RAN-RISPERIDONE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

RISPERIDONE

Dostępny od:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

N05AX08

INN (International Nazwa):

RISPERIDONE

Dawkowanie:

1MG

Forma farmaceutyczna:

TABLET

Skład:

RISPERIDONE 1MG

Droga podania:

ORAL

Sztuk w opakowaniu:

500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ATYPICAL ANTIPSYCHOTICS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0124332003; AHFS:

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2012-06-13

Charakterystyka produktu

_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
...................................................................