Laennec (Solution) Instructions for Use

Marketing Authorization Holder

Medical Corporation RANA LLC (Russia)

Manufactured By

Japan Bio Products, Co. Ltd. (Japan)

Contact Information

Medical Corporation RANA LLC (Russia)

ATC Codes

A05BA (Drugs for the treatment of liver diseases)

L03 (Immunostimulants)

Dosage Form

Laennec

Solution for injection 112 mg/2 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Solution for injection in the form of a clear liquid from light yellow to brown in color, with a characteristic odor.

Excipients: water for injections, sodium hydroxide or hydrochloric acid (for pH adjustment).

2 ml – dark glass ampoules (10) – cardboard packs with partitions.

Clinical-Pharmacological Group

Immunomodulator and hepatoprotector

Pharmacotherapeutic Group

Immunostimulants; drugs for the treatment of liver and biliary tract diseases; drugs for the treatment of liver diseases, lipotropic agents; drugs for the treatment of liver diseases

Pharmacological Action

Laennec exhibits immunomodulatory properties due to its ability to stimulate humoral immunity and increase the functional activity of phagocytes and natural killer cells.

It increases the bactericidal activity of peripheral blood leukocytes, manifested in their ability to destroy the captured pathogen.

The cytokines that are part of the drug activate the metabolic and surveillance functions of skin cells.

Biologically active substances contained in the hydrolysate stimulate the regeneration (proliferation) of hepatocytes, exhibit detoxification properties, reduce the deposition of lipids and cholesterol in liver cells, increase the activity of tissue respiration, activate metabolism in the liver, and reduce the intensity of connective tissue development in the liver.

Pharmacokinetics

It is impossible to study the pharmacokinetic parameters of the drug Laennec using pharmacokinetic methods, since it consists only of physiological components that are normally present in the body.

Indications

As part of complex therapy for the following diseases

• Chronic recurrent herpes;
• Atopic dermatitis of moderate and severe course (including complicated).

As monotherapy

• Chronic liver diseases – steatohepatitis (of alcoholic, metabolic, and mixed etiology).

ICD codes

Dosage Regimen

For chronic recurrent herpes and atopic dermatitis, the drug is administered intravenously by drip: 10 ml (560 mg of placenta hydrolysate) of the drug (5 ampoules) is dissolved in 250-500 ml of 5% dextrose solution or physiological saline and administered through the cubital vein over 1.5-2 hours.

Injections are performed 3 times a week with an interval of 2 days. The course of treatment is 10 injections.

For chronic liver diseases – steatohepatitis (of alcoholic, metabolic, and mixed etiology), the drug is administered intramuscularly at 2 ml/day (112 mg of placenta hydrolysate).

Depending on the severity of the disease, the frequency of injections can be increased to 2-3 times (up to 6 ml) per day.

Intravenous drip administration 10 ml (560 mg of placenta hydrolysate) of the drug (5 ampoules) is dissolved in 250-500 ml of 5% dextrose solution or physiological saline and administered through the cubital vein over 1.5-2 hours.

Injections are performed daily. The course of treatment is 2-3 weeks.

Adverse Reactions

Side effects are observed in 3.7% of patients.

Clinically significant adverse reactions possible allergic reactions, including anaphylactic shock.

Other undesirable phenomena pain at the injection site (2.56%), allergic reactions (redness, skin itching) (0.37%), numbness at the injection site (0.37%); gynecomastia (0.37%) – a causal relationship with the drug administration has not been established.

Contraindications

• Hypersensitivity to the drug;
• Childhood;
• Pregnancy;
• Lactation period.

With caution should be used in patients with polyvalent allergy to drugs, in elderly persons.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Studies on the safety of Laennec use in newborns (including premature) and minor children have not been conducted. Use in children is not recommended.

Geriatric Use

With caution should be used in elderly patients.

Special Precautions

According to the currently available data, old age is not a contraindication for prescribing Laennec.

Nevertheless, since physiological functions in elderly persons are impaired, the use of the drug should be carried out under careful supervision.

Use in pediatrics

Studies on the safety of Laennec use in newborns (including premature) and minor children have not been conducted. Use in children is not recommended.

Effect on the ability to drive vehicles and mechanisms

The effect on the ability to drive vehicles and mechanisms has not been established.

Overdose

To date, no cases of Laennec overdose have been reported.

Drug Interactions

Pharmaceutical interaction

When mixing Laennec solution with other drugs that are strong bases (pH above 8.5), the activity of the drug decreases.

To date, no other clinically significant drug interactions of the drug have been identified.

Storage Conditions

The drug should be stored in a light-protected place, out of the reach of children, at a temperature from 18°C (64.4°F) to 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.