AG-METFORMIN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

METFORMIN HYDROCHLORIDE

Saadav alates:

ANGITA PHARMA 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

Terapeutiline ala:

BIGUANIDES

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2019-12-02

Toote omadused

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
...............................