natgillin/translations-raw huggingface dataset:
Mean half-life increased from 1.9 hours to 4.9 hours. 
Srednja razpolovna doba se je z 1,9 ure podaljšala na 4,9 ur.
Talk to your doctor for advice on how to minimize the risk of bleeding. 
Z zdravnikom se posvetujte, kako čim bolj zmanjšati tveganje krvavitev.
See section 6.6. 
Glejte poglavje 6.6.
Tell you doctor if you think any of these could apply to you. 
Zdravniku morate povedati, če menite, da kaj od tega velja za vas.
Extravasation has been reported very rarely. 
Ekstravazacija je bila opisana zelo redko.
- Infections. 
- Okužbe.
Volume of distribution was slightly decreased and thus half-life only increased by 14 %. 
Volumen porazdelitve je bil malo manjši, zato se je razpolovna doba podaljšala le za 14%.
However there are insufficient data available to make a dose recommendation for this patient group. 
Vseeno za sedaj nimamo na voljo zadostne količine podatkov, da bi priporočili odmerek za to skupino bolnikov.
This can lead to severe bleeding from relatively small injuries such as a small cut. 
Posledica so lahko hude krvavitve iz razmeroma majhnih poškodb, npr. majhnih ureznin.
Always wash hands after removing gloves. 
Potem, ko snamete rokavice, si vedno umijte roke.
- Itching (pruritus). 
- Srbenje (pruritus).
Date of latest renewal: 6 June 2014 
Datum prve odobritve: 24 julij 2009 Datum zadnjega podaljšanja: 6 junij 2014
The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely: 
Pri tem morate upoštevati običajne postopke za ustrezno ravnanje z zdravili proti raku in njihovo odstranjevanje, in sicer:
Use in children and adolescents The experience in children and adolescents is limited and treatment is therefore not recommended. 
Uporaba pri otrocih in mladostnikih Izkušenj pri otrocih in mladostnikih je malo, zato zdravljenje s tem zdravilom ni priporočljivo.
If you experience this, do not drive or use machines. 
Če se vam pojavita, ne upravljajte vozil in strojev.
Liquid waste may be flushed with large amounts of water. 
Tekoče odpadke je mogoče sprati z veliko količino vode.
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11 Ion Mihalache Blvd 011171 Bukarešta Romunija
Topotecan also had a high volume of distribution, about 132 l, (SD 57) and a relatively short half-life of 2-3 hours. 
Topotekan ima tudi velik volumen porazdelitve, približno 132 l (SD 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
Adverse reactions are listed below, by system organ class and absolute frequency (all reported events). 
V nadaljevanju navajamo neželene učinke, razvrščene v razrede po organskih sistemih in po absolutni pogostnosti (vsi dogodki, o katerih so poročali).
The pharmacokinetics of topotecan given as a 30-minute infusion for 5 days were evaluated in two studies. 
Farmakokinetika topotekana, ki so ga dajali v obliki 30-minutne infuzije 5 dni, je bila ovrednotena v dveh študijah.
This concentrate (1 mg/ml) must be diluted prior to administration. 
Ta koncentrat (1 mg/ml) je treba pred uporabo razredčiti.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), including isolated reports and not known (cannot be estimated from the available data). 
Pogostnost je definirana z izrazi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < /1.000) in zelo redki (< 1/10.000), vključno s posameznimi primeri in ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
The doctor will evaluate your general health during the treatment and you should tell him/her in case you have fever, infection or are in some ways feeling unwell. 
Zdravnik bo spremljal vaše splošno zdravstveno stanje med zdravljenjem in povedati mu morate, če se vam pojavi zvišana telesna temperatura, okužba ali se kako drugače slabo počutite.
It must be reconstituted and further diluted before use (see section 6.6). 
Pred uporabo ga je potrebno rekonstruirati in nato še nadalje redčiti (glejte poglavje 6.6).
Do not use this medicine after the expiry date which is stated on the vial and carton. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
11 Ion Mihalache Blvd Bucharest 
11 Ion Mihalache Blvd Bukarešta
The incidence of side effects is more frequent in patients who are in poor general health. 
Neželeni učinki so pogostejši pri bolnikih, ki imajo slabo splošno zdravstveno stanje.
This treatment schedule is repeated every 21 days for six courses or until progressive disease. 
Takšna shema zdravljenja se ponavlja vsakih 21 dni, šest ciklov ali dokler je bolezen v progresiji.
All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. 
Vso opremo za dajanje zdravila ali čiščenje, vključno z rokavicami, je treba dati v vreče za odlaganje zelo tveganih odpadkov za upepelitev pri visoki temperaturi.
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 pri človeku izloča v materinem mleku, je treba dojenje na začetku zdravljenja prekiniti.
- Hair loss. 
- Izpadanje las.
