BUSPIRONE-10 TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

BUSPIRONE HYDROCHLORIDE

Dostupné z:

PRO DOC LIMITEE

ATC kód:

N05BE01

INN (Medzinárodný Name):

BUSPIRONE

Dávkovanie:

10MG

Forma lieku:

TABLET

Zloženie:

BUSPIRONE HYDROCHLORIDE 10MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Prehľad produktov:

Active ingredient group (AIG) number: 0116263001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-01-05

Súhrn charakteristických

_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
...................................................................................................