ESFOS (Solution) Instructions for Use

Marketing Authorization Holder

Velpharm, LLC (Russia)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids (Grouping Name)

Dosage Form

ESFOS

Solution for intravenous administration 50 mg/1 ml: amp. 5 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous administration transparent, yellow in color.

Excipients: benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide, sodium riboflavin phosphate, ethanol (ethyl alcohol) 95%, water for injections.

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

Clinical-Pharmacological Group

Hepatoprotective agent

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

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 toxicosis; 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; this formulation is not for oral use.

Initiate therapy with a slow intravenous injection of 5 ml to 10 ml (250 mg to 500 mg) per day.

For severe conditions, increase the dose to 15 ml-20 ml (750 mg-1000 mg) per day.

Alternatively, administer the daily dose as a single intravenous infusion.

Dilute the required volume in 250 ml to 500 ml of a compatible infusion solution, such as dextrose 5% or 10%.

Do not dilute with electrolyte solutions (e.g., saline).

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

Transition to an oral hepatoprotective formulation for maintenance therapy once the acute condition is controlled.

The duration of treatment is determined by the treating physician based on clinical response and disease severity.

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.