FrancophonIA/ELRC3.0 huggingface dataset:
English: Vaxelis will not prevent disease caused by pathogens other than Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, hepatitis B virus, poliovirus or Haemophilus influenzae type b. However, it can be expected that hepatitis D will be prevented by immunisation as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Croatian: Vaxelis neće spriječiti bolesti prouzročene patogenima koji nisu bakterija Corynebacterium diphtheriae, bakterija Clostridium tetani, bakterija Bordetella pertussis, virus hepatitisa B, poliovirus ili bakterija Haemophilus influenzae tipa b.
English: Vaxelis suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Croatian: Vaxelis suspenzija za injekciju u napunjenoj štrcaljki Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK), poliomijelitisa (inaktivirano) i hemofilusa tip b (konjugirano), adsorbirano.
English: Injection site erythema, injection site pain, injection site swelling Pyrexia
Croatian: Vrlo često plač, razdražljivost eritem na mjestu injiciranja, bol na mjestu injiciranja, oticanje na mjestu injiciranja pireksija
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Croatian: Cjepivo protiv difterije, tetanusa, hripavca (nestanično, komponentno), hepatitisa B (rDNK), poliomijelitisa (inaktivirano) i hemofilusa tip b konjugirano, (adsorbirano).
English: Vaxelis suspension for injection in pre-filled syringe.
Croatian: Vaxelis suspenzija za injekciju u napunjenoj štrcaljki.
English: Rare
Croatian: Nuspojave
English: Your doctoror nurse will assess the potential benefit offered by vaccination, once the condition is stabilized.
Croatian: Kada se stanje djeteta stabilizira,Vaš će liječnik ilimedicinska sestra procijeniti potencijalne koristi cijepljenja.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - multipack of 5 packs of 10.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklenoj, tip I) s čepom klipa (butil) i zatvaračem vrha (butil), bez igle - višestruko pakiranje s 5 pakiranja od po 10 komada.
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 2 separate needles - pack size of 1 or 10.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklenoj, tip I) s čepom klipa (butil) i zatvaračem vrha (butil), s 2 zasebne igle - veličina pakiranja 1 ili 10.
English: 2, 4, 6 months
Croatian: 6.3 Rok valjanosti
English: Vaxelis injection
Croatian: Injekcija cjepiva Vaxelis i.m.
English: Vascular disorders
Croatian: Toksoid difterije
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), without needle - pack size of 1 or 10.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklenoj, tip I) s čepom klipa (butil) i zatvaračem vrha (butil), bez igle - veličina pakiranja 1 ili 10.
English: Uncommon Lymphadenopathy
Croatian: Manje često limfadenopatija
English: 0.5 ml suspension in pre-filled syringe (type I glass) with plunger stopper (butyl) and tip cap (butyl), with 1 separate needle - pack size of 1 or 10.
Croatian: 0,5 ml suspenzije u napunjenoj štrcaljki (staklenoj, tip I) s čepom klipa (butil) i zatvaračem vrha (butil), s 1 zasebnom iglom - veličina pakiranja 1 ili 10.
English: Hrvatska Merck Sharp & Dohme d.o.o.
Croatian: UAB Merck Sharp & Dohme Tel.
English: Very Common Vomiting Common
Croatian: Poremećaji probavnog sustava Vrlo često povraćanje
English: 1 pre-filled syringe in a blister + 2 alcohol pads
Croatian: 1 napunjena brizgalica u blisteru + 2 jastučića natopljena alkoholom
English: 1 pre-filled pen in a blister + 2 alcohol pads
Croatian: 1 napunjena štrcaljka u blisteru + 2 jastučića natopljena alkoholom
English: After first opening
Croatian: Nakon prvog otvaranja
English: Study 396
Croatian: studija 396
English: The following information is intended for medical or healthcare professionals only.
Croatian: Sljedeće informacije namijenjene su samo medicinskim ili zdravstvenim radnicima:
English: You should use an effective method of contraception.
