PROPAFENONE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PROPAFENONE HYDROCHLORIDE

제공처:

SANIS HEALTH INC

ATC 코드:

C01BC03

INN (국제 이름):

PROPAFENONE

복용량:

150MG

약제 형태:

TABLET

구성:

PROPAFENONE HYDROCHLORIDE 150MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

CLASS IC ANTIARRYTHMICS

제품 요약:

Active ingredient group (AIG) number: 0116258001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2010-02-08

제품 특성 요약

_ _
_PROPAFENONE propafenone hydrochloride Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
PR
PROPAFENONE
Propafenone Hydrochloride Tablets
Film-coated tablets, 150 mg and 300 mg, Oral
Antiarrhythmic Agent
ATC-Code: C01BC03
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
April 18, 2017
Date of Revision:
June 08, 2022
Submission Control Number: 264304
_ _
_PROPAFENONE propafenone hydrochloride _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2022
7 WARNINGS AND PRECAUTIONS
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
.........................