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warnings
WARNINGS This injection is for compounding only, not for direct infusion. Supplementation of branched chain amino acids should occur only with concomitant administration of solutions having complete amino acid profiles and energy substrates designed to meet minimal protein and calorie requirements. 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. Hyperammonemia has been reported to occur in infants receiving various amino acid supplementation regimens. Blood ammonia monitoring may be prudent in 4% BranchAmin® infusions.