Patients who are concerned about their fertility should ask their doctor for counselling on fertility and family planning options prior to starting treatment. 
Bolniki, ki so zaskrbljeni glede svoje plodnosti naj se o tem in o načrtovanju družine pred začetkom zdravljenja posvetujejo s svojim zdravnikom.
Further management should be as clinically indicated or as recommended by the national poisons centre, where available. 
Nadaljnje ravnanje mora biti klinično indicirano ali priporočeno s strani nacionalnega centra za zastrupitve.
Other medicines and Topotecan Actavis Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Druga zdravila in zdravilo Topotekan Actavis Obvestite svojega zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo.
Topotecan Actavis is available in cartons containing 1 vial and 5 vials. 
Topotekan Actavis je na voljo v škatlah, ki vsebujejo 1 ali 5 vial.
Then seek medical evaluation by a physician. 
Potem je potreben pregled pri zdravniku.
This increase is considered unlikely to be of clinical relevance. 
Verjetnost, da bi to povečanje imelo klinični pomen je majhna.
They may require hospitalisation and could even be life-threatening. 
Potreben je lahko sprejem v bolnišnico, ti učinki pa so lahko celo smrtno nevarni.
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to dose reduce to maintain neutrophil counts. 
Standardna onkološka praksa za obvladovanje nevtropenije je bodisi uporaba topotekana z drugimi zdravili (npr. G-CSF) bodisi zmanjšanje odmerka za ohranitev števila nevtrofilcev.
If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1). 
Če ga bolniki dobro prenašajo, smemo z zdravljenjem nadaljevati, dokler je bolezen v progresiji (glejte poglavji 4.8 in 5.1).
Antitumour activity was demonstrated primarily in patients with neuroblastoma. 
Protitumorsko delovanje je bilo dokazano predvsem pri bolnikih z nevroblastomom.
A doctor or nurse will give you the reconstituted and diluted Topotecan Actavis solution as an infusion (drip), usually into your arm, over about 30 minutes. 
Zdravnik ali medicinska sestra vam bosta dala pripravljeno in razredčeno raztopino zdravila Topotekan Actavis v infuziji (kapalni), po navadi v roko; infuzija bo trajala približno 30 minut.
Each vial is sheathed in a protective sleeve. 
Vsaka viala je obdana z zaščitno oblogo.
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 osnovnimi dejavniki tveganja so anamneza ILD, pljučna fibroza, pljučni rak, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih snovi in/ali kolonije stimulirajočih faktorjev.
In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form). 
V populacijski študiji številni dejavniki, med drugim starost, telesna masa in ascites, niso značilno vplivali na očistek celotnega topotekana (aktivne in neaktivne oblike).
The median survival was 30.3 weeks (95 % CI: 27.6, 33.4). 
Srednji čas preživetja je bil 30,3 tednov (95% interval zaupanja: 27,6; 33,4).
Your dose of Topotecan Actavis will depend on: - the disease being treated, - your body surface area (m - the results of blood tests carried out before and during treatment, - how well you tolerate treatment. 
Odmerek zdravila Topotekan Actavis bo odvisen od: - zdravljene bolezni, - vaše telesne površine (m - izvidov preiskav krvi, opravljenih pred zdravljenjem in med njim, - tega, kako dobro prenašate zdravljenje.
The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were less than 2.0 %. 
Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid sta v urinu v manj kot 2,0%.
In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients. 
Med kliničnimi preskušanji so o izpuščaju poročali pri 4% bolnikov in o pruritusu pri 1,5% bolnikov.
Adequate protective disposable gloves, goggles, gown and mask should be worn. 
Osebje mora nositi ustrezne zaščitne rokavice, očala, haljo in masko.
Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever. 
Nenormalno majhno število nevtrofilnih granulocitov (vrste belih krvnih celic) v krvi, z zvišano telesno temperaturo ali brez nje.
- Decrease in the number of all blood cells (pancytopenia) - Feeling unwell. 
- Zmanjšano število vseh krvnih celic (pancitopenija) - Slabo počutje.
Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. 
Potrebni so ustrezni previdnostni ukrepi, da bi preprečili naključen stik zdravila z očmi.
Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses). 
Anemija: Zmerna do huda (Hb ≤ 8,0 g/dl) pri 37% bolnikov (14% ciklov zdravljenja).
Storage after reconstitution and dilution 
Shranjevanje po pripravi in razredčenju
Topotecan Actavis should not be used in pregnant women, unless clearly necessary. 
Zdravila Topotekan Actavis se pri nosečnicah ne sme uporabiti, če ni nujno potrebno.
In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4). 
Poleg tega je pri 5% vseh zdravljenih bolnikov (1% ciklov zdravljenja) prišlo do sepse (glejte poglavje 4.4).
Metabolism accounts for < 10 % of the elimination of topotecan. 
