MYLAN-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

A02BC05

INN (International Name):

ESOMEPRAZOLE

Dosering :

20MG

Legemiddelform:

TABLET (DELAYED-RELEASE)

Sammensetning:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

PROTON-PUMP INHIBITORS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2020-06-16

Preparatomtale

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