AMINOSOL-NEO
Active material: combination of active ingredients
When ATH: B05BA01
CCF: The preparation for parenteral nutrition – amino acid solution
ICD-10 codes (testimony): A40, A41, E46, K85, K86.1, R63.3, T14, T30
At KFU: 21.08.01.01
Manufacturer: HEMOFARM A.D. (Serbia)
Pharmaceutical form, composition and packaging
Solution for infusion clear, colorless to slightly yellow.
| 1 l 10% r-ra | 1 l 15% r-ra | |
| L-isoleucine | 5 g | 5.2 g |
| L-leucine | 7.4 g | 8.9 g |
| L-valine | 6.2 g | 5.5 g |
| L-lysine monoacetate | 9.31 g | 15.66 g, |
| that corresponds to the content of L-lysine | 6.6 g | 11.1 g |
| L-methionine | 4.3 g | 3.8 g |
| L-threonine | 4.4 g | 8.6 g |
| L-phenylalanine | 5.1 g | 5.5 g |
| L-alanine | 14 g | 25 g |
| L-arginine | 12 g | 20 g |
| glycine | 11 g | 18.5 g |
| L-histidine | 3 g | 7.3 g |
| L-proline | 11.2 g | 17 g |
| L-serine | 6.5 g | 9.6 g |
| L-tyrosine | 0.4 g | 0.4 g |
| taurine | 1 g | 2 g |
| L-tryptophan | 2 g | 1.6 g |
| energy value | 400 kcal / l (1680 kJ / l) | 600 kcal / l (2520 kJ / l) |
| osmolarity | 990 mosm / l | 1505 mosm / l |
| pH | 5.5-6.5 | 5.5-6.5 |
| L-malic acid | – | q.s. |
Excipients: glacial acetic acid, water d / and.
500 ml – bottles (1) complete with holder vial – packs cardboard.
Pharmacological action
Combined preparation for parenteral nutrition, which contains essential and nonessential amino acids in the optimal ratio. All amino acids are in L-form, that enables their direct involvement in the biosynthesis of proteins.
The preparation contains 8 essential amino acids (is not synthesized in humans): L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-tryptophan and L-valine, and conditionally-essential L-arginine and L-histidine. They are synthesized in the body, but under some pathophysiological conditions (eg, kidney and liver failure) in young children and their concentration reaches the desired level.
L-arginine promotes optimal conversion of ammonia to urea, linking toxic ammonium ions, which are formed during the catabolism of proteins in the liver.
L-isoleucine, L-leucine and L-valine – essential amino acids with branched side chains satisfy the energy needs of the organism, which is especially important directly postoperatively.
Amino acids, containing aromatic ring, represented by L-phenylalanine and L-tyrosine in a small amount and safe, which is caused by the potential for tserebrotoksicheskogo action at high concentrations. Mainly, minimizing concentration extends to L-tyrosine, one derivatives which is octopamine – false neurotransmitter, have a toxic effect on the CNS.
Nitrogen content 10% solution -16.2 g / l, in 15% solution – 25.7 g / l.
The content of amino acids in 10% solution – 100 g / 1 liter, in 15% solution – 150 g / 1 liter.
Pharmacokinetics
Administered parenterally amino acids used in protein synthesis in the body. Unused in this process deaminated amino acid to form urea, which is then excreted in the urine. T1/2 amino acids in healthy people is 5-15 m. Part of the amino acids can not undergo biotransformation and is excreted unchanged in the, desired effect of the use of these compounds in such a case disappears. This pharmacokinetic characteristics can be eliminated, injecting the drug slowly enough, The concentration of amino acids in the blood is not rapidly increased. This route of administration avoids removing amino acids through the kidneys in unchanged form.
Testimony
Parenteral nutrition partial or complete (adding fat emulsions, electrolytes and carbohydrates), as well as the prevention and treatment of loss of protein and fluid, when it is impossible to use enteral nutrition:
- Severe cases of gastrointestinal diseases (obstruction, malabsorption, inflammatory bowel disease, pancreatitis, intestinal fistula);
- Hypermetabolic state (injury, burns, sepsis);
- Other cases, requiring parenteral nutrition (malignant diseases, in preparation for surgery and after surgery).
