TARO-ESOMEPRAZOLE TABLET (DELAYED-RELEASE)

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)

Beszerezhető a:

SUN PHARMA CANADA 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:

10/30

Recept típusa:

Prescription

Terápiás terület:

PROTON-PUMP INHIBITORS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2022-03-07

Termékjellemzők

_Pr_
_TARO-ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets)
Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-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
Sun Pharma Canada Inc.,
126 East Drive
Brampton, ON, Canada
L6T 1C1
Date of Initial Authorization:
May 29, 2014
Date of Revision:
March 1, 2022
Submission Control No. 257429
_Pr_
_TARO-ESOMEPRAZOLE (Esomeprazole Magnesium Delayed Release Tablets)
Product Monograph _
_Page 2 of 50_
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
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
.................................................................................