Salmeterol/Flutikason Devatis 25 mikrogram/250 mikrogram/dos Inhalationsspray, suspension

Land: Sverige

Språk: svensk

Kilde: Läkemedelsverket (Medical Products Agency)

Aktiv ingrediens:

flutikasonpropionat; salmeterolxinafoat

Tilgjengelig fra:

Devatis GmbH

ATC-kode:

R03AK06

INN (International Name):

fluticasone propionate; salmeterol

Dosering :

25 mikrogram/250 mikrogram/dos

Legemiddelform:

Inhalationsspray, suspension

Sammensetning:

flutikasonpropionat 250 mikrog Aktiv substans; salmeterolxinafoat 36,3 mg Aktiv substans

Resept typen:

Receptbelagt

Produkt oppsummering:

Förpacknings: Spraybehållare, 120 doser; Spraybehållare, 10 x 120 doser (sjukhusförpackning); Spraybehållare, 3 x 120 doser; Spraybehållare, 2 x 120 doser

Autorisasjon status:

Godkänd

Autorisasjon dato:

2019-01-25

Preparatomtale

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Salmeterol/Flutikason Devatis 25 microgram/250 microgram/actuation,
pressurised inhalation,
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
36.3 microgram salmeterol xinafoate equivalent to 25 micrograms of
salmeterol and 250 micrograms
of fluticasone propionate. This is equivalent to a delivered dose (ex
actuator) of 21 micrograms of
salmeterol and 220 micrograms of fluticasone propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension (pressurised inhalation).
White to off-white suspension in a metal container.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{invented name} 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
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Route of administration: Inhalation use.
Patients should be made aware that {invented name} must be used daily
for optimum benefit, even
when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of {invented name} they are
receiving remains optimal and is only changed on medical advice.
THE DOSE SHOULD BE TITRATED TO THE
LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS IS MAINTAINED.
WHERE THE CONTROL OF
SYMPTOMS IS MAINTAINED WITH {INVENTED NAME} 25/250 MICROGRAM/ACTUATION
GIVEN TWICE DAILY
THEN THE NEXT STEP COULD INCLUDE A SWAP TO A DIFFERENT INHALED
SALMETEROL FLUTICASONE PRODUCT
AVAILABLE IN LOWER STRENGTH (25/125 MICROGRAM OR 25/50 MICROGRAM).
As an alternative, patients requiring a long-acting β
2
-agonist could be titrated to {invented name}
given once daily if, in the opinion of the prescriber,