Each 100 ml contains.
Active ingredients.
Specification.
Quantity.
Essential Amino Acids.
L-Isoleucine.
USP.
0.352 g.
L-Leucine.
USP.
0.49 g.
L-Lysine Hydrochloride.
USP.
0.43 g.
L-Methionine.
USP.
0.225 g.
L-Phenylalanine.
USP.
0.333 g.
L-Threonine.
USP.
0.25 g.
L-Tryptophan.
USP.
0.09 g.
L-Valine.
USP.
0.36 g.
L-Histidine.
USP.
0.25 g.
L-Tyrosine.
USP.
0.025 g.
Non-Essential Amino Acids.
L-Arginine.
USP.
0.50 g.
L-Aspartic Acid.
USP.
0.25 g.
L-Glutamic Acid.
BP.
0.075 g.
L-Alanine.
USP.
0.20 g.
L-Cystine.
BP.
0.01 g.
Glycine (Aminoacetic Acid).
USP.
0.76 g.
L-Proline.
USP.
0.10 g.
L-Serine.
USP.
0.10 g.
Carbohydrate.
D-Sorbitol.
BP.
5.00 g.
Electrolytes (mmol/L).
Sodium (Na⁺).
35.5.
Potassium (K⁺).
25.0.
Magnesium (Mg⁺⁺).
2.5.
Chloride (Cl⁻).
53.4.
Acetate (CH₃COO⁻).
25.0.
Amisol® is a sterile aqueous solution of crystalline Amino Acids and D-Sorbitol with electrolytes, which are necessary as the nitrogen sources for parenteral nutrition. Nitrogen is provided in the form of essential and non-essential amino acids. The solution is clear, colorless, having a pH lying in the range of 5.0 to 7.0.
Clinical Pharmacology:
Amisol® contains all 18 essential and non-essential amino acid needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition.
Amisol® is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Amisol® is particularly suitable for patients with basal amino acid requirements. Amisol® is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.
Adults:
The nitrogen requirement for maintenance of body protein mass depends on the patient’s condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.10-0.25g nitrogen/kg/day corresponds to 15-35 ml Amisol®/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Amisol® may be infused intravenously per 24 hours. Amisol® should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.
Infants and children:
In children and infants, the rate of infusion is 28-35 ml/kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.
At the recommended dosage the amino.
Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Amisol®.
Hyperphenylaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate is adjusted as needed. Do not use if the solution is turbid or contains particles. Discard any unused portion.
Protect from light and store at below 25°C temperature. Avoid freezing. Keep out of reach of children.