RONIDAZOLE (tablet for oral administration)

Round-shaped coated tablets, white to yellow in colour, with a characteristic odour of the constituent components.

1 gram of the product contains the active substance:

- ronidazole — 250 mg.

Excipients: sugar, polyvinylpyrrolidone, potato starch, calcium stearate, talc, albumin, skim milk powder, flavouring agent, lactose.

ATCvet QP51 — Antiprotozoal veterinary medicinal products. QP51CA02 — Ronidazole.

Ronidazole belongs to the group of nitroimidazole compounds. It acts on protozoa of the genera Trichomonas, Hexamita, Cochlosoma, Histomonas, Entamoeba, and Giardia. The binding of Ronidazole reaction products to the DNA of protozoal or bacterial cells leads to their death. The formation of strong bonds significantly increases the acidic intracellular pH level, which, among other things, confirms the selective action of 5-nitroimidazole derivatives against anaerobic bacteria and certain protozoa. Furthermore, the reaction of Ronidazole produces compounds that act as intracellular donors of free aerobic radicals, additionally damaging intracellular molecules other than DNA. This intensifies cellular destruction and leads to the most rapid death of protozoa or bacteria.

Following oral administration, Ronidazole  is almost completely and rapidly absorbed from the gastrointestinal tract and reaches peak plasma concentration (8,5 ± 2,5 µg/mL) within 12–14 hours. Its bioavailability exceeds 90%. The half-life of Ronidazole in plasma after oral administration in most animals and birds is approximately 11 hours, blocking the replication of protozoal cells by inhibiting DNA synthesis. The volume of distribution of Ronidazole in pigeons is approximately 0,86 L/kg. The clearance of Ronidazole in pigeons is only 0,056 L/h/kg. Excretion of Ronidazole and its metabolites occurs slowly and incompletely, primarily via the kidneys and intestines.

Metaphylaxis and treatment of pigeons affected by trichomoniasis and hexamitiasis caused by protozoa of the genera Trichomonas and Hexamita susceptible to Ronidazole .

Route of administration: Oral, administered with wet feed. Prior to use, tablets should be ground or crushed and mixed with a small portion of wet feed, then given to pigeons before the main feeding.

Metaphylaxis: The dose is 25 mg of Ronidazole per 1 kg of body weight of the pigeon, equivalent to 1 tablet of 120 mg (containing 30 mg of Ronidazole) per 3 pigeons, or 1 tablet of 480 mg (containing 120 mg of Ronidazole) per 12 pigeons, for 1–3 days.

Treatment: The dose is 25 mg of Ronidazole per 1 kg of body weight of the pigeon, equivalent to 1 tablet of 120 mg (containing 30 mg of Ronidazole) per 3 pigeons, or 1 tablet of 480 mg (containing 120 mg of Ronidazole) per 12 pigeons. Treatment course: 3–5 days.

Hypersensitivity to the components of the product.

Do not use in birds showing signs of viral infection or with impaired hepatic or urinary system function.

Do not use during moulting.

Do not use in production poultry!

Do not use in breeding pigeons.

When used in accordance with the package leaflet, adverse reactions and complications are generally not observed.

In rare cases, reduced water intake and impaired spermatogenesis have been observed in birds.

The product should be used in accordance with the package leaflet. Recommended doses must be observed.

No studies have been conducted. Use in birds during the laying period is permitted only following a benefit/risk assessment by a veterinarian.

Concomitant use with antimicrobial and antiparasitic veterinary medicinal products is not recommended.

Tablets of 120 mg, packaged in polymer containers of 50 tablets; and tablets of 480 mg, packaged in polymer containers of 20 tablets. Secondary packaging — cardboard box together with the package leaflet.

Store in a dry, dark place, out of reach of children and animals, at a temperature of 5 to 25 °C.

3 years.