AMIODARONE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMIODARONE HYDROCHLORIDE

Available from:

SIVEM PHARMACEUTICALS ULC

ATC code:

C01BD01

INN (International Name):

AMIODARONE

Dosage:

200MG

Pharmaceutical form:

TABLET

Composition:

AMIODARONE HYDROCHLORIDE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

CLASS III ANTIARRYTHMICS

Product summary:

Active ingredient group (AIG) number: 0118593001; AHFS:

Authorization status:

APPROVED

Authorization date:

2012-05-31

Summary of Product characteristics

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_Amiodarone _
_Page 1 of 65_
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PRODUCT MONOGRPAH
PR
AMIODARONE
Amiodarone Hydrochloride tablets, BP
200 mg
Antiarrhythmic Agent
SIVEM PHARMACEUTICALS ULC
Date of Revision:
4705 Dobrin Street
October 27, 2016
St. Laurent, Quebec
H4R 2P7
www.sivem.ca
Control number: 198891
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_Amiodarone _
_Page 2 of 65_
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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
.......................................................................................................................................
19
DRUG
INTERACTIONS........................................................................................................................................
23
DOSAGE
AND
ADMINISTRATION
....................................................................................................................
28
OVERDOSAGE
......................................................................................................................................................
30
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................................................
31
STORAGE
AND
STABILITY
................................................................................................................................
34
SPECIAL
HANDLING
INSTRUCTIONS
....................................