FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Croatian: Topotekan Teva ne upotrebljavati ako sadrži vidljive čestice ili ako otopina nije bistra.
English: Contents of the pack and other information What Topotecan Teva contains
Croatian: Sadržaj pakiranja i druge informacije Što Topotekan Teva sadrži
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10);
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često
English: There were no signs of cumulative haematological or non- haematological toxicity.
Croatian: Nema znakova koji bi upućivali na kumulativnu hematološku ili nehematološku toksičnost.
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: 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 primjećena super-ovulacija i blagi porast predimplantacijskog gubitka.
English: The carcinogenic potential of topotecan has not been studied.
Croatian: Nisu provedena ispitivanja karcinogenog potencijala topotekana.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Croatian: Postotak odgovora na liječenje u cjelokupnom programu karcinoma jajnika (n = 392, koje su sve prethodno liječene cisplatinom ili cisplatinom i paklitakselom) bio je 16%.
English: Personnel should be trained to dilute the medicinal product.
Croatian: Osoblje mora biti educirano za razrjeđivanje lijeka.
English: Weight loss and loss of appetite (anorexia), tiredness, weakness.
Croatian: - Gubitak na težini i gubitak teka (anoreksija); umor; slabost.
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 funkcionalnog stanja (PS > 1, od engl. performance status) imaju slabiji odgovor na liječenje i veću incidenciju komplikacija poput vrućice, infekcija i sepse (vidjeti dio 4.8).
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, sa medijanom vremena trajanja od sedam dana.
English: The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Croatian: Na tiskanoj uputi o lijeku moraju biti navedeni naziv i adresa proizvođača odgovornog za stavljanje navedene serije lijeka u promet.
English: Topotecan Teva should not be used in pregnant women, unless clearly necessary.
Croatian: Trudnice ne smiju uzimati Topotekan Teva osim ako to nije nužno potrebno.
English: There is no known antidote for topotecan overdose.
Croatian: Nije poznat antidot za predoziranje topotekanom.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Croatian: Potpuna ili izrazita alopecija zabilježena je u 30%, a djelomična u 15% bolesnika.
English: Metabolism accounts for <10 % of the elimination of topotecan.
Croatian: Metaboliziranjem se eliminira < 10% topotekana.
English: Combination therapy (cervical carcinoma)
Croatian: Kombinirana terapija (karcinom vrata maternice)
English: Adverse reactions are listed below, by system organ class and absolute frequency (all reported events).
Croatian: Nuspojave su navedene niže, prema organskim sustavima i apsolutnoj učestalosti (sve prijavljene nuspojave).
English: A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into your arm over about 30 minutes.
Croatian: Liječnik ili medicinska sestra dati će Vam odgovarajuću dozu razrijeđene otopine lijeka Topotekan Teva u obliku infuzije, obično u ruku, u trajanju od oko 30 minuta.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Croatian: Topotekan se smije primjenjivati samo na odjelima specijaliziranim za primjenu citotoksične kemoterapije i smije se primjenjivati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije (vidjeti dio 6.6).
English: Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Braillea
English: How to store Topotecan Teva Contents of the pack and other information
Croatian: Kako čuvati Topotekan Teva Sadržaj pakiranja i druge informacije
English: In a population study, a number of factors including age, weight and ascites had no significant effect on clearance of total topotecan (active and inactive form).
Croatian: U populacijskim ispitivanjima, razni čimbenici uključujući dob, tjelesnu težinu i ascites, nisu imali značajan učinak na klirens ukupnog topotekana (aktivnog i inaktivnog oblika).
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 do 5,2 mg/m2 u djece (n = 8), adolescenata (n = 3) i mlađih odraslih osoba (n = 3) s leukemijom.
English: Topotecan must be further diluted before use (see section 6.6).
Croatian: Topotekan se mora prije primjene dodatno razrijediti (vidjeti dio 6.6).
English: The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Croatian: O-glukuronida topotekana i N-desmetil O-glukuronida topotekana u urinu bilo je manje od 2,0 %.
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 ukoliko bolesnica zatrudni tijekom liječenja topotekanom, bolesnicu se mora upozoriti na potencijalne štetne učinke 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: Pretklinička ispitivanja ukazuju na nisko vezanje topotekana na proteine plazme (35%) i prilično homogenu distribuciju između krvnih stanica i plazme.
English: Abnormally low white blood cell count (leucopenia, neutropenia) which may be accompanied with fever and signs of infections (febrile neutropenia).
Croatian: - neuobičajeno nizak broj bijelih krvnih stanica (leukopenija, neutropenija), što može biti praćeno vrućicom i znakovima infekcije (febrilna neutropenija).
