RAN-RISPERIDONE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
05-03-2009
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Aktiva substanser:
RISPERIDONE
Tillgänglig från:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC-kod:
N05AX08
INN (International namn):
RISPERIDONE
Dos:
2MG
Läkemedelsform:
TABLET
Sammansättning:
RISPERIDONE 2MG
Administreringssätt:
ORAL
Enheter i paketet:
500
Receptbelagda typ:
Prescription
Terapiområde:
ATYPICAL ANTIPSYCHOTICS
Produktsammanfattning:
Active ingredient group (AIG) number: 0124332004; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2012-06-13
Produktens egenskaper
_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
RAN™-RISPERIDONE
risperidone tablets
0.25, 0.5, 1, 2, 3 and 4 mg
Antipsychotic Agent
This Product Monograph is the exclusive property of Ranbaxy
Pharmaceuticals Canada Inc.
It may not be copied in whole or in part without the written
permission of Ranbaxy Pharmaceuticals
Canada Inc.
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5
Date of Revision:
March 5, 2009
Submission Control No: 128096
TM: Trade-Mark owned by Ranbaxy Laboratories Limited.
_Page 2 of 54 _
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.......................................................................................................
12
DRUG INTERACTIONS
.......................................................................................................
22
DOSAGE AND ADMINISTRATION
...................................................................................
25
OVERDOSAGE
.....................................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 28
STORAGE AND
STABILITY...............................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 31
PART II: SCIENTIFIC INFORMATION
...................................................................
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