País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
BETAMETHASONE VALERATE
G & A Licensing Limited
0.1 %v/w
Cutaneous Solution
2009-12-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betnovate Scalp Application 0.1 % w/w Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Betamethasone Valerate equivalent to 0.1% w/w Betamethasone For full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Cutaneous solution. _Imported from Greece_ A colourless, hazy slightly viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Betamethasone valerate is a topical corticosteroid used in the management of steroid-responsive dermatoses of the scalp, such as psoriasis, seborrhoea capitis and inflammation associated with severe dandruff. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A small quantity of Betnovate Scalp Application should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or even less frequently. 4.3 CONTRAINDICATIONS Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin. Hypersensitivity to the preparation. Dermatoses in children under one year of age, including dermatitis and napkin eruptions. Use in acne vulgaris, rosacea or in perioral dermatoses. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Prolonged use of uninterrupted occlusion (including napkin) or use with extensive occlusive dressings may suppress adrenocortical function. Continuous treatment for longer than three weeks on use of occlusion (including napkins) should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression or of growth suppression, systemic absorption and hypercorticism. Care must be taken to keep the preparation away from the eyes. Do not use near a naked flame. Betnovate preparations are usually well tolerated, b Llegiu el document complet