NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.
Nutrimix ® Dual-chamber Flexible Container
The Upper Chamber Contains 500 mL of Aminosyn II 7%
(An Amino Acid Injection)
The Lower Chamber Contains 500 mL of 50% Dextrose Injection, USP
Rx only
DESCRIPTION
Upper Chamber: Aminosyn II 7%, an amino acid injection, 500 mL.
Aminosyn II 7% is a sterile, nonpyrogenic solution for intravenous infusion. The formulation is described in the table below.
Lower Chamber: 50% Dextrose Injection, USP, 500 mL.
50% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection. The table below indicates the characteristics of this concentrated solution.
The container must be used only after removing the clamp and thoroughly mixing the contents of the two chambers. The solution resulting from mixing the contents of the upper and the lower chamber will be 3.5% amino acids in 25% dextrose. Mixing the contents of the upper and lower chambers yields a concentrated source of amino acids and carbohydrate calories for intravenous infusion. Headspace contains Nitrogen gas. The composition of this admixture is described in the table below.
|
Solution Composition per 100 mL
|
|
Upper
Chamber
|
Lower
Chamber
|
Admixture
|
|
Dextrose, hydrous (g)
| |
50
|
25
|
|
Essential Amino Acids (mg)
| | | |
|
Isoleucine
|
462
| |
231
|
|
Leucine
|
700
| |
350
|
|
Lysine (as acetate salt)*
|
735
| |
368
|
|
Methionine
|
120
| |
60
|
|
Phenylalanine
|
209
| |
104
|
|
Threonine
|
280
| |
140
|
|
Tryptophan
|
140
| |
70
|
|
Valine
|
350
| |
175
|
|
Nonessential Amino Acids (mg)
| | | |
|
Alanine
|
695
| |
348
|
|
Arginine
|
713
| |
356
|
|
L-Aspartic Acid
|
490
| |
245
|
|
L-Glutamic Acid
|
517
| |
258
|
|
Histidine
|
210
| |
105
|
|
Proline
|
505
| |
252
|
|
Serine
|
371
| |
186
|
|
N-Acetyl-L-Tyrosine
|
189
| |
94
|
|
Glycine
|
350
| |
175
|
|
Total Amino Acids (g)
|
7
| |
3.5
|
|
Protein Equivalent (g)
|
7
| |
3.5
|
|
Total Nitrogen (g)
|
1.07
| |
0.54
|
|
*Amount cited is for lysine alone and does not include the acetate salt.
|
|
Upper Chamber
|
Lower
Chamber
|
Admixture
|
|
Electrolytes (mEq/liter)
| | | |
|
Sodium a (Na+)
|
36
| |
18
|
|
Acetate b (C2H3O2−)
|
50.3
| |
25.2
|
|
Sodium hydrosulfite (mg/100 mL)
|
60
| |
30
|
|
Osmolarity mOsmol/liter (actual)
|
647
|
1997
|
1515
|
|
pH
|
5.8
|
4.3
|
5.8
|
|
range
|
5.0 to 6.5 c
|
3.2 to 6.5
|
5.0 to 6.5
|
The formulas for the individual amino acids present are as follows:
|
|
|
_______________________________________________________________________________
|
|
aIncludes sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite.
|
|
bIncludes acetate from lysine acetate.
|
|
cMay contain sodium hydroxide for pH adjustment.
|
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H20), a hexose sugar freely soluble in water.
The flexible plastic container is fabricated from a specially formulated nonplasticized thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
