MYLAN-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Disponible desde:

MYLAN PHARMACEUTICALS ULC

Código ATC:

A02BC05

Designación común internacional (DCI):

ESOMEPRAZOLE

Dosis:

20MG

formulario farmacéutico:

TABLET (DELAYED-RELEASE)

Composición:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

PROTON-PUMP INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0145162001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-06-16

Ficha técnica

Page 1 of 58
PRODUCT MONOGRAPH
PR
MYLAN-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
20 mg and 40 mg esomeprazole (as esomeprazole magnesium trihydrate)
H
+
, K
+
-ATPase Inhibitor
Mylan Pharmaceuticals ULC
85 Advance Rd.
Etobicoke, Ontario Canada
M8Z 2S6
Control Number: 212758
Date of Revision: February 9, 2018
Page 2 of 58
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
....................................................................................................
9
DRUG
INTERACTIONS
..................................................................................................
17
DOSAGE
AND
ADMINISTRATION
................................................................................
20
OVERDOSAGE
..................................................................................................................
23
ACTION
AND
CLINICAL
PHARMACOLOGY
............................................................... 24
STORAGE
AND
STABILITY
..........................................................................................
28
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ................................................ 28
PART II: SCIENTIFIC INFORMATION .......................................................................
30
PHARMACEUTICAL
INFORMATION
.........................................................................
30
DETAILED
PHARMACOLOGY
.......................................................................................
38
TOXICOLOGY
.............................................