MINT-RISPERIDON TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

RISPERIDONE

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

N05AX08

INN (Internationale Bezeichnung):

RISPERIDONE

Dosierung:

0.25MG

Darreichungsform:

TABLET

Zusammensetzung:

RISPERIDONE 0.25MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

60/100

Verschreibungstyp:

Prescription

Therapiebereich:

ATYPICAL ANTIPSYCHOTICS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2010-12-08

Fachinformation

_MINT-RISPERIDON Product Monograph _
Page 1 of 62
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-RISPERIDON
Risperidone Tablets
Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, Oral
House Standard
Antipsychotic Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive,
Mississauga, Ontario,
Canada, L5T 2M3
Date of Initial Authorization:
DEC 8, 2010
Date of Revision:
October 11, 2022
Submission Control No: 263636
_MINT-RISPERIDON Product Monograph _
Page 2 of 62
RECENT MAJOR LABEL CHANGES
7
WARNINGS AND PRECAUTIONS, Skin, 10/2022
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX............................................................. 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 5
4.3
Administration
..........................................................................................................
8
4.4
Missed Dose
............................................................................................................
8
5
OVERDOSAGE
................................................................................................................
8
6
DOSAGE FORMS, STRENGTHS, COM