APO-AMIODARONE TABLETS

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Boleh didapati daripada:

APOTEX INC

Kod ATC:

C01BD01

INN (Nama Antarabangsa):

AMIODARONE

Dos:

200MG

Borang farmaseutikal:

TABLET

Komposisi:

AMIODARONE HYDROCHLORIDE 200MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

CLASS III ANTIARRYTHMICS

Ringkasan produk:

Active ingredient group (AIG) number: 0118593001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2002-07-30

Ciri produk

Page 1 of 64
PRODUCT MONOGRAPH
APO-AMIODARONE
AMIODARONE TABLETS BP
200 MG AMIODARONE HYDROCHLORIDE
ANTIARRHYTHMIC AGENT
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
CANADA M9L 1T9
APRIL 6, 2017
CONTROL #204336
Page 2 of 64
TABLE OF CONTENTS
PART I:HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
.......................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
4
ADVERSE REACTIONS
......................................................................................................
19
DRUG INTERACTIONS
......................................................................................................
25
DOSAGE AND ADMINISTRATION
..................................................................................
30
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 33
STORAGE AND STABILITY
..............................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 37
PART II: SCIENTIFIC INFORMATION
..............................................................................
38
PHARMACEUTICAL INFORMATION
..............................................................................
38
CLINICAL TRIALS
..............................................................................................................
38
DETAILED PHARMACOLOGY
.................................................