AMIODARONE OMEGA SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

AMIODARONE HYDROCHLORIDE

Verfügbar ab:

OMEGA LABORATORIES LIMITED

ATC-Code:

C01BD01

INN (Internationale Bezeichnung):

AMIODARONE

Dosierung:

50MG

Darreichungsform:

SOLUTION

Zusammensetzung:

AMIODARONE HYDROCHLORIDE 50MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

CLASS III ANTIARRYTHMICS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2004-04-05

Fachinformation

_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