natgillin/translations-raw huggingface dataset:
As a result the working party undertook a review of the benefits and risks of all fibrates-containing medicines, on behalf of the medicines regulatory authorities of the countries where the medicines are marketed. 
Posledično je delovna skupina opravila pregled koristi in tveganj za vsa zdravila, ki vsebujejo fibrate, v imenu regulativnih organov za zdravila v državah, v katerih se ta zdravila tržijo.
Consequently, the UK medicines regulatory agency referred the matter to the CHMP on 20 October 2009, to carry out a full assessment of the benefit-risk balance of fibrates and to issue an opinion on whether the marketing authorisations for fibrates-containing medicines should be maintained or varied across the European Union. 
Posledično je regulatorna agencija za zdravila v Združenem kraljestvu 20. oktobra 2009 zadevo napotila k odboru CHMP, ki naj bi celovito presodil razmerje med koristmi in tveganji fibratov ter izdal mnenje o tem, ali naj se dovoljenja za promet z zdravili, ki vsebujejo fibrate, po vsej Evropski uniji ohranijo ali spremenijo.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of fibrates continue to outweigh their risks within these restrictions. 
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v odboru CHMP, je ta zaključil, da koristi fibratov še vedno odtehtajo z njimi povezana tveganja, če se uporabljajo z upoštevanjem teh omejitev.
The CHMP looked at the information gathered by PhVWP during its review, as well as the responses provided by the companies to specific questions. 
Odbor CHMP je pregledal informacije, ki jih je med pregledom zbrala delovna skupina PhVWP, in odgovore družb na posebna vprašanja.
The conclusions of the PhVWP were transmitted to the companies that market fibrates, so that they could implement the changes recommended by the working party. 
Ti zaključki so bili predloženi družbam, ki tržijo fibrate, da bi lahko te uveljavile spremembe, ki jih je priporočila delovna skupina.
• Patients who are currently taking fibrates to lower their blood lipid levels should continue to do so. 
• Bolniki, ki trenutno jemljejo fibrate za zniževanje ravni lipidov v krvi, naj to nadaljujejo.
Fibrates should be used only when statins are contraindicated or not tolerated. 
Fibrati se smejo uporabljati samo, kadar so statini kontraindicirani ali jih bolnik ne prenaša.
Blood lipid disorders are a risk factor of heart disease (such as heart attack and stroke) and fibrates are used to improve lipid levels in patients in whom dietary restrictions and exercise have not been enough. 
Motnje lipidov v krvi so dejavnik tveganja za bolezen srca (kot sta srčni napad ali kap), fibrati pa se uporabljajo za izboljšanje ravni lipidov pri bolnikih, ki jim prehranske omejitve in telesna vadba ne zadostujejo.
This means that newlydiagnosed patients with blood lipid disorders should not be treated using these medicines in the first instance, unless they have very high levels of triglycerides (a type of fat). 
To pomeni, da se na novo diagnosticirani bolniki z motnjami lipidov v krvi ne smejo začeti zdraviti s temi zdravili, razen če imajo zelo visoke ravni trigliceridov (vrsto maščob).
As a result, the Committee also allowed the use of fenofibrate together with a statin in some circumstances for patients at risk when using a statin on its own was not enough to completely control blood lipid levels. 
Posledično je dovolil tudi uporabo fenofibrata skupaj s statinom v nekaterih okoliščinah pri bolnikih, ki so v nevarnosti, ker jim uporaba samega statina ne zadostuje za popolno obvladovanje ravni lipidov v krvi.
This receptor can be found in many cells throughout the body, where it is involved in breaking down dietary fat, especially triglycerides and cholesterol. 
Ta receptor se pojavlja v številnih celicah po vsem telesu, kjer sodeluje pri razgradnji zaužitih maščob, zlasti trigliceridov in holesterola.
• Doctors are reminded that fibrates should not be used as first-line treatment in patients with high lipid levels, except in specific groups: patients with severe hypertriglyceridaemia; patients for whom statins are contra-indicated or who cannot tolerate them. 
