AVANDARYL TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE); GLIMEPIRIDE

Available from:

GLAXOSMITHKLINE INC

ATC code:

A10BD04

INN (International Name):

GLIMEPIRIDE AND ROSIGLITAZONE

Dosage:

4MG; 1MG

Pharmaceutical form:

TABLET

Composition:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG; GLIMEPIRIDE 1MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SULFONYLUREAS

Product summary:

Active ingredient group (AIG) number: 0250381001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2011-08-29

Summary of Product characteristics

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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.
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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...