Today's Veterinary Nurse

SEP-OCT 2017

Practical, peer reviewed, state-of-the-art companion animal nursing and technical educational articles with CE. Promotes better health for animals and career growth and development for veterinary technicians and veterinary assistants.

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(fluralaner topical solution) for Cats 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 fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of Ixodes scapularis (black-legged tick) infestations for 12 weeks in cats and kittens 6 months of age and older, and weighing 2.6 pounds or greater. Bravecto is also indicated for the treatment and control of Dermacentor variabilis (American dog tick) infestations for 8 weeks in cats and kittens 6 months of age and older and weighing 2.6 pounds or greater. Contraindications: There are no known contraindications for the use of the product. WARNINGS Human Warnings: Not for human use. Keep this and all drugs out of the reach of children. Do not contact or allow children to contact the application site until dry. 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. Avoid contact with skin and eyes. If contact with eyes occurs, then flush eyes slowly and gently with water. Wash hands and contacted skin thoroughly with soap and water immediately after use of the product. The product is highly flammable. Keep away from heat, sparks, open flame or other sources of ignition. Precautions: For topical use only. Avoid oral ingestion. Use with caution in cats with a history of neurologic abnormalities. Neurologic abnormalities have been reported in cats receiving Bravecto, even in cats without a history of neurologic abnormalities. Bravecto has not been shown to be effective for 12-weeks duration in kittens less than 6 months of age. Bravecto is not effective against Dermacentor variabilis ticks beyond 8 weeks after dosing. The safety of Bravecto has not been established in breeding, pregnant and lactating cats. Adverse Reactions: In a well-controlled U.S. field study, which included a total of 161 households and 311 treated cats (224 with fluralaner and 87 with a topical active control), there were no serious adverse reactions. Percentage of Cats with Adverse Reactions (AR) in the Field Study Adverse Reaction (AR) Bravecto Group: Percent of Cats with the AR During the 105-Day Study (n=224 cats) Control Group: Percent of Cats with the AR During the 84-Day Study (n=87 cats) Vomiting 7.6% 6.9% Pruritus 5.4% 11.5% Diarrhea 4.9% 1.1% Alopecia 4.9% 4.6% Decreased Appetite 3.6% 0.0% Lethargy 3.1% 2.3% Scabs/Ulcerated Lesions 2.2% 3.4% In the field study, two cats treated with fluralaner topical solution experienced ataxia. One cat became ataxic with a right head tilt 34 days after the first dose. The cat improved within one week of starting antibiotics. The ataxia and right head tilt, along with lateral recumbency, reoccurred 82 days after administration of the first dose. The cat recovered with antibiotics and was redosed with fluralaner topical solution 92 days after administration of the first dose, with no further abnormalities during the study. A second cat became ataxic 15 days after receiving its first dose and recovered the next day. The cat was redosed with fluralaner topical solution 82 days after administration of the first dose, with no further abnormalities during the study. In a European field study, two cats from the same household experienced tremors, lethargy, and anorexia within one day of administration. The signs resolved in both cats within 48-72 hours. In a European field study, there were three reports of facial dermatitis in humans after close contact with the application site which occurred within 4 days of application. For technical assistance or to report a suspected adverse drug reaction, or to obtain a copy of the Safety Data Sheet (SDS), 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 three strengths for use in cats (112.5, 250, and 500 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton. Distributed by: Intervet Inc (d/b/a Merck Animal Health) Madison, NJ 07940 Made in the USA. Copyright © 2016 Intervet Inc, a subsidiary of Merck & Company Inc. All rights reserved 155373 R8 NADA 141-459, Approved by FDA

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