RISPERIDONE TABLETS

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

RISPERIDONE

Verfügbar ab:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-Code:

N05AX08

INN (Internationale Bezeichnung):

RISPERIDONE

Dosierung:

0.25MG

Darreichungsform:

TABLET

Zusammensetzung:

RISPERIDONE 0.25MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

10/1000

Verschreibungstyp:

Prescription

Therapiebereich:

ATYPICAL ANTIPSYCHOTICS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0124332006; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-08-19

Fachinformation

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