Lyasten®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIASTENUM®

Composition:

Active substance: glucosaminylmuramylpentapeptide (N-acetylglucosaminyl-N-acetylmuramyl-L-alanyl-D-glutamyl-L-lysyl-D-alanyl-L-aspartyl);

1 vial contains 0.002 g of glucosaminylmuramylpentapeptide (N-acetylglucosaminyl-N-acetylmuramyl-L-alanyl-D-glutamyl-L-lysyl-D-alanyl-L-aspartyl) calculated as peptides;

Excipient: dextran 40.

Pharmaceutical form. Powder for solution for injection.

Main physicochemical properties: lyophilized powder or porous mass of white or white with yellowish tint color, easily soluble in water for injection and 0.9% sodium chloride solution for injection.

Pharmacotherapeutic group. Immunostimulants. ATC code L03A.

Pharmacological properties / immunological and biological properties.

LIASTENUM® belongs to naturally derived immunomodulators with a broad spectrum of action. It represents fragments of the cell wall of lactobacilli. LIASTENUM® stimulates macrophage function and normalizes the number of T-lymphocytes. LIASTENUM® activates cells of the monocyte-macrophage lineage, enhances phagocytosis, increases lysosomal enzyme activity, production of reactive oxygen species, and strengthens the cytotoxic effect of macrophages against cells infected with viruses and bacteria, as well as tumor cells. The medicinal product enhances cytokine synthesis, particularly interleukin-1. LIASTENUM® increases cytotoxic activity of natural killer cells. Immunomodulating activity of the medicinal product is also manifested by preservation of thymus endocrine function and reduction of circulating immune complexes. LIASTENUM® promotes stimulation of leukopoiesis, exhibits weak antimetastatic and antitumor effects, and reduces adverse effects of chemotherapy and radiation therapy. The drug has no embryotoxic, mutagenic, or teratogenic effects.

Clinical characteristics.

Indications.

LIASTEN® is prescribed as part of combination therapy as an immunomodulating agent in various diseases associated with secondary immunodeficiency and leukopenia, particularly during chemotherapy and radiation therapy in cancer patients and patients with leukemia, aiming to reduce the toxic effects of cytostatics; in acute and chronic radiation injuries; in surgical treatment of cancer patients and other patient groups, as part of combination therapy. LIASTEN® is indicated in acute and chronic bacterial and viral infections, particularly in tuberculosis, as well as for the treatment of patients with leukopenia of various origins.

Contraindications.

Hypersensitivity to the components of the drug and autoimmune diseases. Pediatric age, pregnancy, breastfeeding. Conditions associated with diseases accompanied by hyperthermia (>38°C) at the time of drug administration.

Interaction with other medicinal products and other forms of interactions. Unknown.

Special precautions for use.

Use with caution in patients with allergic disorders.

Use during pregnancy or breastfeeding. There is no experience with the use of the medicinal product in pregnant women or women who are breastfeeding.

Ability to affect reaction speed when driving or operating machinery. Has no effect.

Method of administration and dosage.

LIASEN® is administered subcutaneously or intramuscularly. Prior to use, 1–2 ml of 0.9% isotonic sodium chloride solution for injection or water for injection is added to the vial.

If subcutaneous administration is intended, 1 ml of solvent may be used. After adding the solvent, the vial is shaken thoroughly until the contents are completely dissolved. The usual daily dose of the drug for adults is 0.002 g of active substance. The treatment course consists of 3–5 injections given at intervals of 5–7 days. If necessary, repeated treatment courses may be performed after 3–6 and 12 months.

Children. There is no experience with the use of LIASEN® in children.

Overdose. Cases of overdose with LIASEN® have not been reported.

Adverse reactions.

Sometimes, a short-term slight increase in body temperature, local reactions, or joint pain may occur. In such cases, the interval between injections of the medicinal product should be increased to 10 days.

Reporting of suspected adverse reactions

Reporting of adverse reactions after registration of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product through the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions. Store at a temperature not exceeding 25 °C. The medicinal product solution should be stored for no more than 24 hours in a refrigerator at a temperature of +4 to +6 °C.

Incompatibility. The medicinal product must not be mixed with other medicinal products.

Packaging. Powder for preparation of injection solution in 6 ml or 10 ml vials, pack of 5 in a blister. The blister containing the vials is placed in a cardboard box.

Prescription status. Prescription only.

Manufacturer/Marketing Authorization Holder. State Enterprise "Enzym".

Manufacturer's address and location of its business activities / Marketing Authorization Holder's address.

2 Khlibozavodska Street, Ladizhin, Vinnytsia region, 24321, Ukraine.