מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
TERBINAFINE HYDROCHLORIDE
Novartis Consumer Health UK Limited
1 %w/w
Cutaneous Spray Solution
2006-10-20
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lamisil AT 1% Cutaneous Spray Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 10 mg terbinafine hydrochloride per 1 g spray solution. _For excipients, see 6.1._ 3 PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, colourless to faintly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Fungal infections of the skin caused by dermatophytes. Pityriasis (tinea) versicolor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Lamisil AT 1% Cutaneous Spray Solution is applied once or twice daily, depending on the indication. Cleanse and dry the affected areas thoroughly before applying Lamisil AT 1% Cutaneous Spray Solution. A sufficient amount of spray solution should be applied to wet the treatment area(s) thoroughly, and to cover the affected skin and surrounding area. Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment carries the risk of recurrence. Use of Lamisil AT 1% Cutaneous Spray Solution in the elderly: There is no evidence to suggest that elderly patients require different dosages or experience side effects different from those in younger patients. Use of Lamisil AT 1% Cutaneous Spray Solution in children: Experience with Lamisil AT 1% Cutaneous Spray Solution in children is limited and its use cannot, therefore, be recommended. 4.3 CONTRAINDICATIONS Known hypersensitivity to terbinafine or any of the excipients contained in the spray solution _(see 6.1 List of_ _Duration and frequency of treatment:_ Tinea corporis, cruris: 1 week once a day Interdigital type tinea pedis: 1 week once a day Pityriasis versicolor: 1 week twice a day IRISH MEDICINES BOARD ___________________________________________________________________________ קרא את המסמך השלם