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

Pharmacy Bulk Package – Not For Direct Infusion.

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)100150

Total Nitrogen

(grams/liter)15.323.0

Osmolarity

(mOsmol/liter, actual)8401270

pHa

5.8 (5.0 – 6.5)5.8 (5.0 – 6.5)

Specific Gravity

1.031.05

Electrolytes

(mEq/L)

Sodium

(Na+)b 3850

Acetate

(C2 H3 O2 )c 71.8107.6

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:

structural formula amino acids
(click image for full-size original)

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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