MINT-BUSPIRONE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BUSPIRONE HYDROCHLORIDE

Dostupné s:

MINT PHARMACEUTICALS INC

ATC kód:

N05BE01

INN (Mezinárodní Name):

BUSPIRONE

Dávkování:

10MG

Léková forma:

TABLET

Složení:

BUSPIRONE HYDROCHLORIDE 10MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2021-08-11

Charakteristika produktu

_MINT-BUSPIRONE (Buspirone Hydrochloride) _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-BUSPIRONE
Buspirone Hydrochloride Tablets
Tablets, 10 mg, Oral
USP
Anxiolytic
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
AUG 11, 2021
Date of Revision:
APR 26, 2023
Submission Control Number: 269744
_MINT-BUSPIRONE (Buspirone Hydrochloride) _
_Page 2 of 37 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
04/2023
2 Contraindications
04/2023
3 Serious warnings and precautions box
04/2023
4 Dosage and administration, 4.1 Dosing Considerations
04/2023
7 Warnings and precautions, General
04/2023
7 Warnings and Precautions, Serotonin Toxicity/Serotonin
Syndrome
04/2023
7 Warnings and precautions, Dependence/Tolerance
04/2023
7 Warnings and precautions, Withdrawal
04/2023
7 Warnings and precautions, Falls and Fractures
04/2023
7 Warnings and precautions, 7.1.4 Geriatrics
04/2023
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
..........................................