Nasonex 50 micrograms/actuation Nasal Spray, Suspension

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Mometasone furoate

제공처:

Imbat Limited

ATC 코드:

R01AD; R01AD09

INN (국제 이름):

Mometasone furoate

복용량:

50 Mcg/Acutuation

약제 형태:

Nasal spray, suspension

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Corticosteroids; mometasone

승인 상태:

Authorised

승인 날짜:

2008-02-01

환자 정보 전단

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
NASONEX
® 50 MICROGRAMS/ACTUATION
NASAL SPRAY, SUSPENSION
(mometasone furoate)
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
WHAT NASONEX IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASONEX
3.
HOW TO USE NASONEX
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE NASONEX
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT NASONEX IS AND WHAT IT IS USED FOR
WHAT IS NASONEX?
Nasonex Nasal Spray contains mometasone furoate, one of a group of
medicines called
corticosteroids. When mometasone furoate is sprayed into the nose, it
can help to relieve
inflammation (swelling and irritation of the nose), sneezing, itching
and a blocked up or runny
nose.
WHAT IS NASONEX USED FOR?
Hay fever and perennial rhinitis
Nasonex is used to treat the symptoms of hay fever (also called
seasonal allergic rhinitis) and
perennial rhinitis in adults and children aged 3 and older.
Hay fever, 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. Nasonex reduces
the swelling and irritation in your nose and thereby relieving
sneezing, itching and a blocked-up
or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Nasonex is used to treat nasal polyps

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasonex 50 micrograms/actuation Nasal Spray, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered actuation (spray) delivers 50 micrograms of mometasone
furoate (as the monohydrate).
Excipient: Benzalkonium chloride
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal Spray, Suspension.
_Product imported from the UK and Greece:_
White to off-white opaque suspension.
4 CLINICAL PARTICULARS
As per PA1286/038/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/038/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Dispersable cellulose
Glycerol
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 80
Benzalkonium chloride
Purified water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
Discard two months after first opening.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not freeze.
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6.5 NATURE AND CONTENTS OF CONTAINER
Nasal spray in a cardboard outer. 140 actuations
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUC