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Procalamine Indications, Dosage, Storage, Stability - Amino Acid and Glycerin

Procalamine Indications, Dosage, Storage, Stability - Amino Acid and Glycerin

INDICATIONS AND USAGE

ProcalAmine 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 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 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 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.

Pediatric Use

ProcalAmine is intended for use in adults. Use of ProcalAmine 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.

HOW SUPPLIED

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.

NDC

Cat. No.

Size

ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes)

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

ProcalAmine is a registered trademark of B. Braun Medical Inc.

Made in USA

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