PROPAFENONE-150 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PROPAFENONE HYDROCHLORIDE

Διαθέσιμο από:

PRO DOC LIMITEE

Φαρμακολογική κατηγορία (ATC):

C01BC03

INN (Διεθνής Όνομα):

PROPAFENONE

Δοσολογία:

150MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PROPAFENONE HYDROCHLORIDE 150MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CLASS IC ANTIARRYTHMICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2016-07-18

Αρχείο Π.Χ.Π.

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