• Zdravniki morajo upoštevati, da se fibrati ne smejo uporabljati kot zdravljenje prve izbire pri bolnikih z visokimi ravnmi lipidov, razen v posebnih skupinah: bolniki s hudo hipertrigliceridemijo; bolniki, pri katerih so statini kontraindicirani ali ki teh zdravil ne prenašajo.
However, fibrates can be used in patients who cannot take statins (another type of medicine used to lower blood lipid levels). 
Kljub temu se smejo fibrati uporabljati pri bolnikih, ki ne morejo jemati statinov (druge vrste zdravil, ki se uporabljajo za zniževanje ravni lipidov v krvi).
Fibrates are a class of medicines that can be used to lower the level of lipids, such as cholesterol and triglycerides, in the blood. 
Fibrati so skupina zdravil, ki se lahko uporabljajo za zniževanje ravni lipidov, kot so holesterol in trigliceridi, v krvi.
The aim of the review was to establish how fibrates should now be used, taking into account their safety, their effectiveness in lowering lipid levels and the availability of other lipid-lowering medicines that were not around when fibrates were first used. 
Cilj pregleda je bil ugotoviti, kako bi se fibrati morali uporabljati zdaj, ob upoštevanju njihove varnosti, učinkovitosti pri zniževanju ravni lipidov in razpoložljivosti drugih zdravil za zniževanje ravni lipidov, ki jih na začetku uporabe fibratov še ni bilo.
In 2005, the CHMP's PharmacoVigilance Working Party (PhVWP) noted that there was limited evidence of the long-term benefit of fibrates in reducing cardiovascular risk, compared with the stronger evidence for statins (another type of medicines used for lowering blood cholesterol). 
Leta 2005 je Delovna skupina za farmakovigilanco (PhVWP) odbora CHMP opazila, da je dokazov o dolgoročni koristi fibratov za zmanjšanje tveganja za bolezni srca in ožilja malo v primerjavi z močnejšimi dokazi za statine (drugo vrsto zdravil, ki se uporabljajo za zniževanje ravni holesterola v krvi).
The Committee also looked at the latest data from clinical studies including a trial looking at the effect of using fenofibrate as an ‘add-on' to statins. 
Upošteval je tudi najnovejše podatke iz kliničnih študij, vključno s preskušanjem, v katerem so raziskali učinek fenofibrata, kadar se ta uporablja kot „dodatek“ pri zdravljenju s statini.
However, the Committee noted that fibrates are more effective than statins in lowering triglyceride levels and therefore their use as a first-line treatment in patients with severe hypertriglyceridaemia (very high blood levels of triglycerides) is still appropriate. 
Vendar je Odbor dodal, da fibrati v primerjavi s statini učinkoviteje znižujejo ravni trigliceridov, zato je njihova uporaba kot zdravljenje prve izbire pri bolnikih s hudo hipertrigliceridemijo (zelo visokimi ravnmi trigliceridov v krvi) še vedno ustrezna.
When the receptors are activated, the break down of fats is accelerated, and this helps clear the blood of cholesterol and triglycerides. 
Ko so receptorji aktivirani, se maščobe pospešeno razgrajujejo, kar pomaga pri odstranjevanju holesterola in trigliceridov iz krvi.
The Committee endorsed the conclusions of the PhVWP that fibrates are still a safe option for lowering lipid levels, but that their use as first-line treatment is not justified. 
Odbor je podprl zaključke delovne skupine PhVWP, da so fibrati še vedno varna izbira za zniževanje ravni lipidov, vendar njihova uporaba kot zdravljenje prve izbire ni upravičena.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of fibrates continue to outweigh their risks but that they should not be used as ‘first line' in the treatment of blood lipids (fats) disorders, such as high cholesterol, except in rare cases. 
Odbor za zdravila za uporabo v humani medicini (CHMP) Evropske agencije za zdravila je zaključil, da koristi fibratov še vedno odtehtajo z njimi povezana tveganja, vendar pa se ne smejo uporabljati kot „prva izbira“ za zdravljenje motenj lipidov (maščob) v krvi, kot je visoka raven holesterola, razen v redkih primerih.
