Tibsovo

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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

Active ingredient:

Ivosidenib

Available from:

Les Laboratoires Servier

ATC code:

L01XX62

INN (International Name):

ivosidenib

Therapeutic group:

Antineoplastilised ained

Therapeutic area:

Leukemia, Myeloid, Acute; Cholangiocarcinoma

Therapeutic indications:

Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5. Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

Authorization status:

Volitatud

Authorization date:

2023-05-04

Patient Information leaflet

                                34
B. PAKENDI INFOLEHT
35
PAKENDI INFOLEHT: TEAVE PATSIENDILE
TIBSOVO 250 M
G ÕHUKESE POLÜMEERIKATTEGA TABLETID
ivosideniib
Sellele ravimile kohaldatakse täiendavat järelevalvet, mis
võimaldab kiiresti tuvastada uut
ohutusteavet. Te saate sellele kaasa aidata, teatades ravimi kõigist
võimalikest kõrvaltoimetest.
Kõrvaltoimetest teatamise kohta vt lõik 4.
ENNE RAVIMI VÕTMIST 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 apteekriga.
-
Ravim on välja kirjutatud üksnes teile. Ärge andke seda kellelegi
teisele. Ravim võib olla neile
kahjulik, isegi kui haigusnähud on sarnased.
-
Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti
või apteekriga. Kõrvaltoime
võib olla ka selline, mida selles infolehes ei ole nimetatud. Vt
lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Tibsovo ja milleks seda kasutatakse
2.
Mida on vaja teada enne Tibsovo võtmist
3.
Kuidas Tibsovo’t võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Tibsovo’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON TIBSOVO JA MILLEKS SEDA KASUTATAKSE
MIS RAVIM ON TIBSOVO
Tibsovo sisaldab toimeainena ivosideniibi. See on ravim, mida
kasutatakse teatud tüüpi vähi raviks,
mis sisaldab muteerunud (muutunud) geeni, mis toodab valku, mida
teatakse kui IDH1 ja mis mängib
olulist rolli rakkudele energia tootmises. Kui IDH1 geen on
muteerunud, on muutunud ka IDH1 valk
ja see ei funktsioneeri õigesti ning need muutused rakus võivad viia
vähi tekkeni. Tibsovo blokeerib
IDH1 valgu muteerunud vormi ja aitab aeglustada või peatada vähi
kasvu.
MILLEKSTIBSOVO’T KASUTATAKSE
Tibsovo’t kasutatakse täiskasvanud patsientide raviks, kellel on:
•
äge müeloidne leukeemia. Kui seda kasutatakse ägeda müeloidse
leukeemiaga patsientidel, siis
manustatakse seda kombinatsioonis teise vähivastase ravimiga, mida
nimetatakse asatsitidiiniks.
•
sapipõievähk (nimetatakse ka kolangiokartsinoomiks). Tibs
                                
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Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
Sellele ravimile kohaldatakse täiendavat järelevalvet, mis
võimaldab kiiresti tuvastada uut
ohutusteavet. Tervishoiutöötajatel palutakse teatada kõigist
võimalikest kõrvaltoimetest.
Kõrvaltoimetest teatamise kohta vt lõik 4.8.
1.
RAVIMPREPARAADI NIMETUS
Tibsovo 250 mg õhukese polümeerikattega tabletid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks õhukese polümeerikattega tablett sisaldab 250 mg ivosideniibi.
Teadaolevat toimet omav abiaine
Üks õhukese polümeerikattega tablett sisaldab laktoosmonohüdraati
koguses, mis on võrdne 9,5 mg
laktoosiga (vt lõik 4.4).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Õhukese polümeerikattega tablett (tablett).
Sinine ovaalse kujuga õhukese polümeerikattega tablett, mille pikkus
on ligikaudu 18 mm ning, mille
ühele küljele on pressitud „IVO“ ja teisele küljele „250“.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Tibsovo kombinatsioonis asatsitidiiniga on näidustatud täiskasvanud
patsientide raviks, kellel on äsja
diagnoositud isotsitraatdehüdrogenaas-1 (IDH1) R132 mutatsiooniga
äge müeloidne leukeemia ning
kellele ei ole võimalik rakendada standardset induktsioon-keemiaravi
(vt lõik 5.1).
Tibsovo monoteraapia on näidustatud täiskasvanud patsientide raviks,
kellel on
isotsitraatdehüdrogenaas-1 (IDH1) R132 mutatsiooniga lokaalselt
kaugelearenenud või metastaatiline
kolangiokartsinoom ning kes on eelnevalt juba saanud vähemalt ühte
tüüpi süsteemset esmavalikuravi
(vt lõik 5.1).
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Ravi tuleb alustada vähivastaste ravimite kasutamise kogemusega arsti
järelevalve all.
Enne Tibsovo kasutamist tuleb sobiliku diagnostilise testiga kinnitada
IDH1 R132 mutatsioon.
Annustamine
_Äge müeloidne leukeemia _
Soovitatav annus on 500 mg ivosideniibi (2 x 250 mg tabletti)
manustatuna suukaudselt üks kord
ööpäevas. Ravi ivosideniibiga tuleb alustada esimese ravitsükli
1.päeval kombinatsioonis
asatsitidiiniga annuses 75 mg/m
2
keha pindala kohta süstituna intraven
                                
