FrancophonIA/ELRC3.0 huggingface dataset:
English: A phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n=71) with BSC alone (n=70) in patients who had relapsed following first-line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate.
Croatian: Best Supportive Care) (n=71) uspoređivan je sa samim BSC (n=70) u bolesnika s recidivom karcinoma nakon prve linije liječenja (medijan vremena do progresije od prve linije liječenja [TTP] iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za samo BSC) i u bolesnika koji nisu bili kandidati za ponovljenu intravensku kemoterapiju.
English: • Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]).
Croatian: • rane u ustima, otežano gutanje, bol u trbuhu, mučnina, povraćanje, krvave stolice (mogući znakovi upale sluznice usta, želuca i crijeva [upala sluznica]).
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p=0.0104).
Croatian: Skupina koja je primala topotekan peroralno uz BSC imala je statistički značajno poboljšanje u ukupnom preživljenju u odnosu na skupinu koja je liječena samo BSC-om (log-rank p=0,0104).
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Croatian: Bolesnice bez prethodne kemoradioterapije cisplatinom cisplatin topotekan/cisplatin preživljenje (mjeseci)
English: • Occasionally severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (colitis) can be signs of bowel inflammation (colitis).
Croatian: • Ponekad jaka bol u trbuhu, vrućica i mogući proljev (rijetko krvavi) mogu biti znakovi upale crijeva (kolitisa).
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Croatian: Primjena topotekana u monoterapiji i u kombinaciji s cisplatinom obično je povezana s klinički značajnom trombocitopenijom.
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Croatian: Plazmatski klirens u bolesnika s oštećenjem jetre (vrijednosti bilirubina u serumu između 1,5 i 10 mg/dl) smanjen je na oko 67% u usporedbi s kontrolnom skupinom bolesnika.
English: The usual dose • Ovarian and small cell lung cancer: 1.5 milligrams per m2 of body surface area per day.
Croatian: Uobičajena doza • Za rak jajnika ili rak pluća malih stanica: 1,5 miligrama po m2 površine tijela dnevno.
English: The approved diluents for the concentrate are sodium chloride 9 mg/ml (0.9%) solution for injection and glucose 50 mg/ml (5%) solution for injection.
Croatian: Odobrene otopine za razrjeđivanje koncentrata su 0,9%-tna (9 mg/ml) otopina natrijevog klorida za injekciju i 5 %-tna (50 mg/ml) otopina glukoze za injekciju.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥1.5 x 10
Croatian: Prije primjene prvog ciklusa topotekana, bolesnici moraju imati početni broj neutrofila ≥ 1,5x10
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 days 1-3, every 21 days
Croatian: ITT populacija cisplatin 50 mg/m2 1. dan, svakih 2l dan cisplatin 50 mg/m2 1. dan + topotekan 0,75 mg/m2 1.-3. dana, svakih 21 dan preživljenje (mjeseci)
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 redovit određivanje kompletne krvne slike, uključujući broj trombocita (vidjeti dio 4.2).
English: A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m2/day for five days every three weeks.
Croatian: Malom broju bolesnika s oštećenjem jetre (serumski bilirubin između 1,5 i 10 mg/dl) intravenski je primijenjeno 1,5 mg/m2/dan topotekana kroz pet dana svaka tri tjedna.
English: Overall, the N-desmethyl metabolite contributed a mean of < 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: Chemical and physical in-use stability has been demonstrated for 24 hours at 25°C under normal light conditions and at 2°C -8°C when protected from light.
Croatian: Dokazana je kemijska i fizikalna stabilnost lijeka u primjeni tijekom 24 sata na 25 oC kod normalne izloženosti svjetlosti te na 2 oC - 8
English: In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum-based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, respectively.
Croatian: U komparativnom ispitivanju topotekana i paklitaksela u bolesnica s karcinomom jajnika prethodno liječenih kemoterapijom na bazi platine (n=112 i n=114 po istom redoslijedu), stopa odgovora na lijek (95% CI) iznosila je 20,5% (13%, 28%) naspram 14% (8%, 20%), a medijan vremena do progresije iznosio je 19 tjedana naspram 15 tjedana (omjer hazarda 0,7 [0,6; 1,0]) za topotekan i paklitaksel.
English: Monotherapy (ovarian and small cell lung carcinoma):
Croatian: Monoterapija (karcinom jajnika i karcinom pluća malih stanica)
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Croatian: Medijan vremena preživljenja bio je 62 tjedna za topotekan u odnosu na 53 tjedna za paklitaksel (omjer hazarda 0,9 [0,6; 1,3]).
English: Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2day with G-CSF and 1.4 mg/m2/day without G-CSF in a pharmacokinetic study in paediatric patients with refractory solid tumours (see section 5.2).
