দেশ: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BIFONAZOLE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC10
SOLUTION
BIFONAZOLE 1 %W/V / 100 ML
DERMAL
Not required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
BIFONAZOLE
BIFONAZOLE
Broad spectrum antimycotic agent.
2023-10-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed without a doctor’s prescription AGISPOR CREAM, GEL, SOLUTION EACH AGISPOR TUBE OF CREAM OR GEL OR BOTTLE OF SOLUTION CONTAINS: BIFONAZOLE 1% 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. Refer to the doctor if the symptoms worsen or if they do not improve within 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Broad spectrum antifungal medicine. THERAPEUTIC GROUP: Imidazole antifungal. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • if you are sensitive )allergic( to the active ingredient or to any of the other ingredients in the medicine. • for treatment of diaper rash. If your baby has a diaper rash, refer to a doctor for appropriate treatment. • for treatment of inflammation of the nails and scalp. • f o r t re a t m e n t o f v a g i n a l inflammations. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH AGISPOR, INFORM THE DOCTOR IF • you have previously had an allergic reaction to any kind of antifungal agent. • AGISPOR SOLUTION: WARNING! FLAMMABLE, KEEP AWAY FROM FIRE. DO NOT LIGHT A CIGARETTE OR BE EXPOSED TO AN OPEN FLAME UNTIL THE PRODUCT HAS COMPLETELY DRIED. 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 Do not use the medicine if you are pregnant or breastfeeding, except with the doctor’s recommendation. USE IN CHILDREN AND INFANTS Use in infants and toddlers must be done under medical supervision. IMPORTANT INFORMATION REGARDING SOME OF THE INGREDIENTS OF THE MEDICINE The medicine contains cetyl সম্পূর্ণ নথি পড়ুন
PRESCRIBING INFORMATION 1. NAME OF THE MEDICINAL PRODUCT AGISPOR SOLUTION AGISPOR GEL 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ 1 ml solution contains 10 mg bifonazole 1 g gel contains 10 mg bifonazole For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution Gel 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Broad spectrum antimycotic agent. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION AGISPOR SOLUTION AND GEL: Posology: To achieve a lasting cure, treatment with AGISPOR 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: 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. Solution: A few drops (about 3 drops) is generally sufficient to treat an area of about the size of the palm of the hand. Gel: A strip of gel (1/2 cm long) is generally sufficient to treat an area of about the size of the palm of the hand. USE IN CHILDREN No in-depth studies have been performed in children. From a survey of the clinical data reported there is no indication that harmful effects should be anticipated in children. However, in infants and toddlers, Agispor should only be used under medical supervision. 4.3. CONTRAINDICATIONS Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 Agispor solution is not suitable for use in the ear canal. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) should use bifonazole containing products with cautio সম্পূর্ণ নথি পড়ুন