Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
BETAMETHASONE AS DIPROPIONATE; CALCIPOTRIOL AS MONOHYDRATE
DEXCEL LTD, ISRAEL
D05AX52
CUTANEOUS FOAM
BETAMETHASONE AS DIPROPIONATE 0.5 MG / 1 G; CALCIPOTRIOL AS MONOHYDRATE 50 MCG / 1 G
TOPICAL
Required
LEO PHARMA A/S , DENMARK
CALCIPOTRIOL, COMBINATIONS
Topical treatment of psoriasis vulgaris in adults
2020-03-10
PATIENT PACKAGE INSERT ACCORDING TO PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine can be sold with a physician’s prescription only ® NSTILAR E CUTANEOUS FOAM ACTIVE INGREDIENTS: Betamethasone (as dipropionate) 0.5 mg/g Calcipotriol (as monohydrate) 50 mcg/g Inactive ingredients and allergens in the medicine - see section 6 "Additional information" and in section 2 "Important information about some of the ingredients of the medicine". READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if you think that their medical condition is the same as yours. 1. WHAT IS THE MEDICINE INTENDED FOR? ENSTILAR is used on the skin to treat psoriasis vulgaris in adults. THERAPEUTIC GROUP: Calcipotriol – a synthetic vitamin D derivative used for external treatment of psoriasis. Betamethasone – a synthetic corticosteroid. Psoriasis is caused by the skin cells being produced too quickly, which causes redness, scaling and thickening of the skin. ENSTILAR contains Calcipotriol and Betamethasone. Calcipotriol helps control the rate of skin cell formation and Betamethasone reduces inflammation. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: • You are hypersensitive (allergic) to the active ingredients (Calcipotriol, Betamethasone) or to any of the other ingredients this medicine contains (see section 6). • You have problems with calcium levels in the blood (ask the doctor). • You have certain types of psoriasis: erythrodermic or pustular psoriasis (ask the doctor if you are unsure). • As ENSTILAR contains a strong steroid, do NOT use ENSTILAR on skin areas affected by: o skin infections caused by viruses (e.g. cold sores or chicken pox) o skin infections caused by a fungus (e.g. athlete’s foot or ringworm) o skin infections caused by bacteria o skin infections caus Прочитайте повний документ
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Enstilar 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One gram of cutaneous foam contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate). Excipient with known effect: Butylhydroxytoluene (E321) 50 micrograms/g cutaneous foam. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous foam. After spraying, a white to off-white foam is formed. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Topical treatment of psoriasis vulgaris in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Enstilar foam should be applied to the affected area once daily. The recommended treatment period is 4 weeks. The daily maximum dose of Enstilar should not exceed 15 g, i.e. one 60 g can should last for at least 4 days of treatment. 15 g corresponds to the amount administered from the can if the actuator is fully depressed for approximately one minute. A two-second application delivers approximately 0.5 g. As a guide, 0.5 g of foam should cover an area of skin roughly corresponding to the surface area of an adult hand. If using other topical products containing calcipotriol in addition to Enstilar, the total dose of all calcipotriol containing products should not exceed 15 g per day. The total body surface area treated should not exceed 30%. Special populations _Renal and hepatic impairment_ The safety and efficacy of Enstilar foam in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. _Paediatric population_ The safety and efficacy of Enstilar foam in children below 18 years have not been established. Enstilar is not indicated for children below 18 years of age. Method of administration For cutaneous use. The can should be shaken for a few seconds before use. Enstilar should be applied by spraying holding the can at least 3 cm from the skin. The foam can be sprayed holding the can in any orientation except horizontally. Enstilar should be sprayed d Прочитайте повний документ