FrancophonIA/ELRC3.0 huggingface dataset:
English: Topotecan also had a high volume of distribution, about 132 l, (SD 57), and a relatively short half-life of 2-3 hours.
Croatian: Topotekan je također imao veliki volumen distribucije, oko 132 l (SD 57) te relativno kratak poluvijek od 2-3 sata.
English: Potactasol should not be used in pregnant women, unless clearly necessary.
Croatian: Potactasol se ne smije koristiti tijekom trudnoće, osim ako je neophodno.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičnih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Women of childbearing potential / Contraception in males and females
Croatian: Žene u generativnoj dobi / Kontracepcija u muškaraca i žena
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Croatian: Od bolesnica koje su primile više od 6 ciklusa liječenja, 91% je završilo sa sudjelovanjem u ispitivanju kako je i predviđeno, ili su liječene do progresije bolesti uz samo 3% povučenih iz ispitivanja zbog pojave štetnih događaja.
English: In the unlikely event of an overdose, your doctor will monitor you for side effects.
Croatian: U malo vjerojatnom slučaju predoziranja, Vaš liječnik će Vas nadgledati radi nuspojava.
English: - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands,
Croatian: - oticanje uzrokovano nakupljanjem tekućine (angioedem), npr. oko očiju i usana, ali i ruku,
English: extravasation3
Croatian: ekstravazacija3
English: - Serious blood infection, which can be fatal.
Croatian: - ozbiljna infekcija krvi, koja može imati smrtni ishod. - svrbež (pruritus).
English: infection
Croatian: infekcija
English: - Allergic (hypersensitivity) reactions (including rash).
Croatian: - alergijske reakcije (reakcije preosjetljivosti) (uključujući osip).
English: - The active substance is topotecan.
Croatian: - Djelatna tvar je topotekan.
English: Accurate assessment of performance status at the time therapy is given is important, to ensure that patients have not deteriorated to PS 3.
Croatian: Važno je točno procijeniti funkcionalno stanje bolesnika u trenutku započinjanja liječenja kako bi se moglo utvrditi da se ono nije pogoršalo na PS 3.
English: alopecia
Croatian: alopecija
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Croatian: Provedena je i dodatna retrospektivna analiza podataka dobivenih od 523 bolesnice s recidivom raka jajnika.
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Croatian: Nuspojave su navedene dolje prema organskim sustavima i apsolutnoj učestalosti (svi prijavljeni događaji).
English: Effective contraception methods should be used to avoid becoming pregnant or fathering a child while on treatment with Potactasol.
Croatian: Moraju se koristiti učinkovite metode kontracepcije kako bi se izbjegla trudnoća/ili očinstvo tijekom liječenja lijekom Potactasol.
English: No studies of the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja učinaka na sposobnost upravljanja vozilima i rada sa strojevima.
English: What Potactasol is and what it is used for What you need to know before you use Potactasol How to use Potactasol
Croatian: Što je Potactasol i za što se koristi Što morate znati prije nego počnete primjenjivati Potactasol
English: A doctor or nurse will give you the reconstituted and diluted Potactasol solution as an infusion (drip), usually into your arm, over about 30 minutes.
Croatian: Liječnik ili medicinska sestra dat će Vam pripremljenu i razrijeđenu otopinu lijeka Potactasol u obliku infuzije (drip), obično u ruku, tijekom otprilike 30 minuta.
English: Pharmacotherapeutic group: antineoplastic agents, other antineoplastic agents, ATC code: L01XX17.
Croatian: Farmakoterapijska skupina: antineoplastici, ostali antineoplastici, ATK oznaka: L01XX17.
English: Talk to your doctor before using Potactasol: - if you have any kidney problems.
Croatian: Obratite se svom liječniku prije nego primijenite Potactasol: - ako imate bilo kakvih problema s bubrezima.
English: What Potactasol looks like and contents of the pack
Croatian: Kako Potactasol izgleda i sadržaj pakiranja
English: There is no known antidote for topotecan overdose.
Croatian: Nema poznatog antidota za predoziranje topotekanom.
English: Abnormal low number of neutrophil granulocytes (a type of white blood cell) in the blood, with or without fever.
Croatian: Neuobičajeno mali broj neutrofilnih granulocita (vrsta bijelih krvnih stanica) u krvi, s ili bez vrućice.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Croatian: Ostali teški događaji koji su bili povezani ili se mogu povezati s liječenjem topotekanom bili su anoreksija (12%), malaksalost (3%) i hiperbilirubinemija (1%).
English: What Potactasol is and what it is used for
Croatian: Što je Potactasol i za što se koristi
English: Potactasol is available in cartons containing 1 vial.
