ALLERGY CONTROL DESLORATADINE TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
22-11-2013
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Aktiv ingrediens:
DESLORATADINE
Tilgjengelig fra:
PHARMASCIENCE INC
ATC-kode:
R06AX27
INN (International Name):
DESLORATADINE
Dosering :
5MG
Legemiddelform:
TABLET
Sammensetning:
DESLORATADINE 5MG
Administreringsrute:
ORAL
Enheter i pakken:
10/20/30/50/100/120/180
Resept typen:
OTC
Terapeutisk område:
SECOND GENERATION ANTIHISTAMINES
Produkt oppsummering:
Active ingredient group (AIG) number: 0143961001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2013-11-26
Preparatomtale
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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