Published: February 02, 2011
ADDING MULTIMEDIA Baxter Introduces OLIMEL in Canada as the First Triple-Chamber Bag for Nutrition
VANCOUVER, British Columbia - (BUSINESS WIRE) - 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.
OLIMEL - Baxter's newest triple-chamber container - 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. (Photo: Business Wire)
This press release has an accompanying Smart Marketing Page providing
further details about the organization, products and services introduced
below. You can access the Smart Marketing Page via the following link: http://www.businesswire.com/smp/baxter-launches-olimel-for-parenteral-nutrition-in-canada/.
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, 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'
requirements,4,5,6 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."
About OLIMEL
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
About Baxter
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.
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.
1 Isabel M., Correia TD, Waitzberg D.The impact of
malnutrition on morbidity, mortality, length of hospital stay and costs
evaluated through a multivariate model analysis. Clin Nutr 2003;22
(3): 235-239.
2 Laporte M., Villalon, L., Payette H. Simple Nutrition
Screening Tools for Healthcare Facilities: Development and Validity
Assessment. Can J Diet Prac Res 2001; 62:26-34.
3 Keller
HH. Malnutrition in institutionalized elderly: how and why? J
Am Geriatr Soc. 1993 Nov;41(11):1212-8.
4 Braga M, et al. ESPEN Guidelines on Parenteral Nutrition:
Surgery. Clin Nutri. 28 (2009) 378-386.
5 Singer P, et al. ESPEN Guidelines on Parenteral Nutrition:
Intensive Care. Clin Nutr. 28 (2009) 387-400.
6 Cano NJM, et al. ESPEN Guidelines on Parenteral Nutrition:
Adult Renal Failure. Clin Nutr. 28 (2009) 400-414.
7 Rennie MJ. Muscle Protein Turnover and the Wasting Due to
Injury and Disease. British Medical Bulletin (1985) Vol. 41, No.
3, pp. 257-264.
8 McCowen KC et al. Hypocaloric total parenteral nutrition:
Effectiveness in prevention of hyperglycemia and infectious
complications-A randomized clinical trial. Crit Care Med 2000;
28: 3606.
9 Flynn EA, et al. Observational study of accuracy in
compounding IV admixtures at five hospitals. Am J Health-Syst Pharm.
1997;54:904-912.
10 A.S.P.E.N. Statement on Parenteral Nutrition
Standardization, JPEN, 2007: Vol. 31, No. 5
11 OLIMEL Product Monograph.
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Baxter International Inc.
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