BLEXTEN SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BILASTINE

Tersedia dari:

ARALEZ PHARMACEUTICALS CANADA INC

Kode ATC:

R06AX29

INN (Nama Internasional):

BILASTINE

Dosis:

2.5MG

Bentuk farmasi:

SOLUTION

Komposisi:

BILASTINE 2.5MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

SECOND GENERATION ANTIHISTAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0158051002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-08-11

Karakteristik produk

_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.......