高级搜索
立即登录 | 免费注册
当前位置 >   首页 > 医药资讯 >  药品动态  > 药品资讯内容

由于担心污染,FDA和Hospira召回部分批次的丙泊酚乳剂和全肠外营养产品Liposyn

Contamination concern prompts recall of some lots of Hospira's propofol emulsion and TPN product Liposyn

2009-11-12 【发表评论】
中文 | ENGLISH | 打印| 推荐给好友


ST LOUIS (MD Consult) - On November 6, 2009, the US Food and Drug Administration and Hospira announced a recall of 85 lots of Liposyn II 10%, Liposyn II 20%, Liposyn III 10%, Liposyn III 20%, and Liposyn III 30%, as well as 73 lots of propofol injectable emulsion 1% products whose lot numbers start with 79 or 80. The products are being recalled because some of the containers may contain particulate matter.


The source of the particulate matter has been identified as stainless steel equipment used in the manufacturing process. Because the particulate contaminants do not dissolve in blood, they could potentially act as emboli and impede blood flow. Restriction in blood supply to tissues could lead to stroke, respiratory failure, kidney failure, liver failure, myocardial infarction, and/or death. Particulates may also cause mechanical damage to the body and may serve to escalate damage through the systemic inflammatory response syndrome.


Hospira has not received any reports of adverse events related to this issue. The company has also identified the root cause, and corrective actions have been implemented.


Liposyn is an intravenous fat emulsion used in total parenteral nutrition (TPN) therapy. Propofol is a sedative-hypnotic agent used in the induction and maintenance of sedation or anesthesia.

 

Any existing inventory of the products should be quarantined immediately, and a call should be placed to Stericycle at 1-866-654-0725 to arrange for product return. Medical inquiries should be directed to Hospira Medical Communications at 1-800-615-0187.

 

圣路易斯(MD Consult)——2009116日,美国食品药品管理局(FDA)Hospira共同宣布,召回85个批次的Liposyn II 10%Liposyn II 20%Liposyn III 10%Liposyn III 20%Liposyn III 30%,以及编号以7980开头的73个批次的1%丙泊酚注射乳剂。此次召回是因为一些容器可能沾染了微粒物质。

微粒的来源是生产过程中的不锈钢设备。因为这些微粒不溶于血液,所以可能引起栓塞、阻断血流。组织血液供应不足将导致卒中、呼吸衰竭、肾功能衰竭、肝功能衰竭、心肌梗死,甚至死亡。微粒也可以造成机体的机械损害,并可引起全身炎性反应综合征(SIRS)而加重机体损伤。

 

Hospira尚未收到过任何关于此类副作用的报告。该公司已找到其根本原因,并已采取改进措施。

 

Liposyn是静脉应用的全肠外营养(TPN)脂肪乳剂。丙泊酚是镇静催眠药物,用于诱导和维持镇静或麻醉。

 

所有这些产品的库存应立即封存,可以致电1-866-654-0725Stericycle公司咨询退货事宜。有关医疗问题可致电1-800-615-0187Hospira公司。


Subjects:
surgery, pain
学科代码:
普通外科学, 麻醉与疼痛治疗

请登录后发表评论, 点击此处登录。

疾病资源中心  疾病资源中心
 病例分析

 王燕燕 王曙

上海交通大学附属瑞金医院内分泌科

患者,女,69岁。2009年1月无明显诱因下出现乏力,当时程度较轻,未予以重视。2009年3月患者乏力症状加重,尿色逐渐加深,大便习惯改变,颜色变淡。4月18日入我院感染科治疗,诉轻度头晕、心慌,体重减轻10kg。无肝区疼痛,无发热,无腹痛、腹泻、腹胀、里急后重,无恶性、呕吐等。入院半月前于外院就诊,查肝功能:ALT 601IU/L,AST 785IU/L,TBIL 97.7umol/L,白蛋白 41g/L,甲状腺功能:游离T3 30.6pmol/L,游离T4 51.9pmol/L,心电图示快速房颤。
 

医学数据库  医学数据库



友情链接:中文版柳叶刀 | MD CONSULT | Journals CONSULT | Procedures CONSULT | eClips CONSULT | Imaging CONSULT | 论文吧 | 世界医学书库 医心网 | 前沿医学资讯网

公司简介 | 用户协议 | 条件与条款 | 隐私权政策 | 网站地图 | 联系我们

 互联网药品信息服务资格证书 | 卫生局审核意见通知书 | 药监局行政许可决定书 
电信与信息服务业务经营许可证 | 京ICP证070259号 | 京ICP备09068478号

Copyright © 2009 Elsevier.  All Rights Reserved.  爱思唯尔版权所有