País: Canadà
Idioma: anglès
Font: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM)
PHARMASCIENCE INC
A02BC02
PANTOPRAZOLE
40MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG
ORAL
100/500
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229001; AHFS:
APPROVED
2008-06-03
_pms-PANTOPRAZOLE _ _Page 1 of 53_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-PANTOPRAZOLE Pantoprazole Sodium Delayed-Release Tablets, 20 mg and 40 mg, Oral House Standard (20 mg) & USP (40 mg) Proton Pump Inhibitor PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Submission Control Number: 275567 Date of Initial Authorization: FEB 7, 2007 Date of Revision: SEP 19, 2023 _pms-PANTOPRAZOLE _ _Page 2 of 53_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Immune 05/2023 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 .............................................................................................................. 6 4.5 Mis Llegiu el document complet