AG-METFORMIN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

METFORMIN HYDROCHLORIDE

มีจำหน่ายจาก:

ANGITA PHARMA INC.

รหัส ATC:

A10BA02

INN (ชื่อสากล):

METFORMIN

ปริมาณ:

500MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

METFORMIN HYDROCHLORIDE 500MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

15G/50G

ประเภทใบสั่งยา:

Prescription

พื้นที่บำบัด:

BIGUANIDES

สรุปสินค้า:

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

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2019-12-02

สรุปลักษณะสินค้า

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