Affera K-haler 125 mikrogram/5 mikrogram/puff Inhalationsspray, suspension

Negara: Swedia

Bahasa: Swedia

Sumber: Läkemedelsverket (Medical Products Agency)

Selebaran informasi Selebaran informasi (PIL)
14-03-2019
Karakteristik produk Karakteristik produk (SPC)
11-04-2019

Bahan aktif:

flutikasonpropionat; formoterolfumaratdihydrat

Tersedia dari:

Mundipharma AB

Kode ATC:

R03AK11

INN (Nama Internasional):

fluticasone propionate; formoterol

Dosis:

125 mikrogram/5 mikrogram/puff

Bentuk farmasi:

Inhalationsspray, suspension

Komposisi:

etanol, vattenfri Hjälpämne; flutikasonpropionat 125 mikrog Aktiv substans; formoterolfumaratdihydrat 5 mikrog Aktiv substans

Jenis Resep:

Receptbelagt

Ringkasan produk:

Förpacknings: Inhalator, 3 x 120 puffar; Inhalator, 120 puffar

Status otorisasi:

Avregistrerad

Tanggal Otorisasi:

2019-04-11

Selebaran informasi

                                1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AFFERA K-HALER 50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED
INHALATION, SUSPENSION
AFFERA K-HALER 125 MICROGRAM /5 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

is and what it is used for
2.
What you need to know before you use

3.
How to use

4.
Possible side effects
5.
How to store

6.
Contents of the pack and other information
1.
WHAT  IS AND WHAT IT IS USED FOR
Please note:-

pressurised inhalation, suspension is the full name of the product,
however throughout
this leaflet it is referred to as

or simply as an inhaler, sometimes together with a reference
to a specific strength.

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 sh
                                
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Karakteristik produk

                                MARKNADSFÖRS EJ FÖR NÄRVARANDE.
_Produktinformation_
                                
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Dokumen dalam bahasa lain

Selebaran informasi Selebaran informasi Inggris 14-03-2019
Karakteristik produk Karakteristik produk Inggris 11-04-2019
Laporan Penilaian publik Laporan Penilaian publik Inggris 12-05-2020