ABBOTT-PANTOPRAZOLE TABLET (DELAYED-RELEASE)
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
03-06-2015
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Aktiva substanser:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM)
Tillgänglig från:
ABBOTT LABORATORIES, LIMITED
ATC-kod:
A02BC02
INN (International namn):
PANTOPRAZOLE
Dos:
40MG
Läkemedelsform:
TABLET (DELAYED-RELEASE)
Sammansättning:
PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 40MG
Administreringssätt:
ORAL
Enheter i paketet:
100/500
Receptbelagda typ:
Prescription
Terapiområde:
PROTON-PUMP INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0133229001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2015-12-31
Produktens egenskaper
_ _
_Abbott-Pantoprazole Product Monograph _
_Page 1 of 39 _
PRODUCT MONOGRAPH
PR
ABBOTT-PANTOPRAZOLE
Pantoprazole Sodium Delayed Release Tablets USP
20 and 40 mg pantoprazole (as pantoprazole sodium sesquihydrate)
H
+
, K
+
-ATPase Inhibitor
Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Date of Preparation:
September 18, 2013
Date of Revision:
June 3, 2015
Submission Control No.: 184223
_ _
_Abbott-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
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................16
SPECIAL HANDLING INSTRUCTIONS
.......................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................18
PHARMACEUTIC
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