PRO-AMIODARONE - 200 TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-09-2017
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Active ingredient:
AMIODARONE HYDROCHLORIDE
Available from:
PRO DOC LIMITEE
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:
2008-05-21
Summary of Product characteristics
Page 1 of 65
PRODUCT MONOGRAPH
PRO-AMIODARONE - 200
AMIODARONE TABLETS BP
200 MG AMIODARONE HYDROCHLORIDE
ANTIARRHYTHMIC AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, boul. Industriel
September 15, 2017
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NO: 209239
Page 2 of 65
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
......................................................................................................
25
DOSAGE AND ADMINISTRATION
..................................................................................
30
OVERDOSAGE
....................................................................................................................
32
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 33
STORAGE AND STABILITY
..............................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 37
PART II: SCIENTIFIC INFORMATION
..............................................................................
38
PHARMACEUTICAL INFORMATION
..............................................................................
38
CLINICAL TRIALS
..............................................................................................................
38
DETAILED PHARMACOLOGY
..........................
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