Baxter Receives Marketing Authorization in the United Kingdom and Denmark for NUMETA G13E Ready-To-Use IV Nutrition for Preterm Newborns
OREANDA-NEWS. To support the needs of vulnerable, preterm infants (less than 37 weeks gestation age) who are at high risk for malnutrition1, Baxter International Inc. (NYSE: BAX) today announced it has received Marketing Authorization from the Competent Authorities in the United Kingdom and Denmark for NUMETA G13E 300 mL, a parenteral (intravenous) nutrition (PN) product. These national approvals are the first of 20 European countries where Baxter is seeking authorization for NUMETA G13E in 2016.
NUMETA G13E is indicated for PN administration for neonatal patients when oral or enteral nutrition is impossible, insufficient or contraindicated. NUMETA addresses an important medical need to support neonatal patients who have acute nutritional requirements by providing a balanced formulation of amino acids (protein), glucose (carbohydrates), lipids (fats) and electrolytes in a triple-chamber system that was pioneered by Baxter.
“The early hours and days of a preterm infant’s life are critical, as neonates are at high risk for infection and malnutrition,” said Mark DeLegge, M.D., senior medical director, Baxter. “Baxter has developed a well-balanced solution to help meet the nutritional needs of these patients in the hospital with a triple-chamber system that simplifies the preparation process for healthcare workers and reduces the risk to patients of infection and dosing errors.”
NUMETA G13E is designed for activation and administration at the point of care. Research indicates ready-to-use PN may reduce the potential risk of medication errors and associated infections.2 NUMETA G13E was reformulated to meet the current pediatric nutritional guidelines developed by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN).
“Parenteral nutrition in the hospital is an essential component of providing safe and effective nutrition for seriously ill patients,” said Brik Eyre, president of Baxter's Hospital Products business. “Baxter’s innovations to support efficiency in hospital pharmacies, coupled with its expertise in sterile manufacturing and container technology, helps bring safety to the patient’s bedside while increasing efficiency for clinicians who administer treatment.”
Baxter offers additional pediatric triple-chamber PN solutions, including NUMETA G16E 500mL for term infants and toddlers (term infants through two years of age); and NUMETA G19E 1,000mL for children and adolescents (2-18 years of age), which were introduced in 2011.
Important Risk Information
The general contraindications for administering NUMETA as an activated two-chamber container system (with the lipid chamber inactivated for intravenous infusion) are as follows: hypersensitivity to egg, soy or peanut proteins, or to any of the active substances, excipients or components of the container; congenital abnormality of the amino acid metabolism; pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorous; severe hyperglycemia; and concomitant treatment with ceftriaxone in newborns (<= 28 days of age), even if separate infusion lines are used.
The addition of lipids (administering NUMETA as an activated three-chamber container system for intravenous emulsion) is contraindicated in the following additional clinical situations: severe hyperlipidemia and severe disorders of lipid metabolism characterized by hypertriglyceridemia. Refer to the NUMETA product label for full prescribing information.
About Baxter's Nutrition Business
Baxter has been assisting clinicians in treating patients' diverse nutrient needs since the 1940s, when the company first introduced liquid proteins in the form of amino acids. Since then, Baxter has continued to advance intravenous (IV) nutrition. As an example, Baxter pioneered the world's first "triple-chamber system" for IV nutrition, which provides many of the essential ingredients of balanced nutrition - protein, carbohydrates, lipids and electrolytes in a single container - simplifying the preparation of parenteral nutrition for patients. Today, Baxter provides one of the broadest PN portfolios globally, which includes premix IV solutions, vitamins and lipids, as well as pharmacy workflow management, labeling and compounding technology.
About Baxter International Inc.
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.
This release includes forward-looking statements concerning NUMETA, including expectations with regard to its availability in the European Union and expected benefits associated with its use. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Baxter and NUMETA are trademarks of Baxter International Inc.
1Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005.
2Riskin A, Shiff Y, Shamir R. Parenteral Nutrition in Neonatology – To Standardize or Individualize? IMAJ 2006;8:641-645.