Country: Канада
Језик: Енглески
Извор: Health Canada
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE)
MYLAN PHARMACEUTICALS ULC
A02BC05
ESOMEPRAZOLE
20MG
TABLET (DELAYED-RELEASE)
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM TRIHYDRATE) 20MG
ORAL
100
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0145162001; AHFS:
CANCELLED POST MARKET
2020-06-16
Page 1 of 58 PRODUCT MONOGRAPH PR MYLAN-ESOMEPRAZOLE Esomeprazole Delayed Release Tablets 20 mg and 40 mg esomeprazole (as esomeprazole magnesium trihydrate) H + , K + -ATPase Inhibitor Mylan Pharmaceuticals ULC 85 Advance Rd. Etobicoke, Ontario Canada M8Z 2S6 Control Number: 212758 Date of Revision: February 9, 2018 Page 2 of 58 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................... 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS .................................................................................................... 9 DRUG INTERACTIONS .................................................................................................. 17 DOSAGE AND ADMINISTRATION ................................................................................ 20 OVERDOSAGE .................................................................................................................. 23 ACTION AND CLINICAL PHARMACOLOGY ............................................................... 24 STORAGE AND STABILITY .......................................................................................... 28 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 28 PART II: SCIENTIFIC INFORMATION ....................................................................... 30 PHARMACEUTICAL INFORMATION ......................................................................... 30 DETAILED PHARMACOLOGY ....................................................................................... 38 TOXICOLOGY ............................................. Прочитајте комплетан документ