For the treatment and prevention of bovine respiratory disease (BRD) associated with Histophilus somni, Mannheimia haemolytica and Pasteurella multocida.

The presence of the disease in the group must be established before the product is used.

Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.

Do not administer simultaneously with other macrolides or lincosamides (see section ‘Interactions’).

There is cross resistance with other macrolides.

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.

People with known hypersensitivity to tildipirosin should avoid contact with the veterinary medicinal product.

Tildipirosin may cause sensitisation by skin contact. If accidental skin exposure occurs, wash the skin immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with clean water.

Wash hands after use.

Special caution should be taken to avoid accidental self-injection, as toxicology studies in laboratory animals showed cardiovascular effects after intramuscular administration of tildipirosin. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Do not use in automatically powered syringes which have no additional protection system.

1 may be present up to 21 days post treatment

2 may be present up to 1 day post treatment

3 pathomorphological, will largely resolve within 35 days

4 may be fatal

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. However, there was no evidence for any selective developmental or reproductive effects in any of the laboratory studies.

Use only according to the benefit/risk assessment by the responsible veterinarian.

The product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides. Please also refer to sections “Contraindications” and “Special warnings for each target species”.

It is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 2 to 3 days after injection. If clinical signs of respiratory disease persist or increase, treatment should be changed using another antibiotic, and continued until clinical signs have resolved.

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.