ALLERNIX MULTI SYMPTOM TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DESLORATADINE

MAH:

TEVA CANADA LIMITED

ATC_code:

R06AX27

INN:

DESLORATADINE

dosage:

5MG

pharmaceutical_form:

TABLET

composition:

DESLORATADINE 5MG

administration_route:

ORAL

units_in_package:

10

prescription_type:

OTC

therapeutic_area:

SECOND GENERATION ANTIHISTAMINES

leaflet_short:

Active ingredient group (AIG) number: 0143961001; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2020-05-11

SPC

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_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
....