TEVA-AMIODARONE TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

AMIODARONE HYDROCHLORIDE

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

C01BD01

INN (International Name):

AMIODARONE

Dosering:

200MG

Lægemiddelform:

TABLET

Sammensætning:

AMIODARONE HYDROCHLORIDE 200MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100/500/1000

Recept type:

Prescription

Terapeutisk område:

CLASS III ANTIARRYTHMICS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2010-06-01

Produktets egenskaber

1
PRODUCT MONOGRAPH
PR
TEVA-AMIODARONE
Amiodarone Hydrochloride Tablets
200 mg amiodarone hydrochloride
Teva Standard
ANTIARRHYTHMIC AGENT
Teva Canada Limited
Date of Revision:
30 Novopharm Court
December 6, 2021
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control Number: 252202
2
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
.................................................................................34
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING .........................................................35
PART II: SCIENTIFIC INFORMATION
................................................................................
36
PHARMACEUTICAL
INFORMATION
...........................................................................