DOM-RISPERIDONE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

RISPERIDONE

Предлага се от:

DOMINION PHARMACAL

АТС код:

N05AX08

INN (Международно Name):

RISPERIDONE

дозиране:

0.5MG

Лекарствена форма:

TABLET

Композиция:

RISPERIDONE 0.5MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

ATYPICAL ANTIPSYCHOTICS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2006-07-27

Данни за продукта

PRODUCT MONOGRAPH
PR
DOM-RISPERIDONE
Risperidone tablets
0.25, 0.5, 1, 2, 3 and 4 mg
Risperidone tartrate oral solution
risperidone 1 mg/mL
PR
DOM-RISPERIDONE ODT
Risperidone orally disintegrating tablets
0.5, 1 and 2 mg
ANTIPSYCHOTIC AGENT
DOMINION PHARMACAL
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
July 26, 2006
Montreal, Quebec
H4P 2T4
DATE OF REVISION
:
April 23, 2008
Control No. 121490
Page 2 of 60
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
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................
29
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................
31
PART II: SCIENTIFIC INFORMATION
................................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
...............................................................