Essliver (Solution) Instructions for Use

Marketing Authorization Holder

Nabros Pharma, Pvt. Ltd. (India)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids (Grouping name)

Dosage Form

Essliver

Solution for intravenous administration 250 mg/5 ml: amp. 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration in the form of a transparent yellow liquid.

Excipients: benzyl alcohol, riboflavin, propylene glycol, butylated hydroxytoluene, butylated hydroxyanisole, alpha-tocopherol acetate (vit. E), sodium deoxycholate, water for injections.

5 ml – dark glass ampoules (5) – contour packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Hepatoprotective agent

Pharmacological Action

Hepatoprotective agent; the phospholipids included in the composition are the main elements in the structure of the cell membrane and mitochondria.

It regulates lipid and carbohydrate metabolism, improves the functional state of the liver and its detoxification function, promotes the preservation and restoration of the structure of hepatocytes; inhibits the formation of connective tissue in the liver.

Pharmacokinetics

Binding mainly to high-density lipoproteins, phosphatidylcholine enters, in particular, into liver cells.

The T_1/2 of the choline component is 66 hours, and that of unsaturated fatty acids is 32 hours.

Indications

Fatty liver degeneration (including in diabetes mellitus); acute and chronic hepatitis, liver cirrhosis, liver cell necrosis, hepatic coma and precoma, toxic liver lesions; pregnancy toxemia; pre- and postoperative treatment, especially for operations in the hepatobiliary area; psoriasis (as an auxiliary therapy); radiation syndrome.

ICD codes

Dosage Regimen

Administer intravenously only; do not administer intramuscularly or subcutaneously.

For adult patients, administer 250 mg to 500 mg (5-10 ml) per day via slow intravenous injection.

For severe conditions, including liver cirrhosis or hepatic coma, the daily dosage may be increased to 500 mg to 1000 mg (10-20 ml).

Dilute the solution immediately before administration with the patient’s own blood, dextrose solution (5-10%), or xylitol solution (5-10%).

Do not dilute the solution with electrolyte solutions such as sodium chloride or Ringer’s solution.

Infuse the diluted solution slowly at a rate not exceeding 40 drops per minute.

The total daily infusion volume should not exceed 250-500 ml.

Transition to oral phospholipid formulations for maintenance therapy as the patient’s clinical condition improves.

The duration of intravenous treatment is determined by the severity of the disease and the clinical response.

Adverse Reactions

From the digestive system: when used in high doses – diarrhea.

From the immune system: hypersensitivity reactions, including skin allergic reactions: skin rash, skin itching, exanthema or urticaria.

Contraindications

Age under 18 years; soy intolerance; hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Use during pregnancy is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

It is not recommended for use during breastfeeding due to the lack of data on safety of use.

Special Precautions

As the patient’s condition improves, parenteral administration is replaced by oral administration of a drug containing phospholipids in the appropriate dosage form.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.