Nasonex spray nasal (suspension)

国家: 亚美尼亚

语言: 英文

来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

有效成分:

mometasone (mometasone furoate)

可用日期:

Schering-Plough Labo N.V.

ATC代码:

R01AD09

INN（国际名称）:

mometasone (mometasone furoate)

剂量:

50mcg/dose

药物剂型:

spray nasal (suspension)

每包单位数:

18g (140 dose) plastic bottle with spray pump 18g (140 dose)

处方类型:

Prescription

授权状态:

Registered

授权日期:

2021-06-29

产品特点

2
[Organon] Proprietary
SUMMARY OF PRODUCT CHARACTERISTICS
10
[Organon] Proprietary
1.
NAME OF THE MEDICINAL PRODUCT
NASONEX
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_composition: _one spray dose contains mometasone furoate monohydrate
equivalent to 50 mcg
mometasone furoate (anhydrous).
_excipients: _dispersible cellulose, glycerol, sodium citrate
dehydrate, citric acid, polysorbate 80,
benzalkonium chloride, purified water.
3.
PHARMACEUTICAL FORM
A metered-dose nasal spray.
_basic physical and chemical properties_: white to off-white powder
opaque suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of seasonal allergic or perennial rhinitis in adults and
children 2 years of age and
older.
•
In patients 12 years of age and older who have a history of moderate
to severe symptoms of
seasonal allergic rhinitis, prophylactic treatment may be initiated up
to 2-4 weeks prior to the
anticipated start of the pollen season.
•
Treatment of symptoms associated with acute rhinosinusitis in patients
12 years of age and
older without signs of severe bacterial infection.
•
Treatment of nasal polyps and associated symptoms including congestion
and loss of smell
in adult patients 18 years of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Treatment of seasonal or perennial allergic rhinitis: _for adults
(including geriatric patients) and
children 12 years of age and older the recommended preventive and
therapeutic dose is 2
actuations (50 micrograms/actuation) in each nostril once daily (total
dose 200 micrograms).
Once symptoms are controlled, dose reduction to one actuation in each
nostril (total dose 100
micrograms) may be effective for maintenance.
If symptoms are inadequately controlled at the recommended therapeutic
dose, the daily dose
may be increased to a maximum daily dose: of 4 actuations in each
nostril once daily (total
dose 400 micrograms). Dose reduction is recommended following control
of symptoms.
This medicinal product demonstrates a clinically significant onset of
ac