MAR-ACARBOSE TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
12-11-2019
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有効成分:
ACARBOSE
から入手可能:
MARCAN PHARMACEUTICALS INC
ATCコード:
A10BF01
INN（国際名）:
ACARBOSE
投薬量:
50MG
医薬品形態:
TABLET
構図:
ACARBOSE 50MG
投与経路:
ORAL
パッケージ内のユニット:
15G/50G
処方タイプ:
Prescription
治療領域:
ALPHA-GLUCOSIDASE INHIBITORS
製品概要:
Active ingredient group (AIG) number: 0123099002; AHFS:
認証ステータス:
APPROVED
承認日:
2019-11-14
製品の特徴
Page 1 of 27
MAR-ACARBOSE
PRODUCT MONOGRAPH
PR
MAR-ACARBOSE
Acarbose Tablets
50 and 100 mg
Oral Antidiabetic Agent
Alpha-glucosidase Inhibitor Marcan Pharmaceuticals Inc.
Date of Preparation:
2 Gurdwara Road, Suite #112,
November 12, 2019
Ottawa, ON, K2E 1A2
Control Number: 217547
Page 2 of 27
MAR-ACARBOSE
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....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
8
DOSAGE AND ADMINISTRATION
...................................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
.................................................................. 10
STORAGE AND STABILITY
............................................................................................
12
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 12
PART II: SCIENTIFIC INFORMATION
........................................................................................
14
PHARMACEUTICAL INFORMATION
..............................................................................
14
CLINICAL TRIALS
...........................................................................................................
15
DETA
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