PMS-PROPAFENONE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PROPAFENONE HYDROCHLORIDE

Διαθέσιμο από:

PHARMASCIENCE INC

Φαρμακολογική κατηγορία (ATC):

C01BC03

INN (Διεθνής Όνομα):

PROPAFENONE

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PROPAFENONE HYDROCHLORIDE 300MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CLASS IC ANTIARRYTHMICS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2017-05-24

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR
PMS-PROPAFENONE
Propafenone hydrochloride
150 mg and 300 mg Film Coated Tablets
Professed Standard
ANTIARRHYTHMIC AGENT
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, CANADA
H4P 2T4
DATE OF REVISION:
OCTOBER 5, 2016
CONTROL NO. 198300
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_Page 2_
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
.................................................................