AMIODARONE HYDROCHLORIDE FOR INJECTION SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMIODARONE HYDROCHLORIDE

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

C01BD01

INN (International Name):

AMIODARONE

Dosering:

50MG

Lægemiddelform:

SOLUTION

Sammensætning:

AMIODARONE HYDROCHLORIDE 50MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

3/6/9/18ML

Recept type:

Prescription

Terapeutisk område:

CLASS III ANTIARRYTHMICS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2005-08-08

Produktets egenskaber

_Amiodarone Hydrochloride for Injection Page 1 of 58 _
PRODUCT MONOGRAPH
PR
AMIODARONE HYDROCHLORIDE FOR INJECTION
Amiodarone hydrochloride for injection
Vials: 50 mg/mL
Antiarrhythmic Agent
Date of Preparation: September 30, 2011
Sandoz Canada Inc.
Date of Revision: November 20, 2023
110, De Lauzon Street
Boucherville, QC, Canada
J4B 1E6
Control Number: 277176
_Amiodarone Hydrochloride for Injection Page 2 of 58 _
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
.......................................................................................................................
17
DOSAGE AND ADMINISTRATION
...................................................................................................
22
OVERDOSAGE
.....................................................................................................................................
26
ACTION AND CLINICAL
PHARMACOLOGY..................................................................................
26
STORAGE AND STABILITY
...............................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
............................................................................................
30
DOSAGE FORMS, COMPOSITION AND