APO-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Mevcut itibaren:

APOTEX INC

ATC kodu:

A02BC02

INN (International Adı):

PANTOPRAZOLE

Doz:

20MG

Farmasötik formu:

TABLET (DELAYED-RELEASE)

Kompozisyon:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 20MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

PROTON-PUMP INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0133229002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2008-03-05

Ürün özellikleri

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