AG-RISPERIDONE TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

RISPERIDONE

Disponible desde:

ANGITA PHARMA INC.

Código ATC:

N05AX08

Designación común internacional (DCI):

RISPERIDONE

Dosis:

0.25MG

formulario farmacéutico:

TABLET

Composición:

RISPERIDONE 0.25MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

ATYPICAL ANTIPSYCHOTICS

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2011-06-07

Ficha técnica

_AG-Risperidone Product Monograph _Page 1 of 61
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AG-RISPERIDONE
Risperidone Tablets
Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg, Oral
House Standard
Antipsychotic Agent
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No.: 263793
Date of Initial Authorization:
August 22, 2011
Date of Revision:
June 2, 2022
_AG-Risperidone Product Monograph _Page 2 of 61
RECENT MAJOR LABEL CHANGES
7
WARNINGS AND PRECAUTIONS, Skin
,06/2022
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
...............................................................................................................
7
4.4
Missed
Dose
.................................................................................................................
7
5
OVERDOSAGE.....................................................................................................................
8