RISPERDAL M-TAB TABLET (ORALLY DISINTEGRATING)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

RISPERIDONE

Предлага се от:

JANSSEN INC

АТС код:

N05AX08

INN (Международно Name):

RISPERIDONE

дозиране:

3MG

Лекарствена форма:

TABLET (ORALLY DISINTEGRATING)

Композиция:

RISPERIDONE 3MG

Начин на приложение:

ORAL

Броя в опаковка:

28

Вид предписание :

Prescription

Терапевтична област:

ATYPICAL ANTIPSYCHOTICS

Каталог на резюме:

Active ingredient group (AIG) number: 0124332002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2016-11-29

Данни за продукта

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