RISPERIDONE TABLETS

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

RISPERIDONE

Предлага се от:

RANBAXY PHARMACEUTICALS CANADA INC.

АТС код:

N05AX08

INN (Международно Name):

RISPERIDONE

дозиране:

0.5MG

Лекарствена форма:

TABLET

Композиция:

RISPERIDONE 0.5MG

Начин на приложение:

ORAL

Броя в опаковка:

10/1000

Вид предписание :

Prescription

Терапевтична област:

ATYPICAL ANTIPSYCHOTICS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2009-08-19

Данни за продукта

_Page 1 of 53 _
PRODUCT MONOGRAPH
PR
RISPERIDONE TABLETS
(risperidone)
(house standard)
0.25, 0.5, 1, 2, 3 and 4 mg
Antipsychotic Agent
Ranbaxy Pharmaceuticals Canada Inc.
2680 Matheson Blvd. East, Suite 200
Mississauga, Ontario L4W 0A5
Date of Preparation:
August 18, 2009
Submission Control No: 132004
_Page 2 of 53 _
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…………………………………………………………………..
21
DOSAGE AND
ADMINISTRATION……………………………………………………..
24
OVERDOSAGE……………………………………………………………….……………27
ACTION AND CLINICAL
PHARMACOLOGY………………………………………….
27
STORAGE AND
STABILITY…………………………………………...………………..
30
DOSAGE FORMS, COMPOSITION AND
PACKAGING……………........................…. 30
PART II: SCIENTIFIC
INFORMATION………………………………………………...……
32
PHARMACEUTICAL
INFORMATION…………………………………………………..
32
CLINICAL
TRIALS……………………………………………………........................…..
33
DETAILED
PHARMACOLOGY………………………………………........................….
36
TOXICOLOGY…………………………………………………………........................….
38
REFERENCES…………………………………………………………........................…