Zuprevo 180 mg/ml solution for injection for cattle 50ml

Target species Cattle Indications for use For the treatment and prevention of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to tildipirosin. The presence of the disease in the herd should be confirmed before preventive treatment. Contraindications Do not use in case 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 None. Special precautions for use Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. Official, national and regional antimicrobial policies should be taken into account when the product is used. Operator warnings 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 In very rare cases, anaphylactic reactions, with a potentially fatal outcome, might occur. Pain on injection and injection site swellings are very common in treated animals. Following the maximum recommended injection site volume of 10 ml, injection site swellings may be associated with pain on palpation for about one day in individual animals. The swellings are transient and will usually resolve within 7 to 16 days; in individual animals swellings may persist for 21 days. Pathomorphological injection site reactions will largely resolve within 35 days. The frequency of adverse reactions is defined using the following convention: •very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) •common (more than 1 but less than 10 animals in 100 animals) •uncommon (more than 1 but less than 10 animals in 1,000 animals) •rare (more than 1 but less than 10 animals in 10,000 animals) •very rare (less than 1 animal in 10,000 animals, including isolated reports). 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 in accordance with the benefit/risk assessment by the responsible veterinarian. Interactions There is cross resistance with other macrolides. Therefore, the product should not be administered with antimicrobials with a similar mode of action such as other macrolides or lincosamides.