Croatian: Trebate koristiti učinkovite metode kontracepcije.
English: If you feel tired or weak, do not drive or use machines.
Croatian: Ukoliko se osjećate umornim ili slabim nemojte upravljati vozilom ni raditi sa strojevima.
English: Reactions have been mild and have not generally required specific therapy.
Croatian: Reakcije su bile blage i uglavnom nisu zahtijevale specifično liječenje.
English: • if you are pregnant or plan to become pregnant.
Croatian: • ste trudni ili planirate ostati trudni.
English: Study results Study GOG-0179
Croatian: Tablica 2. Rezultati studije GOG-0179
English: It may harm a baby conceived before, during or soon after treatment.
Croatian: On može naškoditi djetetu začetom prije, tijekom ili ubrzo nakon liječenja.
English: CI = Confidence interval.
Croatian: CI = interval pouzdanosti
English: 1316 BN, Almere The Netherlands
Croatian: 1316 BN, Almere Nizozemska ili
English: This medicine is for single use only.
Croatian: Ovaj lijek je isključivo za jednokratnu upotrebu.
English: Volume of distribution was slightly decreased and thus half-life only increased by 14 %.
Croatian: Volumen distribucije je lagano smanjen i zbog toga je poluvijek povećan samo 14%.
English: Talk to your doctor for advice on how to minimise the risk of bleeding.
Croatian: Upitajte liječnika za savjet kako smanjiti rizik od krvarenja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pročitajte pažljivo cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Currently available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2 međutim nije moguće dati preporuku o doziranju.
English: Dilute before use.
Croatian: Razrijediti prije uporabe.
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Croatian: Rijetko, to može uzrokovati jače krvarenje (hemoragija).
English: Serious side effects: tell your doctor
Croatian: Ozbiljne nuspojave: obavijestite liječnika
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Croatian: To može dovesti do jakog krvarenja iz manjih ozljeda, kao što je posjekotina.
English: Topotecan is not recommended for pregnant women.
Croatian: Topotekan se ne preporučuje u trudnica.
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: Učestalost je definirana kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Croatian: Nadalje 5% svih liječenih bolesnika (1% ciklusa) je razvilo sepsu (vidjeti dio 4.4).
English: Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed.
Croatian: Poluvijek topotekana povećao se oko 30% bez opaženih jasnih promjena u volumenu distribucije.
English: If your partner becomes pregnant during your treatment, tell your doctor immediately.
Croatian: Ukoliko se trudnoća dogodi za vrijeme liječenja, odmah o tome obavijestite svog liječnika.
English: Date of first authorisation: 10 June 2010 Date of latest renewal: 28 May 2015
Croatian: Datum posljednje obnove odobrenja: 28. svibnja 2015.
English: Area under the curve increased approximately in proportion to the increase in dose.
Croatian: Površina ispod krivulje povećavala se približno proporcionalno povećanju doze.
English: Male patients who wish to father a child should ask their doctor for family planning advice or treatment.
Croatian: Bolesnici muškog spola koji žele postati očevi moraju se savjetovati sa svojim liječnikom o planiranju obitelji ili liječenju.
English: • if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na topotekan ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stanovišta, lijek treba odmah upotrijebiti.
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta ili biljne lijekove.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilacije ili minimizacije rizika).
English: If well tolerated, treatment may continue until disease progression (see sections 4.8 and 5.1).
Croatian: Ukoliko se dobro podnosi, liječenje se može nastaviti sve do progresije osnovne bolesti (vidjeti dijelove 4.8 i 5.1).
English: If not used immediately, Topotecan Hospira can be used for up to 24 hours when stored in the fridge (protected from light) or at room temperature (in normal daylight conditions).
Croatian: Ukoliko se ne upotrijebi odmah, Topotekan Hospira se može upotrijebiti unutar 24 sata ako se čuva u hladnjaku (zaštićeno od svjetlosti) ili na sobnoj temperaturi (kod normalne izloženosti dnevnoj svjetlosti).
