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NerBloc Injection 1Vial×2500Units(B型肉毒杆菌毒素注射液)
药店国别  
产地国家 日本 
处 方 药: 是 
所属类别 2500単位/瓶 
包装规格 2500単位/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
卫材制药
生产厂家英文名:
Eisai Co.Ltd.
该药品相关信息网址1:
https://www.rxlist.com/myobloc-drug.htm
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:
NerBloc(ナーブロック筋注)2500Units/Vial
原产地英文药品名:
Botulinum Toxin Type B
中文参考商品译名:
NerBloc(ナーブロック筋注)2500単位/瓶
中文参考药品译名:
B型肉毒杆菌毒素
曾用名:
简介:

 

部份中文B型肉毒杆菌毒素处方资料(仅供参考)
英文名:Botulinum Toxin Type B
商品名:NerBloc Injection
中文名:B型肉毒杆菌毒素注射液
生产商:卫材制药
药品简介
2013年3月27日,卫材宣布,神经肌肉阻断剂NeuroBloc(botulinum toxin type B)在日本推出,将成为痉挛性斜颈的治疗方法的第一选择。
B型肉毒杆菌毒素是一种由B型肉毒梭菌厌氧菌产生的蛋白质。通过特异性作用于神经肌肉连接处的运动神经末梢,它抑制胆碱能神经末梢释放乙酰胆碱,并表现出肌肉放松作用。 
ナーブロック筋注2500単位
药效分类名称
B型肉毒杆菌毒素制剂
批准日期:2013年 3月
商標名
NerBloc for Intramuscular Injection
一般的名称
B型ボツリヌス毒素(Botulinum Toxin Type B)
本質
由B型肉毒杆菌产生的二硫键连接的一条重链(分子量约100000)和一条轻链(分子量约50000)组成的一分子神经毒素成分(分子量约150000)和五种非有毒成分(分子量约700000)
处理注意事项
打开外盒后,遮光存放(内容物会减少)。
可能会看到略微半透明至白色的细小颗粒,但这并不影响该药物的功效。如果发现任何其他外观异常,请勿使用。
不要剧烈振动小瓶,因为存在起泡和蛋白质聚集的风险。
审批条件
采取必要措施,使之只能由接受过本药课程、充分了解本药安全性和有效性、对本药注射程序有足够知识和经验的医师使用。
采取必要措施确保对该药物进行适当的药物管理,例如在使用该药物后安全可靠地停用/处置,以及妥善保存其记录。
药效药理
作用机制
据认为,泊马度胺通过在末梢神经肌肉接头处的神经末梢中切割参与乙酰胆碱释放的蛋白质突触短蛋白来抑制神经肌肉传递,并表现出肌肉松弛作用。
肌肉收缩抑制作用
当对猴子的斜方肌和腓肠肌施用泊马度胺时,副神经和胫神经刺激的动作电位分别以剂量依赖性方式被抑制。
肌肉松弛作用
当将泊马度胺施用于小鼠的腓肠肌时,观察到剂量依赖性的后肢肌肉麻痹。
适应症
痉挛性斜颈
用法用量
对于成人,将以下剂量的B型肉毒杆菌毒素肌肉注射到张力肌注。如果有多个音调肌肉,则分次给药。
对于第一剂,总共将施用2500-5000单位。
在效果不充分或症状复发的情况下,可以重新给药至多10000单位。但是,避免在2个月内重新给药。
注)张力肌:胸锁乳突肌、斜角肌、斜方肌、肩胛提肌、头脾肌、头半棘肌等。
包装
2500 单位 [1瓶]
制造商(进口商)
卫材株式会社
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/1229406A1022_1_04/?view=frame&style=XML&lang=ja
---------------------------------------------
NerBloc for Intramuscular Injection(Botulinum toxin type B)
Brand name :NerBloc for Intramuscular Injection 2500Units
 Active ingredient:Botulinum toxin type B
 Dosage form:injection
 Print on wrapping:Effects of this medicine
This medicine suppresses muscle tension.
It is usually used to treat cervical dystonia.
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 are treated with an injection of Botulinum toxin at other medical institution.If you have diseases such as generalized muscle weakness.If you have respiratory dysfunction, or severe muscle weakness or atrophy.If you are taking muscle-relaxing medicine or medicine acting on muscle relaxation.
If you are pregnant, possibly 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, for adults, inject this medicine intramuscularly. If you have multiple sites with muscle tension, inject separately.
If its effect is insufficient or recurrent symptoms appear, this medicine may be re-injected. However, avoid re-injecting within 2 months.
Effects of this medicine usually continue for 3 to 4 months. As the effects gradually disappear and return to the state prior to the injections, inject this medicine repeatedly at an interval of 3 to 4 months.
Precautions while taking this medicine
This medicine may cause adverse drug reactions such as lassitude, muscle weakness, dizziness and reduced visual acuity. Pay attention when operating machinery such as driving a car.
If you had any restrictions on your daily activities before treatment, avoid performing physical exertion with excessive muscular contraction and resume activities gradually after starting an injection of this medicine.
Since similar medicines have been reported to have toxicity,male patients and female patients who have a possibility of pregnancy should use adequate contraception.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include swallowing disorder,thirst and dry mouth.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.
respiratory distress, respiratory distress on exertion, shortness of breath [respiratory distress]
skin itching, hives, hoarse voice, sneezing, itching throat, breathing difficulty, palpitation, confused consciousness[anaphylactoid symptoms]
difficulty in swallowing foods[swallowing disorder]
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
Injection
Published: 3/2013
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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