RISPERIDONE TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RISPERIDONE

Saatavilla:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-koodi:

N05AX08

INN (Kansainvälinen yleisnimi):

RISPERIDONE

Annos:

4.0MG

Lääkemuoto:

TABLET

Koostumus:

RISPERIDONE 4.0MG

Antoreitti:

ORAL

Kpl paketissa:

10/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ATYPICAL ANTIPSYCHOTICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0124332005; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2009-08-19

Valmisteyhteenveto

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