AG-METFORMIN TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

METFORMIN HYDROCHLORIDE

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

A10BA02

INN (שם בינלאומי):

METFORMIN

כמות:

850MG

טופס פרצבטיות:

TABLET

הרכב:

METFORMIN HYDROCHLORIDE 850MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

BIGUANIDES

leaflet_short:

Active ingredient group (AIG) number: 0101773002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2019-12-02

מאפייני מוצר

Page 1 of 40
Product
Monograph of
AG-Metformin
PRODUCT MONOGRAPH
Pr
AG-METFORMIN
MetforminHydrochloride Tablets, USP
500 mg, 850mg
Oral Antihyperglycemic Agent
Submission Control No.:
232222
J4B 5H3
Boucherville
,
Qu
e
bec
1310 rue Nobel
Angita Pharma Inc.
November 2
8
,2019
Date of
Revision
:
Page 2 of 40
Product
Monograph of
AG-Metformin
Table of Contents
PART I: HEALTH PROFESSIONAL IN FORMATION
......................................................... 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
PAR T II: SCIENTIFIC
INFORMATION....................................................................................23
PHARMACEUTICAL INFORMATION
.................................................................................
23
CLINICAL TRIALS
...............................