B. Braun Anticipates Becoming First To Deliver FDA Approved 2g Cefazolin

Main Category: Pain / Anesthetics
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 03 Jun 2009 - 1:00 PDT

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B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, said today it anticipates U.S. Food and Drug Administration (FDA) approval for 2g Cefazolin for Injection USP and Dextrose Injection USP in B. Braun's DUPLEX(R) Drug Delivery System.

The FDA approval will make B. Braun the first company to deliver an FDA approved 2g Cefazolin dose to hospitals and other healthcare settings where it is a frequently prescribed antibiotic.

The arrival of 2g Cefazolin will be welcome news in hospital emergency rooms, operating suites and outpatient surgical centers. Until now, Cefazolin had only been available in 1g IV and multi-dose vials. The 2g Cefazolin in the DUPLEX(R) system can be stored, ready to use wherever and whenever it is needed, which means faster, safer and more accurate administration of 2g Cefazolin to patients.

"B. Braun heard physician and pharmacist calls for a 2g Cefazolin dose and we've responded," said Rob Albert, Vice President, Pharma Marketing for B. Braun. "2g Cefazolin will be the latest in an expanding DUPLEX(R) portfolio, which is designed to provide fast, safe, convenient and Joint Commission and USP Chapter < 797 > compliant products that improve the practice of healthcare professionals while advancing patient safety and outcomes."

Frequently used in emergency rooms, operating suites and ambulatory surgery centers, B. Braun will offer 2g Cefazolin delivered via its DUPLEX(R) Delivery System, a ready-to-use two-compartment flexible plastic IV container that stores pre-measured drug and diluent doses. Healthcare workers administering DUPLEX(R) simply squeeze the container and shake it to mix pharmaceuticals and diluent.

The DUPLEX(R) system saves time, labor and speeds dispensing because it can be stored right in emergency and operating rooms until it's needed and is ready immediately. Its PVC-free construction makes it eco-friendly while its DEHP-free and Latex-free construction makes it patient-friendly. A barcode that references the final admixture, lot number and expiration date helps reduce medication errors, automate patient charting, track inventory and facilitate reimbursement tracking.

With the addition of 2g Cefazolin to its drug delivery portfolio, B. Braun will expand its broad spectrum of intravenous cephalosporin antibiotic therapies for the hospital setting: Cefoxitin, CefTRIaxONE, 1g Cefazolin, CefUROXime and Cefotetan.

About DUPLEX

The DUPLEX(R) Drug Delivery System is a revolutionary system designed to simplify intravenous antibiotic delivery to patients, minimize the potential for medication errors, eliminate the pharmacy labor component of IV antibiotic delivery and reduce drug waste.

Consisting of a pre-filled, DEHP-free, PVC-free, Latex-free IV bag containing proper doses of drug and diluent in different compartments separated by a quick release seal, DUPLEX(R) can be stored at room temperature and does not require a messy thawing process. The caregiver simply squeezes the bag to mix the drug and diluent just prior to administration. Special oxygen and moisture barrier technologies are employed to protect the drug powder from vapor and oxygen transfer through the bag over the product's shelf life.

About B. Braun

B. Braun is a leading manufacturer of infusion therapy and pain management products with an environmentally-friendly focus. Guided by the company's "Sharing Expertise(R)" philosophy, B. Braun addresses the critical issues of infection prevention, medication safety and environmental responsibility by promoting best practices that help clinicians reduce medication errors, prevent healthcare-acquired infections (HAIs) and achieve sustainability objectives.

Consistently recognized by Frost & Sullivan and KLAS for its medical technology and support services, B. Braun employees share their knowledge with colleagues and customers to improve working processes in hospitals and medical practices and to enhance the safety of patients and healthcare professionals.

Source: Braun Medical Inc