FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Če je topotekan uporabljen med nosečnostjo ali če bolnica zanosi med zdravljenjem s topotekanom, jo je treba opozoriti na možne nevarnosti za plod.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: - Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Slovenian: - Nenavadne podplutbe ali krvavitve, ki so včasih hude in so posledica zmanjšanega števila krvnih ploščic (trombocitov), potrebnih za strjevanje krvi.
English: Overall recovery of medicinal product-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Slovenian: Celokupno izločanje z zdravilom povezanih snovi po petih dnevnih odmerkih topotekana je bilo od 71 do 76% intravensko prejetega odmerka.
English: 1 x 1 mg vial; 5 x 1 mg vial 1 x 4 mg vial; 5 x 4 mg vial
Slovenian: 1 x 1 mg viala; 5 x 1 mg viala 1 x 4 mg viala; 5 x 4 mg viala
English: 30 minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Slovenian: Zdravljenje se je ponavljalo vsake 3 tedne in trajalo do 1 leta, odvisno od odziva na zdravljenje.
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Slovenian: Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim ali intravenskim topotekanom
English: Patients with impaired kidney function Your doctor might need to reduce your dose based on your kidney function.
Slovenian: Bolniki z okvarjenim delovanjem ledvic Zdravnik vam bo morda moral zmanjšati odmerek, glede na vaše delovanje ledvic.
English: For intravenous use as infusion, after reconstitution and dilution.
Slovenian: Za intravensko uporabo v obliki infuzije, po pripravi in razredčenju.
English: 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
Slovenian: 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
English: 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.
Slovenian: Ne uporabljajte zdravila Topotekan Actavis - če ste alergični na topotekan ali katerokoli sestavino tega zdravila (navedeno v poglavju - če dojite.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to performance status 3.
Slovenian: Pomembno je, da se bolnikovo telesno stanje ob začetku zdravljenja natančno oceni in zagotovi, da se ne poslabša na stanje 3.
English: 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.
Slovenian: 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.
English: Symptoms may include yellow skin (jaundice).
Slovenian: Med simptomi je lahko porumenelost kože (zlatenica).
English: 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.
Slovenian: 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.
English: Your dose of Topotecan Actavis may need to be adjusted.
Slovenian: Morda bo treba odmerek zdravila Topotekan Actavis prilagoditi.
English: 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.
Slovenian: 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.
English: For cervical cancer, it will be used together with another anticancer medicines containing cisplatin.
Slovenian: Za zdravljenje raka materničnega vratu bo uporabljeno skupaj z drugimi zdravili proti raku, ki vsebujejo cisplatin.
English: - Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
Slovenian: - Nenormalno velika koncentracija bilirubina, razgradne snovi, ki nastaja v jetrih med razgradnjo rdečih krvnih celic.
English: The observed signs and symptoms for overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Slovenian: Opazovani znaki in simptomi prevelikega odmerjanja so v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Slovenian: Omejena količina podatkov, ki je na voljo, kaže, da je treba pri zdravljenju bolnikov z zmerno ledvično okvaro odmerek zmanjšati.
English: 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 %).
Slovenian: 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
English: 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.
Slovenian: 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.
English: What you need to know before you use Topotecan Actavis
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Topotekan Actavis
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Slovenian: Predklinične študije kažejo, da se topotekan le malo veže na beljakovine v plazmi (35%), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
English: 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.
Slovenian: 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.
English: 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
Slovenian: 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
English: 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.
Slovenian: Topotekan in vitro pri človeku ni zaviral delovanja encimov P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
Slovenian: Samonavedbe bolnikov o simptomih, pri katerih je bila uporabljena neslepljena ocena, so pokazale dosleden trend k ugodnim spremembam simptomov s peroralnim topotekanom in NPO.
English: Topotecan was also evaluated in the paediatric population; however, only limited data on efficacy and safety are available.
Slovenian: Topotekan so proučevali tudi pri otrocih, vendar je podatkov o učinkovitosti in varnosti pri tej skupini bolnikov malo.
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Slovenian: V primeru prevelikega odmerka bo vaš zdravnik nadzoroval morebitne neželene učinke.
English: Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Slovenian: Pogostejši nehematološki učinki so bile gastrointestinalne težave, kot so navzea (52%), bruhanje (32%), driska (18%), zaprtje (9%) in mukozitis (14%).
