Zuprevo

Zuprevo

Zuprevo Recall

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Questions & Answers

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.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

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.

CHEMICAL NOMENCLATURE AND STRUCTURE

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

Chemical Structure

Zuprevo Manufacturers


  • Merck Sharp & Dohme Corp.
    Zuprevo (Tildipirosin) Injection, Solution [Merck Sharp & Dohme Corp.]

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