RISPERIDONE TABLETS

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

RISPERIDONE

थमां उपलब्ध:

RANBAXY PHARMACEUTICALS CANADA INC.

ए.टी.सी कोड:

N05AX08

INN (इंटरनेशनल नाम):

RISPERIDONE

डोज़:

0.25MG

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

RISPERIDONE 0.25MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

10/1000

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

ATYPICAL ANTIPSYCHOTICS

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2009-08-19

उत्पाद विशेषताएं

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