AMARYL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

GLIMEPIRIDE

から入手可能:

SANOFI-AVENTIS CANADA INC

ATCコード:

A10BB12

INN（国際名）:

GLIMEPIRIDE

投薬量:

1MG

医薬品形態:

TABLET

構図:

GLIMEPIRIDE 1MG

投与経路:

ORAL

パッケージ内のユニット:

30

処方タイプ:

Prescription

治療領域:

SULFONYLUREAS

製品概要:

Active ingredient group (AIG) number: 0146247001; AHFS:

認証ステータス:

CANCELLED POST MARKET

承認日:

2018-07-31

製品の特徴

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_Page 1 of 49_
PRODUCT MONOGRAPH
Pr
AMARYL
®
glimepiride
Tablets 1, 2 and 4 mg
Manufacturer’s standard
Oral Hypoglycemic (Sulfonylurea)
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Revision:
December 29, 2016
Submission Control No.: 198596
s-a Version 5.0 dated December 23, 2016
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_Page 2 of 49_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
.................................................................... 3
INDICATIONS AND CLINICAL USE
..........................................................................
3
CONTRAINDICATIONS
...............................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
4
ADVERSE REACTIONS
................................................................................................
9
DRUG INTERACTIONS
..............................................................................................
12
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
.............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 18
STORAGE AND STABILITY
......................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 22
PART II: SCIENTIFIC INFORMATION
.................................................................................
23
PHARMACEUTICAL INFORMATION
......................................................................
23
CLINICAL TRIALS
......................................................................................................
24
DETAILED PHARMACOLOGY
...................................