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

Land: Svíþjóð

Tungumál: sænska

Heimild: Läkemedelsverket (Medical Products Agency)

Virkt innihaldsefni:

flutikasonpropionat; salmeterolxinafoat

Fáanlegur frá:

Neutec lnhaler lreland Limited

ATC númer:

R03AK06

INN (Alþjóðlegt nafn):

fluticasone propionate; salmeterol

Skammtar:

50 mikrogram/250 mikrogram/dos

Lyfjaform:

Inhalationspulver, avdelad dos

Samsetning:

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

Gerð lyfseðils:

Receptbelagt

Vörulýsing:

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

Leyfisstaða:

Godkänd

Leyfisdagur:

2020-02-12

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Campona Airmaster 50 microgram/100 microgram/ dose inhalation powder,
pre-dispensed
Campona Airmaster 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Campona 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.
Campona 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
Campona Airmaster is indicated in adults and adolescents 12 years of
age and older.
_ASTHMA_
Campona 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: Campona Airmaster 50 microgram /100 microgram strength is not
appropriate in adults and
children w