Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
CLOBETASONE BUTYRATE
GLAXO SMITH KLINE (ISRAEL) LTD
D07AB01
CREAM
CLOBETASONE BUTYRATE 0.05 %W/W
DERMAL
Required
GLAXO OPERATIONS (UK) LIMITED
CLOBETASONE
CLOBETASONE
Eumovate Cream is a moderately potent topical corticosteroid indicated for adults, elderly, children and infants for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.These include the following:- Atopic dermatitis- Irritant or allergic contact dermatitis- Seborrhoeic dermatitis- Nappy rash- Photodermatitis- Otitis externa- Prurigo nodularis- Insect bite reactionsEumovate may be used as maintenance therapy between courses of one of the more potent topical steroids.
2014-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a physician’s prescription only Eumovate Cream Each 1 g contains 0.5 mg of clobetasone butyrate (0.05% w/w). A list of the additional ingredients is detailed in section 6. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. What is the medicine intended for? Eumovate Cream is indicated for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: Atopic dermatitis, Irritant or allergic contact dermatitis, Seborrhoeic dermatitis, Nappy rash, Photodermatitis, Otitis externa, Prurigo nodularis and Insect bite reactions. Therapeutic group: Corticosteroids 2. Before using the medicine Do not use the medicine: • if you are sensitive (allergic) to the active ingredient clobetasone butyrate or any of the additional ingredients contained in the medicine (as listed in section 6). • to treat any of the following skin problems; it could make them worse: - infected skin (unless the infection is being treated concurrently with an anti-infective medicine) - acne - severe flushing of the skin on and around the nose (rosacea) - itchy skin which is not inflamed Do not use if any of the above apply to you. If you are not sure, talk to your physician or pharmacist before using Eumovate Cream. Special warnings regarding the use of the medicine Talk to your physician or pharmacist before using Eumovate Cream if: • you have previously had an allergic reaction with another steroid. • you are using Eumovate Cream for a chronic leg ulcer as you may be at increased risk of a local allergic reaction or infection. • you have been instructed b Leggi il documento completo
_Page 1 of 9_ _The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in September _ _2016,_ _was updated according to the guidelines of the Ministry of Health in November 2017 _ EUMOVATE CREAM 1. NAME OF THE MEDICINAL PRODUCT Eumovate Cream 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 0.05% w/w clobetasone butyrate. Excipients with known effect: Cetostearyl alcohol Chlorocresol For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment for corticosteroids responsive dermatosis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ROUTE OF ADMINISTRATION: CUTANEOUS ADULTS, ELDERLY, CHILDREN AND INFANTS FROM THE AGE OF 3 MONTH Creams are especially appropriate for moist or weeping surfaces. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day until improvement occurs, then reduce the frequency of application or change the treatment to a less potent preparation. Allow adequate time for absorption after each application before applying an emollient. Therapy with topical corticosteroids should be gradually discontinued once control is achieved and an emollient continued as maintenance therapy. _Page 2 of 9_ Rebound of pre-existing dermatoses can occur with abrupt discontinuation of topical corticosteroids especially with potent preparations. DURATION OF TREATMENT FOR ADULTS AND ELDERLY Continuous daily treatment for longer than four weeks is not recommended. If the condition worsens or does not improve within four weeks, treatment and diagnosis should be re-evaluated. PAEDIATRIC POPULATION Use in children under 12 years should be on the advice of a doctor. Care should be taken when using clobetasone to ensure the amount applied is the minimum that provides therapeutic benefit. DURATION OF TREATMENT FOR CHILDREN AND INFANTS When clobetasone is used in the treatment of dermatoses in children, extreme caution is required and treatment should no Leggi il documento completo