Baxter Receives Marketing Authorization in the United Kingdom and Denmark for NUMETA G13E Ready-to-Use IV Nutrition for Preterm Newborns
Only approved triple-chamber, commercially prepared IV product
addressing critical nutritional needs of vulnerable neonatal patients
COMPTON, England–(BUSINESS WIRE)–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.
1 Koletzko B, Goulet O, Hunt J, et al. ESPGHAN / ESPEN
Guidelines on Paediatric Parenteral Nutrition. JPGN. 2005.
2 Riskin A, Shiff Y, Shamir R. Parenteral Nutrition in
Neonatology – To Standardize or Individualize? IMAJ 2006;8:641-645.
Contacts
Baxter International Inc.
Media Contact:
Jill
Carey-Hargrave
(224) 948-5353
media@baxter.com
or
Investor
Contact:
Clare Trachtman
(224) 948-3085
