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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->镇痛药
处方药:处方药
包装规格: 133毫克/10毫升 10瓶/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
Pacira Pharmaceuticals, Inc.
生产厂家英文名:
Pacira Pharmaceuticals, Inc.
该药品相关信息网址1:
www.exparel.com/
该药品相关信息网址2:
www.drugs.com/pro/exparel.html
该药品相关信息网址3:
www.rxlist.com/exparel-drug.htm
原产地英文商品名:
Exparel 133mg SDV 10ml x 10 vials
原产地英文药品名:
BUPIVACAINE LIPOSOME/PF
中文参考商品译名:
EXPAREL SDV 133毫克/10毫升 10瓶/盒
中文参考药品译名:
注射用布比卡因脂质体
原产地国家批准上市年份:
2011/10/28
英文适应病症1:
Analgesic
临床试验期:
完成
中文适应病症参考翻译1:
镇痛
药品信息:

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 详细处方信息以本药内容附件PDF文件(20187423530835.PDF)的“原文Priscribing Information”为准
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 部分中文Exparel处方资料(仅供参考)

FDA批准非阿片类局部镇痛药Exparel用于控制术后疼痛
    2011年10月31日,Pacira制药公司宣布美国食品药品管理局(FDA)已批准Exparel(布比卡因脂质体注射用混悬液)1.3%用于控制术后手术部位的疼痛。Exparel是将布比卡因与储库泡沫(DepoFoam)技术相结合的一种非阿片类局部镇痛药,该给药技术可在所需的时间范围内给药。Pacira宣称单剂Exparel可产生长达72 h的镇痛效果,并可减少这段时间内对阿片类药物的需求。

    在一项比较Exparel与安慰剂的关键性痔切除术试验中,疼痛控制不充分的所有患者均接受阿片类药物缓解疼痛,而接受Exparel用药的患者在累积疼痛评分方面显著降低,同时伴有阿片类药物用量的减少,镇痛效果长达72 h。

    Exparel的安全性已在21项临床试验中得到评价,安全性数据库中涵盖逾1300名受试者的资料。有10项随机、双盲的临床试验对Exparel局部用于手术部位的效果进行了评估,共涉及823例行各种外科手术的患者。对患者所使用的Exparel剂量范围介于66 mg~532 mg之间。

    研究中使用Exparel后最常见的不良反应(发生率>10%)为恶心、便秘和呕吐。

    Exparel禁用于产科宫颈旁阻滞麻醉。

    给予Exparel后的96 h内不宜使用布比卡因的其他制剂。

EXPAREL®
EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®. A single intraoperative injection given at the close of surgery delivers postsurgical pain control with reduced opioid requirements† for up to 72 hours,*1 making it a potentially suitable choice for patients who need effective pain management in the first few days after surgery,* when pain is at its worst.2

A non-opioid analgesic should be considered in populations where the use of opioids is most problematic, including:
•Elderly patients‡
•Obese patients
•Sleep apneic patients3

The safety of EXPAREL has been evaluated in 21 clinical trials which include over 1300 subjects in the safety database. EXPAREL administered locally into the surgical site was evaluated in 10 randomized, double-blind clinical studies involving 823 patients undergoing various surgical procedures. Patients were administered a dose ranging from 66 mg to 532 mg of EXPAREL.1

EXPAREL is indicated for administration into the surgical site to produce postsurgical analgesia.1

Important Safety Information
EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age.

Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL.

Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations.

In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting.

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 详细处方信息以本药内容附件PDF文件(20187423530835.PDF)的“原文Priscribing Information”为准
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更新日期: 2018-05-24
附件:
20187423530835.pdf    







 
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