Budesonide/Formoterol Teva Pharma B.V.

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
08-12-2021
Summary of Product characteristics Summary of Product characteristics (SPC)
08-12-2021
Public Assessment Report Public Assessment Report (PAR)
01-01-1970

Active ingredient:

Budesonide, formoterol fumarate dihydrate

Available from:

Teva Pharma B.V. 

ATC code:

R03AK07

INN (International Name):

budesonide, formoterol fumarate dihydrate

Therapeutic group:

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

Therapeutic area:

Asthma; Pulmonary Disease, Chronic Obstructive

Therapeutic indications:

Budesonide / Formoterol Teva Pharma B. hija indikata fl-adulti ta '18-il sena u akbar biss. AsthmaBudesonide/Formoterol Teva Pharma B. 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. jew f'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'COPD mal-nifs sfurzat'il-volum fl-1 sekonda (FEV1) .

Product summary:

Revision: 2

Authorization status:

Awtorizzat

Authorization date:

2020-04-03

Patient Information leaflet

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. huwa indikat għall-użu
fl-adulti ta’ 18-il sena u aktar, biss.
Ażżma
_ _
Budesonide/Formoterol Teva Pharma B.V. huwa indikat għat-trattament
regolari tal-ażżma, 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 b’mod adegwat
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 b’volum ta’ nifs
sfurzat ’il barra f’sekonda waħda (FEV
1
-
_forced expiratory volume in 1 second_
) < 70% tan-normal imbassar (wara bronkodilatur) 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
Pożoloġija
3
_Ażżma _
_
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Budesonide/Formoterol Teva Pharma B.V. 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 Pharma B.V. huwa indikat għall-użu
fl-adulti ta’ 18-il sena u aktar, biss.
Ażżma
_ _
Budesonide/Formoterol Teva Pharma B.V. huwa indikat għat-trattament
regolari tal-ażżma, 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 b’mod adegwat
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 b’volum ta’ nifs
sfurzat ’il barra f’sekonda waħda (FEV
1
-
_forced expiratory volume in 1 second_
) < 70% tan-normal imbassar (wara bronkodilatur) 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
Pożoloġija
3
_Ażżma _
_
                                
                                Read the complete document

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Active ingredient Budesonide, formoterol fumarate dihydrate

Budesonide, formoterol fumarate dihydrate

ATC code R03AK07

R03AK07

Marketed by Teva Pharma B.V. 

Teva Pharma B.V. 

INN (International Name) budesonide, formoterol fumarate dihydrate

budesonide, formoterol fumarate dihydrate

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Patient Information leaflet Patient Information leaflet Bulgarian 08-12-2021
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-12-2021
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
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Public Assessment Report Public Assessment Report Spanish 01-01-1970
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Public Assessment Report Public Assessment Report Danish 01-01-1970
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