AERIUS SYRUP

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

DESLORATADINE

Disponible desde:

BAYER INC

Código ATC:

R06AX27

Designación común internacional (DCI):

DESLORATADINE

Dosis:

0.5MG

formulario farmacéutico:

SYRUP

Composición:

DESLORATADINE 0.5MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

OTC

Área terapéutica:

SECOND GENERATION ANTIHISTAMINES

Resumen del producto:

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

Estado de Autorización:

APPROVED

Fecha de autorización:

2014-12-18

Ficha técnica

_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
......................