ALVESCO AEROSOL, METERED DOSE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CICLESONIDE

Disponible des:

TAKEDA CANADA INC

Codi ATC:

R03BA08

Designació comuna internacional (DCI):

CICLESONIDE

Dosis:

50MCG

formulario farmacéutico:

AEROSOL, METERED DOSE

Composición:

CICLESONIDE 50MCG

Vía de administración:

INHALATION

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ADRENALS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED PRE MARKET

Data d'autorització:

2017-02-10

Fitxa tècnica

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_Page 1 of 35_
PRODUCT MONOGRAPH
Pr
Alvesco
®
(ciclesonide inhalation aerosol)
50 mcg, 100 mcg and 200 mcg/ actuation (ex-valve)
Corticosteroid for oral inhalation
Takeda Canada Inc.
Oakville, Ontario
L6M 4X8
www.takedacanada.com
Date of Preparation:
June 25, 2012
Control No.: 155860
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_Page 2 of 35_
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
...........................................................................................................
8
DRUG
INTERACTIONS
.........................................................................................................
11
DOSAGE
AND
ADMINISTRATION
.....................................................................................
12
OVERDOSAGE
.......................................................................................................................
14
ACTION
AND
CLINICAL
PHARMACOLOGY
....................................................................
14
STORAGE
AND
STABILITY
.................................................................................................
16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 17
PART II: SCIENTIFIC INFORMATION
..............................................................................
18
PHARMACEUTICAL
INFORMATION
.................................................................................
18
CLINICAL
TRIALS
.......................................................................