Land: New Zealand
Språk: engelsk
Kilde: Medsafe (Medicines Safety Authority)
Calcipotriol 50 µg/g
LEO Pharma Limited
Calcipotriol 50 µg/g
50 mcg/g
Topical ointment
Active: Calcipotriol 50 µg/g Excipient: Dibasic sodium phosphate dihydrate Disodium edetate dihydrate dl-Alpha tocopherol Liquid paraffin Polyoxyethylene stearyl ether Propylene glycol Purified water White soft paraffin
Tube, aluminium, 15g Physician sample pack, 15 g
Prescription
Prescription
Leo Pharma A/S
Package - Contents - Shelf Life: Tube, aluminium, 15g Physician sample pack - 15 g - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C - Tube, aluminium, 30g - 30 g - 24 months from date of manufacture stored at or below 25°C 6 months opened stored at or below 25°C - Tube, aluminium, 100g - 100 g - 6 months opened stored at or below 25°C 24 months from date of manufacture stored at or below 25°C - Tube, aluminium, 120g - 120 g - 6 months opened stored at or below 25°C 24 months from date of manufacture stored at or below 25°C
1990-07-10
CONSUMER MEDICINE INFORMATION DAIVONEX ® OINTMENT _CALCIPOTRIOL (KAL-SIPPO-TRY-ALL)_ Please read this leaflet carefully before you start your treatment. KEEP THIS LEAFLET. You may want to read it again. WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about using Daivonex ® 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 Daivonex ® ointment against the benefits it is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT USING DAIVONEX ® OINTMENT, TALK TO YOUR DOCTOR OR PHARMACIST. WHAT DAIVONEX ® OINTMENT IS USED FOR Daivonex ® ointment is an anti-psoriasis medicine. Daivonex ® ointment contains calcipotriol (related to Vitamin D). DAIVONEX ® OINTMENT DOES NOT CONTAIN STEROIDS. Daivonex ® ointment is used only on skin affected by psoriasis. Psoriasis is a skin disorder in which skin cells are overactive. The calcipotriol in Daivonex ® ointment treats the overactive skin cells. Daivonex ® ointment is used in the commonest type of psoriasis, where "plaques" form in the skin. Plaques are raised, rough, reddened areas covered with fine, dry silvery scales. Plaques are usually a centimetre or two across. Daivonex ® 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. eDoc-000806160 - Version 1. 0 BEFORE YOU USE DAIVONEX ® OINTMENT _WHEN YOU MUST NOT USE DAIVONEX_ _®_ _ OINTMENT_ DO NOT USE DAIVONEX ® OINTMENT IF YOU HAVE AN ALLERGY TO: • any medicine containing calcipotriol • any of the ingredients listed at the end of this leaflet (see PRODUCT DESCRIPTION). Some of the symptoms of an allergic reaction include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or "hives" on the skin. DO NOT USE DAIVONEX ® OINT read_full_document
NEW ZEALAND DATA SHEET 1 DAIVONEX ® 50 MICROGRAM/GRAM TOPICAL OINTMENT _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Daivonex ® ointment contains calcipotriol 50 microgram per gram Daivonex ® ointment contains the anhydrous form of calcipotriol. For full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Daivonex ® is a topical ointment. It is a smooth, white preservative free ointment base. 4 CLINICAL PARTICULARS 4.1 INDICATIONS Daivonex ® ointment is indicated for the topical treatment of psoriasis vulgaris, including plaque psoriasis in adults and children (see section 4.4 Special warnings and precautions for use - paediatric population). In adult patients, Daivonex ® ointment may also be used in combination with systemic acitretin or cyclosporin. 4.2 DOSAGE AND METHOD OF ADMINISTRATION Adults _DAIVONEX_ _®_ _ OINTMENT THERAPY:_ Daivonex ® ointment should be applied topically to the affected area once or twice daily (i.e. in the morning and/or in the evening). Initially, twice daily application of the ointment is usually preferred. Application may then be reduced to once daily, provided individual clinical response is satisfactory. After satisfactory improvement has occurred, treatment should be discontinued. If recurrence develops after reduction in frequency of application or after discontinuation, the treatment may be reinstituted at the initial dosage. Experience is lacking in the use of calcipotriol for periods longer than 1 year. THE MAXIMUM RECOMMENDED WEEKLY DOSE OF DAIVONEX ® OINTMENT IS 100 G/WEEK. When using a combination of ointment and cream the total maximum dose should not exceed 100 g per week. eDoc-000783454 - Version 1. 0 It should be noted that there are no long-term clinical studies assessing the safety of using Daivonex ® ointment during exposure to sunlight. Therefore, all psoriasis-affected areas treated with calcipotriol should be, where possible, protected from direct sunlight and UV- light with items of clothing. Furthermore, topical calcipotriol read_full_document