• However, patients taking a fibrate-containing medicine should arrange to see their doctor to check that the medicine is the most appropriate option to lower their blood lipid levels. 
• Vendar morajo bolniki, ki jemljejo zdravilo z vsebnostjo fibratov, obiskati zdravnika, ki se bo prepričal, ali je to zdravilo zanje najustreznejša možnost za zniževanje ravni lipidov v krvi.
Looking at the data, the PhVWP came to the conclusion that there were no new safety issues with fibrates and that fibrate-containing medicines still had a role to play in improving lipid levels, but that they should not be used as first-line treatment. 
Med pregledom podatkov je delovna skupina ugotovila, da v zvezi s fibrati ni nobenih novih varnostnih vprašanj in da imajo zdravila, ki vsebujejo fibrate, še vedno vlogo pri izboljšanju ravni lipidov, vendar se ne smejo uporabljati kot zdravljenje prve izbire.
• They should review the treatment of patients who are receiving fibrates to help control their lipid levels to ensure that the patient is receiving the most appropriate treatment. 
• Zdravniki, ki predpisujejo zdravilo, morajo znova oceniti zdravljenje bolnikov, ki dobivajo fibrate za obvladovanje ravni lipidov, da bi tako zagotovili, da se vsak bolnik zdravi z najustreznejšim zdravilom.
It is sold in Belgium, Bulgaria, 
Prodaja se v Avstriji, Belgiji, na
The Committee also noted that there were new data for fenofibrate that supported a change to the PhVWP recommendations, based on the results of the add-on study. 
Odbor je ugotovil tudi, da so iz študije dodatnega zdravljenja na voljo novi podatki o fenofibratu, ki podpirajo spremembo priporočil delovne skupine.
Malta, the Netherlands, Portugal, Romania, Spain, Sweden and the United Kingdom; 
Nizozemskem, Portugalskem, v Romuniji, Španiji, na Švedskem in v Združenem kraljestvu;
It is marketed mainly under the trade names Bezalip, Cedur, Eulitop and Befizal, as well as generic medicines. 
Bezalip, Cedur, Eulitop in Befizal ter kot generična zdravila.
It is sold in Austria, Cyprus, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, the Netherlands, Portugal, Slovenia, Slovakia, Spain, Sweden and the United Kingdom. 
Prodaja se v Avstriji, na Cipru, Danskem, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, Islandiji, Irskem, v Italiji, na Nizozemskem, Portugalskem, v Sloveniji, na Slovaškem, v Španiji, na Švedskem in v Združenem kraljestvu.
This medicine has been available since 1977. 
• bezafibrat - to zdravilo je na voljo od leta 1977.
This medicine has been available since 1975. 
• fenofibrat - to zdravilo je na voljo od leta 1975.
It is marketed mainly under the trade name Lipanthyl, as well as generic medicines. 
Trži se večinoma pod lastniškim imenom Lipanthyl in kot generična zdravila.
It is marketed mainly under the trade name Lopid, as well as generic medicines. 
Trži se večinoma pod lastniškim imenom Lopid in kot generična zdravila.
This medicine has been available since 1981. 
• gemfibrozil - to zdravilo je na voljo od leta 1981.
Cyprus, the Czech Republic, Estonia, France, Greece, Hungary, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Portugal, Romania, Slovakia and the United Kingdom; 
v Estoniji, Franciji, Grčiji, na Madžarskem, v Latviji, Litvi, Luksemburgu, na Nizozemskem, Poljskem, Portugalskem, v Romuniji, na Slovaškem in v Združenem kraljestvu;
This medicine has been available since 1995. 
• ciprofibrat- to zdravilo je na voljo od leta 1995.
Austria, Belgium, Cyprus, Finland, France, Germany; Greece, Hungary, Italy, Luxembourg, 
Cipru, Finskem, v Franciji, Nemčiji, Grčiji, na Madžarskem, v Italiji, Luksemburgu, na Malti,
It is marketed mainly under the trade name Lipanor or Modalim, as well as generic medicines. 
