国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
BETAMETHASONE VALERATE NEOMYCIN SULFATE
Glaxo Laboratories Limited
BETAMETHASONE VALERATE NEOMYCIN SULFATE
0.1/0.5 %w/w
Ointment
Withdrawn
2006-08-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnovate-N Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Ointment An off-white, homogenous ointment. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betnovate-N skin preparations are indicated in the management of corticosteroid sensitive dermatoses actually or potentially complicated by infection due to micro-organisms sensitive to the anti-infective contained therein. Betnovate-N preparations are indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected or likely to occur: eczema, including atopic, infantile, discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex; lichen planus; seborrhoeic dermatitis; contact sensitivity reactions, insect bite reactions, prickly heat, anal and genital intertrigo, and otitis externa (see _Contraindications_). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A small quantity should be applied to the affected area one to three times daily until improvement occurs or as directed by a physician. It may then be possible to maintain improvement by applying once a day or even less often. Betnovate-N Ointment is especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so. In the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate-N can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions, thereafter improvement can usually be maintained by regular application without occlusion. Treatment should not be 完全なドキュメントを読む