This infusion is used as a source of amino acids, glucose, and electrolytes in both adults and children who require intravenous nutrition. It is particularly suitable for patients with standard amino acid requirements.

This is a sterile, aqueous solution containing 7% amino acids for intravenous infusion along with 10% glucose and electrolytes. It provides essential nitrogen for parenteral nutrition through both essential and non-essential amino acids required for protein synthesis. The composition supports achieving a positive nitrogen balance, particularly during postoperative recovery and in prolonged intravenous nutritional therapy.

Each 100 ml contains:

Essential Amino Acids:

• L-Isoleucine: 0.390 g
• L-Leucine: 0.530 g
• L-Lysine Hydrochloride: 0.390 g
• L-Methionine: 0.190 g
• L-Phenylalanine: 0.550 g
• L-Threonine: 0.300 g
• L-Tryptophan: 0.100 g
• L-Valine: 0.430 g
• L-Histidine: 0.240 g
• L-Tyrosine: 0.050 g

Non-Essential Amino Acids:

• L-Arginine: 0.330 g
• L-Aspartic Acid: 0.410 g
• L-Glutamic Acid: 0.900 g
• L-Alanine: 0.300 g
• L-Cystine: 0.140 g
• Glycine (Aminoacetic Acid): 0.210 g
• L-Proline: 0.810 g
• L-Serine: 0.750 g

Carbohydrate:

• Anhydrous Glucose: 10.00 g

Electrolytes:

• Sodium (Na⁺): 50.0 mmol/L
• Potassium (K⁺): 20.0 mmol/L
• Calcium (Ca²⁺): 2.5 mmol/L
• Magnesium (Mg²⁺): 1.5 mmol/L
• Chloride (Cl⁻): 32.0 mmol/L

Crystalline amino acid solutions supply essential amino acids that help enhance protein synthesis, support tissue repair, and promote wound healing while reducing the breakdown of body proteins. When administered through central venous infusion along with concentrated dextrose, electrolytes, vitamins, trace elements, and lipid supplements, they form a complete total parenteral nutrition (TPN) regimen. These amino acid solutions can also be given via peripheral veins in combination with dextrose and maintenance electrolytes.

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 is 0.10-0.25 g nitrogen/kg/day corresponds to 11-27 ml/kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon the patient’s requirements, 1000-2000 ml may be infused intravenously per 24 hours. This should be infused slowly; at a rate not exceeding 500 ml in 3 hours corresponding to approximately at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children: In infants & children, a maximal rate of infusion of 30 ml/kg body weight/day is recommended, with a step-wise increase in the rate of administration during the first week of treatment.

At the recommended dosage, this solution does not exert any pharmacological action and is not expected to interact with other medications.

This preparation should not be used in patients with:

• Congenital disorders of amino acid metabolism
• Severe hepatic impairment
• Severe uremia where dialysis is not available
• Hyperosmolar non-ketotic diabetic coma (due to glucose content)
• Known hypersensitivity to any component of the formulation

This preparation is generally well tolerated. Nausea may occur occasionally. Vomiting, flushing, and sweating have been observed when infused at rates higher than recommended. Temporary elevation in liver function tests has been reported during intravenous nutrition. The exact cause is unclear but may be related to the patient’s condition or the composition of the nutritional regimen. Hypersensitivity reactions may occur. As with other hypertonic solutions, thrombophlebitis may develop when administered through peripheral veins. This risk may be reduced by co-infusion with a 10% fat emulsion.

Amino acid solutions have been used safely during pregnancy in humans. However, no animal studies have been conducted with this specific combination (7% amino acids with 10% glucose and electrolytes).

• Hyperphenylalaninemia may occur in severely ill premature infants; monitor phenylalanine levels and adjust infusion rate accordingly
• Use with caution in patients with diabetes, severe heart failure, or renal impairment with fluid restriction
• In cases of hyperglycemia, insulin administration may be required
• Do not use if the solution appears cloudy or contains particles
• Discard any unused portion

Parenteral nutritional preparations

Store between 15°C and 25°C. Protect from light. Do not freeze. Keep out of reach of children.