AG-METFORMIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

METFORMIN HYDROCHLORIDE

Sẵn có từ:

ANGITA PHARMA INC.

Mã ATC:

A10BA02

INN (Tên quốc tế):

METFORMIN

Liều dùng:

850MG

Dạng dược phẩm:

TABLET

Thành phần:

METFORMIN HYDROCHLORIDE 850MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Khu trị liệu:

BIGUANIDES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2019-12-02

Đặc tính sản phẩm

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