Ország: Kanada
Nyelv: angol
Forrás: Health Canada
ARIPIPRAZOLE
SANIS HEALTH INC
N05AX12
ARIPIPRAZOLE
30MG
TABLET
ARIPIPRAZOLE 30MG
ORAL
15G/50G
Prescription
ATYPICAL ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0152514005; AHFS:
APPROVED
2020-10-19
ARIPIPRAZOLE Page 1 of 63 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr ARIPIPRAZOLE Aripiprazole Tablets Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral USP Antipsychotic agent Sanis Health Inc. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Date of Initial Authorization: October 19, 2020 Date of Revision: August 1 7 , 2022 Submission Control No: 266149 ARIPIPRAZOLE Page 2 of 63 RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 08/2022 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES ......................................................................................2 TABLE OF CONTENTS ..............................................................................................................2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................5 1 INDICATIONS....................................................................................................................5 1.1 Pediatrics ..................................................................................................................5 1.2 Geriatrics ..................................................................................................................5 2. CONTRAINDICATIONS ..................................................................................................6 3. SERIOUS WARNINGS AND PRECAUTIONS BOX .................................................6 4. DOSAGE AND ADMINISTRATION ...............................................................................6 4.1 Dosing Considerations ...........................................................................................6 4.2 Recommended Dose and Dosage Adjustment ..................................................7 4.3 Administration ..........................................................................................................8 4.4 Reconstitution ..........................................................................................................8 4.5 Missed Dose . Olvassa el a teljes dokumentumot