BUSPIRONE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

BUSPIRONE HYDROCHLORIDE

Предлага се от:

APOTEX INC

АТС код:

N05BE01

INN (Международно Name):

BUSPIRONE

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

BUSPIRONE HYDROCHLORIDE 10MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Каталог на резюме:

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

Статус Оторизация:

APPROVED

Дата Оторизация:

2020-12-18

Данни за продукта

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