Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE)
PHARMASCIENCE INC
A02BC05
ESOMEPRAZOLE
20MG
CAPSULE (DELAYED RELEASE)
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM DIHYDRATE) 20MG
ORAL
30/90
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0145162001; AHFS:
APPROVED
2014-05-26
_pms-ESOMEPRAZOLE DR Product Monograph _ _Page 1 of 55_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-ESOMEPRAZOLE DR Esomeprazole Magnesium Delayed Release Capsules Delayed-Release Capsules, 20 mg, 40 mg esomeprazole (as esomeprazole magnesium dihydrate), Oral H + , K + -ATPase Inhibitor PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com Submission Control Number: 258544 Date of Initial Authorization: MAY 26, 2014 Date of Revision: MAR 16, 2022 _pms-ESOMEPRAZOLE DR Product Monograph _ _Page 2 of 55_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, General 03/2022 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 03/2022 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 03/2022 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 2 CONTRAINDICATIONS........................................................................................................ 4 4 DOSAGE AND ADMINISTRATION ....................................................................................... 5 4.1 Dosing Considerations ............................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment.......................................................... 5 4.4 Administration.................................................................. Perskaitykite visą dokumentą