TEVA-BUSPIRONE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BUSPIRONE HYDROCHLORIDE

Saatavilla:

TEVA CANADA LIMITED

ATC-koodi:

N05BE01

INN (Kansainvälinen yleisnimi):

BUSPIRONE

Annos:

10MG

Lääkemuoto:

TABLET

Koostumus:

BUSPIRONE HYDROCHLORIDE 10MG

Antoreitti:

ORAL

Kpl paketissa:

35/100/500/1000

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-06-03

Valmisteyhteenveto

_TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-BUSPIRONE
Buspirone Hydrochloride Tablets
Tablets, 10 mg, Oral
USP
Anxiolytic
Teva Canada Limited
Date of Initial Authorization:
30 Novopharm Court
June 18, 1997
Toronto, ON
M1B 2K9 Date of Revision:
Canada December 20, 2023
Submission Control Number: 277097
_TEVA-BUSPIRONE (Buspirone Hydrochloride Tablets)_
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
12/2023
2 Contraindications
12/2023
3 Serious warnings and precautions box
12/2023
4 Dosage and administration, 4.1 Dosing Considerations
12/2023
7 Warnings and precautions, General
12/2023
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
12/2023
7 Warnings and precautions, Dependence/Tolerance
12/2023
7 Warnings and precautions, Withdrawal
12/2023
7 Warnings and precautions, Falls and Fractures
12/2023
7 Warnings and precautions, 7.1.4 Geriatrics
12/2023
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