PMSC-ESOMEPRAZOLE DR TABLET (DELAYED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)

Предлага се от:

PHARMASCIENCE 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

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2022-06-28

Данни за продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMSC-ESOMEPRAZOLE DR
Esomeprazole Delayed Release Tablets
Delayed release tablets, 20 mg, 40 mg, Oral use
H
+
, K
+
-ATPase Inhibitor
Submission Control No.: 254119
PHARMASCIENCE INC
6111 Royalmount Ave., Suite 100
Montréal,
Quebec
Canada
H4P 2T4
Date
of
Initial
Authorization:
June 28, 2022
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General
06-2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
06-2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
06-2022
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
..................................................................................