RISPERIDONE TABLETS

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

RISPERIDONE

Dostopno od:

RANBAXY PHARMACEUTICALS CANADA INC.

Koda artikla:

N05AX08

INN (mednarodno ime):

RISPERIDONE

Odmerek:

0.25MG

Farmacevtska oblika:

TABLET

Sestava:

RISPERIDONE 0.25MG

Pot uporabe:

ORAL

Enote v paketu:

10/1000

Tip zastaranja:

Prescription

Terapevtsko območje:

ATYPICAL ANTIPSYCHOTICS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2009-08-19

Lastnosti izdelka

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