PROPAFENONE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

PROPAFENONE HYDROCHLORIDE

Fáanlegur frá:

SANIS HEALTH INC

ATC númer:

C01BC03

INN (Alþjóðlegt nafn):

PROPAFENONE

Skammtar:

300MG

Lyfjaform:

TABLET

Samsetning:

PROPAFENONE HYDROCHLORIDE 300MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

CLASS IC ANTIARRYTHMICS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2010-02-08

Vara einkenni

_ _
_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
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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
.........................