Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
BEXAGLIFLOZIN (UNII: EY00JF42FV) (BEXAGLIFLOZIN - UNII:EY00JF42FV)
Elanco US Inc.
ORAL
PRESCRIPTION
Bexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a characteristic odor. The empirical formula is C24H29ClO7 and the molecular weight is 464.94 g/mol. The chemical name is (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-(2-cyclopropoxyethoxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol. The chemical structure of bexagliflozin is:
Flavored tablet each containing 15 mg bexagliflozin; 30 or 90 tablets per bottle. Approved by FDA under NADA # 141-566 Manufactured for: Elanco US Inc, Greenfield, IN 46140 Bexacat, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates September 2022 PA103742
New Animal Drug Application
BEXACAT- BEXAGLIFLOZIN TABLETS TABLET ELANCO US INC. ---------- _ELANCO_ BEXACAT (BEXAGLIFLOZIN TABLETS) 15 mg flavored tablets For oral use in cats only Sodium-glucose cotransporter 2 (SGLT2) inhibitor CAUTION Federal law restricts this drug to use by or on the order of a licensed veterinarian. WARNING: DIABETIC KETOACIDOSIS/EUGLYCEMIC DIABETIC KETOACIDOSIS - - - DESCRIPTION Bexacat (bexagliflozin tablets) are flavored pentagonal, 10 mm, speckled white, brown, or tan biconvex with a characteristic odor. The empirical formula is C24H29ClO7 and the molecular weight is 464.94 g/mol. The chemical name is (2S,3R,4R,5S,6R)-2-(4-chloro-3- (4-(2-cyclopropoxyethoxy)benzyl)phenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5- triol. The chemical structure of bexagliflozin is: TM TM CATS TREATED WITH BEXACAT MAY BE AT AN INCREASED RISK OF DIABETIC KETOACIDOSIS OR EUGLYCEMIC DIABETIC KETOACIDOSIS (SEE ADVERSE REACTIONS). AS DIABETIC KETOACIDOSIS AND EUGLYCEMIC DIABETIC KETOACIDOSIS IN CATS TREATED WITH BEXACAT MAY RESULT IN DEATH, DEVELOPMENT OF THESE CONDITIONS SHOULD BE TREATED PROMPTLY, INCLUDING INSULIN ADMINISTRATION AND DISCONTINUATION OF BEXACAT (SEE MONITORING). DUE TO THE RISK OF DEVELOPING DIABETIC KETOACIDOSIS OR EUGLYCEMIC DIABETIC KETOACIDOSIS, DO NOT USE BEXACAT IN CATS WITH DIABETES MELLITUS WHO HAVE PREVIOUSLY BEEN TREATED WITH INSULIN, WHO ARE RECEIVING INSULIN, OR IN CATS WITH INSULIN-DEPENDENT DIABETES MELLITUS (SEE CONTRAINDICATIONS). BEXACAT SHOULD NOT BE INITIATED IN CATS WITH ANOREXIA, DEHYDRATION OR LETHARGY AT THE TIME OF DIAGNOSIS OF DIABETES MELLITUS OR WITHOUT APPROPRIATE SCREENING TESTS (SEE ANIMAL SAFETY WARNINGS). INDICATION Bexacat is indicated to improve glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin. DOSAGE AND ADMINISTRATION Always provide the Client Information Sheet with the prescription. DOSING INSTRUCTIONS Administer one tablet by mouth to cats weighing 6.6 lbs (3.0 kg) or greater once daily, at approximately the same time each day, Preberite celoten dokument