Onivyde pegylated liposomal (previously known as Onivyde)

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-12-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-12-2022
Public Assessment Report Public Assessment Report (PAR)
29-04-2021

Active ingredient:

irinotecan anhydrous free-base

Available from:

Les Laboratoires Servier

ATC code:

L01CE02

INN (International Name):

irinotecan hydrochloride trihydrate

Therapeutic group:

Antineoplastilised ained

Therapeutic area:

Pankrease neoplasmid

Therapeutic indications:

Metastaatilise ravi, koos 5-fluorouratsiili (5-FU) ja leukovoriiniga (LV), täiskasvanud patsientidel, kelle haigus pärast gemtsitabiini ravi põhineb ravi.

Product summary:

Revision: 11

Authorization status:

Volitatud

Authorization date:

2016-10-14

Patient Information leaflet

                                30
B. PAKENDI INFOLEHT
31
PAKENDI INFOLEHT: TEAVE KASUTAJALE
ONIVYDE PEGYLATED LIPOSOMAL 4,3 MG/ML INFUSIOONIDISPERSIOONI
KONTSENTRAAT
irinotekaan
ENNE RAVIMI KASUTAMIST LUGEGE HOOLIKALT INFOLEHTE, SEST SIIN ON
TEILE VAJALIKKU TEAVET.
-
Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
-
Kui teil on lisaküsimusi, pidage nõu oma arsti või meditsiiniõega.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti
või meditsiiniõega.
Kõrvaltoime võib olla ka selline, mida selles infolehes ei ole
nimetatud. Vt lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on ONIVYDE pegylated liposomal ja milleks seda kasutatakse
2.
Mida on vaja teada enne ONIVYDE pegylated liposomal’i kasutamist
3.
Kuidas ONIVYDE pegylated liposomal’i kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas ONIVYDE pegylated liposomal’i säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON ONIVYDE PEGYLATED LIPOSOMAL JA MILLEKS SEDA KASUTATAKSE
MIS RAVIM ON ONIVYDE PEGYLATED LIPOSOMAL JA KUIDAS SEE TOIMIB
ONIVYDE pegylated liposomal on vähivastane ravim, mis sisaldab
toimeainet irinotekaani. See
toimeaine asub väikestes lipiidi(rasva)osakestes, mida nimetatakse
liposoomideks.
Irinotekaan kuulub vähiravimite rühma nimega topoisomeraasi
inhibiitorid. See blokeerib ensüümi
nimega topoisomeraas I, mis osaleb rakkude DNA jagunemisel. See
takistab vähirakkude paljunemist
ja kasvamist ning põhjustab lõpuks vähirakkude surma.
Eeldatakse, et need liposoomid kogunevad kasvajas ja vabastavad
ravimit pikema aja jooksul,
võimaldades ravimil niimoodi kauem toimida.
MILLEKS ONIVYDE PEGYLATED LIPOSOMAL’I
KASUTATAKSE
ONIVYDE pegylated liposomal’i kasutatakse pankrease metastaatilise
vähiga (pankreasevähk, mis on
juba levinud muudesse kehapiirkondadesse) täiskasvanud patsientidel,
kelle varasem vähiraviskeem
sisaldas ravimit nimega gemtsitabiin. ONIVYDE pegylated liposomal’i
kasutatakse koos teiste
vähiravimite 5-fluorouratsiili ja leukovoriiniga.
Kui teil on mis tahes küsimusi ONIVYDE pegylated liposomal’i
toimimise või s
                                
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Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
ONIVYDE pegylated liposomal 4,3 mg/ml infusioonidispersiooni
kontsentraat
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks 10 ml viaal kontsentraati sisaldab 43 mg irinotekaani veevaba
alust (irinotekaansahharosofaadi
soolana pegüleeritud liposomaalses ravimvormis).
Üks ml kontsentraati sisaldab 4,3 mg irinotekaani veevaba alust
(irinotekaansahharosofaadi soolana
pegüleeritud liposomaalses ravimvormis).
Teadaolevat toimet
omav abiaine:
üks ml kontsentraati sisaldab 0,144 mmol (3,31 mg) naatriumit.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Infusioonidispersiooni kontsentraat.
Valge kuni kollakas läbipaistmatu isotooniline liposomaalne
dispersioon.
Kontsentraadi pH on 7,2 ja osmolaalsus 295 mOsm/kg.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Pankrease metastaatilise adenokartsinoomi ravi koos 5-fluorouratsiili
(5-FU) ja leukovoriiniga (LV)
täiskasvanud patsientidel, kelle haigus on gemtsitabiinipõhise ravi
foonil progresseerunud.
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
ONIVYDE pegylated liposomal’i tohivad patsientidele välja kirjutada
ja manustada vaid
tervishoiutöötajad, kellel on vähivastaste ravimite kasutamise
kogemus.
ONIVYDE pegylated liposomal’i ei ole ekvivalentne
mitteliposomaalsete irinotekaani
ravimvormidega ja neid ei tohi üksteisega asendada.
Annustamine
ONIVYDE pegylated liposomal’i, leukovoriini ja 5-fluorouratsiili
tuleb manustada üksteise järel.
ONIVYDE pegylated liposomal’i soovituslik annus ja annustamisskeem
on 70 mg/m
2
intravenoosselt 90 minuti jooksul, millele järgneb
LV 400 mg/m
2
intravenoosselt 30 minuti jooksul, millele
järgneb 5-FU 2400 mg/m
2
intravenoosselt 46 tunni jooksul, manustatuna iga 2 nädala järel.
ONIVYDE
pegylated liposomal’i ei tohi manustada ainsa ravimina.
ONIVYDE pegylated liposomal’i vähendatud algannust 50 mg/m
2
tuleb kaaluda patsientidel, kes on
teadaolevalt homosügootsed UGT1A1*28 alleeli suhtes (vt lõigud 4.8
ja 5.1). Kui seda talutakse, tuleb
järgmiste tsüklite aja
                                
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Similar products

Active ingredient irinotecan anhydrous free-base

irinotecan anhydrous free-base

ATC code L01CE02

L01CE02

Marketed by Les Laboratoires Servier

Les Laboratoires Servier

INN (International Name) irinotecan hydrochloride trihydrate

irinotecan hydrochloride trihydrate

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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 29-04-2021
Patient Information leaflet Patient Information leaflet Spanish 13-12-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-12-2022
Public Assessment Report Public Assessment Report Spanish 29-04-2021
Patient Information leaflet Patient Information leaflet Czech 13-12-2022
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Public Assessment Report Public Assessment Report Czech 29-04-2021
Patient Information leaflet Patient Information leaflet Danish 13-12-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-12-2022
Public Assessment Report Public Assessment Report Danish 29-04-2021
Patient Information leaflet Patient Information leaflet German 13-12-2022
Summary of Product characteristics Summary of Product characteristics German 13-12-2022
Public Assessment Report Public Assessment Report German 29-04-2021
Patient Information leaflet Patient Information leaflet Greek 13-12-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-12-2022
Public Assessment Report Public Assessment Report Greek 29-04-2021
Patient Information leaflet Patient Information leaflet English 13-12-2022
Summary of Product characteristics Summary of Product characteristics English 13-12-2022
Public Assessment Report Public Assessment Report English 29-04-2021
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Summary of Product characteristics Summary of Product characteristics French 13-12-2022
Public Assessment Report Public Assessment Report French 29-04-2021
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Public Assessment Report Public Assessment Report Croatian 29-04-2021

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Onivyde pegylated liposomal (previously known as Onivyde)