FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: Jedno ispitivanje faze II (studija 065) i jedno faze III (studija 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).
English: As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of childbearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Croatian: Kao i ostali citotoksični lijekovi, topotekan može uzrokovati fetalna oštećenja te je, stoga, potrebno savjetovati žene reproduktivne dobi da izbjegavaju trudnoću tijekom liječenja topotekanom.
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 bolesnika s refraktornim karcinomom pluća malih stanica (onih koji nisu odgovorili na prvu liniju liječenja) stopa odgovora na topotekan iznosila je 4,0 %.
English: If either cisplatin or carboplatin is given on day 1 of the topotecan dosing, a lower dose of each agent must be given to improve tolerability compared to the dose of each agent which can be given if the platinum agent is given on day 5 of the topotecan dosing.
Croatian: Ako se cisplatin ili karboplatin primjenjuju prvi dan primjene topotekana, mora se primijeniti manja doza svakog lijeka, kako bi se poboljšala njihova podnošljivost, u usporedbi s dozama svakog od pojedinačnih lijekova koje se mogu dati kada se derivat platine primjenjuje petog dana liječenja topotekanom.
English: A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Croatian: Lijek će Vam primijeniti liječnik ili medicinska sestra u obliku intravenske infuzije (dripom) u bolnici.
English: EU/1/10/633/001 - Single pack EU/1/10/633/002 - 5 pack
Croatian: EU/1/10/633/001 - pakiranje s 1 bočicom EU/1/10/633/002 - pakiranje s 5 bočica
English: Median time to onset of severe thrombocytopenia, was day 15 and the median duration was five days.
Croatian: Medijan vremena do pojave teške trombocitopenije bio je 15. dan liječenja, a medijan vremena trajanja iznosio je pet dana.
English: When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Croatian: Kad se topotekan primjenjuje u kombinaciji s drugim kemoterapijskim lijekovima, može biti potrebno smanjiti dozu svakog primijenjenog lijeka, u svrhu poboljšanja njihove podnošljivosti.
English: • Swelling caused by fluid build up (angioedema).
Croatian: • oticanje uzrokovano nakupljanjem tekućine (angioedem)
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Croatian: Često zabilježene nehematološke nuspojave bile su gastrointestinalne poput mučnine (52%), povraćanja (32%) i proljeva (18%), konstipacije (9%) i mukozitisa (14%).
English: − Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
Croatian: Teška depresija koštane srži prije započinjanja prvog ciklusa, na što ukazuje početni broj neutrofila < 1,5 x 10
English: • if you have any kidney or liver problems.
Croatian: • imate bilo kakvih problema s bubrezima ili s jetrom.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Croatian: Umor je primijećen u otprilike 25%, a astenija u 16% bolesnika koji su primali topotekan.
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Croatian: Ukupni nalaz materijala povezanog s topotekanom nakon pet dnevnih doza topotekana iznosio je 71 do 76% intravenski primijenjene doze.
English: However, when 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.
Croatian: Međutim, kada se topotekan kombinira s derivatima platine, postoji jasna interakcija ovisna o tome je li derivat platine primijenjen prvi ili peti dan primjene topotekana.
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 fertilitet u mužjaka i ženki, dok je u ženki primijećena super-ovulacija i lagano učestaliji gubitak prije implantacije.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Croatian: Potrebno je primijeniti uobičajene postupke za ispravno rukovanje i zbrinjavanje lijekova protiv raka:
English: • All items used in the preparation, administration, and cleaning of the medicinal product, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Croatian: • Svi predmeti za pripremu, primjenu lijeka i čišćenje lijeka, uključujući rukavice, moraju se odložiti u vreće za odlaganje otpada visokog rizika koji se spaljuje na visokim temperaturama.
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 as a 30-minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
Croatian: Nakon intravenske primjene topotekana u dozi od 0,5 do 1,5 mg/m2 u obliku 30-minutne infuzije dnevno tijekom 5 dana, topotekan je pokazao visoki klirens iz plazme u vrijednosti od 62 l/h (SD 22) koji odgovara približno 2/3 protoka krvi kroz jetru.
English: Topotecan Hospira is available in pack sizes of 1 vial and 5 vials.
Croatian: Topotekan Hospira je dostupan u veličinama pakiranja od 1 bočice i 5 bočica.
English: The second study included a dose range of 2.0 to 5.2 mg/m2 in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia.
Croatian: U drugom ispitivanju raspon doza bio je 2,0 mg/m2 do 5,2 mg/m2 u djece (n = 8), adolescenata (n = 3) i mlađih odraslih osoba (n = 3) s leukemijom.
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Croatian: Tijekom prvog ciklusa vrućica ili infekcija povezana s teškom neutropenijom javila se u 16% bolesnika, a tijekom čitavog liječenja u 23% bolesnika (6% ciklusa).
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Croatian: Medijan preživljenja bio je 30,3 tjedana (95% CI: 27,6; 33,4).
English: Each vial contains 4 ml of concentrate.
Croatian: Jedna bočica sadrži 4 ml koncentrata.
