APO-DEXLANSOPRAZOLE CAPSULE (DELAYED RELEASE)

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

DEXLANSOPRAZOLE

可用日期:

APOTEX INC

ATC代码:

A02BC06

INN（国际名称）:

DEXLANSOPRAZOLE

剂量:

60MG

药物剂型:

CAPSULE (DELAYED RELEASE)

组成:

DEXLANSOPRAZOLE 60MG

给药途径:

NASOGASTRIC

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0152766002; AHFS:

授权状态:

APPROVED

授权日期:

2024-01-25

产品特点

_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
......................................................