DESLORATADINE TABLETS
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
17-10-2018
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Active ingredient:
DESLORATADINE
Available from:
APOTEX INC
ATC code:
R06AX27
INN (International Name):
DESLORATADINE
Dosage:
5MG
Pharmaceutical form:
TABLET
Composition:
DESLORATADINE 5MG
Administration route:
ORAL
Units in package:
10/12/20/24/30/36/48/50
Prescription type:
OTC
Therapeutic area:
SECOND GENERATION ANTIHISTAMINES
Product summary:
Active ingredient group (AIG) number: 0143961001; AHFS:
Authorization status:
APPROVED
Authorization date:
2010-02-05
Summary of Product characteristics
Page 1 of 35
PRODUCT MONOGRAPH
DESLORATADINE TABLETS 5 MG DESLORATADINE
HISTAMINE H
1
-RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
OCTOBER 17, 2018
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 220366
Page 2 of 35
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
..........................................................................................................................
7
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
7
STORAGE
AND
STABILITY
..................................................................................................
10
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
10
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 10
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL
INFORMATION
.................................................................................
12
CLINICAL
TRIALS
.............................
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