Target species
Cattle
Indications for use
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.
Contraindications
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’).
Special warnings for each target species
There is cross resistance with other macrolides.
Special precautions for use
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.
Use of the product should be in accordance with official, national and regional antimicrobial policies
Operator warnings
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.
Adverse reactions
Cattle:
Very common (> 1 animal /10 animals treated): | Immediate pain upon injection, Injection site swelling1, Injection site pain2, Injection site reaction3 |
Very rare (<1 animal 1 10,000 animals treated, including isolated reports): | Anaphylaxis4 |
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.
Use during pregnancy or lactation
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.
Interactions
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”.
Amounts to be administered and administration route
Subcutaneous use. Administer 4 mg tildipirosin/kg body weight (equivalent to 1 ml/45 kg body weight) once only. For treatment of cattle over 450 kg body weight, divide the dose so that no more than 10 ml are injected at one site. The rubber stopper of the vial may be safely punctured up to 20 times. Otherwise, the use of a multiple-dose syringe is recommended.To ensure a correct dosage, bodyweight should be determined as accurately as possible.
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.
Overdose
In calves, a single subcutaneous injection of 10 times the recommended dose (40 mg/kg body weight) and repeated subcutaneous administration of tildipirosin (on three occasions in intervals of 7 days) at 4, 12 and 20 mg/kg (1, 3 and 5 times the recommended clinical dose) were well tolerated, apart from transient clinical signs attributed to injection site discomfort and injection site swellings associated with pain in some animals.
Withdrawal periods
Meat and offal: 47 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.