Hepasol-Neo (Hepasol-Neo)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for infusions
Composition:

1000 ml of solution contains:

Active substances:


L is valine

10.08 g

L isoleucine

10.40 g

L-leucine

13.09 g

L lysine

(in the form of L-lysine monoacetate

6.88 g

9.71 g)

L - methionine

1.10 g

L - threonine

4.40 g

L-phenylalanine

0.88 g

L-tryptophan

0.70 g

L-alanine

4.64 g

L-arginine

10.72 g

Glycine

5.82 g

L - histidine

2.80 g

L-proline

5.73 g

L - serine

2.24 g

L-cysteine

(in the form of acetylcysteine

0.52 g

0.70 g)

Excipients:


Glacial acetic acid

4.42 g

Water for Injection

up to 1000 ml

Energy value

1344 kJ / l

(320 kcal / l)

Theoretical osmolality

770 mOsm / l

pH

5,7-6,3
Description:Transparent solution from colorless to slightly yellow in color.
Pharmacotherapeutic group:Parenteral nutrition - amino acids
ATX: & nbsp
  • Amino acids
    • Pharmacodynamics:

    Hepasol-Neo is a combined preparation that is a solution of amino acids.

    The composition of Hepasol-Neo includes all 8 essential amino acids that the human body can not synthesize (L-valine, L-isoleucine, L-leucine, L-lysine, L- methionine, L-threonine, L-phenylalanine, L-tryptophan), 2 conditionally substitutable amino acids (L-arginine and L-histidine), which are synthesized in insufficient quantity in some pathophysiological states, and 5 interchangeable amino acids providing adequate metabolism in patients with liver diseases.Amino acids are in L-form, which allows their direct participation in protein biosynthesis (nitrogen content - only 12.9 g / l).

    L-arginine is involved in the ornithine cycle of urea synthesis.

    L-alanine and L-proline reduce the body's need for glycine (this amino acid is poorly absorbed in the body, when it is replaced, the development of hyperammonemia becomes impossible).

    L-isoleucine, L-leucine and L-valine (irreplaceable amino acids with branched side chains) are directly digested by peripheral tissues (their metabolism does not depend on the degree of liver damage), reduces the assimilation and flow of aromatic amino acids into the central nervous system, reducing manifestations of hepatic encephalopathy.

    Hepasol-Neo allows you to correct amino acid disorders in liver failure, as well as significantly improve the tolerance of proteins in patients with cirrhosis of the liver, hepatitis and reduce the severity of symptoms of hepatic encephalopathy.

    Does not contain carbohydrates and electrolytes.

    Pharmacokinetics:

    Hepasol-Neo contains various amino acids that normally enter the body with food.

    Amino acids introduced into the body by infusion,enter into one of two possible metabolic pathways: an anabolic pathway in which amino acids bind to peptide bonds and form proteins, and the catabolic pathway in which transamination of amino acids occurs. Introduced in the framework of complete parenteral nutrition along with dextrose and fats (carbohydrate and fat ratio 70:30) at a rate of 10.5 mg nitrogen / kg / hour, the amino acids reach a balanced concentration in the blood after 3 hours.

    Amino acids can be excreted unchanged with a rapid increase in their concentration in the blood. The half-life of amino acids (in healthy people) is 5-15 minutes (in this short time period, amino acids should be used for protein synthesis). Remains of amino acids, unused during the synthesis of proteins, are subject to deamination, during which the formation of urea, deduced from the body.

    Arginine is almost completely reabsorbed in the renal tubules.

    Metabolism of amino acids occurs in all tissues of the body. The degree of their splitting depends on the severity of the stress to which the organism is exposed. Stress accelerates the metabolism of amino acids and increases liver function disorders,that for its part reduces the metabolism of amino acids. Sepsis also accelerates their metabolism, and a decrease in the function of the kidneys suppresses.

    With the infusion of Hepasol-Neo, the percentage of assimilation of essential acids is 99%, and the interchangeable - 97%. In this case, the total and renal clearance of essential amino acids is 0.5 l / min and 1.5 ml / min, and for most of the interchangeable amino acids, 0.6 l / min and 3 ml / min.

    Indications:

    Therapy and parenteral nutrition (partial or complete - with the addition of solutions of carbohydrates and fatty emulsions) with a violation of the liver (hepatic insufficiency) with a violation of the function of the brain (hepatic encephalopathy) and without it; therapy of hepatic precoma and coma.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - disturbances in the metabolism of amino acids;

    - hyperhydration;

    - hyponatremia;

    - hypokalemia;

    - renal failure (in hepatic coma in patients with renal insufficiency, it is necessary to consider which of the two conditions threatens the patient's life), heart failure (in the decompensation stage);

    - pregnancy and lactation;

    - Children under 18 years of age (efficacy and safety not established).

    Pregnancy and lactation:

    The use of the drug during pregnancy and lactation is contraindicated.

    Dosing and Administration:

    Therapy with an infusion solution of Hepasol-Neo is performed depending on the concentration of residual nitrogen in the blood and the severity of the disease.

    Hepasol-Neo is administered intravenously by drip.

    It is recommended to carry out infusion at a rate of 1.0-1.25 ml / kg / h (30-35 cap / min), which corresponds to 0.08-0.1 g of amino acids / kg / h.

    The maximum rate of administration is 1.25 ml / kg / h (0.1 g of amino acids / kg / h, respectively).

    The maximum daily dose is 18.75 ml / kg (1.5 g of amino acid / kg / day), i.e. 1300 ml for a patient weighing 70 kg.

    The duration of therapy is set individually until the complete disappearance of the neurological symptomatology.

    Side effects:

    The side effects of this drug are unknown.

    Overdose:

    Symptoms: nausea, vomiting, sweating, fever, tachycardia, increased activity of "liver" enzymes and the concentration of residual nitrogen.

    The increased rate of administration can lead to hyperhydration and the appearance of peripheral edema, the development of pulmonary edema.

    Treatment: it is recommended to stop the infusion of the drug,begin symptomatic treatment (there is no specific antidote).

    Interaction:

    There are data on the interaction in vivo components of Hepasol-Neo with theophylline, leading to an increase in the clearance of theophylline.

    Numerous data on the interaction in vitro, therefore it is not recommended to add other drugs to the solution of Hepasol-Neo.

    Medications that can be administered together with Hepasol-Neo:

    - antibiotics: amikacin, ampicillin, cefotaxin, ceftriaxone, doxycycline, erythromycin, gentamicin, chloramphenicol, clindamycin, netilmicin, benzylpenicillin, 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.

    Special instructions:

    The use of a solution of Hepasol-Neo is expedient only according to the indications given.

    During the application of this drug, periodic monitoring of the electrolyte and acid-base state, the degree of hydration of the body, the state of kidney function is necessary.

    Apply only a clear solution from an intact vial.
    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, 8%.
    Packaging:

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

    1 bottle together with a plastic holder and instructions for medical use are placed in a cardboard pack.

    10 bottles together with plastic holders and an equal number of instructions for medical use are placed in a carton box (for hospitals).

    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 years.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001527
    Date of registration:11.05.2011 / 29.09.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp27.03.2017
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