natgillin/translations-raw huggingface dataset:
Topotecan must be reconstituted and further diluted before use (see section 6.6). 
Pred uporabo je treba topotekan rekonstituirati in nato še dodatno razredčiti (glejte poglavje 6.6).
In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients. 
V kliničnih študijah so o izpuščaju poročali pri 4 % bolnikov in o pruritusu pri 1,5 % bolnikov.
• Mild pain and inflammation at the site of injection. 
• blage bolečine in vnetje na mestu infundiranja,
• Pregnant staff should be excluded from working with this medicinal product. 
• Nosečnice ne smejo delati s tem zdravilom.
• patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1). 
• bolnikih z relapsom drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve izbire ni primerno (glejte poglavje 5.1).
Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients. 
Popolna ali izrazita alopecija se je pojavila pri 30 % bolnikov, delna pa pri 15% bolnikov.
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available. 
Uporabo topotekana so ovrednotili tudi pri otrocih, vendar je podatkov o njegovi učinkovitosti in varnosti za otroke malo.
− Personnel handling this medicinal product should wear protective clothing including mask, goggles and gloves. 
− Osebje, ki ravna s tem zdravilom, mora nositi ustrezno zaščitno obleko, vključno z masko, očali in rokavicami.
Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription. 
Druga zdravila in zdravilo Topotecan Hospira Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, kar velja tudi za vse zeliščne izdelke in za zdravila, ki ste jih dobili brez recepta.
• Inflammation and ulcers of the mouth, tongue or gums. 
• vnetje in razjede v ustih, na jeziku ali na dlesnih,
• Severe allergic or anaphylactic reactions. 
• hude alergijske ali anafilaktične reakcije,
As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression. 
Kakor druga citotoksična zdravila lahko tudi topotekan povzroči hudo mielosupresijo.
One Phase II study (Study 065) and one Phase III study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥90 days after completion of one prior regimen of chemotherapy (see Table 1). 
Opravljena je bila ena študija 2. faze (Študija 065) in ena študija 3. faze (Študija 396) za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki so imeli ponovitev bolezni ≥ 90 dni po zaključku ene predhodne sheme kemoterapije (glejte preglednico 1).
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses. 
Pri večkratni vsakodnevni uporabi se topotekan kopiči le malo ali sploh ne in ni nobenih dokazov, da bi se njegova farmakokinetika spremenila po večkratnem odmerjanju.
• Staff should be adequately trained in the preparation, administration and disposal of cytotoxics 
• Osebje mora biti ustrezno usposobljeno za pripravo, dajanje in odstranjevanje citotoksičnih zdravil.
However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded. 
Ker pa je topotekan - tako kot druga citotoksična zdravila - genotoksičen, ni mogoče izključiti učinkov na plodnost, vključno s plodnostjo samcev.
The second study included a dose range of 2.0 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia. 
V drugi študiji pa so uporabili razpon odmerkov od 2,0 to 5,2 mg/m2 pri otrocih (n = 8), mladostnikih (n = 3) in mlajših odraslih (n = 3) z levkemijo.
Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6). 
Uporaba topotekana naj vedno poteka pod nadzorom izkušenega zdravnika s področja kemoterapije (glejte poglavje 6.6).
These data should be evaluated in the context of the overall safety profile of the medicinal product, in particular of the significant haematological toxicity (see section 4.8). 
Pri vrednotenju teh podatkov je treba upoštevati vsa dejstva o varnosti zdravila; zlasti pomembne oblike hematološke toksičnosti (glejte poglavje 4.8).
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were < 2.0 %. 
Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid sta navzoča v seču v manj kot 2,0 %.
Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %). 
Med pogosteje prijavljenimi nehematološkimi učinki so bilegastrointestinalne težave, kot so navzea (52 %), bruhanje (32 %), diareja (18 %), zaprtje (9 %) in mukozitis (14 %).
Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous. 
Predklinične študije kažejo, da se topotekan le malo veže na plazemske beljakovine (35 %) in da se precej enakomerno porazdeli med krvnimi celicami in plazmo.
