部份甲硝唑中文处方资料(仅供参考) 治疗类别名称 癌性皮肤溃疡气味改良剂 批准上市日期:2015年5月 商標名 Rozex Gel 0.75% 一般名 メトロニダゾール Metronidazole(JAN)[日局] 化学名 2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol 分子式 C6H9N3O3 分子量 171.15 化学構造式
性 状 白色是一个很好的淡黄白色结晶或结晶性粉末。 易溶于乙酸(100),乙醇(99.5),或稍少溶于丙酮,微溶于水。 它可溶于稀盐酸中。 它是由光晒黑。 熔点 159〜163℃ 分配係数 0.81[pH7.4的,1 - 辛醇/缓冲] 操作注意事项 不要让冻结。 审批条件 在制定药品风险管理计划,正确实施。 适应病症 用于炎症性丘疹、脓包疮、酒渣鼻红斑的局部治疗。 用法用量 局部外用,清洗患处后,取适量本品涂于患处,每日早晚各1次。酒渣鼻红斑以2周为1疗程,连用8周。炎症性丘疹、脓庖以4周为1疗程 包装规格 凝胶:0.75%:50克(管)
制造厂商 高德美有限公司[GALDERMA CO.,LTD] 完整资料附件:http://www.info.pmda.go.jp/go/pack/2699713Q1026_1_02/ Rozex Gel 0.75%(Metronidazole) Rozex Gel 0.75%(ロゼックスゲル0.75%) Brand name : Rozex Gel 0.75% Active ingredient: Metronidazole Dosage form: colorless to faint yellow, viscous and homogenous gel Print on wrapping: Effects of this medicine This medicine demonstrates antibacterial action against several species of Gram-negative and Gram-positive anaerobic bacteria that produce malodorous substances (putrescine, cadaverine) in the cutaneous ulcer sites. It is usually used for reducing the malodor generated in cancerous cutaneous ulcers. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: a blood disorder, an organic disorder in the brain or spinal cord. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, apply an appropriate amount according to the symptoms and lesion size: after cleaning up the area, put the medicine on gauze, etc., and apply to the affected area, or apply the medicine directly to the affected area, and cover with gauze, etc., once or twice a day as needed. Strictly follow the instructions. •If the applied area is extensive, systemic adverse drug reactions such as peripheral nerve disorders (motor paralysis, sensory paralysis, numbness in hands and feet, and pain in hands and feet), central nervous system disorders (headache, phonation difficulty, tremor of hands and feet, decreased mental concentration, and amnesia/loss of memory ability), decreased white blood cell, and decreased neutrophil (fever and sore throat) may develop. If you feel some abnormalities, consult with your doctor or pharmacist. •Be careful when replacing gauze, etc. as irritation of the affected areas may cause bleeding at ulceration sites. •If irritative symptoms occur, reduce frequency of the application, temporarily stop the application, or seek medical advice. •Do not taste or drink this medicine. •If you accidentally use more than your prescribed dose, consult with your doctor or pharmacist. •Do not stop using this medicine unless your doctor instructs you to do so. Precautions while taking this medicine •Avoid drinking alcohol while using this medicine, because some cases show psychological symptom, colicky abdominal pain, emesis or flushing. •Avoid UV exposure (sunbathing or sunlamps, etc.) while using this medicine. UV exposure may decrease efficacy. Possible adverse reactions to this medicine The most commonly reported adverse reactions include bleeding from ulcer sites. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. No pertinent entries. The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information •Keep this medicine clean. Keep it out of the reach of infants and children. Store at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture. Do not freeze. •Discard the remainder. Do not store. Galderma K.K.External Published: 4/2015 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. |