Страна: Израел
Език: английски
Източник: Ministry of Health
CLOTRIMAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC01
PASTE
CLOTRIMAZOLE 1 %
DERMAL
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
CLOTRIMAZOLE
CLOTRIMAZOLE
For treatment of abrasions and skin infections caused by species of fungi sensitive to clotrimazole .
2022-01-31
PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Agisten Paste 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1.0% w/w. Excipients with known effect: Wool fat. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white to cream colored paste for topical use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For treatment of abrasions and skin infections caused by species of fungi sensitive to clotrimazole 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 strip of paste ½ cm long is sufficient to treat an area about the size of a hand. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Do not use to treat nail or scalp infections. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid contact with the eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Laboratory tests have suggested that, when Clotrimazole paste is used together, this product may cause damage to latex contraceptives. Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product. 4.6 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 topic Прочетете целия документ