RISPERIDONE TABLETS

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

RISPERIDONE

Prieinama:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC kodas:

N05AX08

INN (Tarptautinis Pavadinimas):

RISPERIDONE

Dozė:

2.0MG

Vaisto forma:

TABLET

Sudėtis:

RISPERIDONE 2.0MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

10/1000

Recepto tipas:

Prescription

Gydymo sritis:

ATYPICAL ANTIPSYCHOTICS

Produkto santrauka:

Active ingredient group (AIG) number: 0124332004; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2009-08-19

Prekės savybės

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