国家: 新加坡
语言: 英文
来源: HSA (Health Sciences Authority)
SERTACONAZOLE NITRATE
DCH AURIGA SINGAPORE
G01AF
300 mg
SUPPOSITORY
SERTACONAZOLE NITRATE 300 mg
VAGINAL
Pharmacy Only
Trommsdorff GmbH & Co, KG
ACTIVE
2002-04-29
PIL – PROPOSED PRISTINE ZALAIN VAGINAL SUPPOSITORY 300 MG PHARMACOLOGICAL ACTION Sertaconazole is a new topical broad-spectrum antifungal. It acts against pathogenic yeasts (Candida albicans, C tropicalis, C spp. Pityrosporum orbiculare), dermatophytes (Trichophyton, Epidermophyton and Microsporum) and gram-positive bacteria (Staphylococcus and Streptococcus). COMPOSITION Per vaginal suppository Sertaconazole nitrate ……………………………………………………………. 0.3g Excipients, q.s. …………………………………………………………………. 3.0g INDICATIONS Local treatment of vaginal candidiasis DOSAGE One vaginal suppository in the evening, to be inserted deeply into the vagina, preferably while lying down. If symptoms persist, repeat with a second vaginal suppository seven days after the first insertion. CONTRAINDICATIONS Known hypersensitivity to any imidazole antimycotic or to any of the excipients. Concomitant use of contraceptive diaphragm. INTERACTIONS The concomitant use with contraceptive diaphragm may cause the sheath or diaphragm to break during the insertion of the vaginal suppository (See Contraindications) The concomitant use with local spermicidal contraception is not recommended as the spermicide may be inactivated. PRECAUTIONS DURING TREATMENT Upon confirmation of diagnosis, etiological factors causing the infection should be investigated, and patients should be counseled so as to avoid future recurrence. Use soaps which are of neutral or alkaline pH when washing the outer genitals, as lower pH favours candidiasis. Practise good personal hygiene; wear preferably cotton underclothes; avoid vaginal douches. If mycosis occurs on the vulvar or perianal areas, 阅读完整的文件