Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Download Patient Information leaflet (PIL)
13-12-2022
Download Summary of Product characteristics (SPC)
13-12-2022
Download Public Assessment Report (PAR)
06-09-2019

Active ingredient:

formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate

Available from:

Chiesi Farmaceutici S.p.A.

ATC code:

R03AL09

INN (International Name):

beclometasone, formoterol

Therapeutic group:

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

Therapeutic area:

Mard tal-Pulmun, Obstructive Kronika

Therapeutic indications:

Trattament ta ' manutenzjoni fil-pazjenti adulti ma moderat severi kronika eliminat pulmonari marda (COPD) li m'humiex ittrattati adegwatament mill-għaqda tal-corticosteroid bin-nifs u a twila u jaġixxu beta2-agonist (għall-effetti fuq is-sintomi kontroll u prevenzjoni ta ' exacerbations ara Taqsima 5.

Product summary:

Revision: 4

Authorization status:

Awtorizzat

Authorization date:

2018-04-23

Patient Information leaflet

                                35
B. FULJETT TA’ TAGĦRIF
36
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-UTENT
RIARIFY 87 MIKROGRAMMA/5 MIKROGRAMMI/9 MIKROGRAMMI SUSTANZA TAĦT
PRESSJONI GĦOLJA LI
TITTIEĦED MAN-NIFS, SOLUZZJONI
beclometasone dipropionate/formoterol fumarate
dihydrate/glycopyrronium
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 jew lill-ispiżjar
tiegħek.
-
Din il-mediċina ġiet mogħtija lilek biss. M’għandekx tgħaddiha
lil persuni oħra. Tista’
tagħmlilhom il-ħsara anke jekk għandhom l-istess sinjali ta’ mard
bħal tiegħek.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
tiegħek. Dan jinkludi xi effett
sekondarju possibbli li mhuwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT
1.
X’inhu Riarify u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Riarify
3.
Kif għandek tuża Riarify
4.
Effetti sekondarji possibbli
5.
Kif taħżen Riarify
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU RIARIFY U GĦALXIEX JINTUŻA
Riarify huwa mediċina li tgħin fit-teħid tan-nifs li fih it-tliet
sustanzi attivi:
•
beclometasone dipropionate,
•
formoterol fumarate dihydrate u
•
glycopyrronium.
Beclometasone dipropionate jagħmel parti minn grupp ta’ mediċini
msejħa kortikosterojdi li jaħdmu
biex inaqqsu n-nefħa u l-irritazzjoni fil-pulmuni tiegħek.
Formoterol u glycopyrronium huma mediċini msejħa bronkodilaturi li
jaħdmu fit-tul. Huma jaġixxu
b’modi differenti biex jirrilassaw il-muskoli fil-passaġġi
tan-nifs tiegħek, u jgħinu biex iwessgħu
l-passaġġi tan-nifs u jippermettu li tieħu n-nifs b’mod aktar
faċli.
Trattament regolari b’dawn it-tliet sustanzi attivi jgħin biex
ittaffi u jipprevjeni sintomi bħal qtugħ ta’
nifs, tħarħir u sogħla f’pazjenti adulti b’mard pulmonari
kroniku ostruttiv (COPD - _chronic obstructive _
_pulmonary dise
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Riarify 87 mikrogramma/5 mikrogrammi/9 mikrogrammi, sustanza taħt
pressjoni għolja li tittieħed
man-nifs, soluzzjoni
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull doża mogħtija (id-doża li toħroġ mill-biċċa tal-ħalq)
fiha 87 mikrogramma ta’ beclometasone
dipropionate, 5 mikrogrammi ta’ formoterol fumarate dihydrate u 9
mikrogrammi ta’ glycopyrronium
(bħala 11-il mikrogramma ta’ glycopyrronium bromide).
Kull doża mkejla (id-doża li toħroġ mill-valv) fiha 100
mikrogramma ta’ beclometasone dipropionate,
6 mikrogrammi ta’ formoterol fumarate dihydrate u 10 mikrogrammi
ta’ glycopyrronium (bħala
12.5 mikrogrammi ta’ glycopyrronium bromide).
Eċċipjent b’effett magħruf
_ _
Riarify fih 8.856 mg ethanol f’kull attwazzjoni.
Għal-lista sħiħa ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Sustanza taħt pressjoni għolja li tittieħed man-nifs,
soluzzjoni(sustanza taħt pressjoni għolja li tittieħed
man-nifs)
Soluzzjoni likwida bla kulur għal-safranija.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Trattament ta’ manteniment f’pazjenti adulti b’mard pulmonari
kroniku ostruttiv (COPD - _chronic _
_obstructive pulmonary disease_) moderata sa severa li mhumiex
ittrattati b’mod adegwat permezz ta’
taħlita ta’ kortikosterojde li jittieħed man-nifs u agonist
tar-riċetturi beta2 li jaħdem fit-tul jew taħlita
ta’ agonist tar-riċetturi beta2 li jaħdem fit-tul u antagonist
tar-riċetturi muskariniċi li jaħdem fit-tul
(għall-effetti fuq kontroll tas-sintomi u l-prevenzjoni ta’
aggravar ara sezzjoni 5.1).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Pożoloġija
Id-doża rakkomandata hija żewġ inalazzjonijiet darbtejn kuljum.
Id-doża massima hija żewġ inalazzjonijiet darbtejn kuljum.
Popolazzjonijiet speċjali
_ _
_Anzjani _
Mhux meħtieġ aġġustament fid-doża f’pazjenti anzjani (65 sena u
aktar).
_ _
_Indeboliment tal-kliewi _
Riarify jista
                                
                                Read the complete document

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Active ingredient formoterol fumarate dihydrate, glycopyrronium, Beclometasone dipropionate

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ATC code R03AL09

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Marketed by Chiesi Farmaceutici S.p.A.

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INN (International Name) beclometasone, formoterol

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Patient Information leaflet Patient Information leaflet Bulgarian 13-12-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-12-2022
Public Assessment Report Public Assessment Report Bulgarian 06-09-2019
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Public Assessment Report Public Assessment Report Spanish 06-09-2019
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Riarify (previously CHF 5993 Chiesi Farmaceutici S.p.A.)