ALLERGY CONTROL DESLORATADINE TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
22-11-2013
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Aktiva substanser:
DESLORATADINE
Tillgänglig från:
PHARMASCIENCE INC
ATC-kod:
R06AX27
INN (International namn):
DESLORATADINE
Dos:
5MG
Läkemedelsform:
TABLET
Sammansättning:
DESLORATADINE 5MG
Administreringssätt:
ORAL
Enheter i paketet:
10/20/30/50/100/120/180
Receptbelagda typ:
OTC
Terapiområde:
SECOND GENERATION ANTIHISTAMINES
Produktsammanfattning:
Active ingredient group (AIG) number: 0143961001; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2013-11-26
Produktens egenskaper
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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