Active substanceAmino acids for parenteral nutritionAmino acids for parenteral nutrition
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    solution d / infusion 
    Hemofarm AD     Serbia
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  • Dosage form: & nbspsolution for infusions
    Composition:

    1000 ml of solution contains:

    Active substance:

    10% solution

    15% solution

    L-isoleucine

    5.00 g

    5.20 g

    L-leucine

    7.40 g

    8.90 g

    L-valina

    6.20 g

    5.50 g

    Llily

    6.60 g

    11,10

    (in the shape of Llysine monoacetate)

    9.31 g

    15.66 g

    L-methionine

    4.30 g

    3.80 g

    L-treonine

    4.40 g

    8.60 g

    L-phenylalanine

    5.10 g

    5.50 g

    L-alanine

    14.00 g

    25.00 grams

    L-arginine

    12.00 g

    20.00 g

    Glycine

    11.00 g

    18.50 grams

    L-histidine

    3.00 grams

    7.30 g

    L-prolin

    11.20 g

    17.00 g

    L-serine

    6.50 g

    9.60 g

    L-tyrosine

    0.40 g

    0.40 g

    Taurine

    1.00 g

    2.00 grams

    L-tryptophan

    2.00 grams

    1.60 g

    Excipients:

    Glacial acetic acid

    q.s.

    4.20 g

    L-black acid

    -

    q.s.

    Water for Injection

    up to 1000 ml

    up to 1000 ml

    Energy value

    1680 kJ / l

    400 kcal / l

    2520 kJ / l

    600 kcal / l

    Theoretical osmolality

    990 mosmole / l

    1505 mosmol / l

    pH

    5,5-6,5

    5,5-6,5

    Description:Transparent, colorless or light-yellow, or light-brown solution.
    Pharmacotherapeutic group:Parenteral nutrition - amino acids
    ATX: & nbsp

    B.05.X.B   Amino acids

    Pharmacodynamics:

    Aminosol-Neo is a combined preparation for parenteral nutrition, which contains essential and non-essential amino acids in a balanced ratio. All amino acids are in L-form, which ensures the possibility of their direct participation in the biosynthesis of proteins.

    Contains eight essential amino acids (not synthesized in the human body): L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-treonine, L-tryptophan and L-valine. The conditionally interchangeable ones are considered L-arginine and L- histidine. Conditionally interchangeable amino acids are synthesized in the body; However, in some pathological conditions (for example, renal and hepatic insufficiency) and in young children, their concentration does not reach the required level.

    L-arginine participates in the cycle of conversion of ammonia to urea, binding toxic ammonium ions, which are formed during the catabolism of proteins in the liver. L-black acid is necessary for regeneration L-arginine in this process and as an energy source for urea synthesis.

    L-isoleucine, L-leucine and L-valine - essential amino acids with branched side chains - are actively involved in the synthesis of proteins, especially in muscle tissue, play a role in the energy and metabolism of nerve cells. Participate in the formation and storage of glycogen, the formation of hemoglobin, the synthesis of pantothenic acid. They contribute to the restoration of bone and muscle tissue, skin, which is especially important in the early postoperative period.

    Amino acids containing aromatic rings are represented by Lphenylalanine and L- tyrosine in a small and safe amount (due to the potential for cerebro-toxic effects at high concentrations). Mainly the concentration minimization is extended to L-tyrosine, one of the derivatives of which is octopamine - a false neurotransmitter, which has a toxic effect on the central nervous system.

    L-phenylalanine is involved in the production of collagen and connective tissues, is involved in the formation of neurotransmitters, stimulates the thyroid gland to produce thyroid hormones,is involved in the transmission of dopamine, helps the formation of insulin, papain, melanin, epinephrine, norepinephrine, dopamine, thyroxine and triiodothyronine.

    L-tryptophan participates in the maintenance of nitrogen equilibrium in metabolic processes, acts of excitation and inhibition, as well as the transformation of one type of energy into another. It stimulates the growth of the level of growth hormone in the blood, participates in the synthesis of serotonin, one of the most important neurotransmitters. Formed from L-tryptophan a nicotinic acid is an important component in the energy exchange.

    The nitrogen content for the 10% solution is 16.2 g / l, for 15% - 25.7 g / l.

    Amino acids in a 10% solution are 100.0 g / 1000 ml, in 15% - 150 g / 1000 ml.

    Pharmacokinetics:

    Parenterally introduced amino acids are used in the body in protein synthesis. The amino acids not used in this process are deaminated to form urea, which is then excreted in the urine. The half-life of amino acids in healthy people is 5-15 minutes. Part of the amino acids can not be biotransformed and excreted unchanged, the desired effect of the drug in this case is not achieved.This pharmacokinetic feature can be eliminated by injecting the drug slowly enough so that the concentration of amino acids in the blood does not increase sharply. Such a method of administration will avoid the excretion of amino acids through the kidneys in an unchanged form.

    Indications:

    Solution for infusion Aminosol-Neo is used with the addition of fat emulsions, carbohydrates and electrolytes for complete or partial parenteral nutrition, as well as for preventing and eliminating protein and fluid deficiency in cases when enteral nutrition is impossible:

    - severe diseases of the gastrointestinal tract (intestinal obstruction, peritonitis, malabsorption, severe inflammatory bowel disease, pancreatitis, intestinal fistula);

    - hypermetabolic conditions (trauma, burns, sepsis);

    - other conditions in which oral or enteral nutrition is impossible, insufficient or contraindicated (anorexia nervosa, oncological diseases, preparation for surgery, postoperative period).