Croatian: U farmakokinetičkom ispitivanju kod pedijatrijskih bolesnika s refraktornim solidnim tumorima, ustanovljena je maksimalna podnošljiva doza od 2,0 mg/m2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF (vidjeti dio 5.2) na temelju toksičnosti ovisne o dozi u obliku mijelosupresije.
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: When treating cervical cancer, Topotecan Hospira is combined with another medicine called cisplatin.
Croatian: U liječenju raka vrata maternice, Topotekan Hospira se kombinira s drugim lijekom koji se zove cisplatin.
English: If you are being treated for cervical cancer, you may get side effects from the othermedicine (cisplatin)that you willbe given along with Topotecan Hospira.
Croatian: Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka (cisplatin) koji ćete primati uz Topotekan Hospira.
English: - Any unused product or waste material should be disposed of in accordance with local requirements.
Croatian: - Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Those effectsaredescribed in the cisplatin patient leaflet.
Croatian: Te nuspojave opisane su u uputi o lijeku za cisplatin.
English: Oral topotecan Intravenous topotecan
Croatian: oralni topotekan intravenski topotekan oralni topotekan intravenski topotekan
English: Use of topotecan in this group of patients is not recommended (see section 4.4).
Croatian: Primjena topotekana u ovoj skupini bolesnika se ne preporučuje (vidjeti dio 4.4).
English: In this study, forty-six (43%) patients received G-CSF over 192 (42.1%) courses; sixty-five (60%) received transfusions of packed red blood cells and fifty (46%) of platelets over 139 and 159 courses (30.5% and 34.9%) respectively.
Croatian: U ovom je ispitivanju 46 bolesnika (43%) nakon 192 (42,1%) ciklusa primilo G-CSF; 65 bolesnika (60%) je nakon 139 (30,5 %) ciklusa primilo transfuziju eritrocita, a 50 njih (46%) nakon 159 (34,9%) ciklusa transfuziju trombocita.
English: − Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Croatian: - U slučaju kontakta topotekana s kožom ili očima odmah je potrebno ispiranje obilnim količinama vode.
English: The other ingredients are: tartaric acid (E334), water for injections and hydrochloric acid (E507) or sodium hydroxide (to adjust the pH of the solution).
Croatian: Drugi sastojci su: tartaratna kiselina (E334), voda za injekcije i kloridna kiselina (E507) ili natrijev hidroksid (za podešavanje pH otopine)
English: An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine.
Croatian: U urinu su pronađeni metabolit O-glukuronidacije topotekana i N-desmetil topotekana.
English: You should not receive Topotecan Hospira:
Croatian: Nemojte primjenjivati Topotekan Hospira:
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Croatian: Kad se topotekan koristi u kombinaciji s cisplatinom, potrebno je slijediti upute za primjenu cisplatina.
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Croatian: Cisplatin se primjenjuje prvog dana intravenskom infuzijom u dozi od 50 mg/m2/dnevno nakon davanja doze topotekana.
English: Total or pronounced alopecia was observed in 30 % of patients and partial alopecia in 15 % of patients.
Croatian: Potpuni ili izraziti gubitak kose zabilježen je u 30%, a djelomičan u 15% bolesnika.
English: The adverse events listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4).
Croatian: Navedene nuspojave imaju veći potencijal pojavljivanja u bolesnika slabog općeg stanja (vidjeti dio
English: In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5mg/dl.
Croatian: U kliničkim ispitivanjima kombinacije topotekana i cisplatina u liječenju karcinoma vrata maternice, liječenje je započeto samo u bolesnica s vrijednošću kreatinina u serumu manjom ili jednakom
English: Special handling and disposal instructions apply (see package leaflet).
Croatian: Primjenjuju se posebne mjere za rukovanje i odlaganje lijeka (pogledajte uputu o lijeku).
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Croatian: Topotekan Hospira je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: 9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m 2/day for subsequent courses (or subsequently down to 0.45 mg/m 2/day if necessary).
Croatian: 9/1) u trajanju od sedam dana ili dulje, s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno, izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20 %, na 0,60 mg/m2/dan (ukoliko je potrebno, moguće je daljnje smanjenje doze na
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Croatian: Incidencija teškog (stupanj 3 ili 4) umora i astenije iznosila je oko 3%.
English: Neutropenia and thrombocytopenia should be managed.
Croatian: Neutropeniju i trombocitopeniju treba liječiti.
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: Ukoliko se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na 2 oC do 8
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral topotecan or intravenous topotecan
Croatian: Sažeti prikaz preživljenja, stope odgovora i vremena do progresije bolesti u bolesnika s karcinomom pluća malih stanica liječenih peroralnim ili intravenskim topotekanom studija 065
English: Your dose of Topotecan Hospira may need to be adjusted.
