Страна: Израиль
Язык: английский
Источник: Ministry of Health
BIFONAZOLE; UREA
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
D01AC10
OINTMENT
UREA 40 %; BIFONAZOLE 1 %
NAIL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
BIFONAZOLE
BIFONAZOLE
For nail stripping and antifungal treatment of fungal infections of the finger nails and toe nails.
2022-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only. AGISPOR ONYCHO-SET/KERATOSPOR OINTMENT EACH TUBE CONTAINS: BIFONAZOLE 1% UREA 40% Inactive ingredients and allergens 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. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THIS MEDICINE INTENDED FOR? Antifungal preparation for the treatment of fungal infections of the fingernails and toenails and for nail stripping. THERAPEUTIC GROUP Bifonazole - imidazole antifungal. Urea – an organic compound for treatment of dry skin. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: if you are sensitive (allergic) to the active ingredients or to any of the other ingredients in the medicine. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH AGISPOR ONYCHO-SET/KERATOSPOR, INFORM THE DOCTOR IF • you have a known sensitivity to antifungals from the imidazole group such as: econazole, clotrimazole, miconazole. • you are sensitive to any food or medicine. IF YOU ARE TAKING, OR HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, INFORM THE DOCTOR OR PHARMACIST. It is particularly important to inform the doctor or pharmacist if you are taking warfarin. PREGNANCY AND BREASTFEEDING If you are pregnant, consult a doctor. Use of this preparation is not recommended in the first trimester of pregnancy. Do not use if you are breastfeeding. USE IN CHILDREN AND INFANTS Use in children and toddlers must be done under medical supervision. IMPORTANT INFORMATION REGARDING SOME OF THE INGREDIENTS OF THE MEDICINE The medicine contains wool wax (=wool fat). Avoid contact Прочитать полный документ
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT AGISPOR Cream, solution, gel, shampoo AGISPOR ONYCHOSET Nail ointment KERATOSPOR Nail ointment 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1. PREPARATIONS QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) (INN): Cream, cutaneous solution, gel, shampoo: Bifonazole Ointment: Bifonazole in combination with urea QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT(S) PER DOSAGE FORM _ _ _ _ 1g cream contains 10 mg bifonazole 1 ml cutaneous solution contains 10 mg bifonazole 1 g gel contains 10 mg bifonazole 1 g shampoo contains 10 mg bifonazole 1 g nail ointment contains 10 mg bifonazole and 400 mg urea _ _ 3. PHARMACEUTICAL FORM 3.1. PREPARATIONS Pharmaceutical formulation in accordance with standardized terminology: Cream Cutaneous solution Gel Shampoo Ointment 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS AGISPOR CREAM, SOLUTION AND GEL: Broad spectrum antimycotic agent. AGISPOR SHAMPOO: Pityriorisis versicolor and sebarrrhoeic dermatitis of the scalp caused by pityrosporum. AGISPOR ONYCHOSET AND KERATOSPOR NAIL OINTMENT: For nail stripping and antifungal treatment of fungal infections of the finger nails and toe nails. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION AGISPOR CREAM, SOLUTION AND GEL: Posology: To achieve a lasting cure, treatment with AGISPOR cream, solution and gel must be carried out reliably and over an adequate period. The usual periods of treatment are summarized in the table below: INDICATION DURATION OF TREATMENT Foot mycoses (Tinea pedis, tinea pedum interdigitalis) 3 weeks Mycoses of the trunk, hands and skin folds (Tinea corporis, tinea manuum, tinea inguinalis) 2-3 weeks Pityriasis versicolor 2 weeks Erythrasma 2 weeks Superficial candidiasis of the skin 2-4 weeks Method of administration: Cream, solution or gel is used once a day, preferably in the evening, before retiring. It should be applied thinly to the affected skin area and rubbed in. Cream: A small amount of cream is generally sufficient to treat an ar Прочитать полный документ