Read these instructions carefully before you start taking this medicine. Save the instructions, you may need them again. This medicine is available without a prescription. To achieve optimal results, it should be used strictly following all recommendations contained in the instructions. If you have any questions, consult your doctor. Contact your doctor if your condition worsens or does not improve after 10 days.
Registration number: PN002408/01 Trade name of the drug: Thymogen® Group name: Alpha-glutamyl-tryptophan Chemical name: Alpha-glutamyl-tryptophan. Dosage form: dosed nasal spray Composition: in one dose (0.1 ml) of the drug Active ingredient: alpha-glutamyl-tryptophan (Thymogen sodium in terms of thymogen) 25 mcg. Excipients: sodium chloride 900 mcg, benzalkonium chloride 10 mcg, purified water to 0.1 ml. Description: Colorless transparent liquid. The presence of a characteristic odor of benzalkonium chloride is allowed. Pharmacotherapeutic group: Immunostimulating agent. ATX code: L03AX.
Pharmacological properties:
Pharmacodynamics: Has a regulatory effect on the reactions of cellular, humoral immunity and nonspecific resistance of the body. Stimulates regeneration processes in case of their inhibition. Improves the course of cellular metabolic processes. Enhances the expression of differentiation receptors on lymphocytes, normalizes the number of T-helpers, cytotoxic T-lymphocytes and their ratio in patients with various immunodeficiency conditions. Pharmacokinetics: The drug quickly enters the systemic circulation after its intranasal administration. Sodium alpha-glutamyl-tryptophan, under the influence of peptidases, is broken down into L-glutamic acid and L-tryptophan, which are involved in peptide synthesis in the body.
Detailed description of the study
In diseases, there is a decrease in local or general immunity in the human body due to the invasion of pathogenic agents (viruses, bacteria), but then cells of the immune system enter the site of inflammation. By using immunostimulating agents, it is possible to enhance the effect of a person’s natural defenses. One of these drugs is Thymogen.
Thymogen belongs to the group of immunostimulating agents. The active ingredient of this drug is alpha-glutamyl tryptophan. This medication is used topically (nasally). Its action is based on the regulation of reactions of both humoral and cellular immunity of the human body. It can be used by adults and children over 1 year old.
Indications for use:
- Complex therapy of acute and chronic viral and bacterial infections of the upper respiratory tract and prevention of these diseases;
- Prevention of decreased immunity during the postoperative and post-traumatic period;
- Complex treatment of patients undergoing radiation therapy and chemotherapy.
In the human body, to combat infectious agents - bacteria, viruses, fungi - there is a system of interferons, which is of great importance in regulating innate and acquired immunity.
Interferons are a family of proteins that are released by immune cells in response to infections caused by viruses and bacteria. Currently, there are three types of interferons. They are classified by structure, interaction with specific receptors and physicochemical properties.
Type I includes the following interferons: α, β, ω. The first two are similar in their functions and form class I, and gamma interferons belong to type II.
Interferon alpha (cellular) is formed by blood cells - leukocytes - and actively responds to the penetration of infectious agents (viruses, bacteria) into the human body.
Interferon beta is synthesized by connective tissue cells - fibroblasts - and is also actively involved in the fight against infectious agents.
A representative of type II interferons is interferon-γ.
Interferon gamma (immune) is produced by T-lymphocytes, providing an immunomodulatory and antitumor effect.
The antiviral activity of interferons is based on the regulation of innate and acquired immune mechanisms. As a result of the protective effect of interferons, the binding of the virus to cells and the penetration of viral particles into cells stops.
The role of interferons is to regulate the antiviral, immunomodulatory and antitumor activity of cells. Interferons are active even in small quantities, and their effect is carried out using receptors that are located on the cell membrane.
The study of the effectiveness of treatment with Thymogen is based on the assessment of interferon status (activity of alpha, beta and gamma interferons).
Determining changes in these interferons during the use of Thymogen is necessary for selecting immunomodulatory therapy, taking into account the individual characteristics of the human body.
Description:
Colorless, transparent, odorless solution.
Pharmacotherapeutic group:
Immunostimulating agent.
Pharmachologic effect.
Pharmacodynamics: Has a regulatory effect on the reactions of cellular, humoral immunity and nonspecific resistance of the body. Stimulates regeneration processes in case of their inhibition. Improves the course of cellular metabolic processes. Enhances the expression of differentiation receptors on lymphocytes, normalizes the number of T-helpers, cytotoxic T-lymphocytes and their ratio in patients with various immunodeficiency conditions.
