国家: 以色列
语言: 英文
来源: Ministry of Health
BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE
DEXCEL LTD, ISRAEL
D07AC01
GEL
BETAMETHASONE AS DIPROPIONATE 0.5 MG / 1 G; CALCIPOTRIOL AS HYDRATE 50 MCG / 1 G
TOPICAL
Required
LEO PHARMA A/S , DENMARK
BETAMETHASONE
BETAMETHASONE
Topical treatment of psoriasis vulgaris on the scalp and topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults 18 years of age and older.
2015-08-31
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Xamiol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of gel contains: 50 microgram of calcipotriol (as hydrate) and 0.5 mg of betamethasone (as dipropionate). Excipient with known effect: Butylhydroxytoluene (E321) 160 microgram/g gel. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gel. An almost clear, colourless to slightly off-white gel. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of psoriasis vulgaris on the scalp and topical treatment of mild to moderate “non-scalp” plaque psoriasis vulgaris in adults 18 years of age and older. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Xamiol gel should be applied to affected areas once daily. The recommended treatment period is 4 weeks for scalp areas and 8 weeks for “non-scalp” areas. If it is necessary to continue or restart treatment after this period, treatment should be continued after medical review and under regular medical supervision. When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30% (see section 4.4). _ _ _If used on the scalp _ All the affected scalp areas may be treated with Xamiol gel. Usually an amount between 1 g and 4 g per day is sufficient for treatment of the scalp (4 g corresponds to one teaspoon). Special populations _Renal and hepatic impairment_ The safety and efficacy of Xamiol gel in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. _ _ _Paediatric population _ The safety and efficacy of Xamiol gel in children below 18 years have not been established. Currently available data in children aged 12 to 17 years are described in section 4.8 and 5.1, but no recommendation on a posology can be made. Method of administration Xamiol gel should not be applied directly to the face or eyes. In order to achieve optimal effect, i 阅读完整的文件