English: Very common side effects (may affect more than 1 in 10 people) - Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Občutek splošne šibkosti in utrujenosti, kar sta lahko simptoma zmanjšanega števila rdečih krvnih celic (anemije).
English: Pregnant staff should not handle the cytotoxic preparation.
Slovenian: Noseče članice osebja ne smejo delati s citotoksičnimi pripravki.
English: Median time to onset of severe thrombocytopenia was Day 15 and the median duration was five days.
Slovenian: Mediana časa do pojava hude trombocitopenije je bila 15. dan, mediana trajanja trombocitopenije pa pet dni.
English: - Severe allergic (anaphylactic) reactions (rare; may affect up to 1 in 1,000 people), with signs such as: - swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash.
Slovenian: - Hude alergijske (anafilaktične) reakcije (redko; pojavijo se lahko pri največ 1 od 1.000 bolnikov) z znaki, kot so npr.: otekanje obraza, ustnic, jezika ali žrela, oteženo dihanje, nizek krvni tlak, omotičnost ali srbeč izpuščaj.
English: 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.
Slovenian: Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost serumskega kreatinina preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnegakoli zmanjšanja odmerka cisplatina ali nadaljevanju zdravljenja.
English: 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.
Slovenian: Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10%.
English: In a randomised, comparative phase III trial conducted by the Gynaecological 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.
Slovenian: Randomizirano primerjalno preskušanje III. faze, ki ga je izvedla ginekološka onkološka skupina (GOG 0179), je primerjalo topotekan in cisplatin (n = 147) s cisplatinom samim (n = 146) pri zdravljenju histološko potrjenega persistentnega rekurentnega karcinoma materničnega vratu ali karcinoma materničnega vratu v stadiju IVB, kjer kurativno zdravljenje s kirurškim posegom in/ali radiacijo ni bilo primerno.
English: extravasation
Slovenian: ekstravazacija
English: Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing.
Slovenian: Med primerjavo farmakokinetičnih parametrov nismo ugotavljali razlik med farmakokinetičnimi podatki v 5 dneh uporabe topotekana.
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Slovenian: Redko lahko to povzroči hujše krvavitve.
English: Other side effects with Topotecan Actavis include:
Slovenian: Med drugimi neželenimi učinki zdravila Topotekan Actavis so:
English: In an intravenous population study, the coadministration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Slovenian: V populacijski študiji po intravenski aplikaciji niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celokupnega topotekana (aktivne in neaktivne oblike).
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Slovenian: Topotekan je kontraindiciran med obdobjem dojenja (glejte poglavje 4.3).
English: In this study, forty-six (43 %) patients received G-CSF over 192 (42.1 %) courses; sixty-five (60 %) received transfusions of Packed Red Blood Cells and fifty (46 %) of platelets over 139 and 159 courses (30.5 % and 34.9 %) respectively.
Slovenian: V tej študiji je šestinštirideset (43%) bolnikov po 192 (42,1%) ciklih prejelo G-CSF, petinšestdeset (60%) bolnikov je po 139 (30,5%) ciklih prejelo transfuzijo eritrocitov, petdeset (46 ) bolnikov pa po 159 (34,9 ) ciklih transfuzijo trombocitov.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Slovenian: Srednji čas do progresije je bil v obeh skupinah podoben, in sicer pri topotekanu 13,3 tedna, pri kombinaciji CAV pa 12,3 tedna.
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Slovenian: Pri bolnikih z zmerno hudo ledvično okvaro se je plazemski očistek zmanjšal na 34 % vrednosti pri bolnikih v kontrolni skupini.
English: - Inflammation of the lining of the mouth and digestive tract.
Slovenian: - Vnetje sluznice v ustih in prebavilih.
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Slovenian: Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina < 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/dl), nimamo dovolj izkušenj.
English: - Weight loss and loss of appetite (anorexia); tiredness; weakness.
Slovenian: - Hujšanje in izguba teka (neješčnost), utrujenost, šibkost.
English: nausea, vomiting and diarrhoea (all of which may be severe)
Slovenian: navzea, bruhanje in driska (vsi so lahko hudi), zaprtje
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Slovenian: Poročali so o prevelikem odmerjanju pri bolnikih, ki so bili zdravljeni z intravenskim topotekanom (do 10-kratni priporočeni odmerek) in topotekanom v kapsulah (do 5-kratni priporočeni odmerek).
English: 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.
Slovenian: 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.
