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Nimbex injection 2mg/ml 10ml(苯磺顺阿曲库铵注射液)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 20毫克/10毫升/瓶 
包装规格 20毫克/10毫升/瓶 
计价单位: 瓶 
生产厂家中文参考译名:
AbbVie Inc
生产厂家英文名:
AbbVie Inc
该药品相关信息网址1:
https://www.rxlist.com/nimbex-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:
Nimbex injection 2mg/ml VL 10ml/Vial
原产地英文药品名:
cisatracurium besylate
中文参考商品译名:
Nimbex注射液 20毫克/10毫升/瓶
中文参考药品译名:
苯磺顺阿曲库铵
曾用名:
简介:

 

NIMBEX是一种用于成人和1个月及以上儿童的外科手术新药。 也适用于需要重症监护的成年人。它可以作为全身麻醉的辅助手段,或在重症监护病房(ICU)中镇静,以放松横纹肌,促进气管插管和辅助通气。
批准日期:2010年12月9日 公司:AbbVie Inc.
NIMBEX(苯磺顺阿曲库铵[cisatracurium besylate])注射液,用于静脉注射
美国最初批准:1995年
最近的重大变化
剂量和用法:7/2018
警告和注意事项,残余麻痹:7/2018
警告和注意事项,药物治疗错误导致的死亡风险:7/2018
作用机制
NIMBEX与运动终板上的胆碱能受体竞争性结合,以拮抗乙酰胆碱的作用,从而阻断神经肌肉传递。 这种作用被乙酰胆碱酯酶抑制剂如新斯的明拮抗。
适应症和用法
NIMBEX是一种非去极化神经肌肉阻滞剂,表明:
作为全身麻醉的辅助手段,以促进成人和1个月至12岁的儿科患者的气管插管。
在成人和2至12岁的儿科患者手术期间提供骨骼肌松弛作为推注金输注维持。
用于成人ICU的机械通气。
使用限制:
NIMBEX不建议用于快速序列气管内插管,因为其开始起效所需的时间。
剂量和用量
仅由熟悉药物作用和可能的并发症的有经验的临床医生监督或在其监督下进行静脉内给药。
仅在个人和复苏和生命支持设施以及NIMBEX拮抗剂立即可用时使用。
通过剂量滴定使用外周神经刺激,以确定阻断的充足(例如,需要额外的剂量),最小化过量或underdosage的风险,从封锁,暴露潜在限于有毒代谢产物回收的评估程度和促进NIMBEX的更快速逆转-诱发瘫痪
请参阅完整处方信息:
成人剂量和给药说明,儿童患者,老年患者,神经肌肉疾病,烧伤,终末期肾病和冠状动脉患者进行搭桥手术引起的体温过低。
持续输注率。
准备说明。
药物相容性。
剂量形式和强度
注:
单剂量小瓶中10mg/5mL(2mg/mL)。
20mg/10mL(2mg/mL)和苄醇作为多剂量小瓶中的防腐剂。
单剂量小瓶中200mg/ 20mL(10mg/mL)。
禁忌症
已知对顺式阿曲库铵的超敏反应。
10mL多剂量小瓶含有苯甲醇,禁用于1个月以下的儿科患者和低出生体重儿。
警告和注意事项
残余麻痹:神经肌肉疾病患者的风险更高。使用较低的初始推注剂量并考虑这些患者的逆转剂。
苄醇:当与10mL多剂量小瓶组合用于婴儿时。
癫痫发作风险:长期接触有毒代谢物时对神经肌肉阻滞的综述。
超敏反应和过敏反应:已报道包括过敏反应在内的严重超敏反应。考虑神经肌肉阻滞剂之间的交叉反应性,去极化和非去极化。
药物治疗错误导致死亡风险:意外管理可导致死亡。
麻醉不足:在适当镇静或全身麻醉的情况下使用NIMBEX并监测患者以确保麻醉水平充足。
不良反应
最常见的不良反应(0.1%至0.4%)是心动过缓,低血压,潮红,支气管痉挛和皮疹。
包装提供/存储和处理
NIMBEX 2MG/ML VL 10ML    CISATRACURIUM BESYLATE  ABBVIE US LLC  74438010 
NIMBEX 2MG/ML VL 5ML    CISATRACURIUM BESYLATE  ABBVIE US LLC  74437805 
NIMBEX 10MG/ML SDV 20ML   CISATRACURIUM BESYLATE  ABBVIE US LLC  74438220 
存储
在纸箱中将NIMBEX冷藏在2°至8°C(36°至46°F),以保持效力。避光。不要冻结。 (25°C/77°F),即使重新冷藏,也要在21天内使用NIMBEX。
Nimbex(cisatracurium besylate)injection
INDICATION AND IMPORTANT SAFETY INFORMATION FOR NIMBEX® (cisatracurium besylate)
INDICATION1
NIMBEX® (cisatracurium besylate) is indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age; to provide skeletal muscle relaxation in adults during surgical procedures or mechanical ventilation in the ICU; and to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older. NIMBEX is not recommended for rapid sequence endotracheal intubation.
IMPORTANT SAFETY INFORMATION1
NIMBEX is contraindicated in patients with known hypersensitivity to cisatracurium; severe anaphylactic reactions have been reported. The use of 10-mL NIMBEX multiple-dose vials is contraindicated in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol.
NIMBEX has been associated with residual paralysis; patients with neuromuscular disease and carcinomatosis may be at higher risk. A lower maximum initial bolus is recommended in these patients to prevent complications.
Serious and fatal adverse reactions including “gasping syndrome,” which is characterized by central nervous system depression, metabolic acidosis, and gasping respirations, can occur in neonates and infants treated with benzyl alcohol–preserved drugs, including NIMBEX 10-mL multiple-dose vials. Single-use vials (5-mL and 20-mL) of NIMBEX do not contain benzyl alcohol.
