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Side Effects & Adverse Reactions
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.
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Other Information
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.
Tildipirosin is the nonproprietary name for (11E,13E)-(4R,5S,6S,7R,9R,15R,16R)-6-(4-Dimethylamino-3,5-dihydroxy-6-methyl-tetrahydro-pyran-2-yloxy)-16-ethyl-4-hydroxy-5,9,13-trimethyl-7-(2-piperidin-1-yl-ethyl)-15-piperidin-1-ylmethyl-oxacyclohexadeca-11,13-diene-2,10-dione. The empirical formula is C41H71N3O8. The chemical structure of tildipirosin is shown below.
Figure 1
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Zuprevo Manufacturers
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Merck Sharp & Dohme Corp.
Zuprevo | Merck Sharp & Dohme Corp.
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.
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 Table 1 Number of punctures tested in the in-use study for the respective vial sizes Vial size [mL] Number of punctures tested in the in-use study 50 8 100 8 250 16
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