RYTHMOL TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PROPAFENONE HYDROCHLORIDE

제공처:

BGP PHARMA ULC

ATC 코드:

C01BC03

INN (국제 이름):

PROPAFENONE

복용량:

300MG

약제 형태:

TABLET

구성:

PROPAFENONE HYDROCHLORIDE 300MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

CLASS IC ANTIARRYTHMICS

제품 요약:

Active ingredient group (AIG) number: 0116258002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-01-07

제품 특성 요약

_RYTHMOL_
_®_
_ propafenone hydrochloride _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
_ _
Pr
RYTHMOL®
propafenone hydrochloride
Film-coated tablets 150 mg and 300 mg, Oral
Antiarrhythmic Agent
ATC-Code: C01BC03
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
December 18, 2014
Date of Revision:
August 26, 2021
Submission Control Number: 251371
®(G.Petrik) Used under licence by BGP Pharma ULC, Etobicoke, Ontario,
M8Z 2S6
_ _
_RYTHMOL_
_®_
_ propafenone hydrochloride _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2020
7 WARNINGS AND PRECAUTIONS
06/2020
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...........................................