    Contraindications:

    Metabolic acidosis, severe renal and hepatic insufficiency, shock, hypoxia, uncompensated heart failure, pregnancy and lactation, children under 18 years of age (efficacy and safety not established).

    Carefully:

    Sepsis, essential hypertension, hepatic insufficiency of mild and moderate severity, diabetes mellitus.

    Pregnancy and lactation:

    The effectiveness and safety of the drug during pregnancy and lactation are not established.

    Dosing and Administration:

    Aminosol-Neo is used as an intravenous infusion through one of the central veins. The dose is selected individually according to the severity of the metabolic disorder and the body's need for amino acids.

    10% solution:

    The average dose for adults is 10-20 ml / kg / day, respectively 1-2 grams of amino acids / kg / day.

    The maximum permissible rate of administration is 1 ml / kg / h, the recommended infusion rate is 20-35 drops / min, the maximum daily dose is 20 ml / kg.

    15% solution:

    The average dose for adults is 6.7-13.3 ml / kg / day, respectively 1-2 grams of amino acids / kg / day.

    The maximum admissible rate of administration is 0.67 ml / kg / h, the maximum daily dose is 13.3 ml / kg.

    For a person weighing 70 kg, the daily dose is 470-930 ml; the recommended rate of administration is -16 drops / min.

    Dosing in renal failure: patients who are not on hemodialysis, recommend the administration of proteins in a dose of 0.6-1.0 g / kg / day. Being on hemodialysis - 1,2-2,7 g / kg / day.

    Dosing for liver failure: patients with hepatic insufficiency does not tolerate an increased number of amino acids and therefore their protein requirements are 0.8-1.1 g / kg / day (8-11 ml / kg / day 10% solution or 5.3-7.3 ml / kg / day 15% solution).

    Side effects:

    With the application of Aminosol-Neo, the development of folate deficiency in the body is possible, and therefore with the treatment with this drug, a daily preventive intake of folic acid is necessary.

    From the central nervous system: encephalopathy (in patients with renal or hepatic insufficiency).

    From the side of the cardiovascular system: thrombophlebitis.

    From the hematopoiesis: megaloblastic anemia due to a deficiency of folic acid.

    From the digestive system: nausea and vomiting due to inadequate speed of administration or dose; hyperamonia (in violation of amino acid metabolism), intrahepatic cholestasis, a short-term increase in the level of bilirubin and the activity of "liver" enzymes.

    Local reactions: damage to tissues and necrosis of the skin (due to extravasation). Allergic reactions: anaphylactic reaction.

    Laboratory indicators: hyperkalemia in patients with concomitant liver disease and renal insufficiency and in patients with diabetes.

    Other: bacterial, fungal infections.

    Overdose:

    Symptoms: nausea, vomiting, trembling, "hot flashes", increased sweating, fever, tachycardia. With a high rate of administration, hypervolemia and a violation of the electrolyte composition of the plasma are possible.

    Treatment: Infusion should be discontinued immediately; to provide monitoring of biochemical parameters, functions of respiratory and cardiovascular systems. Treatment is symptomatic. After the symptoms of an overdose have completely disappeared, the infusion can be resumed by reducing the infusion rate or dose.

    Interaction:

    It is not recommended to uncontrolled addition of other drugs to the Aminosol-Neo solution.

    Pharmaceutically compatible:

    - from antibiotics - amikacin, ampicillin, cefotaxime, ceftriaxone, doxycycline, erythromycin, gentamicin, chloramphenicol, clindamycin, netilmicin, penicillin, piperacillin, tetracycline, tobramycin and vancomycin;

    - other drugs - aminophylline, cyclophosphamide, cimetidine, cytarabine, digoxin, dopamine, famotidine, phytomenadione, fluorouracil, folic acid, furosemide, heparin, chlorpromazine, insulin, calcium gluconate, lidocaine, methyldopa, methylprednisolone, metoclopramide, methotrexate, morphine, nisatidine, norepinephrine, propranolol, ranitidine and riboflavin.

    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 lower the glucagon and insulin response to arginine.

    The interaction of arginine with spironolactone causes severe hyperkalemia.

    Arginine is incompatible with thiopental sodium.

    Special instructions:

    Arginine, which is part of the drug, can lead to a decrease in the concentration of phosphates and an increase in the concentration of potassium in the plasma. These changes are particularly pronounced in patients with diabetes mellitus.

    Insulin interferes with hyperkaliemia caused by arginine, so patients in stressful conditions, as well as patients with diabetes mellitus (both types 1 and 2), if necessary, to introduce short-acting insulin with 5-20% dextrose solution from the calculation of 0.25-0.5 units per 1 g of dextrose.

    In case of damage to the central vein with hemorrhage during catheterization, bacterial or fungal thrombophlebitis is possible.

    Apply only a clear solution from an intact vial!

    Use only in hospitals!

    Effect on the ability to drive transp. cf. and fur:

    There is no evidence of the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration.

    Form release / dosage:

    Solution for infusions, 10% and 15%.

    Packaging:

    500 ml of solution in a glass bottle of glass II hydrolytic group, sealed with a lid of metal, rubber and plastic, with the control of the first opening.

    1 a bottle together with a plastic holder and instructions for use in a pack of cardboard.

    Storage conditions:

    Store in a dark place at a temperature of 15 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 of the year.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001691
    Date of registration:16.09.2011 / 02.10.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Hemomont d.o.o. Montenegro
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp09.08.2017
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