RISPERIDONE TABLETS

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

RISPERIDONE

Fáanlegur frá:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC númer:

N05AX08

INN (Alþjóðlegt nafn):

RISPERIDONE

Skammtar:

0.5MG

Lyfjaform:

TABLET

Samsetning:

RISPERIDONE 0.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

10/1000

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ATYPICAL ANTIPSYCHOTICS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2009-08-19

Vara einkenni

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