Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
IMED Healthcare Ltd.
ITRACONAZOLE
100 Milligram
Capsules Hard
Withdrawn
2014-05-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 100mg Hard Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains itraconazole 100mg. Also contains: sucrose For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard Product imported from the UK: Capsule: 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 IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 08/07/2011_ _CRN 2090597_ _page number: 1_ 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. _Use in Children (below 12 years):_ Clinical data on the use of SPORANOX capsules in paediatric patients are limited. SPORANOX capsules should not be used in children unless the potential benefit outweighs the potentia Pročitajte cijeli dokument