ALVESCO AEROSOL, METERED DOSE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

CICLESONIDE

Saatavilla:

COVIS PHARMA GMBH

ATC-koodi:

R03BA08

INN (Kansainvälinen yleisnimi):

CICLESONIDE

Annos:

200MCG

Lääkemuoto:

AEROSOL, METERED DOSE

Koostumus:

CICLESONIDE 200MCG

Antoreitti:

INHALATION

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ADRENALS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151669002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2020-10-02

Valmisteyhteenveto

COPYRIGHT 2021 COVIS PHARMA GmbH
Page 1 of 37
PRODUCT MONOGRAPH
ALVESCO
®
ciclesonide inhalation aerosol
100 mcg and 200 mcg/ actuation (ex-valve)
Corticosteroid for oral inhalation
Covis Pharma GmbH
Baarn, Zug Branch
Grafenauweg 12
6300 Zug, Switzerland
www.covispharma.com
Importer:
Innomar Strategies Inc.
3470 Superior Court,
Oakville, ON
L6L 0C4
Canada
Date of Revision:
March 30, 2021
Submission Control No.: 249470
ALVESCO
®
is a registered trademark of Covis Pharma GmbH
The Covis logo is a registered trademark of Covis Pharma GmbH
COPYRIGHT 2021 COVIS PHARMA GmbH
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
.................................................................................................
8
DRUG INTERACTIONS
...............................................................................................
12
DOSAGE AND ADMINISTRATION
...........................................................................
13
OVERDOSAGE
..............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 15
STORAGE AND STABILITY
.......................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 18
PART II: SCIENTIFIC INFORMATION
..............................................................................
19
PHARMACEUTICAL INFORMATION
........