Today's Veterinary Practice

JUL-AUG 2014

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NADA 141-426, Approved by FDA BRIEF SUMMARY (For full Prescribing Information, see package insert) Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Indications: Bravecto kills adult feas and is indicated for the treatment and prevention of fea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Ixodes scapularis (black-legged tick), Dermacentor variabilis (American dog tick), and Rhipicephalus sanguineus (brown dog tick)] for 12 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. Bravecto is also indicated for the treatment and control of Amblyomma americanum (lone star tick) infestations for 8 weeks in dogs and puppies 6 months of age and older, and weighing 4.4 pounds or greater. Contraindications: There are no known contraindications for the use of the product. Warnings: Not for human use. Keep this and all drugs out of the reach of children. Keep the product in the original packaging until use, in order to prevent children from getting direct access to the product. Do not eat, drink or smoke while handling the product. Wash hands thoroughly with soap and water immediately after use of the product. Precautions: Bravecto has not been shown to be effective for 12-weeks duration in puppies less than 6 months of age. Bravecto is not effective against Amblyomma americanum ticks beyond 8 weeks after dosing. Adverse Reactions: In a well-controlled U.S. feld study, which included 294 dogs (224 dogs were administered Bravecto every 12 weeks and 70 dogs were administered an oral active control every 4 weeks and were provided with a tick collar); there were no serious adverse reactions. All potential adverse reactions were recorded in dogs treated with Bravecto over a 182-day period and in dogs treated with the active control over an 84-day period. The most frequently reported adverse reaction in dogs in the Bravecto and active control groups was vomiting. Percentage of Dogs with Adverse Reactions in the Field Study Adverse Reaction (AR) Bravecto Group: Percentage of Dogs with the AR During the 182-Day Study (n=224 dogs) Active Control Group: Percentage of Dogs with the AR During the 84-Day Study (n=70 dogs) Vomiting 7.1 14.3 Decreased Appetite 6.7 0.0 Diarrhea 4.9 2.9 Lethargy 5.4 7.1 Polydipsia 1.8 4.3 Flatulence 1.3 0.0 In a well-controlled laboratory dose confrmation study, one dog developed edema and hyperemia of the upper lips within one hour of receiving Bravecto. The edema improved progressively through the day and had resolved without medical intervention by the next morning. For technical assistance or to report a suspected adverse drug reaction, contact Merck Animal Health at 1-800-224-5318. Additional information can be found at www.bravecto.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/ SafetyHealth. How Supplied: Bravecto is available in fve strengths (112.5, 250, 500, 1000, and 1400 mg furalaner per chew). Each chew is packaged individually into aluminum foil blister packs sealed with a peelable paper backed foil lid stock. Product may be packaged in 1, 2, or 4 chews per package. Distributed by: Intervet Inc (d/b/a Merck Animal Health) Summit, NJ 07901 Made in Austria Copyright © 2014 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved 141487 R2

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