DOM-AMIODARONE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Boleh didapati daripada:

DOMINION PHARMACAL

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

PRODUCT MONOGRAPH
Pr
DOM-AMIODARONE
Amiodarone Tablets, BP
100 mg & 200 mg amiodarone hydrochloride
Antiarrhythmic Agent
DOMINION PHARMACAL
DATE OF REVISION:
6111 Royalmount Ave, Suite #100
April 25, 2013
Montreal, Quebec
H4P 2T4
Control No. : 163812
_Dom-AMIODARONE Product Monograph _
_Page 2 of 71 _
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
.........................................................................................................
18
DRUG INTERACTIONS
.......................................................................................................
22
DOSAGE AND ADMINISTRATION
..................................................................................
27
OVERDOSAGE
......................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 30
STORAGE AND
STABILITY...............................................................................................
34
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 34
PART II: SCIENTIFIC INFORMATION
................................................................................36
PHARMACEUTICAL INFORMATION
.................................................................................
36
CLINICAL TR