• Allergic or hypersensitivity reactions (including rash). 
• alergijske ali preobčutljivostne reakcije (vključno z izpuščajem),
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy. 
Čeprav ni znano ali se topotekan izloča v materino mleko, naj matere ob začetku zdravljenja s topotekanom prenehajo dojiti.
The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy. 
Spodaj navedene pogostnosti hematoloških in nehematoloških neželenih dogodkov se nanašajo na poročila o neželenih dogodkih, ki so bili ali bi lahko bili povezani z zdravljenjem s topotekanom.
Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors. 
Med osnovne dejavnike tveganja za to sodijo IPB v pretekli anamnezi, pljučna fibroza, pljučni rak, obsevanje prsnega koša in uporaba pnevmotoksičnih snovi in/ali kolonije stimulirajočih faktorjev.
• Signs of infection: Topotecan may reduce the number of white blood cells and lower your resistance to infection. 
Topotekan lahko zmanjša število belih krvničk v telesu in vašo odpornost proti okužbam.
Summary of survival, response rate, and time to progression in SCLC patients treated with oral topotecan or intravenous topotecan 
Povzetek stopenj preživetja, pogostnosti odziva na zdravljenje in časa do napredovanja bolezni pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim topotekanom ali intravenskim topotekanom
Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo. 
Topotekan je zaradi svojega mehanizma delovanja genotoksičen za celice sesalcev (celice limfoma pri miših in človeške limfocite) in vitro in celice kostnega mozga pri miših in vivo.
Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose. 
Skupno izločanje s topotekanom povezanih snovi po dajanju petih dnevnih odmerkov topotekana je znašalo od 71 do 76 % prejetega intravenskega odmerka.
When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m 2 compared to 21.3 l/h/m 2 [n=9]) (see section 4.5). 
Pri dajanju topotekana v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dne) je bil 5. dan očistek topotekana manjši kot 1. dan (19,1 l/uro/m 2 v primerjavi s 21,3 l/uro/m 2 [n = 9]) (glejte poglavje 4.5).
Median survival (weeks) (95% CI) 
Mediana vrednost preživetja (tedni) (95 % IZ)
In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed. 
V študijah reproduktivne toksičnosti pri podganah topotekan ni vplival na plodnost samcev ali samic; so pa pri samicah opazili superovulacijo in rahel porast predimplantacijskih izgub.
Limited data indicate that the dose should be reduced in patients with moderate renal impairment. 
Malo podatkov, ki so na voljo, kažejo, da je treba odmerek zdravila zmanjšati pri bolnikih z zmerno ledvično okvaro.
When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability. 
Pri sočasni uporabi topotekana z drugimi zdravili za kemoterapijo je lahko potrebno zmanjšanje odmerka vsakega od zdravil zaradi boljšega prenašanja terapije.
This should be taken into account when prescribing Topotecan Hospira, e.g. if patients at increased risk of tumour bleeds are considered for therapy. 
To morate upoštevati pri predpisovanju zdravila Topotekan Hospira, na primer pri bolnikih z večjim tveganjem za krvavitve iz tumorja.
Median survivals for the two groups were 25.0 and 24.7 weeks, respectively. 
Mediana vrednost časa preživetja bolnikov v prvi skupini je znašala 25,0 tednov, v drugi pa 24,7 tedna.
How topotecan is given A doctor or nurse will administer topotecan as an infusion into your arm lasting about 30 minutes. 
Zdravilo Topotecan Hospira vam bo dal zdravnik ali medicinska sestra v obliki infuzije v roko, ki običajno traja približno 30 minut.
Plasma clearance of total topotecan (active and inactive form) in patients with hepatic impairment only decreased by about 10 % compared with the control group of patients. 
Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri bolnikih z jetrno okvaro zmanjšal samo za približno 10 % v primerjavi z bolniki iz kontrolne skupine.
If there is lasting irritation, a doctor should be consulted. 
