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 8%||1000 ml|
|(corresponds a L-lysine to monoacetate)||9,71 g|
|(there corresponds N-acetyl to L-cysteine)||0,7 g|
|excipients: ice acetic acid — 4,42 g; water for injections — to 1000 ml|
|energy value — 1344 kJ/l (320 kcal/l); theoretical osmolarity — 770 ¼Äß¼/l; pH — 5,7–6,3|
The combined drug for parenteral food. Has hepatoprotective and disintoxication effect, takes part in metabolic processes.
All 8 irreplaceable amino acids, 2 conditionally replaceable amino acids (L-arginine and L-histidine) which are synthesized in insufficient quantity at some pathophysiological states, and 5 replaceable amino acids providing an adequate metabolism at patients with liver diseases are a part of drug. Amino acids are in a L-form that provides a possibility of their direct participation in biosynthesis of proteins (content of nitrogen - only 12.9 g/l).
L-arginine promotes transformation of ammonia into urea, connects the toxic ions of ammonium which are formed at a catabolism of proteins in a liver.
L-alanine and L-proline reduce the need of an organism for glycine (this amino acid is poorly acquired in an organism, at its replacement development of a giperammoniyemiya becomes impossible).
L-izoleytsin, L-leucine and L-valine (irreplaceable amino acids with branched side chains) are directly acquired by peripheral fabrics (their metabolism does not depend on extent of damage of a liver), reduce assimilation and intake of aromatic amino acids in TsNS, reducing displays of hepatic encephalopathy, normalize power and nitric balance in an organism.
Gepasol-Neo allows to korrigirovat amino-acid disturbances at a liver failure, and also to considerably improve portability of proteins at patients with cirrhosis and hepatitis and to reduce expressiveness of symptoms of hepatic encephalopathy.
Drug does not contain carbohydrates and electrolytes.
Pharmacokinetics. The amino acids entered infusionally pass one of two possible metabolic ways: the anabolic way in which amino acids communicate peptide bonds and is formed by specific proteins, and a catabolic way in which there is a transamination of amino acids.
Entered within full parenteral food together with glucose and fats (a ratio of carbohydrates and fats 70:30) with a speed of 10.5 mg of nitrogen/kg/h, amino acids reach the balanced concentration in blood in 3 h.
Metabolism of amino acids happens in all body tissues. Extent of their splitting depends on expressiveness of a stress to which will subject an organism. The stress accelerates metabolism of amino acids and strengthens abnormal liver functions that in return reduces metabolism of amino acids. Sepsis accelerates their metabolism too, and depression of function of kidneys - suppresses.
Amino acids can be removed in not changed look at bystry increase in their concentration in blood. T1/2 of amino acids (at healthy people) makes 5-15 min. (during this short time period of amino acid have to be used for synthesis of proteins). The remains of amino acids, unused in the course of protein synthesis, are subject to deamination in the course of which the urea removed from an organism is formed. At infusion of Gepasola-Neo the percent of digestion of irreplaceable acids makes 99%, and replaceable - 97%. At the same time the general and renal clearances of irreplaceable amino acids make 0.5 l/min, i.e. 1.5 ml/min., and for the majority of replaceable amino acids - 0.6 l/min, i.e. 3 ml/min. Arginine almost reabsorbirutsya completely in renal tubules.
Indications to use:
— therapy and parenteral food (partial or full - at addition of solutions of carbohydrates and fatty emulsions) at an abnormal liver function (liver failure) with dysfunction of a brain (hepatic encephalopathy) and without it;
— therapy of a hepatic coma and prekomatozny states.
Route of administration and doses:
Establish individually taking into account concentration of ammonia in blood and severity of a disease.
Gepasol-Neo enter in/in kapelno with a speed of 1.0-1.25 ml/kg of mass of body/h (30-35 кап. / mines) that corresponds to 0.08-0.1 g of amino acids/kg/h. The maximum rate of administering - 1.25 ml/kg/h (respectively 0.1 g of amino acids/kg/h).
The maximum daily dose makes 18.75 ml/kg of body weight (1.5 g of amino acids/kg/days), i.e. 1300 ml for patients with the body weight of 70 kg.
Duration of therapy is established individually before total disappearance of neurologic symptomatology.
Features of use:
Use of Gepasol-Neo solution is reasonable only according to the provided indications.
During use of this drug periodic control of an electrolytic and acid-base state, extent of hydration of an organism, condition of function of kidneys is necessary.
It is necessary to apply only transparent solution from the unimpaired bottle!
Use in pediatrics
Efficiency and safety of use of the drug Gepasol-Neo for children and teenagers aged up to 18 years are not established.
At use according to indications in the recommended doses side effects of this drug are unknown.
Interaction with other medicines:
There are data on the interaction of in vivo of the Gepasola-Neo components with theophylline leading to increase in clearance.
Numerous data on interaction of in vitro therefore it is not recommended to add other medicines to Gepasola-Neo solution are known.
Gepasola-Neo solution is compatible to antibiotics - amikacin, ampicillin, tsefotaksimy, tseftriaksony, doxycycline, erythromycin, gentamycin, chloramphenicol, clindamycin, netilmitsiny, penicillin, piperatsilliny, tetracycline, Tobramycinum and Vancomycinum, and also to Aminophyllinum, cyclophosphamide, Cimetidinum, Cytarabinum, digoxin, a dopamine, famotidine, phytomenadionum, ftoruratsily, folic acid, furosemide, heparin, Chlorpromazinum, insulin, calcium a gluconate, lidocaine, metildopy, Methylprednisolonum, Metoclopramidum, a methotrexate, morphine, nizatidiny, Norepinephrinum, propranolol, ranitidine and Riboflavinum.
— disturbances of metabolism of amino acids;
— a renal failure (at a hepatic coma at patients with a renal failure it is necessary to consider what of two states threatens the patient's life);
— heart failure (in a decompensation stage);
— lactation period;
— children's and teenage age up to 18 years (efficiency and safety are not established);
— hypersensitivity to drug components.
Use of drug GEPASOL-NEO at pregnancy and feeding by a breast
Efficiency and safety of use of the drug Gepasol-Neo at pregnancy and in the period of a lactation are not established. Use of drug for this category of patients is contraindicated.
Use at abnormal liver functions
Use of drug according to indications is possible
Use at renal failures
Drug is contraindicated to use at a renal failure (at a hepatic coma at patients with a renal failure it is necessary to consider what of two states threatens the patient's life).
Use for children
Contraindication: children's and teenage age up to 18 years (efficiency and safety are not established).
Symptoms: nausea, vomiting, perspiration, fever, tachycardia, increase in activity of liver enzymes and concentration of residual nitrogen. The raised rate of administering can lead to an overhydratation and emergence of peripheral hypostases, edematization of lungs.
Treatment: it is recommended to stop drug infusion, to begin symptomatic therapy. The specific antidote does not exist.
Drug should be stored in the unavailable to children, protected from light place at a temperature from 15 °C to 25 °C.
According to the recipe
Solution for infusions of 8% in bottles on 500 ml; in a pack of cardboard 1 or 10 bottles (for hospitals).