Baxter Healthcare Corporation announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market 6 per cent and 10 per cent 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.