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

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

flutikasonpropionat; salmeterolxinafoat

Tillgänglig från:

Neutec lnhaler lreland Limited

ATC-kod:

R03AK06

INN (International namn):

fluticasone propionate; salmeterol

Dos:

50 mikrogram/500 mikrogram/dos

Läkemedelsform:

Inhalationspulver, avdelad dos

Sammansättning:

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

Receptbelagda typ:

Receptbelagt

Produktsammanfattning:

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

Bemyndigande status:

Godkänd

Tillstånd datum:

2020-02-12

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Campona 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
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
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Campona 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 Campona Airmaster must be used
daily for optimal benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Campona Airmaster they
are receiving remains optimal and is