국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
ITRACONAZOLE
B & S Healthcare
100 Milligram
Capsules Hard
2009-05-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sporanox 100mg 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_ _Long Term Usage_ Dosage recommendations vary according to the infection treated. 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. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/09/2011_ _CRN 2097400_ _page number: 1_ _Use in Children (below 12 years):_ Clinical data on the use of Sporanox capsules in pediatric patients are limited. Sporanox capsules should not be used in children unless the potential benefit outweighs the potential risk 전체 문서 읽기