AERIUS SYRUP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DESLORATADINE

Available from:

BAYER INC

ATC code:

R06AX27

INN (International Name):

DESLORATADINE

Dosage:

0.5MG

Pharmaceutical form:

SYRUP

Composition:

DESLORATADINE 0.5MG

Administration route:

ORAL

Units in package:

100

Prescription type:

OTC

Therapeutic area:

SECOND GENERATION ANTIHISTAMINES

Product summary:

Active ingredient group (AIG) number: 0143961002; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-12-18

Summary of Product characteristics

_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 1 of 37 _
PRODUCT MONOGRAPH
AERIUS
®
DESLORATADINE TABLET 5 MG
DESLORATADINE SYRUP 0.5 MG/ML
AERIUS KIDS
®
DESLORATADINE SYRUP 0.5 MG/ML
HISTAMINE H
1
-RECEPTOR ANTAGONIST
Bayer Inc., Consumer Care
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Preparation:
December 4, 2014
Submission Control No: 179382, 179387
_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
..............................................................8
STORAGE AND STABILITY
..........................................................................................11
SPECIAL HANDLING INSTRUCTIONS
.......................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
...............................................................................13
PHARMACEUTICAL INFORMATION
......................