Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
BUSPIRONE HYDROCHLORIDE
TEVA CANADA LIMITED
N05BE01
BUSPIRONE
10MG
TABLET
BUSPIRONE HYDROCHLORIDE 10MG
ORAL
35/100/500/1000
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263001; AHFS:
APPROVED
2015-06-03
_TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_ _Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR TEVA-BUSPIRONE Buspirone Hydrochloride Tablets Tablets, 10 mg, Oral USP Anxiolytic Teva Canada Limited Date of Initial Authorization: 30 Novopharm Court June 18, 1997 Toronto, ON M1B 2K9 Date of Revision: Canada December 20, 2023 Submission Control Number: 277097 _TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_ _Page 2 of 43_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 12/2023 2 Contraindications 12/2023 3 Serious warnings and precautions box 12/2023 4 Dosage and administration, 4.1 Dosing Considerations 12/2023 7 Warnings and precautions, General 12/2023 7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome 12/2023 7 Warnings and precautions, Dependence/Tolerance 12/2023 7 Warnings and precautions, Withdrawal 12/2023 7 Warnings and precautions, Falls and Fractures 12/2023 7 Warnings and precautions, 7.1.4 Geriatrics 12/2023 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 Aqra d-dokument sħiħ