PMS-ESOMEPRAZOLE DR CAPSULE (DELAYED RELEASE)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Disponibil de la:

PHARMASCIENCE INC

Codul ATC:

A02BC05

INN (nume internaţional):

ESOMEPRAZOLE

Dozare:

40MG

Forma farmaceutică:

CAPSULE (DELAYED RELEASE)

Compoziție:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Calea de administrare:

ORAL

Unități în pachet:

30/100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PROTON-PUMP INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-05-26

Caracteristicilor produsului

_pms-ESOMEPRAZOLE DR Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-ESOMEPRAZOLE DR
Esomeprazole Magnesium Delayed Release Capsules
Delayed-Release Capsules, 20 mg, 40 mg esomeprazole (as esomeprazole
magnesium
dihydrate), Oral
H
+
, K
+
-ATPase Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Submission Control Number: 258544
Date of Initial Authorization:
MAY 26, 2014
Date of Revision:
MAR 16, 2022
_pms-ESOMEPRAZOLE DR Product Monograph _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
03/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
03/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
03/2022
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
.......................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment.......................................................... 5
4.4
Administration..................................................................