natgillin/translations-raw huggingface dataset:
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). 
Jedno ispitivanje faze II (ispitivanje 065) i jedno faze III (ispitivanje 396) provedeno je radi procjene djelotvornosti peroralno i intravenski primijenjenog topotekana u bolesnika koji su imali recidiv nakon 90 ili više dana po završetku prethodnog kemoterapijskog protokola (vidjeti Tablicu 1).
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. 
Antitumorska aktivnost topotekana uključuje inhibiciju topoizomeraze-I, enzima neposredno uključenog u replikaciju DNK koji opušta torzijsku napetost, što dovodi do razdvajanja DNK uzvojnice.
• Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day. 
• Rak jajnika i rak pluća malih stanica: 1,5 mg/m² tjelesne površine na dan.
Following co-administration of the ABCB1 (P-gp) and ABCG2 (BCRP) inhibitor, elacridar (GF120918) at 100 to 1000 mg with oral topotecan, the AUC0-∞ of topotecan lactone and total topotecan increased approximately 2.5-fold (see section 4.5 for guidance). 
Nakon istodobne primjene inhibitora ABCB1 (P-gp) i ABCG2 (BCRP), elakridara (GF120918), u dozi od 100 do 1000 mg s oralnim topotekanom, AUC0-∞ topotekan laktona i ukupnog topotekana narasla je približno 2,5 puta (vidjeti dio 4.5).
Storage of the prepared solution 
Čuvanje pripremljene otopine
Proactive management of diarrhoea with anti-diarrhoeal agents is important. 
Važno je proaktivno zbrinjavati proljev antidijaroicima.
Loperamide was administered to 13% of patients in 5% of courses. 
Loperamid je primijenjen u 13% bolesnika, u 5% ciklusa.
Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin 
Bolesnice s prethodnom kemoradioterapijom cisplatinom cisplatin topotekan/cisplatin
What Hycamtin is and what it is used for What you need to know before you take Hycamtin How to take Hycamtin 
Što je Hycamtin i za što se koristi Što morate znati prije nego počnete uzimati Hycamtin Kako uzimati Hycamtin
Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]). 
Medijan vremena preživljenja bio je 62 tjedna za topotekan naspram 53 tjedna za paklitaksel (omjer hazarda 0,9 [0,6;
Median (95% CI) Hazard ratio (95% CI) Log rank p-value 
Medijan (95% CI) Omjer hazarda (95% CI) Log-rang p-vrijednost
Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67% when compared with a control group of patients. 
Klirens plazme u bolesnika s oštećenjem jetre (vrijednosti bilirubina u serumu između 1,5 i 10 mg/dl) smanjen je na oko 67% u usporedbi s kontrolnom skupinom bolesnika.
However, there are insufficient data available to make a dose recommendation for this patient group. 
Međutim, nema dovoljno dostupnih podataka na temelju kojih bi se moglo preporučiti doziranje u ovoj skupini bolesnika.
Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia. 
Primjena topotekana u monoterapiji i u kombinaciji s cisplatinom često je povezana s klinički značajnom trombocitopenijom.
The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4). 
Iznad navedene nuspojave imaju veći potencijal pojavljivanja u bolesnika slabog općeg stanja (vidjeti dio 4.4).
Additional adverse events were seen when topotecan was given in combination with cisplatin; however, these events were seen with cisplatin monotherapy and were not attributable to topotecan. 
Prilikom primjene topotekana u kombinaciji s cisplatinom zabilježene su dodatne nuspojave; međutim one su bile zabilježene i u monoterapiji cisplatinom i nisu bile povezane s topotekanom.
The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided. 
Kapsule se moraju progutati cijele i ne smiju se žvakati, drobiti ili lomiti.
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 Hycamtin. 
Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka, cisplatina, koji primate zajedno s lijekom Hycamtin.
Those effects are described in the cisplatin patient leaflet. 
Te nuspojave opisane su u uputi o lijeku za cisplatin.
The recommended dose of topotecan is 1.5 mg/m body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course. 
Preporučena doza topotekana je 1,5 mg/m tjelesne površine na dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno tijekom pet uzastopnih dana, s intervalom od tri tjedna između početka svakog ciklusa.
