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Contra-indications, warnings, etc
Withdrawal Period
Meat and Offal: 2 days
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only in accordance with benefit-risk assessment by the responsible veterinarian.
Laboratory studies in animals have not produced any evidence of a teratogenic effect. Maternal toxicity in rodents has been observed at doses of 400 mg tylvalosin per kg bodyweight and above. In mice, a slight reduction in the foetal bodyweight was seen at doses causing maternal toxicity.
Special warnings for each target species
Acute cases and severely diseased pigs with reduced food and water intake should be treated with a suitable injectable veterinary medicinal product.
Generally, strains of B.hyodysenteriae have higher minimal inhibitory concentration (MIC) values in cases of resistance against other macrolides such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored.
Cross-resistance between tylvalosin and other macrolides cannot be excluded.
Special precautions for use in animals
It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.
Use of the veterinary medicinal product deviating from the instructions in the SPC may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medical product to animals
Tylvalosin has been shown to cause hypersensitivity (allergic) reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin should avoid contact with this product.
When mixing the veterinary medicinal product and handling the medicated oral powder, direct contact with eyes, skin and mucous membranes should be avoided. Personal protective equipment consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 should be worn when mixing the product. Wash contaminated skin.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.