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Edaravone infusion 30mg,5bag×100ml(依达拉奉点滴静注液「サワイ」)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 30毫克 袋×100毫升 
包装规格 30毫克 袋×100毫升 
计价单位: 盒 
生产厂家中文参考译名:
泽井制药
生产厂家英文名:
Sawai Pharmaceutical Co.Ltd.
该药品相关信息网址1:
http://www.info.pmda.go.jp/go/pack/1190401G1034_1_05/
该药品相关信息网址2:
该药品相关信息网址3:
原产地英文商品名:
Edaravone(エダラボン点滴静注液バッグ「サワイ」)30mg 5bag×100ml
原产地英文药品名:
EDARAVONE
中文参考商品译名:
Edaravone(エダラボン点滴静注液バッグ「サワイ」)30毫克 5袋×100毫升
中文参考药品译名:
依达拉奉
曾用名:
简介:

 

部份中文依达拉奉处方资料(仅供参考)
商品名:Edaravone infusion
英文名:Edaravone
中文名:依达拉奉点滴静注液
生产商:泽井制药
药品简介
依达拉奉是日本三菱-东京制药公司开发的具有新型作用机制的脑保护剂,静脉注射后优先分布在脑中,为高效自由基清除剂及过氧化反应抑制剂。2001年4月4日在日本获得批准,6月上市,适应症为改善急性脑梗塞期的脑神经症状及机能障碍,剂型为水针(20ml:30mg),商品名“RADICUT”。
Edaravone(依达拉奉)是一种脑保护剂(自由基清除剂)。临床研究提示N-乙酰门冬氨酸(NAA)是特异性的存活神经细胞的标志,脑梗塞发病初期含量急剧减少。
エダラボン点滴静注液30mgバッグ「サワイ」
药效分类名称
脑保护剂(自由基清除剂)
批准日期:2011年6月
商品名
EDARAVONE
一般名
エダラボン(Edaravone)
化学名
5-Methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one
分子式
C10H10N2O
分子量
174.20
融点
127-131℃
構造式
性状
依达拉奉为白色至微黄白色结晶或结晶性粉末。易溶于乙醇(99.5)或醋酸 (100),微溶于水。
处理注意事项
处理软袋的注意事项
(1) 由于除氧剂是密封的以保持产品的稳定性,所以在使用前不要打开外袋。另外,开封后请立即使用。
(2) 请勿在以下情况下使用。
1) 如果外袋损坏。
2)当氧气检测仪(粉红色)在打开前颜色从蓝紫色变为蓝色时。
3) 当水滴或化学品泄漏到外袋内时。
4) 药液有色或混浊时。
5) 如果密封出口的薄膜剥落。
(3)使用时,将密封出水口的薄膜去掉。
(4)穿刺时,将橡皮塞的穿刺部分(凹部)笔直穿刺。如果斜刺,可能会刮伤排料口内壁,切屑可能混入药液或刺破排料口侧壁,造成漏液。
不要反复刺伤同一部位。
(5) 不要使用残留液体。
(6) 使用容器的刻度作为粗略的指南。
稳定性测试
使用该包装产品进行加速试验(40℃、75%RH、6个月)后,估计在正常市场流通情况下可稳定使用3年。
药效药理
依达拉奉清除在缺血和缺血再通期间增加的有害自由基,并抑制细胞膜磷脂中不饱和脂肪酸过氧化引起的细胞损伤。 这抑制了脑梗塞急性期缺血性脑血管意外的发生和发展,并显示出脑保护作用。
适应症
改善与脑梗塞急性期相关的神经症状、日常生活活动和功能障碍
用法与用量
成人在使用时用适量生理盐水等稀释1管(依达拉奉30mg),每天早晚2次,每次30分钟以上静脉滴注。
应在发病后24小时内开始给药,给药期应在14天内。
包装
5袋
制造商和分销商
泽井制药株式会社
注:以上中文处方资料不够完整。使用者以原处方资料为准。
完整说明资料附件:
https://www.info.pmda.go.jp/go/pack/1190401G1085_1_07/
--------------------------------------------------
Brand name: EDARAVONE I.V. DRIP INFUSION BAG 30mg
 Active ingredient: Edaravone
 Dosage form: injection
 Print on wrapping:
Effects of this medicine
This medicine protects brain by scavenging free radicals which increase in region with poor blood flow.
It is usually used to improve neurological symptoms associated with cerebral infarction and performance impairment or functional disorder in daily life.
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 renal disorder, hepatic disorder, heart disorder or infectious disease.
If you are depressed consciousness or impaired mind.
•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, administer intravenously with an infusion over 30 minutes twice a day.
The treatment span will be determined while watching your symptoms, but not exceeded 14 days.
Precautions while taking this medicine
•You will be received blood tests frequently for checking your renal, hepatic and blood function, the number of times depends on your symptoms.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include feeling of warmth and elevation of blood pressure. 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.
•decreased urine output, swelling, headache[acute renal failure, nephrotic syndrome]
•loss of appetite, malaise, vomiting [severe hepatitis, impaired liver function, jaundice]
•fever, malaise, bleeding tendency (nose/gum/subcutaneous bleeding, etc.) [thrombocytopenia, granulocytopenia, disseminated intravascular coagulation]
•reddish brown urine, muscle pain, feeling of weakness [rhabdomyolysis]
•rash, respiratory distress, dizziness on standing up [shock, anaphylaxis]
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.
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. 

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