mg benzyl alcohol, 40 mg cetyl alcohol, 40 mg stearyl alcohol, and 50 mg propylene glycol (E 1520) in 1 g of cream. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream. Whitish and homogeneous. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients aged 2 years and over with mild or moderate atopic dermatitis where treatment with topical corticosteroids is either inadvisable or not possible. This may include: • Intolerance to topical corticosteroids • Lack of effect of topical corticosteroids • Use on the face and neck where prolonged intermittent treatment with topical corticosteroids may be inappropriate 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Elidel should be initiated by physicians with experience in the diagnosis and treatment of atopic dermatitis. Elidel can be used in the short term for the treatment of the signs and symptoms of atopic eczema and intermittently in the long term for the prevention of progression to flares. Elidel treatment should begin at the first appearance of signs and symptoms of atopic dermatitis. Elidel should only be applied to areas affected with atopic dermatitis. Elidel should be used for as short period as possible during flares of disease. The patient or caregiver should stop using Elidel when signs and symptoms resolve. Treatment should be intermittent, short-term and not continuous. Data from clinical studies support intermittent treatment with Elidel for up to 12 months. If no improvement occurs after 6 weeks, or in case of disease exacerbation, Elidel should be stopped. The diagnosis of atopic dermatitis should be re- evaluated and further therapeutic options considered. Adults Apply a thin layer of Elidel to the affected skin twice daily and rub in gently and completely. Each affected region of the skin should be treate Preberite celoten dokument