RISPERIDONE TABLETS

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RISPERIDONE

Pieejams no:

RANBAXY PHARMACEUTICALS CANADA INC.

ATĶ kods:

N05AX08

SNN (starptautisko nepatentēto nosaukumu):

RISPERIDONE

Deva:

0.5MG

Zāļu forma:

TABLET

Kompozīcija:

RISPERIDONE 0.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

10/1000

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2009-08-19

Produkta apraksts

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