Lipanor in Modalim ter kot generična zdravila.
Date of first authorisation: 6 January 2011 Date of latest renewal: 5 October 2015 
Datum prve odobritve: 6. januar 2011 Datum zadnjega podaljšanja: 5. oktober 2015
Each pack contains one vial. 
Vsako pakiranje vsebuje eno vialo.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. 
Zdravila ne smete mešati z drugimi zdravili razen s tistimi, ki so omenjena v poglavju 6.6.
Study results Study GOG-0179 
Preglednica 2: Rezultati študije GOG-0179
Vials 4 years. 
Viale 4 leta
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. 
Ker vam bo to zdravilo dal vaš zdravnik ali medicinska sestra je malo verjetno, da boste dobili prevelik odmerek.
This treatment cycle will normally be repeated every three weeks. 
Tak ciklus zdravljenja boste praviloma prejemali vsake 3 tedne.
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) and not known (cannot be estimated from the available data). 
Pogostnosti so opredeljene takole: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < /1.000), zelo redki (< 1/10.000) in pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The experience in children and adolescents is limited and treatment is therefore not recommended. 
Izkušenj pri otrocih in mladostnikih je malo, zato zdravljenje s tem zdravilom ni priporočljivo.
Median time to progression (weeks) 
Mediani čas do napredovanja (tedni)
It must be reconstituted and further diluted before use (see section 6.6). 
Pred uporabo ga je treba rekonstruirati in nato še nadalje razredčiti (glejte poglavje 6.6).
The preparation should be performed in a designated area under aseptic conditions. 
Zdravilo je treba pripraviti v za to namenjenem prostoru in v aseptičnih pogojih.
Always wash hands after removing gloves. 
Po snetju rokavic, si je treba vedno umiti roke.
Your dose of Potactasol may need to be adjusted. 
Morda bo treba odmerek zdravila Potactasol prilagoditi.
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 (s standardno deviacijo 57), in sorazmerno kratko razpolovno dobo, 2-3 ure.
- Allergic (hypersensitivity) reactions (including rash). 
- Alergijske (preobčutljivostne) reakcije (vključno z izpuščajem).
- Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands, 
- Oteklost zaradi kopičenja tekočine (angioedema), npr. okrog oči in ustnic ter v dlaneh,
Your dose of Potactasol will depend on: - the disease being treated, - your body surface area (m2), - the results of blood tests carried out before and during treatment, - how well you tolerate treatment. 
Odmerek zdravila Potactasol bo odvisen od: - bolezni, zaradi katere se zdravite, - vaše telesne površine (m2), - izvidov preiskav krvi, opravljenih pred zdravljenjem in med njim, - tega, kako dobro prenašate zdravljenje.
What you need to know before you use Potactasol Do not use Potactasol 
Kaj morate vedeti, preden boste vzeli zdravilo Potactasol Ne jemljite zdravila Potactasol
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 v urinu predstavljata manj kot 2,0 %.
- Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia). 
- Občutek splošne šibkosti in utrujenosti, kar sta lahko simptoma zmanjšanega števila rdečih krvnih celic (anemije).
- Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage. 
- Blage bolečine in vnetje na mestu injiciranja zaradi naključnega prehajanja zdravila v okoliško tkivo (ekstravazacija), npr. zaradi iztekanja.
Potactasol should not be used in pregnant women, unless clearly necessary. 
Zdravila Potactasol se pri nosečnicah ne sme uporabiti, če ni nujno potrebno.
What Potactasol is and what it is used for What you need to know before you use Potactasol How to use Potactasol 
Kaj je zdravilo Potactasol in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Potactasol Kako jemati zdravilo Potactasol
As would be 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 mogoče pričakovati, se bolniki s slabšo telesno zmogljivostjo (performance status, PS > 1) slabše odzivajo na zdravilo, večja pa je tudi pogostnost zapletov, kot so zvišana telesna temperatura, okužbe in sepsa (glejte poglavje 4.8).
In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4). 
