Expiration date: 10/2025
Release form and composition:
The solution for the/m introduction colorless, transparent.
1 ml contains:
Thymogen (glutamyl-tryptophan) 100 mg
1 ml - ampoules (5) - packs of cardboard.
Spray metered dose nasal colorless, transparent tolerance characteristic smell benzalkonium chloride.
1 dose contains:
Thymogen (apha-glutamyl-tryptophan in the form of sodium salts) 25 mcg
Auxiliary substances: benzalkonium chloride, sodium chloride, sodium hydroxide 1M (until pH 6.5-7.5), purified water.
3 ml - vials with a metering device (1) - packs of cardboard.
5 ml - vials with a metering device (1) - packs of cardboard.
10 ml - vials with a metering device (1) - packs of cardboard.
Cream for external use 0.05% white or white with a yellowish tint.
100 g contains:
Thymogen (apha-glutamyl-tryptophan in the form of sodium salt) 50 mg
Excipients: vaseline oil, petrolatum, polyoxyethylene sorbitan monostearate (Polysorbate 60), glycerol, sorbitan monostearate, stearyl alcohol, cetyl alcohol, diethylene glycol monotropy ether, methyl parahydroxybenzoate (nipagin), xanthan gum, parahydroxybenzoate (nipazol), purified water.
20 g - tubes aluminum (1) - packs of cardboard.
20 g - glass (1) - packs of cardboard.
30 g - tubes aluminum (1) - packs of cardboard.
30 g - banks glass (1) - packs of cardboard.
Pharmacological action:
Immunomodulatory drug. Is a dipeptide, influencing the reaction cell, humoral immunity and nonspecific resistance of the organism. Stimulates regeneration processes in case of their oppression, improves the flow of processes of a cellular metabolism. Enhances differentiation of lymphoid cells, has the ability to stimulate kolonialismus activity of bone marrow cells, induces the expression of differentiation receptors on lymphocytes, normalizes the number of T-helpers, T-suppressors and their ratio in patients with various immunodeficiency States.
The dipeptide activates the expression of CD4+receptor on lymphocytes in all vitr. It was observed a high affinity dipeptide with membrane receptors of thymocytes, as well as specific binding of Thymogen on the surface of lymphocytes that allows to explain its immunomodulatory properties.
In experimental studies, were identified radioprotective properties Thymogen marked anti-inflammatory activity and its ability to inhibit the development of serotonin and histamine edema, stimulate formation of appropriate antibodies. In research in all vitr set the modulating effect of Thymogen on cytokine production.
Pharmacokinetics:
The pharmacokinetics of the drug Thymogen® has not been studied with regard to its peptide nature.
Indications:
— complex therapy of acute and chronic infectious inflammatory diseases accompanied by decline in cellular immunity
— prevention of immunosuppression, hematopoiesis, regeneration processes in post-traumatic and postoperative period, in the process of radiotherapy or chemotherapy, using massive doses of antibiotics
— prevention and complex therapy of viral (including acute respiratory infections and influenza), bacterial and chlamydial infections
— prevention and complex therapy of acute and chronic respiratory diseases.
Dosing regimen:
Solution for I/m administration, use the/m and intranasal. The recommended dose for V/m and intranasal administration are:
Patients Thymogen®
mcg drops
Children up to 1 year 10 2-3
Children from 1 year to 3 years 10-20 3-5
Children 4 to 6 years 20-30 5-7
Children from 7 to 14 years 50 8-10
Adults 50-100 10-20
The therapy duration is 3-10 days depending on the severity of disorders of immunity.
With preventive purpose the drug is administered intranasally or I/m daily for adults 100 mg, children – on 50-75 mcg for 3-5 days.
Nasal spray metered-dose designate adults and 1 dose (25 mcg) in each nostril 2 times/day children aged 7 to 14 years - 1 dose (25 mcg) in each nostril 1 times/day children from 1 year to 6 years - 1 dose (25 mcg) in one nostril 1 times/day. The drug is prescribed for 10 days with a medical purpose and within 3-5 days - with the preventive purpose.
With the introduction of the spray nozzle of the vial with a metering device inserted in the nostril in position vertically upwards and click once.
If necessary, may conduct re-treatment after 1-6 months.
Side effects:
Perhaps: allergic reactions.
Contraindications:
— pregnancy
— lactation (breast feeding)
— hypersensitivity to the drug.
Pregnancy and lactation:
Contraindicated during pregnancy and lactation (breastfeeding).
Special instructions:
There is evidence of the efficiency of Thymogen as an immunomodulator, reducing immune reactivity in the complex therapy of viral hepatitis, tuberculosis, pseudo-tuberculosis, influenza and acute respiratory viral infections, papillomatosis, and sepsis.
According to clinical studies, the application of Thymogen in the acute period of the disease intestinal form of amebiasis, typhoid, acute dysentery, erysipelas, diphtheria, brucellosis, hemorrhagic fever with renal syndrome improves the health of patients, promotes more rapid normalization of biochemical and immunological parameters. As a result of application of the drug reduced the incidence of prolonged recurrent course of disease and chronicity of the process.
The application of Thymogen in bronchopulmonary diseases infectious-inflammatory and allergic etiology allows to reduce the duration of the disease, to restore the activity of the immune system and prevent or substantially reduce the likelihood of complications.
According to clinical studies Thymogen® is successfully used in complex therapy of bacterial, viral and fungal skin infections (pyoderma, furunculosis, erysipelas, papillomatosis, herpes), and also in the treatment of atopic dermatitis.
Medical literature and published reports of the application of Thymogen in the complex therapy of acute pancreatitis, peritonitis, severe mechanical injuries, compartment syndrome, burns, in the treatment and rehabilitation of patients after major abdominal operations.
Not recommended simultaneous application of Thymogen corticosteroids in high doses.
Overdose:
Symptoms: when 10-fold excess dose may develop flu-like syndrome.
Drug interactions:
In a joint application of Thymogen® increases the efficiency of cytostatic and radiation therapy.
Terms and conditions of storage:
List B. the Solution for the on/m introduction should be stored in protected from light place at temperature not exceeding 4°C. shelf Life - 3 years.
Metered-dose nasal spray should be stored in a dry, dark, inaccessible to children place at temperature from 0°to 25°C. shelf Life – 2.5 years.
