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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->神经肌肉松弛药物
处方药:处方药
包装规格: 100毫克/毫升 5毫升/安醅 10安醅/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
默克沙东
生产厂家英文名:
Merck Sharp & Dohme Corp.
该药品相关信息网址1:
http://www.medicalnewstoday.com/releases/116543.php
该药品相关信息网址2:
http://www.medicines.org.uk/EMC/medicine/21299/SPC/Bridion+100+mg+ml+solution+for+injection/
该药品相关信息网址3:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000885/human_med_000680.jsp&mid=WC0b01ac058001d124&murl=menus/medicines/medicines.jsp
原产地英文商品名:
BRIDION SOLUTION INJECTABLE 100mg/ml 5ml/amp 10amps/box
原产地英文药品名:
SUGAMMADEX
中文参考商品译名:
BRIDION血管注射溶液剂 100毫克/毫升 5毫升/安醅 10安醅/盒
中文参考药品译名:
SUGAMMADEX
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Neuromuscular blockade
临床试验期:
完成
中文适应病症参考翻译1:
神经肌肉阻滞
药品信息:

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 详细处方信息以本药内容附件PDF文件(2018102921255819.pdf)的“原文Priscribing Information”为准
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部分中文Bridion处方资料(仅供参考)

欧盟率先批准先灵堡雅突破性新型肌松药拮抗剂sugammadex
    7月29日,先灵堡雅公司宣布麻醉学近年来最大进展之一―新型肌松药拮抗剂sugammadex(Bridion)获得欧盟药品局的批准,本品可帮助患者更快地从麻醉状态恢复。所批准的适应证为逆转目前广泛使用的罗库溴铵和维库溴铵所造成的神经肌肉阻滞作用。

  本品是先灵堡雅公司去年通过花费145亿美元并购欧加农公司而获得的。分析人士称本品是数十年来麻醉学最重要的进展之一,预计将获得10亿美元的年销售额。

  目前本品在美国正等待批准,2008年3月FDA专家委员会投票表决后认为该药安全且有效。

  在临床研究中,本品可在数分钟内逆转患者的神经肌肉阻断效应,较目前的标准逆转药物新斯的明快9~12倍。

  神经肌肉阻滞用于外科手术的肌肉松弛,特别是腹部、胸部和脑部的手术中。但患者需要插管维持呼吸直至药物失效或被逆转。本品可使患者在更快的时间内开始自主呼吸,因此大大缩短需要通气治疗的时间。

BRIDION(R) (sugammadex) Injection - First And Only Selective Relaxant Binding Agent - Approved In European Union
Schering-Plough Corporation (NYSE: SGP) announced that the European Commission (EC) has approved BRIDION(R) (sugammadex) injection, the first and only selective relaxant binding agent (SRBA) and the first major pharmaceutical advance in the field of anesthesia in two decades. BRIDION is indicated for routine reversal of the commonly used muscle relaxants rocuronium or vecuronium and for immediate reversal of rocuronium in adults, and for routine reversal following rocuronium in children and adolescents (2-17 years of age). Rocuronium and vecuronium are given as part of general anesthesia to relax a patient's muscles during surgery, and are marketed in Europe under the trade names ESMERON(R) and NORCURON(R), respectively.

BRIDION works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive. It was specifically designed to reverse within minutes both moderate and deep muscle relaxation induced by rocuronium or vecuronium during general anesthesia. As a result, BRIDION can give anesthesiologists greater control in managing the depth of muscle relaxation through to the end of a surgical procedure. This may help improve surgical conditions in the millions of procedures where these agents are used.

"This approval of BRIDION represents the first advance in two decades for anesthesiologists and their patients, and has the potential to transform the practice of anesthesia," said Thomas P. Koestler, Ph.D., executive vice president and president of Schering-Plough Research Institute. "This is the first major approval of a product from our combination with Organon BioSciences and is a significant achievement for Schering-Plough. This further validates the value of our combination, which closed in November 2007, and is already making a positive contribution to our business."

BRIDION has a rapid onset and, in addition to routine reversal, can be used in critical situations when immediate reversal of rocuronium is needed. In BRIDION clinical studies, the median time to reversal of rocuronium was about three minutes.

A muscle relaxant plays several critical roles in general anesthesia. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. Reversal agents reverse the effects of muscle relaxants, enabling patients to regain normal muscle function sooner and breathe on their own. Current reversal agents are slow and are associated with certain undesirable side effects, including cardiac rhythm disturbances and gastrointestinal and pulmonary side effects.

