Topotecan Actavis

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
02-03-2015
Summary of Product characteristics Summary of Product characteristics (SPC)
02-03-2015
Public Assessment Report Public Assessment Report (PAR)
26-08-2009

Active ingredient:

topotekaan

Available from:

Actavis Group PTC ehf

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Antineoplastilised ained

Therapeutic area:

Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Therapeutic indications:

Topotekaani monoteraapia on näidustatud retsidiveerunud väikerakk-kopsuvähiga patsientide raviks [SCLC], kelle puhul ei peeta esmavaliku raviskeemi korduvat ravi sobivaks. Topotecan koos cisplatin on näidustatud patsientidele, kellel kartsinoomi, emakakaela korduvad pärast kiiritusravi ja patsientidel IVB Staadiumi haigus. Patsientidel, kellel eelnev kokkupuude cisplatin nõuavad pidevat ravi-vaba intervalliga, et õigustada ravi kombinatsioon.

Product summary:

Revision: 6

Authorization status:

Endassetõmbunud

Authorization date:

2009-07-24

Patient Information leaflet

                                38
B. PAKENDI INFOLEHT
39
PAKENDI INFOLEHT: TEAVE KASUTAJALE
TOPOTECAN ACTAVIS, 1 MG INFUSIOONILAHUSE KONTSENTRAADI PULBER
TOPOTECAN ACTAVIS, 4 MG INFUSIOONILAHUSE KONTSENTRAADI PULBER
topotekaan
-
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 Topotecan Actavis ja milleks seda kasutatakse
2.
Mida on vaja teada enne Topotecan Actavis’e kasutamist
3.
Kuidas Topotecan Actavis’t kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Topotecan Actavis’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON TOPOTECAN ACTAVIS JA MILLEKS SEDA KASUTATAKSE
Topotecan Actavis sisaldab toimeainet topotekaani, mis aitab hävitada
kasvajarakke.
Topotecan Actavis’t kasutatakse, et ravida:
-
väikerakulist kopsuvähki, mis on pärast keemiaravi taastunud.
-
kaugelearenenud emakakaela vähki, kui kirurgiline ravi või
kiiritusravi ei ole võimalik. Sellisel
juhul kombineeritakse Topotecan Actavis’e ravi tsisplatiini
sisaldavate ravimitega.
2.
MIDA ON VAJA TEADA ENNE TOPOTECAN ACTAVIS`E KASUTAMIST
ÄRGE KASUTAGE TOPOTECAN ACTAVIS’T
-
kui olete topotekaani või selle ravimi mis tahes koostisosade
(loetletud lõigus 6) suhtes
allergiline
-
kui te toidate rinnaga. Rinnaga toitmine tuleb enne Topotecan
Actavis’e ravi lõpetada.
-
kui teie vererakkude arv on liiga madal.
Kui midagi eelnevast kehtib teie kohta,
ÖELGE SEDA OMA ARSTILE
.
HOIATUSED JA ETTEVAATUSABINÕUD
Enne Topotecan Actavis kasutamist, pidage nõu oma arstiga:
-
kui teil on probleeme neerudega. Teie Topotecan Actavis’e annust
võib olla tarvis kohandada.
Topotecan Actavis’t ei soovitata kasutada raske neerupuudulikkuse
korral.
-
kui teil on maksaprobleeme. Topotecan Actavis’t
                                
                                Read the complete document

Summary of Product characteristics

                                1
I LISA
RAVIMI OMADUSTE KOKKUVÕTE
2
1.
RAVIMPREPARAADI NIMETUS
Topotecan Actavis, 1 mg infusioonilahuse kontsentraadi pulber
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
Üks viaal sisaldab 1 mg topotekaani (vesinikkloriidina).
Pärast lahustamist sisaldab 1 ml kontsentraati 1 mg topotekaani.
Teadaolevat toimet omav abiaine: Iga viaal sisaldab 0,52 mg (0,0225
mmol) naatriumi.
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Infusioonilahuse kontsentraadi pulber.
Kollane lüofilisaat.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Topotekaani monoteraapia on näidustatud retsidiveerunud
väikerakk-kopsuvähi (
_small cell lung _
_cancer, _
SCLC) raviks, kui korduv ravi esimese rea ravimitega ei ole sobiv (vt
lõik 5.1).
Topotekaan kombinatsioonis tsisplatiiniga on näidustatud
patsientidele, kellel esineb pärast kiiritusravi
retsidiveerunud emakakaela kartsinoom, ja patsientidele, kellel on IV
B staadiumi kasvaja. Eelnevalt
tsisplatiini saanud patsiendid vajavad ravivaba intervalli enne ravi
alustamist kombinatsiooniga (vt
lõik 5.1).
4.2
ANNUSTAMINE JA MANUSTAMISVIIS
Topotekaani kasutamine peab toimuma tsütotoksiliseks kemoteraapiaks
mõeldud spetsiaalses
osakonnas ning manustamine tohib aset leida ainult kemoteraapias
kogenud arsti järelevalve all (vt
lõik 6.6).
Annustamine
Kui topotekaani kasutatakse kombinatsioonis tsisplatiiniga, tuleb
tutvuda tsisplatiini ravimi omaduste
kokkuvõttega.
Enne topotekaani esimese ravikuuri manustamist peab patsientide
ravieelne neutrofiilide arv olema
≥ 1,5 x 10
9
/l ja trombotsüütide arv ≥ 100 x 10
9
/l. ja hemoglobiinisisaldus ≥ 9 g/dl (pärast
vereülekannet, kui see on vajalik).
_VÄIKERAKK-KOPSUVÄHK _
_ _
_Algannus_
Topotekaani soovitatav annus on 1,5 mg/m
2
/ööpäevas, mida tuleb manustada intravenoosse
infusioonina 30 minuti jooksul viiel järjestikusel päeval, kusjuures
enne iga ravikuuri algust peetakse
kolmenädalane paus. Hea taluvuse korral võib ravi jätkata kuni
haiguse progresseerumiseni (vt
lõigud 4.8 ja 5.1).
3
_Järgnevad annused_
Topotekaani ei
                                
