MODUS-5 [Timopentin] 10 mg Powder for solution for intramuscular injection, subcutaneous injection

MODUS-5

instructions for medical use of the medicinal product

Tradename

Modus-5, Modus -5

International non-proprietary name

Timopentin, Thymopentin

Compound

Each vial contains:

active ingredient: timopentin 10 mg

excipient: mannitol

The solvent ampoule contains: water for injection 5 ml

Dosage form

Lyophilized powder for solution for injection.

Pharmacotherapeutic group

Immunomodulators.

Pharmacological properties

Pharmacodynamics

Timopentin induces the activation and proliferation of T-lymphocytes, and also increases the production of antibodies and normalizes the ratio of CD4 + / CD8 + T-lymphocyte subtypes. Timopentin regulates/increases cellular immunity, stimulates the maturation of mitogen-activated peripheral blood T-lymphocytes, increases the activation of various cytokines (such as IFN-α, -γ, IL-2 and IL-3), T-cell antigen or mitogen, leads to to increase the level of the T-cell lymphokine receptor. T-4 helper cells, through activation, enhance the response of lymphocytes. In addition, NK precursor cells (natural killers) can be influenced by measuring the corresponding reserve of chemotaxis, precursor cells after exposure to IFN become more toxic to cells. Thus, the drug is intended to regulate and enhance the function of human cellular immunity.
Pharmacokinetics
Completely absorbed from the injection site and destroyed very quickly by protease and aminopeptidase in plasma. T1 / 2 is approximately 30 seconds. T1 / 2 was longer in the abdominal cavity than in plasma and was approximately 3.5-7 minutes. 25% of the drug can be detected in saliva ten minutes after application. Timopentin acts very quickly in the target cell after a single injection, with repeated use the effect lasted for several days.
Indications for use

For the prevention and treatment of immunodeficiency and toxic conditions of various etiologies:
- chronic inflammatory diseases of various etiologies;
- chronic hepatitis B in patients over the age of 18;
- violation of cellular immunity due to a decrease in the thymus gland after 18 years;
- various primary or secondary insufficiency of T-cells;
- autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.);
- violation of cellular immunity caused by various diseases;
- infectious diseases (including opportunistic infections): cytomegalovirus infection, herpetic infection, toxoplasmosis, chlamydia (chlamydial infection), pneumocystosis, cryptosporidiosis, HIV infection / AIDS, chronic viral hepatitis, chronic brucellosis, diphtheria (including . bacteriocarrier);
- tumors (including malignant ones);
- burns, long-term non-healing wounds;
- sepsis, purulent-septic complications, septic endocarditis;
- broncho-obstructive syndrome;
- cholecystopancreatitis;
- psoriasis;
- as an adjuvant for vaccination against bacterial and viral infections.

Contraindications

- hypersensitivity to the drug;
- pregnancy complicated by Rh-conflict;
- organ transplantation.

Dosage and administration

Intramuscularly, subcutaneously.
Intramuscular / subcutaneous injection: dilution with sterile water for injection 1-2 ml.
The drug is used following the recommendations.
Prevention and treatment of immunodeficiency conditions (chronic inflammatory diseases, T-cell deficiency, autoimmune diseases, impaired cellular immunity, due to a decrease in the thymus gland, cholecystopancreatitis, psoriasis) 1-2 bottles 2 times a day. The course of treatment is 15-30 days.
Chronic hepatitis B 1-2 bottles 3 times a week. The course of treatment is 24 weeks.
Infectious diseases (CMV, herpes, toxoplasmosis, chlamydia, pneumocystosis, cryptosporidiosis, HIV infection / AIDS, chronic viral hepatitis, brucellosis, etc.), tumors (including malignant ones) 1-2 bottles 1 time per day. The course of treatment is 15 days. You need 3 courses of treatment with breaks between courses of 20 days.

Burns, long-term non-healing wounds 1-2 bottles 1 time per day. The course of treatment is 20 days.

Sepsis, purulent-septic complications, septic endocarditis according to 1-2 vials 1 time per day. The course of treatment is 10 days. You need 3 courses of treatment with breaks between courses of 20 days. Broncho-obstructive syndrome 2 bottles 1 time per day. The course of treatment is 15-30 days.

As an adjuvant for vaccination against bacterial and viral infections, 1-2 vials 1 time per day. The course of treatment is 15-20 days.

Special instructions and precautions

Since the drug increases the function of the immune system, the drug should not be used in patients receiving immunosuppressive therapy (for example, in organ transplantation), unless the benefits of treatment outweigh the possible risks.
During treatment, constant monitoring of liver function is necessary.
There are no clinical data on the use of the drug in patients under the age of 18 years.
Use during pregnancy and during breastfeeding

During pregnancy, the drug is used only in case of acute clinical need, due to the lack of sufficient data. The drug should be used with caution during breastfeeding.
Interaction with other drugs

There is no interference with the simultaneous use of the drug with interferon, antibiotics, hormonal, anti-inflammatory, analgesic, antihypertensive drugs, diuretics, drugs intended for the treatment of cardiovascular diseases, drugs for the central nervous system, contraceptives.
Interferon acts synergistically to improve immune function.

Side effect

The drug is usually well tolerated; some patients may experience nausea, high fever, dizziness, heaviness in the chest, weakness, drowsiness. Patients with chronic hepatitis B may experience transient increases in ALT without evidence of liver dysfunction.

If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

There were no cases of intentional or accidental overdose. Acute toxicity studies in animals have shown that timopentin does not cause any adverse reactions at a dose of 10 mg/kg (the highest dose studied).

Storage conditions

In a dry, cool and dark place, at a temperature not exceeding 20°C.

Keep out of the reach of children!

Best before date

3 years. Do not use after the expiry date stated on the package.

Holiday conditions

Released by prescription.

Release form

1 bottle of powder for solution preparation.

1 ampoule with solvent.

5 bottles with powder for solution preparation, 5 ampoules with solvent, together with instructions for use in a cardboard box.