BUDAMAX AQUEOUS NASAL SPRAY budesonide 32 microgram/actuation spray bottle

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

budesonide, Quantity: 0.64 mg/mL

Disponibil de la:

Johnson & Johnson Pacific Pty Ltd

Forma farmaceutică:

Spray, suspension

Compoziție:

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

Calea de administrare:

Nasal

Unități în pachet:

120 doses in 10mL

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

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

Rezumat produs:

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

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2000-08-24

Prospect

BUDAMAX
®
1
BUDAMAX
®
_Budesonide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Budamax.
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 Budamax
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING BUDAMAX, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
BUDAMAX.
You may need to read it again.
WHAT BUDAMAX IS
USED FOR
ALLERGIC RHINITIS
Budamax 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
Budamax is also used to treat nasal
polyps, which are small masses of
tissue that grow from the nose lining.
Budamax 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 BUDAMAX HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Budamax is not addictive.
Budamax is available only with a
doctor's prescription.
BEFORE YOU USE
BUDAMAX
_WHEN YOU MUST NOT USE IT _
DO NOT USE BUDAMAX 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:
−
rash, itching or hives on the

Caracteristicilor produsului

1
PRODUCT INFORMATION- BUDAMAX AQUEOUS NASAL SPRAY
(BUDESONIDE), SUSPENSION
1
NAME OF THE MEDICINE
Budesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BUDAMAX contains 32 μg (not available in Australia) 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 in adults and children
6 years and older 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
those randomised to