美国FDA已批准首个软包装的25%人血清白蛋白（Albumin Human），商品名为Flexbumin，用于心脏搭桥手术、中风、严重烧伤等。
Flexbumin治疗作用和相同的稳定性，但是软包装更方便临床使 用，不易破碎也方便储存。之前为玻璃瓶包装是因为软包装还达不到所需的质量要求 。
Flexbumin的包装不含乳胶，能在室温下储存2年，有50ml、100ml两种包装。

FLEXBUMIN 25%, Albumin (Human)

During traumatic events where blood loss can be high, such as a car accident or surgery, patients receive albumin to help restore their blood volume. Albumin is derived from blood plasma collected at collection centers across the US, such as Baxter’s BioLife Plasma Services centers. Baxter's FLEXBUMIN therapy is the first and only albumin in a flexible plastic container. Unlike glass containers, FLEXBUMIN is easier to transport and store, and won't break.1

注册证号 S20080082
原注册证号 
产品名称（中文） 人血白蛋白
产品名称（英文） Human Albumin
商品名（中文） 
商品名（英文） Flexbumin
剂型（中文） 注射剂
规格（中文） 20% 50ml/袋;20% 100ml/袋;25% 50ml/袋;25% 100ml/袋
注册证号备注 
包装规格（中文） 包装规格：50ml/袋，12袋/箱；100ml/袋，6袋/箱
生产厂商（中文） 
生产厂商（英文） Baxter Healthcare Corporation Drug Delivery Division
厂商地址（中文） 
厂商地址（英文） Route 120 & Wilson Road Round Lake, IL 60073 USA
厂商国家（中文） 美国
厂商国家（英文） U.S.A.
分包装批准文号 
发证日期 2008-07-08
有效期截止日 2013-07-07
分包装企业名称 
分包装企业地址 
分包装文号批准日期 
分包装文号有效期截止日 
产品类别 生物制品
药品本位码 86978257000152；86978257000114；86978257000121；86978257000138
药品本位码备注 86978257000152[20%50ml/袋]；86978257000114[20%100ml/袋]；86978257000121[25%50ml/袋]；86978257000138[25%100ml/袋]
公司名称（中文） 
公司名称（英文） Baxter Healthcare Corporation
地址（中文） 
地址（英文） One Baxter Way, Westlake Village,CA 91362 USA
国家（中文） 美国
国家（英文） U.S.A.

拜耳公司生产的Buminate（25%人血清白蛋白）为玻璃瓶包装

BUMINATE 25% Albumin (Human) and BUMINATE 5% Albumin

During traumatic events where blood loss can be high, such as a car accident or surgery, patients receive albumin to help restore their blood volume.3, 4 Albumin is derived from blood plasma collected at collection centers across the U.S., such as Baxter’s BioLife Plasma Services centers.

For more information on FLEXBUMIN therapy and BUMINATE therapy, please visit www.albumintherapy.com

Indications & Usage (FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution)
FLEXBUMIN 25% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN 25% is indicated in hypovolemia, hypoalbuminemia due to inadequate production, excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.

Important Safety Information
FLEXBUMIN 25% [Albumin (Human)], USP, 25% Solution is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.
FLEXBUMIN 25% is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Intravenous infusion rates should not exceed 1mL/min to patients with normal blood volume, due to the risk of developing circulatory overload and pulmonary edema. The quick rise in blood pressure, which may follow rapid administration, necessitates careful observation of the injured or post-operative patient to detect and treat severed blood vessels which failed to bleed at lower blood pressure.
There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent.
Adverse reactions to albumin are rare and may include nausea, fever, chills or urticaria, which may disappear when the infusion rate is slowed or stopped for a short period of time.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of the fluid from the secondary container is complete.

Please see full Prescribing Information

Indications & Usage (BUMINATE 5% Albumin (Human), USP, 5% Solution Safety Statement)
BUMINATE 5% Albumin (Human), USP, 5% Solution is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.

Indications & Usage (BUMINATE 25% Albumin (Human), USP, 25% Solution)
BUMINATE 25% Albumin (Human), USP, 25% Solution is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.

Important Safety Information
BUMINATE 5% [Albumin (Human)], USP, 5% Solution and BUMINATE 25% [Albumin (Human)], USP, 25% Solution is contraindicated in patients with cardiac failure, in patients with severe anemia and in patients with a history of allergic reactions to human albumin.
BUMINATE 5% [Albumin (Human)], USP, 5% Solution and BUMINATE 25% [Albumin (Human)], USP, 25% Solution is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. Intravenous infusion rates should not exceed 1mL/min to patients with normal blood volume, due to the risk of developing circulatory overload and pulmonary edema. The quick rise in blood pressure, which may follow rapid administration, necessitates careful observation of the injured or post-operative patient to detect and treat severed blood vessels which failed to bleed at lower blood pressure.
There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent.
Adverse reactions to albumin are rare and may include nausea, fever, chills or urticaria, which may disappear when the infusion rate is slowed or stopped for a short period of time.

Reference
FLEXBUMIN 25%, Albumin (Human), USP, 25% Solution in GALAXY Single Dose Container [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; June 2007
BUMINATE 5% Albumin (Human), USP, 5% Solution [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2002
BUMINATE 25% Albumin (Human), USP, 25% Solution [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; September 2002