ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)

Boleh didapati daripada:

TEVA CANADA LIMITED

Kod ATC:

A02BC05

INN (Nama Antarabangsa):

ESOMEPRAZOLE

Dos:

40MG

Borang farmaseutikal:

TABLET (DELAYED-RELEASE)

Komposisi:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PROTON-PUMP INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0145162002; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2017-10-31

Ciri produk

PRODUCT MONOGRAPH
Pr
ESOMEPRAZOLE
esomeprazole delayed release tablets
20 and 40 mg esomeprazole (as esomeprazole magnesium trihydrate)
H
+
, K
+
-ATPase Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 195240
Date of Preparation:
June 23, 2016
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
......................................................................................................
8
DRUG INTERACTIONS
....................................................................................................
15
DOSAGE AND ADMINISTRATION
................................................................................
18
OVERDOSAGE
..................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
26
PHARMACEUTICAL INFORMATION
............................................................................
26
CLINICAL TRIALS
............................................................................................................
27
DETAILED PHARMACOLOGY
....................