Nasonex

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Mometasone furoate monohydrate 51.7ug equivalent to 50 mcg mometasone furoate

Mevcut itibaren:

Organon (New Zealand) Limited

INN (International Adı):

Mometasone furoate monohydrate 51.7 µg (= 50 mcg mometasone furoate)

Doz:

50 mcg/dose

Farmasötik formu:

Nasal spray solution

Kompozisyon:

Active: Mometasone furoate monohydrate 51.7ug equivalent to 50 mcg mometasone furoate Excipient: Benzalkonium chloride Citric acid monohydrate Dispersible cellulose Glycerol Polysorbate 80 Purified water Sodium citrate dihydrate

Paketteki üniteler:

Spray bottle, plastic, metered, polyethylene 40 actuations, 40 dose units

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

MSD International GmbH (Singapore Branch)

Terapötik endikasyonlar:

Nasonex nasal spray is indicated for the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis inadults, adolescents and children between the ages of 3 and 11 years.

Ürün özeti:

Package - Contents - Shelf Life: Spray bottle, plastic, metered, polyethylene - 40 dose units - 36 months from date of manufacture stored at or below 25°C - Spray bottle, plastic, metered, polyethylene, - 65 dose units - 36 months from date of manufacture stored at or below 25°C - Spray bottle, plastic, metered, polyethylene - 140 dose units - 36 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

1997-02-26

Ürün özellikleri

NEW ZEALAND DATA SHEET
1
S-CCDS-MK0887-NS-052017_D151105_v3.1
1.
NASONEX
® AQUEOUS NASAL SPRAY
50 micrograms/actuation nasal spray solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Mometasone furoate (as the monohydrate) 50 micrograms/actuation.
Excipient(s) with known effect
This medicinal product contains 0.02 mg of benzalkonium chloride per
actuation.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray solution.
White to off-white opaque suspension.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NASONEX Aqueous Nasal Spray 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 is also indicated for use in adults and
adolescents 12 years of age
and older as adjunctive treatment to antibiotics for acute episodes of
sinusitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSE _
DO NOT EXCEED THE RECOMMENDED DOSAGE.
Seasonal Allergic Rhinitis or Perennial Allergic Rhinitis
The effect of NASONEX Aqueous Nasal Spray 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.
In patients who have a history of moderate to severe symptoms of
seasonal allergic rhinitis, prophylactic
treatment with NASONEX Aqueous Nasal Spray is recommended two to four
weeks prior to the
anticipated start of the pollen season.
Clinically significant onset of action occurs as early as 12 hours
after the first dose.
Adults (including geriatric patients) and children 12 years of age and
over
The usual recommended dose for prophylaxis and treatment is two sprays
(50 micrograms/spray) in
each nostril once daily (total daily dose of 200 micrograms). Once
symptoms are controlled, reducing
the dose to one spray in each nostril (total daily dose of 100
micrograms) may be effective for