מדינה: קנדה
שפה: אנגלית
מקור: Health Canada
ARIPIPRAZOLE
MINT PHARMACEUTICALS INC
N05AX12
ARIPIPRAZOLE
5MG
TABLET
ARIPIPRAZOLE 5MG
ORAL
30
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0152514002; AHFS:
APPROVED
2018-12-03
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR MINT-ARIPIPRAZOLE Aripiprazole Tablets Tablets; 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg; Oral Antipsychotic agent Manufacturer’s Standard MINT PHARMACEUTICALS INC. 6575 Davand Drive, Mississauga, Ontario, L5T 2M3 Date of Initial Authorization: December 03, 2018 Date of Revision: October 4, 2022 Submission Control No: 264121 _MINT-ARIPIPRAZOLE _ _ _ _Product Monograph _ Page 2_ of 68 _ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 11/2021 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 ................................................................................................. 7 4.5 Missed Dose ............................... קרא את המסמך השלם