GEPASOL-NEO

Active material: Combined preparation
When ATH: B05BA01
CCF: The preparation for parenteral nutrition (amino acid solution), used in hepatic insufficiency
ICD-10 codes (testimony): E46, K72, R63.3
When CSF: 11.16.05.01
Manufacturer: HEMOFARM A.D. (Serbia)

Pharmaceutical form, composition and packaging

Solution for infusion 8% clear, colorless to slightly yellow.

Excipients: glacial acetic acid (4.42 g / l), water d / and.

500 ml – glass bottles (1) complete with plastic bottle holder – packs cardboard.

Pharmacological action

Combined preparation for parenteral nutrition. Provides gepatoprotectornoe and desintoksikatine effect, participates in metabolic processes.

The product includes all 8 essential amino acids, 2 conditionally essential amino acids (L-arginine and L-Histidine), which are insufficient in some pathophysiological conditions, and 5 nonessential amino acids, ensure adequate metabolism in patients with liver diseases. Amino acids are L-form, that enables their direct involvement in the biosynthesis of proteins (nitrogen content – Total 12.9 g / l).

L-arginine promotes the transformation of ammonia into urea, binds toxic ammonium ions, from catabolism of proteins in the liver.

L-alanine and L-PROLINE reduces the body's need for glicine (This amino acid is poorly absorbed in the body, when its replacement hyperammoniemia development becomes impossible).

L-isoleucine, L-leucine and L-valine (essential amino acids with branched side chains) directly absorbed by perifericescimi tissues (their metabolism does not depend on the extent of liver damage), lower absorption and flow of aromatic amino acids in the CNS, reducing the manifestations of hepatic encephalopathy, normalize energy and nitrogen balance in the body.

Gepasol-neo allows correct amino acid disorders in liver failure, as well as significantly improve portability of proteins in patients with cirrhosis and hepatitis, and reduce the severity of symptoms of hepatic encephalopathy.

The drug contains no carbohydrates and electrolytes.

Pharmacokinetics

Entered infuzionno amino acids undergo one of two possible metabolic pathways: anabolic path, in which amino acids linked by peptide bonds and form specific proteins, and kataboliceski path, in the transamination of amino acids.

Imposed total parenteral nutrition, together with glucose and fats (the ratio of carbohydrates and fats 70:30) with speed 10.5 nitrogen mg/kg/h, amino acids reach the balanced concentration in blood 3 no.

The metabolism of amino acids occur in all tissues of the body. The degree of splitting depends on the symptoms of stress, that subjected to body. Stress accelerates the metabolism of amino acids and strengthens the liver, that reduces the metabolism of amino acids. Sepsis also speeds up their metabolism, and reduced kidney function – suppresses.

Amino acids can be displayed in an unmodified form with the rapid increase of its concentration in the blood. T_1/2 amino acids (in healthy humans) is 5-15 m (in this short period of amino acids must be used for the synthesis of proteins). Amino acid residues, unused in the synthesis of proteins, subject to dezaminirovaniju, in the process which produces urea, withdrawn from the body. When infusion Gepasola-neo percentage absorption of essential amino acids 99%, and replaceable – 97%. Total and kidney klirensy amino acids make up 0.5 l / min, ie. 1.5 ml / min, and for most of the nonessential amino acids – 0.6 l / min, ie. 3 ml / min. Arginine is almost completely reabsorbed in the kidney tubules.

Testimony

-therapy and parenteral nutrition (partial or full – When you add the solutions of carbohydrates and fat emulsions) If any of the liver (hepatic insufficiency) with impaired brain function (hepatic encephalopathy) and without it;

— therapy of hepatic coma and prekomatoznyh States.

Dosage regimen

Set individually, taking into account the concentration of ammonia in the blood and the severity of the disease.

Gepasol-neo give/drip in at the speed of 1.0-1.25 mL/kg body weight/h (30-35 drop / min.), corresponding 0.08-0.1 g amino acids/kg/h. The maximum speed of introduction – 1.25 ml / kg / h (respectively 0.1 g amino acids/kg/h).

The maximum daily dose is 18.75 ml / kg body weight (1.5 amino acid g / kg / day), ie. 1300 ml for patients weighing 70 kg.

Duration of therapy set individually to complete disappearance of neurological symptoms.

Side effect

In the application shown in the recommended doses, side effects of this drug are unknown.

Contraindications

— metabolism of amino acids;

- Gipergidratatsiya;

- Giponatriemiya;

- Hypokalemia;

- Renal failure (When hepatic coma in patients with renal insufficiency should be taken into account, What two States threatens the life of the patient);

- Heart failure (decompensated);

- Pregnancy;

- Lactation;

- Childhood and adolescence up 18 years (efficacy and safety have not been established);

- Hypersensitivity to the drug.

Pregnancy and lactation

Effectiveness and safety of drug Gepasol-neo in pregnancy and lactation is not installed. The use of the drug in this category is contraindicated in patients.

Cautions

Application of solution Gepasol-neo appropriate only for the reasons.

During the use of this drug requires periodic monitoring electrolyte and acid-base status, the degree of hydration of the body, the condition of the kidney.

Use only clear solution from the bottle intact!

Use in Pediatrics

Effectiveness and safety of drug Gepasol-neo at children and adolescents under the age of 18 years not set.

Overdose

Symptoms: nausea, vomiting, Sweating, fever, tachycardia, increased liver enzymes and concentration of residual nitrogen. Increased speed can lead to gipergidratace and peripheral edema, development of pulmonary edema.

Treatment: It is recommended that you stop the infusion of the drug, start a symptomatic therapy. There is no specific antidote.

Drug Interactions

There is evidence of in vivo interaction components Gepasola-neo with theophylline, leading to increased clearance.

There are many in vitro interaction data, Therefore, we recommend that you do not add other drugs to a solution of Gepasola-neo.

Pharmaceutical interaction

Solution Gepasola-neo compatible with antibiotics – amikacin, Ampicillin, cefotaksimom, with ceftriaxone, doxycycline, Erythromycin, gentamicin, chloramphenicol, klindamiцinom, netilmicinom, penicillin, piperacillinom, tetracycline, tobramycin and vankomitinom, as well as with aminophylline, tsiklofosfamida, cimetidine, citarabinom, digoksinom, dopamine, famotidinom, fitomenadionom, ftoruracilom, folic acid, furosemidom, geparinom, chlorpromazine, insulinom, calcium glukonatom, lidokainom, methyldopa, methylprednisolone, metoklopramidom, metotreksatom, morphine, nizatidinom, norepinephrine, propranolol, ranitidine and Riboflavin.

Conditions of supply of pharmacies

The drug is released under the prescription. The drug should be used only in fixed health facilities.

Conditions and terms

The drug should be stored out of reach of children, dark place at a temperature of 15 ° to 25 ° C . Shelf life – 2 year.