AMIODARONE OMEGA SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Tersedia dari:

OMEGA LABORATORIES LIMITED

Kode ATC:

C01BD01

INN (Nama Internasional):

AMIODARONE

Dosis:

50MG

Bentuk farmasi:

SOLUTION

Komposisi:

AMIODARONE HYDROCHLORIDE 50MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

CLASS III ANTIARRYTHMICS

Ringkasan produk:

Active ingredient group (AIG) number: 0118593002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2004-04-05

Karakteristik produk

_Amiodarone Omega _
_Page 1 of 59 _
PRODUCT MONOGRAPH PR
AMIODARONE OMEGA
Amiodarone hydrochloride for injection
House Standard
Vials: 50 mg/mL
Antiarrhythmic Agent
Omega Laboratories Limited.
Date of Revision: June 4, 2018
11 177 Hamon
Montreal, Quebec
H3M 3E4
Control Number: 213232
_Amiodarone Omega _
_Page 2 of 59 _
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
.......................................................................................................................
15
DRUG INTERACTIONS
.......................................................................................................................
18
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
27
STORAGE AND STABILITY
...............................................................................................................
30
SPECIAL HANDLING INSTRUCTIONS
.............................................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 30
PART II: SCIENT