APO-GLIMEPIRIDE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
17-10-2018
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有効成分:
GLIMEPIRIDE
から入手可能:
APOTEX INC
ATCコード:
A10BB12
INN（国際名）:
GLIMEPIRIDE
投薬量:
4MG
医薬品形態:
TABLET
構図:
GLIMEPIRIDE 4MG
投与経路:
ORAL
パッケージ内のユニット:
100
処方タイプ:
Prescription
治療領域:
SULFONYLUREAS
製品概要:
Active ingredient group (AIG) number: 0146247003; AHFS:
認証ステータス:
APPROVED
承認日:
2007-05-16
製品の特徴
Page 1 of 51
PRODUCT MONOGRAPH
PR
APO-GLIMEPIRIDE
GLIMEPIRIDE TABLETS USP
1 MG, 2 MG AND 4 MG
ORAL HYPOGLYCEMIC (SULFONYLUREA)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
CANADA M9L 1T9
_ _
_ _
SUBMISSION CONTROL NO.: 219952
Page 2 of 51
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
.........................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
...................................................................................
15
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 17
STORAGE AND STABILITY
...............................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 21
PART II: SCIENTIFIC INFORMATION
..............................................................................
23
PHARMACEUTICAL INFORMATION
...............................................................................
23
CLINICAL TRIALS
...............................................................................................................
25
DETAILED PHARMACOLOGY
..
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