Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
BUSPIRONE HYDROCHLORIDE
SANIS HEALTH INC
N05BE01
BUSPIRONE
10MG
TABLET
BUSPIRONE HYDROCHLORIDE 10MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263001; AHFS:
APPROVED
2015-10-27
_BUSPIRONE (Buspirone Hydrochloride Tablets)_ _Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BUSPIRONE Buspirone Hydrochloride Tablets Tablets, 10 mg, Oral USP Anxiolytic Sanis Health Inc. Date of Initial Authorization: 1 President’s Choice Circle OCT 27, 2015 Brampton, Ontario L6Y 5S5 Date of Revision: Canada FEB 16, 2024 Submission Control Number: 283041 _BUSPIRONE (Buspirone Hydrochloride Tablets)_ _Page 2 of 43_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 02/2024 2 Contraindications 02/2024 3 Serious warnings and precautions box 02/2024 4 Dosage and administration, 4.1 Dosing Considerations 02/2024 7 Warnings and precautions, General 02/2024 7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome 02/2024 7 Warnings and precautions, Dependence/Tolerance 02/2024 7 Warnings and precautions, Withdrawal 02/2024 7 Warnings and precautions, Falls and Fractures 02/2024 7 Warnings and precautions, 7.1.4 Geriatrics 02/2024 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 PRECAU Izlasiet visu dokumentu