Presnova predstavlja < 10% izločanja topotekana.
This should be taken into account, when prescribing topotecan e.g. in case patients at increased risk of tumour bleeds are considered for therapy. 
To je treba upoštevati pri predpisovanju topotekana, npr. pri bolnikih, pri katerih obstaja večje tveganje za pojav krvavitve tumorja.
infection 
okužba
- Decrese in number of circulating white blood cells (leucotyes) in the blood. 
- Zmanjšanje števila krožečih belih krvnih celic (levkocitov) v krvi.
Topotecan does not inhibit human P450 enzymes (see section 5.2). 
Topotekan ne zavira encimov humanega citokroma P450 (glejte poglavje 5.2).
Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total medicinal product related material accounted for in the urine and faeces. 
Presnovek N-desmetil predstavlja v povprečju manj kot 7% (razpon 4-9%) skupnih z zdravilom povezanih snovi prisotnih v urinu in blatu.
The powder must be dissolved, and the resulting concentrate further diluted before administration. 
Prašek je treba raztopiti in dobljeni koncentrat pred uporabo dodatno razredčiti.
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.
However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded. 
A tako kot druga citotoksična zdravila je tudi topotekan genotoksičen in vpliva na plodnost (tudi na moško plodnost) ni mogoče izključiti.
The preparation should be performed in a designated area under aseptic conditions. 
Zdravilo je treba pripraviti v prostoru, ki je temu namenjen, in v aseptičnih pogojih.
The experience in children is limited, therefore no recommendation for treatment of paediatric patients with Topotecan Actavis can be given (see sections 5.1 and 5.2). 
Izkušnje pri otrocih so nezadostne, zato ni mogoče dati priporočil za zdravljenje pediatričnih bolnikov z zdravilom Topotekan Actavis (glejte poglavji 5.1 in 5.2).
Contraception in males and females 
Kontracepcijska zaščita pri moških in ženskah
Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed. 
Razpolovna doba topotekana se je podaljšala za 30%, volumen porazdelitve pa se ni bistveno spremenil.
Pharmacotherapeutic group: Other antineoplastic agents, ATC code: L01XX17. 
Farmakoterapevtska skupina: Druga zdravila z delovanjem na novotvorbe (citostatiki), oznaka ATC: L01XX17
As with all cytotoxic chemotherapy, effective contraceptive methods must be advised when either partner is treated with topotecan. 
Kot velja za vsako citotoksično kemoterapijo, je treba svetovati uporabo učinkovite kontracepcijske zaščite, če kateri od partnerjev dobiva terapijo s topotekanom.
If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus. 
Če je topotekan uporabljen med nosečnostjo ali če bolnica zanosi med zdravljenjem s topotekanom, jo je treba opozoriti na možne nevarnosti za plod.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions. 
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2°C do 8°C, razen če ni priprava/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
As expected, patients with poor performance status (PS > 1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8). 
Kot je bilo pričakovati, se bolniki v slabšem telesnem stanju (PS>1) slabše odzivajo na zdravilo in pri njih tudi pogosteje opažamo zaplete, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
- Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets). 
- Nenavadne podplutbe ali krvavitve, ki so včasih hude in so posledica zmanjšanega števila krvnih ploščic (trombocitov), potrebnih za strjevanje krvi.
Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose. 
Celokupno izločanje z zdravilom povezanih snovi po petih dnevnih odmerkih topotekana je bilo od 71 do 76% intravensko prejetega odmerka.
1 x 1 mg vial; 5 x 1 mg vial 1 x 4 mg vial; 5 x 4 mg vial 
1 x 1 mg viala; 5 x 1 mg viala 1 x 4 mg viala; 5 x 4 mg viala
30 minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy. 
Zdravljenje se je ponavljalo vsake 3 tedne in trajalo do 1 leta, odvisno od odziva na zdravljenje.
Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan 
Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim ali intravenskim topotekanom
Patients with impaired kidney function Your doctor might need to reduce your dose based on your kidney function. 
Bolniki z okvarjenim delovanjem ledvic Zdravnik vam bo morda moral zmanjšati odmerek, glede na vaše delovanje ledvic.
For intravenous use as infusion, after reconstitution and dilution. 
Za intravensko uporabo v obliki infuzije, po pripravi in razredčenju.
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 compared to 21.3 l/h/m 
Pri dajanju v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dne) je bil 5. dan očistek topotekana v primerjavi s 1. dnem manjši (19,1 l/uro/m v primerjavi s 21,3 l/uro/m
Do not use Topotecan Actavis - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding. 
Ne uporabljajte zdravila Topotekan Actavis - če ste alergični na topotekan ali katerokoli sestavino tega zdravila (navedeno v poglavju - če dojite.
Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3. 
Pomembno je, da se bolnikovo telesno stanje ob začetku zdravljenja natančno oceni in zagotovi, da se ne poslabša na stanje 3.
