BUSPIRONE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BUSPIRONE HYDROCHLORIDE

Disponibil de la:

APOTEX INC

Codul ATC:

N05BE01

INN (nume internaţional):

BUSPIRONE

Dozare:

5MG

Forma farmaceutică:

TABLET

Compoziție:

BUSPIRONE HYDROCHLORIDE 5MG

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: 0116263002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-12-18

Caracteristicilor produsului

_BUSPIRONE _
_Page 1 of 40_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BUSPIRONE
Buspirone Hydrochloride
Tablets, 5 mg and 10 mg, Oral
USP
Anxiolytic
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Initial Authorization:
FEB 16, 1996
Date of Revision:
OCT 18, 2021
Submission Control Number: 252361
_ _
_BUSPIRONE _
_Page 2 of 40_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
10/2021
2 Contraindications
12/2020
3 Serious warnings and precautions box
10/2021
4 Dosage and administration, 4.1 Dosing Considerations
10/2021
7 Warnings and precautions, General
10/2021
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
12/2020
7 Warnings and precautions, Dependence/Tolerance
10/2021
7 Warnings and precautions, Withdrawal
10/2021
7 Warnings and precautions, Falls and Fractures
10/2021
7 Warnings and precautions, 7.1.4 Geriatrics
10/2021
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
10/2021
9 Drug Interactions
12/2020
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.........................................