ประเทศ: แคนาดา
ภาษา: อังกฤษ
แหล่งที่มา: Health Canada
BUSPIRONE HYDROCHLORIDE
PHARMASCIENCE INC
N05BE01
BUSPIRONE
10MG
TABLET
BUSPIRONE HYDROCHLORIDE 10MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263001; AHFS:
APPROVED
1997-03-18
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-BUSPIRONE Buspirone Hydrochloride Tablets Tablets, 5 mg and 10 mg, Oral USP Anxiolytic PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com Date of Initial Authorization: MAR 18, 1997 Date of Revision: AUG 28, 2023 Submission Control Number: 274314 _pms-BUSPIRONE page 2 of 41 _ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 08/2023 2 Contraindications 08/2023 3 Serious warnings and precautions box 08/2023 4 Dosage and administration, 4.1 Dosing Considerations 08/2023 7 Warnings and Precautions, General 08/2023 7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome 08/2023 7 Warnings and precautions, Dependence/Tolerance 08/2023 7 Warnings and precautions, Withdrawal 08/2023 7 Warnings and precautions, Falls and Fractures 08/2023 7 Warnings and precautions, 7.1.4 Geriatrics 08/2023 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ............................................................ อ่านเอกสารฉบับเต็ม