Topotecan Teva

Country: European Union

Language: Slovenian

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:

topotekan

Available from:

Teva B.V.

ATC code:

L01CE01

INN (International Name):

topotecan

Therapeutic group:

Antineoplastična sredstva

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 v kombinaciji z cisplatin je indicirano za bolnike z karcinom materničnega vratu periodično po radioterapija in za bolnike z Stadiju IVB bolezni. Bolniki s predhodno izpostavljenosti cisplatin zahtevajo trajno zdravljenje prosti interval, da se upraviči zdravljenje s kombinacijo.

Product summary:

Revision: 8

Authorization status:

Umaknjeno

Authorization date:

2009-09-21

Patient Information leaflet

                                21
Shranjujte v hladilniku. Ne zamrzujte.
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred
svetlobo.
10.
POSEBNI VARNOSTNI UKREPI ZA ODSTRANJEVANJE NEUPORABLJENIH
ZDRAVIL ALI IZ NJIH NASTALIH ODPADNIH SNOVI, KADAR SO POTREBNI
Neporabljeno zdravilo ali odpadni material morate odstraniti v skladu
z lokalnimi predpisi.
11.
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Teva B.V.
Swensweg 5
2031GA Haarlem
Nizozemska
12.
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
EU/1/09/552/001 – 1 viala
EU/1/09/552/002 – 5 vial
13.
ŠTEVILKA SERIJE
Lot
14.
NAČIN IZDAJANJA ZDRAVILA
Izdaja zdravila je le na recept.
15.
NAVODILA ZA UPORABO
16.
PODATKI V BRAILLOVI PISAVI
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
17.
EDINSTVENA OZNAKA – DVODIMENZIONALNA ČRTNA KODA
Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
18.
EDINSTVENA OZNAKA – V BERLJIVI OBLIKI
PC:
SN:
NN:
22
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
OVOJNINAH
OZNAKA VIALE
1.
IME ZDRAVILA IN POT(I) UPORABE
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje
topotekan
i.v. uporaba
2.
POSTOPEK UPORABE
3.
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
EXP
4.
ŠTEVILKA SERIJE
Lot
5.
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
1 ml
6.
DRUGI PODATKI
citotoksično zdravilo
23
PODATKI NA ZUNANJI OVOJNINI
ZUNANJA ŠKATLA
1.
IME ZDRAVILA
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje
topotekan
2.
NAVEDBA ENE ALI VEČ UČINKOVIN
1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana
(v obliki topotekanijevega
klorida).
Vsaka viala vsebuje 4 mg topotekana (v obliki topotekanijevega
klorida) v 4 ml koncentrata.
3.
SEZNAM POMOŽNIH SNOVI
Vinska kislina (E334), klorovodikova kislina (E507) (za uravnavanje
pH), natrijev hidroksid (E524)
(za uravnavanje pH) in voda za injekcije.
4.
FARMACEVTSKA OBLIKA IN VSEBINA
koncentrat za raztopino za infundiranje
1 viala s 4 ml (4 mg topotekana)
5 vial s 4 ml (4 mg topotekana)
5.
POSTOPEK IN POT(I) UPORABE ZDRAVILA
Pred upo
                                
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Summary of Product characteristics

                                1
DODATEK I
POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
2
1.
IME ZDRAVILA
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje
2.
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje
1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana
(v obliki topotekanijevega
klorida).
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje
1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana
(v obliki topotekanijevega
klorida).
Ena viala s 4 ml koncentrata za raztopino za infundiranje vsebuje 4 mg
topotekana (v obliki
topotekanijevega klorida).
Za celoten seznam pomožnih snovi glejte poglavje 6.1.
3.
FARMACEVTSKA OBLIKA
koncentrat za raztopino za infundiranje
Bistra, bledo-rumena tekočina. pH = 2,0-2,6.
4.
KLINIČNI PODATKI
4.1
TERAPEVTSKE INDIKACIJE
Samostojno zdravljenje s topotekanom je indicirano pri:

bolnikih z metastatskim karcinomom jajčnikov po neuspehu z zdravili
prvega linije ali
naslednjega izbora.

bolnikih s ponovitvijo drobnoceličnega pljučnega raka, pri katerih
ponovno zdravljenje s
terapijo prve linije ni primerno (glejte poglavje 5.1).
Topotekan je v kombinaciji s cisplatinom indiciran pri bolnicah s
ponovitvijo karcinoma
materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem
IVB karcinoma
materničnega vratu. Pri bolnicah, ki so se predhodno zdravile s
cisplatinom, mora preteči daljše
obdobje brez zdravljenja, da bi bilo zdravljenje s kombinacijo
smiselno (glejte poglavje 5.1).
4.2
ODMERJANJE IN NAČIN UPORABE
Topotekan se sme uporabljati le v ustanovah, ki so specializirane za
uporabo citotoksičnih
kemoterapevtikov. Uporaba topotekana naj vedno poteka pod nadzorom
zdravnika z izkušnjami
na področju kemoterapije (glejte poglavje 6.6).
Odmerjanje
Pri uporabi topotekana v kombinaciji s cisplatinom je treba
upoštevati tudi navodila za
predpisovanje cisplatina.
Pred prvim ciklusom zdravljenja s topotekanom morajo imeti b
                                
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Active ingredient topotekan

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ATC code L01CE01

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INN (International Name) topotecan

topotecan

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Patient Information leaflet Patient Information leaflet Bulgarian 13-07-2018
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-07-2018
Public Assessment Report Public Assessment Report Bulgarian 06-10-2009
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Public Assessment Report Public Assessment Report Spanish 06-10-2009
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