                                Read the complete document

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ATC code L01CE01

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Patient Information leaflet Patient Information leaflet Bulgarian 02-03-2015
Summary of Product characteristics Summary of Product characteristics Bulgarian 02-03-2015
Public Assessment Report Public Assessment Report Bulgarian 26-08-2009
Patient Information leaflet Patient Information leaflet Spanish 02-03-2015
Summary of Product characteristics Summary of Product characteristics Spanish 02-03-2015
Public Assessment Report Public Assessment Report Spanish 26-08-2009
Patient Information leaflet Patient Information leaflet Czech 02-03-2015
Summary of Product characteristics Summary of Product characteristics Czech 02-03-2015
Public Assessment Report Public Assessment Report Czech 26-08-2009
Patient Information leaflet Patient Information leaflet Danish 02-03-2015
Summary of Product characteristics Summary of Product characteristics Danish 02-03-2015
Public Assessment Report Public Assessment Report Danish 26-08-2009
Patient Information leaflet Patient Information leaflet German 02-03-2015
Summary of Product characteristics Summary of Product characteristics German 02-03-2015
Public Assessment Report Public Assessment Report German 26-08-2009
Patient Information leaflet Patient Information leaflet Greek 02-03-2015
Summary of Product characteristics Summary of Product characteristics Greek 02-03-2015
Public Assessment Report Public Assessment Report Greek 26-08-2009
Patient Information leaflet Patient Information leaflet English 02-03-2015
Summary of Product characteristics Summary of Product characteristics English 02-03-2015
Public Assessment Report Public Assessment Report English 26-08-2009
Patient Information leaflet Patient Information leaflet French 02-03-2015
Summary of Product characteristics Summary of Product characteristics French 02-03-2015
Public Assessment Report Public Assessment Report French 26-08-2009
Patient Information leaflet Patient Information leaflet Italian 02-03-2015
Summary of Product characteristics Summary of Product characteristics Italian 02-03-2015
Public Assessment Report Public Assessment Report Italian 26-08-2009
Patient Information leaflet Patient Information leaflet Latvian 02-03-2015
Summary of Product characteristics Summary of Product characteristics Latvian 02-03-2015
Public Assessment Report Public Assessment Report Latvian 26-08-2009
Patient Information leaflet Patient Information leaflet Lithuanian 02-03-2015
Summary of Product characteristics Summary of Product characteristics Lithuanian 02-03-2015
Public Assessment Report Public Assessment Report Lithuanian 26-08-2009
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Public Assessment Report Public Assessment Report Hungarian 26-08-2009
Patient Information leaflet Patient Information leaflet Maltese 02-03-2015
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Public Assessment Report Public Assessment Report Maltese 26-08-2009
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Public Assessment Report Public Assessment Report Dutch 26-08-2009
Patient Information leaflet Patient Information leaflet Polish 02-03-2015
Summary of Product characteristics Summary of Product characteristics Polish 02-03-2015
Public Assessment Report Public Assessment Report Polish 26-08-2009
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Public Assessment Report Public Assessment Report Portuguese 26-08-2009
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Public Assessment Report Public Assessment Report Romanian 26-08-2009
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Public Assessment Report Public Assessment Report Slovak 26-08-2009
Patient Information leaflet Patient Information leaflet Slovenian 02-03-2015
Summary of Product characteristics Summary of Product characteristics Slovenian 02-03-2015
Public Assessment Report Public Assessment Report Slovenian 26-08-2009
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Summary of Product characteristics Summary of Product characteristics Finnish 02-03-2015
Public Assessment Report Public Assessment Report Finnish 26-08-2009
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