PRZ-METFORMIN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

METFORMIN HYDROCHLORIDE

Saadav alates:

PHARMARIS CANADA INC

ATC kood:

A10BA02

INN (Rahvusvaheline Nimetus):

METFORMIN

Annus:

500MG

Ravimvorm:

TABLET

Koostis:

METFORMIN HYDROCHLORIDE 500MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2022-10-12

Toote omadused

Page 1 of 39
PRODUCT MONOGRAPH
Pr
PRZ-METFORMIN
Metformin
Hydrochloride Tablets
BP standard
500 mg, 850 mg
Oral Antihyperglycemic Agent
Pharmaris Canada Inc.
8310 130
th
Street, Unit 102
Surrey, British Columbia
V3W 8J9
Date of Preparation:
October 12, 2022
Submission
Control No.: 247781
Page 2 of 39
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
....................................................................................................
15
DOSAGE AND ADMINISTRATION
.................................................................................
18
OVERDOSAGE
.................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 21
STORAGE AND STABILITY
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................... 22
PART II: SCIENTIFIC
INFORMATION...........................................................................
23
PHARMACEUTICAL INFORMATION
.............................................................................
23
CLINICAL TRIALS
...........................................................................................................
24
DETAILED
PHARMACOLOGY..................