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BAXTER
RECEIVES FDA APPROVAL FOR PREMASOL SULFITE-FREE (AMINO ACID) INJECTIONS
Parenteral Nutrition
Solution Specially Formulated to Provide Nutritional Support for Infants
and Young Children
DEERFIELD, Ill.,
June 23, 2003 -- Baxter Healthcare Corporation announced today it received
approval from the U.S. Food and Drug Administration (FDA) to market 6%
and 10% PREMASOL sulfite-free (Amino Acid) Injections, which provide a
mixture of essential and non-essential amino acids for the nutritional
support of infants (including those of low-birth weight) and young children
requiring total parenteral nutrition (TPN). PREMASOL Injections are therapeutically
equivalent to the most-prescribed solution and are available in 500 mL,
1-liter and 2-liter VIAFLEX plastic containers, providing greater convenience
and cost effectiveness.
"We are proud to offer this treatment option for young patients in
need of nutritional support," said David Bonderud, president of Baxter's
Medication Delivery business in the United States. "We are able to
provide this product in a variety of sizes to give physicians the flexibility
they need in choosing the appropriate nutritional option for their patients."
Advances in neonatal
care and parenteral nutrition have made it possible to support many infants
who would have died early in life from starvation. Patients receiving
TPN rely on intravenous infusions, usually through a central line, to
receive their necessary nutritional intake. PREMASOL Injections are also
sulfite-free (preservative free).
PREMASOL Injections
are for use in compounding only and not for direct infusion. PREMASOL
Injections are contraindicated in patients with untreated anuria, hepatic
coma, inborn errors of amino acid metabolism, or hypersensitivity to one
or more amino acids present in the solution. Reactions reported in clinical
studies as a result of infusion of the parenteral fluid were water weight
gain, edema, increase in BUN, and mild acidosis. Frequent evaluations
and laboratory determinations are necessary for proper monitoring of parenteral
nutrition. See package insert for complete prescribing information, including
warnings, precautions and adverse reactions.
6% and 10% PREMASOL
Injections are available direct from Baxter by calling the Center for
Service at 1-888-229-0001. PREMASOL Injections are also available through
various wholesalers and distributors. For clinical information, please
contact Nutrition Professional Services at 1-800-422-2751.
Baxter Healthcare
Corporation is the principal domestic operating subsidiary of Baxter International
Inc. (NYSE: BAX). Baxter International Inc., through its subsidiaries,
assists health-care professionals and their patients with treatment of
complex medical conditions, including cancer, hemophilia, immune disorders,
kidney disease and trauma. The company applies its expertise in medical
devices, pharmaceuticals and biotechnology to make a meaningful difference
in patients' lives.
(Baxter, PREMASOL
and VIAFLEX are registered trademarks of Baxter International Inc. and
its subsidiaries.)
FOR ADDITIONAL
INFORMATION:
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For Baxter
- Media Contacts:
- Lisa Farrugia,
847-270-2320
Deborah Spak, 847-948-2349
- Investor Contacts:
- Neville Jeharajah,
847-948-2875
Mary Kay Ladone, 847-948-3371
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