Land: Kanada
Språk: engelska
Källa: Health Canada
RISPERIDONE
RANBAXY PHARMACEUTICALS CANADA INC.
N05AX08
RISPERIDONE
4MG
TABLET
RISPERIDONE 4MG
ORAL
60
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0124332005; AHFS:
CANCELLED POST MARKET
2012-06-13
_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 ................................................................... Läs hela dokumentet