Currently there is only limited experience in combining oral topotecan with other chemotherapy agents. 
Trenutno iskustvo u primjeni oralnog topotekana s drugim kemoterapijskim lijekovima je ograničeno.
In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered. 
U bolesnika s vrućicom, neutropenijom i pratećim bolovima u trbuhu, potrebno je posumnjati na neutropenijski kolitis.
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. 
U ispitivanjima u kojima se utvrđuje doza lijeka, provedenima u 523 bolesnice s recidivom karcinoma jajnika i 631 bolesniku s recidivom karcinoma pluća malih stanica, hematotoksičnost se pokazala čimbenikom ograničenja doze u monoterapiji topotekanom.
Dosing recommendations for patients receiving oral topotecan with creatinine clearance less than 30 ml/min have not been established. 
Nisu ustanovljene preporučene doze za bolesnike koji uzimaju oralni topotekan s klirensom kreatinina manjim od 30 ml/min.
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended (see Package Leaflet). 
Ukupni sadržaj djelatne tvari u bočici iznosi 1 mg/ml djelatne tvari nakon pripreme kako je propisano (vidjeti uputu o lijeku).
Intravenous topotecan 
Intravenski topotekan
Titanium dioxide (E171) 
Ovojnica kapsule želatina titanijev dioksid (E171)
Administration of oral cyclosporine A (15 mg/kg), an inhibitor of transporters ABCB1 (P-gp) and ABCC1 (MRP-1) as well as the metabolising enzyme CYP3A4, within 4 hours of oral topotecan increased the dose normalised AUC0-24h of topotecan lactone and total topotecan approximately 2.0and 2.5-fold, respectively (see section 4.5). 
Primjena peroralnog ciklosporina A (15 mg/kg), inhibitora transportnih ABCB1 (P-gp) i ABCC1 (MRP-1), kao i metabolizirajućeg enzima CYP3A4, unutar 4 sata od oralnog topotekana povećala je dozu normalizirane AUC 0-24 h topotekan laktona približno 2,0 i ukupnog topotekana približno 2,5 puta (vidjeti dio 4.5).
Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket. 
Ogulite vanjski ovoj: počevši od obojenog ugla, podignite i povucite ovoj.
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10 
Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila  1,5 x 10
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose. 
Cisplatin se primjenjuje prvog dana u obliku intravenske infuzije u dozi od 50 mg/m tjelesne površine/dan i to nakon doze topotekana.
Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1). 
Kod bolesnica koje su prethodno liječene cisplatinom potrebna je dulja pauza kako bi se navedena kombinacija mogla primijeniti (vidjeti dio 5.1).
Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC. 
Standardizirani upitnici o simptomima koje su ispunjavali sami bolesnici , nakon otvorene (engl. unblinded) procjene pokazali su konzistentan trend u poboljšanju simptoma za oralni topotekan plus BSC.
topotecan was discontinued if the dose had been reduced to 1.0 mg/m 2/day and a further dose reduction was required to manage adverse effects. 
U kliničkim se ispitivanjima primjena topotekana obustavljala ako je doza smanjena na 1,0 mg/m 2/dan i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole nuspojava lijeka.
Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies. 
Peroralno i intravenski primijenjen topotekan pokazali su slično ublažavanje simptoma u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, standardiziranim upitnicima samih bolesnika na otvorenoj (engl. unblinded) skali procjene simptoma u svakoj od ove dvije studije.
The median time to onset of Grade 2 or worse diarrhoea was 9 days. 
Medijan vremena do pojave proljeva stupnja 2 ili većeg bio je 9 dana.
When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. 
Kad se topotekan koristi u kombinaciji s cisplatinom potrebno je slijediti upute za primjenu cisplatina.
The powder needs to be reconstituted and diluted before infusion. 
Prije primjene u obliku infuzije, prašak treba pripremiti i razrijediti.
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day with G-CSF and 1.4 mg/m2/day without GCSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2). 
U farmakokinetičkom ispitivanju kod djece s refraktornim solidnim tumorima, ustanovljena maksimalna podnošljiva doza od 2,0 mg/m 2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF (vidjeti dio 5.2) na temelju toksičnosti ovisne o dozi u obliku mijelosupresije.
