국가: 캐나다
언어: 영어
출처: Health Canada
BUSPIRONE HYDROCHLORIDE
PRO DOC LIMITEE
5MG
TABLET
BUSPIRONE HYDROCHLORIDE 5MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0116263002
APPROVED
2022-01-05
_BUSPIRONE _ _Page 1 of 38_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BUSPIRONE-5 PR BUSPIRONE-10 Buspirone Hydrochloride Tablets 5 mg and 10 mg, Oral USP Anxiolytic PRO DOC LTÉE 2925, boul. Industriel Laval, Québec H7L 3W9 Submission Control Number: 259313 Date of Initial Authorization: January 15, 1997 Date of Revision: December 31, 2021 Buspirone Buspirone En PM.pdf Pg. 1 _ _ _BUSPIRONE _ _Page 2 of 38_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 11/2021 2 Contraindications 04/2021 3 Serious warnings and precautions box 11/2021 4 Dosage and administration, 4.1 Dosing Considerations 11/2021 7 Warnings and precautions, General 11/2021 7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome 04/2021 7 Warnings and precautions, Dependence/Tolerance 11/2021 7 Warnings and precautions, Withdrawal 11/2021 7 Warnings and precautions, Falls and Fractures 11/2021 7 Warnings and precautions, 7.1.4 Geriatrics 11/2021 8 Adverse Reactions, 8.5 Post-Market Adverse Reactions 11/2021 9 Drug Interactions 04/2021 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 ................................................................................................... 전체 문서 읽기