English: Topotecan also had a high volume of distribution, about 132l (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 kratki poluvijek od 2 do 3 sata.
English: Log rank p-value
Croatian: Log-rank p-vrijednost
English: • your body size (surface area measured in square metres)
Croatian: • veličine Vašeg tijela (površina tijela mjerena u kvadratnim metrima)
English: Women of childbearing potential/ Contraception in males and females
Croatian: Žene reproduktivne dobi/ Kontracepcija u muškaraca i žena
English: After opening, the product should be used immediately.
Croatian: Nakon otvaranja, lijek treba odmah upotrijebiti.
English: Do not restart breast-feeding until the doctor tells you it is safe to do so.
Croatian: Ne započinjite dojenje ponovno sve dok Vam liječnik ne kaže da je to sigurno.
English: The dose of topotecan you are given will be worked out by your doctor, based on:
Croatian: Dozu topotekana koju primate će Vam propisati liječnik na temelju:
English: EXP: Use immediately after opening.
Croatian: Rok valjanosti: Upotrijebiti odmah nakon otvaranja.
English: This pattern of treatment will normally be repeated every 3 weeks.
Croatian: Obično se ovakav ciklus liječenja ponavlja svaka tri tjedna.
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: Remember to tell your doctor if you start to take any other medicines while you are on Topotecan Hospira.
Croatian: Nemojte zaboraviti obavijestiti liječnika ako započinjete uzimati bilo koje druge lijekove dok se liječite Topotekanom Hospira.
English: The frequency of some side effects is not known (events from spontaneous reports and the frequency cannot be estimated from the available data):
Croatian: Učestalost nekih nuspojava nije poznata (događaji iz spontanih prijava čija se učestalost ne može procijeniti iz dostupnih podataka):
English: Topotecan Hospira helps to destroy tumours.
Croatian: Topotekan Hospira pomaže pri uništavanju tumora.
English: Dosage: Paediatric population Limited data available.
Croatian: Doziranje: pedijatrijska populacija Dostupni su ograničeni podaci.
English: Topotecan Hospira is a yellow/yellow green solution.
Croatian: Topotekan Hospira je žuta/žuto-zelena otopina.
English: Pharmacotherapeutic group: antineoplastic agents: other antineoplastic agents, ATC code: L01XX17.
Croatian: Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: L01XX17.
English: Infections and infestations Very common
Croatian: Infekcije i infestacije Vrlo često infekcija
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 opće stanje bolesnika prije davanja terapije kako bi se moglo utvrditi da se ono nije pogoršalo na PS 3.
English: Do not try to become pregnant until a doctor advises you it is safe to do so.
Croatian: Nemojte pokušavati ostati trudni sve dok Vam liječnik ne kaže da je sigurno pokušati.
English: The carcinogenic potential of topotecan has not been studied.
Croatian: Nisu provedena ispitivanja kancerogenog potencijala topotekana.
English: Before you are given this medicine your doctor needs to know :
Croatian: Vaš liječnik prije primjene ovog lijeka mora znati ako:
English: Use not recommended.
Croatian: Primjena se ne preporučuje.
English: Tell your doctor if any of these applies to you.
Croatian: Obavijestite svog liječnika ako se nešto od gore navedenog odnosi na Vas.
English: Use the aseptic technique during any further dilution of the solution for infusion.
Croatian: Potrebno je primijeniti aseptičku tehniku za vrijeme bilo kakvog daljnjeg razrjeđenja otopine za infuziju.
English: • Feeling generally weak and tired (temporary anaemia).
Croatian: • Osjećaj opće slabosti i umora (privremena anemija).
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Croatian: Teška neutropenija koja traje dulje od sedam dana javila se u ukupno 11% ciklusa.
English: • the disease being treated.
Croatian: • bolesti koja se liječi
English: Among all patients treated in clinical studies (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.
Croatian: Među svim bolesnicima u kliničkim ispitivanjima (uključujući one s teškom neutropenijom i bez nje), 11% (4% ciklusa) je razvilo vrućicu, a 26% bolesnika (9% ciklusa) infekciju.
