Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
Do not use simultaneously with other macrolides or lincosamides.
Special warnings for specific target species:
Sheep:
The efficacy of antimicrobial treatment of foot rot might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.
Antibiotic treatment of benign foot rot is not considered appropriate. Tulathromycin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.
Special precautions for use in animals
Use of the product should be based 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 the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the tulathromycin and may 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 medicinal product to animals
Tulathromycin is irritating to eyes. In case of accidental eye exposure, flush the eyes immediately with clean water. Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water. Wash hands after use. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Use during pregnancy, lactation or lay: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Overdose:
In cattle at dosages of three, five or ten times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose.
In young pigs weighing approximately 10 kg given three or five times the therapeutic dose transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.
In lambs (approx. 6 weeks old), at dosages of three or five times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, bleating.
Incompatibilities: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Environmental safety: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Withdrawal periods:
Cattle (meat and offal): 22 days. Pigs (meat and offal): 13 days. Sheep (meat and offal): 16 days.
Not authorised for use in animals producing milk for human consumption.
Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.