RAN-RISPERIDONE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

RISPERIDONE

Sẵn có từ:

RANBAXY PHARMACEUTICALS CANADA INC.

Mã ATC:

N05AX08

INN (Tên quốc tế):

RISPERIDONE

Liều dùng:

3MG

Dạng dược phẩm:

TABLET

Thành phần:

RISPERIDONE 3MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

250

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ATYPICAL ANTIPSYCHOTICS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2012-06-13

Đặc tính sản phẩm

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