Amino Acids Injection

Name: Amino Acids Injection

Warnings

Administration of amino acids solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status re-evaluated.

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.

Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Carton

15% Amino Acids
Injection

NDC 0264-3200-55
REF S3200-SS
1000 mL

Protect from light until use.

PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION

Each 100 mL contains:

 Essential Amino Acids  
 Lysine (from Lysine Acetate, USP)  1.18 g
 Leucine, USP  1.04 g
 Phenylalanine, USP  1.04 g
 Valine, USP  960 mg
 Isoleucine, USP  749 mg
 Methionine, USP  749 mg
 Threonine, USP  749 mg
 Tryptophan, USP  250 mg
     
 Nonessential Amino Acids  
 Alanine, USP  2.17 g
 Arginine, USP  1.47 g
 Glycine, USP  1.04 g
 Histidine, USP  894 mg
 Proline, USP  894 mg
 Glutamic Acid  749 mg
 Serine, USP  592 mg
 Aspartic Acid, USP  434 mg
 Tyrosine, USP  39 mg
 Sodium Metabisulfite, NF added  30 mg
 Water for Injection USP qs  

See adjacent panel for further product information.

B. Braun Medical Inc.
Irvine, CA 92614-5895 USA
1-800-227-2862
www.bbraun.com
Made in USA

For Intravenous Use

pH 5.6 (5.2-6.0), adjusted with acetic acid.
Acetate: 151 mEq/L, including quantity used
for pH adjustment.
Calculated Osmolarity: 1383 mOsmol/L

Contains no more than 25 mcg/L of aluminum.

Sterile, nonpyrogenic. Single dose container.
Use only if bottle and seal are undamaged and
solution is clear with vacuum present.
Administer intravenously.

Store at 20 to 25°C (68 to 77°F). [See USP
Controlled Room Temperature.] Solution that
has been frozen must not be used. Do not
expose to light before using. Once closure is
penetrated, transfer contents promptly, total
time not to exceed 4 hours. See package
insert for proper use of Pharmacy Bulk
Package.

Rx only

LD-247-1     X12-002-444

AMINO ACIDS 
lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0264-3200
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LYSINE ACETATE (LYSINE) LYSINE 1.18 g  in 100 mL
LEUCINE (LEUCINE) LEUCINE 1.04 g  in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 1.04 g  in 100 mL
VALINE (VALINE) VALINE 960 mg  in 100 mL
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 749 mg  in 100 mL
METHIONINE (METHIONINE) METHIONINE 749 mg  in 100 mL
THREONINE (THREONINE) THREONINE 749 mg  in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 250 mg  in 100 mL
ALANINE (ALANINE) ALANINE 2.17 g  in 100 mL
ARGININE (ARGININE) ARGININE 1.47 g  in 100 mL
GLYCINE (GLYCINE) GLYCINE 1.04 g  in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 894 mg  in 100 mL
PROLINE (PROLINE) PROLINE 894 mg  in 100 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 749 mg  in 100 mL
SERINE (SERINE) SERINE 592 mg  in 100 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 434 mg  in 100 mL
TYROSINE (TYROSINE) TYROSINE 39 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE 30 mg  in 100 mL
WATER  
ACETIC ACID  
Packaging
# Item Code Package Description
1 NDC:0264-3200-55 6 CARTON in 1 CASE
1 1 BOTTLE, GLASS in 1 CARTON
1 1000 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091112 04/13/2012
AMINO ACIDS 
lysine acetate, leucine, phenylalanine, valine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, histidine, proline, glutamic acid, serine, aspartic acid, and tyrosine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0264-3205
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LYSINE ACETATE (LYSINE) LYSINE 1.18 g  in 100 mL
LEUCINE (LEUCINE) LEUCINE 1.04 g  in 100 mL
PHENYLALANINE (PHENYLALANINE) PHENYLALANINE 1.04 g  in 100 mL
VALINE (VALINE) VALINE 960 mg  in 100 mL
ISOLEUCINE (ISOLEUCINE) ISOLEUCINE 749 mg  in 100 mL
METHIONINE (METHIONINE) METHIONINE 749 mg  in 100 mL
THREONINE (THREONINE) THREONINE 749 mg  in 100 mL
TRYPTOPHAN (TRYPTOPHAN) TRYPTOPHAN 250 mg  in 100 mL
ALANINE (ALANINE) ALANINE 2.17 g  in 100 mL
ARGININE (ARGININE) ARGININE 1.47 g  in 100 mL
GLYCINE (GLYCINE) GLYCINE 1.04 g  in 100 mL
HISTIDINE (HISTIDINE) HISTIDINE 894 mg  in 100 mL
PROLINE (PROLINE) PROLINE 894 mg  in 100 mL
GLUTAMIC ACID (GLUTAMIC ACID) GLUTAMIC ACID 749 mg  in 100 mL
SERINE (SERINE) SERINE 592 mg  in 100 mL
ASPARTIC ACID (ASPARTIC ACID) ASPARTIC ACID 434 mg  in 100 mL
TYROSINE (TYROSINE) TYROSINE 39 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM METABISULFITE 30 mg  in 100 mL
WATER  
ACETIC ACID  
Packaging
# Item Code Package Description
1 NDC:0264-3205-55 6 CARTON in 1 CASE
1 1 BOTTLE, GLASS in 1 CARTON
1 2000 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091112 04/13/2012
Labeler - B. Braun Medical Inc. (002397347)
Revised: 04/2014   B. Braun Medical Inc.
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