BLEXTEN TABLET (ORALLY DISINTEGRATING)

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

BILASTINE

Tilgjengelig fra:

ARALEZ PHARMACEUTICALS CANADA INC

ATC-kode:

R06AX29

INN (International Name):

BILASTINE

Dosering :

10MG

Legemiddelform:

TABLET (ORALLY DISINTEGRATING)

Sammensetning:

BILASTINE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

SECOND GENERATION ANTIHISTAMINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0158051003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-08-11

Preparatomtale

_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.......