Atectura Breezhaler
Land: Den europeiske union
Språk: maltesisk
Kilde: EMA (European Medicines Agency)
Informasjon til brukeren
(PIL)
16-10-2023
Preparatomtale
(SPC)
16-10-2023
Offentlig vurderingsrapport
(PAR)
23-06-2020
Aktiv ingrediens:
indacaterol acetate, Mometasone furoate
Tilgjengelig fra:
Novartis Europharm Limited
ATC-kode:
R03AK
INN (International Name):
indacaterol, mometasone
Terapeutisk gruppe:
Mediċini għall-imblokkar tal-passaġġ tan-nifs mard,
Terapeutisk område:
Ażma
Indikasjoner:
Atectura Breezhaler is indicated as a maintenance treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.
Produkt oppsummering:
Revision: 9
Autorisasjon status:
Awtorizzat
Autorisasjon dato:
2020-05-30
Informasjon til brukeren
1
ANNESS 1
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Atectura Breezhaler 125 mikrogramma/127.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Atectura Breezhaler 125 mikrogramma/260 mikrogramma trab li jittieħed
man-nifs, kapsuli iebsa
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 80 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
62.5 mkg ta’ mometasone furoate.
Atectura Breezhaler 125 mikrogramma/127.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 160 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
127.5 mkg ta’ mometasone furoate.
Atectura Breezhaler 125 mikrogramma/260 mikrogramma trab li jittieħed
man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 320 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
260 mkg ta’ mometasone furoate.
Eċċipjent(i) b’effett magħruf
Kull kapsula fiha madwar 25 mg lattosju monoidrat.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Trab li jittieħed man-nifs, kapsula iebsa (trab li jittieħed
man-nifs).
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Il-kapsuli trasparenti (bla kulur) fihom trab abjad, bil-kodiċi
tal-prodott “IM150-80” stampat bil-blu
fuq strixxa waħda blu fuq il-qafas u bil-logo tal-prodott stampat
bil-blu u mdawwar b’żewġ strixxi blu
fuq it-tapp.
Atectura Breezhaler 125 mikrogramma/127.5 mikrog
Les hele dokumentet
Preparatomtale
1
ANNESS 1
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Atectura Breezhaler 125 mikrogramma/127.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Atectura Breezhaler 125 mikrogramma/260 mikrogramma trab li jittieħed
man-nifs, kapsuli iebsa
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 80 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
62.5 mkg ta’ mometasone furoate.
Atectura Breezhaler 125 mikrogramma/127.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 160 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
127.5 mkg ta’ mometasone furoate.
Atectura Breezhaler 125 mikrogramma/260 mikrogramma trab li jittieħed
man-nifs, kapsuli iebsa
Kull kapsula fiha 150 mkg ta’ indacaterol (bħala acetate) u 320 mkg
ta’ mometasone furoate.
Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 125
mkg ta’ indacaterol (bħala acetate) u
260 mkg ta’ mometasone furoate.
Eċċipjent(i) b’effett magħruf
Kull kapsula fiha madwar 25 mg lattosju monoidrat.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Trab li jittieħed man-nifs, kapsula iebsa (trab li jittieħed
man-nifs).
Atectura Breezhaler 125 mikrogramma/62.5 mikrogrammi trab li
jittieħed man-nifs, kapsuli iebsa
Il-kapsuli trasparenti (bla kulur) fihom trab abjad, bil-kodiċi
tal-prodott “IM150-80” stampat bil-blu
fuq strixxa waħda blu fuq il-qafas u bil-logo tal-prodott stampat
bil-blu u mdawwar b’żewġ strixxi blu
fuq it-tapp.
Atectura Breezhaler 125 mikrogramma/127.5 mikrog
Les hele dokumentet
