PHL-RISPERIDONE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

RISPERIDONE

Pieejams no:

PHARMEL INC

ATĶ kods:

N05AX08

SNN (starptautisko nepatentēto nosaukumu):

RISPERIDONE

Deva:

4.0MG

Zāļu forma:

TABLET

Kompozīcija:

RISPERIDONE 4.0MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

ATYPICAL ANTIPSYCHOTICS

Produktu pārskats:

Active ingredient group (AIG) number: 0124332005; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2006-08-09

Produkta apraksts

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
.....................................................................