Country: Нови Зеланд
Језик: Енглески
Извор: Medsafe (Medicines Safety Authority)
Methylprednisolone aceponate 0.1%
Schering (NZ) Limited
Methylprednisolone aceponate 0.1%
0.1 %
Topical ointment
Active: Methylprednisolone aceponate 0.1% Excipient: Hydrogenated castor oil Liquid paraffin Microcrystalline wax White soft paraffin
Tube, aluminium, epoxide coating, screw cap, 15 g
Prescription
Prescription
Bayer AG
Package - Contents - Shelf Life: Tube, aluminium, epoxide coating, screw cap - 15 g - 60 months from date of manufacture stored at or below 30°C
1997-11-05
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 Прочитајте комплетан документ