Dosage regimen
Aminosol-neo is used as / in infusion through a central venous. Dose set individually, according to the severity of metabolic disturbances and the body's need for amino acids.
When administered 10% solution The average dose for Adult is 10-20 ml / kg / day, respectively – 1-2 amino acid g / kg / day. The maximum speed of introduction – 1 ml / kg / h, The recommended infusion rate – 20-35 drops / min, The maximum daily dose is 20 ml / kg.
When administered 15% solution The average dose for Adult is 6.7-13.3 ml / kg / day, respectively – 1-2 amino acid g / kg / day. The maximum speed of introduction – 0.67 ml / kg / h, The maximum daily dose is 13.3 ml / kg.
To patients with a body weight 70 kg daily dose is 470-930 ml, the recommended rate of administration – 16 drops / min.
Patients with renal insufficiency (without dialysis) recommends the introduction of proteins in a dose 0.6-1 g / kg / day, patients with renal insufficiency, dialysis, – 1.2-2.7 g / kg / day.
At hepatic insufficiency protein requirement is 0.8-1.1 g / kg / day.
Side effect
In applying the drug possible deficiency of folate in the body, resulting in the treatment of this drug requires a daily intake of folic acid.
Contraindications
- Metabolic acidosis;
- Severe renal insufficiency;
- Severe hepatic impairment;
- Shock;
- Hypoxia;
- Heart failure decompensation;
- Pregnancy;
- Lactation (breast-feeding);
- Childhood and adolescence up 18 years (efficacy and safety have not been established).
FROM caution It should be prescribed the drug for sepsis, essential hypertension, liver diseases, diabetes.
Pregnancy and lactation
Efficacy and safety of the drug during pregnancy and lactation (breast-feeding) not set.
Cautions
Arginine, part of the drug, may reduce the phosphorus concentration and the increase in the concentration of potassium in the plasma. These changes are particularly pronounced in patients with diabetes.
Insulin prevents the development of hyperkalemia, vыzvannoy argininom, so patients in stressful conditions, as well as patients with diabetes (as a type of 1, and such 2), you must inject insulin, if they get Aminosol-Neo.
As a result, damage to the central vein with hemorrhage during catheterization possible bacterial or fungal thrombophlebitis.
Not recommended uncontrolled addition of other drugs to the solution Aminosol-Neo.
Use only clear solution from the bottle intact.
Overdose
Symptoms: nausea, vomiting, increased perspiration, fever, tachycardia. At high speed the introduction of possible violation of hypervolemia and electrolyte composition of plasma.
Treatment: Overdose symptoms are reversible. It is necessary to reduce the rate of administration or discontinue administration of the drug and Symptomatic treatment.
Drug Interactions
Odnovremennoe vvedenie arginine with tiazidnыmi diuretikami and aminofillinom uvelichivaet soderzhanie insulin Resurrection.
Estrogens and oral contraceptives can cause an increased concentration of growth hormone, vыzvannoe argininom, and ponizity glyukagonovыy and insulinovыy require it of arginine.
With simultaneous use of arginine with spironolactone may develop severe hyperkalemia.
Pharmaceutical interaction
With the introduction of the drug should be considered, arginine that is incompatible with thiopental sodium.
The product is compatible with antibiotics (amikacin, ampicillin, cefotaxime, ceftriaxone, doxycycline, Erythromycin, gentamicin, chloramphenicol, klindamiцin, netilmycin, penicillin, piperacillin, tetracycline, tobramycin and vancomycin), as well as other drugs (aminofillin, cyclophosphamide, cimetidine, цitaraʙin, Digoxin, Dopamine, famotidin, phytomenadione, ftoruracil, folic acid, furosemid, Heparin, chlorpromazine, insulin, kalytsiya gluconate, lidokain, methyldopa, methylprednisolone, metoclopramide, methotrexate, morphine, nizatidin, norepinephrine, propranolol, ranitidine and riboflavin).
Conditions of supply of pharmacies
The drug prescription. The drug should be used only in fixed health facilities.
Conditions and terms
The drug should be stored in the dark, inaccessible to children at temperature from 15 ° to 25 ° C. Shelf life – 2 year.