Croatian: Možda će Vam biti potrebna prilagodba doze lijeka Topotekan Hospira.
English: the platelet count is ≥ 100 x 10
Croatian: broj trombocita ≥100x10
English: There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Croatian: Nedovoljno je iskustva s primjenom topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min).
English: In patients presenting with fever, neutropenia and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Croatian: U bolesnika s vrućicom, neutropenijom i bolovima u trbuhu koji upućuju na tu bolest, potrebno je posumnjati na neutropenijski kolitis.
English: Dosage: Ovarian and Small Cell Lung Carcinoma Initial dose: 1.5 mg/ m2 body surface area/day, administered by intravenous infusion over 30 minutes for 5 consecutive days, with a 3 week interval between the start of each course.
Croatian: Doziranje: rak jajnika i rak pluća malih stanica Početna doza: 1,5 mg/m2 površine tijela/dnevno, primijenjeno intravenskom infuzijom u trajanju od 30 minuta kroz 5 uzastopnih dana, s periodom od 3 tjedna između početka svakog ciklusa.
English: Do not use Topotecan Hospira after the expiry date stated on the vial and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na bočici i kutiji iza oznake EXP.
English: Ovarian and small cell lung carcinoma
Croatian: Karcinom jajnika i karcinom pluća malih stanica
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da topotekan uzrokuje smrt i malformacije embrija i fetusa (vidjeti dio 5.3).
English: Additional adverse events were seen when topotecan was given in combination with cisplatin; however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
Croatian: Prilikom primjene topotekana u kombinaciji s cisplatinom zabilježene su dodatne nuspojave, međutim one su zabilježene i u monoterapiji cisplatinom i nisu povezane s topotekanom.
English: s r.o.
Croatian: oC -8
English: 9/l) during course 1 in 55% of patients, with duration ≥seven days in 20 % and overall in 77 % of patients (39 % of courses).
Croatian: 9/1) tijekom prvog ciklusa u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju sedam dana ili dulje.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count ˂ 0.5 x 10
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila 0,5 x 10
English: • Inflammation and ulcers of the mouth, tongue or gums.
Croatian: • upala sluznice i stvaranje rana u usnoj šupljini, na jeziku ili desnima
English: Initial dose The recommended dose of topotecan is 1.5 mg/m2 body surface area perday administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Croatian: Početna doza Preporučena doza topotekana je 1,5 mg/m2 tjelesne površine/dan, primijenjena intravenskom infuzijom u trajanju od 30 minuta dnevno tijekom 5 uzastopnih dana, s periodom od tri tjedna između početka svakog ciklusa.
English: Dosage: Cervical Carcinoma
Croatian: Doziranje: karcinom vrata maternice
English: There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Croatian: Nema dovoljno podataka o primjeni topotekana u bolesnika s teškim oštećenjem jetrene funkcije (serumski bilirubin ≥ 10 mg/dl) zbog ciroze.
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Croatian: Posljedica inhibicije topoizomeraze-I topotekanom na staničnoj razini je cijepanje jednostrukog lanca DNK vezanog na proteine.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Nuspojave su unutar iste skupine učestalosti navedene u padajućem nizu prema ozbiljnosti.
English: A reduction in topotecan clearance was observed.
Croatian: Primijećeno je smanjenje klirensa kreatinina.
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds, have been infrequent.
Croatian: Rijetko su zabilježene ozbiljne posljedice povezane s trombocitopenijom, uključujući smrtne slučajeve zbog krvarenja povezanog s tumorom.
English: Subsequent doses: Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10
Croatian: Daljnje doze: Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije veći ili jednak 1,5x10
English: Initial dose: 0.75 mg/m2/day administered as 30 minute intravenous infusion daily, on days 1, 2 and 3.
Croatian: Početna doza: 0,75 mg/m2/dnevno primijenjeno kao 30 minutna intravenska infuzija prvog, drugog i trećeg dana ciklusa.
English: See section “Pregnancy and breast-feeding”
Croatian: Pogledajte dio „Trudnoća i dojenje“ u nastavku.
English: Topotecan Hospira is available in two pack sizes, containing either 1 vial or 5 vials.
Croatian: Dostupne su dvije veličine pakiranja Topotekana Hospira, od 1 ili 5 bočica.
English: Very rare
Croatian: Vrlo rijetko ekstravazacija
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion requires dilution to a final concentration of 25-50 micrograms/ml, prior to administration to the patient.
