BRICANYL TURBUHALER POWDER (METERED DOSE)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

TERBUTALINE SULFATE

Disponível em:

ASTRAZENECA CANADA INC

Código ATC:

R03AC03

DCI (Denominação Comum Internacional):

TERBUTALINE

Dosagem:

0.5MG

Forma farmacêutica:

POWDER (METERED DOSE)

Composição:

TERBUTALINE SULFATE 0.5MG

Via de administração:

INHALATION

Unidades em pacote:

200

Tipo de prescrição:

Prescription

Área terapêutica:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Resumo do produto:

Active ingredient group (AIG) number: 0110482003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2000-05-01

Características técnicas

_ _
BRICANYL
®
TURBUHALER
®
Product Monograph_ _
_Page 1 of 23_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
BRICANYL
®
TURBUHALER
®
terbutaline sulfate
Dry powder, 0.5 mg/dose, Oral Inhalation
Bronchodilator
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
NOV 16, 1988
Date of Revision:
MAY 24, 2023
Submission Control Number: 270964
BRICANYL
®
, TURBUHALER
®
and the AstraZeneca logo are registered trademarks of
AstraZeneca AB, used under license by AstraZeneca Canada Inc.
© AstraZeneca Canada Inc. 2023
_ _
BRICANYL
®
TURBUHALER
®
Product Monograph_ _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
06/2021
1 INDICATIONS, 1.2 Geriatrics
06/2021
2 CONTRAINDICATIONS
06/2021
7 WARNINGS AND PRECAUTIONS, General
12/2022
7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance
06/2021
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
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
.................