SPORANOX 100MG CAPSULES
国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
製品の特徴
(SPC)
04-06-2024
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有効成分:
ITRACONAZOLE
から入手可能:
PCO Manufacturing
投薬量:
100 Milligram
医薬品形態:
Capsules Hard
承認日:
2004-11-26
製品の特徴
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sporanox 100mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains itraconazole 100 mg.
Also contains sucrose.
For a full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
_Product imported from Greece:_
Gelatin capsule with 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
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/08/2011_
_CRN 2104693_
_page number: 1_
Treatment should not exceed four weeks
_Long-term usage:_
Dosage recommendations vary according to the infection treated.
Impaired absorption in AIDS and neutropenic patients may lead to low intraconazole blood levels and lack of efficacy.
In such cases, blood level monitoring is indicated.
_Use in children (below 12 years):
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