RHINOCORT TURBUHALER 100 MCG/DOSE POWDER

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

BUDESONIDE

Saatavilla:

ASTRAZENECA CANADA INC

ATC-koodi:

R01AD05

INN (Kansainvälinen yleisnimi):

BUDESONIDE

Annos:

100MCG

Lääkemuoto:

POWDER

Koostumus:

BUDESONIDE 100MCG

Antoreitti:

INHALATION

Kpl paketissa:

200 DOSES

Prescription tyyppi:

Prescription

Terapeuttinen alue:

CORTICOSTEROIDS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0116807002; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2020-02-27

Valmisteyhteenveto

COPYRIGHT 1993-2018 ASTRAZENECA CANADA INC.
PRODUCT MONOGRAPH
RHINOCORT
® TURBUHALER
®
Budesonide Dry Powder for Nasal Inhalation
100 mcg/metered dose
Corticosteroid for Nasal Use
AstraZeneca Canada Inc.
1004 Middlegate Road
Mississauga, Ontario
L4Y 1M4
www.astrazeneca.ca
Date of Revision:
June 13, 2018
Control No. 215281
RHINOCORT
®
, TURBUHALER
®
and the AstraZeneca logo are registered trademarks of
AstraZeneca AB, used under license by AstraZeneca Canada Inc.
- 2 -
COPYRIGHT 1993-2018 ASTRAZENECA CANADA INC.
RHINOCORT
® TURBUHALER
®
Budesonide Dry Powder for Nasal Inhalation
100 mcg/metered dose
ACTIONS AND CLINICAL PHARMACOLOGY
RHINOCORT TURBUHALER contains pure budesonide which is a potent
synthetic
glucocorticosteroid with strong topical and weak systemic effects.
RHINOCORT TURBUHALER has a high topical anti-inflammatory potency and
it is rapidly
biotransformed in the liver. This favourable separation between
topical anti-inflammatory
activity and systemic effect is due to strong glucocorticosteroid
receptor affinity and an
effective first-pass metabolism with a short half-life. The mechanism
of action of intranasally
administered budesonide has not yet been completely defined.
INDICATIONS AND CLINICAL USE
The treatment of seasonal allergic and allergic/non-allergic perennial
and vasomotor rhinitis
unresponsive to conventional therapy. Also indicated for the treatment
of nasal polyps and the
prevention of nasal polyps after polypectomy.
CONTRAINDICATIONS

Hypersensitivity to budesonide;

Active or quiescent tuberculosis;

Untreated fungal, bacterial or viral infections;

Children under 6 years of age.
WARNINGS
In patients previously on prolonged periods or high doses of systemic
steroids, withdrawal of
steroids may cause symptoms such as tiredness, aches and pains, and
depression. In severe
cases, adrenal insufficiency may occur necessitating a temporary
resumption of systemic
steroids.
Careful attention must be given to patients with asthma or other
clinical conditions in whom a
rapid dec