Topotecan Actavis is used to treat: - small cell lung cancer that has come back after chemotherapy, or - advanced cervical cancer if surgery or radiotherapy is not possible. 
Zdravilo Topotekan Actavis uporabljamo za zdravljenje: - drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji ali - napredovalega karcinoma materničnega vratu, ko kirurško zdravljenje in zdravljenje z obsevanjem ni možno.
Symptoms may include yellow skin (jaundice). 
Med simptomi je lahko porumenelost kože (zlatenica).
An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces. 
Presnovek N-desmetil (za katerega so v celičnem testu dokazali, da ima podobno ali manjšo aktivnost kot izvorna učinkovina) so odkrili v urinu, plazmi in blatu.
Your dose of Topotecan Actavis may need to be adjusted. 
Morda bo treba odmerek zdravila Topotekan Actavis prilagoditi.
If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Topotecan Actavis. 
Če se zdravite zaradi raka materničnega vratu, se vam lahko neželeni učinki pojavijo tudi zaradi drugega zdravila (cisplatina), ki ga boste dobili skupaj z zdravilom Topotekan Actavis.
For cervical cancer, it will be used together with another anticancer medicines containing cisplatin. 
Za zdravljenje raka materničnega vratu bo uporabljeno skupaj z drugimi zdravili proti raku, ki vsebujejo cisplatin.
- Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells. 
- Nenormalno velika koncentracija bilirubina, razgradne snovi, ki nastaja v jetrih med razgradnjo rdečih krvnih celic.
The observed signs and symptoms for overdose were consistent with the known undesirable events associated with topotecan (see section 4.8). 
Opazovani znaki in simptomi prevelikega odmerjanja so v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
Limited data indicate that the dose should be reduced in patients with moderate renal impairment. 
Omejena količina podatkov, ki je na voljo, kaže, da je treba pri zdravljenju bolnikov z zmerno ledvično okvaro odmerek zmanjšati.
Other severe events occurring in patients that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %). 
Drugi hujši učinki, ki so se pojavili pri bolnikih in so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12%), občutek slabosti (3%) in hiperbilirubinemija
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 je treba kontrolirati glede pljučnih simptomov, ki nakazujejo ILD (npr. kašelj, zvišana telesna temperatura, dispneja in/ali hipoksija); če je diagnoza intersticijske bolezni pljuč potrjena, je treba zdravljenje s topotekanom prekiniti.
What you need to know before you use Topotecan Actavis 
Kaj morate vedeti, preden boste uporabili zdravilo Topotekan Actavis
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 beljakovine v plazmi (35%), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
Among all patients treated in clinical trials (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection. 
11% vseh bolnikov (4% ciklov zdravljenja), ki so se zdravili v kliničnih raziskavah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se nevtropenija ni pojavila), je imelo zvišano telesno temperaturo, pri 26% (9% ciklov zdravljenja) pa so se pojavile okužbe.
Topotecan is contraindicated in patients who - have a history of severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - are breast-feeding (see section 4.6) - already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 10 
Topotekan je kontraindiciran pri: - bolnikih, ki imajo v anamnezi hudo preobčutljivostno reakcijo na za zdravilno učinkovino ali katero koli pomožno snov navedeno v poglavju 6.1; - bolnicah, ki dojijo (glejte poglavje 4.6); - bolnikih, ki imajo hudo depresijo kostnega mozga že pred začetkom prvega cikla, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 10
In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase. 
Topotekan in vitro pri človeku ni zaviral delovanja encimov P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A).
In dose-finding trials 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. 
Preskušanja za določitev odmerka, ki so zajela 523 bolnic z recidivom raka jajčnika in 631 bolnikov z recidivom drobnoceličnega pljučnega raka, so pokazala, da so toksični učinki, ki omejujejo odmerek topotekana v monoterapiji, hematološki.
topotecan was discontinued if the dose had been reduced to 1.0 mg/m and a further dose reduction was required to manage adverse effects. 
Med kliničnimi preskušanji so topotekan prenehali uporabljati, če je bil odmerek že zmanjšan na 1,0 mg/m in bi ga bilo treba zaradi neželenih učinkov še dodatno zmanjšati.
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 vpliva na sposobnost razmnoževanja pri podganah topotekan ni vplival na plodnost samcev ali samic; so pa pri samicah opazili superovulacijo in rahel porast predimplantacijskih izgub.
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC. 
Samonavedbe bolnikov o simptomih, pri katerih je bila uporabljena neslepljena ocena, so pokazale dosleden trend k ugodnim spremembam simptomov s peroralnim topotekanom in NPO.
Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available. 
Topotekan so proučevali tudi pri otrocih, vendar je podatkov o učinkovitosti in varnosti pri tej skupini bolnikov malo.