Country: কানাডা
ভাষা: ইংরেজি
সূত্র: Health Canada
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM)
MYLAN PHARMACEUTICALS ULC
A02BC05
ESOMEPRAZOLE
20MG
CAPSULE (DELAYED RELEASE)
ESOMEPRAZOLE (ESOMEPRAZOLE MAGNESIUM) 20MG
ORAL
100
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0145162001; AHFS:
CANCELLED PRE MARKET
2017-01-11
1 PRODUCT MONOGRAPH PR MYLAN-ESOMEPRAZOLE esomeprazole delayed release capsules 20 and 40 mg esomeprazole (as esomeprazole magnesium) H + , K + -ATPase Inhibitor Mylan Pharmaceuticals ULC 85 Advance Rd. Etobicoke, Ontario M8Z 2S6 Control Number: 194955 Submission Control No. Date of Revision: June 03, 2016 2 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 ...................................................................................................... 8 DRUG INTERACTIONS .................................................................................................... 14 DOSAGE AND ADMINISTRATION ................................................................................ 17 OVERDOSAGE .................................................................................................................. 19 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 19 STORAGE AND STABILITY ............................................................................................ 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 22 PART II: SCIENTIFIC INFORMATION ............................................................................ 24 PHARMACEUTICAL INFORMATION ........................................................................ 24 CLINICAL TRIALS ............................................................................................................ 25 DETAILED PHARMACOLOGY ................ সম্পূর্ণ নথি পড়ুন