국가: 캐나다
언어: 영어
출처: Health Canada
PROPAFENONE HYDROCHLORIDE
BGP PHARMA ULC
C01BC03
PROPAFENONE
150MG
TABLET
PROPAFENONE HYDROCHLORIDE 150MG
ORAL
100
Prescription
CLASS IC ANTIARRYTHMICS
Active ingredient group (AIG) number: 0116258001; AHFS:
APPROVED
2015-01-07
_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........................................... 전체 문서 읽기