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DRUG DESCRIPTION
Aminosyn® II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection with electrolytes) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II 8.5% (amino acid injection with electrolytes) WITH ELECTROLYTES is oxygen sensitive. The following formulation is available:
Essential Amino Acids (mg/100 mL)
| Isoleucine | 561 |
| Leucine | 850 |
| Lysine (acetate)* | 893 |
| Methionine | 146 |
| Phenylalanine | 253 |
| Threonine | 340 |
| Tryptophan | 170 |
| Valine | 425 |
| *Amount cited is for lysine alone and does not include the acetate salt. | |
Nonessential Amino Acids (mg/100 mL)
| Alanine | 844 |
| Arginine | 865 |
| L-Aspartic Acid | 595 |
| L-Glutamic Acid | 627 |
| Histidine | 255 |
| Proline | 614 |
| Serine | 450 |
| N-Acetyl-L-Tyrosine | 230 |
| Glycine | 425 |
Product Characteristics
| Protein Equivalent (approx. g/liter) | 85 |
| Total Nitrogen (g/liter) | 13.0 |
| Osmolarity (mOsmol/L) | 920 |
| pHa | 5.8 |
| range | 5.0 - 6.5 |
| aContains sodium hydroxide for pH adjustment. | |
Electrolytes (mEq/liter)
| Sodium (Na+)b | 78 |
| Potassium (K+) | 66 |
| Magnesium (Mg++) | 10 |
| Phosphorus mMc | 30 |
| Chloride (CI-) | 86 |
| Acetate (C2H3O2-) | 61d |
| b Includes sodium from the pH adjustor. c mM = millimoles; one mM of phosphorus = 31 mg P. d Includes acetate from lysine acetate. |
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Electrolytes (mg/100 mL)
| Sodium Chloridee | 60 mg |
| Magnesium Chloride hexahydratef | 102 mg |
| Sodium Phosphate, dibasicg | 425 mg |
| Potassium Chlorideh | 492 mg |
| e Sodium Chloride, USP is chemically designated
NaCI, a white crystalline powder freely soluble in water. f Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate, MgCl2•6H2O, deliquescent crystals very soluble in water. g Sodium Phosphate, dibasic, USP is chemically designated Na2HPO4, white granules very soluble in water. h Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. |
|
The formulas for the individual amino acids present in Aminosyn II 8.5% (amino acid injection with electrolytes) WITH ELECTROLYTES are as follows:
Essential Amino Acids
| Isoleucine, USP | C6H13NO2 |
| Leucine, USP | C6H13NO2 |
| Lysine Acetate, USP | C6H14N2O2 • CH3COOH |
| Methionine, USP | C5H11NO2S |
| Phenylalanine, USP | C9H11NO2 |
| Threonine, USP | C4H9NO3 |
| Tryptophan, USP | C11H12N2O2 |
| Valine, USP | C5H11NO2 |
Nonessential Amino Acids
| Alanine, USP | C3H7NO2 |
| Arginine, USP | C6H14N4O2 |
| L-Aspartic Acid | C4H7NO4 HO2CCH2CH(NH2)CO2H |
| L-Glutamic Acid | C5H9NO4 HO2CCH2CH2CH(NH2)CO2H |
| Glycine, USP | C2H5NO2 |
| Histidine, USP | C6H9N3O2 |
| Proline, USP | C5H9NO2 |
| Serine, USP | C3H7NO3 |
| N-Acetyl-L-Tyrosine | C11H13NO4 |
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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.