Budesonide/Formoterol Teva

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Download Patient Information leaflet (PIL)
31-01-2017
Download Summary of Product characteristics (SPC)
31-01-2017
Download Public Assessment Report (PAR)
31-01-2017

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V.

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol

Therapeutic group:

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

Therapeutic area:

Pulmonary Disease, Chronic Obstructive; Asthma

Therapeutic indications:

Budesonide / Formoterol Teva huwa indikat fl-adulti ta '18-il sena' l fuq biss. AsthmaBudesonide/Formoterol Teva huwa indikat fit-trattament regolari ta ' l-ażżma, fejn l-użu tal-kombinazzjoni (kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonist) huwa xieraq:f'pazjenti li mhumiex adegwatament ikkontrollati bil-kortikosterojdi meħuda man-nifs u l - "kif meħtieġ" man-nifs qasir waqt li jaġixxi β2 adrenoceptor agonisti. fjorin pazjenti li diġà ikkontrollati adegwatament fuq iż-żewġ kortikosterojdi meħuda man-nifs u li jaħdem fit-tul β2 adrenoceptor agonisti. COPDSymptomatic-trattament ta ' pazjenti b'indeboliment serju COPD (FEV1 < 50% mbassra-normal) u l-istorja tal-aggravar tal-attakki ripetuti, li għandhom sinifikanti sintomi minkejja regolari it-terapija b'taġixxi fit-tul bronkodilataturi.

Product summary:

Revision: 2

Authorization status:

Irtirat

Authorization date:

2014-11-19

Patient Information leaflet

                                43
B. FULJETT TA’ TAGĦRIF
Prodott mediċinali li m’għadux awtorizzat
44
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
BUDESONIDE/FORMOTEROL TEVA 160 MIKROGRAMMA/4.5 MIKROGRAMMI, TRAB LI
JITTIEĦED MAN-NIFS
(budesonide/formoterol fumarate dihydrate)
AQRA SEW DAN IL-FULJETT KOLLU QABEL TIBDA TUŻA 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, lill-ispiżjar jew
l-infermier 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
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju, kellem lit-tabib, lill-ispiżjar
jew l-infermier tiegħek. Dan
jinkludi xi effett sekondarju li mhuwiex elenkat f’dan il-fuljett.
Ara sezzjoni 4.
F’DAN IL-FULJETT
1.
X’ inhu Budesonide/Formoterol Teva u għalxiex jintuża (paġna 3)
2.
X’ għandek tkun taf qabel ma tuża Budesonide/Formoterol Teva
(paġna 5)
3.
Kif għandek tuża Budesonide/Formoterol Teva (paġna 9)
4.
Effetti sekondarji possibbli (paġna 18)
5.
Kif taħżen Budesonide/Formoterol Teva (paġna 21)
6.
Kontenut tal-pakkett u informazzjoni oħra (paġna 22)
1.
X’ INHU BUDESONIDE/FORMOTEROL TEVA U GĦALXIEX JINTUŻA
Budesonide/Formoterol Teva fih żewġ sustanzi attivi differenti:
budesonide u formoterol fumarate
dihydrate.

Budesonide jappartjeni għal grupp ta’ mediċini msejħa
kortikosterojdi’ magħrufin ukoll bħala
‘sterojdi’. Huwa jaħdem billi jnaqqas u jipprevjeni n-nefħa u
l-infjammazzjoni fil-pulmuni
tiegħek u jgħinek tieħu n-nifs aktar faċilment.

Formoterol fumarate dihydrate jappartjeni għal grupp ta’ mediċini
msejħa’agonisti tal-
adrenoriċetturi β2 li jaħdmu fit-tul’ jew ‘bronkodilaturi’ .
Huwa jaħdem billi jirrilassa l-muskoli
fil-passaġġi tal-arja tiegħek. Dan sejjer jgħin biex jiftaħ
il-passaġġi tal-arja u sejjer jgħinek
sabiex tieħu 
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
Prodott mediċinali li m’għadux awtorizzat
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Budesonide/Formoterol Teva 160 mikrogramma/4.5 mikrogrammi trab li
jittieħed man-nifs.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull doża mogħtija (id-doża li toħroġ mill-biċċa tal-ħalq
tal-iSpiromax) fiha 160 mikrogramma ta’
budesonide u 4.5 mikrogrammi ta’ formoterol fumarate dihydrate.
Dan huwa ekwivalenti għal doża mkejla ta’ 200 mikrogramma
budesonide u 6 mikrogrammi ta’
formoterol fumarate dihydrate.
Eċċipjent(i) b’effett magħruf:
Kull doża fiha madwar 5 milligrammi ta’ lactose (bħala
monohydrate).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Trab li jittieħed man-nifs.
Trab abjad.
Inalatur abjad b’għatu tal-biċċa tal-ħalq aħmar lewn l-inbid,
semi-trasparenti.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Budesonide/Formoterol Teva hu indikat għall-użu fl-adulti ta’
18-il sena u aktar, biss.
Ażma
_ _
Budesonide/Formoterol Teva hu indikat għat-trattament regolari
tal-ażma, fejn l-użu ta’
kombinazzjoni (kortikosterojd li jittieħed man-nifs u agonist
tal-adrenoriċetturi β
2
li jaħdem fit-tul)
ikun adattat:
-
f’pazjenti li ma jkunux ikkontrollati adegwatament
b’kortikosterojdi li jittieħdu man-nifs u
agonisti tal-adrenoriċettur β
2
li jaħdmu malajr, meħudin man-nifs kif “meħtieġa”.
jew
-
f’pazjenti li diġà jkunu kkontrollati adegwatament kemm
b’kortikosterojdi li jittieħdu man-nifs
kif ukoll b’agonisti tal-adrenoriċettur β
2
li jaħdmu fit-tul.
COPD
_ _
Trattament sintomatiku ta’ pazjenti b’COPD sever (FEV
1
< 50% tan-normal imbassar) u storja ta’
taħrix ripetut, li jkollhom sintomi sinifikanti minkejja terapija
regolari bi bronkodilaturi li jaħdmu fit-
tul.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Prodott mediċinali li m’għadux awtorizzat
3
Budesonide/Formoterol Teva hu indikat għall-użu fl-adulti ta’
18-il sena u aktar, biss.
Budeso
                                
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Active ingredient Budesonide, formoterol fumarate dihydrate

Budesonide, formoterol fumarate dihydrate

ATC code R03AK07

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Marketed by Teva Pharma B.V.

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INN (International Name) budesonide, formoterol

budesonide, formoterol

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