warnings
WARNINGS These injections are for compounding only, not for direct infusion. Caution should be exercised when admixing 5.5% and 8.5% Travasol ® (Amino Acid) Injections. Studies have shown that admixtures of Travasol ® (Amino Acid) Injection, 10% and 20% Travamulsion ® Intravenous Fat Emulsion Injection and high concentration dextrose injection (10 to 70%) from Baxter Healthcare Corporation, are stable over short periods of time. These solutions should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Reference should be made to Travamulsion ® Injection and high concentration dextrose injection from Baxter Healthcare Corporation package inserts for detailed information on each component. Proper administration of these injections requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur. Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma. Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants. Conservative doses of these injections should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated. Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes. These injections should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. Administration by central venous catheter should be used only by those familiar with this technique and its complications.