PMS-ROSIGLITAZONE-METFORMIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE); METFORMIN HYDROCHLORIDE

Available from:

PHARMASCIENCE INC

ATC code:

A10BD03

INN (International Name):

METFORMIN AND ROSIGLITAZONE

Dosage:

2MG; 1000MG

Pharmaceutical form:

TABLET

Composition:

ROSIGLITAZONE (ROSIGLITAZONE MALEATE) 2MG; METFORMIN HYDROCHLORIDE 1000MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BIGUANIDES

Product summary:

Active ingredient group (AIG) number: 0248901004; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2017-08-03

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-ROSIGLITAZONE-METFORMIN
rosiglitazone maleate/metformin hydrochloride
1 mg/500 mg Tablets
1 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
2 mg/500 mg Tablets
2 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
4 mg/500 mg Tablets
4 mg rosiglitazone (as rosiglitazone maleate) and 500 mg metformin
hydrochloride
2 mg/1000 mg Tablets
2 mg rosiglitazone (as rosiglitazone maleate) and 1000 mg metformin
hydrochloride
4 mg/1000 mg Tablets
4 mg rosiglitazone (as rosiglitazone maleate) and 1000 mg metformin
hydrochloride
Antidiabetic Agent
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave. suite 100
July 12, 2013
Montreal, Canada
H4P 2T4
Submission Control No. 166029
_ _
_pms-ROSIGLITAZONE-METFORMIN Product Monograph _
_Page 2 of 56_
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
.................................................................................................
14
DRUG INTERACTIONS
.................................................................................................
19
DOSAGE AND ADMINISTRATION
.............................................................................
22
OVERDOSAGE
................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 24
STORAGE AND STABILITY
..........................................................................