GLUCOBAY TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ACARBOSE

Disponible des:

BAYER INC

Codi ATC:

A10BF01

Designació comuna internacional (DCI):

ACARBOSE

Dosis:

100MG

formulario farmacéutico:

TABLET

Composición:

ACARBOSE 100MG

Vía de administración:

ORAL

Unidades en paquete:

120

tipo de receta:

Prescription

Área terapéutica:

ALPHA-GLUCOSIDASE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0123099001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2023-07-10

Fitxa tècnica

_ _
_GLUCOBAY Product Monograph_
_Page 1 of 28 _
PRODUCT MONOGRAPH
PR
GLUCOBAY™
acarbose
50 and 100 mg tablets
Oral Antidiabetic Agent
Alpha-glucosidase Inhibitor
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
www.bayer.ca
Date of Revision: June 10, 2010
Submission Control No: 137275
©
2010, Bayer Inc.
™ GLUCOBAY is a registered trademark of Bayer AG, used under license
by Bayer Inc.
_ _
_GLUCOBAY Product Monograph_
_Page 2 of 28 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND
STABILITY..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL
INFORMATION..........................................................................14
CLINICAL
TRIALS......................................