Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
RABEPRAZOLE SODIUM
PRO DOC LIMITEE
A02BC04
RABEPRAZOLE
10MG
TABLET (ENTERIC-COATED)
RABEPRAZOLE SODIUM 10MG
ORAL
10/100/500
Prescription
PROTON-PUMP INHIBITORS
Active ingredient group (AIG) number: 0143681001; AHFS:
CANCELLED POST MARKET
2023-07-10
PRODUCT MONOGRAPH PR PRO-RABEPRAZOLE Rabeprazole Sodium Enteric-Coated Tablets 10 mg and 20 mg H + , K + -ATPASE INHIBITOR DATE OF REVISION: September 5, 2019 PRO DOC LTÉE 2925, boul. Industriel, Laval, Quebec H7L 3W9 _Control #: 230299_ Rabeprazole pm en Pg. 1 _PRO-RABEPRAZOLE Product Monograph _ _Page 2 of 52_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................5 ADVERSE REACTIONS ....................................................................................................9 DRUG INTERACTIONS ..................................................................................................13 DOSAGE AND ADMINISTRATION ..............................................................................15 OVERDOSAGE ................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY ..........................................................................................22 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................22 PART II: SCIENTIFIC INFORMATION ................................................................................23 PHARMACEUTICAL INFORMATION ..........................................................................23 CLINICAL TRIALS ..........................................................................................................24 DETAILED PHARMACOLOGY ....................................... Baca dokumen lengkap