APO-DEXLANSOPRAZOLE CAPSULE (DELAYED RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DEXLANSOPRAZOLE

זמין מ:

APOTEX INC

קוד ATC:

A02BC06

INN (שם בינלאומי):

DEXLANSOPRAZOLE

כמות:

30MG

טופס פרצבטיות:

CAPSULE (DELAYED RELEASE)

הרכב:

DEXLANSOPRAZOLE 30MG

מסלול נתינה (של תרופות):

NASOGASTRIC

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0152766001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2024-01-25

מאפייני מוצר

_APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules)_
_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DEXLANSOPRAZOLE
Dexlansoprazole Delayed-Release Capsules
Capsule (delayed release), 30 mg and 60 mg, Nasogastric and Oral
Proton Pump Inhibitor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control Number: 268660
Date of Initial Authorization:
JUL 12, 2022
Date of Revision:
JUN 07, 2023
_APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules)_
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
06/2023
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
......................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................ 5
4.4
Administration
......................................................