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 (ie with a similar mode of action). Cross resistance occurs with other macrolides.
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.
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 tulathromycin and may decrease the effectiveness of treatment with other macrolides, lincosamides and group B streptogramins, due to the potential for cross resistance.
If a hypersensitivity reaction occurs appropriate treatment should be administered without delay.
Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are present for approximately 30 days after injection.
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 vocalization and restlessness. Lameness was also observed when the hind leg was used as the injection site.
Withdrawal period
Meat and offal: 13 days.
User warnings
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 resulting in eg reddening of the skin (erythema) and/or dermatitis. 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.
If there is suspicion of a hypersensitivity reaction following accidental exposure (recognised by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea, vomitus) appropriate treatment should be administered. Seek medical advice immediately and show the package leaflet or the label to the physician.