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B. Braun Receives FDA Approval For 70% Dextrose Injection, USP

Company expands offering of TITAN™ XL, the only large-volume, flexible containers approved in the U.S. that are DEHP and PVC free

BETHLEHEM, PA – July 8, 2015 – B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, announced today that it has received FDA approval of 70% Dextrose for Injection in a 2L flexible container. The pharmacy bulk package new product will be used with B.Braun’s PINNACLE® TPN Management System and other automated compounding devices. B.Braun’s clinical nutrition compounding offerings now include Sterile Water for Injection USP in 2L and 3L flexible containers, Nutrilipid® 20% (I.V. fat emulsion) in flexible containers and the newly approved 70% Dextrose, which is now available. 

“In light of the current Dextrose shortage, we are pleased that the FDA issued this approval,” said Rick Williamson, Vice President of Pharmaceutical Marketing at B.Braun. “B.Braun is committed to expanding its clinical nutrition product portfolio and has been a pioneer in developing fluid containers that are environmentally friendly and focused on patient safety. Our TITAN™ XL line of large-volume, flexible containers for irrigation and parenteral nutrition solutions for compounding, truly complement our broad family of IV containers,” added Williamson.

With these additional TITAN XL containers, B.Braun will further expand its line of solution containers that are not made with natural rubber latex, DEHP (a plasticizer and known toxicant) or PVC (a likely carcinogen when incinerated).

Exposure to these toxic materials has been a growing concern for healthcare facilities around the world. Studies show that excessive exposure to DEHP can potentially lead to adverse health effects, especially to a patient’s liver, kidneys and lungs, as well as their heart rate and blood pressure. More than three decades ago, B.Braun recognized the environmental and patient risks posed by products containing DEHP and PVC. As a result, B.Braun was the first medical device manufacturer to remove these harmful substances from many products and today is the only supplier that offers a full line of solution containers that are not made with DEHP or PVC. B.Braun is strongly committed to finding alternative methods to manufacture safer products such as the TITAN XL irrigation bags. B.Braun is a proud member of Practice Greenhealth, a membership organization for institutions and businesses in the healthcare field who are engaged in reducing their environmental footprints.

About TITAN™
The TITANTM XL containers offer injection and irrigation solutions in large volume, flexible bags. TITAN XL containers are made from a multilayered film specifically developed for parenteral drugs. The innovative, convenient port system allows for easy access and provides a tamper-evident injection site, presenting clinicians with visual evidence of medication addition. TITAN XL is highly transparent for quick and accurate volume monitoring.

TITAN XL containers are stored at room temperature. B.Braun’s TITAN XL offerings currently include 2L and 3L Sterile Water for Irrigation and 0.9% Sodium Chloride for Irrigation and 3L Glycine for Irrigation.

Customers interested in more information click here or call 1-800-227-2862.

About B. Braun
B. Braun Medical Inc. (B.Braun), a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. The Company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. Guided by its “Sharing Expertise®” philosophy, B.Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs.

The B.Braun Group of Companies in the U.S. includes B.Braun, B.Braun Interventional Systems, Aesculap® and CAPS®. B.Braun’s U.S. headquarters is located in Bethlehem, Pennsylvania. The B.Braun Group of Companies employs more than 54,000 employees in more than 60 countries throughout the world. To learn more about B.Braun visit www.BBraunUSA.com


1 http://www.wsna.org/Topics/Workplace-Environment-You/Environmental-Hazards/PVC-DEHP/