ALLERGY CONTROL DESLORATADINE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-11-2013
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Active ingredient:
DESLORATADINE
Available from:
PHARMASCIENCE INC
ATC code:
R06AX27
INN (International Name):
DESLORATADINE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
DESLORATADINE 5MG
Administration route:
ORAL
Units in package:
10/20/30/50/100/120/180
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0143961001; AHFS:
Authorization status:
APPROVED
Authorization date:
2013-11-26
Summary of Product characteristics
PRODUCT MONOGRAPH
ALLERGY CONTROL DESLORATADINE
Desloratadine tablets
5 mg
Histamine H
1
-Receptor Antagonist
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Canada
H4P 2T4
Date of Preparation:
November 5, 2013
Submission Control No: 169400
_ _
_ALLERGY CONTROL DESLORATADINE Product Monograph _
_Page 2 of 33_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................6
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
...............................................................................12
PHARMACEUTICAL INFORMATION
..........................................................................12
CLINICAL TRIALS
....................................................
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