"LONDON, UK â€” The European Commission (EC) has followed the recommendation last year from its Committee for Medicinal Products for Human Use (CHMP) for an additional indication for the oral platelet inhibitor ticagrelor (Brilique, AstraZe"...
ProcalAmine (amino acid and glycerin) is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition.
DOSAGE AND ADMINISTRATION
ProcalAmine (amino acid and glycerin) is a convenient source of nonprotein calories to preserve lean body mass, amino acids, maintenance electrolytes, and water for adult patients.
Determination of nitrogen balance and accurate daily body weights (corrected for fluid balance) are probably the best means of assessing individual protein requirements.
Approximately three liters per day of ProcalAmine (amino acid and glycerin) will provide a total of 90 grams of amino acids, 390 nonprotein calories and the recommended daily intake of principal intra- and extracellular electrolytes for the stable patient. Therapy can begin with three liters of ProcalAmine (amino acid and glycerin) on the first day with close monitoring of the patient.
As with all intravenous fluid therapy, the goal is to provide adequate water to compensate for insensible, urinary and other losses, and electrolytes for replacement and maintenance. These requirements should be determined frequently and appropriately administered.
Additional electrolytes should be administered evenly throughout the day, and irritating medications should be injected at an alternate infusion site.
ProcalAmine (amino acid and glycerin) is intended for use in adults. Use of ProcalAmine (amino acid and glycerin) in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Venous irritation at an infusion site can be minimized by the selection of a large peripheral vein as well as by slowing the rate of infusion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Parenteral drug products should be inspected visually for particulate matter and discoloration, prior to administration, whenever solution and container permit.
ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is supplied sterile and nonpyrogenic in 1000 mL intravenous infusion bottles, packaged six per case.
|0264-1915-07||S9050 (Solid Stopper)||1000 mL|
|0264-1915-00||S9150 (Air Tube)||1000 mL|
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.
Protect from light until use.
Revised May 2003. B. Braun Medical Inc., Irvine CA USA 92614-5895. FDA Rev date: 12/24/2003This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/18/2008
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