Pharmacokinetics: The drug quickly enters the systemic circulation after parenteral administration. Sodium alpha-glutamyl-tryptophan, under the influence of peptidases, is broken down into L-glutamic acid and L-tryptophan, which are used by the body in peptide synthesis.
Indications for use:
In the complex therapy of acute and chronic viral and bacterial diseases accompanied by decreased immunity:
- viral hepatitis;
- acute and chronic nonspecific lung diseases (CNPD): chronic bronchitis, acute and chronic pneumonia;
- diseases of the skin and subcutaneous tissue (pyoderma, furunculosis, erysipelas);
- in complex therapy of severe diffuse forms of atopic dermatitis;
- in complex therapy of severe mechanical, chemical, radiation and thermal injuries (burn disease);
- complex treatment of wound and surgical infections, including purulent-septic complications in the postoperative period;
- during the period of preoperative preparation for planned surgical operations in order to prevent infectious complications and stimulate regeneration processes.
- after radiation therapy, chemotherapy, and long-term antibiotic therapy in high doses.
Contraindications for use:
Hypersensitivity to the components of the drug. Children's age up to 6 months.
Method of administration and dose. Dosage regimen, route of administration, duration of treatment:
Intramuscularly 1 time per day. Adults and children from 14 years old: 100 mcg (300-1000 mcg per course), children from 6 months to 1 year - 10 mcg, from 1 year to 3 years - 10-20 mcg, from 4 to 6 years - 20-30 mcg, from 7 to 14 years - 50 mcg. The duration of treatment is from 3 to 10 days. A repeat course is possible no earlier than after 1 month. It is possible to conduct 4 courses during the year.
Precautions for use:
Not required.
Indication of the peculiarities of the action of the drug upon first administration or upon its withdrawal, the actions of the doctor and the patient:
The drug has no peculiarities of action when first taken and when discontinued.
Possible side effects when using the drug:
Allergic reactions.
Symptoms of overdose and measures to help in case of overdose:
Overdose symptoms are not described.
Interaction with other drugs:
Not found.
Indication of the possibility and features of medical use of the drug by pregnant women, women during breastfeeding, children, adults with chronic diseases:
For safety reasons, due to insufficient data, the use of the drug during pregnancy and breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child. There are no particularities in the use of the drug by children and adults with chronic diseases.
Information about the possible effect of a medicinal product for medical use on the ability to drive vehicles and machinery:
The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Release form:
solution for intramuscular administration 100 mcg/ml, 1 ml in colorless glass ampoules with a pinch and a break ring, or with a pinch, a notch and a dot. 5 ampoules per blister pack made of polyvinyl chloride film and aluminum foil or without foil. 1 or 2 blister packs (with or without foil) along with instructions for use in a cardboard pack. 5 ampoules along with instructions for use in a cardboard pack.
Storage conditions:
At temperatures from 0 oC to 10 oC.
Expiration date and indication of the prohibition of use of the medicinal product after the expiration date:
3 years. Do not use after the expiration date stated on the packaging.
Indication of the need to store the medicinal product in places inaccessible to children:
Keep out of the reach of children.
Vacation conditions:
on prescription.
Manufacturer/owner of the registration certificate/organization receiving complaints regarding the quality of the drug: JSC Medical-Biological Research and Production Complex Cytomed. Address : Russia 191023, St. Petersburg, Muchnoy lane, 2, tel/fax, www.cytomed.ru. Address of the place of production: 199178, St. Petersburg, Vasilyevsky Island, Maly Prospekt, 57, bldg. 4, lit. AND.
General Director A.N. Khromov JSC Medical-Biological Research and Production Complex Cytomed
What else is prescribed with this study?
Humoral immunity (immunoglobulins IgA, IgM, IgG, IgE, circulating immunocomplexes, complement components C3, C4)
17.51. Ven. blood 8 days
3,890 ₽ Add to cart
Immune status (screening) (Phagocytic activity of leukocytes, cellular immunity, total immunoglobulin IgE, immunoglobulins IgA, IgM, IgG)
27.960. Ven. blood 3 days
7,640 ₽ Add to cart
Immune status expanded
17.61. Ven. blood 14 days
22 310 ₽ Add to cart
Cellular immunity (T-lymphocytes, T-helpers, T-cytotoxic cells, Immunoregulatory index, B-lymphocytes, NK-T cells, NK cells, Leukocyte formula)
17.50. Ven. blood 3 days
5 200 ₽ Add to cart
Thymogen 0.025% 10ml dosed nasal spray
pharmachologic effect
Immunomodulatory drug. It has a regulatory effect on the reactions of cellular, humoral immunity and nonspecific resistance of the body. Stimulates regeneration processes in case of their inhibition. Improves the course of cellular metabolic processes. Enhances the expression of differentiation receptors on lymphocytes, normalizes the number of T-helpers, cytotoxic T-lymphocytes and their ratio in patients with various immunodeficiency conditions.
