TEVA-PANTOPRAZOLE MAGNESIUM TABLET (DELAYED-RELEASE)

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM)

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

A02BC02

INN (Међународно име):

PANTOPRAZOLE

Дозирање:

40MG

Фармацеутски облик:

TABLET (DELAYED-RELEASE)

Састав:

PANTOPRAZOLE (PANTOPRAZOLE MAGNESIUM) 40MG

Пут администрације:

ORAL

Јединице у пакету:

30/100

Тип рецептора:

Prescription

Терапеутска област:

PROTON-PUMP INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0133229001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-11-16

Карактеристике производа

_ _
TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium)
Page 1 of 55
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR TEVA-PANTOPRAZOLE MAGNESIUM
Pantoprazole Magnesium Enteric-Coated Tablets
Tablets, 40 mg pantoprazole (as pantoprazole magnesium), Oral
Proton Pump Inhibitor
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Date of Initial Authorization:
NOV 16, 2015
Date of Revision:
NOV 21, 2023
www.tevacanada.com
Submission Control Number: 277792
_ _
TEVA-PANTOPRAZOLE MAGNESIUM (pantoprazole magnesium)
_ _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
11/2023
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
1.2
Geriatrics
.................................................................................................................
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
..........................................................................