VANCOUVER, BC - January 31, 2011 - Baxter International Inc. (NYSE:BAX) today announced the launch of OLIMEL (Amino Acids, Dextrose and Lipids, with/without Electrolytes) emulsion for infusion in Canada at the American Society of Parenteral and Enteral Nutrition's (A.S.P.E.N.) Clinical Nutrition Week. OLIMEL is the country's first triple-chamber bag for parenteral nutrition (PN) and provides adult patients with the essential ingredients of balanced nutrition: protein, carbohydrates and lipids (fats), in a single container, simplifying the preparation of PN for hospitalized patients.
The prevalence of malnutrition is especially high for hospitalized patients, who may not be able to ingest food orally or have impaired digestion, and PN, or intravenous (IV) nutrition, can help to restore optimal nutrition status. These patients often have different nutritional needs, based on disease severity and progression. The range of OLIMEL formulations, with various concentrations of protein and carbohydrates and an olive oil-based lipid emulsion, address the needs of specific patient groups, such as the critically ill, surgery patients and the chronically ill.
"There is no one-size-fits-all approach to nutrition," said Paul Wischmeyer, MD, professor of Anesthesiology and director of Nutrition Support, University of Colorado at Denver School of Medicine. "As healthcare practitioners, we need to be flexible in our approach to nutrition therapy to meet individual patient needs, and having a wide range of formulas in a convenient premixed bag gives us this enhanced flexibility."
When malnutrition is left unmanaged, it can increase morbidity, mortality, and complications such as poor wound healing.1 Studies have shown as many as 40 percent of hospitalized elderly patients and 45 percent of long-term care residents in Canadian institutions suffer from malnutrition.2,3
"Malnutrition is a frequent and serious problem in the hospital, particularly as patients' nutritional needs may be overlooked," said Donald Duerksen, MD, associate professor of Medicine, Section of Gastroenterology, University of Manitoba, Canada. "The increased incidence of complications caused by malnutrition can lead to extended hospitalization and increased costs."
To help address malnutrition, OLIMEL is available in multiple formulations, offering the highest protein concentration in a multi-chamber bag and formulations that provide a proportionate amount of glucose. OLIMEL is unique in that it contains a lipid in the form of an olive oil-based IV fat emulsion, Baxter's proprietary CLINOLEIC. The European Society of Clinical Nutrition and Metabolism (ESPEN) guidelines stress the need to adjust protein and energy formulas based on patients' requirements4,5,6 as is offered in the OLIMEL formulations. For example, patients who have undergone trauma (such as surgery) experience a breakdown in muscle mass to support healing, so they need protein to help replace the lost muscle mass.7 Hospitalized patients also need energy supplied by carbohydrates, but supplying too much can lead to hyperglycemia (excessive sugar in the blood), and can impact clinical outcomes.8
"The OLIMEL family of products enables clinicians to match the nutritional therapy to the patient, through a premixed bag that requires fewer steps from preparation to administration," said Scott Luce, general manager of Baxter's global IV Therapy business. "With this latest introduction, Baxter continues to advance IV nutrition for healthcare professionals and patients through ongoing improvements in both nutritional contents and in container technology.
"OLIMEL contains the first new lipid introduced in Canada in more than three decades and represents a step forward in the preparation of parenteral nutrition for Canadian patients," said Barbara M. Leavitt, general manager for Baxter Corporation (Canada). "We are pleased to add this important innovation to Baxter's 70-year history in Canada and commitment to safe and effective therapies."
OLIMEL is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated, and is approved by Health Canada and numerous European regulatory agencies. OLIMEL offers the flexibility to meet patients' nutritional requirements while simplifying the order and preparation process. The availability of OLIMEL in Canada is the latest in a series of launches and builds upon widespread availability in Europe, where OLIMEL is already offered in Germany, France, Switzerland, Austria, the United Kingdom, the Netherlands, Norway, Denmark, Sweden, Finland, Ireland and Portugal. Baxter expects to introduce OLIMEL in several additional European countries, including Belgium, Spain and Italy, in 2011. Full Prescribing Information for OLIMEL is available at www.olimel.ca.
About Multi-chamber Bags
Parenteral nutrition formulations can be complex, involving numerous calculations, multiple ingredients, additive dosages and administration rates. Multi-chamber bags are a practical option for hospitals to provide standard premix PN for patients in a convenient and easy-to-activate system. The nutritional components are stored in different sections or chambers of a bag, separated by special seals. A clinician breaks the seal between the chambers and gently mixes the admixture or solutions. Maintenance vitamins, additional electrolytes and trace elements are not included and should be administered as required. With multi-chamber bag technology, fewer steps from preparation to administration may reduce the opportunities for error and the potential for touch contamination of the contents.9
The A.S.P.E.N. guidelines support the use of standard formulations to help facilitate a standard process that reduces variation and promotes uniformity among clinicians and healthcare facilities.10
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Important Risk Information
Contraindications: Patients who are hypersensitive to any ingredient in the formulation or component of the container. Congenital abnormalities of amino acid metabolism, severe dyslipidemia, non-corrected metabolism disorders, severe sepsis, severe liver disease, blood coagulation disorders, thrombophlebitis, acute myocardial infarction, lipoid nephrosis, acute pancreatitis associated with hyperlipidemia, severe hyperglycemia. OLIMEL formulations with electrolytes must not be administered to patients with pathologically elevated plasma concentrations of sodium, potassium, magnesium, calcium and/or phosphorus.
Adverse Reactions: Treatment related adverse events reported during clinical trials include abdominal pain, diarrhea, nausea, tachycardia, hypertension, hypertriglyceridema and anorexia (3.57%).11
Baxter, Olimel and Clinoleic are trademarks of Baxter International Inc.
Note: OLIMEL will be displayed at the Baxter Corporation (Canada) exhibit booth at A.S.P.E.N.'s Clinical Nutrition Week 2011 Meeting, January 30-February 1, 2011.
This release includes forward-looking statements concerning the company's expectations with respect to the introduction of OLIMEL in additional European countries in 2011. 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; and other risks identified in the company's most recent filing on Form 10-Q and other Securities and Exchange Commission filings, all of which are available on the company's website. The company does not undertake to update its forward-looking statements.
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5Singer P, et al. ESPEN Guidelines on Parenteral Nutrition: Intensive Care. Clin Nutr. 28 (2009) 387-400.
6Cano NJM, et al. ESPEN Guidelines on Parenteral Nutrition: Adult Renal Failure. Clin Nutr. 28 (2009) 400-414.
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9Flynn EA, et al. Observational study of accuracy in compounding IV admixtures at five hospitals. Am J Health-Syst Pharm. 1997;54:904-912.
10A.S.P.E.N. Statement on Parenteral Nutrition Standardization, JPEN, 2007: Vol. 31, No. 5
11OLIMEL Product Monograph.