OMNARIS HFA AEROSOL, METERED DOSE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CICLESONIDE

Tersedia dari:

TAKEDA CANADA INC

Kode ATC:

R01AD13

INN (Nama Internasional):

CICLESONIDE

Dosis:

50MCG

Bentuk farmasi:

AEROSOL, METERED DOSE

Komposisi:

CICLESONIDE 50MCG

Rute administrasi :

NASAL

Unit dalam paket:

30/60 ACTUATIONS

Jenis Resep:

Prescription

Area terapi:

CORTICOSTEROIDS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-02-10

Karakteristik produk

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