Amiparcenin^® (Solution) Instructions for Use

Marketing Authorization Holder

TK Asia LLC (Russia)

Manufactured By

SP Remedy Group, LLC (Uzbekistan)

ATC Code

B05BA10 (Combined preparations for parenteral nutrition)

Dosage Form

Amiparcenin®

Solution for infusion

Dosage Form, Packaging, and Composition

Solution for infusion in the form of a transparent solution from almost colorless to yellow.

100 ml – bottles – cardboard packs – By prescription
200 ml – bottles – cardboard packs – By prescription

Clinical-Pharmacological Group

Agent for parenteral nutrition – amino acid and electrolyte solution

Pharmacotherapeutic Group

Blood substitutes and perfusion solutions; solutions for intravenous administration; solutions for parenteral nutrition

Pharmacological Action

Amino acid solutions for parenteral nutrition provide the body with substrates for protein synthesis.

The administration of all amino acids necessary for protein synthesis (including essential, conditionally essential, and non-essential amino acids) ensures high nutritional efficiency and reduces the load on the body that occurs during protein synthesis.

In addition to amino acids, preparations for parenteral nutrition may include minerals, dextrose, xylitol, as well as lipids.

Minerals are necessary to maintain water-electrolyte and acid-base balance.

As an energy source, amino acid solutions for parenteral nutrition may contain dextrose, xylitol, Sorbitol, which are involved in the processes of glycolysis and gluconeogenesis.

Fat emulsion is a source of energy and essential fatty acids.

Indications

For parenteral nutrition in inpatient and outpatient settings to cover the daily requirement of patients for amino acids, electrolytes, and fluid during parenteral nutrition in patients with a degree of catabolism from moderate to severe in cases where enteral nutrition is impossible, insufficient, or contraindicated, as well as in combination with it.

Means for parenteral nutrition should be used strictly in accordance with the indications in the instructions for medical use.

ICD codes

Dosage Regimen

Administer Amiparcenin^®intravenously via central or peripheral vein.

Determine the daily dosage based on the patient’s age, body weight, clinical condition, and nitrogen balance.

For adults, infuse 0.7 to 1.5 grams of amino acids per kilogram of body weight per day.

Adjust the infusion rate and volume to meet the patient’s individual protein and energy requirements.

Infuse at a maximum rate of 0.1 grams of amino acids per kilogram per hour to ensure optimal utilization.

Do not exceed a daily volume of 40 ml per kilogram of body weight.

Always administer with a sufficient energy source, such as glucose or lipid emulsions, to promote protein synthesis.

For pediatric patients, use only formulations specifically approved for this age group and calculate dosage based on body surface area or weight.

Monitor the patient’s fluid, electrolyte, and acid-base balance continuously during therapy.

Regularly check blood glucose, liver enzymes, and renal function parameters.

Discontinue infusion immediately if signs of intolerance or metabolic disturbance occur.

Adverse Reactions

From the immune system allergic reactions.

From the cardiovascular system phlebitis, thrombosis.

From the respiratory system bronchospasm.

From the digestive system nausea, vomiting.

From the urinary system renal aminoacidosis.

General disorders chills, redness.

Contraindications

General for parenteral nutrition: severe circulatory disorders (collapse and shock); pronounced tissue hypoxia; overhydration; disturbances of water-electrolyte balance; pulmonary edema; decompensated heart failure, severe renal failure; acute period of traumatic brain injury; coma or impaired brain functions that can cause a comatose state.

Before prescribing a preparation for parenteral nutrition, the contraindications for its use in a particular patient should be carefully studied.

With caution

Patients with increased plasma osmolarity, heart failure, hepatic and/or renal failure.

In children and adolescents under the age of 18 years, only those preparations for parenteral nutrition that are intended for the corresponding age category should be used.

Use in Pregnancy and Lactation

If it is necessary to prescribe a preparation for parenteral nutrition during pregnancy, the presence of contraindications for use and precautions in the current clinical situation should be taken into account.

The use of solutions for parenteral nutrition during lactation (breastfeeding) is not recommended.

Pediatric Use

In children and adolescents under the age of 18 years, only those preparations for parenteral nutrition that are intended for the corresponding age category should be used.

Special Precautions

Intravenous administration of amino acid solutions is accompanied by increased excretion of trace elements in the urine, especially copper and zinc. This must be taken into account when selecting doses of trace elements, especially during long-term therapy.

When administering a preparation for parenteral nutrition, regular monitoring of water-electrolyte balance and blood acid-base status, monitoring of blood sugar concentration, and serum ionogram should be performed. During long-term therapy, monitoring of blood parameters (coagulogram, liver function indicators) is necessary.

Due to the risk of pseudoagglutination, it is not recommended to use the same infusion systems for the administration of blood preparations and multicomponent amino acid solutions.

Use in pediatrics

During parenteral nutrition of young children, the following indicators must be taken into account: urine nitrogen, ammonia content, glucose, electrolytes, triglycerides (with additional administration of fat emulsions), liver enzymes, serum osmolarity, acid-base balance, and water-salt metabolism. Too rapid infusion can lead to the loss of amino acids through the kidneys, and consequently, to an imbalance of amino acids.

In pediatrics, only those preparations for parenteral nutrition that are intended for this category of patients should be used.

Drug Interactions

Preparations for parenteral nutrition are multicomponent solutions. When adding other solutions or a lipid emulsion to the preparation used, the compatibility of all ingredients must be taken into account.

Simultaneous administration of arginine with thiazide diuretics and aminophylline increases the insulin content in the blood.

Estrogens and oral contraceptives can cause an increase in the concentration of growth hormone caused by arginine and reduce the glucagon and insulin response to arginine.

With the simultaneous use of arginine with spironolactone, the development of severe hyperkalemia is possible.

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.