MYL-PROPAFENONE TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

PROPAFENONE HYDROCHLORIDE

Saadav alates:

MYLAN PHARMACEUTICALS ULC

ATC kood:

C01BC03

INN (Rahvusvaheline Nimetus):

PROPAFENONE

Annus:

300MG

Ravimvorm:

TABLET

Koostis:

PROPAFENONE HYDROCHLORIDE 300MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

CLASS IC ANTIARRYTHMICS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2018-02-27

Toote omadused

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PRODUCT MONOGRAPH
PR
MYL-PROPAFENONE
Propafenone hydrochloride
150 mg and 300 mg Film Coated Tablets
Professed Standard
ANTIARRHYTHMIC AGENT
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Control No.: 196359
DATE OF REVISION:
August 11, 2016
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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
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
...............................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
23
DETAILED PHARMACOLOGY
........................................................