English: 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).
Croatian: Kao što se može očekivati, bolesnici slabijeg općeg stanja (PS > 1, od engl. performance status) imaju slabiju stopu odgovora na liječenje i veću incidenciju komplikacija poput vrućice, infekcija i sepse (vidjeti dio 4.8).
English: Storage, Use, Handling & Disposal of Topotecan Hospira
Croatian: Čuvanje, upotreba, rukovanje i odlaganje Topotekana Hospira
English: Your doctor will tell you whether this is the case, based on the results of your last blood test.
Croatian: Liječnik će to zaključiti na temelju posljednjih nalaza krvnih pretraga.
English: Your doctor will decide with you whether Topotecan Hospira therapy is better than further treatment with your initial chemotherapy.
Croatian: Vaš liječnik će u dogovoru s Vama odlučiti je li liječenje Topotekanom Hospira bolje od nastavka liječenja dosadašnjom kemoterapijom.
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses.
Croatian: Pri ponovljenom svakodnevnom doziranju topotekan se malo ili uopće ne kumulira te nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12 %), malaise (3 %) and hyperbilirubinaemia (1 %).
Croatian: Ostale teške nuspojave koje su povezane ili se mogu povezati s liječenjem topotekanom bile su anoreksija (12%), opća slabost (3%) i hiperbilirubinemija (1%).
English: A clear yellow to yellow-green solution.
Croatian: Bistra žuta do žuto-zelena otopina.
English: • ovarian cancer or small cell lung cancer that has come back after chemotherapy.
Croatian: • raka jajnika ili raka pluća malih stanica koji su se ponovno pojavili nakon prethodne kemoterapije
English: Topotecan must be reconstituted and further diluted before use (see section 6.6).
Croatian: Topotekan se mora rekonstituirati i dodatno razrijediti prije primjene (vidjeti dio 6.6).
English: Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Croatian: Toksičnost topotekana u pedijatrijskih bolesnika s recidivirajućim i refraktornim solidnim tumorima bila je slična onoj već zabilježenoj u odraslih bolesnika.
English: • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Croatian: • bolesnica s metastatskim karcinomom jajnika nakon neuspjeha prve ili naknadnih linija liječenja.
English: Median time to onset of severe neutropenia was nine days and the median duration was seven days.
Croatian: Medijan vremena do pojave teške neutropenije iznosio je devet dana s medijanom vremena trajanja od sedam dana.
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Croatian: • Neuobičajeno stvaranje modrica ili krvarenje, uzrokovano smanjenjem broja stanica koje omogućavaju zgrušavanje krvi.
English: This treatment schedule is repeated every 21 days for 6 courses or until progressive disease.
Croatian: Ovaj raspored liječenja ponavlja se svakih 21 dan tijekom 6 ciklusa ili do napredovanja bolesti.
English: Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI)
Croatian: omjer hazarda (95% CI) stopa odgovora (%) (95% CI) razlika u stopi odgovora (95% CI) medijan vremena do progresije (tjedni) (95% CI)
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.
Croatian: Ukoliko se topotekan primjenjuje tijekom trudnoće ili bolesnica zatrudni tijekom liječenja topotekanom, mora biti upozorena na potencijalne rizike za fetus.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Croatian: Neklinička ispitivanja ukazuju da je vezanje topotekana za proteine plazme nisko (35%), a distribucija između krvnih stanica i plazme jednakomjerna.
English: − Severe hypersensitivity to the active substance or to any of the excipients.
Croatian: Teška preosjetljivost na djelatnu tvar ili bilo koju od pomoćnih tvari.
English: WARNING: This is a cytotoxic agent.
Croatian: UPOZORENJE: Ovo je citotoksični lijek.
English: What you need to know before you are given Topotecan Hospira
Croatian: Što morate znati prije nego počnete primati Topotekan Hospira
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 skupini bolesnica s karcinomom jajnika (n=392, koje su sve prethodno liječene cisplatinom ili cisplatinom i paklitakselom) bila je 16%.
