AMINOSYN-PF- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine and tyrosine injection, solution
ICU Medical Inc.
AN AMINO ACID INJECTION — PEDIATRIC FORMULA
Pharmacy Bulk Package − Not for Direct Infusion.
Flexible Plastic Container
Aminosyn® -PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-PF 10% is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulation is described below:
An Amino Acid Injection — Pediatric Formula
Essential Amino Acids (mg/100 mL)
* Amount cited is for lysine alone and does not include the acetate salt.
Nonessential Amino Acids (mg/100 mL)
Acetate (C2 H3 O2 −) a
Protein Equivalent (Approx. grams/L)
Total Nitrogen (grams/L)
5.5 (5.0 to 6.5)
a From lysine acetate.
The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:
Essential Amino Acids
CH3 CH2 CH(CH3 )CH(NH2 )COOH
(CH3 )2 CHCH2 CH(NH2 )COOH
H2 N(CH2 )4 CH(NH2 )COOH • CH3 COOH
CH3 S(CH2 )2 CH(NH2 )COOH
CH3 CH(OH)CH(NH2 )COOH
(CH3 )2 CHCH(NH2 )COOH
Nonessential Amino Acids
CH3 CH(NH2 )COOH
H2 NC(NH)NH(CH2 )3 CH(NH2 )COOH
HOOCCH2 CH(NH2 )COOH
HOOC(CH2 )2 CH(NH2 )COOH
H2 NCH2 COOH
HOCH2 CH(NH2 )COOH
H2 N − CH2 CH2 − SO3 H
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
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.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
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. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.
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