APO-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

Beszerezhető a:

APOTEX INC

ATC-kód:

A02BC05

INN (nemzetközi neve):

ESOMEPRAZOLE

Adagolás:

40MG

Gyógyszerészeti forma:

TABLET (DELAYED-RELEASE)

Összetétel:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 40MG

Az alkalmazás módja:

ORAL

db csomag:

28/100/500

Recept típusa:

Prescription

Terápiás terület:

PROTON-PUMP INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-06-17

Termékjellemzők

_Pr_
_APO-ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets)_
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_Page 1 of 52_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ESOMEPRAZOLE
Esomeprazole Magnesium Delayed Release Tablets
Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole
magnesium amorphous)
,Oral use
H
+
, K
+
-ATPase Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Submission Control Number: 270101
Date of initial authorization:
JUN 17, 2010
Date of Revision:
DEC 20, 2022
_Pr_
_APO-ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets)_
_ _
_Page 2 of 52_
_ _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
12/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
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 (12 to 17 years of age)
.....................................................................................
4
2 CONTRAINDICATIONS
................................................................................................................
4
4 DOSAGE AND ADMINISTRATION
................................................................................................
5
4.1
Dosing Considerations
......................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................