AERIUS TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DESLORATADINE

Available from:

BAYER INC

ATC code:

R06AX27

INN (International Name):

DESLORATADINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

DESLORATADINE 5MG

Administration route:

ORAL

Units in package:

10/20/30/100

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0143961001; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-11-07

Summary of Product characteristics

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_ Desloratadine Syrup 0.5 mg/mL> _
_Page 1 of 40 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
AERIUS®
Desloratadine
Tablet, 5mg, Oral
USP
AERIUS® KIDS
Desloratadine
Syrup, 0.5 mg/mL Oral
Professed Standard
Histamine H1-Receptor Antagonist
Bayer Inc.
2920 Matheson Blvd. East
Mississauga, ON
L4W 5R6
Date of Revision:
October 11, 2022
Submission Control Number: 263344
®TM see www.bayer.ca/tm-mc
_ _
_ _
_ Desloratadine Syrup 0.5 mg/mL> _
_Page 2 of 40_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS....................................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics...................................................................................................................
4
2 CONTRAINDICATIONS
......................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS
BOX..................................................................
4
4 DOSAGE AND ADMINISTRATION
......................................................................................
4
4.1 Dosing
Considerations....................................................................................................
4
4.2 Recommended Dose and Dosage
Adjustment.................................................................
4
4.3 Administration
...............................................................................................................
5
4.4 Mi