英文药名:Edaravone inj(Edaravone)
中文药名:依达拉奉注液剂
生产厂家:日本富士制药
エダラボン点滴静注液30mg「F」
药物分类名称 脑保护剂(自由基清除剂) 批准日期:2012年8月 商標名 Edaravone inj 30mg 一般名 エダラボン(Edaravone) 化学名 5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one 構造式
分子式 C10H10N2O 分子量 174.20 性状 白色至淡黄色白色结晶或结晶性粉末。 易溶于乙醇(99.5)或乙酸(100),难溶于水。 熔点 127〜131℃ 操作注意事项 稳定性测试 使用最终包装产品的加速试验(40±1℃,相对湿度75±5%,6个月)的结果是,在正常市场流通下,30mg“F”的依达拉奉IV输注液稳定3年 这是推测。 药效药理 依达拉奉是一种脑保护剂。 通过消除自由基,抑制细胞膜脂质过氧化是有效的。 它被用于脑梗塞的急性期。 适应病症 伴随脑梗塞急性期的神经症状改善,日常生活功能障碍,功能障碍。 用法与用量 正常情况下,一瓶(依达拉奉30mg)用适量的生理盐水稀释,成人一次使用,早晚各30分钟,每天两次静脉滴注。 发病后24小时内开始用药,用药时间14天以内。 包装规格 30毫克/20毫升 10瓶/盒
制造商 富士制药公司 注:以上中文资料不够完整,使用者以原处方资料为准。 完整说明书附件:http://www.info.pmda.go.jp/go/pack/1190401G1204_1_04/ Edaravone(依达拉奉)一种高效自由基清除剂,具有较广的治疗谱,目前已批准的临床适应症除用于改善急性期缺血性脑梗死的各种症状和机能障碍外,对于脑部蛛网膜下腔出血急性期、脑梗水肿,脑神经细胞损伤,中风后遗症等方面均有较为显著的治疗效果。 Edaravone Clinical Studies Pharmacological and clinical studies have shown that: Edaravone (Edaravone) is one of the most effective treatment of cerebral infarction, is the first-line treatment of cerebral infarction. Compared with other commonly used drugs in clinical, the drug has the following characteristics: 1, high-effect - pharmacological and clinical studies have shown that the drug can significantly reduce the extent of cerebral infarction lesions, increased peripheral blood flow lesions, reduce cerebral edema, reduce nerve cell death, so that patients with symptoms improved significantly, patients with severe cerebral infarction The effective rates of medication in 72 hours and 24 hours were 64.8% and 73.8%, respectively, which became the first-line drug for the acute phase of cerebral infarction after being listed in various countries, and its clinical application has been rapidly increasing 2, broad-spectrum effect - edaravone is a highly effective free radical scavenger, has a broad spectrum of treatment, the current approved clinical indications used in addition to improving the symptoms of acute ischemic cerebral infarction and Dysfunction, the brain subarachnoid hemorrhage in acute stage, cerebral infarction edema, brain nerve cell injury, stroke sequelae and other aspects have a more significant therapeutic effect. The company is located in: 3, low toxicity - According to hundreds of thousands of clinical reports at home and abroad show: Edaravone side effects of low toxicity, the main side effects are mild liver dysfunction, AST, ALT, LDH may rise, but the stop After the medicine will disappear. Clinical studies have shown that: each 20- 30mg, 1-2 times a day, continuous medication after 14 days no obvious side effects; prognosis in the acute phase after the rehabilitation process, each 10mg, 1-2 times a day dose of medication , The incidence of side effects is even lower. 4, the unique mechanism of action - This product is a new brain neuroprotective agent, which can quickly clear brain free radicals to protect the brain tissue, reduce nerve damage, can effectively clear the brain lesions of various free radicals , Inhibit the activity of 15-HPETA, which can effectively protect the brain cells from damage, protect the normal physiological function of patients and prevent the occurrence of nerve injury in patients with disabilities, is the only clear mechanism of action and target for the treatment of cerebral infarction drugs, It can also be applied to cerebral thrombosis which can not be treated by anticoagulant drugs and to have thrombosis tendency. This product can significantly improve the post-disease brain dysfunction (today the medical profession to evaluate the gold standard of such products, one), to reduce sequelae, to promote cerebral nerve function recovery after cerebral infarction is of far-reaching significance. The company is located in: 5. The preparation is stable and reliable - A large number of prescriptions of edaravone preparations are screened by scientific methods. The finished products are stable and clear and can be stored at room temperature for a long time. The products are stored for 3 years without any degradation products under long-term room temperature. Long-term preservation of the clarity of the product under the Pharmacopoeia requirements, reducing the circulation of this product after the market risk. Research and listing at home and abroad: Edaravone, developed by Mitsubishi-Tokyo Pharmaceuticals Inc., undergoes a number of very rigorous and innovative pharmacological studies in pharmacology, toxicology and clinical applications. Pharmacodynamics results show that the drug anti-ischemic brain lipid peroxidation, scavenging free radicals, inhibition of free radicals caused by lipid peroxidation and necrosis, the brain damage caused by cerebral ischemia has the exact effect. Is the first-line treatment of cerebral infarction.
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