Pays: Canada
Langue: anglais
Source: Health Canada
ARIPIPRAZOLE
APOTEX INC
N05AX12
ARIPIPRAZOLE
15MG
TABLET
ARIPIPRAZOLE 15MG
ORAL
30/100/500
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0152514003; AHFS:
APPROVED
2018-04-10
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 ............................................................................................... Lire le document complet