البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
METHYLBENZETHONIUM CHLORIDE; PAROMOMYCIN AS SULFATE
TEVA ISRAEL LTD
A07AA06
OINTMENT
METHYLBENZETHONIUM CHLORIDE 12 %W/W; PAROMOMYCIN AS SULFATE 15 %W/W
TOPICAL
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
PAROMOMYCIN
PAROMOMYCIN
Topical treatment of cutaneous leishmaniasis.
2023-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only LESHCUTAN ® OINTMENT COMPOSITION Paromomycin )as sulfate( 15% Methylbenzethonium chloride 12% For information on inactive ingredients, see section 6 – “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS 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 for the treatment of your ailment. 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 THE MEDICINE INTENDED FOR? Topical treatment of cutaneous leishmaniasis. THERAPEUTIC GROUP: Paromomycin: aminoglycoside antibiotic. Methylbenzethonium chloride: quaternary ammonium with antimicrobial activity. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE: • If there is a known sensitivity to any of its ingredients or to neomycin. • Do not use in the eyes. • Do not use in the external ear in case of a perforated eardrum. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: DO NOT USE THE MEDICINE WITHOUT CONSULTING A DOCTOR BEFORE STARTING TREATMENT: • If you are pregnant or breastfeeding. • If you are suffering, or have suffered in the past, from impaired function of the liver, kidney/urinary system or hearing. • If you are sensitive to any food or medicine, such as neomycin, inform the doctor before taking the medicine. DRUG INTERACTIONS: IF YOU ARE TAKING, OR IF YOU HAVE RECENTLY TAKEN, OTHER MEDICINES, INCLUDING NON-PRESCRIPTION MEDICINES AND NUTRITIONAL SUPPLEMENTS, TELL THE DOCTOR OR PHARMACIST. PREGNANCY, BREASTFEEDING AND FERTILITY Do not use the preparation if you are pregnant or breastfeeding without consulting a doctor before starting treatment. 3. HOW SHOULD YOU USE THE MEDICINE? Always use the medicine according to the doctor’s instructions. Check with the doctor or p اقرأ الوثيقة كاملة
lesh,4.3.97,zk IDC SUMMARY OF PRODUCT CHARACTERISTICS LESHCUTAN OINTMENT 1. NAME OF MEDICAL PRODUCT LESHCUTAN OINTMENT OINTMENT 2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION _Active Ingredients _ Paromomycin (as sulfate) 15% Methylbenzethonium chloride 12% For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Ointment White yellowish ointment 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Topical treatment of cutaneous leishmaniasis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The ointment should be applied twice daily for a period of 10 days. If complete healing has not occurred after 10 days of therapy, an additional 10-day course of treatment may be recommended. If unacceptable severe local reactions occur, treatment may be interrupted for 2-3 days and resumed after symptoms have subsided. METHOD OF ADMINISTRATION The affected area should be cleaned. The ointment should completely cover the lesion. The lesion may then be covered with a sterile bandage. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the active ingredients or to any of the excipients listed in section 6.1. The preparation is not intended for ophthalmic use nor should it be applied in the external auditory canal of patients with perforated eardrum. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 2 Leshcutan Ointment FW Minor updates 01-2022 Caution should be exercised in the administration of Leshcutan to patients sensitive to neomycin. Caution should be exercised in patients with renal, hepatic or hearing impairment because of possible accumulation of paromomycin, which is potentially nephrotoxic and ototoxic. Leshcutan should not be used over a wide area or for extended periods of time, because of the risk of nephrotoxicity and ototoxicity associated with aminoglycoside antibiotics. Ototoxicity and nephrotoxicity have been reported with the topical use of neomycin. If unacceptable severe local reactions occur, treatment may be interrupted for 2- 3 days and resumed after symptoms have subsided . 4.5 INT اقرأ الوثيقة كاملة