"The ability to rapidly reverse both moderate and deep levels of muscle relaxation during general anesthesia was not possible before BRIDION," said Rajinder Mirakhur, M.D., professor of anesthetics at The Queen's University of Belfast, Northern Ireland, and a principal investigator in the BRIDION clinical trials program. "BRIDION can provide us with greater flexibility to induce and maintain the level of muscle relaxation with rocuronium or vecuronium necessary throughout surgery and reverse that relaxation quickly when needed."

BRIDION (sugammadex) Clinical Trials
The EC approval of BRIDION is based on an extensive clinical trial database of approximately 1,800 patients and volunteers, including data from the SIGNAL, AURORA and SPECTRUM clinical trials. The SIGNAL trial involved adult patients undergoing surgery. Rocuronium was administered at a standard dose to allow intubation, followed by maintenance doses as required. When 1-2 post-tetanic counts (PTC) were observed following neuromuscular stimulation (deep block), patients were administered either sugammadex or neostigmine plus glycopyrrolate, a current reversal regimen. In the SIGNAL trial, the median time to reversal of muscle relaxation to a train-of-four (TOF) ratio of 0.9 occurred in 2.7 minutes in the sugammadex group compared to 49.0 minutes in the neostigmine/glycopyrrolate group.

The AURORA trial involved adult patients undergoing surgery. Rocuronium was administered at a standard dose to allow intubation, followed by maintenance doses as required. At the reappearance of the second twitch (T2) in a TOF stimulation (moderate block) patients were administered either sugammadex or neostigmine plus glycopyrrolate. In the AURORA trial, the median time to reversal of muscle relaxation to a TOF ratio of 0.9 occurred in 1.4 minutes in the sugammadex group compared to 17.6 minutes in the neostigmine/glycopyrrolate group.

The SPECTRUM trial was conducted in adult patients undergoing surgery to study the immediate reversal of muscle relaxation. Patients were randomized to receive either rocuronium plus sugammadex or the rapid-onset, short- duration muscle relaxant succinylcholine. The trial demonstrated that rocuronium followed by sugammadex is an effective alternative to succinylcholine.

The EC approval of BRIDION follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) that was received in May of this year.

About BRIDION (sugammadex)
BRIDION, the first and only selective relaxant binding agent (SRBA), is the first major pharmaceutical advance in the field of anesthesia in two decades. It was specifically designed to rapidly reverse both moderate and deep muscle relaxation induced by the commonly used muscle relaxants rocuronium bromide (ZEMURON(R)/ESMERON/ESLAX(R)) or vecuronium bromide (NORCURON/MUSCULAX(R)), which can give anesthesiologists greater control over muscle relaxation during surgery. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. BRIDION works in an entirely novel way by encapsulating the muscle relaxant molecule and rendering it inactive, allowing patients to more rapidly regain muscle function after surgery and breathe on their own.

BRIDION is approved in the European Union (EU) for reversal of neuromuscular blockade induced by rocuronium or vecuronium. In children and adolescents, BRIDION is only recommended for routine reversal of rocuronium induced blockade.

In the United States, a New Drug Application (NDA) for sugammadex has been filed with the U.S. Food and Drug Administration (FDA) and assigned priority review status. The FDA Advisory Committee on Anesthetics and Life Support in March of this year unanimously recommended approval of sugammadex. In Japan, a New Drug Application seeking marketing approval of sugammadex has been filed with the Japanese Ministry of Health, Labour and Welfare (MHLW) and is currently under review.

Schering-Plough acquired BRIDION (sugammadex) through its combination with Organon BioSciences in November 2007.

Important Safety Information About BRIDION
BRIDION (sugammadex) should only be administered by or under the supervision of an anesthesiologist. The use of an appropriate neuromuscular monitoring technique is recommended to monitor the recovery of neuromuscular blockade. The use of sugammadex in patients with severe renal impairment is not recommended.

In clinical trials, the most commonly reported adverse reaction was metal or bitter taste. Also commonly reported were anesthetic complications, indicative of the restoration of neuromuscular function, including movement of a limb or the body or coughing during the anesthetic procedure or during surgery, grimacing, or suckling on the endotracheal tube. In a few individuals, allergic-like reactions (i.e. flushing, erythematous rash) following sugammadex were reported.

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 详细处方信息以本药内容附件PDF文件(2018102921255819.pdf)的“原文Priscribing Information”为准
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更新日期: 2018-10-29
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