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: Plazmatski klirens ukupnog topotekana (aktivni i inaktivni oblik) u bolesnika s oštećenjem jetre smanjio se samo oko 10% u usporedbi s kontrolnom skupinom bolesnika.
English: • Yellow skin.
Croatian: • žutilo kože (žutica)
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Croatian: • gubitak na težini i gubitak teka (anoreksija), umor, slabost
English: • Signs of infection: Topotecan may reduce the number of white blood cells and lower your resistance to infection.
Croatian: Topotekan može smanjiti broj bijelih krvnih stanica i Vašu otpornost na infekciju.
English: The topotecan-O-glucuronide and N-desmethyl topotecan-O-glucuronide in the urine were < 2.0 %.
Croatian: Topotekan-Oglukuronida i N-desmetil topotekan-O-glukuronida topotekana u urinu bilo je manje od 2,0 %.
English: What Topotecan Hospira looks like and the contents of the pack Topotecan Hospira is a clear, yellow or yellow-green concentrate for solution for infusion supplied in clear glass vials, each containing 4 ml concentrate.
Croatian: Kako Topotekan Hospira izgleda i sadržaj pakiranja Topotekan Hospira je bistri, žuti ili žuto-zeleni koncentrat za otopinu za infuziju dostupan u prozirnim staklenim bočicama od kojih svaka sadrži 4 ml koncentrata.
English: You will have treatment once a day for 5 days.
Croatian: Ovaj će se postupak ponavljati jednom dnevno tijekom 5 dana.
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: Temeljni rizični faktori uključuju anamnezu intersticijske bolesti pluća, plućne fibroze, karcinoma pluća, izloženosti prsnog koša zračenju i primjene pneumotoksičnih lijekova i/ili čimbenika stimulacije kolonija.
English: Doses should be similarly reduced if the platelet count falls below 25 x 10
Croatian: Dozu bi na sličan način trebalo smanjiti ako broj trombocita padne ispod 25 x 10
English: Adverse reactions are listed below by system organ class and absolute frequency (all reported events).
Croatian: Nuspojave su navedene prema organskim sustavima i apsolutnoj učestalosti (sve prijavljene nuspojave).
English: Median survival (weeks) (95% CI)
Croatian: medijan preživljenja (tjedni) (95% CI)
English: Hazard ratio (95% CI) N = total number of patients treated.
Croatian: omjer hazarda (95% CI) N = ukupan broj liječenih bolesnika
English: − Personnel handling this medicinal product should wear protective clothing including mask, goggles and gloves.
Croatian: - Osoblje koje rukuje ovim lijekom mora nositi zaštitnu odjeću koja uključuje masku, zaštitne naočale i rukavice.
English: 9/l) in 25 % of patients (15 % of courses).
Croatian: 9/l) u 25% bolesnika (15% ciklusa).
English: • Staff should be adequately trained in the preparation, administration and disposal of cytotoxics
Croatian: • Osoblje mora biti odgovarajuće obučeno za pripremu, primjenu i zbrinjavanje citotoksičnih lijekova.
English: What Topotecan Hospira is and what it is used for 2.
Croatian: Što je Topotekan Hospira i za što se koristi 2.
English: Other medicines and Topotecan Hospira
Croatian: Drugi lijekovi i Topotekan Hospira
English: Limited data indicate that the dose should be reduced in patients with moderate renal impairment.
Croatian: Ograničeni podaci pokazuju da se doza treba smanjiti u bolesnika s umjerenim oštećenjem bubrega.
English: As with other cytotoxic medicinal products, topotecan can cause severe myelosuppression.
Croatian: Kao i kod ostalih citotoksičnih lijekova, primjena topotekana može dovesti do teške mijelosupresije.
English: 9/l and/or a platelet count of < 100 x 10
Croatian: 9/1 i/ili broj trombocita < 100 x 10