FDA label 483a61ef-78af-473b-b24b-8b4c2ca554c9

SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

WARNINGS Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued or nitrogen content reduced if BUN levels continue to rise inappropriately. Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients. Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants. Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure. 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 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

ADVERSE REACTIONS Adverse effects include metabolic, fluid, electrolyte and acid-base imbalances unless appropriate monitoring and corrective management are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) therapy.