PMS-BUSPIRONE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BUSPIRONE HYDROCHLORIDE

Доступна з:

PHARMASCIENCE INC

Код атс:

N05BE01

ІПН (Міжнародна Ім'я):

BUSPIRONE

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

BUSPIRONE HYDROCHLORIDE 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

1997-03-18

Характеристики продукта

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-BUSPIRONE
Buspirone Hydrochloride Tablets
Tablets, 5 mg and 10 mg, Oral
USP
Anxiolytic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
MAR 18, 1997
Date of Revision:
AUG 28, 2023
Submission Control Number: 274314
_pms-BUSPIRONE page 2 of 41 _
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
08/2023
2 Contraindications
08/2023
3 Serious warnings and precautions box
08/2023
4 Dosage and administration, 4.1 Dosing Considerations
08/2023
7 Warnings and Precautions, General
08/2023
7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome
08/2023
7 Warnings and precautions, Dependence/Tolerance
08/2023
7 Warnings and precautions, Withdrawal
08/2023
7 Warnings and precautions, Falls and Fractures
08/2023
7 Warnings and precautions, 7.1.4 Geriatrics
08/2023
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
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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
............................................................