PROPAFENONE-150 TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PROPAFENONE HYDROCHLORIDE

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

C01BC03

INN (International Adı):

PROPAFENONE

Doz:

150MG

Farmasötik formu:

TABLET

Kompozisyon:

PROPAFENONE HYDROCHLORIDE 150MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

CLASS IC ANTIARRYTHMICS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-07-18

Ürün özellikleri

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