Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Methylprednisolone aceponate 0.1%{relative}
LEO Pharma Limited
Methylprednisolone aceponate 0.1% w/w
0.1 %
Topical cream
Active: Methylprednisolone aceponate 0.1%{relative} Excipient: Benzyl alcohol Butylated hydroxytoluene Cetostearyl alcohol Decyl oleate Glycerol Glyceryl monostearate Hard fat Macrogol stearate 2000 Purified water Sodium edetate Softisan 378
Tube, aluminium, 5g physician's sample, 5 g
Prescription
Prescription
Bayer AG
Atopic dermatitis (endogenous eczema, neurodermatitis), contact eczema, degenerative, dyshidrotic, vulgar eczema, eczema in children.
Package - Contents - Shelf Life: Tube, aluminium, physician's sample - 5 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 30 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, - 50 g - 36 months from date of manufacture stored at or below 25°C
1992-03-26
ADVANTAN ® Consumer Medicine Information Page 1 of 6 CONSUMER MEDICINE INFORMATION ADVANTAN ® 1g cream or ointment contains 1 mg methylprednisolone aceponate. WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using ADVANTAN ® . It will advise you about how to use ADVANTAN ® properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist. This preparation has been prescribed for you personally and you should not pass it on to others. It may harm them. WHAT IS ADVANTAN USED FOR AND HOW DOES IT WORK ADVANTAN ® is an anti-inflammatory medicine (a corticosteroid) to be used on the skin. ADVANTAN ® suppresses inflammatory and allergic skin reactions and thus relaxes symptoms originating from the skin problem like redness (erythema), thickening of the skin, coarseness of the skin surface, fluid build-up (oedema), itchiness, and other complaints (burning sensation or pain). ADVANTAN ® is used for the treatment of atopic dermatitis (endogenous eczema, neurodermatitis), eczema in children, contact eczema, or degenerative, dyshidrotic, or vulgar eczema. ADVANTAN ® is available in two different formulations which have a different therapeutic effect which are listed below. • ADVANTAN ® cream ADVANTAN ® cream has a high water and low fat content. ADVANTAN ® cream is particularly suitable for acute and so-called weeping stages of eczema, for very greasy skin and for use on exposed or hairy parts of the body. • ADVANTAN ® ointment In certain skin ailments where the skin is neither very dry nor in a weeping state (that is, producing fluid), treatment requires a foundation with balanced proportions of fat and water. ADVANTAN ® ointment makes the skin slightly greasy without retaining warmth and fluid. Of the two formulations, ADVANTAN ® ointment has the widest field of use. ADVANTAN ® Consumer Medicine Information Page 2 of 6 BEFORE YOU USE ADVANTAN ® Do not use ADVANT Read the complete document
NEW ZEALAND DATA SHEET Page 1 of 8 1 ADVANTAN® Cream: ADVANTAN® methylprednisolone aceponate 0.1% cream Ointment: ADVANTAN® methylprednisolone aceponate 0.1% ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 g cream or ointment contains 1 mg (0.1%) methylprednisolone aceponate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Topical cream. Topical ointment. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications Atopic dermatitis (endogenous eczema, neurodermatitis), contact eczema, degenerative, dyshidrotic, vulgar eczema, eczema in children. 4.2 Dose and method of administration ADVANTAN® is for EXTERNAL TOPICAL USE ONLY and NOT FOR OPTHALMIC USE. In general, the ADVANTAN® formulation appropriate to the skin condition is applied thinly once per day to the diseased areas of skin. In general, the duration of use should not exceed 12 weeks in adults and 4 weeks in children. 4.3 Contraindications ADVANTAN® is contraindicated in most viral diseases (e.g. vaccinia, varicella/herpes zoster) and when tuberculous or syphilitic processes and post-vaccination skin reactions are present in the area to be treated. If rosacea, acne vulgaris, ulcera, atrophic skin diseases, or perioral dermatitis are present, ADVANTAN® must not be applied to the face. Hypersensitivity to the active substance or to any of the excipients listed in 6.1. 4.4 Special warnings and precautions for use Care must be taken when using ADVANTAN® to avoid contact with the eyes, deep open wounds and mucosae. Additional specific therapy is required in bacterially infected skin diseases and/or in fungal infections. Any spread of infection may require withdrawal of topical corticosteroid therapy. If the skin dries out excessively under protracted use of ADVANTAN® Cream, a switch should be made to ADVANTAN® ointment, a formulation which has a higher fat content. If signs of hypersensitivity develop, ADVANTAN® should be discontinued and appropriate treatment instituted. eDoc-000782917 - Version 6. 0 NEW ZEALAND DATA SHEET Page 2 Read the complete document