국가: 이스라엘
언어: 영어
출처: Ministry of Health
CLOTRIMAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC01
CREAM
CLOTRIMAZOLE 1 %W/W
DERMAL
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
CLOTRIMAZOLE
CLOTRIMAZOLE
For the treatment of fungal infections of the skin and mucosa caused by dermatophytes, yeasts, molds and other fungi such as Malassezia furfur, as well as skin infections caused by Corynebacterium minutissimum.Indicated also for Candida Vulvitis and Candida balanitis.
2014-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription AGISTEN ALOEVERA CREAM CLOTRIMAZOLE 1% Inactive and allergenic ingredients in the preparation – see section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Use this medicine in the correct manner. Consult the pharmacist if you need further information. Refer to the doctor if symptoms of the illness worsen or if they do not improve after 4 weeks. 1. WHAT IS THE MEDICINE INTENDED FOR? For the treatment of skin infections caused by dermatophytes or Candida strains. Agisten Aloevera Cream is intended for the treatment of skin fungi and jock itch. The preparation treats a variety of fungal strains, which may appear in different parts of the body; the feet and toes, armpits, groin, skin folds and other areas of the skin. THERAPEUTIC GROUP: An antifungal preparation of the imidazole group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: ∙ if you or your child are sensitive )allergic( to the active ingredient, cetostearyl alcohol or any of the additional ingredients contained in the medicine. ∙ for treatment of infections of the scalp or nails. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE As with other creams, Agisten Aloevera Cream may lower the effectiveness of contraceptives made of rubber, such as a condom or diaphragm. Therefore, if the medicine is intended for use on the genitals, use an alternative contraceptive for at least five days after using this medicine. Do not use this medicine often or for a prolonged period without consulting a doctor. Avoid contact of the preparation with the eyes and mouth. In case of contact with the eyes or mouth, wash thoroughly with water and refer to a doctor. BEFORE TREATMENT WITH AGISTEN ALOEVERA CREAM, TELL THE DOCTOR IF: ∙ You are not sure if you )or your ba 전체 문서 읽기
PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Agisten Aloevera Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Clotrimazole 1.0% w/w. Excipient with known effect: cetostearyl alcohol For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM A white cream for topical use. 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 times daily. A strip of cream 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, including cetostearyl alcohol. Do not use the cream to treat nail or scalp infections. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Agisten Aloevera cream contains cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis). Avoid contact with the eyes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Laboratory tests have suggested that, when Clotrimazole cream 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 repr 전체 문서 읽기