AVAMYS

Страна: Израиль

Язык: английский

Источник: Ministry of Health

Активный ингредиент:

FLUTICASONE FUROATE

Доступна с:

GLAXO SMITH KLINE (ISRAEL) LTD

код АТС:

R01AD12

Фармацевтическая форма:

SPRAY

состав:

FLUTICASONE FUROATE 27.5 MCG/DOSE

Администрация маршрут:

NASAL

Тип рецепта:

Required

Производитель:

GLAXO OPERATIONS (UK) LIMITED

Терапевтическая группа:

FLUTICASONE

Терапевтические области:

FLUTICASONE FUROATE

Терапевтические показания :

AVAMYS (fluticasone furoate) Nasal Spray is indicated for the treatment of the symptoms of seasonal and perennial allergic rhinitis in patients aged 2 years and older.

Дата Авторизация:

2014-10-31

тонкая брошюра

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a physician's prescription only
AVAMYS
NASAL SPRAY
EACH SPRAY RELEASES FLUTICASONE FUROATE 27.5 MCG
The list of additional ingredients is detailed in section 6. Pay
attention to the
important information about some of the ingredients of the medicine in
section
2.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This
leaflet contains concise information about the medicine. If you have
further
questions, refer to the physician or the pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not
pass it on to others. It may harm them even if it seems to you that
their
ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Avamys is intended for the treatment of symptoms of seasonal and
perennial
allergic rhinitis in patients aged 2 years and older.
THERAPEUTIC GROUP: Corticosteroids
Avamys is used to treat symptoms of allergic rhinitis including:
stuffy nose,
runny nose, itchy nose, sneezing, and watery, itchy and red eyes.
Avamys contains the active ingredient fluticasone furoate. This
medicine
belongs
to
a
group
of
medicines
known
as
corticosteroids,
which
are
frequently called “steroids”. These are not “anabolic
steroids” which athletes
often abuse.
Avamys reduces the inflammation caused by allergy (rhinitis).
Avamys is not addictive.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients contained in the medicine as detailed in section 6.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE BEGINNING TREATMENT WITH AVAMYS, TELL YOUR PHYSICIAN IF:
•
you are allergic to foods, dyes, preservatives or other medicines.
DURING THE COURSE OF TREATMENT WITH AVAMYS, REFER TO YOUR PHYSICIAN
IF:
•
you experience vision changes.
CHILDREN AND ADOLESCENTS
Avamys is not intended for children under two years of age.
DRUG INTERACTIONS
IF YOU ARE TAK

Характеристики продукта

1
AVAMYS
1.
NAME OF THE MEDICINE
AVAMYS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AVAMYS Nasal Spray is a white suspension of micronised fluticasone
furoate for
topical administration to the nasal mucosa by means of a metering
atomising spray
pump. Each spray of the suspension delivers approximately 27.5
micrograms of
micronised fluticasone furoate as an ex-device dose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
Spray
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
AVAMYS (fluticasone furoate) Nasal Spray is indicated for the
treatment of the
symptoms of seasonal and perennial allergic rhinitis in patients aged
2 years and
older.
4.2
DOSE AND METHOD OF ADMINISTRATION
Administer AVAMYS Nasal Spray by the intranasal route only. Prime
AVAMYS Nasal
Spray before using for the first time by shaking the contents well and
releasing 6
sprays into the air away from the face. When AVAMYS Nasal Spray has
not been
used for more than 30 days or if the cap has been left off the bottle
for 5 days or
longer, prime the pump again until a fine mist appears. Shake AVAMYS
Nasal Spray
well before each use.
Titrate an individual patient to the minimum effective dosage to
reduce the possibility
of side effects.
ADULTS AND ADOLESCENTS AGED 12 YEARS AND OLDER
The recommended starting dosage is 110 mcg once daily administered as
2 sprays
(27.5 mcg/spray) in each nostril. When the maximum benefit has been
achieved and
symptoms have been controlled, reducing the dosage to 55 mcg (1 spray
in each
nostril) once daily may be effective in maintaining control of
allergic rhinitis symptoms.
CHILDREN AGED 2 TO 11 YEARS
The recommended starting dosage in children is 55 mcg once daily
administered as
2
1 spray (27.5 mcg/spray) in each nostril. Children not adequately
responding to 55
mcg may use 110 mcg (2 sprays in each nostril) once daily. Once
symptoms have
been controlled, dosage reduction to 55 mcg once daily is recommended.
4.3
CONTRAINDICATIONS
AVAMYS is contraindicated in patients with a