AG-METFORMIN TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

METFORMIN HYDROCHLORIDE

Beszerezhető a:

ANGITA PHARMA INC.

ATC-kód:

A10BA02

INN (nemzetközi neve):

METFORMIN

Adagolás:

500MG

Gyógyszerészeti forma:

TABLET

Összetétel:

METFORMIN HYDROCHLORIDE 500MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

BIGUANIDES

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2019-12-02

Termékjellemzők

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