Laudanosine, an active metabolite of NIMBEX, has been shown to cause seizures in animals. NIMBEX-treated patients with renal or hepatic impairment may have higher metabolite concentrations (including laudanosine) than patients with normal renal and hepatic function.
Patients with renal or hepatic impairment receiving extended administration of NIMBEX may be at higher risk of seizures. The level of neuromuscular blockade during long-term NIMBEX administration should be monitored with a nerve stimulator to titrate NIMBEX administration to the patient’s needs and limit exposure to toxic metabolites.
Severe hypersensitivity reactions to NIMBEX have been reported, including life-threatening and fatal anaphylactic reactions. There have been reports of wheezing, laryngospasm, bronchospasm, rash, and itching following NIMBEX administration in pediatric patients. Precaution should be taken in those individuals who have had previous anaphylactic reactions to other neuromuscular blocking agents.
Confirm proper selection of intended product, avoid confusion with other injectable solutions, and ensure that the intended dose is clearly labelled and communicated. Administration of NIMBEX results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended.
Neuromuscular blockade in the conscious patient can lead to distress. Use NIMBEX in the presence of appropriate sedation or general anesthesia. Monitor patients to ensure that the level of anesthesia is adequate.
The 20-mL vial of NIMBEX is intended only for administration as an infusion for use in a single patient in the ICU.
It should not be used multiple times because it does not contain a preservative, and there is a higher risk of infection.
Certain drugs may enhance the neuromuscular blocking action of NIMBEX, including inhalational anesthetics, antibiotics, magnesium salts, lithium, local anesthetics, procainamide, and quinidine.
Acid-base and/or serum electrolyte abnormalities may potentiate the action of neuromuscular blocking agents. Shorter durations of neuromuscular block may occur and NIMBEX infusion rate requirements may be higher in patients chronically administered phenytoin or carbamazepine. Use peripheral nerve stimulation and monitor clinical signs of neuromuscular blockade to determine adequacy of neuromuscular blockage and the need to adjust the NIMBEX dosage.
NIMBEX has not been studied in patients susceptible to malignant hyperthermia (MH). Because MH can develop in the absence of established triggering agents, the clinician should be prepared to recognize and treat MH in any patient undergoing general anesthesia.
The use of succinylcholine prior to NIMBEX may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration. Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve 1.25 MAC may prolong the duration of action of initial and maintenance doses of NIMBEX. This may potentiate the neuromuscular blockade.
Adverse reactions reported by <1% of the surgical patients treated with NIMBEX during clinical trials include bradycardia, hypotension, flushing, bronchospasm, and/or rash.
Adverse reactions occurred among the 68 adult ICU patients who received NIMBEX in conjunction with other drugs in US and European clinical studies. One out of 68 patients experienced bronchospasm. In one study, there were 2 reports of prolonged recovery among 28 patients administered NIMBEX compared with 13 reports among 30 patients administered vecuronium.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=24b9880e-626b-14e7-23a6-4960f1008e97 

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