Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ARIPIPRAZOLE
NORA PHARMA INC
N05AX12
ARIPIPRAZOLE
5MG
TABLET
ARIPIPRAZOLE 5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152514002; AHFS:
APPROVED
2023-06-01
NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 1 of 74 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATIO N PR NRA-ARIPIPRAZOLE Aripiprazole Tablets Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral USP Antipsychotic agent Nora Pharma Inc. 1565, boul. Lionel-Boulet Varennes, Québec, Canada J3X 1P7 Date of Initial Authorization: January 19, 2018 Date of Revision: May 15, 2023 Submission Control No: 270875 NRA-ARIPIPRAZOLE (Aripiprazole Tablets) Page 2 of 74 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 05/2023 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 .................................................................................................... 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 .......................................................... 6 4.3 Administration .......................................................................................................... 6 4.4 Reconstitution .... Prečítajte si celý dokument