APO-ARIPIPRAZOLE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
24-07-2023
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Aktiv ingrediens:
ARIPIPRAZOLE
Tilgjengelig fra:
APOTEX INC
ATC-kode:
N05AX12
INN (International Name):
ARIPIPRAZOLE
Dosering :
5MG
Legemiddelform:
TABLET
Sammensetning:
ARIPIPRAZOLE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100/500
Resept typen:
Prescription
Terapeutisk område:
ATYPICAL ANTIPSYCHOTICS
Produkt oppsummering:
Active ingredient group (AIG) number: 0152514002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2018-04-10
Preparatomtale
Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
USP
Antipsychotic agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada, M9L 1T9
Date of Initial Authorization:
APR 10, 2018
Date of Revision:
JUL 24, 2023
Submission Control No: 265939
Page 2 of 66
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
11/2022
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES...........................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
.......................................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
.....................................................................................................................
4
2
CONTRAINDICATIONS
........................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1
Dosing Considerations
................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
............................................................ 6
4.3
Administration
..............................................................................................................
7
4.4
Reconstitution
...............................................................................................
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