Če draženje ne preneha, se je treba posvetovati z zdravnikom.
What you need to know before you are given Topotecan Hospira 
Kaj morate vedeti, preden boste prejeli zdravilo Topotecan Hospira
In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients. 
Pri bolnikih z zmerno ledvično okvaro pa se je plazemski očistek topotekana zmanjšal na 34 % vrednosti od bolnikov v kontrolni skupini.
Median time to onset of severe thrombocytopenia, was day 15 and the median duration was five days. 
Mediana vrednost časa do pojava hude trombocitopenije je bila na 15. dan, mediana vrednost trajanja trombocitopenije pa pet dni.
The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8). 
Opazovani znaki in simptomi, ki so jih opažali po prevelikem odmerjanju, so v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
This treatment schedule is repeated every 21 days for six courses or until progressive disease. 
To shemo zdravljenja ponavljajte na vsakih 21 dni za skupaj šest ciklusov ali dokler bolezen ne napreduje.
Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. 
Topotekan v kombinaciji s cisplatinom je indiciran pri bolnicah s ponovitvijo karcinoma materničnega vratu po radioterapiji in pri bolnicah s stadijem bolezni IVB.
In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form). 
V populacijski študiji intravenske aplikacije niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov bistveno vplivalo na farmakokinetiko celotne količine topotekana (aktivne in neaktivne oblike).
In patients refractory to or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %. 
Pri bolnicah, ki se jim je bolezen kljub zdravljenju s cisplatinom ponovila v roku 3 mesecev, ali ki se niso odzvale na zdravilo (n = 186), pa je bila odzivnost 10 %.
In dose-finding studies involving 523 patients with relapsed ovarian cancer and 631 patients with relapsed small cell lung cancer, the dose-limiting toxicity of topotecan monotherapy was found to be haematological. 
V študijah za določitev odmerka, v katerih je sodelovalo 523 bolnic s ponovitvijo (relapsom) raka jajčnikov in 631 bolnikov s ponovitvijo drobnoceličnega pljučnega raka, so ugotovili, da je pri monoterapiji s topotekanom toksičnost, ki omejuje njegov odmerek, hematološka.
• All items used in the preparation, administration, and cleaning of the medicinal product, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. 
• Vse predmete, ki so bili uporabljeni pri pripravi, dajanju in čiščenju zdravila, vključno z rokavicami, morate odlagati v vreče za sežig nevarnih odpadkov pri visoki temperaturi, tekoče odpadke pa lahko sperete z veliko količino vode.
Driving and using machines Topotecan can make people feel tired. 
Vpliv na sposobnost upravljanja vozil in strojev Topotekan lahko povzroča utrujenost.
This can lead to severe bleeding from relatively small injuries such as a small cut. 
To lahko vodi do hudih krvavitev že iz sorazmerno majhnih poškodb, kot so majhne vreznine, v redkih primerih pa tudi do hujših krvavitev (hemoragij).
Remember to tell your doctor if you start to take any other medicines while you are on Topotecan Hospira. 
Ne pozabite zdravniku povedati, če med zdravljenjem z zdravilom Topotecan Hospira začnete jemati katerokoli drugo zdravilo.
As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan. 
Tako kot druga citotoksična zdravila lahko tudi topotekan škoduje plodu, zato je treba ženskam v rodni dobi svetovati, da naj ne zanosijo med zdravljenjem s topotekanom.
One study included a dose range of 1.4 to 2.4 mg/m2 in children (aged 2 up to 12 years, n = 18), adolescents (aged 12 up to 16 years, n = 9), and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours. 
V eni so uporabili razpon odmerkov od 1,4 do 2,4 mg/m2 pri otrocih (starih od 2 do 12 let, n = 18), mladostnikih (starih od 12 do 16 let, n = 9) in mlajših odraslih (starih od 16 do 21 let, n = 9) s solidnimi tumorji, ki se niso odzvali na zdravljenje.
In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan. 
