Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
robenacoxib (UNII: Z588009C7C) (robenacoxib - UNII:Z588009C7C)
Elanco US Inc.
robenacoxib
robenacoxib 10 mg
ORAL
PRESCRIPTION
ONSIOR should not be used in dogs that have a hypersensitivity to robenacoxib or known intolerance to NSAIDs.
ONSIOR tablets are available as 10, 20 and 40 mg round flavored tablets in perforated blisters and are supplied in cards containing 6 tablets. Each carton holds 10 blister cards (60 tablets per carton). The appropriate number of tablets per patient is to be dispensed in an ONSIOR dispensing envelope containing an Information for Dog Owners Sheet.
New Animal Drug Application
ONSIOR- ROBENACOXIB TABLET ELANCO US INC. ---------- ONSIOR™ (ROBENACOXIB) 10 MG, 20 MG AND 40 MG TABLETS FOR DOGS FOR ORAL USE IN DOGS ONLY DO NOT USE IN CATS. Cats cannot be accurately dosed with the tablet sizes intended to be used in dogs. CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. DESCRIPTION: ONSIOR (robenacoxib) is a non-narcotic, non-steroidal anti-inflammatory drug (NSAID) of the coxib class. Tablets are round, beige to brown in color, not scored, flavored and contain robenacoxib. The molecular weight of robenacoxib is 327.28. The empirical formula is C -H - F -NO . Robenacoxib is [5-Ethyl-2-(2,3,5,6-tetrafluoro-phenylamino)- phenyl]-acetic acid. The structural formula is: INDICATION: ONSIOR tablets are indicated for the control of postoperative pain and inflammation associated with soft tissue surgery in dogs ≥ 5.5 lbs (2.5 kg) AND ≥ 4 months of age; for up to a MAXIMUM OF 3 DAYS. DOSAGE AND ADMINISTRATION: ALWAYS PROVIDE “INFORMATION FOR DOG OWNERS” SHEET WITH PRESCRIPTION. CAREFULLY CONSIDER THE POTENTIAL BENEFITS AND RISK OF ONSIOR TABLETS AND OTHER TREATMENT OPTIONS BEFORE DECIDING TO USE ONSIOR TABLETS. Use the lowest effective dose for the shortest duration consistent with individual response. The dose of ONSIOR tablets is 0.91 mg/lb (2 mg/kg) orally once daily, for a MAXIMUM OF 3 DAYS. (SEE WARNINGS, PRECAUTIONS AND ADVERSE REACTIONS). 16 13 4 2 DOSAGE DIRECTIONS: For oral use in dogs ≥ 5.5 lbs AND ≥ 4 months of age; for up to a MAXIMUM OF 3 DAYS. Tablets are not scored and should not be broken. The calculated dosage should be provided using a combination of whole tablet sizes. Do not use in dogs weighing less than 5.5 lbs (2.5 kg), as dogs less than 5.5 lbs (2.5 kg) cannot be accurately dosed. DO NOT USE IN CATS. CATS CANNOT BE ACCURATELY DOSED WITH THE TABLET SIZES INTENDED TO BE USED IN DOGS. The first dose should be administered approximately 45 minutes prior to surgery, at the same time as the pre-anesthetic agents are g Pročitajte cijeli dokument