Titanium dioxide (E171) Red iron oxide (E172) 
Ovojnica kapsule želatina titanijev dioksid (E171) željezov oksid, crveni (E172)
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
Nuspojave unutar iste skupine učestalosti navedene su u padajućem nizu prema ozbiljnosti.
Erythropoietin was administered to 10% of patients in 8% of courses. 
Eritropoetin je bio primijenjen u 10% bolesnika u 8% ciklusa.
Since the vial contains a 10% overage, the clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml. 
Kako bočica sadrži 10% suviška, rekonstituirana otopina je prozirna, žute do žuto-zelene boje i sadrži 1 mg topotekana u 1 ml otopine.
Powder for concentrate for solution for infusion. 
Prašak za koncentrat za otopinu za infuziju.
Neutropenia Severe neutropenia (Grade 4 - neutrophil count <0.5 x 10 
Neutropenija Teška neutropenija (Stupanj 4 - broj neutrofila < 0,5 x 10
• Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. 
• U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
What Hycamtin is and what it is used for What you need to know before you are given Hycamtin How Hycamtin is used 
Što je Hycamtin i za što se koristi Što morate znati prije nego počnete primati Hycamtin Kako se primjenjuje Hycamtin Moguće nuspojave
A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n = 71) with BSC alone (n = 70) in patients who had relapsed following first-line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate. 
U ispitivanju faze III (ispitivanje 478), uspoređivana je kombinacija topotekana primijenjenog peroralno i najboljeg potpornog liječenja (BSC; engl. best supportive care) (n = 71), sa samim BSC-om (n = 70) u bolesnika s recidivom karcinoma nakon prve linije liječenja (medijan vremena do progresije od prve linije liječenja [TTP] iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za sam BSC) i u bolesnika koji nisu bili pogodni za ponovno liječenje intravenski primijenjenom kemoterapijom.
The mean metabolite:parent AUC ratio was <10% for both total topotecan and topotecan lactone. 
Prosječan omjer AUC metabolita i roditeljskog spoja bio je < 10% i za topotekan i za topotekan lakton.
What you need to know before you take Hycamtin 
Što morate znati prije nego počnete uzimati Hycamtin
Type I flint glass vial, with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 4 mg of topotecan. 
Bočica od kremenog stakla tipa I, zatvorena sivim čepom od butilne gume i aluminijskim pokrovom te pokrivena plastičnom flip off kapicom, koja sadrži 4 mg topotekana.
Cyclosporin A (an inhibitor of ABCB1, ABCC1 [MRP-1], and CYP3A4) administered with oral topotecan increased topotecan AUC to approximately 2-2.5-fold of control. 
Ciklosporin A (inhibitor ABCB1, ABCC1 [MRP-1] i CYP3A4), primijenjen istovremeno s oralnim topotekanom povećava AUC topotekana prosječno 2 - 2,5 puta u usporedbi s kontrolnom skupinom.
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). 
Predoziranja su prijavljena u bolesnika liječenih intravenskom formulacijom topotekana (dozama do 10 puta većima od preporučene) i kapsulama topotekana (dozama do 5 puta većima od preporučene).
The capsules are opaque, white to yellowish white and imprinted with “HYCAMTIN” and “0.25 mg”. 
Kapsule su neprozirne, bijele do žućkasto bijele boje s otisnutim „HYCAMTIN“ i „0,25 mg“.
The integrated safety data for topotecan monotherapy are presented below. 
U daljnjem tekstu su navedeni cjelokupni podaci o sigurnosti primjene topotekana u monoterapiji.
Very rare 
Rijetke nuspojave
See section “Pregnancy and breast-feeding” 
Pogledajte dio „Trudnoća i dojenje“.
The total content of active substance in the vial provides 1 mg per ml of active substance when reconstituted as recommended. 
Ukupni sadržaj djelatne tvari u bočici daje 1 mg/ml djelatne tvari nakon pripreme kako je propisano.
Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts. 
