Aminosyn II

AMINOSYN II- isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyltyrosine and glycine injection, solution
Hospira, Inc.

AN AMINO ACID INJECTION, Sulfite-Free

Flexible Plastic Container

Rx only

DESCRIPTION

Aminosyn^™ II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II 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 formulations are described below:

Essential Amino Acids (mg/100 mL)		Aminosyn II
		10%	15%
Isoleucine		660	990
Leucine		1000	1500
Lysine (acetate)*		1050	1575
Methionine		172	258
Phenylalanine		298	447
Threonine		400	600
Tryptophan		200	300
Valine		500	750
*Amount cited is for lysine alone and does not include the acetate.
Nonessential Amino Acids (mg/100 mL)
Alanine		993	1490
Arginine		1018	1527
L-Aspartic Acid		700	1050
L-Glutamic Acid		738	1107
Histidine		300	450
Proline		722	1083
Serine		530	795
N-Acetyl-L-Tyrosine		270	405
Glycine		500	750
Other Characteristics
Protein Equivalent	(approx. grams/liter)	100	150
Total Nitrogen	(grams/liter)	15.3	23.0
Osmolarity	(mOsmol/liter, actual)	840	1270
pHa		5.8 (5.0 – 6.5)	5.8 (5.0 – 6.5)
Specific Gravity		1.03	1.05
Electrolytes	(mEq/L)
Sodium	(Na+)b	38	50
Acetate	(C2 H3 O2 –)c	71.8	107.6
a Solution contains sodium hydroxide for pH adjustment. b Figure includes Na+ from the pH adjustor. c Includes acetate from lysine acetate.

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 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 formulas for the individual amino acids are as follows:

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.