English: What Topotecan Hospira contains
Croatian: Što Topotekan Hospira sadrži
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 2 compared to 21.3 l/h/m 2 [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/m 2 u odnosu na 21,3 l/h/m 2 [n=9]) (vidjeti dio 4.5).
English: • Staff handling this medicinal product should wear adequate 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: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Croatian: Standardizirani upitnici o simptomima koje su ispunjavali sami bolesnici, nakon otvorene (unblinded) procjene pokazali su konzistentan trend u poboljšanju simptoma za oralni topotekan plus BSC.
English: In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).
Croatian: U populacijskom ispitivanju intravenske primjene istodobna primjena granisetrona, ondansetrona, morfija ili kortikosteroida nije pokazala značajan učinak na farmakokinetiku ukupnog topotekana (aktivnog i inaktivnog oblika).
English: Unopened vial: Store in a refrigerator (2°C-8°C).
Croatian: Neotvorena bočica: Čuvati u hladnjaku (2°C - 8°C).
English: Combination therapy (cervical carcinoma):
Croatian: Kombinacijsko liječenje (karcinom vrata maternice):
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 kombinacijskom liječenju karcinoma pluća malih stanica (n=480) za bolesnike s recidivirajućom bolešću osjetljivom na prvu liniju liječenja iznosila je 20,2%.
English: 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: This should be taken into account when prescribing Topotecan Hospira, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Croatian: To treba uzeti u obzir kod uključivanja Topotekana Hospira u terapiju, npr. u bolesnika s povećanim rizikom krvarenja zbog tumora.
English: 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/m2 given as a 30minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy.
Croatian: 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/m2 u obliku 30-minutne infuzije tijekom 5 dana svaka 3 tjedna, u trajanju do godine dana ovisno o terapijskom odgovoru.
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: One study included a dose range of 1.4 to 2.4 mg/m2 in children (aged 2 up to 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.
Croatian: U prvom ispitivanju raspon doza bio je od 1,4 mg/m2 do 2,4 mg/m2 u djece (u dobi od 2-12 godina, n = 18), adolescenata (u dobi od 12-16 godina, n = 9) i mlađih odraslih osoba (u dobi od 16-21 godine, n = 9) s refraktornim solidnim tumorima.
English: Concentrate for solution for infusion 4 mg/4 ml
Croatian: koncentrat za otopinu za infuziju 4 mg/4 ml
English: Topotecan Hospira 4 mg/4 ml is supplied in Type I clear glass vials, each sealed with a chlorobutyl rubber stopper, aluminium seal and plastic flip-off closure.
Croatian: Topotekan Hospira 4 mg/4 ml pakiran je u prozirne bočice od stakla tipa I, zatvorene gumenim čepom od klorbutilne gume, aluminijskim zatvaračem i plastičnom ˝flip-off˝ kapicom.
English: • Cervical cancer: 0.75 milligrams per m2 of body surface area per day.
Croatian: • Za rak vrata maternice: 0,75 miligrama po m2 površine tijela dnevno.
English: You will have treatment once a day for 3 days.
Croatian: Ovaj će se postupak ponavljati jednom dnevno tijekom 3 dana.
English: 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.
Croatian: Antitumorska aktivnost topotekana uključuje inhibiciju topoizomeraze-I, enzima neposredno uključenog u replikaciju DNK koji opušta torzijsku napetost ispred replikacijske rašlje.
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-desmetil topotekana.
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% kao N-desmetil topotekan.
English: Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Croatian: Iako nije poznato izlučuje li se topotekan u majčino mlijeko, dojenje treba prekinuti na početku liječenja topotekanom.
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, provedenim 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.
English: 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.
Croatian: Peroralno i intravenski primijenjen topotekan pokazali su slično ublažavanje simptoma u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje prema samoprocjeni bolesnika u standardiziranim upitnicima na otvorenoj (unblinded) skali procjene simptoma u svakoj od ove dvije studije.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Croatian: Nisu provođena ispitivanja farmakokinetičkih interakcija u ljudi in vivo.
English: Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p =0.033).
Croatian: Kombinacija topotekana i cisplatine pokazala je statistički značajnu korist u ukupnom preživljenju u odnosu na monoterapiju cisplatinom nakon prilagodbe rezultata za međuanalizu (log-rank p =0,033).
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: − All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Croatian: - Svi predmeti za primjenu lijeka ili čišćenje, uključujući rukavice, moraju se odložiti u vreće za odlaganje otpada visokog rizika koji se spaljuje na visokim temperaturama.
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 (studija 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: Side effects with frequency not known
Croatian: Nuspojave čija je učestalost nepoznata
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Croatian: Ako se tijekom liječenja kombinacijom topotekana i cisplatina vrijednost kreatinina u serumu poveća iznad 1,5 mg/dl, preporučuje se proučiti detaljne upute o lijeku cisplatina radi informacije o smanjenju doze ili nastavku liječenja cisplatinom.
English: The active substance in Topotecan Hospira is topotecan (as hydrochloride).
