RISPERDAL M-TAB TABLET (ORALLY DISINTEGRATING)

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

RISPERIDONE

Disponibil de la:

JANSSEN INC

Codul ATC:

N05AX08

INN (nume internaţional):

RISPERIDONE

Dozare:

0.5MG

Forma farmaceutică:

TABLET (ORALLY DISINTEGRATING)

Compoziție:

RISPERIDONE 0.5MG

Calea de administrare:

ORAL

Unități în pachet:

28

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ATYPICAL ANTIPSYCHOTICS

Rezumat produs:

Active ingredient group (AIG) number: 0124332007; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2017-05-26

Caracteristicilor produsului

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_Non-Ann PM 205384 - RISPERDAL - Revised PM.doc 10122017 _
_EDMS-ERI-94631857 v 5.0 _
_Page 1 of 65 _
PRODUCT MONOGRAPH
PR
RISPERDAL
®
risperidone tablets House Standard
0.25, 0.5, 1, 2, 3 and 4 mg
risperidone tartrate oral solution
risperidone 1 mg/mL
PR
RISPERDAL M-TAB
®
risperidone orally disintegrating tablets
0.5, 1, 2, 3 and 4 mg
Antipsychotic Agent
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Revision:
October 12, 2017
Submission Control No: 205384
All trademarks used under license.
© 2017 Janssen Inc.
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_Non-Ann PM 205384 - RISPERDAL - Revised PM.doc 10122017 _
_EDMS-ERI-94631857 v 5.0 _
_Page 2 of 65 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
15
DRUG INTERACTIONS
.................................................................................................
28
DOSAGE AND ADMINISTRATION
.............................................................................
33
OVERDOSAGE
...............................................................................................................
35
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 36
STORAGE AND STABILITY
.........................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 39
PART II: SCIENTIFIC INFORMATION
.................