Abriff 250 mikrogram/10 mikrogram/puff Inhalationsspray, suspension

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

flutikasonpropionat; formoterolfumaratdihydrat

Dostopno od:

Mundipharma AB

Koda artikla:

R03AK11

INN (mednarodno ime):

fluticasone propionate; formoterol

Odmerek:

250 mikrogram/10 mikrogram/puff

Farmacevtska oblika:

Inhalationsspray, suspension

Sestava:

formoterolfumaratdihydrat 10 mikrog Aktiv substans; etanol, vattenfri Hjälpämne; flutikasonpropionat 250 mikrog Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Inhalator, 120 puffar

Status dovoljenje:

Godkänd

Datum dovoljenje:

2019-04-11

Navodilo za uporabo

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ABRIFF 50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION,
SUSPENSION
ABRIFF 125 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
ABRIFF 250 MICROGRAM /10 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
fluticasone propionate/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
ABRIFF
is and what it is used for
2.
What you need to know before you use
ABRIFF
3.
How to use
ABRIFF
4.
Possible side effects
5.
How to store
ABRIFF
6.
Contents of the pack and other information
1.
WHAT ABRIFF IS AND WHAT IT IS USED FOR
Please note:-
ABRIFF
pressurised inhalation, suspension is the product name, however
throughout this leaflet it is
shortened to
ABRIFF
inhaler. Sometimes this may refer to a specific strength.
ABRIFF
is an inhaler (a pressurised inhalation suspension) which contains two
active ingredients:

Fluticasone propionate which belongs to a group of medicines called
steroids. Steroids help to reduce
swelling and inflammation in the lungs.

Formoterol fumarate dihydrate which belongs to a group of medicines
called long-acting beta
2
agonists.
Long-acting beta
2
agonists are long-acting bronchodilators which help the airways in
your lungs to stay
open, making it easier for you to breathe.
Together these two active ingredients help to improve your breathing.
It is advised that you should use this
medicine every day as directed

Lastnosti izdelka

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Abriff 50 microgram/5 microgram per actuation pressurised inhalation,
suspension.
Abriff 125 microgram/5 microgram per actuation pressurised inhalation,
suspension.
Abriff 250 microgram/10 microgram per actuation pressurised
inhalation, suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:

50 micrograms of fluticasone propionate and 5 micrograms of formoterol
fumarate dihydrate. This is
equivalent to a delivered dose (ex-actuator) of approximately 46
microgram of fluticasone
propionate/4.5 microgram of formoterol fumarate dihydrate.

125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate. This is
equivalent to a delivered dose (ex-actuator) of approximately 115
microgram of fluticasone
propionate/4.5 microgram of formoterol fumarate dihydrate.

250 micrograms of fluticasone propionate and 10 micrograms of
formoterol fumarate dihydrate. This is
equivalent to a delivered dose (ex-actuator) of approximately 230
microgram of fluticasone
propionate/9.0 microgram of formoterol fumarate dihydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension
The canister contains white to off white liquid suspension. The
canister is in a white actuator with a grey
integrated dose indicator and a light grey mouthpiece cover.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This fixed-dose combination of fluticasone propionate and formoterol
fumarate () is
indicated in the regular treatment of asthma where the use of a
combination product (an inhaled
corticosteroid and a long -acting β
2
agonist) is appropriate:

For patients not adequately controlled with inhaled corticosteroids
and ‘as required’ inhaled short -acting
β
2
agonist.
Or

For patients already adequately controlled on both an inhaled
corticosteroid and a long-acting β
2
agonist.
50 microgram
_ /_
5 microgram per