Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
MYLAN PHARMACEUTICALS ULC
A02BC05
ESOMEPRAZOLE
40MG
TABLET (DELAYED-RELEASE)
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 40MG
ORAL
100/500
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0145162002; AHFS:
APPROVED
2018-07-26
_MYL-ESOMEPRAZOLE (esomeprazole) _ _Page 1 of 58_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MYL-ESOMEPRAZOLE Esomeprazole Delayed Release Tablets Delayed release tablets, 20 mg and 40 mg esomeprazole (as esomeprazole magnesium trihydrate), Oral H + , K + -ATPase Inhibitor Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, Ontario M8Z 2S6 Date of Initial Authorization: JUL 26, 2018 Date of Revision: JUN 22, 2023 Submission Control Number: 271970 _MYL-ESOMEPRAZOLE (esomeprazole) _ _Page 2 of 58_ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 06/2023 7 WARNINGS AND PRECAUTIONS, General 06/2023 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 06/2023 7 WARNINGS AND PRECAUTIONS, Gastrointestinal 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women 06/2023 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 06/2023 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 ..................................................................... 5 1 INDICATIONS .............................................................................................................. 5 1.1 Pediatrics ................................................................................................................... 5 2 CONTRAINDICATIONS ................................................................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 4.1 Dosing Considerations .............................................................................................. 6 4.2 Recommended Dose and Dosage Adjustment ......................................................... 6 4. Soma hati kamili