MYLAN-AMIODARONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

AMIODARONE HYDROCHLORIDE

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

C01BD01

Designación común internacional (DCI):

AMIODARONE

Dosis:

200MG

formulario farmacéutico:

TABLET

Composición:

AMIODARONE HYDROCHLORIDE 200MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

CLASS III ANTIARRYTHMICS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2018-07-12

Ficha técnica

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
...............................