Tameron^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Institute Of Engineering Physics Of Moscow Open University (Russia)

ATC Code

L03 (Immunostimulants)

Active Substance

Aminodihydrophtalazinedione sodium (Grouping name)

Dosage Form

Tameron®

Lyophilizate for the preparation of a solution for intramuscular administration 100 mg: 5 vial

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of a solution for intramuscular administration in the form of a compacted mass of white or white with a yellowish tint; hygroscopic; the reconstituted solution is a clear, colorless or light yellow liquid.

Glass vials with a capacity of 5 ml (5) – cardboard packs.

Clinical-Pharmacological Group

Immunomodulating and anti-inflammatory preparation

Pharmacotherapeutic Group

Immunomodulatory and anti-inflammatory agent

Pharmacological Action

Immunostimulating agent. The mechanism of action is associated with the ability to influence the functional and metabolic activity of phagocytic cells (monocytes/macrophages, neutrophils, natural killer cells). It normalizes antibody production and indirectly stimulates the production of endogenous interferons (interferon alpha, interferon gamma).

In inflammatory diseases, it reversibly (for 6-8 hours) inhibits the excessive synthesis of TNFα, interleukin-1, interleukin-6 and other pro-inflammatory cytokines, as well as reactive oxygen species by hyperactivated macrophages; the levels of these substances determine the degree of inflammatory reactions, their cyclicity, as well as the severity of intoxication and the level of oxidative stress. Normalization of the functional state of macrophages leads to the restoration of their antigen-presenting and regulatory functions and a reduction in the level of autoaggression.

It stimulates the bactericidal activity of neutrophilic granulocytes, enhancing phagocytosis and increasing the body’s nonspecific resistance to infectious diseases.

Pharmacokinetics

It is eliminated from the body mainly by the kidneys. After intramuscular injection, the T_1/2 is 30-40 minutes; after rectal administration, it is 40-60 minutes. The main pharmacological effects are observed for 72 hours.

Indications

As an immunomodulatory and anti-inflammatory agent in the complex therapy of immunodeficiency states in adults and adolescents from 12 years of age: gastric and duodenal ulcer; viral hepatitis; chronic recurrent diseases caused by the herpes virus; diseases caused by the human papillomavirus; infectious and inflammatory urogenital diseases (chlamydial and trichomonal urethritis, chlamydial prostatitis, acute and chronic salpingo-oophoritis, endometritis); purulent-inflammatory diseases of the pelvic organs; postoperative rehabilitation of patients with uterine fibroids; postoperative complications in women of reproductive age; postoperative purulent-septic complications and their prevention (including in oncological patients); chronic recurrent furunculosis, erysipelas; asthenic conditions, neurotic and somatoform disorders, reduced physical performance (including in athletes); mental, behavioral and post-abstinence disorders in alcohol and drug dependence; inflammatory diseases of the oral mucosa and throat, periodontal diseases.

In adults and adolescents from 12 years of age as monotherapy: acute and chronic infectious and inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and/or diarrhea; chronic urogenital infections, including during immunorehabilitation measures in the inter-relapse period to maintain clinical remission.

As an immunomodulatory and anti-inflammatory agent in the complex therapy of immunodeficiency states in children over 6 years of age: purulent surgical diseases (burn injuries, recurrent furunculosis, chronic osteomyelitis, gangrenous appendicitis with omentitis, peritonitis, purulent pleurisy); frequent recurrent diseases of the respiratory tract and ENT organs of bacterial and viral etiology (frequent acute respiratory viral infections, bronchitis, pneumonia, chronic tonsillitis, chronic otitis media, chronic adenoiditis).

ICD codes

Dosage Regimen

Administer Tameron^®intramuscularly or rectally as directed.

Determine the dose and treatment schedule individually based on the patient’s age, specific indication, and clinical response.

For adults and adolescents from 12 years of age, use a 100 mg vial. Reconstitute the lyophilisate with 2-3 ml of water for injection or 0.9% sodium chloride solution immediately before administration.

For complex therapy of immunodeficiency states, administer 100 mg intramuscularly every 48-72 hours. The typical course consists of 5 to 10 injections.

For monotherapy of gastrointestinal or urogenital infections, administer 100 mg rectally daily for 10 days. For immunorehabilitation, use a prolonged regimen of 100 mg rectally once every 72 hours for up to 30 days.

For children over 6 years of age, calculate the dose based on 1.5 mg per kg of body weight. Administer intramuscularly every 48 hours. The course typically includes 5 to 7 injections.

Do not exceed the recommended single and course doses. Adjust the interval between injections based on tolerability and therapeutic effect.

For postoperative complication prevention in adults, administer 100 mg intramuscularly 24-48 hours before surgery and again 24-48 hours after surgery.

Complete the full prescribed course of treatment unless otherwise directed by a physician. Do not mix with other medications in the same syringe.

Adverse Reactions

Rarely, allergic reactions are possible.

Contraindications

Pregnancy, breastfeeding period; children under 6 years of age.

In children over 6 years of age, it is used in appropriate dosage forms.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Use in children under 6 years of age is contraindicated. In children over 6 years of age, it is used in appropriate dosage forms.

Special Precautions

To prevent urogenital infection, it is recommended to consider simultaneous treatment of the sexual partner.

Drug Interactions

With simultaneous use, a reduction in the course doses of antibiotics is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.