Momate Nasal Spray (Mometasone Furoate 50 mcgspray)

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

MOMETASONE FUROATE

Доступна з:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

ІПН (Міжнародна Ім'я):

MOMETASONE FUROATE

Одиниць в упаковці:

60 ACTUATIONS; 120 ACTUATIONS; 140 ACTUATIONS

Виробник:

Glenmark Pharmaceuticals Ltd.

інформаційний буклет

_CONSUMER_
_ _
_MEDICATION_
_ _
_INFORMATION_
_ _
_LEAFLET_
_ _
_(RIMUP) _
MOMATE™ NASAL SPRAY
MOMETASONE FUROATE 50 MCG/ SPRAY
What is in this leaflet
1.
What MOMATE is used for
2.
How
MOMATE
works
3.
Before you use MOMATE
4.
How to use MOMATE
5.
While you are using it
6.
Side
Effects
7.
Storage and Disposal of
MOMATE
8.
Product
Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT IS MOMATE AND WHAT
IS IT USED FOR?
MOMATE
contains
mometasone
furoate, one of a group of medicines
called corticosteroids. Momate is used
in
adults,
adolescents
and
children
between the ages of 3 and 11 years to
treat the symptoms of hayfever (also
called seasonal allergic rhinitis) and
perennial
rhinitis.
In
adults
and
adolescents
aged
18
and
over,
MOMATE is also used to treat nasal
polyps. In patients aged 12 and over
without signs or symptoms of severe
bacterial infection, MOMATE is used
to treat acute rhinosinusitis.
WHAT
IS
HAYFEVER
AND
PERENNIAL
RHINITIS?
Hayfever,
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.
Momate
reduces the swelling and irritation in
your nose and so relieves sneezing,
itching and 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.
Momate
Nasal
Spray
reduces the inflammation in the nose,
causing the polyps to gradually shrink,
thereby relieving a blocked feeling in
the nose
which may affect breathing through
the nose. Watering from the nose, a
feeling
of
something
running
down
the back of the throat and loss of taste
and smell may also occur. MOMATE
reduces the inf

Характеристики продукта

SAME SIZE ARTWORK
LEAFLET SIZE: 276 mm x 135 mm
FOLDING SIZE: 23 mm x 135 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
23 mm
25 mm
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE:
PE50767
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
NASAL SPRAY
MOMETASONE FUROATE 50 MCG/SPRAY
60/120/140 METERED DOSES
_For the use only of Registered Medical Practitioner or a _
_Hospital or a Laboratory_
COMPOSITION
Mometasone Furoate Monohydrate equivalent to
Mometasone Furoate
0.05% w/w
Each spray delivers:
Mometasone Furoate monohydrate equivalent to
Mometasone Furoate
50 mcg
Preservative:
Benzalkonium Chloride BP
0.02% w/w
Excipients
q.s
FOR INTRANASAL ADMINISTRATION
DESCRIPTION:
Mometasone Furoate Aqueous Nasal Spray is a metered-dose, manual pump
spray unit
containing a suspension of mometasone furoate. Each metered dose pump
actuation of
Mometasone
Furoate
Aqueous
Nasal
Spray
delivers
approximately
100
mg
of
mometasone
furoate
suspension,
containing
mometasone
furoate
monohydrate
equivalent to 50 micrograms mometasone furoate.
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
morepotent than
other
steroids,
including
beclomethasone
dipropionate
(BDP),
betamethasone,
hydrocortisone and dexamethasone; at inhibiting thesynthesis/release
of IL-1, IL-6 and
TNF-
α
. Mometasone furoate (IC = 0.12 Nm) wasalso at least six times more
potent than
50
BDP and betamethasone at inhibiting IL-5 production. Also, in mixed
leucocytes from
atopic patients, mometasone was a more potent leukotriene pr