PRO-RABEPRAZOLE TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
05-09-2019
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Active ingredient:
RABEPRAZOLE SODIUM
Available from:
PRO DOC LIMITEE
ATC code:
A02BC04
INN (International Name):
RABEPRAZOLE
Dosage:
10MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
RABEPRAZOLE SODIUM 10MG
Administration route:
ORAL
Units in package:
10/100/500
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0143681001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2023-07-10
Summary of Product characteristics
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
.......................................
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