Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
calcipotriol, Quantity: 52.2 microgram/g; betamethasone dipropionate, Quantity: 643 microgram/g (Equivalent: betamethasone, Qty microgram/g)
Sandoz Pty Ltd
Betamethasone dipropionate,Calcipotriol
Ointment
Excipient Ingredients: dl-alpha-tocopherol; oleyl alcohol; liquid paraffin; white soft paraffin
Topical
30 g
(S4) Prescription Only Medicine
Indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy.
Visual Identification: Off white ointment; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2016-08-26
CALCIPOTRIOL / BETAMETHASONE SANDOZ ® 50/500 1 CALCIPOTRIOL / BETAMETHASONE SANDOZ ® 50/500 _Calcipotriol and betamethasone dipropionate ointment _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about using the medicine Calcipotriol / Betamethasone Sandoz ointment. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Calcipotriol / Betamethasone Sandoz ointment against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT CALCIPOTRIOL / BETAMETHASONE SANDOZ 50/500 OINTMENT IS USED FOR Calcipotriol / Betamethasone Sandoz ointment is an anti-psoriasis medicine. Calcipotriol / Betamethasone Sandoz ointment contains two active ingredients: • Calcipotriol (related to Vitamin D); • Betamethasone dipropionate (a corticosteroid). Calcipotriol / Betamethasone Sandoz ointment is used only on skin affected by plaque-type psoriasis. Psoriasis is a skin disorder in which skin cells are overactive. The calcipotriol in Calcipotriol / Betamethasone Sandoz ointment treats the overactive skin cells. The betamethasone dipropionate relieves redness, swelling, itching and irritation of the skin. Calcipotriol / Betamethasone Sandoz ointment is used in the type of psoriasis, where "plaques" form in the skin. Plaques are raised, rough, reddened areas covered with fine, dry silvery scales. Plaques are usually about one to two centimetres across. Calcipotriol / Betamethasone Sandoz ointment is available only with a doctor's prescription. This medicine is not expected to affect your ability to drive a car or operate machinery. This medicine is not addictive. BEFORE YOU USE CALCIPOTRIOL / BETAMETHASONE SANDOZ 50/500 OINTMENT _WHEN YOU MUST NOT USE _ _CALCIPOTRIOL / _ _BETAMETHASONE SANDO Прочитайте повний документ
201216-calcipotriol/betamethasone sandoz 50/500-pi Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION CALCIPOTRIOL/BETAMETHASONE SANDOZ ® 50/500 (CALCIPOTRIOL/BETAMETHASONE) OINTMENT 1. NAME OF THE MEDICINE Calcipotriol and betamethasone (as dipropionate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calcipotriol/Betamethasone Sandoz ® 50/500 is a combination ointment containing calcipotriol 50 microgram/g and betamethasone (as dipropionate) 500 microgram/g. For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Calcipotriol/Betamethasone Sandoz 50/500 is an off-white ointment base. 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Calcipotriol and betamethasone ointment is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy. 4.2. D OSE AND METHOD OF ADMINISTRATION Calcipotriol/Betamethasone Sandoz 50/500 ointment is indicated FOR TOPICAL USE ONLY. Calcipotriol/Betamethasone Sandoz 50/500 ointment is NOT FOR OPHTHALMIC USE. The phototoxic effects of calcipotriol and betamethasone ointment have not been studied in psoriasis patients. All psoriasis-affected areas treated with calcipotriol and betamethasone ointment should be, where possible, protected from direct sunlight and UV-light with items of clothing. ADULTS: Calcipotriol and betamethasone ointment should be applied topically to the affected area once daily. The maximum daily dose should not exceed 15 grams. _THE MAXIMUM RECOMMENDED WEEKLY DOSE OF CALCIPOTRIOL AND BETAMETHASONE OINTMENT IS 100 _ _GRAMS/WEEK. _ The treated area should not be more than 30% of the body surface. The use of calcipotriol and betamethasone ointment should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods with calcipotriol used alone for one month between periods of use of calcipotriol and betamethasone ointment as needed. CHILDREN: Calcipotriol and betamethasone ointment is not recommended for use in children and adolescents b Прочитайте повний документ