PANTOPRAZOLE TABLET (DELAYED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-01-2014
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Active ingredient:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM)
Available from:
MELIAPHARM INC
ATC code:
A02BC02
INN (International Name):
PANTOPRAZOLE
Dosage:
40MG
Pharmaceutical form:
TABLET (DELAYED-RELEASE)
Composition:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
PROTON-PUMP INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0133229001; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2014-06-25
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets, House Standard
(as pantoprazole 20 mg, 40 mg)
H
+
, K
+
-ATPase Inhibitor
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
January 17, 2014
Submission Control No: 170312
_ _
_PANTOPRAZOLE Product Monograph _
_Page 2 of 39_
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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
CLINICAL TRIALS
...................................
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