Neuair Airmaster 50 mikrogram/250 mikrogram/dos Inhalationspulver, avdelad dos

Ülke: İsveç

Dil: İsveççe

Kaynak: Läkemedelsverket (Medical Products Agency)

Aktif bileşen:

flutikasonpropionat; salmeterolxinafoat

Mevcut itibaren:

Neutec lnhaler lreland Limited

ATC kodu:

R03AK06

INN (International Adı):

fluticasone propionate; salmeterol

Doz:

50 mikrogram/250 mikrogram/dos

Farmasötik formu:

Inhalationspulver, avdelad dos

Kompozisyon:

laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans; flutikasonpropionat 250 mikrog Aktiv substans

Reçete türü:

Receptbelagt

Ürün özeti:

Förpacknings: Inhalator, 1 x 60 doser; Inhalator, 10 x 60 doser; Inhalator, 3 x 60 doser; Inhalator, 2 x 60 doser

Yetkilendirme durumu:

Godkänd

Yetkilendirme tarihi:

2020-02-11

Ürün özellikleri

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neuair Airmaster 50 microgram/100 microgram/ dose inhalation powder,
pre-dispensed
Neuair Airmaster 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neuair Airmaster 50 microgram /100 microgram
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 47 micrograms
of salmeterol (as salmeterol xinafoate) and 92 micrograms of
fluticasone propionate. This corresponds
to a pre-metered dose of 50 micrograms of salmeterol (as salmeterol
xinafoate) and 100 micrograms
fluticasone propionate.
Neuair Airmaster 50 microgram /250 microgram
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 45 micrograms
of salmeterol (as salmeterol xinafoate) and 229 micrograms of
fluticasone propionate. This
corresponds to a pre-metered dose of 50 micrograms of salmeterol (as
salmeterol xinafoate) and
250 micrograms fluticasone propionate.
Excipient with known effect
Each delivered dose contains approximately 13 milligrams of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Moulded plastic device containing a foil strip with 60 regularly
placed blisters. Each blister contains
pre-dispensed dose of white to off white inhalation powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neuair Airmaster is indicated in adults and adolescents 12 years of
age and older.
_ASTHMA_
Neuair Airmaster is indicated in the regular treatment of asthma where
use of a combination product
(long- acting β
2
agonist and inhaled corticosteroid) is appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
'as needed' inhaled short-
acting β
2
agonist
or
-
patients already adequately controlled on both inhaled corticosteroid
and long-acting β
2
agonist
Note: Neuair Airmaster 50 microgram /100 microgram strength is not
appropriate in adults and
children with