English: Very common Infection Common
Croatian: Vrlo često infekcija
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 109/1.
English: Other side effects with Topotecan Teva include: Very common (may affect more than 1 in 10 people)
Croatian: Druge nuspojave pri primjeni lijeka Topotekan Teva: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba)
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Croatian: Transfuziju eritrocita primilo je 52% bolesnika (21% ciklusa).
English: Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Croatian: Jaka preosjetljivost na djelatnu tvar ili bilo koju pomoćnu tvar navedenu u dijelu 6.1.
English: If you have any further questions, ask your doctor or nurse.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku.
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 i stoga je ženama u reproduktivnoj dobi potrebno savjetovati da izbjegavaju trudnoću tijekom liječenja topotekanom.
English: Overall, 87 complete and partial responses were observed, with 13 of these occurring during cycles 5 and 6 and 3 occurring thereafter.
Croatian: Sveukupno je zabilježeno 87 cjelokupnih i djelomičnih odgovora, od kojih se 13
English: Itching (pruritus).
Croatian: - Svrbež (pruritus).
English: In vitro data using human liver microsomes indicate the formation of small amounts of N-demethylated topotecan.
Croatian: In vitro podaci, dobiveni primjenom mikrosomalnih enzima ljudske jetre, upućuju na stvaranje male količine N-demetiliranog topotekana.
English: What Topotecan Teva looks like and contents of the pack
Croatian: Kako Topotekan Teva izgleda i sadržaj pakiranja
English: Yellow skin (jaundice) caused by abnormal liver function.
Croatian: - Žutilo kože (žutica) zbog oštećenja funkcije jetre.
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 inaktivni oblik) kod bolesnika s oštećenjem jetre smanjio se samo oko 10% u usporedbi s kontrolnom skupinom bolesnika.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Croatian: Umor je primjećen u otprilike 25%, a astenija u 16% bolesnika koji su primali topotekan.
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 štetnih događaja dobivena je iz prijava štetnih događaja koji se smatraju povezanim/moguće povezanim s terapijom topotekanom.
English: For more information about cisplatin, please refer to the corresponding Package Leaflet.
Croatian: Za više informacija o cisplatinu, molimo pogledajte odgovarajuću Uputu o lijeku.
English: Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Croatian: - Neuobičajene modrice ili krvarenje, ponekad teško, uzrokovano padom broja krvnih pločica
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Croatian: U kliničkim ispitivanjima osip je zabilježen u 4% bolesnika, a svrbež u 1,5% bolesnika.
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: If you experience this, do not drive or use machines.
Croatian: Ukoliko se osjećate umornim ili slabim, nemojte upravljati vozilom ili raditi sa strojevima.
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 bolesnice s recidivom karcinoma vrata maternice nakon provedene radioterapije i za bolesnice u stadiju IVB.
English: pH = 2.0-2.6.
Croatian: Bistra blijedo žuta tekućina. pH = 2,0 - 2,6.
English: Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Croatian: Topotekan Teva je bistra blijedo žuta tekućina u bezbojnoj staklenoj bočici s bromobutilnim gumenim čepom, aluminijskim prstenom i zaštitnom kapicom.
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: Podležeći rizični čimbenici uključuju anamnezu IBP-a, plućne fibroze, karcinoma pluća, izloženosti prsnog koša zračenju i primjene pneumotoksičnih tvari i/ili čimbenika stimulacije kolonija.
English: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Croatian: Umjerena do teška anemija (Hb ≤ 8,0 g/dl) javila se u 37% bolesnika (14% ciklusa).
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 u kojem se koristila intravenska primjena, istovremena primjena granisetrona, ondansetrona, morfina ili kortikosteroida nije pokazala značajan učinak na farmakokinetiku ukupnog topotekana (aktivnog i inaktivnog oblika).
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 (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).
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Croatian: Medijan vremena do progresije bio je sličan u obje skupine (13,3 tjedana za topotekan i 12,3 tjedana za CAV protokol).
English: Topotecan Teva helps to kill tumour cells.
Croatian: Topotekan Teva pomaže pri uništavanju tumorskih stanica.
English: Feeling unwell (malaise).
Croatian: - Loše osjećanje (malaksalost).
English: You must not breast-feed while on treatment with Topotecan Teva.
Croatian: Ne smijete dojiti dok primate lijek Topotekan Teva.
English: Mild abdominal pain was reported in 4 % of patients.
Croatian: Prijavljena je pojava blage abdominalne boli u 4% bolesnika.
English: This should be taken into account when prescribing Topotecan Teva, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Croatian: To treba uzeti u obzir kod propisivanja lijeka Topotekan Teva, npr. u bolesnika s povećanim rizikom za krvarenje zbog tumora.
