AG-RISPERIDONE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RISPERIDONE

Saatavilla:

ANGITA PHARMA INC.

ATC-koodi:

N05AX08

INN (Kansainvälinen yleisnimi):

RISPERIDONE

Annos:

2MG

Lääkemuoto:

TABLET

Koostumus:

RISPERIDONE 2MG

Antoreitti:

ORAL

Kpl paketissa:

250ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ATYPICAL ANTIPSYCHOTICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0124332004; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2011-06-07

Valmisteyhteenveto

_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