RHINOCORT AQUEOUS NASAL SPRAY budesonide 64 microgram/actuation spray bottle

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

budesonide, Quantity: 1.28 mg/mL

Verfügbar ab:

Johnson & Johnson Pacific Pty Ltd

Darreichungsform:

Spray, suspension

Zusammensetzung:

Excipient Ingredients: glucose; disodium edetate; dispersible cellulose; polysorbate 80; purified water; hydrochloric acid; potassium sorbate

Verabreichungsweg:

Nasal

Einheiten im Paket:

2 x 120 doses in 10mL, 50 doses in 10mL (sample pack), 1 x 120 doses in 10mL

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

Rhinitis: Prophylaxis and treatment of seasonal allergic rhinitis. Prophylaxis and treatment of perennial allergic rhinitis. Nasal Polyps: Treatment of nasal polyps.

Produktbesonderheiten:

Visual Identification: White to off-white, viscous thixotropic suspension.; Container Type: Bottle; Container Material: Glass Type II Coloured; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2000-08-24

Gebrauchsinformation

RHINOCORT
®
1
RHINOCORT
®
_Budesonide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Rhinocort.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Rhinocort
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING RHINOCORT, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
RHINOCORT.
You may need to read it again.
WHAT RHINOCORT IS
USED FOR
ALLERGIC RHINITIS
Rhinocort is sprayed into the nose to
help prevent and treat allergic
rhinitis). Allergic rhinitis is an
inflammation or swelling of the nose
lining (which may cause blockage,
runny nose, itching and/or sneezing).
This is often, but not always, due to
an allergy to something in the air (eg
pollen, dust mites).
You may have symptoms only during
spring or summer. This type of
allergy is generally due to various
pollens and is commonly referred to
as hayfever. Some people may
experience symptoms all year round.
This is usually caused by house dust
mites, pets or moulds and is
commonly referred to as perennial
allergic rhinitis
NASAL POLYPS
Rhinocort is also used to treat nasal
polyps, which are small masses of
tissue that grow from the nose lining.
Rhinocort contains budesonide.
This belongs to a family of medicines
called corticosteroids, which are used
to help reduce inflammation.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY RHINOCORT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Rhinocort is not addictive.
Rhinocort is available only with a
doctor's prescription.
BEFORE YOU USE
RHINOCORT
_WHEN YOU MUST NOT USE IT _
DO NOT USE RHINOCORT IF:
1.
YOU HAVE AN ALLERGY TO:
•
any medicines containing
budesonide
•
any of the ingredients listed at the
end of this leaflet.
•
Other corticosteroid medicines
Some of the symptoms of an
allergic reaction may include:
−

Fachinformation

1
PRODUCT INFORMATION- RHINOCORTAQUEOUS NASAL SPRAY
(BUDESONIDE) SUSPENSION
1
NAME OF THE MEDICINE
Budesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RHINOCORT contains 32 μg (not available as a Prescription only
medicine) or 64 μg budesonide
Per actuation
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Spray suspension.
White to off-white, viscous thixotropic suspension.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
RHINITIS
Prophylaxis and treatment of seasonal and perennial allergic rhinitis
NASAL POLYPS
Treatment of nasal polyps.
4.2
D
OSE AND METHOD OF ADMINISTRATION
There is no evidence that efficacy improves when the recommended dose
is exceeded.
FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS (ADULTS AND CHILDREN 6
YEARS AND OVER) AND
PERENNIAL ALLERGIC RHINITIS (ADULTS).
INITIALLY
Total daily dose, 256 micrograms given as either a single daily
application of 128 micrograms
into each nostril in the morning, or divided into two applications of
64 micrograms into each
nostril, morning and evening.
MAINTENANCE – INDIVIDUALISATION OF DOSAGE
When a satisfactory therapeutic response has been achieved, the
maintenance dose should be
titrated to the minimum effective dose. This may be a total daily dose
of 128 micrograms given
as 64 micrograms into each nostril in the morning, however clinical
trials suggest that a
maintenance dose of 32 micrograms in each nostril in the morning may
be sufficient in some
patients.
2
Continuous long-term use in children is not recommended due to the
possibility of growth
suppression. Whilst no long-term studies are available for intranasal
budesonide, long-term
studies in a clinical practice environment suggest that children
treated with orally inhaled
budesonide on average achieve their adult target height. However, in a
long-term double-blind
study, in which the budesonide dose was generally not titrated to the
lowest effective dose,
children treated with inhaled budesonide became on average 1.2 cm
shorter as adults than
th