INSTRUCTIONS FOR MEDICAL USE
TIMPRAIMIN
Trade name of the drug: Timpraimine
Active substance (INN): arginine-alpha-aspartyl-lysyl-valyl-tyrosyl-arginine (thymopentine)
Dosage form: lyophilized powder for preparation of solution for injection
Contents:
1 vial contains:
active ingredient: thymopentin 1.0 mg
Excipients: mannitol, glacial acetic acid, sodium hydroxide
Description: lyophilized powder of white color.
Pharmacotherapeutic group: immunomodulatory agent.
ATX code: L03
Pharmacological properties
Timopentin is a drug for biphasic regulation of immune system function.
Pharmacodynamics
Timopentin induces the activation and proliferation of T-lymphocytes and increases antibody production and normalizes the ratio of CD4+/CD8+ T-lymphocyte subtypes. Timopentin regulates/increases cellular immunity, stimulates maturation of mitogen-activated peripheral blood T-lymphocytes, increases activation of various cytokines (such as: IFN-α, – γ, IL-2 and IL-3), T cell antigen or mitogen, results in increased T cell lymphokine receptor levels. T-4 helper cells, through activation, enhance lymphocyte responses. In addition, NK progenitor cells (natural killers) can be influenced by measuring the corresponding chemotaxis reserve, progenitor cells become more toxic to cells after exposure to IFN. Thus, the drug is intended to regulate and enhance human cellular immunity function.
Pharmacokinetics
Fully absorbed from the injection site and degraded very rapidly by plasma protease and aminopeptidase. The T1/2 is approximately 30 seconds. The T1/2 was longer in the abdomen than in plasma and was approximately 3.5-7 minutes. 25% of the drug could be detected in saliva ten minutes after administration. Timopentin acts very rapidly in the target cell after a single injection, and when repeatedly administered, 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 18 years of age;
- Cellular immunity disorders due to reduction of the thymus gland after 18 years of age;
- Various primary or secondary T-cell deficiencies;
- autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, etc.)
- Cellular immunity disorders caused by various diseases;
- Infectious diseases (including opportunistic infections): cytomegalovirus infection, herpes infection, toxoplasmosis, chlamydia (chlamydia infection), pneumocystis, cryptosporidiosis, HIV/AIDS, chronic viral hepatitis, chronic brucellosis, diphtheria (including bacterial carrier)
- Tumors (including malignant);
- Burns, long non-healing wounds;
- Sepsis, septic complications, septic endocarditis;
- bronchoobstructive syndrome;
- cholecystopancreatitis;
- psoriasis;
- As an adjuvant in vaccinations against bacterial and viral infections.
Dosage and administration
Intramuscular, intravenous drops
- intramuscular injection: dilute 1 ml with sterile water for injection;
- Intravenous drip infusion: dissolved in 250 ml of 0.9% injectable sodium chloride solution.
The drug shall be administered following the recommendations.
Prevention and treatment of immunodeficiency conditions (chronic inflammatory diseases, T-cell deficiency, autoimmune diseases, cellular immunity disorders, due to thymus gland reduction, cholecystopancreatitis, psoriasis): 1-2 vials 2 times a day. The course of treatment 15-30 days;
Chronic hepatitis B: 1-2 bottles 3 times a week. The course of treatment 24 weeks.
Infectious diseases (CMV, herpes, toxoplasmosis, chlamydia, pneumocystis, cryptosporidiosis, HIV infection / AIDS, chronic viral hepatitis, brucellosis, etc.), tumors (including malignant): 1-2 bottles once a day. The course of treatment is 15 days. Need three courses of treatment with a break between courses of 20 days.
Burns, long-term non-healing wounds: 1-2 bottles 1 time a day. The course of treatment 20 days.
Sepsis, septic-septic complications, septic endocarditis: 1-2 bottles 1 time a day. The course of treatment is 10 days. Three courses of treatment with 20-day intervals between courses are required. Bronchoobstructive syndrome: 2 bottles 1 time a day. The course of treatment is 15-30 days;
As an adjuvant during vaccination against bacterial and viral infections: 1-2 vials 1 time a day. The course of treatment 15-20 days.
Side effects
Usually the drug is well tolerated; some patients may have nausea, fever, dizziness, heaviness in the chest, weakness, somnolence. In patients with chronic hepatitis B a transient ALT elevation without signs of liver function failure may be observed. In case of the above-mentioned side effects, the drug should be continued.
Contraindications
- Individual intolerance (including hypersensitivity in history) to the components of the drug
- Pregnancy complicated by Rh conflict
- organ transplantation
Drug interactions
No interference is observed with the simultaneous use of the drug with interferon, antibiotics, hormones, anti-inflammatory, analgesic, hypotensive drugs, diuretics, drugs intended for the treatment of cardiovascular diseases, central nervous system drugs, contraceptives. Interferon acts synergistically to improve immune function.
Special indications
Because the drug enhances the immune system function, the drug should not be used in patients receiving immunosuppressive therapy (e.g., organ transplants), except in cases when the benefits of treatment exceed the possible risks.
Continuous monitoring of liver function is required during treatment.
There are no clinical data on the use of the drug in patients under 18 years of age.
Administration during pregnancy and lactation: During pregnancy the drug is used only in case of acute clinical need due to the lack of sufficient data. Caution must be exercised when using the drug during lactation.
Overdose
No cases of intentional or accidental overdose have been reported. Tests of acute toxicity in animals showed that thymopentin causes no undesirable reactions at a dose of 10 mg/kg (the highest studied dose).
Form of production
In 1 mg glass vials.
Storage conditions
Store in a dark place at temperatures under 25ºC. Keep out of the reach of children.
Shelf life
2 years. Do not use after the expiration date.
Conditions of dispensing from pharmacies.
Released by a doctor’s prescription.