Rienso

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-07-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2015
Public Assessment Report Public Assessment Report (PAR)
13-07-2015

Active ingredient:

Ferumoxytol

Available from:

Takeda Pharma A/S

ATC code:

B03

INN (International Name):

ferumoxytol

Therapeutic group:

Oħra antianemic preparazzjonijiet

Therapeutic area:

Anemia; Kidney Failure, Chronic

Therapeutic indications:

Rienso huwa indikat għall-kura ġol-vina ta 'anemija ta' defiċjenza tal-ħadid f'pazjenti adulti b'mard kroniku tal-kliewi (CKD). Id-dijanjożi ta 'defiċjenza ta' ħadid għandha tkun ibbażata fuq testijiet tal-laboratorju xierqa (ara sezzjoni 4.

Product summary:

Revision: 7

Authorization status:

Irtirat

Authorization date:

2012-06-15

Patient Information leaflet

                                24
B. FULJETT TA’ TAGĦRIF
_ _
Prodott mediċinali li m’għadux awtorizzat
25
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
_ _
RIENSO 30 MG/ML SOLUZZJONI GĦALL-INFUŻJONI
Ħadid bħala ferumoxytol
Dan il-prodott mediċinali huwa suġġett għal monitoraġġ
addizzjonali. Dan ser jippermetti
identifikazzjoni ta’ malajr ta’ informazzjoni ġdida dwar
is-sigurtà. Inti tista’ tgħin billi 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 TINGĦATA 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.
-
Jekk ikollok xi effett sekondarju kellem lit-tabib, lill-ispiżjar jew
l-infermier tiegħek. Dan jinkludi
xi effett sekondarju li m'huwiex elenkat f’dan il-fuljett. Ara
sezzjoni 4.
F’DAN IL-FULJETT:
1.
X’inhu Rienso u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tingħataRienso
3.
Kif jingħata Rienso
4.
Effetti sekondarji possibbli
5.
Kif taħżen Rienso
6.
Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU RIENSO U GĦALXIEX JINTUŻA
Rienso huwa preparazzjoni tal-ħadid li fiha s-sustanza attiva,
ferumoxytol, li tingħata permezz ta’
infużjoni fil-vina. Huwa jintuża biex jikkura anemija kkawżata minn
defiċjenza ta’ ħadid li tirriżulta
minn nuqqas ta' ħadid maħżun f'pazjenti adulti b'funzjoni mnaqqsa
tal-kliewi.
Il-ħadid huwa element essenzjali meħtieġ biex jipproduċi
l-emoglobina, molekula fiċ-ċelluli ħomor
tad-demm li tippermetti li l-ossiġnu jinġarr madwar il-ġisem. Meta
ma jkunx hemm biżżejjed ħadid
fil-ġisem, l-emoglobina ma tistax tiġi ffurmata u dan iwassal għal
anemija (levelli baxxi ta’
emoglobina).
L-għan ta’ terapija b’Rienso huwa li jerġgħu jimtlew
il-ħażniet tal-ħadid tal-ġisem.
2.
X’GĦANDEK TKUN TAF QABEL MA TINGĦATA RIENSO
Qa
                                
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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
Rienso 30 mg/ml soluzzjoni għall-infużjoni.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
1 ml ta' soluzzjoni fiha 30 mg ta’ ħadid bħala ferumoxytol.
Kull kunjett ta' 17 ml ta' soluzzjoni fih 510 mg ta’ ħadid bħala
ferumoxytol.
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
_ _
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-infużjoni.
Soluzzjoni ta' lewn iswed għall-dak kannella jagħti fl-aħmar
Osmolarità: 270-330 mosm/kg
pH: 6.5 sa 8.0
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Rienso huwa indikat għall-kura ġol-vini ta’ anemija kkawżata minn
defiċjenza ta’ ħadid f’pazjenti
adulti b’mard kroniku tal-kliewi (CKD).
Id-dijanjosi ta’ defiċjenza ta’ ħadid għandha tkun ibbażata
fuq testijiet xierqa tal-laboratorju (ara
sezzjoni 4.2).
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Rienso għandu jingħata biss meta staff imħarreġ biex jevalwa u
jimmaniġġja r-reazzjonijiet
anafilattiċi jkun disponibbli immedjatament, f’ambjent fejn
faċilitajiet kompluti ta’ risuxxitazzjoni
jistgħu jiġi assigurati.
Il-pazjenti għandhom jiġu immonitorjati b’attenzjoni għal sinjali
u sintomi ta’ reazzjonijiet ta’
sensittività eċċessiva inkluż monitoraġġ tal-pressjoni u l-polz
matul u għal mill-inqas 30 minuta wara
kull infużjoni ta’ Rienso. Barra dan, il-pazjenti għandhom
jitpoġġew f’pożizzjoni minduda jew kważi
minduda b’daharhom mitfuħ lura waqt l-infużjoni u għal mill-inqas
30 minuta wara dan (ara sezzjoni
4.4).
Pożoloġija
_ _
_Kors ta’ Kura _
_ _
Il
                                
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Active ingredient Ferumoxytol

Ferumoxytol

ATC code B03

B03

Marketed by Takeda Pharma A/S

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INN (International Name) ferumoxytol

ferumoxytol

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