Croatian: Prije primjene bolesniku, potrebno je razrjeđivanje Topotekan Hospira 4 mg/4 ml koncentrata za otopinu za infuziju kako bi se postigla konačna koncentracija od 25-50 mikrograma/ml.
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin
Croatian: Nedovoljno je iskustva s primjenom topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥ 10 mg/dl).
English: The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively.
Croatian: Incidencija teške (stupanj 3 ili 4) mučnine bila je 4%, povraćanja 3%, proljeva 2% i mukozitisa 1%.
English: 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary).
Croatian: 1,0 mg/m 2/dan).
English: Tell your doctor immediately if you get any symptoms of these conditions, as hospitalisation may be necessary.
Croatian: Znakovi uključuju: otežano disanje kašalj vrućicu Odmah obavijestite svog liječnika ako primijetite bilo što od navedenog jer ćete možda morati biti liječeni u bolnici.
English: Median (95% CI.)
Croatian: medijan (95% CI) omjer hazarda (95% CI)
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Croatian: Prijavljeni su slučajevi intersticijske bolesti pluća (IBP), vezani uz primjenu topotekana, koja je u nekih bolesnika bila fatalna (vidjeti dio 4.8).
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1.5 x 10
Croatian: Topotekan se ne smije ponovno primijeniti ukoliko broj neutrofila nije 1,5 x 10
English: In those patients (n=102) with recurrence after 180 days, the median survival in the topotecan plus cisplatin arm was 9.9 months (95% CI:: 7, 12.6) versus 6.3 months (95%CI:: 4.9, 9.5) for the cisplatin arm, with a hazard ratio of 0.75 (0.49, 1.16).
Croatian: U bolesnica (n=102) s recidivom nakon 180 dana, medijan preživljenja u skupini liječenoj kombinacijom topotekana i cisplatina iznosio je 9,9 mjeseci (95% CI: 7; 12,6), u odnosu na 6,3 mjeseca (95% CI: 4,9; 9,5) u skupini liječenoj cisplatinom, uz omjer hazarda od 0,75
English: If there is lasting irritation, a doctor should be consulted.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain mucositis
Croatian: Poremećaji probavnog sustava Vrlo često mučnina, povraćanje i proljev (svi mogu biti teški), konstipacija, bolovi u abdomenu
English: Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (for pH adjustment) Water for injections
Croatian: 6.1 Popis pomoćnih tvari tartaratna kiselina (E334) kloridna kiselina (E507) (za podešavanje pH) natrijev hidroksid (za podešavanje pH) voda za injekcije
English: Use of topotecan in these patient groups is not recommended (see section
Croatian: Primjena topotekana u ovih skupina bolesnika se ne preporučuje (vidjeti dio 4.2).
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
Croatian: Topotekan Hospira 4 mg/4 ml koncentrat za otopinu za infuziju
English: • Pregnant staff should be excluded from working with this medicinal product.
Croatian: • Trudne radnice ne smiju rukovati ovim lijekom.
English: Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia
Croatian: Poremećaji krvi i limfnog sustava Vrlo često febrilna neutropenija, neutropenija (vidjeti “Poremećaji probavnog sustava”), trombocitopenija, anemija, leukopenija
English: Topotecan Hospira 4 mg/4 ml sterile concentrate topotecan
Croatian: Topotekan Hospira 4 mg/4 ml sterilni koncentrat topotekan primjena u venu
English: Parenteral products should be visually inspected for particulate matter and discolouration prior to administration.
Croatian: Parenteralne lijekove prije primjene treba vizualno pregledati radi prisutnosti čestica i promjene boje.
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma and faeces.
Croatian: U urinu, plazmi i fecesu pronađen je jedan N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od ishodišnog spoja u staničnoj kulturi.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Croatian: U kliničkim ispitivanjima topotekana zabilježeni su slučajevi neutropenijskog kolitisa sa smrtnim ishodom.
English: • if you are breast-feeding
Croatian: • ako dojite
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Croatian: Zabilježeni su slučajevi sepse zbog mijelosupresije, kao i smrtni ishodi zbog sepse u bolesnika liječenih topotekanom (vidjeti dio 4.8).
English: How to store Topotecan Hospira
Croatian: Kako čuvati Topotekan Hospira
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion topotecan
Croatian: Topotekan Hospira 4 mg/4 ml koncentrat za otopinu za infuziju topotekan
English: If visible particles are observed, the medicine should not be administered.
Croatian: Lijek se ne smije primijeniti ukoliko se primijete vidljive čestice.
English: Median survivals for the two groups were 25.0 and 24.7 weeks, respectively.
Croatian: Medijan preživljenja iznosio je 25,0 za topotekan, odnosno 24,7 tjedana za CAV protokol.