Tamerit^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Abidapharma, LLC (Russia)

Manufactured By

Ellara, LLC (Russia)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Aminodihydrophtalazinedione sodium

Dosage Form

Tamerit®

Lyophilizate for the preparation of solution for intramuscular administration 100 mg: amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for the preparation of solution for intramuscular administration in the form of a powder or compacted mass of white or yellowish-white color.

100 mg – ampoules of light-protective glass with a capacity of 5 ml (5) – cardboard packs.
100 mg – ampoules of light-protective glass with a capacity of 5 ml (10) – cardboard packs.
100 mg – ampoules of light-protective glass with a capacity of 5 ml (5) – contour cell packs (1) – cardboard packs.
100 mg – ampoules of light-protective glass with a capacity of 5 ml (5) – contour cell packs (2) – cardboard packs.
100 mg – ampoules of light-protective glass with a capacity of 5 ml (5) – contour cell packs (1) in a set with a solvent* – cardboard packs.

* Solvent water for injections (amp. 3 ml 5 pcs. in a contour cell pack).

Clinical-Pharmacological Group

Immunomodulating and anti-inflammatory preparation

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

Sodium 5-amino-1,2,3,4-tetrahydrophthalazine-1,4-dione.

An immunostimulating agent that also has an anti-inflammatory effect.

It suppresses (reversibly, for 6-8 hours) macrophage hyperreactivity, reduces excessive synthesis of TNF, interleukin-1, the production of reactive oxygen species and other acute-phase proteins responsible for the development of toxic and diarrheal syndromes.

It normalizes the functional state of macrophages, leading to the restoration of their antigen-presenting and regulatory function.

By increasing the functional antibacterial activity of neutrophilic granulocytes, it enhances phagocytosis and increases the nonspecific defense of the body.

Pharmacokinetics

Eliminated mainly by the kidneys. T_1/2 – 15-30 min.

Indications

Acute and chronic inflammatory diseases of the gastrointestinal tract, accompanied by intoxication and/or diarrhea.

Rectal suppositories (additionally): chronic recurrent furunculosis; chronic recurrent herpesvirus infection; postoperative purulent-septic complications – as part of complex therapy.

ICD codes

Dosage Regimen

Intramuscularly, rectally, in the acute period of the disease, the initial dose is 0.2 g, then 0.1 g 2-3 times/day (every 4-6 hours); for chronic diseases – 0.1 g 2 times/day (every 6-8 hours) until the symptoms of intoxication and/or diarrhea disappear. The course of treatment is up to 10 days.

Chronic recurrent herpesvirus infection – rectally, 0.1 g daily for 20 days, postoperative purulent-septic complications – 0.1 g every other day, course – 15-20 suppositories.

Before administration, the powder is dissolved in the vial with 2-3 ml of water for injections or 0.9% NaCl solution, observing the requirements of asepsis.

Adverse Reactions

Allergic reactions.

Contraindications

Hypersensitivity; pregnancy; lactation period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

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.