APO-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

זמין מ:

APOTEX INC

קוד ATC:

A02BC02

INN (שם בינלאומי):

PANTOPRAZOLE

כמות:

40MG

טופס פרצבטיות:

TABLET (DELAYED-RELEASE)

הרכב:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

PROTON-PUMP INHIBITORS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2008-03-05

מאפייני מוצר

_APO-PANTOPRAZOLE (pantoprazole sodium) _
_ _
_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablets, 20 mg and 40 mg pantoprazole (as pantoprazole
sodium), Oral
USP
Proton Pump Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario M9L 1T9
Date of Initial Authorization:
March 5, 2008
Date of Revision:
November 8, 2023
Submission Control Number: 273811
_APO-PANTOPRAZOLE (pantoprazole sodium) _
_ _
_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
06/2023
7 WARNINGS AND PRECAUTIONS,
Immune
06/2023
7 WARNINGS AND PRECAUTIONS, Skin
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
..................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
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