Aminosol-Neo
Producer: Hemofarm, A.D. (A.D. Hemofarm) Serbia
Code of automatic telephone exchange: B05BA01
Release form: Liquid dosage forms. Solution for infusions.
General characteristics. Structure:
Solution for infusions of 10% | 1000 ml |
L-L-izoleytsin | 5 g |
L-leucine | 7,4 g |
L-valine | 6,2 g |
L-lysine | 6,6 g |
(corresponds a L-lysine to monoacetate) | 9,31 g |
L-methionine | 4,3 g |
L-threonine | 4,4 g |
L-phenylalanine | 5,1 g |
L-alanine | 14 g |
L-arginine | 12 g |
glycine | 11 g |
L-histidine | 3 g |
L-proline | 11,2 g |
L-serine | 6,5 g |
L-tyrosine | 0,4 g |
taurine | 1 g |
L-tryptophane | 2 g |
excipients: ice acetic acid — q.s.; water for injections — to 1000 ml | |
energy value — 1680 kJ/l (400 kcal/l); theoretical osmolarity — 990 ¼Äß¼/l; pH — 5,5–6,5 |
Solution for infusions of 15% | 1000 ml |
L-L-izoleytsin | 5,2 g |
L-leucine | 8,9 g |
L-valine | 5,5 g |
L-lysine | 11,1 g |
(corresponds a L-lysine to monoacetate) | 15,66 g |
L-methionine | 3,8 g |
L-threonine | 8,6 g |
L-phenylalanine | 5,5 g |
L-alanine | 25 g |
L-arginine | 20 g |
glycine | 18,5 g |
L-histidine | 7,3 g |
L-proline | 17 g |
L-serine | 9,6 g |
L-tyrosine | 0,4 |
taurine | 2 g |
L-tryptophane | 1,6 g |
excipients: ice acetic acid — 4,2 g; L-apple acid — q.s.; water for injections — to 1000 ml | |
energy value — 2520 kJ/l (600 kcal/l); theoretical osmolarity — 1505 ¼Äß¼/l; pH — 5,5–6,5 |
Pharmacological properties:
The combined drug for parenteral food which contains irreplaceable and replaceable amino acids in an optimum ratio. All amino acids are in a L-form that provides a possibility of their direct participation in biosynthesis of proteins.
Drug contains 8 irreplaceable amino acids (which are not synthesized in a human body): L-izoleytsin, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-threonine, L-tryptophane and L-valine, and also conditionally replaceable L-arginine and L-histidine. They are synthesized in an organism, but at some pathophysiological states (for example, a renal and liver failure) and at small children concentration them does not reach necessary level.
L-arginine promotes optimum transformation of ammonia into urea, connecting toxic ions of ammonium which are formed at a catabolism of proteins in a liver.
L-izoleytsin, L-leucine and L-valine - irreplaceable amino acids with branched side chains satisfy energy demands of an organism that especially important directly in the postoperative period.
The amino acids containing aromatic rings are presented by L-phenylalanine and L-tyrosine in small and safe amount that is caused by potentiality of tserebrotoksichesky action at high concentration. Mainly, minimization of concentration extends to L-tyrosine, one of derivatives of which is октопамин - the false neurotransmitter having toxic effect on TsNS.
Content of nitrogen is 10% solution - 16.2 g/l, in 15% solution - 25.7 g/l.
Content of amino acids is 10% solution - 100 g / 1 l, in 15% solution - 150 g / 1 l.
Pharmacokinetics. The amino acids entered parenterally are used in an organism at protein synthesis. Unused amino acids in this process are deaminized with an ureapoiesis which then is removed with urine. T1/2 of amino acids at healthy people makes 5-15 min. A part of amino acids can not undergo biotransformation and is excreted in not changed look, the desirable effect of use of these connections in that case vanishes. This pharmacokinetic feature can be eliminated, administering the drug rather slowly that concentration of amino acids sharply did not increase in blood. Such way of introduction will allow to avoid removal of amino acids through kidneys in not changed look.
Indications to use:
Parenteral food partial or full (with addition of fatty emulsions, electrolytes and carbohydrates), and also prevention and therapy of loss of proteins and liquid when it is impossible to apply an enteroalimentation:
— hard cases of gastrointestinal diseases (obstruction, malabsorption, inflammatory diseases of intestines, pancreatitis, intestinal fistulas);
— hyper metabolic states (injuries, burns, sepsis);
— other cases demanding parenteral food (at malignant diseases, at a preparation for surgery and after an operative measure).
Route of administration and doses:
In/in (by infusion in one of the central veins).
The dosage is individual, according to weight of metabolic disturbance and the need of an organism for amino acids.
