Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g betamethasone; ; Calcipotriol 50 µg/g (as calcipotriol hydrate 52.2µg/g)
LEO Pharma Limited
Betamethasone dipropionate 643 µg/g (equivalent to 500 µg/g betamethasone)
50µg/500µg/g
Topical ointment
Active: Betamethasone dipropionate 643 µg/g equivalent to 500 µg/g betamethasone Calcipotriol 50 µg/g (as calcipotriol hydrate 52.2µg/g) Excipient: Ceteareth-15 dl-Alpha tocopherol Liquid paraffin White soft paraffin
Tube, aluminium, sample pack (not marketed), 3 g
Prescription
Prescription
Crystal Pharma SA
Package - Contents - Shelf Life: Tube, aluminium, sample pack - 3 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 15 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 30 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 60 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 100 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C - Tube, aluminium, - 120 g - 24 months from date of manufacture stored at or below 25°C 12 months opened stored at or below 25°C
2004-01-29
DAIVOBET ® 50/500 OINTMENT 1 DAIVOBET 50/500 OINTMENT _Dye-vo-bet _ Calcipotriol _(Kal-sippo-try-all)/ _ Betamethasone _(Beet-ah-meth-ah sown ) _ CONSUMER MEDICINE INFORMATION (CMI) PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START YOUR TREATMENT. Daivobet ® 50/500 ointment is the brand name. Calcipotriol and betamethasone are the generic names of the combination product, which is Daivobet ® ointment. KEEP THIS LEAFLET. You may want to read it again. WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about using the medicine Daivobet ® 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 Daivobet ® ointment against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING DAIVOBET ® OINTMENT , TALK TO YOUR DOCTOR OR PHARMACIST. WHAT DAIVOBET ® OINTMENT IS USED FOR Daivobet ® ointment is an anti- psoriasis medicine. Daivobet ® ointment contains two active ingredients: • calcipotriol [as monohydrate] (related to Vitamin D) • betamethasone dipropionate (a corticosteroid). Daivobet ® 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 Daivobet ® ointment treats the overactive skin cells. The betamethasone dipropionate relieves redness, swelling, itching and irritation of the skin. Daivobet ® 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. _ _ Daivobet ® 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 DAIVOBET ® OINTMENT _WHEN YOU MUST NOT USE _ _DAIVOBET_ _®_ _ OINTMENT_ _ _ DO NOT U Lire le document complet
Page 1 of 12 NEW ZEALAND DATA SHEET 1 DAIVOBET ® 50/500 OINTMENT Daivobet ® 50/500 calcipotriol 50 microgram/g and betamethasone 500 microgram/g (as dipropionate) ointment 2 QUANTITATIVE AND QUALITATIVE COMPOSITION One gram of Daivobet ® ointment contains 50 micrograms of calcipotriol (as monohydrate) and 500 micrograms of betamethasone (as dipropionate). 3 PHARMACEUTICAL FORM Ointment Off-white to yellow ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Daivobet ® ointment is indicated for the once daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy in adult patients 18 years and older. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Daivobet ® ointment is indicated FOR TOPICAL USE ONLY and NOT FOR OPHTHALMIC USE. All psoriasis-affected areas treated with Daivobet ® should be, where possible, protected from direct sunlight and UV-light with items of clothing. Topical calcipotriol should only be used with UV radiation if the physician and patient consider that the potential benefits outweigh the potential risks. The potential phototoxic effects of Daivobet ® over long term exposure have not been fully investigated. ADULTS: Daivobet ® 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 DAIVOBET ® OINTMENT IS 100 G/WEEK. The treated area should not be more than 30% of the body surface. THE RECOMMENDED TREATMENT PERIOD OF DAIVOBET ® OINTMENT IS 4 WEEKS. At the completion of the treatment period, repeated treatment with Daivobet ® ointment can be initiated under medical supervision. There is no clinical experience with Daivobet ® Ointment beyond 52 weeks. CHILDREN: Daivobet ® ointment is not recommended for use in children and adolescents below the age of 18 years. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Patients with known disorders of calcium metabolism (see section 4.4). eDoc-000637271 Lire le document complet