MYLAN-AMIODARONE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
22-04-2016
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Aktiv bestanddel:
AMIODARONE HYDROCHLORIDE
Tilgængelig fra:
MYLAN PHARMACEUTICALS ULC
ATC-kode:
C01BD01
INN (International Name):
AMIODARONE
Dosering:
200MG
Lægemiddelform:
TABLET
Sammensætning:
AMIODARONE HYDROCHLORIDE 200MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
CLASS III ANTIARRYTHMICS
Produkt oversigt:
Active ingredient group (AIG) number: 0118593001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2018-07-12
Produktets egenskaber
PAGE 1 OF 64
PRODUCT MONOGRAPH
PR
MYLAN-AMIODARONE
(Amiodarone Hydrochloride Tablets, BP)
200 MG
Antiarrhythmic Agent
Mylan Pharmaceuticals ULC
Date of revision:
85 Advance Road
April 14, 2016
Etobicoke, Ontario
M8Z 2S6
Control number: 193651
PAGE 2 OF 64
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
5
ADVERSE
REACTIONS
.........................................................................................................
20
DRUG
INTERACTIONS
.........................................................................................................
23
DOSAGE
AND
ADMINISTRATION
.....................................................................................
29
OVERDOSAGE
.......................................................................................................................
31
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
32
STORAGE
AND
STABILITY
...............................................................................................
36
SPECIAL
HANDLING
INSTRUCTIONS
...........................................................................
36
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
................................................ 36
PART II: SCIENTIFIC INFORMATION
..............................................................................
37
PHARMACEUTICAL
INFORMATION
.................................................................................
37
CLINICAL
TRIALS
...............................
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