Temozolomide Teva

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
18-02-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
18-02-2022
Public Assessment Report Public Assessment Report (PAR)
18-09-2014

Active ingredient:

temosolomiid

Available from:

Teva B.V. 

ATC code:

L01AX03

INN (International Name):

temozolomide

Therapeutic group:

Antineoplastilised ained

Therapeutic area:

Glioma; Glioblastoma

Therapeutic indications:

Uute diagnoositud multiformse glioblastoomi täiskasvanud patsientide raviks koos kiiritusravi (RT) ja seejärel monoteraapiaga. Ravi lapsed vanuses kolm aastat, noorukid ja täiskasvanud patsientidele, kellel on pahaloomuline glioma, nagu glioblastoma erüteem või anaplastic astrocytoma, näidates kordumise või progresseerumise pärast standardset ravi.

Product summary:

Revision: 21

Authorization status:

Volitatud

Authorization date:

2010-01-28

Patient Information leaflet

                                43
B. PAKENDI INFOLEHT
44
PAKENDI INFOLEHT: TEAVE KASUTAJALE
TEMOZOLOMIDE TEVA 5 MG KÕVAKAPSLID
TEMOZOLOMIDE TEVA 20 MG KÕVAKAPSLID
TEMOZOLOMIDE TEVA 100 MG KÕVAKAPSLID
TEMOZOLOMIDE TEVA 140 MG KÕVAKAPSLID
TEMOZOLOMIDE TEVA 180 MG KÕVAKAPSLID
TEMOZOLOMIDE TEVA 250 MG KÕVAKAPSLID
temosolomiid
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, apteekrivõi
meditsiiniõega.
•
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,
apteekri või meditsiiniõega.
Kõrvaltoime võib olla ka selline, mida selles infolehes ei ole
nimetatud. Vt lõik 4.
INFOLEHE SISUKORD
1.
Mis ravim on Temozolomide Teva ja milleks seda kasutatakse
2.
Mida on vaja teada enne Temozolomide Teva võtmist
3.
Kuidas Temozolomide Teva’t võtta
4.
Võimalikud kõrvaltoimed
5.
Kuidas Temozolomide Teva’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON TEMOZOLOMIDE TEVA JA MILLEKS SEDA KASUTATAKSE
Temozolomide Teva sisaldab toimeainet nimega temosolomiid. See on
kasvajavastane aine.
Temozolomide Teva’t kasutatakse teatud ajukasvajate raviks:
•
täiskasvanutel
esma
kord
selt diagnoositud multiformse glioblastoom
i korral
.
Temozolomide Teva’t kasutatakse esmalt
kombinatsioonis
kiiritusraviga (samaaegse ravi
faas) ning sellele järgnevaks monoteraapiaks (ravi monoteraapia
faas).
•
3-aastastel ja vanematel lastel ning täiskasvanud patsientidel
pahaloomulise glioomi korral, nt
nagu multiformne glioblastoom või anaplastiline astrotsütoom.
Temozolomide Teva’t
kasutatakse nende kasvajate korral, kui need uuesti tekivad või
standardravi järel
progresseeruvad.
2.
MIDA ON VAJA TEADA ENNE TEMOZOLOMIDE TEVA VÕTMIST
TEMOZOLOMIDE TEVA’T EI TOHI VÕTTA
•
kui olete
temosolomiidi või selle ravimi mis tahes koostisosa
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Temozolomide Teva 5 mg kõvakapslid
Temozolomide Teva 20 mg kõvakapslid
Temozolomide Teva 100 mg kõvakapslid
Temozolomide Teva 140 mg kõvakapslid
Temozolomide Teva 180 mg kõvakapslid
Temozolomide Teva 250 mg kõvakapslid
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Temozolomide Teva 5 mg kõvakapslid
Iga kõvakapsel sisaldab 5 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 87 mg laktoosi.
Temozolomide Teva 20 mg kõvakapslid
Iga kõvakapsel sisaldab 20 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 72 mg laktoosi ja toiduvärvi
päikseloojangukollane FCF (E110).
Temozolomide Teva 100 mg kõvakapslid
Iga kõvakapsel sisaldab 100 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 84 mg laktoosi.
Temozolomide Teva 140 mg kõvakapslid
Iga kõvakapsel sisaldab 140 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 117 mg laktoosi.
Temozolomide Teva 180 mg kõvakapslid
Iga kõvakapsel sisaldab 180 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 150 mg laktoosi.
Temozolomide Teva 250 mg kõvakapslid
Iga kõvakapsel sisaldab 250 mg temosolomiidi.
_Teadaolevat toimet omav abiaine _
Iga kõvakapsel sisaldab 209 mg laktoosi.
Abiainete täielik loetelu vt lõik 6.1.
3
3.
RAVIMVORM
Kõvakapsel
Temozolomide Teva 5 mg kõvakapslid
Kõvakapslitel on opaakne valge kapslikorpus ja kapslikaas, kaanel
rohelise tindiga tehtud kaks triipu
ning kapslikorpusel rohelise tindiga märgistus „T 5 mg”. Iga
kapsel on ligikaudu 16 mm pikkune.
Temozolomide Teva 20 mg kõvakapslid
Kõvakapslitel on opaakne valge kapslikorpus ja kapslikaas, kaanel
oranži tindiga tehtud kaks triipu
ning kapslikorpusel oranži tindiga märgistus „T 20 mg”. Iga
kapsel on ligikaudu 18 mm pikkune.
Temozolomide Teva 100 mg kõvakapslid
Kõvakapslitel on opaakne valge kapslikorpus ja kapslikaas, kaanel
roosa tindiga tehtud kaks triipu
ning kapslikorpus
                                
                                Read the complete document

Similar products

Active ingredient temosolomiid

temosolomiid

ATC code L01AX03

L01AX03

Marketed by Teva B.V. 

Teva B.V. 

INN (International Name) temozolomide

temozolomide

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Summary of Product characteristics Summary of Product characteristics Bulgarian 18-02-2022
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Summary of Product characteristics Summary of Product characteristics German 18-02-2022
Public Assessment Report Public Assessment Report German 18-09-2014
Patient Information leaflet Patient Information leaflet Greek 18-02-2022
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Public Assessment Report Public Assessment Report Greek 18-09-2014
Patient Information leaflet Patient Information leaflet English 18-02-2022
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Public Assessment Report Public Assessment Report English 18-09-2014
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