Baxter Receives Marketing Authorization of Nutrition for Preterm Newborns in UK and Denmark

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Baxter International Inc 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.

World pharma today/Press releases /-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.

Mark DeLegge, M.D., senior medical director, Baxter said that the early hours and days of a preterm infant’s life are critical, as neonates are at high risk for infection and malnutrition. 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.

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.

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.