Daliresp

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
06-02-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
06-02-2018
Public Assessment Report Public Assessment Report (PAR)
06-02-2018

Active ingredient:

roflumilast

Available from:

AstraZeneca AB

ATC code:

R03DX07

INN (International Name):

roflumilast

Therapeutic group:

Mediċini għall-imblokkar tal-passaġġ tan-nifs mard,

Therapeutic area:

Mard tal-Pulmun, Obstructive Kronika

Therapeutic indications:

Daliresp huwa indikat għall-manutenzjoni trattament severi kronika eliminat pulmonari marda (COPD) (FEV1 bronchodilator wara inqas minn 50% mbassra) assoċjati ma ' bronchitis kroniċi fil-pazjenti adulti bi storja ta ' spiss exacerbations bħala żieda trattament bronchodilator.

Product summary:

Revision: 9

Authorization status:

Irtirat

Authorization date:

2011-02-28

Patient Information leaflet

                                24
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
25
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
DALIRESP 500 MIKROGRAMMA PILLOLI MIKSIJA B’RITA
Roflumilast
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin tirrapporta
kwalunkwe effett sekondarju li jista’ jkollok. Ara t-tmiem ta’
sezzjoni 4 biex tara kif għandek
tirrapporta effetti sekondarji.
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TIEĦU DIN IL-MEDIĊINA
PERESS LI FIH INFORMAZZJONI
IMPORTANTI GĦALIK.
-
Żomm dan il-fuljett. Jista’ jkollok bżonn terġa’ taqrah.
-
Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara, anki jekk ikollhom l-istess sinjali ta’ mard
bhal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li m’huwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Daliresp u għal xiex jintuża
2.
X’għandek tkun taf qabel ma tieħu Daliresp
3.
Kif għandek tieħu Daliresp
4.
Effetti sekondarji possibbli
5.
Kif taħżen Daliresp
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU DALIRESP U GĦAL XIEX JINTUŻA
Daliresp fih is-sustanza attiva roflumilast, li hi mediċina kontra
l-infjammazzjoni msejħa inibitur ta’
phosphodiesterase 4. Roflumilast inaqqas l-attività ta’
phosphodiesterase 4, proteina li tinsab b’mod
naturali fiċ-ċelluli tal-ġisem. Meta l-attività ta’ din proteina
titnaqqas, ikun hemm inqas infjammazzjoni
fil-pulmun. Dan jgħin biex iwaqqaf it-tidjiq tal-passaġġi tan-nifs
li jseħħ f’mard pulmonari ostruttiv
kroniku (COPD). Għaldaqstant Daliresp itaffi l-problemi biex tieħu
n-nifs.
Daliresp jintuża bħala terapija ta’ manteniment ta’ COPD severa
fl-adulti li
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Il-professjonisti dwar il-kura
tas-saħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa
suspettata. Ara sezzjoni 4.8 dwar
kif għandhom jiġu rappurtati reazzjonijiet avversi.
1.
ISEM IL-PRODOTT MEDIĊINALI
Daliresp 500 mikrogramma pilloli miksija b’rita
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull pillola fiha 500 mikrogramma ta’ roflumilast.
Eċċipjent b’effett magħruf:
Kull pillola miksija b’rita fiha 188.72 mg lactose (bħala
monohydrate).
Għal-lista kompluta ta’ eċċipjenti ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Pillola miksija b’rita (pillola).
Pillola ta’ 9 mm safra miksija b’rita, b’forma tal-ittra D,
imnaqqxa b“D” fuq naħa waħda.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Daliresp hu indikat għal kura ta’ manteniment ta’ mard pulmonari
ostruttiv kroniku (COPD) sever
(FEV
1
wara l-użu ta’ bronkodilatur, inqas minn 50% ta’ dak imbassar)
assoċjat ma’ bronkite kronika
f’pazjenti adulti bi storja ta’ aggravamenti frekwenti flimkien
ma’ kura bi bronkodilatur.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Id-doża rakkomandata hi 500 mikrogramma (pillola waħda) roflumilast
darba kuljum.
Daliresp jista’ jkollu bżonn jittieħed għal diversi ġimgħat
biex iwettaq l-effett tiegħu (ara sezzjoni 5.1).
Daliresp ġie studjat fi provi kliniċi għal sa perjodu ta’ sena.
Popolazzjonijiet speċjali
_Anzjani_
L-ebda aġġustament fid-doża mhu meħtieġ.
_Indeboliment tal-kliewi_
L-ebda aġġustament fid-doża mhu meħtieġ.
Prodott mediċinali li m’għadux awtorizzat
3
_Indeboliment tal-fwied_
Id-dejta klinika dwar Daliresp f’pazjenti b’indeboliment ħafif
epatiku ikklassifikat bħala Child-Pugh A
hi insuffiċjenti biex wieħed jirrakkomanda aġġustam
                                
                                Read the complete document

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Active ingredient roflumilast

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ATC code R03DX07

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Marketed by AstraZeneca AB

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INN (International Name) roflumilast

roflumilast

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