Palonosetron Accord

Country: European Union

Language: Maltese

Source: EMA (European Medicines Agency)

Patient Information leaflet Patient Information leaflet (PIL)
13-01-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-01-2022
Public Assessment Report Public Assessment Report (PAR)
08-06-2016

Active ingredient:

Palonosetron

Available from:

Accord Healthcare S.L.U.

ATC code:

A04AA05

INN (International Name):

palonosetron

Therapeutic group:

Anti-emetiċi u anti-nawżjanti,

Therapeutic area:

Vomiting; Nausea; Cancer

Therapeutic indications:

Palonosetron Qbil huwa indikat fl-adulti għall -: il-prevenzjoni ta ' dardir u rimettar assoċjati ma'kimoterapija tal-kanċer ferm emetoġenika,il-prevenzjoni ta'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika. Palonosetron Qbil huwa indikat f'pazjenti pedjatriċi 1 xahar ta'l-età u akbar għal:prevenzjoni ta ' dardir u rimettar assoċjati ma'kimoterapija tal-kanċer ferm emetoġenika u għall-prevenzjoni ta'nawseja u rimettar assoċjati ma'kimoterapija tal-kanċer moderatament emetoġenika.

Product summary:

Revision: 5

Authorization status:

Awtorizzat

Authorization date:

2016-05-26

Patient Information leaflet

                                24
B. FULJETT TA’ TAGĦRIF
25
FULJETT TA’ TAGĦRIF: INFORMAZZJONI GĦALL-PAZJENT
PALONOSETRON ACCORD 250 MIKROGRAMMA SOLUZZJONI GĦALL-INJEZZJONI
palonosetron
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 jew lill-ispiżjar
jew lill-infermier tiegħek.
Jekk ikollok xi effett sekondarju kellem lit-tabib jew lill-ispiżjar
jew lill-infermier tiegħek.
Dan jinkludi xi effett sekondarju possibbli li mhuwiex elenkat f’dan
il-fuljett. Ara sezzjoni 4.
F’DAN IL-FULJETT
:
1.
X’inhu Palonosetron Accord u għalxiex jintuża
2.
X’għandek tkun taf qabel ma tuża Palonosetron Accord
3.
Kif jingħata Palonosetron Accord
4. Effetti sekondarji possibbli
5.
Kif taħżen Palonosetron Accord
6. Kontenut tal-pakkett u informazzjoni oħra
1.
X’INHU PALONOSETRON ACCORD U GЋALXIEX JINTUŻA
Palonosetron Accord jappartjeni għal grupp ta’ mediċini magħrufa
bħala antagonisti (5HT3) ta’
serotonin.
Dawn għandhom il-ħila li jimblukkaw l-azzjoni tal-kimika msejħa
serotonin, li jista’ jikkawża dardir u
rimettar.
Palonosetron Accord jintuża għall-prevenzjoni ta’ dardir u
rimettar marbuta mal-kimoterapija tal-
kanċer f’pazjenti adulti, adolexxenti u tfal li jkollhom aktar minn
xahar.
2.
X'GĦANDEK TKUN TAF QABEL MA TUŻA PALONOSETRON ACCORD
TIĦUX PALONOSETRON ACCORD
-
Jekk inti allerġiku għal palonosetron jew għal xi sustanza oħra
ta’ din il-mediċina (elenkati fis-
sezzjoni 6).
TWISSIJIET U PREKAWZJONIJIET
Kellem lit-tabib, l-ispiżjar, jew lill-infermier tiegħek qabel tuża
Palonosetron Accord
-
jekk għandek ostruzzjoni akuta fl-imsaren jew storja medika ta’
stitikezza ripetuta.
-
jekk qed tuża Palonosetron Accord flimkien ma’ mediċini oħrajn li
jistgħu jikkaġunaw ritmu ta’
taħbit tal-qalb mhux floku bħal amiodarone, nicardipine, quinidine,
moxifloxacin, erythromycin,
haloperidol,chlorpromazine, quetiapine, 
                                
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Summary of Product characteristics

                                1
ANNESS I
SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT
2
1.
ISEM IL-PRODOTT MEDIĊINALI
Palonosetron Accord 250 mikrogramma soluzzjoni għall-injezzjoni.
2.
GĦAMLA KWALITATTIVA U KWANTITATTIVA
Kull ml ta’ soluzzjoni fih 50 mikrogramma ta’ palonosetron (bħala
hydrochloride).
Kull kunjett ta’ 5 ml ta’ soluzzjoni fih 250 mikrogramma ta’
palonosetron (bħala hydrochloride).
Għal-lista kompluta ta’ eċċipjenti, ara sezzjoni 6.1.
3.
GĦAMLA FARMAĊEWTIKA
Soluzzjoni għall-injezzjoni.
Soluzzjoni ċara u mingħajr kulur, prattikament mingħajr partikoli
barranin, pH 3.0 sa 3.9, osmolarità
260-320 mOsm/l.
4.
TAGĦRIF KLINIKU
4.1
INDIKAZZJONIJIET TERAPEWTIĊI
Palonosetron Accord hu indikat fl-adulti għal:
•
prevenzjoni ta’ dardir u rimettar akut assoċjat ma’ kimoterapija
tal-kanċer li hi emetoġenika
b’mod qawwi,
•
prevenzjoni ta’ dardir u rimettar marbut ma’ kimoterapija
tal-kanċer li hi moderatament
emetoġenika.
Palonosetron Accord hu indikat f’pazjenti pedjatriċi li jkollhom
minn xahar ’il fuq:
•
il-prevenzjoni ta’ nawsja u rimettar akuti assoċjati ma’
kimoterapija emetoġenika ħafna kontra l-
kanċer u l-prevenzjoni ta’ nawsja u rimettar assoċjati ma’
kimoterapija moderatament
emetoġenika kontra l-kanċer.
4.2
POŻOLOĠIJA U METODU TA’ KIF GĦANDU JINGĦATA
Palonosetron Accord għandu jintuża biss qabel l-għoti
tal-kimoterapija. Dan il-prodott mediċinali
għandu jingħata minn professjonist fil-qasam tal-kura tas-saħħa
taħt superviżjoni medika adattata.
Pożoloġija
_ _
_Adulti_
250 mikrogramma ta’ palonosetron mogħtija bħala bolus wieħed
ġol-vina madwar 30 minuta qabel il-
bidu tal-kimoterapija. Palonosetron Accord għandu jkun injettat fuq
perijodu ta’ 30 sekonda.
L-effikaċja ta’ palonosetron fil-prevenzjoni ta’ dardir u
rimettar ikkaġunati minn kimoterapija tal-
kanċer li hi emetoġenika b’mod qawwi tista’ tittaffa biż-żieda
ta’ kortikosterojd li jingħata qabel il-
kimoterapija.
_Popolazzjoni anzjana_
L-ebda aġġustament fid-doża 
                                
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Active ingredient Palonosetron

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ATC code A04AA05

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Marketed by Accord Healthcare S.L.U.

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INN (International Name) palonosetron

palonosetron

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