OMNARIS HFA AEROSOL, METERED DOSE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CICLESONIDE

Disponible desde:

TAKEDA CANADA INC

Código ATC:

R01AD13

Designación común internacional (DCI):

CICLESONIDE

Dosis:

50MCG

formulario farmacéutico:

AEROSOL, METERED DOSE

Composición:

CICLESONIDE 50MCG

Vía de administración:

NASAL

Unidades en paquete:

30/60 ACTUATIONS

tipo de receta:

Prescription

Área terapéutica:

CORTICOSTEROIDS

Resumen del producto:

Active ingredient group (AIG) number: 0151669001; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2017-02-10

Ficha técnica

_OMNARIS_
_®_
_ HFA_
_(ciclesonide nasal aerosol) _
_ _
_ _
_Page 1 of 30 _
PRODUCT MONOGRAPH
OMNARIS
®
HFA
ciclesonide nasal aerosol
50 mcg/metered aerosol (ex-valve)
Corticosteroid for nasal use
Takeda Canada Inc.
Oakville, Ontario
L6M 4X8
www.takedacanada.com
Date of Revision:
10 February 2014
Submission Control No: 170760
_OMNARIS_
_®_
_ HFA_
_(ciclesonide nasal aerosol) _
_ _
_ _
_Page 2 of 30 _
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
......................................................................................................
9
DOSAGE
AND
ADMINISTRATION
.................................................................................
10
OVERDOSE
........................................................................................................................
11
ACTION
AND
CLINICAL
PHARMACOLOGY
................................................................ 11
STORAGE
AND
STABILITY
............................................................................................
13
SPECIAL
HANDLING
INSTRUCTIONS
.........................................................................
13
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION .............................................................................
15
PHARMACEUTICAL
INFORMATION
..............................