LANAFINE Cream 1 %w/w
מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
מאפייני מוצר
(SPC)
04-05-2024
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מרכיב פעיל:
TERBINAFINE HYDROCHLORIDE
זמין מ:
Niche Generics Limited
כמות:
1 %w/w
טופס פרצבטיות:
Cream
תאריך אישור:
2005-11-11
מאפייני מוצר
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lanafine 1% (w/w) Cream
Terbinafine hydrochloride
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
10 mg terbinafine hydrochloride (equivalent to 8.89 mg terbinafine) in 1 g cream.
Excipients: also contains cetyl alcohol and cetostearyl alcohol
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
White or almost white cream, with slight almond odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fungal infections of the skin caused by _Trichophyton _(e.g. _T. Rubrum_, _T.Mentagrophytes, T. Verrucosum, T._
_Violaceum), Microsporum canis _and _Epidermophyton floccosum_.
Yeast infections of the skin, principally those caused by the genus _Candida _(eg. _C. albicans_).
Pityriasis (tinea) versicolor due to _Pityrosporum orbiculare _(also known as _Malassezia furfur_).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Terbinafine cream can be applied once or twice daily. Cleanse and dry the affected areas thoroughly before application
of Terbinafine cream. Apply the cream to the affected skin and surrounding area in a thin layer and rub in lightly. In the
case of intertriginous infections (submammary, interdigital, intergluteal, inguinal) the application may be covered with
a gauze strip, especially at night.
The likely durations of treatment are as follows:
Tinea corporis, cruris: 1 to 2 weeks
Tinea pedis: 1 week
Cutaneous candidiasis: 2 weeks
Pityriasis versicolor: 2 weeks
Relief of clinical symptoms usually occurs within a few days. Irregular use or premature discontinuation of treatment
carries the risk of recurrence. If there are no signs of improvement after two weeks, the diagnosis should be verified.
Children
The experience with topical terbinafine cream in children is still limited and its use cannot
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