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Similar products

Active ingredient Ivosidenib

Ivosidenib

ATC code L01XX62

L01XX62

Marketed by Les Laboratoires Servier

Les Laboratoires Servier

INN (International Name) ivosidenib

ivosidenib

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Bulgarian 01-01-1970
Public Assessment Report Public Assessment Report Bulgarian 01-01-1970
Patient Information leaflet Patient Information leaflet Spanish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Spanish 01-01-1970
Public Assessment Report Public Assessment Report Spanish 01-01-1970
Patient Information leaflet Patient Information leaflet Czech 01-01-1970
Summary of Product characteristics Summary of Product characteristics Czech 01-01-1970
Public Assessment Report Public Assessment Report Czech 01-01-1970
Patient Information leaflet Patient Information leaflet Danish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Danish 01-01-1970
Public Assessment Report Public Assessment Report Danish 01-01-1970
Patient Information leaflet Patient Information leaflet German 01-01-1970
Summary of Product characteristics Summary of Product characteristics German 01-01-1970
Public Assessment Report Public Assessment Report German 01-01-1970
Patient Information leaflet Patient Information leaflet Greek 01-01-1970
Summary of Product characteristics Summary of Product characteristics Greek 01-01-1970
Public Assessment Report Public Assessment Report Greek 01-01-1970
Patient Information leaflet Patient Information leaflet English 01-01-1970
Summary of Product characteristics Summary of Product characteristics English 01-01-1970
Public Assessment Report Public Assessment Report English 01-01-1970
Patient Information leaflet Patient Information leaflet French 01-01-1970
Summary of Product characteristics Summary of Product characteristics French 01-01-1970
Public Assessment Report Public Assessment Report French 01-01-1970
Patient Information leaflet Patient Information leaflet Italian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Italian 01-01-1970
Public Assessment Report Public Assessment Report Italian 01-01-1970
Patient Information leaflet Patient Information leaflet Latvian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Latvian 01-01-1970
Public Assessment Report Public Assessment Report Latvian 01-01-1970
Patient Information leaflet Patient Information leaflet Lithuanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Lithuanian 01-01-1970
Public Assessment Report Public Assessment Report Lithuanian 01-01-1970
Patient Information leaflet Patient Information leaflet Hungarian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Hungarian 01-01-1970
Public Assessment Report Public Assessment Report Hungarian 01-01-1970
Patient Information leaflet Patient Information leaflet Maltese 01-01-1970
Summary of Product characteristics Summary of Product characteristics Maltese 01-01-1970
Public Assessment Report Public Assessment Report Maltese 01-01-1970
Patient Information leaflet Patient Information leaflet Dutch 01-01-1970
Summary of Product characteristics Summary of Product characteristics Dutch 01-01-1970
Public Assessment Report Public Assessment Report Dutch 01-01-1970
Patient Information leaflet Patient Information leaflet Polish 01-01-1970
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Public Assessment Report Public Assessment Report Polish 01-01-1970
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Public Assessment Report Public Assessment Report Portuguese 01-01-1970
Patient Information leaflet Patient Information leaflet Romanian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Romanian 01-01-1970
Public Assessment Report Public Assessment Report Romanian 01-01-1970
Patient Information leaflet Patient Information leaflet Slovak 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovak 01-01-1970
Public Assessment Report Public Assessment Report Slovak 01-01-1970
Patient Information leaflet Patient Information leaflet Slovenian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Slovenian 01-01-1970
Public Assessment Report Public Assessment Report Slovenian 01-01-1970
Patient Information leaflet Patient Information leaflet Finnish 01-01-1970
Summary of Product characteristics Summary of Product characteristics Finnish 01-01-1970
Public Assessment Report Public Assessment Report Finnish 01-01-1970
Patient Information leaflet Patient Information leaflet Swedish 01-01-1970
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Public Assessment Report Public Assessment Report Swedish 01-01-1970
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Patient Information leaflet Patient Information leaflet Icelandic 01-01-1970
Summary of Product characteristics Summary of Product characteristics Icelandic 01-01-1970
Patient Information leaflet Patient Information leaflet Croatian 01-01-1970
Summary of Product characteristics Summary of Product characteristics Croatian 01-01-1970
Public Assessment Report Public Assessment Report Croatian 01-01-1970

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