Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE)
TEVA CANADA LIMITED
A02BC02
PANTOPRAZOLE
20MG
TABLET (DELAYED-RELEASE)
PANTOPRAZOLE (PANTOPRAZOLE SODIUM SESQUIHYDRATE) 20MG
ORAL
15G/50G
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0133229002; AHFS:
APPROVED
2008-04-11
TEVA-PANTOPRAZOLE _(pantoprazole sodium sesquihydrate)_ Page 1 of 52 - PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-PANTOPRAZOLE Pantoprazole Delayed-Release Tablets, 20 mg, 40 mg, Oral (as pantoprazole sodium sesquihydrate) Teva Standard Proton Pump Inhibitor Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court April 11, 2008 Toronto, Ontario M1B 2K9 Date of Revision: September 19, 2023 Submission Control Number: 275827 TEVA-PANTOPRAZOLE _(pantoprazole sodium sesquihydrate)_ Page 2 of 52 - RECENT MAJOR LABEL CHANGES 7.0 WARNINGS AND PRECAUTIONS, Immune 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 .................................................................................................................. 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 ......................................................................................................... Izlasiet visu dokumentu