NASONEX aqueous nasal spray mometasone furoate 50 microgram/actuation (as monohydrate) spray

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

mometasone furoate, Quantity: 50 microgram/actuation

Boleh didapati daripada:

ORGANON PHARMA PTY LTD

Borang farmaseutikal:

Spray, suspension

Komposisi:

Excipient Ingredients: dispersible cellulose; citric acid monohydrate; glycerol; purified water; benzalkonium chloride; citric acid; sodium citrate dihydrate; polysorbate 80

Laluan pentadbiran:

Nasal

Unit dalam pakej:

65-dose, 40-dose, 140 metered sprays, 2 x 140 dose

Jenis preskripsi:

(S4) Prescription Only Medicine

Tanda-tanda terapeutik:

For the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis in adults, adolescents and children between the ages of 3 and 11 years. The treatment of nasal polyps in adult patients 18 years of age and older. For the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without the signs and symptoms of severe bacterial infection.

Ringkasan produk:

Visual Identification: A white to off-white opaque suspension; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Status kebenaran:

Registered

Tarikh kebenaran:

2001-02-14

Risalah maklumat

NASONEX
® AQUEOUS
NASAL SPRAY 0.05%
_Mometasone Furoate Monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NASONEX. 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 this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NASONEX IS
USED FOR
NASONEX contains the active
ingredient mometasone furoate. This
belongs to a family of medicines
called corticosteroids, which are used
to help reduce inflammation.
ALLERGIC RHINITIS (HAYFEVER):
NASONEX is sprayed into the nose
to help relieve symptoms that may
occur with hayfever or other year-
round allergies, including stuffiness
(congestion) in the nose, discharge,
itching and sneezing. Your doctor
may also prescribe this medicine to
help prevent these symptoms two to
four weeks before the beginning of
the pollen season.
NASAL POLYPS:
Swollen tissue in the nose can cause
grape-like swellings called 'polyps'.
Polyps can cause nasal stuffiness,
discomfort and loss of smell.
NASONEX can be used for the
treatment of nasal polyps in patients
over 18 years of age.
ACUTE RHINOSINUSITIS:
Rhinosinusitis is the swelling of the
sinuses resulting in stuffiness of the
nose, large quantities of mucus from
the nose, cough, face pain and/or
fever. These symptoms usually last
for less than 4 weeks. NASONEX is
used to treat the symptoms of
rhinosinusitis in adults and children
12 years of age and older, who do not
have the signs or symptoms of a
severe bacterial infection.
YOUR DOCTOR MAY HAVE PRESCRIBED
IT FOR ANOTHER REASON. ASK YOUR
DOCTOR IF YOU HAVE ANY QUESTIONS
ABOUT WHY THIS MEDICINE HAS BEEN
PRESCRIBED FOR YOU.
There is no evidence that this
medicine is addictive.
This medicine is available only w

Ciri produk

S-CCDS-MK0887-NS-082017
1
AUSTRALIAN PRODUCT INFORMATION –
NASONEX
® AQUEOUS NASAL SPRAY 0.05%, ALCOHOL FREE
(MOMETASONE FUROATE MONOHYDRATE)
1
NAME OF THE MEDICINE
Mometasone furoate (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NASONEX Aqueous Nasal Spray 0.05% is a metered-dose, manual pump spray
unit containing
a
suspension
of
mometasone
furoate.
Each
actuation
delivers
approximately
100 mg
of
mometasone furoate monohydrate suspension, containing mometasone
furoate monohydrate
equivalent to mometasone furoate 50 micrograms.
NASONEX
Aqueous
Nasal
Spray
0.05%
contains
mometasone furoate
0.5 mg/g (as
the
monohydrate).
For the full list of
excipients, see Section 6.1 LIST OF EXCIPIEINTS.
3
PHARMACEUTICAL FORM
Nasal Spray, suspension
NASONEX Aqueous Nasal Spray 0.05% does not contain fluorocarbon
propellants.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NASONEX Aqueous Nasal Spray 0.05% is indicated for the treatment of
symptoms associated
with seasonal allergic rhinitis and perennial allergic rhinitis and
the prophylaxis of seasonal
allergic rhinitis in adults, adolescents and children between the ages
of 3 and 11 years.
NASONEX Aqueous Nasal Spray 0.05% is also indicated for the treatment
of nasal polyps in
adult patients 18 years of age and older.
NASONEX Aqueous Nasal Spray 0.05% is indicated for the treatment of
symptoms associated
with acute rhinosinusitis in patients 12 years of age and older
without signs or symptoms of
severe bacterial infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
DO NOT EXCEED THE RECOMMENDED DOSAGE.
The effect of NASONEX Aqueous Nasal Spray 0.05% is not immediate. Full
therapeutic benefit
takes a few days to develop. Dosage should be administered as directed
and not be taken by
the patients at will for symptomatic relief.
S-CCDS-MK0887-NS-082017
2
Administration to young children should be aided by an adult.
ALLERGIC RHINITIS
In patients who have a history of moderate to severe symptoms of
seasonal allergic rhinitis,
prophylactic treatment with NASONEX Aqueous