TEVA-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

A02BC05

INN (Jina la Kimataifa):

ESOMEPRAZOLE

Kipimo:

40MG

Dawa fomu:

TABLET (DELAYED-RELEASE)

Tungo:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

PROTON-PUMP INHIBITORS

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-09-08

Tabia za bidhaa

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
...