Ornilatex^® (Concentrate) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Active Substance

Ornithine (Rec.INN registered by WHO)

Dosage Form

Ornilatex®

Concentrate for solution for infusion 500 mg/1 ml: amp. 10 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion in the form of a colorless or light yellow, transparent liquid.

Excipients: water for injections.

10 ml – ampoules of light-protective glass with a colored break ring or with a colored dot and a notch (5) – contour cell packs (1) – cardboard boxes.
10 ml – ampoules of light-protective glass with a colored break ring or with a colored dot and a notch (5) – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Hypoammonemic drug

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

Hypoammonemic agent. It reduces the elevated level of ammonia in the body, particularly in liver diseases.

The action is associated with participation in the ornithine cycle of urea formation (the Krebs cycle), which is the formation of urea from ammonia.

It promotes the production of insulin and somatotropic hormone.

It 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 (in steatosis and steatohepatitis).

Pharmacokinetics

In the body, it dissociates into the amino acids ornithine and aspartate, which are absorbed in the small intestine by active transport through the intestinal epithelium.

It is excreted in the urine through the urea cycle.

Indications

Acute and chronic liver diseases accompanied by hyperammonemia. Hepatic encephalopathy.

Steatosis and steatohepatitis of various origins (for oral administration).

As a corrective additive to drugs for parenteral nutrition in patients with protein deficiency (for parenteral use).

ICD codes

Dosage Regimen

Administer orally or by slow intravenous infusion. Determine the dose, route, and duration of therapy individually based on indication and clinical severity.

For intravenous infusion, dilute the concentrate before administration. Withdraw the required volume from the ampoule. Dilute each 5 g (10 ml) ampoule in at least 500 ml of a suitable infusion solution, such as 0.9% sodium chloride or 5% glucose.

Infuse the prepared solution slowly. The recommended infusion rate is up to 5 g per hour. Do not exceed this rate to minimize the risk of nausea and vomiting.

For severe hepatic impairment, closely monitor the patient’s condition. Adjust the infusion rate as necessary based on tolerability and clinical response.

The typical daily adult dose for hyperammonemia in liver disease is 20-40 g (4-8 ampoules). This equates to 100-200 ml of concentrate, diluted in a correspondingly large volume of infusion fluid.

Divide the total daily dose into one or two infusions. The maximum single dose should not exceed 40 g (8 ampoules).

Continue treatment until clinical symptoms and laboratory parameters, notably plasma ammonia levels, have normalized. The treatment course is typically several weeks.

For oral administration, use only the specific dosage form intended for enteral use. Do not administer the concentrate for infusion orally.

If nausea or vomiting occurs during intravenous administration, reduce the infusion rate immediately. Discontinue use if severe hypersensitivity reactions occur.

Adverse Reactions

Immune system disorders: frequency unknown – allergic reactions.

Gastrointestinal disorders: rarely – nausea, vomiting, abdominal pain, flatulence, diarrhea.

Musculoskeletal and connective tissue disorders: very rarely – pain in the extremities.

Contraindications

Hypersensitivity to ornithine; severe renal failure (serum creatinine content more than 3 mg/100 ml); lactation period (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

During pregnancy, it should be used only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

With parenteral use in patients with severe liver dysfunction, strict monitoring of the patient’s condition and correction of the ornithine infusion rate are necessary to prevent the development of nausea and vomiting.

Use in Renal Impairment

Contraindicated in severe renal failure (serum creatinine content more than 3 mg/100 ml).

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

If nausea or vomiting occurs, the infusion rate should be optimized.

When using a specific dosage form of ornithine, the correspondence to specific indications should be observed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.