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首页 » FDA信息 » 百特Flexbumin(软袋装人血白蛋白)获FDA批准

百特Flexbumin(软袋装人血白蛋白)获FDA批准

来源:生物谷 2014-08-05 15:18

2014年8月5日讯 /生物谷BIOON/ --百特国际(Baxter International)8月4日宣布,Flexbumin(软袋人血白蛋白,USP,5%溶液)获FDA批准,该药的适应症包括:常见原因导致的血容量不足(hypovolemia)、低白蛋白血症( hypoalbuminemia )、烧伤、心肺旁路手术患者。此次批准,扩大了Flexbumin的产品组合,规格包括:5%溶液(250ml),25%溶液(50ml),25%溶液(100ml)。

Flexbumin是全球首个及唯一一个软袋白蛋白,同时也是全球首个、迄今唯一获低碳认证的医疗产品。百特计划在今年晚些时候在美国推出Flexbumin(5%溶液)新品。

与传统瓶装白蛋白相比,Flexbumin软袋白蛋白带来了更多的应用利益,包括:(1)升级为闭合输注系统,降低中心静脉导管相关输液感染风险;(2)缩短输液准备时间达40%,减少操作失误;(3)抗摔抗压,可以避免高值药品的损耗;(4)质量轻40%,体积小60%,可以降低运输和仓储成本;(5)医用废物处置成本比瓶装白蛋白减少88.2%。

闭合式输液系统极大地提高了静脉输液的安全性,是目前临床输液的发展方向。Flexbumin采用了百特专有的Galaxy柔性容器,该容器采用了Galaxy专利膜,由4层特殊结构层组成,实现了白蛋白溶液从瓶装升级为软袋装的历史性突破。(生物谷Bioon.com)

英文原文:FDA Approves Baxter's FLEXBUMIN 5%, First and Only 5% Human Albumin Solution in a Flexible Container 

Unique Flexible Container Offers Enhanced Safety, Efficiency, and Sustainability Features

DEERFIELD, Ill., AUGUST 4, 2014 - Baxter International Inc. (NYSE:BAX) today announced that the United States Food and Drug Administration (FDA) has approved FLEXBUMIN® [Albumin (Human)], USP, 5% Solution. FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery.

This approval expands Baxter's FLEXBUMIN product portfolio to include both 5% in a 250 mL solution and 25% in 50 and 100 mL solutions. FLEXBUMIN is the first and only preparation of human albumin to be packaged in a flexible plastic container. The new FLEXBUMIN 5% solution will be available to U.S. customers later this year.

The FLEXBUMIN flexible, shatterproof container offers unique safety features for hospitals by eliminating risk of glass breakage and affords the ability to infuse without a vented administration set. In addition, FLEXBUMIN 5% solution provides efficiency features for healthcare professionals through its streamlined three-step administration process, lighter weight and reduced space requirements compared to glass containers of equal volume, making it more compatible with hospital inventory storage systems.

"Human albumin is essential for hospitals in providing care to surgical, trauma and other critically ill patients," said Ron Lloyd, head of Baxter's BioTherapeutics business. "Our customers value the benefits of having this treatment available in a flexible container that more efficiently meets their needs for reduced waste and improved safety."

FLEXBUMIN uses Baxter's GALAXY® flexible container, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at room temperature. The GALAXY container, which employs barrier technology and a continuous aseptic filling process, has been used in the United States for more than 16 years to package pharmaceutical products. The flexible infusion system allows for simple administration steps with a non-vented administration set.

Compared with glass bottles of equal volume, shipping containers for FLEXBUMIN 5% contain approximately 45% less packaging materials and empty containers are 95% lighter, resulting in less waste.

About FLEXBUMIN 5%
FLEXBUMIN 5% [Albumin (Human)] 5% Solution is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration.

FLEXBUMIN 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.

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