Podatki in vitro, dobljeni s pomočjo človeških jetrnih mikrosomov, so pokazali, da nastane majhna količina N-demetiliranega topotekana.
ITT population Cisplatin 50 mg/m2 on day 1, every 2l days. 
Populacija ITT Cisplatin 50 mg/m2 na 1. dan vsakih 2l dni
Unopened vial: Store in a refrigerator (2°C-8°C). 
Neodprte viale: Shranjujte v hladilniku (2 °C - 8 °C).
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed. 
Bolnike morate spremljati, da boste ugotovili morebitne pljučne znake, ki kažejo na razvoj IPB (npr. kašelj, zvišano telesno temperaturo, dispnejo in/ali hipoksijo), in jim topotekan ukinite, če se potrdi diagnoza IPB.
The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %. 
Odzivnost na zdravilo za celoten program raziskav raka na jajčnikih (n = 392, pri bolnicah, ki so se pred tem zdravile s cisplatinom ali cisplatinom in paklitakselom) je bila 16 %.
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. 
• Nenamerni stik zdravila s kožo ali očmi je treba nemudoma zdraviti s spiranjem z veliko količino vode.
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds, have been infrequent. 
Poročila o resnih posledicah trombocitopenije, vključno s smrtnimi primeri zaradi krvavitve iz tumorja, pa so bila redka.
In an open-label study involving children (n = 108, age range: infant to 16 years) with recurrent or progressive solid tumours, topotecan was administered at a starting dose of 2.0 mg/m2 given as a 30minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy. 
V odprti študiji pri otrocih (n = 108, razpon starosti: od dojenčkov do starosti 16 let) s ponavljajočimi se ali napredujočimi solidnimi tumorji so otroci prejemali topotekan v obliki 30-minutne infuzije v začetnem odmerku 2,0 mg/m2 5 dni, kar so potem ponavljali na vsake 3 tedne do 1 leta, odvisno od bolnikovega odziva na zdravljenje.
Doses should be similarly reduced if the platelet count falls below 25 x 10 
Odmerke je treba podobno zmanjšati tudi, če število trombocitov pade pod 25 x 10
Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 days 1-3, every 21 days 
Cisplatin 50 mg/m2 na 1. dan + topotekan 0,75 mg/m2 na 1.-3. dan vsakih 21 dni
• Weight loss and loss of appetite (anorexia); tiredness; weakness. 
• hujšanje in izguba teka (anoreksija), utrujenost, oslabelost,
Use the aseptic technique during any further dilution of the solution for infusion. 
Pri vsakem nadaljnjem redčenju raztopine za infundiranje uporabite aseptično tehniko.
9/l) during course 1 in 55% of patients, with duration ≥seven days in 20 % and overall in 77 % of patients (39 % of courses). 
9/l) med prvim ciklusom zdravljenja je imelo 55 % bolnikov in je pri 20 % bolnikov trajala ≥ sedem dni, pri vseh ciklusih pa jo je imelo 77 % bolnikov (39 % ciklusov zdravljenja).
9/l) in 25 % of patients (15 % of courses). 
9/l) pa pri 25 % bolnikov (15 % ciklusov zdravljenja).
− Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. 
− Nenamerni stik zdravila s kožo ali očmi je treba nemudoma zdraviti s spiranjem z veliko količino vode.
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism. 
Topotekan zavira delovanje topoizomeraze I s stabilizacijo kovalentnega kompleksa tega encima in razdvojenih verig DNA, ki sta vmesna produkta katalitičnega mehanizma.
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC. 
Prijavljanje simptomov s strani samih bolnikov na podlagi nezakrite samoocene je pokazalo stalno tendenco boljšega vpliva na simptome v tisti skupini, ki je prejemala peroralni topotekan in NPO.
Overall, the N-desmethyl metabolite contributed a mean of < 7% (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces. 
Skupaj je presnovek N-desmetil predstavljal manj kot 7 % (srednja vrednost, razpon od 4 do 9 %) celotne količine s topotekanom povezanih snovi v seču in blatu.
