MYLAN-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

A02BC05

INN (Nama Internasional):

ESOMEPRAZOLE

Dosis:

20MG

Bentuk farmasi:

TABLET (DELAYED-RELEASE)

Komposisi:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

PROTON-PUMP INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2020-06-16

Karakteristik produk

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