Country: Израел
Језик: Енглески
Извор: Ministry of Health
BETAMETHASONE AS VALERATE
GLAXO SMITH KLINE (ISRAEL) LTD
D07AC01
SOLUTION
BETAMETHASONE AS VALERATE 0.1 %W/W
TOPICAL- SCALP
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
BETAMETHASONE
BETAMETHASONE
Steroid responsive dermatoses of the scalp, such as psoriasis, seborrheic capitis and inflammation associated with severe dandruff.
2021-02-28
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only BETNOVATE SCALP APPLICATION BETAMETHASONE VALERATE 0.1% W/W Each 10 ml contains 0.01 ml of betamethasone valerate The 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. The medicine is not intended for children under 1 year of age. 1. WHAT IS THE MEDICINE INTENDED FOR? BETNOVATE Scalp Application (called ’Betnovate’ in this leaflet) contains a medicine called betamethasone valerate. BETNOVATE is used to help reduce the redness and itchiness of certain scalp problems, such as psoriasis and dermatitis associated with dandruff. THERAPEUTIC GROUP: Corticosteroids. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • if you are sensitive (allergic) to betamethasone valerate or to any of the additional ingredients of Betnovate (as listed in Section 6) • if you have a skin infection on your scalp (viral, bacterial and fungal) • on children under 1 year of age. Do not use Betnovate if any of the above apply to you. If you are not sure, talk to your physician or pharmacist before using Betnovate. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE Talk to your physician or pharmacist before you use this medicine if: • you have previously had an allergic reaction to another steroid. • you are applying the solution under an airtight dressing. These types of dressings make the absorption of the active ingredient through the skin easier and it is possible to accidentally end up using too high a dosage of the solution. • you have psoriasis; your physician will want to see you more often. • you Прочитајте комплетан документ
BETNOVATE SCALP APPLICATION PRODUCT SUMMARY 1. TRADE NAME OF THE MEDICINAL PRODUCT BETNOVATE SCALP APPLICATION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone Valerate BP 0.122% w / w. Equivalent to 0.11% w/w betamethasone 3. PHARMACEUTICAL FORM Aqueous Suspension. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Steroid responsive dermatoses of the scalp, such as psoriasis seborrhoeic capitis and inflammation associated with severe dandruff. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION A small quantity of Betnovate Scalp Application 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. For topical application. This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition including smoking during application and immediately after use. PAEDIATRIC POPULATION Betamethasone valerate is contraindicated in children under one year of age. 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; therefore, courses should be limited to five days and occlusion should not be used. Care should be taken when using betamethasone valerate to ensure the amount applied is the minimum that provides therapeutic benefit. 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 absorption occurs. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit. RENAL / HEPATIC IMPAIRMENT In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest durati Прочитајте комплетан документ