In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n=147) was compared with cisplatin alone (n=146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate. 
V randomizirani primerjalni študiji III. faze, ki ga je izvedla Ginekološka onkološka skupina (GOG 0179), so primerjali uporabo topotekana v kombinaciji s cisplatinom (n = 147) s samim cisplatinom (n = 146) pri zdravljenju histološko potrjenega trdovratnega ponavljajočega se karcinoma materničnega vratu ali karcinoma materničnega vratu v stadiju IVB, pri katerem kurativno zdravljenje s kirurškim posegom in/ali obsevanjem ni bilo primerno.
− Pregnant staff should be excluded from working with this medicinal product. 
− Nosečnice ne smejo delati s tem zdravilom.
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork. 
Protitumorsko delovanje topotekana zajema zaviranje encima topoizomeraze I, ki aktivno sodeluje pri replikaciji DNA, saj sprošča torzijsko napetost, ki se pojavlja pred napredujočimi replikacijskimi vilicami.
In another randomised Phase III trial which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3% for topotecan compared to 18.3% for the CAV group. 
V drugi randomizirani študiji III. faze, v katerem so primerjali intravenski topotekan s ciklofosfamidom, doksorubicinom in vinkristinom (CAV), je bila pri bolnikih s ponovitvijo za zdravilo občutljivega drobnoceličnega pljučnega raka skupna stopnja odziva na topotekan 24,3 %, v primerjavi z 18,3 % v skupini, ki je prejemala kombinacijo CAV.
− Breast-feeding (see section 4.6). 
− dojenje (glejte poglavje 4.6),
Concentrate for solution for infusion 4 mg/4 ml 
Koncentrat za raztopino za infundiranje 4 mg/4 ml
Topotecan Hospira 4 mg/4 ml is supplied in Type I clear glass vials, each sealed with a chlorobutyl rubber stopper, aluminium seal and plastic flip-off closure. 
Zdravilo Topotekan Hospira 4 mg/4 ml je pakirano v viale iz prozornega stekla tipa I, ki so zaprte z zamaškom iz klorobutilne gume, aluminijasto zaporko in plastično odmično zaporko.
• Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage. 
Tveganje je največje, če že imate pljučno bolezen, če ste se zdravili z obsevanjem pljuč ali če ste pred tem prejemali zdravila, ki so povzročila okvaro pljuč.
The primary complications of overdose are bone marrow suppression and mucositis. 
Primarna zapleta prevelikega odmerjanja sta supresija kostnega mozga in mukozitis.
Topotecan Hospira is provided as a sterile concentrate containing 4 mg topotecan in 4 ml solution (1 mg/ml). 
Zdravilo Topotecan Hospira je na voljo v obliki sterilnega koncentrata, ki vsebuje 4 mg topotekana v 4 ml raztopine (1 mg/ml).
If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation. 
Če med kombiniranim zdravljenjem s topotekanom in cisplatinom vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo, da proučite celotna navodila za predpisovanje cisplatina in v njih poiščete nasvete glede zmanjšanja odmerka cisplatina in nadaljnjega zdravljenja z njim.
When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. 
Pri uporabi topotekana v kombinaciji s cisplatinom je treba upoštevati tudi celotna navodila za predpisovanje cisplatina.
You should not receive Topotecan Hospira: 
Ne prejemajte zdravila Topotecan Hospira:
• ovarian cancer or small cell lung cancer that has come back after chemotherapy. 
• ponovitve raka na jajčniku ali drobnoceličnega pljučnega raka po kemoterapiji,
In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0%. 
pri bolnikih, ki se niso odzvali na zdravljenje s terapijo prve izbire) je bila stopnja odziva na zdravljenje s topotekanom 4,0 %.
Subsequent doses 
Poznejši odmerki
9/l) in 25 % of patients (8 % of courses); moderate 
9/l) je bila pri 25 % bolnikov (8 % ciklusov), zmerna
- Any unused product or waste material should be disposed of in accordance with local requirements. 
− Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.