Esfolive-Lekpharm (Solution) Instructions for Use

Marketing Authorization Holder

Lekpharm, SOOO (Republic of Belarus)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids (Group)

Dosage Form

Esfolive-Lekpharm

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 or yellow with a greenish tint.

Excipients: sodium deoxycholate, ethanol 96%, alpha-tocopherol acetate, riboflavin sodium phosphate, benzyl alcohol, sodium chloride, 1M sodium hydroxide solution or 1M hydrochloric acid solution, water for injections.

5 ml – ampoules of dark glass (5) – blister packs (1) – cardboard boxes.
5 ml – ampoules of dark glass (5) – blister packs (2) – cardboard boxes.

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 as a slow stream injection or infusion. Do not administer intramuscularly or subcutaneously.

For adults and adolescents, the usual daily dose is 250 mg (one 5 ml ampoule). In severe cases, the dose may be increased to 500 mg-1 g (two to four 5 ml ampoules) per day.

Dilute the solution before intravenous infusion. For a 250 mg dose, dilute with 250-300 ml of carrier solution. For higher doses, use a correspondingly larger volume of diluent. Use only compatible carrier solutions such as dextrose 5%, dextrose 10%, or xylitol solutions. Do not mix with electrolyte solutions.

Administer the total daily dose as one intravenous infusion or divide it into two slow intravenous injections.

The infusion rate should not exceed 1 ml of the undiluted solution per minute. Adjust the infusion rate to administer 250-300 ml of the diluted solution over approximately 60-90 minutes.

The duration of therapy is determined by the severity of the condition. Transition to an oral hepatoprotective formulation for maintenance therapy as clinically indicated.

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 to 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.