ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Предлага се от:

SANIS HEALTH INC

АТС код:

A02BC05

INN (Международно Name):

ESOMEPRAZOLE

дозиране:

40MG

Лекарствена форма:

TABLET (DELAYED-RELEASE)

Композиция:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 40MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

PROTON-PUMP INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2021-02-15

Данни за продукта

ESOMEPRAZOLE_ _
Page 1 of 46
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ESOMEPRAZOLE
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg, 40 mg, Oral use
H
+
, K
+
-ATPase Inhibitor
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
September 18, 2014
Date of Revision:
February 9, 2023
Submission Control No: 267215
_ _
ESOMEPRAZOLE_ _
Page 2 of 46
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
02-2023
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
02-2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
02-2023
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
....................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.4
Administration................................................................................................................
6
4.5 Missed Dose
.......................