RISPERIDONE TABLETS

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RISPERIDONE

Boleh didapati daripada:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

N05AX08

INN (Nama Antarabangsa):

RISPERIDONE

Dos:

0.5MG

Borang farmaseutikal:

TABLET

Komposisi:

RISPERIDONE 0.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

10/1000

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ATYPICAL ANTIPSYCHOTICS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2009-08-19

Ciri produk

_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…………………………………………………………........................…