Aminoven (Solution) Instructions for Use

ATC Code

B05BA01 (Amino acids)

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid solution

Pharmacotherapeutic Group

Parenteral nutrition agent, amino acid

Pharmacological Action

It is intended for parenteral nutrition of patients with various pathologies with low, normal, or increased protein requirements when enteral nutrition is ineffective or impossible. The essential and non-essential L-amino acids contained in this agent are natural physiological compounds. Like amino acids supplied with food and obtained through protein breakdown, parenterally administered amino acids enter the general pool of free amino acids in the blood plasma, and from there into cells for protein synthesis and into various metabolic pathways.

Pharmacokinetics

The pharmacokinetic characteristics of intravenously administered amino acids are the same as when they are supplied with food. However, amino acids from dietary proteins first enter the portal vein of the liver and only then the systemic bloodstream, while amino acids administered into a vein enter directly into the systemic bloodstream.

From the intravascular space, amino acids are redistributed into the interstitial fluid and transported into the cells of various tissues.

The concentrations of free amino acids in blood plasma and tissues are regulated by endogenous mechanisms within a narrow range, which depends on the patient’s age, nutritional status, and clinical condition.

Balanced amino acid solutions, including this agent, when administered slowly, do not significantly alter the physiological amino acid pool.

Only a small portion of the amino acids administered via infusion is excreted through the kidneys.

For most amino acids, the plasma T_1/2 is 10-30 minutes.

Indications

It is used as a component of a parenteral nutrition regimen, usually in combination with sufficient energy sources (carbohydrate solutions, fat emulsions).

When conducting parenteral nutrition with the need to limit the volume of fluid administered, the administration of a 15% solution of this agent is most indicated.

ICD codes

Dosage Regimen

Solution

Intravenously. The choice of a central or peripheral vein for the administration of a 5% or 10% solution of this agent depends on the final osmolarity when administered together with other solutions. The 15% solution should be administered only into central veins. The infusion can be continued for as long as required by the patient’s clinical condition, based on the daily requirement for amino acids.

10% solution

Adults

Average daily dose: 10-20 ml of 10% solution per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight), which corresponds to 700 -1400 ml of 10% solution for a patient weighing 70 kg.

Maximum daily dose: 20 ml of 10% solution per kg of body weight (equivalent to 2.0 g of amino acids per kg of body weight), which corresponds to 1400 ml of 10% solution for a patient weighing 70 kg.

Children

Maximum daily dose for children from 2 years old – 10-20 ml of 10% solution per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight).

The maximum rate of administration for children from 2 years old does not differ from the maximum rate for adults.

15% solution

Adults

Average daily dose: 6.7-13.3 ml of 15% solution per kg of body weight (equivalent to 1.0-2.0 g of amino acids per kg of body weight), which corresponds to 470-930 ml of 15% solution for a patient weighing 70 kg.

Maximum daily dose: 13.3 ml of 15% solution per kg of body weight (equivalent to 2.0 g of amino acids per kg of body weight), which corresponds to 930 ml of 15% solution for a patient weighing 70 kg.

Maximum infusion rate: 0.67 ml of 15% solution per kg of body weight per hour (equivalent to 0.1 g of amino acids per kg of body weight/hour).

Children

It is not recommended to use the 15% solution in children and adolescents under 18 years of age.

Adverse Reactions

Not known with proper use.

Side effects developing with overdose are usually reversible and disappear when the drug administration is stopped.

Any infusion into a peripheral vein can cause irritation of the vessel wall and thrombophlebitis.

Contraindications

• Disorders of amino acid metabolism;
• Metabolic acidosis,
• Renal failure in the absence of hemodialysis or hemofiltration;
• Severe hepatic insufficiency;
• Fluid overload;
• Shock;
• Hypoxia;
• Decompensated heart failure;
• Children under 2 years of age – for administration of the 10% solution;
• Children and adolescents under 18 years of age – for administration of the 15% solution.

Use in Pregnancy and Lactation

No specific studies on the safety of using this agent during pregnancy and lactation have been conducted. However, clinical experience with similar parenteral amino acid solutions indicates no risk for pregnant and breastfeeding women.

Before administering this agent during pregnancy and breastfeeding, the expected benefit of therapy for the mother and the potential risk to the fetus or breastfed infant should be assessed.

Use in Hepatic Impairment

Contraindicated: severe hepatic insufficiency.

Use in Renal Impairment

Contraindicated: renal failure in the absence of hemodialysis or hemofiltration.

Pediatric Use

It is not recommended to use the 15% solution in children and adolescents under 18 years of age.

Special Precautions

Electrolyte levels, fluid balance, and kidney function should be monitored.

In case of hypokalemia and/or hyponatremia, sufficient amounts of potassium and/or sodium should be administered simultaneously.

The administration of any amino acid solutions can provoke an acute folate deficiency, so patients should receive folic acid daily.

Caution should be exercised when infusing large volumes of fluid in patients with heart failure.

Any infusion into a peripheral vein can cause irritation of the vessel wall and thrombophlebitis. Therefore, it is recommended to inspect the catheter insertion site daily. If the patient is also prescribed a fat emulsion infusion, it should be administered simultaneously with this agent whenever possible to reduce the risk of phlebitis.

The choice of catheter insertion site (central or peripheral vein) is determined by the final osmolarity of the mixture – for infusion into a peripheral vein, the osmolarity limit is 800-900 mOsm/l. In addition, the patient’s age, clinical condition, and the state of their peripheral veins should be taken into account.

Use in pediatrics

For parenteral nutrition of newborns, infants, and children under 2 years of age, adapted pediatric amino acid preparations, the composition of which is specifically designed to meet the metabolic needs of children, should be used.

It is not recommended to use the 15% solution of this agent in children and adolescents under 18 years of age due to the lack of sufficient clinical experience in this age group.

Drug Interactions

Currently, cases of interaction are unknown.

Due to the increased risk of microbiological contamination and incompatibility, amino acid solutions should not be mixed with other drugs not intended for parenteral nutrition.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.