Uobičajena onkološka metoda sprečavanja neutropenije je primjena topotekana s drugim lijekovima (npr. G-CSF) ili smanjenje doze s ciljem održanja primjerenog broja neutrofila.
Growth factors were administered to 19% of patients in 8% of courses. 
Čimbenici rasta primijenjeni su u 19% bolesnika, u 8% ciklusa liječenja.
Relapsed ovarian cancer 
Recidiv karcinoma jajnika
In clinical studies involving patients with relapsed small cell lung cancer, the dose-limiting toxicity of oral topotecan monotherapy was found to be haematological. 
U kliničkim ispitivanjima koja su uključivala bolesnike s recidivom karcinoma pluća malih stanica, hematotoksičnost se pokazala čimbenikom ograničenja doze u monoterapiji oralnim topotekanom.
After opening, the product should be used immediately. 
Lijek treba primijeniti odmah nakon otvaranja.
Approximately 20% was excreted as total topotecan and 2% was excreted as N-desmethyl topotecan in the urine. 
Oko 20% bilo je izlučeno urinom kao ukupni topotekan, a 2% kao N-desmetiltopotekan.
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. 
Učestalost dolje opisanih hematoloških i nehematoloških nuspojava dobivena je iz prijava nuspojava koje su ocijenjene kao povezane/moguće povezane s terapijom topotekanom.
Faecal elimination of total topotecan accounted for 18% while faecal elimination of N-desmethyl topotecan was 1.7%. 
Fecesom se eliminiralo 18% ukupnog topotekana i 1,7% N-desmetiltopotekana.
The capsules are opaque, pink and imprinted with “HYCAMTIN” and “1 mg”. 
Kapsule su neprozirne, ružičaste boje s otisnutim „HYCAMTIN“ i „1 mg“.
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks. 
Posljedica inhibicije topoizomeraze-I topotekanom na staničnoj razini je indukcija cijepanja jednog lanca DNK povezanih s proteinom.
• Itchy rash (or hives). 
• urtikarija (ili koprivnjača)
Geometric mean topotecan lactone dose-normalised AUC(0-) values for Korean patients were 7.9, 12.9 and 19.7 ng*h/ml in subjects with creatinine clearance values of more than 80 ml/min, 50 to 80 ml/min and 30 to 49 ml/min, respectively (see section 4.2 and 4.4). 
Geometrijska srednja vrijednost AUC(0-) topotekan laktona normalizirana prema dozi u bolesnika korejskog podrijetla iznosila je 7,9 ng*h/ml u ispitanika s klirensom kreatinina većim od 80 ml/min, 12,9 ng*h/ml u ispitanika s klirensom kreatinina od 50-80 ml/min i 19,7 ng*h/ml u ispitanika s klirensom kreatinina od 30-49 ml/min (vidjeti dijelove 4.2 i 4.4).
Pregnant staff should be excluded from working with this medicinal product. 
Trudne djelatnice ne smiju rukovati ovim lijekom.
Overdoses have been reported in patients being treated with topotecan capsules (up to 5 fold of the recommended dose) and intravenous topotecan (up to 10 fold of the recommended dose). 
Predoziranja su prijavljena u bolesnika liječenih kapsulama topotekana (dozama do 5 puta većima od preporučene) i intravenskom formulacijom topotekana (dozama do 10 puta većima od preporučene).
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. 
U ovom je ispitivanju 46 bolesnika (43%) nakon 192 (42,1%) ciklusa primilo filgrastim (G-CSF); 65 bolesnika (60%) je nakon 139 (30,5%) ciklusa primilo transfuziju eritrocita, a 50 njih (46%) nakon 159 (34,9%) ciklusa transfuziju trombocita.
Platelet transfusions were given to 10% of patients in 4% of courses. 
Transfuzije trombocita primijenjene su u 10% bolesnika u 4% ciklusa.
Accidental contact with the skin or eyes should be treated immediately with copious amounts of water. 
U slučaju kontakta topotekana s kožom ili očima, odmah je potrebno ispiranje obilnim količinama vode.
The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m2/day and 4 mg/m2/day administered daily for 5 days. 
