Baxter announced the launch of a ready-to-use VANCOMYCIN Injection in sodium chloride for US

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Only Manufacturer to Offer the Antibiotic in a Ready-to-Use Premixed Presentation

World pharma today/Press releases /-Advancing Baxter’s longstanding commitment to provide hospitals with convenient presentations of medications that drive efficiency during drug preparation and enhance patient safety in administration, Baxter International Inc. announced the launch of a ready-to-use VANCOMYCIN injection in 0.9% Sodium Chloride (Normal Saline) in 500 mg, 750 mg and 1 gram presentations. VANCOMYCIN injection is an antibiotic used to treat serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci bacteria.

Baxter is the only manufacturer to offer VANCOMYCIN in a premixed presentation, which uses the company’s proprietary frozen GALAXY container technology. Baxter’s innovative frozen premix technology is specifically designed for unstable molecules that are often administered using standardized doses. Premixed molecules offered in the GALAXY container are illustrative of the leading innovation in medical manufacturing that Baxter has been bringing to the healthcare industry for more than 80 years.

VANCOMYCIN saline injection augments Baxter’s expanding portfolio of generic injectable drugs in the United States available in easy-to-use presentations that hospitals, physicians and patients can rely on because they are manufactured to the Current Good Manufacturing Practice (cGMP) regulations established by the U.S. Food and Drug Administration (FDA). Premixed medications in standardized drug concentrations can help support hospitals’ goals for safe and efficient medication preparation because compounding is not necessary.

Brik Eyre, president of Baxter’s Hospital Products business said that, as a company whose mission is focused on saving and sustaining lives, Baxter’s launch of VANCOMYCIN injection in an innovative premixed saline presentation provides new options of an important antibiotic to address patient needs and demonstrates our commitment to making premixed preparations of medications more efficient for healthcare practitioners.

The launch is an extension of Baxter’s existing VANCOMYCIN injection in 5% dextrose in 500 mg, 750 mg and 1 gram presentations and provides an alternative to certain patients who may need to avoid receiving additional dextrose. By providing VANCOMYCIN in bothsaline and dextrose presentations, Baxter makes additional therapy options available of a critical antibiotic that has appeared on and off of the FDA Drug Shortage list.

VANCOMYCIN saline injection is the second of nine clinically important molecules coming out of a collaborative partnership with Celerity Pharmaceuticals, LLC, a company of Water Street Healthcare Partners, to develop new products that use Baxter’s proprietary container technology, enhanced packaging platform, and aseptic filling manufacturing process.

Baxter’s VANCOMYCIN saline injection in 500 mg, 750 mg and 1 gram presentations are available in the United States.

INDICATIONS for Vancomycin Injection, USP:

  • For the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly.
  • Vancomycin is effective in the treatment of staphylococcal endocarditis. Vancomycin has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by Streptococcus viridans or S. bovis. For endocarditis caused by enterococci (e.g., E. faecalis), vancomycin has been reported to be effective only in combination with an aminoglycoside. Vancomycin has been reported to be effective for the treatment of diphtheroid endocarditis. Vancomycin has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to vancomycin. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections. When staphylococcal infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measures.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin and other antibacterial drugs, vancomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.