Hepatrim ®- concentrate for preparation of infusion solution

MEDICAL INSTRUCTIONS FOR USE

HEPATRIM®

Trade name of the drug: Hepatrim®

Active substance (INN): L-ornithine L-aspartate

Pharmaceutical form: concentrate for preparation of solution for infusion 5 g/10 ml

Contents:

Active substance: L-ornithine L-aspartate-5 g

excipient: water for injection up to 10 ml.

Description: colorless or slightly yellowish transparent solution.

Pharmacotherapeutic group: hepatoprotector.

ATX code: A05BA

Pharmacological properties

Pharmacodynamics

Has a detoxifying effect. It reduces the increased level of ammonia in plasma, in particular in liver diseases. The action of the drug is related with its participation in ornithine cycle of Krebs urea formation (formation of urea from ammonia). It promotes the production of insulin and somatotropic hormone. Improves protein metabolism in diseases requiring parenteral nutrition. It promotes reduction of asthenic, dyspeptic and pain syndromes, as well as normalization of increased body weight (in steamosis and steatohepatitis).

Pharmacokinetics

Ornithine aspartate dissociates into its components – the amino acids ornithine and aspartate, which are absorbed in the small intestine by active transport through the intestinal epithelium and begins to work within 15-25 minutes. Excreted by the kidneys.

Indications for use

Acute and chronic liver diseases accompanied by hyperammonemia. Hepatic encephalopathy, including as a part of complex therapy of impaired consciousness (at precoma and coma stages).

As a corrective addition to preparations for parenteral nutrition in patients with protein deficiency.

Dosage and administration

Up to 40 ml (4 ampoules) per day are administered intravenously by dissolving the contents of the ampoules in 500 ml of solution for infusion. In patients with hepatic encephalopathy, depending on severity of the condition, up to 80 ml (8 ampoules) per day are administered. Duration of infusion, frequency and duration of treatment are determined individually, the maximum rate of intravenous administration is 5 g per hour. Do not dissolve more than 60 ml (6 ampoules) in 500 ml of infusion solution! Do not give intra-arterially!

Side effects

Allergic reactions are rare; in isolated cases, nausea and vomiting, abdominal pain, flatulence, diarrhea may occur. The mentioned side effects are usually transient and do not require cancellation of the drug. If they occur, the dose and speed of administration of the drug should be optimized.

Contraindications

Hypersensitivity to L-ornithine-L-aspartate or other drug components. Severe renal insufficiency with creatinine greater than 3 mg/100 ml.

Period of lactation.

Drug interactions

Not described.

Special indications

Caution is prescribed for patients engaged in potentially hazardous activities requiring increased attention and quick psychomotor reactions. At high doses of the drug, serum and urine urea levels should be monitored. If liver function is significantly impaired, the rate of administration should be adjusted taking into account the individual condition of the patient to prevent nausea and vomiting.

Administration during pregnancy

As there is no sufficient data concerning the effect of the drug on the fetus, its application is possible only under close supervision of a physician.

Administration for children

No data on application in children are available.

Overdose

Signs of intoxication in case of overdose are not described.

Symptomatic therapy is indicated in case of overdose.

Form of production

Concentrate for infusion solution preparation 5 g/10 ml, 10 ml in ampoules.

Storage conditions

Store in a dry, dark place at a temperature not exceeding 25°C. Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiration date.

Conditions of dispensing from pharmacies

Released by doctor’s prescription

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