L’esfal (Solution) Instructions for Use

Marketing Authorization Holder

Farmak, JSC (Ukraine)

ATC Code

A05BA10 (Phospholipids)

Active Substance

Phospholipids (Grouping name)

Dosage Form

L’esfal

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 – 9 mg, deoxycholic acid – 23 mg, sodium chloride – 2.4 mg, sodium hydroxide – 2.3 mg, riboflavin (E101) – 0.1 mg, water for injections – up to 1 ml.

5 ml – ampoules of dark glass (5) – blisters (1) – cardboard packs.
5 ml – ampoules of dark glass (5) – blisters (2) – cardboard packs.
5 ml – ampoules of dark glass (5) – cardboard packs with inserts.
5 ml – ampoules of dark glass (10) – cardboard packs with inserts.

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 dystrophy (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 L’esfal solution by slow intravenous injection only; do not administer by rapid IV bolus.

Prepare the injection by diluting the contents of one 5 ml ampoule (250 mg) in the patient’s own blood, dextrose solution, or plasma in a 1:1 ratio.

Inject the prepared solution very slowly at a rate not exceeding 1 ml (50 mg) per minute.

The recommended adult dosage is 250 mg to 500 mg (one to two ampoules) per day.

For severe cases, the dosage may be increased up to 1,000 mg (four ampoules) per day.

Transition from intravenous to oral administration of a phospholipid preparation as the patient’s clinical condition improves.

Do not use in pediatric patients under 18 years of age due to a lack of safety and efficacy data.

Inspect the solution visually for particulate matter and discoloration prior to administration; use only if the solution is clear and yellow.

Adverse Reactions

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

From the immune system hypersensitivity reactions, incl. 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 safety data.

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.