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

Riik: Rootsi

keel: rootsi

Allikas: Läkemedelsverket (Medical Products Agency)

Toimeaine:

flutikasonpropionat; salmeterolxinafoat

Saadav alates:

Neutec lnhaler lreland Limited

ATC kood:

R03AK06

INN (Rahvusvaheline Nimetus):

fluticasone propionate; salmeterol

Annus:

50 mikrogram/250 mikrogram/dos

Ravimvorm:

Inhalationspulver, avdelad dos

Koostis:

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

Retsepti tüüp:

Receptbelagt

Toote kokkuvõte:

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

Volitamisolek:

Godkänd

Loa andmise kuupäev:

2020-02-11

Toote omadused

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