RISPERIDONE TABLETS

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

RISPERIDONE

Commercializzato da:

RANBAXY PHARMACEUTICALS CANADA INC.

Codice ATC:

N05AX08

INN (Nome Internazionale):

RISPERIDONE

Dosaggio:

0.25MG

Forma farmaceutica:

TABLET

Composizione:

RISPERIDONE 0.25MG

Via di somministrazione:

ORAL

Confezione:

10/1000

Tipo di ricetta:

Prescription

Area terapeutica:

ATYPICAL ANTIPSYCHOTICS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2009-08-19

Scheda tecnica

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