Topotecan Teva

Country: European Union

Language: Estonian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-07-2018
Summary of Product characteristics Summary of Product characteristics (SPC)
13-07-2018
Public Assessment Report Public Assessment Report (PAR)
06-10-2009

Active ingredient:

topotekaan

Available from:

Teva B.V.

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Antineoplastilised ained

Therapeutic area:

Ovarian Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma

Therapeutic indications:

Topotecan monotherapy is indicated for the treatment of: , patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy;, patients with relapsed small cell lung cancer [SCLC] for whom re-treatment with the first-line regimen is not considered appropriate. , 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: 8

Authorization status:

Endassetõmbunud

Authorization date:

2009-09-21

Patient Information leaflet

                                B. PAKENDI INFOLEHT
25
PAKENDI INFOLEHT: TEAVE KASUTAJALE
TOPOTECAN TEVA 1 MG/1 ML INFUSIOONILAHUSE KONTSENTRAAT
Topotekaan (
_topotecanum_
)
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 õega.
-
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 Teva ja milleks seda kasutatakse
2.
Mida on vaja teada enne Topotecan Teva kasutamist
3.
Kuidas Topotecan Teva’t kasutada
4.
Võimalikud kõrvaltoimed
5.
Kuidas Topotecan Teva’t säilitada
6.
Pakendi sisu ja muu teave
1.
MIS RAVIM ON TOPOTECAN TEVA JA MILLEKS SEDA KASUTATAKSE
Topotecan Teva aitab tappa kasvajarakke.
Topotecan Teva’t kasutatakse:
-
MUNASARJAVÄHI VÕI VÄIKERAKK-KOPSUVÄHI RAVIKS
, mis on taaspuhkenud pärast keemiaravi
-
KAUGELEARENENUD EMAKAKAELAVÄHI
RAVIKS
, kui kirurgiline või kiiritusravi ei ole võimalik.
Emakakaelavähi ravis kombineeritakse Topotecan Teva’t teise
ravimiga, mida tuntakse
tsisplatiini nime all.
2.
MIDA ON VAJA TEADA ENNE TOPOTECAN TEVA KASUTAMIST
ÄRGE KASUTAGE TOPOTECAN TEVA’T
-
kui olete topotekaani või selle ravimi mis tahes koostisosade
(loetletud lõigus 6) suhtes
allergiline.
-
kui te toidate last rinnaga;
-
kui teie vererakkude arv on liiga madal. Sel juhul ütleb teile arst
seda viimase vereanalüüsi
vastuse põhjal.
→
Kui te arvate, et midagi eelnevast võib kehtida teie kohta,
ÖELGE SEDA OMA ARSTILE
.
HOIATUSED JA ETTEVAATUSABINÕUD
Rääkige oma arsti või meditsiiniõega enne, kui kasutate Topotecan
Teva’t:
-
kui teil on mõni neeruhaigus. Teie Topotecan Teva annus võib vajada
kohandamist. Topotecan
Teva’t ei ole soovitatav kasutada raske neerukahjustusega
patsientidel;
-
kui teil on maksahaigus. Võib osutuda vajalikuks vähendada teie
Topotecan Teva annust.
Topotecan Teva’
                                
                                Read the complete document

Summary of Product characteristics

                                I LISA
RAVIMI OMADUSTE KOKKUVÕTE
1
1.
RAVIMPREPARAADI NIMETUS
Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat
Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat
2.
KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
_ _
Topotecan Teva 1 mg/1 ml infusioonilahuse kontsentraat
1 ml infusioonilahuse kontsentraati sisaldab 1 mg topotekaani
(vesinikkloriidina).
Topotecan Teva 4 mg/4 ml infusioonilahuse kontsentraat
1 ml infusioonilahuse kontsentraati sisaldab 1 mg topotekaani
(vesinikkloriidina).
Üks 4 ml viaal infusioonilahuse kontsentraati sisaldab 4 mg
topotekaani (vesinikkloriidina).
Abiainete täielik loetelu vt lõik 6.1.
3.
RAVIMVORM
Infusioonilahuse kontsentraat.
Selge kahvatukollane vedelik. pH = 2,0…2,6.
4.
KLIINILISED ANDMED
4.1
NÄIDUSTUSED
Topotekaani monoteraapia on näidustatud:

metastaatilise munasarja kartsinoomi raviks, kui esimese rea ravi või
sellele järgnev ravi ei ole
andnud tulemusi.

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 kuuri manustamist peab patsientide ravieelne
neutrofiilide arv olema
≥ 1,5 x 10
9
/l, trombotsüütide arv ≥ 100 x 10
9
/l ning hemoglobiini tase ≥ 9 g/dl (vajadusel pärast
vereülekannet).
_Munasarja kartsinoom ja väikerakk-kopsuvähk _
_Algannus _

                                
                                Read the complete document

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Active ingredient topotekaan

topotekaan

ATC code L01CE01

L01CE01

Marketed by Teva B.V.

Teva B.V.

INN (International Name) topotecan

topotecan

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Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2018
Public Assessment Report Public Assessment Report Bulgarian 06-10-2009
Patient Information leaflet Patient Information leaflet Spanish 13-07-2018
Summary of Product characteristics Summary of Product characteristics Spanish 13-07-2018
Public Assessment Report Public Assessment Report Spanish 06-10-2009
Patient Information leaflet Patient Information leaflet Czech 13-07-2018
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Public Assessment Report Public Assessment Report Czech 06-10-2009
Patient Information leaflet Patient Information leaflet Danish 13-07-2018
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Public Assessment Report Public Assessment Report Danish 06-10-2009
Patient Information leaflet Patient Information leaflet German 13-07-2018
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Public Assessment Report Public Assessment Report German 06-10-2009
Patient Information leaflet Patient Information leaflet Greek 13-07-2018
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Public Assessment Report Public Assessment Report Greek 06-10-2009
Patient Information leaflet Patient Information leaflet English 13-07-2018
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Public Assessment Report Public Assessment Report English 06-10-2009
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