AVANDARYL TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE); GLIMEPIRIDE

Disponible des:

GLAXOSMITHKLINE INC

Codi ATC:

A10BD04

Designació comuna internacional (DCI):

GLIMEPIRIDE AND ROSIGLITAZONE

Dosis:

4MG; 2MG

formulario farmacéutico:

TABLET

Composición:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 4MG; GLIMEPIRIDE 2MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

SULFONYLUREAS

Resumen del producto:

Active ingredient group (AIG) number: 0250381002; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2011-07-31

Fitxa tècnica

_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...