Description

Lesfal 50 mg/ml. injection 5 ml. #5

Lesfal is an injectable solution used to treat liver-related conditions. It contains phosphatidylcholine derived from soybeans as the active ingredient. The solution is intended for intravenous use and should be administered under the supervision of a healthcare professional.

Composition

Each 1 ml of Lesfal solution contains:

• Phosphatidylcholine from soybeans: 50 mg
• Other ingredients: benzyl alcohol, deoxycholic acid, sodium chloride, sodium hydroxide, riboflavin (E101), water for injections

Dosage Form

Injection solution.

Physical and Chemical Properties

Lesfal is a transparent yellow solution.

Pharmacotherapeutic Group

Hepatotropic agents. ATC code: A05BA.

Pharmacological Properties

Pharmacodynamics

Lesfal contains phospholipids, which are chemically similar to endogenous phospholipids but have a higher content of polyunsaturated (essential) fatty acids. These molecules integrate into cell membranes, particularly in liver cells, aiding the repair of damaged liver tissues. Phospholipids in Lesfal improve lipid metabolism by regulating lipoproteins, which transport cholesterol and neutral fats. The treatment reduces the lithogenic index, stabilizing bile.

Pharmacokinetics

When administered orally, more than 90% of phosphatidylcholine is absorbed in the small intestine. It is metabolized by phospholipase-A into 1-acyl-lyso-phosphatidylcholine, with about 50% of it reesterified into polyunsaturated phosphatidylcholine before absorption. Maximum phosphatidylcholine concentration in blood is achieved within 6–24 hours after oral intake. The half-life for the choline component is 66 hours, while for the saturated fatty acids, it is 32 hours.

Indications

Lesfal is indicated for the treatment of:

• Non-alcoholic steatohepatitis
• Alcoholic steatohepatitis
• Acute and chronic hepatitis of various origins
• Liver cirrhosis
• Pre- and post-operative liver surgeries and biliary tract conditions
• Toxicosis during pregnancy
• Psoriasis
• Radiation syndrome

Contraindications

Lesfal is contraindicated in patients with:

• Hypersensitivity to the components
• Use in newborns and premature infants, as the solution contains benzyl alcohol

Drug Interactions

Lesfal should not be diluted with electrolyte solutions. When preparing for infusion, use non-electrolyte solutions such as 5% or 10% glucose or 5% xylitol.

Special Precautions

Lesfal contains 5.02 mg/ml of alcohol. In patients on sodium-controlled diets, it is important to note that 1 ml of Lesfal contains 0.1 mmol of sodium. The solution should be administered intravenously and slowly. It is not intended for intramuscular use as it may cause local irritation.

Use During Pregnancy and Lactation

Due to limited clinical data and the presence of benzyl alcohol, which can cross the placenta, Lesfal is not recommended for use during pregnancy or breastfeeding.

Ability to Drive and Use Machines

No effects on the ability to drive or use machinery have been observed.

Dosage and Administration

For adults and children over 12 years of age, Lesfal is administered intravenously at a dose of 5-10 ml per day, or in severe cases, 10-20 ml per day. Up to 10 ml can be given in a single administration. When diluted, it is recommended to mix the solution with the patient’s own blood in a 1:1 ratio. Intravenous infusion therapy typically lasts up to 10 days, followed by oral administration of phosphatidylcholine-containing medications.

Overdose

No cases of overdose have been reported.

Side Effects

In rare cases, high doses of Lesfal may cause gastrointestinal disturbances such as diarrhea. Hypersensitivity reactions such as rash, itching, urticaria, and injection site reactions may also occur.

Shelf Life

3 years. Do not use the product after the expiration date indicated on the packaging.

Storage Conditions

Store in a light-protected place at temperatures between 2-8°C. Keep out of reach of children.

Packaging

Lesfal is available in ampoules of 5 ml, packed in blister packs of 5 or 10 ampoules per box.