देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
OMEPRAZOLE (OMEPRAZOLE MAGNESIUM)
LABORATOIRE RIVA INC.
A02BC01
OMEPRAZOLE
20MG
TABLET (DELAYED-RELEASE)
OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) 20MG
ORAL
14/30
OTC
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0121643001; AHFS:
APPROVED
2015-04-17
_OMEPRAZOLE - Product Monograph _ _ _ _Page 1 of 32_ PRODUCT MONOGRAPH OMEPRAZOLE Omeprazole Delayed Release Tablets 20 mg (as Omeprazole Magnesium) H + /K + -ATPase Inhibitor LABORATOIRE RIVA INC. 660 Boul. Industriel Blainville, Québec J7C 3V4 www.labriva.com Date of Revision: November 07, 2019 Submission Control No: 231179 _OMEPRAZOLE - Product Monograph _ _ _ _Page 2 of 32_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .......................................................3 SUMMARY PRODUCT INFORMATION .....................................................................3 INDICATIONS AND CLINICAL USE ...........................................................................3 CONTRAINDICATIONS ...............................................................................................3 WARNINGS AND PRECAUTIONS ..............................................................................3 ADVERSE REACTIONS ................................................................................................6 DRUG INTERACTIONS ................................................................................................9 DOSAGE AND ADMINISTRATION ........................................................................... 14 OVERDOSAGE ............................................................................................................ 15 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 15 STORAGE AND STABILITY ...................................................................................... 16 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 17 PART II: SCIENTIFIC INFORMATION ............................................................................. 18 PHARMACEUTICAL INFORMATION....................................................................... 18 CLINICAL TRIALS...................................................................................................... 18 DETAILED PHARMACOLOGY ............... पूरा दस्तावेज़ पढ़ें