APO-PROPAFENONE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PROPAFENONE HYDROCHLORIDE

제공처:

APOTEX INC

ATC 코드:

C01BC03

INN (국제 이름):

PROPAFENONE

복용량:

300MG

약제 형태:

TABLET

구성:

PROPAFENONE HYDROCHLORIDE 300MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

치료 영역:

CLASS IC ANTIARRYTHMICS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2001-02-08

제품 특성 요약

_APO-PROPAFENONE (Propafenone hydrochloride) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PROPAFENONE
Propafenone Hydrochloride Tablets
Film-coated tablets, 150 mg and 300 mg, Oral
Apotex Standard
Antiarrhythmic Agent
ATC-Code: C01BC03
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
FEB 08, 2001
Date of Revision:
APR 03, 2023
Submission Control Number: 269487
_APO-PROPAFENONE (Propafenone hydrochloride) _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
NA
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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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
...............................................................