BLEXTEN TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BILASTINE

Disponível em:

ARALEZ PHARMACEUTICALS CANADA INC

Código ATC:

R06AX29

DCI (Denominação Comum Internacional):

BILASTINE

Dosagem:

20MG

Forma farmacêutica:

TABLET

Composição:

BILASTINE 20MG

Via de administração:

ORAL

Unidades em pacote:

2/10/20/30/40/50

Tipo de prescrição:

Prescription

Área terapêutica:

SECOND GENERATION ANTIHISTAMINES

Resumo do produto:

Active ingredient group (AIG) number: 0158051001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2018-12-14

Características técnicas

_BLEXTEN_
_® _
_Product Monograph _
_ _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BLEXTEN
®
(bilastine)
Orodispersible tablets 10 mg
Tablets 20 mg
Oral solution 2.5 mg/mL
Histamine H1-Receptor Antagonist
Aralez Pharmaceuticals Canada Inc.*
6733 Mississauga Road, Suite 800
Mississauga, Ontario
Canada L5N 6J5
Date of Initial Approval:
April 20, 2016
Date of Revision:
August 10, 2021
Submission Control No:
241318
*Doing business as (d/b/a) Miravo Healthcare
_ _
_BLEXTEN_
_®_
_ Product Monograph _
_ _
_Page 2 of 41_
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
TABLE OF
CONTENTS.......................................................................................................
2
1
INDICATIONS
...........................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics
..........................................................................................................
4
2
CONTRAINDICATIONS
...........................................................................................
4
4
DOSAGE AND ADMINISTRATION
.........................................................................
4
4.1
Dosing
Considerations.....................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.............................................. 5
4.4
Administration...................................................................................................
5
4.5
Missed
Dose.....................................................................................................
6
5
OVERDOSAGE
.........................................................................................................
6
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 7
7
WARNINGS AND
PRECAUTIONS.......