Composition and release form Thymogen 0.025% 10ml dosed nasal spray
Nasal spray – 1 dose:
- Active ingredients: sodium alpha-glutamyl-tryptophan (in terms of alpha-glutamyl-tryptophan) 25 mcg;
- Excipients: sodium chloride - 900 mg, benzalkonium chloride - 10 mg, purified water - up to 0.1 ml.
10 ml (at least 80 doses) - dark glass bottles (1) with a dispenser pump (100 µl) with a plastic body, nozzle and protective cap - cardboard packs.
Description of the dosage form
Nasal spray dosed in the form of a colorless, transparent liquid; The presence of a characteristic odor of benzalkonium chloride is allowed.
Directions for use and doses
Locally.
Hold the bottle by the base with your thumb and the dispenser nozzle between your middle and index fingers. Insert the nozzle of the dosing device into the nasal passage in a vertical upward position. Press the nozzle once. The drug is administered intranasally (into the nose) in doses:
Adults - 1 dose (one injection) into each nostril 2 times a day for 10 days for therapeutic purposes or for 3-5 days for preventive purposes.
Children aged 1 to 6 years - 1 dose in one nasal passage 1 time / day, from 7 to 14 years - 1 dose in each nasal passage 1 time / day. The drug is used for 10 days for therapeutic purposes or for 3-5 days for prophylactic purposes.
A repeated course of the drug Thymogen® is carried out no earlier than after 1 month.
Pharmacokinetics
The drug quickly enters the systemic circulation after parenteral administration. Sodium alpha-glutamyl-tryptophan, under the influence of peptidases, is broken down into L-glutamic acid and L-tryptophan, which are used by the body in peptide synthesis.
Indications for use Thymogen 0.025% 10ml dosed nasal spray
In the complex therapy of acute and chronic viral and bacterial diseases accompanied by decreased immunity:
- viral hepatitis;
- acute and chronic nonspecific lung diseases (CNPD) - chronic bronchitis, acute and chronic pneumonia;
- diseases of the skin and subcutaneous tissue (pyoderma, furunculosis, erysipelas);
- in complex therapy of severe diffuse forms of atopic dermatitis;
- in complex therapy of severe mechanical, chemical, radiation and thermal injuries (burn disease);
- complex treatment of wound and surgical infections, incl.
- purulent-septic complications in the postoperative period;
- during the period of preoperative preparation for planned surgical operations in order to prevent infectious complications and stimulate regeneration processes;
- after radiation therapy, chemotherapy, as well as long-term antibiotic therapy in high doses.
Contraindications
- Hypersensitivity to the components of the drug;
- children up to 6 months of age.
Use of Thymogen 0.025% 10ml dosed nasal spray during pregnancy and breastfeeding
For safety reasons, due to insufficient data, prescribing the drug during pregnancy and breastfeeding is possible only if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Use in children
Dosed nasal spray is prescribed to children aged 7 to 14 years - 1 dose (25 mcg) in each nostril 1 time / day; children aged 1 to 6 years - 1 dose (25 mcg) in one nostril 1 time / day. The drug is prescribed for 10 days for therapeutic purposes and for 3-5 days for prophylactic purposes.
special instructions
No precautions are required during use.
The drug has no peculiarities of action when first used and when discontinued.
There are no particularities in the use of the drug Thymogen® in children and adults with chronic diseases.
Impact on the ability to drive vehicles and machinery
The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
Symptoms of an overdose of Thymogen® have not been described.
Side effects Thymogen 0.025% 10ml dosed nasal spray
Possible: allergic reactions.
Drug interactions
No drug interactions have been identified with Thymogen®.
References
- Tikhomirova, A.R., Romanyuk, F.P., Sidorova, T.A. and others. The use of Thymogen in children of early and preschool age with acute obstructive bronchitis and bronchial asthma against the background of acute respiratory infections. Pediatrics. Journal named after G.N. Speransky, 2008. - No. 4.
- Nacharova, E.P. Thymogen as a means of increasing the effectiveness and safety of specific prevention of measles and mumps. PF, 2005. - No. 8.
- Bandurska, K., Król, I., Myga-Nowak, M. Interferony: międzystrukturą a funkcją. PostepyHig Med Dosw., 2014. - Vol. 68. - P. 428-40.
- Lazear, H., Schoggins, J., Diamond, M. Shared and Distinct Functions of Type I and Type III Interferons. Immunity, 2021. - Vol. 50(4). — P. 907-923.
