Neuair Airmaster 50 mikrogram/500 mikrogram/dos Inhalationspulver, avdelad dos

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

flutikasonpropionat; salmeterolxinafoat

Dostępny od:

Neutec lnhaler lreland Limited

Kod ATC:

R03AK06

INN (International Nazwa):

fluticasone propionate; salmeterol

Dawkowanie:

50 mikrogram/500 mikrogram/dos

Forma farmaceutyczna:

Inhalationspulver, avdelad dos

Skład:

flutikasonpropionat 500 mikrog Aktiv substans; laktosmonohydrat Hjälpämne; salmeterolxinafoat 73 mikrog Aktiv substans

Typ recepty:

Receptbelagt

Podsumowanie produktu:

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

Status autoryzacji:

Godkänd

Data autoryzacji:

2020-02-11

Charakterystyka produktu

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neuair Airmaster 50 microgram/500 microgram/ dose inhalation powder,
pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 43 micrograms
of salmeterol (as salmeterol xinafoate) and 432 micrograms of
fluticasone propionate. This
corresponds to a pre-metered dose of 50 micrograms of salmeterol (as
salmeterol xinafoate) and
500 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
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Neuair Airmaster is indicated for the symptomatic treatment of
patients with COPD, with a
FEV
1
< 60 % predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have
significant symptoms despite regular bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients are to be made aware that Neuair Airmaster must be used daily
for optimal benefit, even when
asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Neuair Airmaster they are
receiving remains optimal and is o