البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
CLOTRIMAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC01
SOLUTION
CLOTRIMAZOLE 1 %
DERMAL
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
CLOTRIMAZOLE
CLOTRIMAZOLE
Skin infection caused by dermatophytes or candida species.
2014-05-31
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agisten ® Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1.0% w/v. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Colourless to slightly yellowish liquid solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Skin infections caused by dermatophytes or candida species. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION To ensure complete healing, treatment should be continued for about 2 weeks after the disappearance of the subjective symptoms. The following are the usual periods of treatment: Dermatomycoses 3-4 weeks Erythrasma 2-4 weeks Pityriasis versicolor 1-3 weeks Candida vulvitis and balanitis 1-2 weeks A thin layer should be applied to the affected sites and gently rubbed in 2-3 times daily. A few drops is sufficient to treat an area about the size of a hand. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance clotrimazole or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Not known 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Not known 4.6 FERTILITY, PREGNANCY AND LACTATION Fertility: No human studies of the effects of clotrimazole on fertility have been performed; however, animal studies have not demonstrated any effects of the drug on fertility. Pregnancy: There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician. Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be اقرأ الوثيقة كاملة