DESLORATADINE ALLERGY CONTROL TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-09-2023
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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
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0143961001; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-11-06
Summary of Product characteristics
_DESLORATADINE ALLERGY _CONTROL page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
DESLORATADINE ALLERGY CONTROL
Desloratadine
Tablet, 5mg, Oral
House Standard
Histamine H1-Receptor Antagonist
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Canada
H4P 2T4
Date of initial Authorization:
SEP 22, 2011
Date of Revision:
SEP 12, 2023
Submission Control Number: 272961
_DESLORATADINE ALLERGY _CONTROL page 2 of 37
TABLE OF CONTENTS
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
.............................................................................
5
4.3
ADMINISTRATION
............................................................................................................................
5
4.4
MISSED DOSE
................................................................................................................................
5
5
OVERDOSAGE
......................................
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