Liascen®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIASTEN® (LIASETENUM®)

Composition:

Active ingredient: 1 tablet contains 2 mg of glucosaminylmuramylpentapeptide calculated as peptides;

Excipients: hypromellose (hydroxypropylmethylcellulose); lactose monohydrate; magnesium stearate; sodium croscarmellose; sorbitol (D-sorbitol) (E 420); microcrystalline cellulose.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or light-yellow, flat cylindrical tablets, uncoated, with beveled edges.

Pharmacotherapeutic group. Immunostimulants.

ATC code: L03AX.

Pharmacological properties.

Lyasten® belongs to naturally derived immunomodulators with a broad spectrum of activity. It consists of fragments of lactobacterial cell walls. Lyasten® stimulates macrophage function and normalizes the number of T-lymphocytes. Lyasten® activates cells of the monocyte-macrophage lineage and enhances phagocytosis; it increases the activity of lysosomal enzymes and production of reactive oxygen species, and strengthens the cytotoxic effect of macrophages against tumor cells. The drug enhances cytokine synthesis. Lyasten® increases the cytotoxic activity of natural killer cells. The immunomodulatory activity of Lyasten® is also manifested in preserving the endocrine function of the thymus and promoting a reduction in circulating immune complexes.

Lyasten® supports stimulation of leukopoiesis, has a weak antimetastatic and antitumor effect, and reduces adverse effects of chemotherapy and radiation therapy. The drug does not exhibit embryotoxic, mutagenic, or teratogenic effects.

Clinical characteristics.

Indications.

Lyasten® should be prescribed as an immunomodulating agent in acute and chronic bacterial and viral infections; in various diseases accompanied by secondary immunodeficiency, particularly during chemotherapy and radiation therapy in cancer patients and patients with leukemia, for reducing the toxic effects of cytostatics; in acute and chronic radiation injuries; in surgical treatment of cancer patients. Lyasten® is indicated for the treatment of patients with leukopenia of various origins.

Contraindications.

Hypersensitivity to the components of the drug; autoimmune thyroiditis in the phase of exacerbation; conditions associated with diseases accompanied by hyperthermia (>38 °C) at the time of drug administration.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

Patients with such rare hereditary diseases as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

If you have been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine, as the product contains D-sorbitol and lactose monohydrate.

Use during pregnancy or breastfeeding.

There is no experience with the use of this medicinal product in pregnant or breastfeeding women.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product does not affect the reaction rate when driving or operating machinery.

Method of Administration and Dosage.

Liasten® tablets are intended for slow dissolution in the oral cavity. It is recommended to slowly dissolve the tablet sublingually. The usual dose is 1 tablet twice daily. The treatment course with the drug usually lasts 10–20 days. If necessary, repeated treatment courses may be conducted after 3–6 and 12 months.

Children.

There is no experience with the use of the drug in children.

Overdose.

Practically impossible, since the minimum toxic doses of the drug exceed therapeutic doses by 650 times.

Side effects.

Short-term slight increase in body temperature may occasionally occur, which does not require discontinuation of the drug or special medical interventions. Hypersensitivity reactions are possible.

Shelf life.

3 years.

Storage conditions. Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

Tablets of 2 mg, pack sizes: № 10 (10×1), № 20 (10×2) in blisters, № 10 and № 20 in containers.

Prescription status.

Prescription only.

Manufacturer.

State Enterprise «Enzym», Ukraine, with JSC «Tekhnolohiya», Ukraine.

Manufacturer's address and place of business.

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

8, Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.

Marketing Authorization Holder.

State Enterprise «Enzym».

Address of the Marketing Authorization Holder.

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