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Pharmacological properties

in vivo, the effect of l-ornithine-l-aspartate is due to amino acids, ornithine and aspartate through two key methods of ammonia detoxification: urea synthesis and glutamine synthesis.

Urea is synthesized in perortal hepatocytes, where ornithine aspartate acts as an activator of two enzymes: ornithine carbamoyltransferase and carbamoyl phosphate synthetase, as well as a substrate for the synthesis of urea.

Glutamine is synthesized in the circulatory hepatocytes. Especially under pathological conditions, aspartate and dicarboxylate, including metabolic products of ornithine aspartate, are absorbed in cells and used there to bind ammonia in the form of glutamine.

Glutamate is an amino acid that binds ammonia in both physiological and pathological conditions. The resulting amino acid glutamine is not only a non-toxic form for the excretion of ammonia, but also activates an important urea cycle (intracellular glutamine metabolism).

Under physiological conditions, ornithine and aspartate do not limit urea synthesis.

Experimental animal studies have shown that the ammonia-lowering property of L-ornithine-L-aspartate is caused by accelerated glutamine synthesis. Separate clinical studies have found this improvement with respect to the branched chain amino acids / aromatic amino acids.

Pharmacokinetics L-ornithine-L-aspartate is rapidly absorbed and cleaved into ornithine and aspartate. T½ and ornithine, and aspartate is short - 0.3-0.4 hours. An insignificant part of aspartate is excreted unchanged in the urine.

Indications

Treatment of concomitant diseases and complications caused by impaired liver detoxification (for example, with cirrhosis) with symptoms of latent or severe hepatic encephalopathy.

Application

Inside. Dissolve the contents of 1-2 packets of hepamerz in a large amount of liquid (for example, in a glass of water or juice) and take it during or after meals up to 3 times a day.

In / in. Typically, the dose is up to 4 ampoules (40 ml) per day.

In case of precoma or coma, administer up to 8 ampoules (80 ml) within 24 hours, depending on the severity of the condition.

The Hepa-Merz infusion concentrate can be mixed with conventional infusion solutions. The contents of the ampoules should be mixed with the infusion solution immediately before use. Before administration, the contents of the ampoule should be added to 500 ml of solution, but more than 6 ampoules should not be dissolved in 500 ml of infusion solution.

The maximum rate of administration of L-ornithine-L-aspartate is 5 g / h (which corresponds to the contents of 1 ampoule).

The course of treatment with Hepa-Merz is determined by the doctor depending on the clinical condition of the patient.

Contraindications

Hypersensitivity to l-ornithine-l-aspartate, dye yellow-orange s or to any of the excipients; severe renal impairment (chronic or acute renal failure); at a creatinine level above 3 mg / 100 ml hepamerz granules should not be used ..

Side effects

The following are the adverse reactions observed during clinical trials and post-marketing use of hepa merts, concentrate for infusion solution. frequency categories are defined as follows: very often (≥1 / 10); often (from ≥1 / 100 to 1/10); infrequently (from ≥1 / 1000 to 1/100); rarely (from ≥1 / 10,000 to 1/1000); very rarely (1/10 000); unknown (impossible to estimate based on available data).

From the side of the immune system: unknown - hypersensitivity, anaphylactic reactions.

From the digestive tract: infrequently - nausea, rarely - vomiting.

In general, symptoms of the digestive tract are short-term and do not require discontinuation of treatment. They disappear with a decrease in the dose or rate of administration of the drug.

When using Hepa-Merz granulate, adverse reactions from the gastrointestinal tract were observed: rarely - nausea, vomiting, stomach pain, flatulence, diarrhea; from the musculoskeletal system: very rarely - joint pain.

These adverse reactions are usually short-lived and do not require discontinuation of the drug. Allergic reactions are possible.

special instructions

Hepa-merts, a concentrate for infusion solution, should not be injected into the artery.

With the on / in the introduction of Hepa-Merz in high doses, the level of urea in blood plasma and urine should be monitored.

In case of impaired liver function, the infusion rate should be adjusted in accordance with the patients condition to prevent nausea or vomiting.

Hepa-Merz granulate contains 1.13 g of fructose in each bag (equivalent to 0.11 XE), which must be considered for patients with diabetes mellitus. Do not use in patients with congenital fructose intolerance. Long-term use can be harmful to the teeth (tooth decay).

Use during pregnancy or lactation. There are no data on the use of the Hepa-Merz preparation during pregnancy. Animal studies using L-ornithine-L-aspartate to study its toxic effects on reproductive function have not been conducted. Therefore, the use of the drug during pregnancy should be avoided.

However, if treatment with Hepa-Merz during pregnancy is considered essential for health reasons, the doctor should carefully weigh the ratio of the possible risk to the fetus / child and the expected benefits for the pregnant / mother.

It is not known whether L-Ornithine-L-Aspartate passes into breast milk. Avoid the use of the drug during lactation.

Children. The experience of use in children is limited, therefore, the drug should not be used in pediatric practice.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. The ability to drive vehicles or work with other mechanisms may be impaired during treatment with L-ornithine-L-aspartate, so this activity should be avoided during treatment.

Interactions

No studies have been conducted; data are not available.

Incompatibility. Since incompatibility studies have not been conducted, the drug should not be mixed with other drugs when given iv.

Hepa-Merz can be mixed with conventional solutions for infusion. However, you should not dissolve more than 6 ampoules in 500 ml of solution for infusion.

Overdose

Signs of intoxication due to an overdose of l-ornithine-l-aspartate were not observed. possibly increased side effects. in case of overdose, symptomatic treatment is recommended.

Storage conditions

At a temperature not exceeding 25 ° c.

Exclusive Distributor: Naturfarm, ul. Lesnaya, 30a, Kiev, Pushcha-Voditsa, 04075; phone: (044) 401-81-03.

Supplier: Alpen Pharma AG (Switzerland).

Tags: ornithine-L-aspartate