Država: Izrael
Jezik: angleščina
Source: Ministry of Health
CLOBETASOL PROPIONATE
GLAXO SMITH KLINE (ISRAEL) LTD
D07AD01
SOLUTION - EXTERNAL
CLOBETASOL PROPIONATE 0.05 %W/W
TOPICAL- SCALP
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
CLOBETASOL
CLOBETASOL
For the topical treatment of inflammatory conditions of the scalp responsive only to corticosteroids.
2015-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician’s prescription only DERMOVATE SCALP APPLICATION CLOBETASOL PROPIONATE (0.05% W/W) Each 1 gram contains 0.5 mg clobetasol propionate (0.05% w/w). The list of additional ingredients is detailed in section 6. READ THE 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. The medicine is not intended for children under 1 year of age. 1. WHAT IS THE MEDICINE INTENDED FOR? Dermovate Scalp Application is used to treat inflammatory conditions responsive only to corticosteroids. It contains a medicine called clobetasol propionate. It belongs to a group of medicines called steroids. THERAPEUTIC GROUP Corticosteroids 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • if you are sensitive (allergic) to clobetasol propionate or to any of the additional ingredients contained in the medicine, as listed in section 6. • if you have a skin infection on the scalp. • on ch ildren under 1 year of age. Do not use if any of the above apply to you. If you are not sure, talk to your physician or pharmacist before using Dermovate Scalp Application. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH DERMOVATE SCALP APPLICATION, TELL THE PHYSICIAN IF: • You experience newly developed bone pain or worsening of previous bone symptoms during treatment with Dermovate especially if you have been using Dermovate for a long time or have used it repeatedly. • You use other oral/topical medication containing corticosteroids or medication intended to regulate your immune system (e.g., for autoimmune disease or after a transplantation). Combining Dermovate with these medicines may cause seriou Preberite celoten dokument
Page 1 of 8 DERMOVATE SCALP APPLICATION 1. NAME OF THE MEDICINAL PRODUCT Dermovate Scalp Application 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 g contains 0.5 mg of clobetasol propionate (0.05% w/w) 3. PHARMACEUTICAL FORM Scalp application 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the topical treatment of inflammatory conditions of the scalp responsive only to corticosteroids. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION CLOBETASOL PROPIONATE BELONGS TO THE MOST POTENT CLASS OF TOPICAL CORTICOSTEROIDS (GROUP IV) AND PROLONGED USE MAY RESULT IN SERIOUS UNDESIRABLE EFFECTS (SEE SECTION 4.4). IF TREATMENT WITH A LOCAL CORTICOSTEROID IS CLINICALLY JUSTIFIED BEYOND 4 WEEKS, A LESS POTENT CORTICOSTEROID PREPARATION SHOULD BE CONSIDERED. REPEATED BUT SHORT COURSES OF CLOBETASOL PROPIONATE MAY BE USED TO CONTROL EXACERBATIONS (SEE DETAILS BELOW). Route of administration: Topical, on the scalp. Owing to the flammable nature of the product, Dermovate Scalp Application should be kept away from open fire and flames and all sources of ignition, including smoking, during and immediately after use. ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR A small quantity of clobetasol should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently. PAEDIATRIC POPULATION Children are more likely to develop local and systemic side effects of topical corticosteroids and, in general, require shorter courses and less potent agents than adults. Page 2 of 8 Care should be taken when using clobetasol propionate to ensure the amount applied is the minimum that provides therapeutic benefit. DURATION OF TREATMENT FOR CHILDREN AND INFANTS Courses should be limited if possible to a few days and reviewed weekly. ELDERLY Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or renal function in the elderly may delay elimination if systemic Preberite celoten dokument