Instructions for Hepa-Merz concentrate for infusion solution 5 g ampoule 10 ml No. 10
Composition
active ingredient: L-ornithine-L-aspartate;
10 ml of concentrate contains 5 g of L-ornithine-L-aspartate;
excipient: water for injections.
Dosage form
Concentrate for solution for infusion.
Main physicochemical properties: clear solution from colorless to pale yellow.
Pharmacotherapeutic group
Drugs used in liver diseases, lipotropic substances. Hepatotropic drugs. ATX code A05B A.
Pharmacological properties
Pharmacodynamics.
In vivo, the action of L-ornithine-L-aspartate is due to the amino acids, ornithine and aspartate, which cause ammonia detoxification through urea synthesis and glutamine synthesis.
Urea synthesis occurs in periportal hepatocytes, where ornithine acts as an activator of two enzymes: ornithine carbamoyltransferase and carbamoylphosphate synthetase, as well as a substrate for urea synthesis.
Glutamine synthesis occurs in perivenous hepatocytes. In particular, under pathological conditions, aspartate and dicarboxylate, including products of ornithine metabolism, are absorbed into the cells and used there to bind ammonia in the form of glutamine.
Glutamate is an amino acid that binds ammonia under both physiological and pathophysiological conditions. The resulting amino acid glutamine is not only a non-toxic form for ammonia excretion, but also activates the 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 properties of L-ornithine-L-aspartate are due to increased glutamine synthesis. In some clinical studies, this improvement has been shown to be relative to branched-chain amino acids/aromatic amino acids.
Pharmacokinetics.
The half-life of ornithine and aspartate is short – 0.3–0.4 hours. A small part of aspartate is excreted in the urine unchanged.
Indication
Symptomatic treatment of latent and overt hepatic encephalopathy.
Contraindication
Hypersensitivity to L-ornithine-L-aspartate or to any other component of the drug.
Severe renal impairment (renal failure). Creatinine level above 3 mg/100 ml (considered as an approximate value).
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted. Interactions are unknown to date.
Application features
Hepa-Merz, concentrate for solution for infusion, must not be administered into an artery.
When administering high doses of Hepa-Merz, it is necessary to monitor the level of urea in blood plasma and urine.
In case of impaired liver function, the infusion rate should be adjusted according to the individual patient's condition to prevent nausea and vomiting.
Use during pregnancy or breastfeeding
There are no data on the use of Hepa-Merz during pregnancy. Animal studies with L-ornithine-L-aspartate to study its toxic effects on reproductive function have not been conducted. Therefore, the use of Hepa-Merz during pregnancy should be avoided.
However, if treatment with Hepa-Merz during pregnancy is considered necessary for vital indications, the doctor should carefully weigh the ratio of the possible risk to the fetus/child and the expected benefit to the mother.
It is not known whether L-ornithine-L-aspartate passes into breast milk. Therefore, the use of Hepa-Merz should be avoided during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The ability to drive or operate machinery may be impaired during treatment with L-ornithine-L-aspartate, so such activities should be avoided during treatment.
Method of administration and doses
Administer intravenously.
Usually 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.
Hepa-Merz infusion concentrate can be mixed with conventional infusion solutions. The contents of the ampoules should be mixed with the infusion solution only immediately before use. Before administration, the contents of the ampoules should be added to 500 ml of infusion solution, but no more than 6 ampoules should be dissolved in 500 ml of infusion solution.
The maximum rate of administration of L-ornithine-L-aspartate is 5 g/h (corresponding to the contents of 1 ampoule).
The course of treatment is determined by the doctor depending on the patient's clinical condition.
Children.
Experience in children is limited, so the drug should not be used in pediatric practice.
Overdose
To date, no signs of intoxication due to an overdose of L-ornithine-L-aspartate have been observed. Side effects may be exacerbated. In case of overdose, symptomatic treatment is recommended.
Side effects
very common (≥ 1/10),
common (≥ 1/100, < 1/10),
uncommon (≥ 1/1000, < 1/100),
rare (≥ 1/10,000, < 1/1,000),
very rare (< 1/10,000),
unknown: cannot be estimated from the available data.
Immune system disorders:
Not known: hypersensitivity, anaphylactic reactions.
Gastrointestinal disorders
Uncommon: nausea.
Rare: vomiting.
In general, gastrointestinal symptoms are short-lived and do not require discontinuation of treatment. They disappear when the dose or rate of administration of the drug is reduced.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Incompatibility
Since incompatibility studies have not been performed, this drug should not be mixed with other drugs.
Hepa-Merz can be mixed with conventional infusion solutions. However, no more than 6 ampoules should be dissolved in 500 ml of infusion solution.
Packaging
10 ml in an ampoule; 10 ampoules in a cardboard box.
Vacation category
According to the recipe.
Producer
Merz Pharma GmbH and Co. KgaA/ Merz Pharma GmbH & Co. KGaA.
Address
Ludwigstrasse 22, 64354 Reinheim, Germany.
