Zuprevo 18% (Tildipirosin) Injectable Solution for Cattle is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle, and for the control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni. Zuprevo 18% is a ready-to-use sterile injectable solution containing tildipirosin, a semi-synthetic macrolide antibiotic. Each mL of Zuprevo 18% contains 180 mg of tildipirosin as the free base, 82.5 mg citric acid monohydrate and 400 mg propylene glycol, and water qs with citric acid monohydrate added to adjust pH.

Cattle

The fast-acting, long-lasting BRD treatment. When BRD takes hold, time is of the essence. That’s why there’s ZUPREVO – the BRD treatment that’s rapidly absorbed in as little as 45 minutes.1 Once in the lungs, it remains there for 28 days.2* Not to mention one low-dose volume of 1 mL/100 lbs. means less handling and more doses per bottle.

ABSORBS FAST: Reaches peak plasma levels just 45 minutes after administration.1 LONG-LASTING: 28 days*2 in the lungs. 21 days*2 in the bronchial fluid. HIGH CONCENTRATION: One low-volume dose of 1 mL/100 lbs. means less handling and more doses per bottle. 1Preview: Economic effects of Bovine Respiratory Disease. J Anim Sci. 2020;98(2). 2Menge M, et al. Pharmacokinetics of tildipirosin in bovine plasma, lung tissue, and bronchial fluid (from live, non-anesthetized cattle). J Vet Pharm Ther. 2011;1349:1365-2885.

For a complete listing of adverse reactions for Zuprevo 18% reported to CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Tildipirosin

Contact your nearest emergency animal hospital.

WARNINGS: FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. TO AVOID ACCIDENTAL INJECTION, DO NOT USE IN AUTOMATICALLY POWERED SYRINGES WHICH HAVE NO ADDITIONAL PROTECTION SYSTEM. IN CASE OF HUMAN INJECTION, SEEK MEDICAL ADVICE IMMEDIATELY AND SHOW THE PACKAGE INSERT OR LABEL TO THE PHYSICIAN. Avoid direct contact with skin and eyes. If accidental eye exposure occurs, rinse eyes with clean water. If accidental skin exposure occurs, wash the skin immediately with soap and water. Tildipirosin may cause sensitization by skin contact. For technical assistance or to report a suspected adverse reaction, call: 1-800-219-9286. For customer service or to request a Material Safety Data Sheet (MSDS), call: 1-800-211-3573. For additional Zuprevo™ 18% information go to www.zuprevo.com. For a complete listing of adverse reactions for Zuprevo™ 18% reported to CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth. DO NOT USE ZUPREVO 18% IN SWINE. Fatal adverse events have been reported following the use of tildipirosin in swine. NOT FOR USE IN CHICKENS OR TURKEYS. RESIDUE WARNING: Cattle intended for human consumption must not be slaughtered within 21 days of the last treatment. Do not use in female dairy cattle 20 months of age or older. Use of this drug product in these cattle may cause milk residues. A withdrawal period has not been established in pre-ruminating calves. Do not use in calves to be processed for veal. PRECAUTIONS: The effects of Zuprevo™ 18% on bovine reproductive performance, pregnancy and lactation have not been determined. Swelling and inflammation, which may be severe, may be seen at the injection site after administration. Subcutaneous injection may result in local tissue reactions which persist beyond the slaughter withdrawal period. This may result in trim loss of edible tissue at slaughter.

Available in vials of 100 ml and 250 ml.

Merck Animal Health

Inject subcutaneously as a single dose in the neck at a dosage of 4 mg/kg (1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site. Do not puncture the stopper of the respective vial size more than the tested number of punctures, shown in Table 1 on the label. Clinical field studies indicate that administration of Zuprevo™ 18% (tildipirosin) Injectable Solution is effective for the control of respiratory disease in beef and non-lactating dairy cattle at “high risk” of developing BRD. Calves at high risk of developing BRD typically experience one or more of the following risk factors: • Commingling from multiple sale barns/sources • Extended transport times and shrink • Exposure to wet or cold weather conditions or wide temperature swings • Stressful arrival processing procedures (such as castration, dehorning, or branding) • Recent weaning and poor vaccination history

(Tildipirosin) Injectable Solution for Cattle Antimicrobial Drug 180 mg of tildipirosin/mL