AG-PANTOPRAZOLE SODIUM TABLET (DELAYED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)

Dostępny od:

ANGITA PHARMA INC.

Kod ATC:

A02BC02

INN (International Nazwa):

PANTOPRAZOLE

Dawkowanie:

40MG

Forma farmaceutyczna:

TABLET (DELAYED-RELEASE)

Skład:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 40MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

PROTON-PUMP INHIBITORS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2018-10-11

Charakterystyka produktu

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