Contraindications
None.
Withdrawal period
Meat and offal: 2 days.
Eggs (chicken): zero days.
Turkeys: Not for use in birds producing or intended to produce eggs for human consumption. Do not use within 21 days of the start of the laying period.
Use during pregnancy, lactation or lay
The safety of the veterinary product has not been established during lay in turkeys.
The product can be used in chickens laying eggs for human consumption and breeding birds producing eggs for hatching broiler stock or replacement layers.
Special warnings for each target species
In field studies investigating the effect of treatment and metaphylaxis on mycoplasmosis, all birds (approximately 3 weeks old) received the product when clinical signs were evident in 2-5% of the flock. At 14 days after initiation of treatment, 16.7 - 25.0% morbidity and 0.3 - 3.9% mortality were observed in the treated group in comparison to 50.0 - 53.3% morbidity and 0.3 - 4.5% mortality in an untreated group.
In further field studies, chicks from parent stock with evidence of Mycoplasma gallisepticum infection were administered Aivlosin for the first three days of life followed by a second course at 16-19 days of age (a period of management stress). By 34 days after the initiation of treatment, 17.5 - 20.0% of morbidity and 1.5-2.3% mortality were observed in the treated groups in comparison to 50.0 - 53.3% morbidity and 2.5 - 4.8% mortality in the untreated groups.
The strategy for Mycoplasma gallisepticum infection should include efforts to eliminate the pathogen from the parent generation.
Infection with Mycoplasma gallisepticum is reduced but not eliminated at the recommended dose.
Medication should only be used for short-term amelioration of clinical signs in breeder flocks whilst awaiting confirmation of diagnosis of Mycoplasma gallisepticum infection.
Special precautions for use in animals
Good management and hygiene practices should be introduced to reduce the risk of re-infection.
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 veterinary medicinal product deviating from the instructions may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with other macrolides due to potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal 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 water, 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.