Farmakokinetika topotekana ispitivana je u bolesnika s karcinomom nakon peroralne primjene topotekana u dozi od 1,2 do 3,1 mg/m2/dan i 4 mg/m2/dan tijekom 5 dana.
Approximately 51% was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine. 
Oko 51% bilo je izlučeno urinom kao ukupni topotekan, a 3% kao N-desmetiltopotekan.
The recommended monotherapy dose of oral topotecan in patients with small cell lung carcinoma with creatinine clearance between 30 and 49 ml/min is 1.9 mg/m2/day for five consecutive days. 
Preporučena doza kod monoterapije oralnim topotekanom u bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 30 i 49 ml/min iznosi 1,9 mg/m2/dan tijekom pet uzastopnih dana.
Type I flint glass vial with grey butyl rubber stopper and aluminium seal with plastic flip-off cap containing 1 mg of topotecan. 
Bočica od kremenog stakla tipa I, zatvorena sivim čepom od butilne gume i aluminijskim pokrovom te pokrivena plastičnom flip off kapicom, koja sadrži 1 mg topotekana.
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/m given as a 
U otvorenom ispitivanju u koje su bila uključena djeca (n = 108, raspon dobi: od dojenačke dobi do 16 godina) s recidivirajućim ili progresivnim solidnim tumorima, topotekan se primjenjivao u početnoj dozi od 2,0 mg/m u obliku 30-minutne infuzije tijekom 5 dana ponavljano svaka 3 tjedna, u trajanju do godine dana, ovisno o terapijskom odgovoru.
The clear, reconstituted solution is yellow to yellow-green in colour and provides 1 mg of topotecan per ml. 
Rekonstituirana otopina je prozirna, žute do žuto-zelene boje i sadrži 1 mg topotekana u 1 ml otopine.
How to take Hycamtin 
Kako uzimati Hycamtin
Red blood cell transfusions were given in 30% of patients (13% of courses). 
Transfuziju eritrocita primilo je 30% bolesnika (13% ciklusa).
9/l, and the haemoglobin level is 9 g/dl (after transfusion if necessary). 
9/l i razina hemoglobina  9 g/dl (nakon transfuzije, ukoliko je potrebna).
The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days. 
Preporučena doza topotekana u monoterapiji bolesnica s karcinomom jajnika i bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 20 i 39 ml/min iznosi 0,75 mg/m2/dan tijekom pet uzastopnih dana.
The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone. 
U bolesnica liječenih kombinacijom topotekana i cisplatina ukupna hematološka toksičnost je manja nego kod monoterapije topotekanom, ali veća nego pri monoterapiji cisplatinom.
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum-based chemotherapy (n = 112 and 114, respectively), the response rate (95% CI) was 20.5% (13%, 28%) versus 14% (8%, 20%) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively. 
U komparativnom ispitivanju topotekana i paklitaksela u bolesnica s karcinomom jajnika prethodno liječenih platinom (n = 112 i n = 114 po istom redoslijedu), stopa odgovora na lijek (95% CI) iznosila je 20,5% (13%, 28%) naspram 14% (8%, 20%), a medijan vremena do progresije iznosio je 19 tjedana naspram 15 tjedana (omjer hazarda 0,7 [0,6; 1,0]) za topotekan i paklitaksel.
Each capsule contains topotecan hydrochloride equivalent to 1 mg of topotecan. 
Jedna kapsula sadržava topotekanklorid u količini koja odgovara 1 mg topotekana.
The frequencies associated with the haematological and non-haematological adverse events presented are for adverse events considered to be related/possibly related to oral topotecan therapy. 
Navedene su učestalosti hematoloških i nehematoloških nuspojava za koje se smatra da su povezane/vjerojatno povezane s liječenjem oralnim topotekanom.
Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively. 
Infekcija se razvila u 17% bolesnika, sepsa u 2% bolesnika, a neutropenija s vrućicom javila se u 4% bolesnika.
9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.4 mg/m 2/day to 
9/l) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti za 0,4 mg/m 2/dan na
Total or pronounced alopecia was observed in 30% of patients and partial alopecia in 15% of patients. 
Potpuni ili izraziti gubitak kose zabilježen je u 30%, a djelomičan u 15% bolesnika.