Parenteral nutrition with Aminosyn-PF 10% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes (2) gastrointestinal absorption of protein is impaired or (3) protein requirements are substantially increased as with extensive burns. Taurine has also been shown to play a role in central nervous system development.Īminosyn-PF 10%, Sulfite-Free, (an amino acid injection - pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Taurine deficiency because of its effect on bile salt conjugation and, therefore, on bile salt flow may be of major importance in the genesis of cholestasis. The human newborn conjugates bile with taurine which becomes the primary method of biliary excretion. The electrolyte content of any additives that are introduced should be carefully considered and included in input computations. The addition of a cysteine hydrochloride additive will contribute to the chloride load. The amounts of sodium and acetate in Aminosyn-PF 10% are not of clinical significance. Clinical evidence seems to support this thinking however, confirmatory experimental evidence is not available. It is thought that the acetate from lysine acetate under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, Aminosyn-PF 10% provides TPN for infants and young children, with the exception of essential fatty acids. In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status. The rationale for Aminosyn-PF 10% is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions.Ĭlinical studies in infants who required TPN therapy showed that infusion of Aminosyn-PF 10% resulted in plasma amino acid concentrations approximating those of normal breast or formula fed infants. When administered in conjunction with a cysteine hydrochloride additive, Aminosyn-PF 10% results in plasma amino acid concentrations approximating a profile consistent with that of a breast-fed infant. The amino acid composition has been specifically formulated to provide a well-tolerated nitrogen source for nutritional support and therapy for infants and young children. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.Īminosyn-PF 10%, Sulfite-Free, (an amino acid injection - pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. Multiple single doses may be dispensed during continual aliquoting operations. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures it contains no bacteriostat. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. Higher temperatures lead to greater losses. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts however, biological testing was supportive of the safety of the plastic container materials.Įxposure to temperatures above 25☌/77☏ during transport and storage will lead to minor losses in moisture content. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. The flexible plastic container is fabricated from a specially formulated polyvinylchloride.
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