English: Platelet transfusions were given in 4 % of courses.
Croatian: Transfuzije trombocita davane su u 4% ciklusa.
English: Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Croatian: Vrlo često febrilna neutropenija, neutropenija (vidjeti „Poremećaji probavnog sustava”), trombocitopenija, anemija, leukopenija
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, kad se topotekan kombinira sa spojevima platine, postoji različita interakcija, ovisna o redoslijedu, s obzirom na to je li spoj platine primijenjen prvi ili peti dan primjene topotekana.
English: In clinical studies, topotecan was discontinued if the dose had been reduced to 1.0 mg/m2/day and a further dose reduction was required to manage adverse effects.
Croatian: U kliničkim se ispitivanjima primjena topotekana obustavljala ako je 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 prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Croatian: Kod bolesnica koje su prethodno bile izložene cisplatinu potrebno je dulje razdoblje bez liječenja kako bi liječenje kombinacijom bilo opravdano (vidjeti dio 5.1).
English: • Infections (very common (may affect more than 1 in 10 people)), with signs such as:
Croatian: • Znakovi infekcije (vrlo često (mogu se javiti u više od 1 na 10 osoba)), sa sljedećim simptomima:
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: 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 terapiju iznosila je 10%.
English: Topotecan-induced neutropenia can cause neutropenic colitis.
Croatian: Neutropenija izazvana topotekanom može uzrokovati neutropenični kolitis.
English: Difference in response rate (95% CI)
Croatian: Razlika u stopi odgovora (95% CI)
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 vremena preživljenja bio je 62 tjedna za topotekan u odnosu na 53 tjedna za paklitaksel (omjer hazarda 0,9 [0,6, 1,3]).
English: Median survival (weeks)
Croatian: Medijan preživljenja (tjedni)
English: Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Croatian: Hematološka toksičnost je ovisna o dozi, te je stoga potrebno redovito određivanje kompletne krvne slike, uključujući trombocite (vidjeti dio 4.2).
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 napredujućih replikacijskih rašlji.
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 bolesnika s recidivom karcinoma pluća malih stanica, hematološka toksičnost se pokazala čimbenikom ograničenja doze u monoterapiji topotekanom.
English: Subsequent doses
Croatian: Daljnje doze
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 30- minute 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 tri tjedna, u trajanju do godine dana, ovisno o terapijskom odgovoru.
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 plućni simptomi koji ukazuju na IBP (npr. kašalj, vrućica, dispneja i/ili hipoksija) te prekinuti primjenu topotekana ako se potvrdi nova dijagnoza IBP-a.
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: Fever.
Croatian: - vrućicu.
English: The mean metabolite: parent AUC ratio was < 10% for both total topotecan and topotecan lactone.
Croatian: Prosječan omjer AUC metabolita i ishodišnog spoja bio je < 10% i za ukupni topotekan i za topotekan lakton.
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 (engl. unblinded) procjene pokazali su konzistentan trend u poboljšanju simptoma za oralni topotekan plus BSC.
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: The recommended dose of topotecan is 1.5 mg/m2 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.
Croatian: Preporučena doza topotekana je 1,5 mg/m2 tjelesne površine na dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno tijekom pet uzastopnih dana, s intervalom od tri tjedna između započinjanja svakog ciklusa.
English: Topotecan Teva can make you feel tired or weak.
Croatian: Topotekan Teva izaziva osjećaj umora ili slabosti.
English: CYTOTOXIC, special handling instructions (see package leaflet).
Croatian: CITOTOKSIČAN LIJEK, posebne upute za rukovanje (vidjeti uputu o lijeku).
English: Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Croatian: Teška depresija koštane srži prije započinjanja prvog ciklusa, što se odnosi na početni broj neutrofila < 1,5 x 109/1 i/ili broj trombocita < 100 x 109/1.
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-rang p = 0,033).
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: Gastrointestinal perforation
Croatian: Nepoznato gastrointestinalna perforacija
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 klirens plazme za topotekan je smanjen na 34% vrijednosti kontrolne skupine bolesnika.
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Croatian: Medijan vremena preživljenja bio je 30,3 tjedana (95% CI: 27,6; 33,4).
English: Topotecan Teva is used to treat:
Croatian: Topotekan Teva primjenjuje se u liječenju:
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 smanjenog broja crvenih krvnih stanica
English: Personnel handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
Croatian: Osoblje koje rukuje lijekom tijekom razrjeđivanja lijeka mora nositi zaštitnu odjeću koja uključuje masku, zaštitne naočale i rukavice.