Exnise Nasal Spray 0.05% wv

Страна: Сингапур

Език: английски

Източник: HSA (Health Sciences Authority)

Активна съставка:

Mometasone furoate monohydrate eqv mometasone furoate

Предлага се от:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

АТС код:

R01AD09

Лекарствена форма:

SPRAY, SUSPENSION

Композиция:

Mometasone furoate monohydrate eqv mometasone furoate 0.05% w/v

Начин на приложение:

NASAL

Вид предписание :

Prescription Only

Произведено от:

Teva Czech Industries s.r.o.

Статус Оторизация:

ACTIVE

Дата Оторизация:

2021-08-30

Листовка

IN THIS LEAFLET:
1.
What EXNISE is and what it is used for
2.
Before you use EXNISE
3.
How to use EXNISE
4.
Possible side effects
5.
How to store EXNISE
6.
Further information
1. WHAT EXNISE IS AND WHAT IT IS USED FOR?
WHAT IS EXNISE?
EXNISE Nasal Spray contains mometasone furoate, one of a group of
medicines
called corticosteroids.
Mometasone furoate should not be confused with “anabolic” steroids
misused by some athletes and taken as
tablets or injections. When tiny amounts of mometasone furoate are
sprayed into the nose, it can help to relieve
inflammation, sneezing, itching and a blocked up or runny nose.
WHAT IS EXNISE USED FOR?
EXNISE is used in adults and children aged 2 and older to treat the
symptoms of seasonal or perennial rhinitis.
To help prevent moderate to severe symptoms of seasonal allergic
rhinitis, EXNISE may be used 2 to 4 weeks
before the beginning of the pollen season.
In adults aged 18 and over, EXNISE is also used to treat nasal polyps.
EXNISE may also be used in adults and children 12 years of age and
older for the treatment of symptoms of
acute rhinosinusitis (inflammation and blockage of the sinuses behind
the nose) without signs or symptoms of
bacterial infection.
WHAT IS SEASONAL AND PERENNIAL RHINITIS?
Seasonal allergic rhinitis, which occurs at certain times of the year,
is an allergic reaction caused by breathing in
pollen from trees, grasses, weeds and also moulds and fungal spores.
Perennial rhinitis occurs throughout the
year and symptoms can be caused by a sensitivity to a variety of
things including house dust mite, animal hair
(or dander), feathers and certain foods. These allergies cause a runny
nose and sneezing and make the lining of
the nose swell, causing a stuffy blocked-up feeling. EXNISE reduces
the swelling and irritation in your nose and
so relieves sneezing, itching and a blocked-up or runny nose.
WHAT ARE NASAL POLYPS?
Nasal polyps are small growths on the lining of the nose and usually
affect both nostrils.
The main symptom is a blocked feeling in the nose wh

Данни за продукта

DESCRIPTION:
EXNISE NASAL SPRAY is a milky white suspension of mometasone furoate
monohydrate filled into white high-density
polyethylene (HDPE) bottles. The nasal spray unit consists of the
white HDPE bottle, a pump and a separate actuator
with a cap. Each metered-dose pump actuation of EXNISE NASAL SPRAY
delivers approximately 100 mg of mometasone
furoate suspension, containing mometasone furoate monohydrate
equivalent to 50 micrograms mometasone furoate
Inactive ingredients: Microcrystalline cellulose and carmellose sodium
(Avicel RC-591), glycerol, citric acid monohydrate,
sodium citrate dihydrate, polysorbate 80, benzalkonium chloride and
purified water. Preservative: benzalkonium chloride.
ACTIONS: Mometasone furoate is a topical glucocorticosteroid with
local anti-inflammatory properties at doses that are
not systemically active.
PRECLINICAL PHARMACOLOGY AND TOXICOLOGY:
Preclinical studies demonstrate that mometasone furoate is devoid of
androgenic, antiandrogenic, estrogenic or
antiestrogenic activity but, like other glucocorticoids, it possesses
some antiuterotrophic activity and delays vaginal
opening in animal models at high oral doses of 56 mg/kg/day and 280
mg/kg/day.
In cell culture, mometasone furoate was shown to be at least ten times
more potent than other steroids, including
beclomethasone dipropionate (BDP), betamethasone, hydrocortisone and
dexamethasone, at inhibiting the synthesis/
release of IL-1, IL-6 and TNF
α
. Mometasone furoate (IC50 = 0.12 Nm) was also at least six times more
potent than
BDP and betamethasone at inhibiting IL-5 production. Also, in mixed
leukocytes from atopic patients, mometasone was
a more potent leukotriene production inhibitor than BDP.
In a preclinical model, the compound has been shown to reduce the
accumulation of eosinophils markedly at the site
of an allergic reaction. For example, in allergic mice with
IgE-mediated allergy, inhaled mometasone furoate at doses
as low as 10 micrograms/kg inhibited eosinophil infiltration into
bronchoalveolar lavage fluid and