BUSPIRONE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUSPIRONE HYDROCHLORIDE

Disponibil de la:

SANIS HEALTH INC

Codul ATC:

N05BE01

INN (nume internaţional):

BUSPIRONE

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

BUSPIRONE HYDROCHLORIDE 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2015-10-27

Caracteristicilor produsului

_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