ACH-METFORMIN TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

METFORMIN HYDROCHLORIDE

MAH:

ACCORD HEALTHCARE INC

ATC_code:

A10BA02

INN:

METFORMIN

dosage:

500MG

pharmaceutical_form:

TABLET

composition:

METFORMIN HYDROCHLORIDE 500MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

BIGUANIDES

leaflet_short:

Active ingredient group (AIG) number: 0101773001; AHFS:

authorization_status:

APPROVED

authorization_date:

2021-03-01

SPC

PRODUCT MONOGRAPH
PR
ACH-METFORMIN
Metformin Hydrochloride Tablets, Mfr Std
500 mg and 850 mg tablets
Oral Antihyperglycemic Agent
Accord Healthcare Inc.
3535 Boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
DATE OF REVISION:
FEBRUARY 23, 2021
SUBMISSION CONTROL NO.: 244440
_Page 2 of 37_
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
.........................................................................................................
12
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
19
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL
INFORMATION..................................................................................
21
CLINICAL TRIALS
........................................................................................