Страна: Канада
Език: английски
Източник: Health Canada
ROSIGLITAZONE (ROSIGLITAZONE MALEATE); GLIMEPIRIDE
GLAXOSMITHKLINE INC
A10BD04
GLIMEPIRIDE AND ROSIGLITAZONE
4MG; 1MG
TABLET
ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG; GLIMEPIRIDE 1MG
ORAL
100
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0250381001; AHFS:
CANCELLED POST MARKET
2011-08-29
_2011-03-01/131-pristine-english-avandaryl.doc _ _ _ _ _ _Page 1 of _ 58 PRODUCT MONOGRAPH Pr AVANDARYL ® rosiglitazone maleate and glimepiride 4 mg/1 mg Tablets 4 mg rosiglitazone (as rosiglitazone maleate) and 1 mg glimepiride 4 mg/2 mg Tablets 4 mg rosiglitazone (as rosiglitazone maleate) and 2 mg glimepiride 4 mg/4 mg Tablets 4 mg rosiglitazone (as rosiglitazone maleate) and 4 mg glimepiride Antidiabetic Agent GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Revision: MARCH 1, 2011 SUBMISSION CONTROL NO: 143643 © 2011 GlaxoSmithKline Inc., All Rights Reserved ® AVANDARYL, is a registered trademark, used under license by GlaxoSmithKline Inc. ® AVANDIA is a registered trademark, used under license by GlaxoSmithKline Inc. Amaryl ® is a registered trademark of the group sanofi-aventis. _2011-03-01/131-pristine-english-avandaryl.doc _ _ _ _ _ _Page 2 of _ 58 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS..................................................................................5 ADVERSE REACTIONS..................................................................................................13 DRUG INTERACTIONS ..................................................................................................20 DOSAGE AND ADMINISTRATION..............................................................................24 OVERDOSAGE ................................................................................................................26 ACTION AND CLINICAL PHARMACOLOGY ............................................................27 STORAGE AND STABILITY... Прочетете целия документ