Poleg tega je pri 5 % vseh zdravljenih bolnikov (v 1% ciklusov zdravljenja) prišlo do sepse (glejte poglavje 4.4).
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
Potactasol can make you feel tired or weak. 
Zdravilo Potactasol lahko povzroči utrujenost in šibkost.
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 plodnost samcev) ni mogoče izključiti.
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.
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 Potactasol. 
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 Potactasol.
Potactasol is available in cartons containing 1 vial. 
Zdravilo Potactasol je na voljo v škatlah, ki vsebujejo 1 vialo.
- The active substance is topotecan. 
− Učinkovina je topotekan.
Median survival was 30.3 weeks (95 % CI: 27.6, 33.4). 
Mediana časa preživetja je bila 30,3 tedna (95-odstotni interval zaupanja: 27,6; 33,4).
In this case Potactasol treatment is combined with medicines containing cisplatin. 
V tem primeru se zdravilo Potactasol uporablja skupaj z zdravili, ki vsebujejo cisplatin.
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 matična učinkovina) so odkrili v urinu, plazmi in blatu.
Potactasol contains the active substance topotecan which helps to kill tumour cells. 
Zdravilo Potactasol vsebuje učinkovino topotekan, ki pomaga uničiti tumorske celice.
- Decrease in the number of all blood cells (pancytopenia). 
- Zmanjšano število vseh krvnih celic (pancitopenija).
This should be taken into account, when prescribing topotecan, e.g. if patients at increased risk of tumour bleeds are considered for therapy. 
To je treba upoštevati pri predpisovanju zdravila Potactasol, npr. pri odločanju za zdravljenje bolnikov, pri katerih obstaja večje tveganje za krvavitve tumorja.
Cytotoxic, special handling instructions (see package leaflet). 
Citotoksično zdravilo, posebna navodila za ravnanje (glejte navodilo za uporabo).
Other medicines and Potactasol 
Druga zdravila in zdravilo Potactasol
(95 % CI) 
(95-odstotni IZ)
− All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration. 
• Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, morate odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
This condition can be fatal. 
To stanje se lahko konča s smrtjo.
What Potactasol is and what it is used for 
Kaj je zdravilo Potactasol in za kaj ga uporabljamo
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 po zdravljenju s cisplatinom ponovila v roku 3 mesecev ali ki se niso odzvale na zdravilo (n = 186), je bila stopnja odziva 10 %.
- if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding. 
- če ste alergični na topotekan ali katero koli sestavino tega zdravila (navedeno v poglavju - če dojite, - če imate prenizko število krvnih celic.
In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients. 
V kliničnimi študijah so o izpuščaju poročali pri 4 % bolnikov, o srbenju pa pri 1,5 % bolnikov.
Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces. 
Presnovek N-desmetil predstavlja v povprečju manj kot 7 % (od 4 do 9 %) vseh s topotekanom povezanih snovi prisotnih v urinu in blatu.
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.
Doses should be similarly reduced if the platelet count falls below 25 x 109/l. 
Odmerke je treba podobno zmanjšati, če se število trombocitov zniža pod 25 x 109/l.
If you are given too much Potactasol 
Če ste dobili preveč zdravila Potactasol
If, during topotecan/cisplatin combination therapy serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation. 
Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnega koli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
Vials may or may not be sheathed in a protective sleeve. 
Viale so lahko obdane z zaščitnim ovojem ali so brez njega.
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 ustreznega odmerka, v katere je bilo vključenih 523 bolnic s ponovitvijo raka na jajčniku in 631 bolnikov s ponovitvijo drobnoceličnega pljučnega raka, so pokazala, da so toksični učinki, ki omejujejo odmerek topotekana v monoterapiji, hematološki.
Do not use this medicine after the expiry date which is stated on the vial and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses). 
Anemija: Zmerna do huda oblika (Hb ≤ 8,0 g/dl) se je razvila pri 37 % bolnikov (v 14 % ciklusov zdravljenja).
There is no known antidote for topotecan overdose. 
Antidota za preveliko odmerjanje s topotekanom ni.
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus 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.