Croatian: Potactasol je dostupan u kutijama koje sadrže 1 bočicu.
English: - Abnormal high level of bilirubin, a waste product produced by the liver during breakdown of red blood cells.
Croatian: - neuobičajeno visoka razina bilirubina, razgradnog produkta kojeg proizvodi jetra tijekom razgradnje crvenih krvnih stanica.
English: - Decrese in number of circulating white blood cells (leucotyes) in the blood.
Croatian: - smanjenje broja cirkulirajućih bijelih krvnih stanica (leukociti) u krvi.
English: Doses should be similarly reduced if the platelet count falls below 25 x 109/l.
Croatian: Dozu je potrebno smanjiti na isti način ako broj trombocita padne ispod 25 x 109/l.
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Croatian: Uvjete čuvanja rekonstituiranog i razrijeđenog lijeka vidjeti u dijelu 6.3.
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.
Croatian: U ispitivanjima reproduktivne toksičnosti topotekana u štakora nije zabilježen učinak na mušku ili žensku plodnost; međutim, u ženki je primijećena superovulacija i i blagi porast predimplementacijskog gubitka.
English: sepsis1
Croatian: sepsa1
English: You must not breast-feed while on treatment with Potactasol.
Croatian: Ne smijete dojiti za vrijeme liječenja lijekom Potactasol.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Croatian: U kliničkim ispitivanjima osip je prijavljen u 4% bolesnika, a svrbež u 1,5% bolesnika.
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.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika i ne bi trebali biti dulji od 24 sata pri temperaturi od 2°C do 8°C, osim ako su rekonstitucija/razrjeđivanje provedeni u kontroliranim i validiranim aseptičkim uvjetima.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Croatian: Stopa odgovora na liječenje u svih bolesnica s karcinomom jajnika (n = 392, koje su sve prethodno liječene cisplatinom ili cisplatinom i paklitakselom) bila je 16%.
English: - Decrease in the number of all blood cells (pancytopenia).
Croatian: - smanjenje broja svih krvnih stanica (pancitopenija).
English: - Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia).
Croatian: - osjećaj opće slabosti i umora, što mogu biti simptomi smanjenja broja crvenih krvnih stanica (anemija).
English: Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous.
Croatian: Pretklinička ispitivanja ukazuju na nisko vezanje topotekana na proteine plazme nisko (35%) i prilično homogenu distribuciju između krvnih stanica i plazme.
English: - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding.
Croatian: - ako ste alergični na topotekan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako dojite; - ako imate prenizak broj krvnih stanica.
English: Combination therapy (cervical carcinoma)
Croatian: Kombinacijska terapija (karcinom vrata maternice)
English: Potactasol can make you feel tired or weak.
Croatian: Potactasol može izazvati osjećaj umora ili slabosti.
English: Adequate protective disposable gloves, goggles, gown and mask should be worn.
Croatian: Moraju se nositi odgovarajuće zaštitne jednokratne rukavice, naočale, odijela i maske.
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.
Croatian: - Teške alergijske (anafilaktičke) reakcije (rijetko; mogu se javiti u do 1 na 1000 osoba) sa znakovima poput: - oticanja lica, usana, jezika ili grla, otežanog disanja, niskog krvnog tlaka, omaglice i osipa praćenog svrbežom.
English: One study included a dose range of 1.4 to 2.4 mg/m2 in children (aged 2 up to 12 years,
Croatian: U prvom ispitivanju raspon doza bio je od 1,4 do 2,4 mg/m2 u djece (u dobi od 2
English: 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).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000), uključujući izolirana izvješća i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Then seek medical evaluation by a physician.
Croatian: Zatim zatražite liječnički pregled.
English: of patients (6 % of courses).
Croatian: 23% bolesnika (6% ciklusa).
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 Potactasol.
Croatian: Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka (cisplatina) kojeg primate zajedno s lijekom Potactasol.
English: What you need to know before you use Potactasol Do not use Potactasol
Croatian: Što morate znati prije nego počnete primjenjivati Potactasol
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.
Croatian: Klirens plazme za ukupni topotekan (aktivni i neaktivni oblik) kod bolesnika s oštećenjem jetre smanjio se samo oko 10% u usporedbi s kontrolnom skupinom.
English: - Feeling unwell.
Croatian: - opće loše osjećanje.
English: Difference in response rate (95 % CI)
Croatian: Razlika u stopi odgovora (95% CI)
English: Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease.
Croatian: Topotekan u kombinaciji s cisplatinom indiciran je za liječenje recidiva karcinoma vrata maternice nakon provedene radioterapije i za liječenje bolesnica u IVB stadiju bolesti.
