INSTRUCTIONS FOR MEDICAL USE
Trade name of the drug: Aminorem
Active ingredients (INN): Amino acids: L-proline, L-serine, L-alanine, L-isoleucine, L-leucine, L-aspartic acid, L-tyrosine, L-glutamic acid, L-phenylalanine, L-arginine hydrochloride, L-lysine hydrochloride, L-valine, L-threonine, L-histidine hydrochloride monohydrate, L-tryptophan, L-methionine, L-cystine/L-cysteine hydrochloride monohydrate, glycine.
Dosage form: solution for infusion.
100 ml of the solution contains:
L-serine – 0.1 g
L-proline – 0.1 g
L-alanine – 0.2 g
L-isoleucine – 0.352 g
L-leucine – 0,49 g
L-aspartic acid – 0.25 g
L-tyrosine – 0,025 g
L-glutamic acid – 0.075 g
L-phenylalanine – 0.533 g
L-arginine hydrochloride – 0,50 g
L-lysine hydrochloride – 0,43g
L-valine – 0,36g
L-threonine – 0,25g
L-histidine hydrochloride monohydrate – 0.25 g
L-tryptophan – 0.09 g
L-methionine – 0.225g
L-cysteine – 0.01g
or L-cysteine hydrochloride monohydrate – 0.0172 g
Glycine – 0.76 g
Excipients: 1 M sodium hydroxide solution, sorbitol, sodium metabisulfite (sodium disulfite), water for injection up to 100 ml.
Description: Colorless or almost colorless transparent solution.
Pharmacotherapeutic group: parenteral nutrition, amino acids.
ATX code: B05BA01
L-amino acid infusion solution for parenteral nutrition. Amino acids are components necessary for protein synthesis. Amino acids contained in preparation are in L-form, which enables their direct participation in protein biosynthesis. Solutions containing amino acids are used for parenteral nutrition simultaneously with energy carriers, electrolytes and fluids, in order to maintain or improve body condition or minimize weight loss. In pathological conditions in the absence of exogenous administration of amino acids, a typical pronounced change in the set of amino acids in the blood plasma develops, both the absolute concentration of individual amino acids and their percentage ratio in the blood plasma.
The preparation contains all eight essential amino acids as well as conditionally substituted L-arginine and L-histidine. L-arginine promotes the conversion of ammonia into urea and binds toxic ammonium ions, which are formed during protein catabolism in the liver. L-amino acids are involved in anabolic processes (protein synthesis), slow down catabolic processes, accelerate reparation processes, are part of the buffer system regulating homeostasis of extra- and intracellular body fluids. Sorbitol is an energy carrier and is phosphorylated in the liver into fructose-6-phosphate. Sorbitol is a better solvent for amino acids than glucose, because it does not contain aldehyde and ketone groups, so there is no combining them with the amino groups of amino acids into complexes that reduce the effect of amino acids.
Bioavailability of the drug is 100%. After drug administration, the amino acids are included in the process of protein synthesis. Excessive amino acids that are not included in the synthesis of proteins and other biomolecules are not accumulated (unlike fatty acids and glucose), but are broken down by deamination of α-amino group, which is metabolized to form urea, which is excreted by kidneys. Only a small part of the amino acids (5%) is excreted unchanged.
Indications for use
Parenteral protein nutrition for:
- Hypoproteinemia and fluid loss of different genesis;
- Inability or severe limitation of food intake in the usual way in pre- or postoperative periods;
- Extensive deep burns (especially burn exhaustion);
- Trauma, fractures, purulent processes, sepsis;
- inflammatory bowel diseases, cachexia, poisoning;
- malignant tumors of the gastrointestinal tract, permanent febrile states;
- In children with protein dystrophy, hypotrophy, GI defects.
If necessary to improve the metabolic and reparative processes in the postoperative period.
Replenishment or elimination of protein deficiency resulting from increased need or cost and in violation of protein metabolism during digestion, absorption and excretion.
Dosage and administration
The drug is administered intravenously (IV) dropwise, slowly with careful monitoring of the patient’s condition. Dosage is adjusted for the patient’s clinical condition and his requirements for amino acids and fluids, body weight and degree of catabolism.
Adults: 0.6 to 1.0 g of amino acids (up to 20 ml of the solution/kg of body weight per day).
In catabolic states: 1.3 to 2 g amino acids (up to 40 ml of solution/kg of body weight per day).
Children aged 2 to 18 years: 1.0 to 2.0 g amino acids (up to 40 ml of solution/kg of body weight per day).
Maximum daily dose is 2.0 g of amino acids (up to 40 ml of solution/kg of body weight).
Maximum infusion rate: 2 ml/kg of body weight per hour, which equals 0.1 g amino acids/kg of body weight per hour.
When parenteral nutrition in adults, the total amount of fluid administered should not exceed 40 ml/kg body weight per day.
The drug is used until the patient is fully transferred to enteral or oral nutrition.
Usually the drug is well tolerated. Nausea, vomiting, chills, phlebitis (especially if administered quickly) may occur in single cases. Due to the sodium disulfite content in the drug, in single cases (especially in patients with bronchial asthma) hyperergic reactions, vomiting, diarrhea, dyspnea, bronchial asthma attacks, loss of consciousness, shock are possible. In addition, the products of interaction of sodium disulfite with another component of the drug – tryptophan – may increase bilirubin content and activity of liver enzymes in the blood plasma.
Contraindications to use are distinguished as relative and absolute.
- heart failure;
- Severe renal or hepatic insufficiency (only in the absence of adequate diuresis);
- impaired amino acid metabolism;
- acute period of craniocerebral trauma;
- Hypersensitivity to sodium disulfite and drug components;
- metabolic acidosis.
- Tissue hypoxia – insufficient supply of oxygen to cells and tissues of the body;
- Shock and other conditions with unstable blood circulation and life-threatening
Do not mix with other drugs in the same solution.
It is possible to use during pregnancy and lactation period as indicated. The drug is used only under hospital conditions.
Use with caution in case of increased serum osmolarity.
Correction of dosage regimen is required in case of moderate hepatic and renal insufficiency.
Blood water and electrolyte balance, blood glucose concentration and acid-base balance should be controlled.
Complete parenteral nutrition requires simultaneous addition of substances – energy carriers, electrolytes, vitamins and trace elements.
After opening the vial the drug should be used immediately. Do not store opened vial.
Do not use the drug again from the vial, which has already been used. Use only clear solution in an undamaged vial! Failure to observe the storage and transportation conditions can lead to the formation of micro-cracks on the vial, thus increasing the risk of microbial contamination of the solution.
For single-use sampling only! Do not freeze or heat!
No data on overdose have been reported.
Form of production
Infusion solution in 100 ml, 200 ml and 250 ml vials.
Store in a dry place, protected from light, at a temperature not more than 25ºC. Keep out of the reach of children!
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies
Released by a doctor’s prescription.