AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Tilgængelig fra:

ANGITA PHARMA INC.

ATC-kode:

A02BC02

INN (International Name):

PANTOPRAZOLE

Dosering:

40MG

Lægemiddelform:

TABLET (DELAYED-RELEASE)

Sammensætning:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

PROTON-PUMP INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2018-10-11

Produktets egenskaber

AG-PANTOPRAZOLE SODIUM Page 1 of 46
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-PANTOPRAZOLE SODIUM
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablet, 20 mg and 40 mg pantoprazole
(as pantoprazole sodium sesquihydrate), Oral
USP
Proton Pump Inhibitor
Angita Pharma Inc
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
October 11, 2018
Date of Revision:
September 27, 2023
Submission Control Number: 273071
AG-PANTOPRAZOLE SODIUM Page 2 of 46
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
09/2023
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 (< 18 years of age)
..................................................................................
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
.......................................................................................................
6
4.5
Missed