AMIODARONE FOR INJECTION 50MG/ML SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

C01BD01

INN (Nama Internasional):

AMIODARONE

Dosis:

50MG

Bentuk farmasi:

SOLUTION

Komposisi:

AMIODARONE HYDROCHLORIDE 50MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

3ML/18ML

Jenis Resep:

Prescription

Area terapi:

CLASS III ANTIARRYTHMICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-02-23

Karakteristik produk

1
PRODUCT MONOGRAPH
PR
TEVA-AMIODARONE
Amiodarone Hydrochloride Tablets
200 mg amiodarone hydrochloride
PR
AMIODARONE FOR INJECTION
Amiodarone Hydrochloride for Injection
50 mg/mL amiodarone hydrochloride
Teva Standard
ANTIARRHYTHMIC AGENT
Teva Canada Limited
Date of Revision:
30 Novopharm Court
May 9, 2016
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Control Number: 194101
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
...............................................................................................................
20
DRUG INTERACTIONS
................................................................................................................
25
DOSAGE AND ADMINISTRATION
............................................................................................
31
OVERDOSAGE
..............................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
36
STORAGE AND STABILITY
.......................................................................................................
40
SPECIAL HANDLING INSTRUCTIONS
.....................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................... 41
PART II: SCIENTIFIC INFORMATION
....................