Страна: Канада
мова: англійська
Джерело: Health Canada
BILASTINE
ARALEZ PHARMACEUTICALS CANADA INC
R06AX29
BILASTINE
10MG
TABLET (ORALLY DISINTEGRATING)
BILASTINE 10MG
ORAL
15G/50G
Prescription
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0158051003; AHFS:
APPROVED
2021-08-11
_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....... Прочитайте повний документ