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Croatian: Anemija: Umjerena do teška anemija (Hb ≤ 8,0 g/dl) javila se u 37% bolesnika (14% ciklusa).
English: − Staff should be trained to reconstitute and dilute the the medicinal product.
Croatian: Osoblje mora biti educirano za rekonstituciju i razrjeđivanje lijeka.
English: The mean metabolite:parent AUC ratio was < 10 % for both total topotecan and topotecan lactone.
Croatian: Prosječan omjer AUC metabolita i roditeljskog spoja bio je < 10% i za ukupni topotekan i za topotekan lakton.
English: hypersensitivity reaction including rash
Croatian: reakcije preosjetljivosti uključujući osip
English: Potactasol contains the active substance topotecan which helps to kill tumour cells.
Croatian: Potactasol sadrži djelatnu tvar topotekan koja pomaže pri uništavanju tumorskih stanica.
English: In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0 %.
Croatian: U populaciji bolesnika s refraktornim karcinomom pluća malih stanica (onih koji nisu odgovorili na prvu liniju liječenja) stopa odgovora na topotekan iznosila je 4,0%.
English: Cytotoxic, special handling instructions (see package leaflet).
Croatian: Citotoksičan lijek, posebne upute za rukovanje (vidjeti uputu o lijeku).
English: Pregnant staff should not handle the cytotoxic preparation.
Croatian: Trudne djelatnice ne smiju rukovati citotoksičnim pripravcima.
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/m2 compared to 21.3 l/h/m2 [n = 9]) (see section 4.5).
Croatian: Kad se primjenjuje u kombinaciji s cisplatinom (cisplatin 1. dan, topotekan 1. do 5. dan), klirens topotekana 5. dan smanjen je u odnosu na 1. dan (19,1 l/h/m2 u odnosu na 21,3 l/h/m2 [n=9]) (vidjeti dio 4.5).
English: Volume for 25 microgram/ml solution
Croatian: Volumen za otopinu od 25 mikrograma/ml
English: Potactasol 1 mg powder for concentrate for solution for infusion EU/1/10/660/001
Croatian: Potactasol 1 mg prašak za koncentrat za otopinu za infuziju EU/1/10/660/001
English: - Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Croatian: - neuobičajena pojava modrica ili krvarenja, ponekad teške prirode, uzrokovana smanjenjem broja krvnih stanica koje omogućavaju zgrušavanje krvi (trombociti).
English: Your dose of Potactasol may need to be adjusted.
Croatian: Možda će Vam biti potrebna prilagodba doze lijeka Potactasol.
English: This should be taken into account, when prescribing topotecan, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Croatian: To je potrebno uzeti u obzir kod uključivanja topotekana u terapiju, npr. u bolesnika s povećanim rizikom za krvarenje zbog tumora.
English: Reconstituted and diluted solution
Croatian: Rekonstituiranai razrijeđena otopina
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Croatian: Medijan ukupnog preživljenja bio je 62 tjedna za topotekan naspram 53 tjedna za paklitaksel (omjer hazarda 0,9 [0,6; 1,3]).
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.
Croatian: Potrebno je pratiti bolesnike kako bi se uočili plućni simptomi koji ukazuju na IBP (npr. kašalj, vrućica, dispneja i/ili hipoksija) te prekinuti primjenu topotekana ako se potvrdi dijagnoza.
English: Potactasol 4 mg powder for concentrate for solution for infusion EU/1/10/660/002
Croatian: Potactasol 4 mg prašak za koncentrat za otopinu za infuziju EU/1/10/660/002
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Croatian: U bolesnica čija je bolest rezistentna na liječenje ili koje dožive recidiv unutar 3 mjeseca od liječenja cisplatinom (n = 186), stopa odgovora na liječenje iznosila je 10%.
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Croatian: Fecesom se eliminiralo 18% ukupnog topotekana i 1,7% N-desmetiltopotekana.
English: 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.
Croatian: U ispitivanjima u kojima se utvrđuje doza lijeka, provedenima u 523 bolesnice s recidivom raka jajnika i 631 bolesnika s recidivom raka pluća malih stanica, hematotoksičnost se pokazala čimbenikom ograničenja doze u monoterapiji topotekanom.
English: 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.
Croatian: - površini Vašeg tijela (m2), - rezultatima krvnih pretraga koje se provode prije i tijekom liječenja,
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy, was 20.2 %.
Croatian: Stopa odgovora na topotekan u kombiniranom liječenju karcinoma pluća malih stanica (n = 480) za bolesnike s recidivirajućom bolešću osjetljivom na prvu liniju liječenja iznosila je 20,2%.
English: 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.
Croatian: 12 godina, n=18), adolescenata (u dobi od 12-16 godina, n=9) i mlađih odraslih osoba (u dobi od 16
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 %, CI 0.78 -1.40).
