البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
BETAMETHASONE AS VALERATE
GLAXO SMITH KLINE (ISRAEL) LTD
D07AC01
CREAM
BETAMETHASONE AS VALERATE 0.1 %W/W
DERMAL
Required
GLAXO OPERATIONS (UK) LIMITED
BETAMETHASONE
BETAMETHASONE
Betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses.
2011-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only Betnovate Ointment Betamethasone (as valerate) 0.1% w/w Each 1 g contains 1 mg of betamethasone (as valerate). For the list of the inactive and allergenic ingredients in the medicine, see section 6 – “Additional information”. 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 the treatment of your ailment. 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? Betnovate contains a medicine called betamethasone valerate. Betamethasone valerate is a potent topical steroid indicated for adults, elderly and children over 1 year of age for the relief of inflammatory and pruritic manifestations of steroid responsive dermatoses including the following: • Atopic dermatitis (including infantile atopic dermatitis) • Nummular dermatitis (also called discoid eczema) • Prurigo nodularis • Psoriasis (excluding widespread plaque psoriasis) • Lichen simplex chronicus (neurodermatitis) and lichen planus • Seborrhoeic dermatitis • Irritant or allergic contact dermatitis • Discoid lupus erythematosus • Adjunct to systemic steroid therapy in generalised erythroderma 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 contained in this medicine (as listed in section 6) ∙ For treatment of any of the following skin problems, as the medicine could make them worse: - acne - severe flushing of the skin on and around the nose (rosacea) - spotty red rash around the mouth - itching around your anus or genitals (penis or vagina) - skin i اقرأ الوثيقة كاملة
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnovate Cream Betnovate Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Betamethasone Valerate B.P. 0.122% w/w Equivalent to 0.1 w/w betamethasone Betnovate Cream: Excipients with known effect: Chlorocresol Cetostearyl alcohol For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Ointment Cream 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Betamethasone valerate is a potent topical corticosteroid indicated for adults, elderly and children over 1 year for the relief of the inflammatory and pruritic manifestations of steroid responsive dermatoses. These include the following: Atopic dermatitis (including infantile atopic dermatitis) Nummular dermatitis (discoid eczema) Prurigo nodularis Psoriasis (excluding widespread plaque psoriasis) Lichen simplex chronicus (neurodermatitis) and lichen planus Seborrhoeic dermatitis Irritant or allergic contact dermatitis Discoid lupus erythematosus Adjunct to systemic steroid therapy in generalised erythroderma 4.2 Posology and method of administration Route of administration: Cutaneous Creams are especially appropriate for moist or weeping surfaces Ointments are especially appropriate for dry, lichenified, scaly lesions. Apply thinly and gently rub in using only enough to cover the entire affected area once or twice daily for up to 4 weeks 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. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of betamethasone valerate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter, improvement can usually be maintained by regular application without occlusion. If the condition worsens or does not im اقرأ الوثيقة كاملة