Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FLURALANER (UNII: WSH8393RM5) (FLURALANER - UNII:WSH8393RM5)
Merck Sharp & Dohme Corp.
Fluralaner
Fluralaner 112.5 mg
TOPICAL
PRESCRIPTION
Bravecto kills adult fleas and is indicated for the treatment and prevention of flea 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. There are no known contraindications for the use of the product.
Bravecto is available in five strengths for use in dogs (112.5, 250, 500, 1000, and 1400 mg fluralaner per tube). Each tube is packaged individually in a pouch. Product may be supplied in 1 or 2 tubes per carton.
New Animal Drug Application
BRAVECTO- FLURALANER SOLUTION MERCK SHARP & DOHME CORP. ---------- BRAVECTO (FLURALANER TOPICAL SOLUTION) FOR DOGS CAUTION Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: Each tube is formulated to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. Each milliliter contains 280 mg of fluralaner. The chemical name of fluralaner is (±)-4-[5-(3,5-dichlorophenyl)-5-(trifluoromethyl)-4,5- dihydroisoxazol-3-yl]-2-methyl-_N_-[2-oxo-2-(2,2,2- trifluoroethylamino) ethyl]benzamide. Inactive ingredients: dimethylacetamide, glycofurol, diethyltoluamide, acetone INDICATIONS: Bravecto kills adult fleas and is indicated for the treatment and prevention of flea 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. DOSAGE AND ADMINISTRATION: Bravecto should be administered topically as a single dose every 12 weeks according to the DOSAGE SCHEDULE below to provide a minimum dose of 11.4 mg/lb (25 mg/kg) body weight. Bravecto may be administered every 8 weeks in case of potential exposure to _Amblyomma americanum_ ticks (see EFFECTIVENESS). DOSAGE SCHEDULE BODY WEIGHT RANGES (LB) FLURALANER CONTENT (MG)/TUBE TUBES ADMINISTERED 4.4 – 9.9 112.5 One >9.9 – 22.0 250 One >22.0 – 44.0 500 One >44.0 – 88.0 1000 One ® * * >88.0 – 123.0 1400 One STEP 1: Immediately before use, open the pouch and remove the tube. Hold the tube at the crimped end with the cap in an upright position (tip up). The cap should be rotated clockwise or counter clockwise one full turn. The cap is designed to stay on the t Lire le document complet