Croatian: Djelatna tvar u Topotekanu Hospira je topotekan (u obliku topotekanklorida).
English: Signs include: fever serious deterioration ofyour general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be aurinary infection).
Croatian: vrućicu ozbiljno pogoršanje Vašeg općeg stanja lokalne simptome kao što su grlobolja ili problemi s mokrenjem (npr. osjećaj pečenja pri mokrenju što može biti simptom infekcije mokraćnog sustava)
English: − Breast-feeding (see section 4.6).
Croatian: Dojenje (vidjeti dio 4.6).
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 na vrijeme uočili znakovi i simptomi IBP-a (npr. kašalj, vrućica, dispneja i/ili hipoksija) te prekinuti primjenu topotekana ako se potvrdi dijagnoza iste.
English: In another randomised Phase III trial 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 uspoređivao s ciklofosfamidom, doksorubicinom i vinkristinom (CAV protokol) u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, stopa ukupnog odgovora na topotekan iznosila je 24,3%, u usporedbi s 18,3% za skupinu koja je primala CAV protokol.
English: What Topotecan Hospira is and what it is used for
Croatian: Što je Topotekan Hospira i za što se koristi
English: 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.
Croatian: Učestalost dolje opisanih hematoloških i nehematoloških nuspojava dobivena je iz prijava nuspojava koje su ocijenjene kao povezane/moguće povezane s liječenjem topotekanom.
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Croatian: • jaka bol u trbuhu, mučnina, povraćanje krvi, stolica crne boje ili krvava (mogući znakovi gastrointestinalne perforacije)
English: • Lung inflammation (interstitial lung disease): You are most at risk if you have existing lung disease, have had radiation treatment to your lungs, or have previously taken medicines that caused lung damage.
Croatian: Pod povišenim ste rizikom ukoliko već imate bolest pluća, liječeni ste zračenjem pluća, ili ako ste prije uzimali lijekove koji mogu oštetiti pluća.
English: Skin and subcutaneous tissue disorders Very common
Croatian: Poremećaji kože i potkožnog tkiva Vrlo često alopecija
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 prekinutog jednostrukog lanca DNK koji je međuprodukt katalitičkog mehanizma.
English: Topotecan Hospira is provided as a sterile concentrate containing 4 mg topotecan in 4 ml solution (1 mg/ml).
Croatian: Topotekan Hospira je sterilni koncentrat koji sadrži 4 mg topotekana u 4 ml otopine (1 mg/ml).
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Croatian: U bolesnika s umjerenim oštećenjem bubrega plazmatski klirens topotekana je smanjen na 34% vrijednosti kontrolne skupine.
English: 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.
Croatian: Uobičajena onkološka metoda sprječavanja neutropenije je primjena topotekana s drugim lijekovima (npr. G-CSF) ili smanjenje doze s ciljem održavanja primjerenog broja neutrofila.
English: BN:
Croatian: SN:
English: However, there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Croatian: Međutim, nema dovoljno podataka na temelju kojih bi se mogla dati preporuka o doziranju u ovoj skupini bolesnika (vidjeti dio 4.2).
English: Haematological Neutropenia: Severe (neutrophil count <0.5 x 10
Croatian: Hematološke nuspojave Neutropenija: Teška neutropenija (broj neutrofila < 0,5 x 10
English: Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Croatian: U bolesnica koje su prethodno liječene cisplatinom potrebna je dulja pauza kako bi se navedena kombinacija mogla primijeniti (vidjeti dio 5.1).
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95% CI: 0.45, 0.90).
Croatian: Neprilagođeni omjer hazarda za skupinu liječenu topotekanom peroralno uz BSC, u odnosu na skupinu koja je liječena samo BSCom, iznosio je 0,64 (95% CI: 0,45; 0,90).
English: 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.
Croatian: U kliničkim se ispitivanjima primjena topotekana obustavljala ako je njegova doza smanjena na 1,0 mg/m2/dan i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole nuspojava lijeka.
English: • patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Croatian: • bolesnika s recidivom karcinoma pluća malih stanica u kojih ne postoji mogućnost ponavljanja prve linije liječenja (vidjeti dio 5.1).
English: How topotecan is given A doctor or nurse will administer topotecan as an infusion into your arm lasting about 30 minutes.
Croatian: Liječnik ili medicinska sestra primijenit će Vam odgovarajuću dozu topotekana u obliku infuzije u trajanju od približno 30 minuta.
English: Topotecan Hospira is used to treat:
Croatian: Topotekan Hospira se primjenjuje u liječenju:
English: Also contains: tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment).
Croatian: Također sadrži: tartaratnu kiselinu (E334), vodu za injekcije, i kloridnu kiselinu (E507) ili natrijev hidroksid (za podešavanje pH).
English: How to store Topotecan Hospira 6.
Croatian: Kako čuvati Topotekan Hospira 6.
English: However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Croatian: Međutim, topotekan je genotoksičan, kao i ostali citotoksični lijekovi, te se ne mogu isključiti učinci na plodnost muškaraca i žena.