AERIUS SYRUP

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DESLORATADINE

Tilgjengelig fra:

BAYER INC

ATC-kode:

R06AX27

INN (International Name):

DESLORATADINE

Dosering :

0.5MG

Legemiddelform:

SYRUP

Sammensetning:

DESLORATADINE 0.5MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

OTC

Terapeutisk område:

SECOND GENERATION ANTIHISTAMINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0143961002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2014-12-18

Preparatomtale

_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 1 of 37 _
PRODUCT MONOGRAPH
AERIUS
®
DESLORATADINE TABLET 5 MG
DESLORATADINE SYRUP 0.5 MG/ML
AERIUS KIDS
®
DESLORATADINE SYRUP 0.5 MG/ML
HISTAMINE H
1
-RECEPTOR ANTAGONIST
Bayer Inc., Consumer Care
2920 Matheson Blvd. E
Mississauga, ON
L4W 5R6
Date of Preparation:
December 4, 2014
Submission Control No: 179382, 179387
_AERIUS Tablets / AERIUS Syrup / AERIUS KIDS Syrup _
_Page 2 of 37 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
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
...............................................................................13
PHARMACEUTICAL INFORMATION
......................