Baxter India, a 100% subsidiary of Baxter International Inc. (NYSE: BAX) today announced the launch of U. S. Food and Drug Administration (FDA) approved FLEXBUMIN™ [Albumin (Human)] Solution, the first preparation of human albumin to be packaged in a flexible container.
FLEXBUMIN uses Baxter’s GALAXY® flexible container system, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at less than 300C for up to 2 years. GALAXY employs barrier technology and a continuous aseptic filling process. FLEXBUMIN has the same indications and provides the same stability as BUMINATE, and will be available in both 50 mL and 100 mL flexible containers.
About FLEXBUMIN
FLEXBUMIN is a sterile, non-pyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN is indicated in hypovolemia, hypoalbuminemia due to excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.
FLEXBUMIN is contraindicated in patients with a history of allergic reactions to albumin, in severely anemic patients, and in patients with cardiac failure.
FLEXBUMIN is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.
The potential risks and benefits of albumin should be weighed against those of alternative therapies for all patients for whom albumin administration is being considered.
About Baxter
Baxter India Private Limited is a wholly owned subsidiary of Baxter International Inc., that develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
FLEXBUMIN uses Baxter’s GALAXY® flexible container system, a proprietary multi-layer system that helps maintain albumin quality and allows the solution to be stored at less than 300C for up to 2 years. GALAXY employs barrier technology and a continuous aseptic filling process. FLEXBUMIN has the same indications and provides the same stability as BUMINATE, and will be available in both 50 mL and 100 mL flexible containers.
About FLEXBUMIN
FLEXBUMIN is a sterile, non-pyrogenic preparation of albumin in a single dosage form for intravenous administration. FLEXBUMIN is indicated in hypovolemia, hypoalbuminemia due to excessive catabolism, hemorrhage, major surgery or burns, and for use during cardiopulmonary bypass surgery.
FLEXBUMIN is contraindicated in patients with a history of allergic reactions to albumin, in severely anemic patients, and in patients with cardiac failure.
FLEXBUMIN is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, such as viruses, that can cause disease.
The potential risks and benefits of albumin should be weighed against those of alternative therapies for all patients for whom albumin administration is being considered.
About Baxter
Baxter India Private Limited is a wholly owned subsidiary of Baxter International Inc., that develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
