Aminosyn-PF

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

R_x only

DESCRIPTION

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:

Aminosyn-PF 10%
An Amino Acid Injection — Pediatric Formula
Essential Amino Acids (mg/100 mL)
Isoleucine	760
Leucine	1200
Lysine (acetate)*	677
Methionine	180
Phenylalanine	427
Threonine	512
Tryptophan	180
Valine	673
* Amount cited is for lysine alone and does not include the acetate salt.

Nonessential Amino Acids (mg/100 mL)
Alanine	698
Arginine	1227
Aspartic Acid	527
Glutamic Acid	820
Glycine	385
Histidine	312
Proline	812
Serine	495
Taurine	70
Tyrosine	44

Electrolytes (mEq/L)
Sodium (Na+)	None
Potassium (K+)	None
Chloride (Cl−)	None
Acetate (C2 H3 O2 −) a	46

Product Characteristics
Protein Equivalent (Approx. grams/L)	100
Total Nitrogen (grams/L)	15.2
Osmolarity (mOsmol/L)	788
pH (range)	5.5 (5.0 to 6.5)
Specific Gravity	1.03
a From lysine acetate.

The formulas for the individual amino acids present in Aminosyn-PF 10% are as follows:

Essential Amino Acids
Isoleucine	CH3 CH2 CH(CH3 )CH(NH2 )COOH
Leucine	(CH3 )2 CHCH2 CH(NH2 )COOH
Lysine Acetate	H2 N(CH2 )4 CH(NH2 )COOH • CH3 COOH
Methionine	CH3 S(CH2 )2 CH(NH2 )COOH
Phenylalanine
Threonine	CH3 CH(OH)CH(NH2 )COOH
Tryptophan
Valine	(CH3 )2 CHCH(NH2 )COOH

Nonessential Amino Acids
Alanine	CH3 CH(NH2 )COOH
Arginine	H2 NC(NH)NH(CH2 )3 CH(NH2 )COOH
L-Aspartic Acid	HOOCCH2 CH(NH2 )COOH
L-Glutamic Acid	HOOC(CH2 )2 CH(NH2 )COOH
Glycine	H2 NCH2 COOH
Histidine
Proline
Serine	HOCH2 CH(NH2 )COOH
Taurine	H2 N − CH2 CH2 − SO3 H
Tyrosine

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.