Hepa-mertz granules for preparation of oral solution 5g, No. 30

• Acute and chronic liver diseases accompanied by hyperammonemia.

• Hepatic encephalopathy (latent and severe).

• Steatoses and steatohepatitis (of various origins).

Inside, 1-2 sachets of granules dissolved in 200 ml of liquid, 3 times a day, after meals.

The course of administration depends on the severity of the disease.

Active substance:
L-ornithine-L-aspartate 3 g

Excipients:
anhydrous citric acid 0.55 g
lemon flavor 0.02 g
orange flavor 0.2 g
sodium saccharinate (sodium saccharin) 0.0045 g
sodium cyclomate 0.0405 g
sunset yellow dye 0.0005 g
polyvinylpyrrolidone (povidone) 0.05 g
fructose (levulose) 1.1345 g

• Severe renal failure with a creatinine value of more than 3 mg / 100 ml,

• hypersensitivity to the components of the drug,

• lactation period,

• children's age (due to insufficient data).

With care: pregnancy.

Trade name Hepa-Merz

International non-proprietary name
ornithine

Dosage form of granules for preparation of oral solution

Composition:
5 g of granules contain
Active ingredient:
L-ornithine-L-aspartate 3 g
Excipients:
anhydrous citric acid 0.55 g
lemon flavor 0.02 g
orange flavor 0.2 g
sodium saccharinate (sodium saccharin) 0.0045 g
sodium cyclomate 0.0405 g
sunset dye yellow 0.0005 g
polyvinylpyrrolidone (povidone) 0.05 g
fructose (levulose) 1.1345 g

Description: A mixture of orange and white granules

Pharmacotherapeutic group: Drugs for the treatment of liver diseases.

ATX code: ј05¬ј

Pharmacological properties:

Has a detoxifying effect, reducing the increased level of ammonia in the body, in particular, in liver diseases. The effect of the drug is associated with its participation in the ornithine cycle of Krebs urea formation (activates the cycle, restoring the activity of liver cell enzymes: ornithine-carbamoyltransferase and carbamoyl-phosphate synthetase). Promotes the production of insulin and growth hormone.
Improves protein metabolism in diseases requiring parenteral nutrition.
It helps to reduce asthenic, dyspeptic and pain syndromes, as well as to normalize increased body weight (with steatosis and steatohepatitis).

Pharmacokinetics:

L-ornithine-L-aspartate rapidly dissociates into ornithine and aspartate, and takes effect within 15-25 minutes, with a short half-life.
It is excreted in the urine through the urea cycle.

Indications for use:

• Acute and chronic liver diseases accompanied by hyperammonemia.

• Hepatic encephalopathy (latent and severe).

• Steatoses and steatohepatitis (of various origins).

Contraindications:

• Severe renal failure with a creatinine value of more than 3 mg / 100 ml,

• hypersensitivity to the components of the drug,

• lactation period,

• children's age (due to insufficient data).

With care: pregnancy.

Method of administration and dosage:

Inside, 1-2 sachets of granules dissolved in 200 ml of liquid, 3 times a day, after meals.

The course of administration depends on the severity of the disease.

Side effect:

From the gastrointestinal tract: infrequently: nausea, vomiting, abdominal pain, flatulence, diarrhea.
Musculoskeletal and connective tissue disorders: very rare: pain in the limbs. Sunset yellow dye can cause allergic reactions.

Overdose:

Symptoms: increased severity of side effects.
Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.
Interaction with other medicinal products: not described

Special instructions:

When making a diagnosis of hepatic encephalopathy due to the underlying disease, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form:

Granules for preparation of oral solution, 3 g. 10 or 30 sachets (5 g) of granules for preparation of oral solution containing 3 g of L-ornithine-L-aspartate are packed in a cardboard box with instructions for use.

Shelf life:

5 years
do not use after the expiration date

Storage conditions:

At a temperature not higher than 25 ? C, out of the reach of children

Terms of dispensing from pharmacies: Without prescription.

Manufacturing company:
'Merz Pharma GmbH & Co.KGaA'
D-60318, Germany, Frankfurt am Main

Claims should be sent to the address:
OOO Merz Pharma
123317, Moscow, Presnenskaya nab., 10,
BC Tower on Naberezhnaya, block S.