PROPAFENONE-150 TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
04-09-2013
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有効成分:
PROPAFENONE HYDROCHLORIDE
から入手可能:
PRO DOC LIMITEE
ATCコード:
C01BC03
INN（国際名）:
PROPAFENONE
投薬量:
150MG
医薬品形態:
TABLET
構図:
PROPAFENONE HYDROCHLORIDE 150MG
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:
CLASS IC ANTIARRYTHMICS
製品概要:
Active ingredient group (AIG) number: 0116258001; AHFS:
認証ステータス:
CANCELLED POST MARKET
承認日:
2016-07-18
製品の特徴
Page 1 of 38
PRODUCT MONOGRAPH
Pr
PROPAFENONE – 150
Pr
PROPAFENONE – 300
PROPAFENONE HYDROCHLORIDE TABLETS
FILM COATED
150 MG AND 300 MG
ANTIARRHYTHMIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
September 4, 2013
Laval, Québec
H7L 3W9
Control Number: 166802
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
5
DRUG INTERACTIONS
.......................................................................................................
13
DOSAGE AND ADMINISTRATION
...................................................................................
16
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
17
STORAGE AND STABILITY
...............................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 20
PART II: SCIENTIFIC INFORMATION
.............................................................................
21
PHARMACEUTICAL INFORMATION
...............................................................................
21
CLINICAL TRIALS
...............................................................................................................
21
DETAILE
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