AERIUS TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
11-10-2022
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Aktiv bestanddel:
DESLORATADINE
Tilgængelig fra:
BAYER INC
ATC-kode:
R06AX27
INN (International Name):
DESLORATADINE
Dosering:
5MG
Lægemiddelform:
TABLET
Sammensætning:
DESLORATADINE 5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
10/20/30/100
Recept type:
OTC
Terapeutisk område:
SECOND GENERATION ANTIHISTAMINES
Produkt oversigt:
Active ingredient group (AIG) number: 0143961001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2014-11-07
Produktets egenskaber
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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
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_ 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