10% solution
The average dose for adults makes 10–20 ml/kg/days, respectively 1-2 g of amino acids/kg/days. The maximum admissible rate of administering — 1 ml/kg/h, the recommended infusion speed — 20–35 thaws/min., the maximum admissible daily dose — 20 ml/kg.
15% solution
The average dose for adults makes 6,7–13,3 ml/kg/days, respectively 1-2 g of amino acids/kg/days. The maximum admissible rate of administering — 0,67 ml/kg/h, the maximum admissible daily dose — 13,3 ml/kg.
For the person weighing 70 kg the daily dose makes 470–930 ml, and the recommended rate of administering — 16 thaws/min.
Dosing at a renal failure: to patients who are not on dialysis, recommend administration of proteins in a dose of 0,6-1 g/kg/days; being on dialysis — 1,2–2,7 g/kg/days.
Dosing at a liver failure: patients with a liver failure do not transfer the increased amount of amino acids and therefore their need for proteins makes 0,8–1,1 g/kg/days.
Features of use:
The arginine which is a part of drug can lead to reduction of concentration of phosphorus and increase in potassium concentration in plasma. These changes are especially expressed at patients with a diabetes mellitus.
Insulin interferes with development of the hyperpotassemia caused by arginine, therefore the patient in stressful states, and also a sick diabetes mellitus (both type 1, and type 2), it is necessary to enter insulin if they receive Aminosol-Neo.
As a result of injury of the central vein with hemorrhage at catheterization bacterial or fungal thrombophlebitis is possible.
Uncontrollable addition of other medicines to Aminosol-Neo solution is not recommended.
It is necessary to apply only transparent solution from the unimpaired bottle.
Side effects:
At use of drug deficit of folates in an organism is possible owing to what at therapy by this drug daily reception of folic acid is necessary.
Interaction with other medicines:
Simultaneous administration of arginine with thiazide diuretics and Aminophyllinum increases the content of insulin in blood.
Are oestrogenic and oral contraceptives can cause the increase in concentration of a growth hormone caused by arginine and lower the glyukagonovy and insulin answer to arginine.
At simultaneous use of arginine with Spironolactonum development of a heavy hyperpotassemia is possible.
Pharmaceutical interaction
At administration of drug it is necessary to consider that arginine is incompatible with sodium thiopental.
Drug is compatible to antibiotics (amikacin, ampicillin, tsefotaksy, цефтриаксон, doxycycline, erythromycin, gentamycin, chloramphenicol, clindamycin, нетилмицин, penicillin, пиперациллин, tetracycline, Tobramycinum and Vancomycinum), and also to other drugs (Aminophyllinum, cyclophosphamide, Cimetidinum, Cytarabinum, digoxin, a dopamine, famotidine, phytomenadionum, ftoruratsit, folic acid, furosemide, heparin, Chlorpromazinum, insulin, calcium a gluconate, lidocaine, Methyldopum, Methylprednisolonum, Metoclopramidum, a methotrexate, morphine, низатидин, Norepinephrinum, propranolol, ranitidine and Riboflavinum).
Contraindications:
— metabolic acidosis;
— heavy renal failure;
— heavy liver failure;
— shock;
— hypoxia;
— heart failure in a decompensation stage;
— pregnancy;
— period of a lactation (breastfeeding);
— children's and teenage age up to 18 years (efficiency and safety are not established).
With care it is necessary to appoint drug at sepsis, essential arterial hypertension, liver diseases, a diabetes mellitus.
Use of drug AMINOSOL-NEO at pregnancy and feeding by a breast
Efficiency and safety of use of drug at pregnancy and in the period of a lactation (breastfeeding) are not established.
Use at abnormal liver functions
At a liver failure need of patients for proteins sostavlt 0.8-1.1 g/kg/days.
Use at renal failures
To patients with a renal failure who are not on dialysis, recommend administration of proteins in a dose of 0.6-1 g/kg/days, to the patients with a renal failure who are on dialysis - 1.2-2.7 g/kg/days.
Use for children
Contraindication: children's and teenage age up to 18 years (efficiency and safety are not established).
Overdose:
Symptoms: nausea, vomiting, the increased sweating, fever, tachycardia. At the high speed of introduction the hypervolemia and disturbance of electrolytic composition of plasma are possible.
Treatment: symptoms of overdose are reversible. It is necessary to reduce rate of administering or to stop administration of drug and to appoint symptomatic therapy.
Storage conditions:
Drug should be stored in protected from light, the place, unavailable to children, at a temperature from 15 °C to 25 °C.
Issue conditions:
According to the recipe
Packaging:
Solution for infusions of 10% in bottles on 500 ml; in a pack a cardboard 1 bottle.
Solution for infusions of 15% in bottles on 500 ml; in a pack a cardboard 1 bottle.