TIAMUN ® 10% (solution for injection)

Oily liquid, light yellow to dark yellow in colour.

1 ml of the product contains the active substance:

- tiamulin hydrogen fumarate — 100 mg.

Excipients: 1,2-propylene glycol, benzyl alcohol, phosphoric acid, water for injections.

ATC vet classification code QJ01 — antibacterial veterinary medicinal products for systemic use. QJ01XQ01 — Tiamulin.

Tiamulin is a semi-synthetic antibiotic belonging to the pleuromutilin group.

Tiamulin acts at the level of 70S ribosomes. The primary binding site of tiamulin on the ribosome is located on the 50S subunit, with a possible secondary binding site at the junction of the 50S and 30S subunits. It inhibits microbial protein synthesis by forming biochemically inactive initiation complexes, thereby preventing polypeptide chain elongation. Tiamulin exerts bacteriostatic activity against mycoplasmas (Mycoplasma hyopneumoniae, M. hyosynoviae, M. hyorhinis) and spirochetes (Brachyspira innocens, Brachyspira pilosicoli), Gram-positive aerobes (Staphylococcus spp., Streptococcus spp., Corynebacterium pyogenes), anaerobes (Clostridium spp.), and Gram-negative anaerobes (Lawsonia intracellularis, Bacteroides spp. and Fusobacterium spp.). Gram-negative aerobes (Actinobacillus pleuropneumoniae, Pasteurella multocida) demonstrate high sensitivity to tiamulin in vitro. Tiamulin shows weak activity against Enterobacteriaceae such as Salmonella spp. or Escherichia coli.

Following intramuscular administration, tiamulin is rapidly absorbed into the bloodstream, distributed widely throughout the body, and concentrated in lung tissue. After parenteral administration at a dose of 10–15 mg/kg body weight, peak serum concentrations were observed 2 hours post-administration. Two hours after administration, tiamulin concentrations in pulmonary tissue (15,6 µg/ml) and bronchial epithelium (6,0 µg/ml) were considerably higher than plasma concentrations. Following parenteral administration to pigs at a dose of 13,6 mg/kg body weight per day for 4 days, tiamulin concentration in the lungs was 26,9 µg/ml, in the colonic mucosa — 2,58 µg/ml, and in the colon — 3,09 µg/ml.

More than 95% of the tiamulin dose is eliminated from pigs within less than 24 hours, with a half-life of less than 24 hours. Tiamulin undergoes extensive metabolism; approximately 60% of the administered dose is excreted via bile and approximately 29% via urine.

Pigs: Treatment of dysentery, enzootic pneumonia, pleuropneumonia, and mycoplasmal arthritis caused by microorganisms susceptible to tiamulin.

- for the treatment of dysentery — 1,0 ml of the product per 10 kg body weight, equivalent to 10 mg tiamulin hydrogen fumarate per 1 kg body weight, once daily for 3–5 days;

- for the treatment of enzootic pneumonia and mycoplasmal arthritis — 1,5 ml of the product per 12,5 kg body weight, equivalent to 12 mg tiamulin hydrogen fumarate per 1 kg body weight, once daily for 3 days;

- for the treatment of pleuropneumonia caused by Actinobacillus spp. — 1,5 ml of the product per 12,5 kg body weight, equivalent to 12 mg tiamulin hydrogen fumarate per 1 kg body weight, once daily for 3 days.

To improve tiamulin absorption, it is advisable to warm the vial to 37 °C before administration. When the dose volume exceeds 7 ml, it should be divided and injected into different sites.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in non-target species.

Do not administer products containing monensin, narasin, or salinomycin for at least 7 days before, during, or after tiamulin treatment, as this may result in deterioration of health or death.

Do not use in sows during the first 5–6 weeks of gestation.

Do not administer concomitantly with beta-lactam antibiotics.

Do not use in animals with hepatic impairment.

In isolated cases, a small proportion of animals may develop swelling, pain, or erythema at the injection site, which resolve spontaneously within 2–3 days without intervention.

In rare cases (in animals sensitive to the product's components), allergic reactions may occur (skin rash, pruritus, and oedema). If such reactions occur, administration of the product must be discontinued and desensitising therapy initiated.

Special precautions for use

The product should initially be tested on a small group (7–8 animals). In the absence of adverse reactions within 2–3 days, the product may be administered to the entire herd. It is recommended that no more than 7 ml of the product be administered at a single injection site.

It is recommended to determine the susceptibility of the isolated pathogen to tiamulin prior to use.

Use during pregnancy, lactation and lay

The product may be used during lactation without restriction.

Animals may be slaughtered for human consumption 10 days after the last administration of the product. Meat obtained before this period must be disposed of or fed to non-productive animals, subject to the decision of a veterinarian.

Vials of neutral glass (Type I or II) / Vials of neutral glass grades NS-1, NS-2, USP-1, sealed with rubber stoppers and aluminium crimp caps, in volumes of 10, 20, 50, 100, and 200 ml. Secondary packaging: cardboard box.

Store in a dry, dark place, out of reach of children, at a temperature between 10 °C and 25 °C.

24 months.

Shelf life after first opening the immediate packaging: 14 days, provided that the product is withdrawn under aseptic conditions and the vial is subsequently stored at a temperature between 10 °C and 15 °C.