Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
G & A Licensing Limited
ITRACONAZOLE
100 Milligram
Capsules Hard
Product subject to prescription which may be renewed (B)
Withdrawn
2012-03-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 100mg Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains itraconazole 100 mg. Excipient: Contains Sucrose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard _Imported from Greece:_ Sporanox capsules have an opaque blue cap and pink transparent body containing coated beads. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Vulvovaginal candidosis 2. Pityriasis versicolor 3. Dermatophytoses caused by organisms susceptible to itraconazole 4. Oral candidosis 5. Fungal keratitis 6. Systemic mycoses 7. Onychomycosis 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Sporanox is for oral administration and must be taken immediately after a meal for maximal absorption. The capsules must be swallowed whole. Treatment schedules in adults for each indication are as follows: _Short-Term Usage_ INDICATION DOSE Vulvovaginal candidosis 200 mg twice daily for 1 day or 200 mg once daily for 3 days. Pityriasis versicolor 200 mg once daily for 7 days Tinea corporis, tinea cruris 100 mg once daily for 2 weeks or 200 mg once daily for 7 days Tinea pedis, tinea manuum 100 mg once daily for 4 weeks Oral candidosis 100 mg once daily for 2 weeks Fungal keratitis 200 mg once daily for 3 weeks Treatment should not exceed 4 weeks. _Long Term Usage_ Dosage recommendations vary according to the infection treated. INDICATION DOSE MEDIAN DURATION Onychomycosis 200 mg od 3 months Aspergillosis 200 mg od 2-5 months IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/10/2011_ _CRN 2106776_ _page number: 1_ _Use in Children (below 12 years):_ Clinical data on the use of Sporanox capsules in pediatric patients are limit Preberite celoten dokument