מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS HYDRATE
DEXCEL LTD, ISRAEL
D05AX52
OINTMENT
BETAMETHASONE AS DIPROPIONATE 0.5 MG/G; CALCIPOTRIOL AS HYDRATE 50 MCG/G
DERMAL
Required
LEO PHARMA A/S , DENMARK
CALCIPOTRIOL, COMBINATIONS
CALCIPOTRIOL, COMBINATIONS
Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy.
2023-01-31
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Daivobet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of ointment contains 50 micrograms of calcipotriol (as hydrate) and 0.5 mg of betamethasone (as dipropionate). Excipient with known effects: Butylhydroxytoluene (E321) 50 micrograms/g ointment For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ointment. Off-white to yellow. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Daivobet ointment should be applied to the affected area once daily. The recommended treatment period is 4 weeks. There is experience with repeated courses of Daivobet up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, 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). Special populations _Renal and hepatic impairment _ The safety and efficacy of Daivobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. Paediatric population The safety and efficacy of Daivobet ointment 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 Daivobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Daivobet ointment. 4.3 CONTRAINDICATIONS 2 Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Daivobet ointment is contraindicated in erythrodermic, exfoliative and pustula קרא את המסמך השלם