TEVA-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

A02BC05

INN (Διεθνής Όνομα):

ESOMEPRAZOLE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET (DELAYED-RELEASE)

Σύνθεση:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

PROTON-PUMP INHIBITORS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2017-09-08

Αρχείο Π.Χ.Π.

Teva-Esomeprazole_ _
Page 1 of 46
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg, 40 mg, Oral use
H
+
, K
+
-ATPase Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, ON
Canada, M1B 2K9
www.tevacanada.com
Date of Initial Authorization:
June 19, 2015
Date of Revision:
May 20, 2022
Submission Control No: 259159
_ _
Teva-Esomeprazole_ _
Page 2 of 46
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
05-2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
05-2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
05-2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS
.....................................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................................
4
1 INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics
.......................................................................................................................
4
2
CONTRAINDICATIONS............................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
4
4.1 Dosing Considerations
....................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.4
Administration................................................................................................................
6
4.5 Missed Dose
...