AMIODARONE OMEGA SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
04-06-2018
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Active ingredient:
AMIODARONE HYDROCHLORIDE
Available from:
OMEGA LABORATORIES LIMITED
ATC code:
C01BD01
INN (International Name):
AMIODARONE
Dosage:
50MG
Pharmaceutical form:
SOLUTION
Composition:
AMIODARONE HYDROCHLORIDE 50MG
Administration route:
INTRAVENOUS
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
CLASS III ANTIARRYTHMICS
Product summary:
Active ingredient group (AIG) number: 0118593002; AHFS:
Authorization status:
APPROVED
Authorization date:
2004-04-05
Summary of Product characteristics
_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
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