ALLERNIX MULTI SYMPTOM TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
15-04-2013
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Werkstoffen:
DESLORATADINE
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
R06AX27
INN (Algemene Internationale Benaming):
DESLORATADINE
Dosering:
5MG
farmaceutische vorm:
TABLET
Samenstelling:
DESLORATADINE 5MG
Toedieningsweg:
ORAL
Eenheden in pakket:
10
Prescription-type:
OTC
Therapeutisch gebied:
SECOND GENERATION ANTIHISTAMINES
Product samenvatting:
Active ingredient group (AIG) number: 0143961001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2020-05-11
Productkenmerken
_ _
_ALLERNIX MULTI SYMPTOM _
_Page 1 of 36_
PRODUCT MONOGRAPH
ALLERNIX MULTI SYMPTOM
Desloratadine Tablets
5 mg
HISTAMINE H
1
-RECEPTOR ANTAGONIST
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation:
April 3, 2013
Submission Control No: 163170
_ _
_ALLERNIX MULTI SYMPTOM _
_Page 2 of 36_
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
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 11
PART II: SCIENTIFIC INFORMATION
..............................................................................
12
PHARMACEUTICAL INFORMATION
.........................................................................
12
CLINICAL TRIALS
.........................................................................................................
13
DETAILED PHARMACOLOGY
....
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