Instruction for use: Ornilatex

Active substance Ornithine

ATX code A05BA Preparations for the treatment of liver diseases

Pharmacological group

Proteins and amino acids

Hepatoprotectors

Nosological classification (ICD-10)

E46 Protein-energy deficiency, unspecified

Malnutrition, Unbalanced nutrition, Period of intensive growth, The period of intensive growth and development, Oral nutrition, Alimentary dystrophy, Alimentary infectious dystrophy, Protein deficiency, Protein starvation, Protein-calorie deficiency, Protein-energy deficiency, Feeding premature babies, Severe protein deficiency, Nursing premature babies, Hypotrophy, Hypotrophy in children, Protein deficiency, Dystrophy, Dystrophy of newborns, Additional parenteral nutrition, Additional source of amino acids, An additional source of essential amino acids, Probe or oral feeding, Probe feeding, Enteral probe nutrition, Altered Protein Metabolism, Violation of protein anabolism, Disruption of protein metabolism, Protein metabolism disorders, Amino acid deficiency, Protein deficiency, Lack of essential amino acids, Protein malnutrition, Malnutrition during the period of intensive growth, Low protein in the diet, Normalization of amino acid balance disorders

E72.2 Disruption of the urea cycle metabolism

Argininemia, Arginine Succinatemia, Hyperammonemia, Ornithine transcarbamylase deficiency, Urea cycle enzyme deficiency, Citrullinemia

E72.9 Disorders of amino acid metabolism, unspecified

Hartnap disease, Prolinemia, Lysinemia

K72 Hepatic insufficiency, not elsewhere classified (including hepatic coma)

Insufficiency of the liver-cell, Pronounced hepatic encephalopathy, Coma hepatic, Latent hepatic encephalopathy, Insufficiency of the liver, Hepatic coma, Hepatic coma and precoma, Hepatic encephalopathy, Development of hepatic impairment, Encephalopathy of the liver, Inflammatory liver disease, Gepatargy, Encephalopathy portosystemic, Hepatocellular insufficiency, Hepatic precoma and coma, Portal-systemic encephalopathy

K76.9 Liver disease, unspecified

Change in liver function in heart failure, Restoration of impaired liver function, Severe liver function disorders, Hepatitis, Hepatosis, Hepatopathy, Liver dysfunction, Diseases of the liver, Impaired liver function, Dysfunction of the liver, Infringements of function of a liver of an inflammatory etiology, Functional liver failure, Functional disorders of the liver, Chronic liver disease, Chronic diffuse liver disease, Enterogenic diseases of the gallbladder and liver

Composition

Concentrate for preparation of solution for infusions of 1 amp.

active substance:

ornithine aspartate (in terms of dry substance) 5 g

excipient: water for injection - up to 10 ml

Description of the dosage form

Colorless or light yellow transparent liquid.

pharmachologic effect

Pharmacological action - hypoazotemic.

Pharmacodynamics

Reduces the increased concentration of ammonia in the body, particularly in liver diseases. The action of the drug is associated with its participation in the Krebs ornithine cycle of urea formation (the formation of urea from ammonia). Ornithine acts as a catalyst for the carbamoyl phosphate synthetase and ornithine carbamoyl transferase enzymes, and is also the basis for the synthesis of urea. In addition, the drug activates the ornithine cycle of urea formation, which also contributes to the reduction of ammonia levels. Promotes the production of insulin and somatotropic hormone. Improves protein metabolism in diseases requiring parenteral nutrition.

Pharmacokinetics

In vivo, it forms 2 active metabolites: aspartate and ornithine, which have a short T1 / 2 of 0.3–0.4 h, are excreted by the kidneys through the urea cycle. A small part of aspartate is excreted by the kidneys in unchanged form.

Indications

acute and chronic liver disease, accompanied by hyperaemonemia;

hepatic encephalopathy, including as part of a complex therapy of impaired consciousness (precoma and coma);

as a corrective additive to drugs for parenteral nutrition in patients with protein deficiency.

Contraindications

hypersensitivity to the drug;

severe renal impairment (serum creatinine> 3 mg / 1 dl);

breastfeeding period;

children's age up to 18 years.

pregnancy and lactation

During pregnancy, the use of the drug ORNILATEKS® is possible only under the strict supervision of a physician, taking into account the benefit / risk ratio for the mother and the fetus. At the time of treatment with the drug should stop breastfeeding.

Side effects

Very rarely (less than 0.01%) - nausea, vomiting; allergic reactions.

Interaction

Not found.

ORNILATEKS® should not be mixed with other drugs. For dilution, use only the solutions indicated in the description.

Dosage and administration

In / in, drip. The contents of the ampoules are mixed with 500 ml of infusion solution (0.9% sodium chloride solution, 5% dextrose solution (glucose) or Ringer's solution).

Adults. The average therapeutic dose of ornithine is 20 g / day.

In case of hepatic encephalopathy (depending on the severity of the condition), up to 40 g / day of ornithine is injected / in.

It is recommended to dissolve no more than 30 g of ornithine in 500 ml of infusion solution. The maximum infusion rate is 5 g / h ornithine.

The duration of drug therapy is determined in each case individually, based on the pathology and severity of the patient’s condition. For severely impaired liver function, strict monitoring of the patient’s condition and correction of the rate of administration of the drug are needed to prevent the development of nausea and vomiting.

Children. No data on the use of the drug in pediatric practice.

Overdose

Symptoms: increased severity of dose-related side effects.

Treatment: the drug should be stopped and symptomatic treatment should be carried out.

special instructions

With the introduction of the drug in high doses should be controlled by the concentration of urea in the blood plasma and urine. In severe impaired liver function in accordance with the patient's condition, it is necessary to reduce the rate of infusion solution in order to prevent nausea or vomiting.

Influence on ability to drive vehicles and mechanisms. Does not affect the ability to drive a vehicle and potentially dangerous machinery.

Release form

Concentrate for solution for infusion, 500 mg / ml. On 10 ml in ampoules of light-protective glass with a color ring of a break or with a color point and a notch. 1, 2 or 3 color rings and / or two-dimensional bar code and / or alphanumeric coding with or without additional color rings, two-dimensional bar code, alpha-numeric coding are additionally applied to the ampoules.

5 amp. in a blister strip packaging of PVC film and aluminum foil or polymer film or without foil and without film.

1 or 2 blisters are placed in a pack of cardboard.

Pharmacy sales terms

On prescription.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

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