Croatian: Omjer hazarda za preživljenje kod intravenski primijenjenog topotekana u odnosu na CAV protokol bio je 1,04 (95% CI: 0,78 - 1,40).
English: Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Croatian: Oko 51% bilo je izlučeno urinom kao ukupni topotekan, a 3%
English: In a randomised, comparative Phase III study conducted by the Gynecologic Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate.
Croatian: U randomiziranom komparativnom ispitivanju faze III Ginekološke onkološke grupe istraživača (ispitivanje GOG 0179), uspoređivana je kombinacija topotekana i cisplatina (n = 147) s monoterapijom cisplatinom (n=146) u liječenju histološki potvrđenog perzistentnog recidivirajućeg karcinoma vrata maternice ili karcinoma vrata maternice stadija IVB koji nije bio pogodan za kurativno kirurško liječenje i/ili radioterapiju.
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Croatian: Topotekan inhibira topoizomerazu-I na način da stabilizira kovalentni kompleks enzima i jednostrukog lanca DNK koja je međuproizvod katalitičkog mehanizma.
English: Patients with impaired kidney function Your doctor might need to reduce your dose based on your kidney function.
Croatian: Vaš liječnik možda će morati smanjiti dozu na temelju Vaše funkcije bubrega.
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Croatian: Međutim, kao i ostali citotoksični lijekovi, topotekan je genotoksičan te se učinci na plodnost muškaraca i žena ne mogu isključiti.
English: For intravenous use as infusion, after reconstitution and dilution.
Croatian: Za intravensku infuziju, nakon pripreme i razrjeđivanja.
English: In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Croatian: U randomiziranom ispitivanju faze III u kojem se topotekan primijenjen intravenski (i.v.) uspoređivao s ciklofosfamidom, doksorubicinom i vinkristinom (CAV protokol) u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, ukupna stopa odgovora na topotekan iznosila je 24,3%, u usporedbi s 18,3% za skupinu koja je primala CAV protokol.
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Croatian: Sažeti prikaz preživljenja, stope odgovora i vremena do progresije bolesti u bolesnika s karcinomom pluća malih stanica liječenih oralnim ili intravenskim topotekanom
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 %
Croatian: Tijekom prvog ciklusa vrućica ili infekcija povezana s teškom neutropenijom javila se u 16% bolesnika, a tijekom čitavog liječenja u
English: The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Croatian: Ispitani koncentrati su bili pohranjeni na temperaturi od 25 ± 2°C u trajanju od 12 sati, odnosno 24 sata nakon rekonstitucije i potom razrijeđeni.
English: Potactasol is used to treat: - ovarian cancer or small cell lung cancer that has come back after chemotherapy - advanced cervical cancer if surgery or radiotherapy is not possible.
Croatian: - raka jajnika ili raka pluća malih stanica koji su se ponovno pojavili nakon prethodne kemoterapije - uznapredovalog raka vrata maternice ako kirurški zahvat ili zračenje nije moguće provesti.
English: Potactasol contains sodium
Croatian: Potactasol sadrži natrij
English: − Personnel handling this medicinal product during reconstitution and dilution should wear protective clothing including mask, goggles and gloves.
Croatian: - Osoblje koje rukuje lijekom tijekom rekonstitucije i razrjeđivanja lijeka mora nositi zaštitnu odjeću koja uključuje masku, zaštitne naočale i rukavice.
English: 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.
Croatian: plućne fibroze, raka pluća, izloženosti prsnog koša zračenju i primjene pneumotoksičnih tvari i/ili čimbenika stimulacije kolonija.
English: Storage after reconstitution and dilution
Croatian: Čuvanje nakon pripreme i razrjeđivanja
English: The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days.
Croatian: Uobičajena doza je 1,5 mg po m2 tjelesne površine jedanput na dan tijekom 5 dana.
English: In this case Potactasol treatment is combined with medicines containing cisplatin.
Croatian: U tom slučaju Potactasol se kombinira s lijekovima koji sadrže cisplatin.
English: Potactasol is for intravenous infusion after reconstitution and dilution.
Croatian: Način primjene Potactasol je namijenjen za intravensku infuziju nakon rekonstitucije i razrjeđivanja.
English: 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.
Croatian: Sveukupno, doprinos N-desmetil metabolita ukupnom materijalu povezanom s topotekanom u urinu i fecesu je bio prosječno manji od 7% (u rasponu od 4-9%).
English: Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Croatian: Hematotoksičnost topotekana je ovisna o dozi te je stoga potrebno redovito određivanje kompletne krvne slike, uključujući broj trombocita (vidjeti dio 4.2).