English: The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Slovenian: Koncentrati, ki so bili testirani, so bili shranjenih pri temperaturi 25 ± 2°C za 12 ur in 24 ur in potem razredčeni.
English: Effective contraception methods should be used to avoid becoming pregnant/fathering a child while on treatment.
Slovenian: Uporabljati morate učinkovito kontracepcijo zaščito, da v času zdravljenja ne zanosite oz. zaplodite otroka.
English: Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells.
Slovenian: Zdravilo Topotekan Actavis vsebuje zdravilno učinkovino topotekan, ki pomaga uničiti tumorske celice.
English: febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leukopenia
Slovenian: febrilna nevtropenija nevtropenija (glejte Bolezni prebavil, spodaj) trombocitopenija anemija levkopenija
English: The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Slovenian: Nekorigirano razmerje ogroženosti za skupino s peroralnim topotekanom in NPO glede na skupino s samo NPO je bilo 0,64 (95% IZ: 0,45, 0,90).
English: Τηλ: +30 210 5401500
Slovenian: Specifar ABEE Τηλ: +30 210 5401500
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10
Slovenian: Pred prvim ciklom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev ≥ 1,5 x 10
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Slovenian: Poročila o resnih zapletih, povezanih s trombocitopenijo, vključno s smrtnimi primeri in krvavitvami tumorjev, so bila redka.
English: What Topotecan Actavis is and what it is used for
Slovenian: Kaj je zdravilo Topotekan Actavis in za kaj ga uporabljamo
English: In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Slovenian: Pri sočasni uporabi topotekana z drugimi kemoterapevtiki bo morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Slovenian: Pri bolnicah, ki so se predhodno zdravile s cisplatinom mora preteči daljše obdobje brez zdravljenja, da se opraviči zdravljenje s kombinacijo (glejte poglavje 5.1).
English: - Feeling sick (nausea), vomiting; diarrhoea; stomach pain; constipation.
Slovenian: - Siljenje na bruhanje (navzea), bruhanje, driska, bolečine v trebuhu, zaprtje.
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m for five days every three weeks.
Slovenian: Le manjše število bolnikov z jetrno okvaro (vrednost serumskega bilirubina med 1,5 in 10 mg/dl) je prejelo intravenski odmerek 1,5 mg/m2 po pet dni na vsake tri tedne.
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Slovenian: Huda nevtropenija je pri 11% vseh ciklov zdravljenja trajala več kot sedem dni.
English: The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 -1.40).
Slovenian: Razmerje tveganja za preživetje z intravenskim topotekanom relativno glede na kombinacijo CAV je bilo 1,04 (95% interval zaupanja: 0,78-1,40).
English: In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %.
Slovenian: V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (obliko, ki se ne odziva na zdravljenje s terapijo prve izbire) je bil odziv na topotekan 4,0%.
English: However, in combining with platinum agents, there is a distinct sequence-dependent interaction depending on whether the platinum agent is given on day 1 or 5 of the topotecan dosing.
Slovenian: Pri sočasni uporabi s platinovimi spojinami pride do izrazite interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega ali damo pripravek s platino na 1. ali 5. dan dajanja topotekana.
English: 9/l) in 25 % of patients (8 % of courses);
Slovenian: 9/l) pri 25% bolnikov (8%
English: 9/l, a platelet count of ≥ 100 x 10
Slovenian: 9/l, število trombocitov ≥ 100 x 10
English: Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
Slovenian: Hematološka toksičnost je odvisna od odmerka, zato je treba bolnikom redno nadzorovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4.2).
English: 25 microgram/ml solution
Slovenian: 50 mikrogramov/ml
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Slovenian: Bolniki brez predhodne cisplatinske kemoradioterapije cisplatin topotecan/cisplatin
English: 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.
Slovenian: V eni študiji so otroci (stari od 2 do 12 let, n = 18), mladostniki (stari od 12 do 16 let, n = 9) in mlajši odrasli (stari od 16 do 21 let, n = 9) z neodzivnim solidnim tumorjem prejemali odmerek od 1,4 mg/m do 2,4 mg/m 2.
English: The incidence of adverse reactions listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Slovenian: Pojavnost zgoraj navedenih neželenih učinkov je lahko pogostejša pri bolnikih s slabšim telesnim stanjem (glejte poglavje 4.4).
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan.
Slovenian: Med zdravljenjem s topotekanom so pri približno 25% bolnikov opazili utrujenost, pri 16% pa astenijo.