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

Rx 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

structural Phenylalanine

Threonine

CH3 CH(OH)CH(NH2 )COOH

Tryptophan

structural formula 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

structural formula Histidine

Proline

structural formula Proline

Serine

HOCH2 CH(NH2 )COOH

Taurine

H2 N − CH2 CH2 − SO3 H

Tyrosine

structural formula 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.

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