- NUMETA G13E is only approved, commercially prepared IV nutrition product available for preterm newborns in a triple-chamber system pioneered by Baxter
- First patients receiving NUMETA G13E IV nutrition therapy located in Sweden
COPENHAGEN, Denmark, Sept. 19, 2016 — Baxter International Inc. (NYSE: BAX), a global leader in PN therapy, announced the European launch of NUMETA G13E 300 mL, the only ready-to-use parenteral (intravenous) nutrition (PN) product available to treat preterm infants (less than 37 weeks gestation age) who are at high risk for infection and malnutrition1 in the early hours and days of their lives. The announcement was made during the 38th ESPEN (The European Society for Clinical Nutrition and Metabolism) Congress in Copenhagen, Sept. 17-20, with recognition that the first preterm patients have received PN therapy on NUMETA G13E in Sweden.
NUMETA G13E is indicated for PN administration in preterm newborn infants when oral or enteral nutrition is not possible, insufficient or contraindicated. NUMETA G13E addresses an important medical need to support preterm 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.
“Baxter’s NUMETA G13E is a well-balanced, ready-to-use formula in a triple-chamber system that simplifies the preparation process for healthcare workers and helps reduce the potential risk to patients of infection and dosing errors,” said Brik Eyre, president of Baxter's Hospital Products business. “NUMETA G13E is truly innovative nutritional therapy for preterm babies – among the most susceptible patients – when time and safety are critical factors to their care.”
NUMETA G13E is designed for activation and administration at the bedside. 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 ESPEN.
Baxter’s NUMETA G13E has Marketing Authorization from the Competent Authorities in 15 Western European countries, including Austria, Belgium, France, Germany, Ireland, Malta Netherlands, Poland, Switzerland, the U.K., and the Nordics where the launch initiated. Baxter plans to continue pursuing regulatory approvals and launching NUMETA G13E globally, including in additional European countries and Latin America in 2017.
Baxter offers additional pediatric triple-chamber PN solutions in Europe and select Latin American countries, 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).
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.
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 and future availability in the European Union, Latin America and other regions, 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.