PROPAFENONE-150 TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

PROPAFENONE HYDROCHLORIDE

MAH:

PRO DOC LIMITEE

ATC_code:

C01BC03

INN:

PROPAFENONE

dosage:

150MG

pharmaceutical_form:

TABLET

composition:

PROPAFENONE HYDROCHLORIDE 150MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

CLASS IC ANTIARRYTHMICS

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2016-07-18

SPC

Page 1 of 38
PRODUCT MONOGRAPH
Pr
PROPAFENONE – 150
Pr
PROPAFENONE – 300
PROPAFENONE HYDROCHLORIDE TABLETS
FILM COATED
150 MG AND 300 MG
ANTIARRHYTHMIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
September 4, 2013
Laval, Québec
H7L 3W9
Control Number: 166802
Page 2 of 38
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
...................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
5
DRUG INTERACTIONS
.......................................................................................................
13
DOSAGE AND ADMINISTRATION
...................................................................................
16
OVERDOSAGE
......................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY..................................................................
17
STORAGE AND STABILITY
...............................................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 20
PART II: SCIENTIFIC INFORMATION
.............................................................................
21
PHARMACEUTICAL INFORMATION
...............................................................................
21
CLINICAL TRIALS
...............................................................................................................
21
DETAILE