Rilast mite Turbuhaler 80 mikrogram/4,5 mikrogram/inhalation Inhalationspulver

מדינה: שוודיה

שפה: שוודית

מקור: Läkemedelsverket (Medical Products Agency)

מרכיב פעיל:

budesonid; formoterolfumaratdihydrat

זמין מ:

Orifarm AB

קוד ATC:

R03AK07

INN (שם בינלאומי):

budesonide; formoterol

כמות:

80 mikrogram/4,5 mikrogram/inhalation

טופס פרצבטיות:

Inhalationspulver

הרכב:

formoterolfumaratdihydrat 4,5 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; budesonid 80 mikrog Aktiv substans

סוג מרשם:

Receptbelagt

איזור תרפויטי:

Formoterol och budesonid

מצב אישור:

Avregistrerad

תאריך אישור:

2004-04-01

עלון מידע

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
GARDETTE MITE 80 MICROGRAMS/4.5 MICROGRAMS /INHALATION, INHALATION
POWDER
Budesonide/Formoterol fumarate dihydrate
READ ALL OF 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 only. 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 Gardette mite is and what it is used for
2.
What you need to know before you use Gardette mite
3.
How to use Gardette mite
4.
Possible side effects
5.
How to store Gardette mite
6.
Contents of the pack and other information
1.
WHAT GARDETTE MITE IS AND WHAT IT IS USED FOR
Gardette mite is an inhaler that is used to treat asthma in adults,
adolescents and children aged 6 years
and older. It contains two different medicines: budesonide and
formoterol fumarate dihydrate.

Budesonide belongs to a group of medicines called
‘corticosteroids’. It works by
reducing and preventing swelling and inflammation in your lungs.

Formoterol fumarate dihydrate belongs to a group of medicines called
‘long-acting beta
2
adrenoceptor agonists’ or ‘bronchodilators’. It works by
relaxing the muscles in your
airways. This helps you to breathe more easily.
This medicine is not suitable for people with severe asthma. It can be
prescribed for asthma in two
different ways.
A) SOME PEOPLE ARE PRESCRIBED TWO ASTHMA INHALERS: GARDETTE MITE AND A
SEPARATE ‘RELIEVER
INHALER’.

They use Gardette mite every day. This helps to prevent asthma
symptoms from
happening.

They use their ‘reliever inhaler’ when they get asthma symptoms,
to make it easier to
breathe again.
B

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Gardette mite, 80 micrograms/4.5 micrograms/inhalation, inhalation
powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each delivered dose (the dose that leaves the mouthpiece) contains:
budesonide
80 micrograms/inhalation and formoterol fumarate dihydrate 4.5
micrograms/inhalation.
Each metered dose contains: budesonide 100 micrograms/inhalation and
formoterol fumarate
dihydrate 6 micrograms/inhalation.
Excipient with known effect
Lactose monohydrate 810 micrograms per delivered dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder.
White powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gardette mite is indicated in adults, adolescents, and children aged 6
years and older.
Gardette is indicated in the regular treatment of asthma where use of
a combination (inhaled
corticosteroid and long-acting β
2
adrenoceptor agonist) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
“as needed” inhaled short-
acting β
2
adrenoceptor agonists.
or
-
patients already adequately controlled on both inhaled corticosteroids
and long-acting β
2
adrenoceptor agonists.
NOTE:
Gardette mite (80 micrograms/4.5 micrograms/inhalation) is not
appropriate in patients with
severe asthma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: For inhalation use
Posology
Gardette is not intended for the initial management of asthma.
The dosage of the components of Gardette is individual and should be
adjusted to the severity of the
disease. This should be considered not only when treatment with
combination products is initiated but
also when the maintenance dose is adjusted. If an individual patient
should require a combination of
doses other than those available in the combination inhaler,
appropriate doses of β
2
adrenoceptor
agonists and/or corticosteroids by individual inhalers should be
prescribed.
3
The dose should be titrated to the lowest dose at whic