AMIODARONE HYDROCHLORIDE INJECTION SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

AMIODARONE HYDROCHLORIDE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C01BD01

INN (Nama Internasional):

AMIODARONE

Dosis:

50MG

Bentuk farmasi:

SOLUTION

Komposisi:

AMIODARONE HYDROCHLORIDE 50MG

Rute administrasi :

INTRAVENOUS

Unit dalam paket:

10X3ML

Jenis Resep:

Prescription

Area terapi:

CLASS III ANTIARRYTHMICS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-07-06

Karakteristik produk

_Amiodarone Hydrochloride Injection _
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_Page 1 of 58_
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PRODUCT MONOGRAPH
PR AMIODARONE HYDROCHLORIDE INJECTION
(Amiodarone Sterile Concentrate, BP)
50 mg/mL
Antiarrhythmic Agent
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Submission Control No: 193735
Date of Revision: May 3, 2016
_Amiodarone Hydrochloride Injection _
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_Page 2 of 58_
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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
..............................................................................................................
14
DRUG INTERACTIONS
...............................................................................................................
17
DOSAGE AND ADMINISTRATION
...........................................................................................
21
OVERDOSAGE
.............................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
25
STORAGE AND STABILITY
......................................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 28
PART II: SCIENTIFIC INFORMATION
..............................................