PHL-RISPERIDONE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

RISPERIDONE

זמין מ:

PHARMEL INC

קוד ATC:

N05AX08

INN (שם בינלאומי):

RISPERIDONE

כמות:

0.25MG

טופס פרצבטיות:

TABLET

הרכב:

RISPERIDONE 0.25MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100/500

סוג מרשם:

Prescription

איזור תרפויטי:

ATYPICAL ANTIPSYCHOTICS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2006-08-09

מאפייני מוצר

PRODUCT MONOGRAPH
PR
PHL-RISPERIDONE
Risperidone tablets
0.25, 0.5, 1, 2, 3 and 4 mg
Risperidone tartrate oral solution
risperidone 1 mg/mL
PR
PHL-RISPERIDONE ODT
Risperidone orally disintegrating tablets
0.5, 1 and 2 mg
ANTIPSYCHOTIC AGENT
PHARMEL INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
July 26, 2006
Montreal, Quebec
H4P 2T4
DATE OF REVISION
:
April 29, 2008
Control No. 121494
Page 2 of 60
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................
3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
4
CONTRAINDICATIONS
..................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
13
DRUG INTERACTIONS
.................................................................................................
23
DOSAGE AND ADMINISTRATION
.............................................................................
25
OVERDOSAGE
...............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
............................................................
29
STORAGE AND STABILITY
.........................................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................
31
PART II: SCIENTIFIC INFORMATION
................................................................................
34
PHARMACEUTICAL INFORMATION
.........................................................................
34
CLINICAL TRIALS
.....................................................................