FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: V drugi randomizirani študiji III. faze, v katerem so primerjali intravenski topotekan s ciklofosfamidom, doksorubicinom in vinkristinom (CAV), je bila pri bolnikih s ponovitvijo za zdravilo občutljivega drobnoceličnega pljučnega raka skupna stopnja odziva na topotekan 24,3 %, v primerjavi z 18,3 % v skupini, ki je prejemala kombinacijo CAV.
English: − Breast-feeding (see section 4.6).
Slovenian: − dojenje (glejte poglavje 4.6),
English: Concentrate for solution for infusion 4 mg/4 ml
Slovenian: Koncentrat za raztopino za infundiranje 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.
Slovenian: Zdravilo Topotekan Hospira 4 mg/4 ml je pakirano v viale iz prozornega stekla tipa I, ki so zaprte z zamaškom iz klorobutilne gume, aluminijasto zaporko in plastično odmično zaporko.
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.
Slovenian: Tveganje je največje, če že imate pljučno bolezen, če ste se zdravili z obsevanjem pljuč ali če ste pred tem prejemali zdravila, ki so povzročila okvaro pljuč.
English: The primary complications of overdose are bone marrow suppression and mucositis.
Slovenian: Primarna zapleta prevelikega odmerjanja sta supresija kostnega mozga in mukozitis.
English: Topotecan Hospira is provided as a sterile concentrate containing 4 mg topotecan in 4 ml solution (1 mg/ml).
Slovenian: Zdravilo Topotecan Hospira je na voljo v obliki sterilnega koncentrata, ki vsebuje 4 mg topotekana v 4 ml raztopine (1 mg/ml).
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.
Slovenian: Če med kombiniranim zdravljenjem s topotekanom in cisplatinom vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo, da proučite celotna navodila za predpisovanje cisplatina in v njih poiščete nasvete glede zmanjšanja odmerka cisplatina in nadaljnjega zdravljenja z njim.
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Slovenian: Pri uporabi topotekana v kombinaciji s cisplatinom je treba upoštevati tudi celotna navodila za predpisovanje cisplatina.
English: You should not receive Topotecan Hospira:
Slovenian: Ne prejemajte zdravila Topotecan Hospira:
English: • ovarian cancer or small cell lung cancer that has come back after chemotherapy.
Slovenian: • ponovitve raka na jajčniku ali drobnoceličnega pljučnega raka po kemoterapiji,
English: In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0%.
Slovenian: pri bolnikih, ki se niso odzvali na zdravljenje s terapijo prve izbire) je bila stopnja odziva na zdravljenje s topotekanom 4,0 %.
English: Subsequent doses
Slovenian: Poznejši odmerki
English: 9/l) in 25 % of patients (8 % of courses); moderate
Slovenian: 9/l) je bila pri 25 % bolnikov (8 % ciklusov), zmerna
English: - Any unused product or waste material should be disposed of in accordance with local requirements.
Slovenian: − Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
English: Haematological toxicity is dose-related and full blood count including platelets should be determined regularly (see section 4.2).
Slovenian: Hematološka toksičnost je odvisna od odmerka, zato je treba pri bolnikih redno pregledovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4.2).
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.
Slovenian: Če se zdravite zaradi raka materničnega vratu, se lahko pojavijo neželeni učinki drugega zdravila (cisplatina), ki ga boste prejeli skupaj z zdravilom Topotecan Hospira.
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95% CI: 0.78 - 1.40).
Slovenian: Razmerje tveganj za preživetje pri zdravljenju z intravenskim topotekanom v primerjavi s kombinacijo CAV je bilo 1,04 (95 % IZ: 0,78 - 1,40).
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.
Slovenian: Pri sočasni uporabi s spojinami platine pa lahko pride do značilne interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega ali boste uporabili zdravilo s platino na 1. ali na 5. dan odmerjanja topotekana.
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.
Slovenian: Izgled zdravila Topotecan Hospira in vsebina pakiranja Zdravilo Topotecan Hospira je bister rumen ali rumenkasto zelen koncentrat za raztopino za infundiranje, ki je pakiran v prozorne steklene viale s po 4 ml koncentrata.
English: Topotecan Hospira is used to treat:
Slovenian: Zdravilo Topotecan Hospira se uporablja pri zdravljenju:
English: • Swelling caused by fluid build up (angioedema).
Slovenian: • otekanje zaradi kopičenja tekočine (angioedem),
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).
Slovenian: Nekorigirano razmerje tveganj med skupino, ki je prejemala peroralni topotekan in NPO, ter skupino, ki je prejemala samo NPO, je bilo 0,64 (95 % IZ: 0,45, 0,90).
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.
Slovenian: V študiji III. faze (študija 478) so primerjali uporabo peroralnega topotekana skupaj z najboljšo podporno oskrbo (NPO) (n = 71) s samo NPO (n = 70) pri bolnikih, ki so imeli ponovitev bolezni po zdravljenju s terapijo prve izbire (mediana vrednost časa do napredovanja bolezni [TTP], ki je minil od zdravljenja s terapijo prve izbire: 84 dni za peroralni topotekan v kombinaciji z NPO in 90 dni za samo NPO) in pri katerih ponovno zdravljenje z intravensko kemoterapijo ni bilo primerno.
English: The active substance in Topotecan Hospira is topotecan (as hydrochloride).
Slovenian: Zdravilna učinkovina v zdravilu Topotecan Hospira je topotekan (v obliki klorida).
English: Approximately 51% was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Slovenian: S sečem se ga je približno 51 % izločilo v obliki samega topotekana, 3 % pa v obliki N-desmetil topotekana.
English: Topotecan-induced neutropenia can cause neutropenic colitis.
Slovenian: Nevtropenija zaradi uporabe topotekana lahko povzroči nevtropenični kolitis.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Slovenian: Mediana vrednost časa do napredovanja bolezni je bila v obeh skupinah podobna: pri topotekanu je znašala 13,3 tedna, pri kombinaciji CAV pa 12,3 tedna.
English: BN:
Slovenian: SN:
English: − Severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils <1.5 x 10
Slovenian: − huda depresija kostnega mozga, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 10
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.
Slovenian: Plazemski očistek topotekana pri bolnikih z jetrno okvaro (serumski bilirubin med 1.5 in 10 mg/dl) se je zmanjšal na približno 67 % v primerjavi z bolniki iz kontrolne skupine.
English: No effects on male or female fertility have been observed in reproductive toxicity studies in rats (see section 5.3).
Slovenian: V študijah reproduktivne toksičnosti pri podganah niso ugotovili učinkov na plodnost samcev ali samic (glejte poglavje 5.3).
English: What Topotecan Hospira is and what it is used for
Slovenian: Kaj je zdravilo Topotecan Hospira in za kaj ga uporabljamo
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.
Slovenian: Če ste dali cisplatin ali karboplatin na 1. dan odmerjanja topotekana, boste morali zaradi boljšega prenašanja zmanjšati odmerek obeh zdravil v primerjavi z odmerkoma, ki ju lahko uporabite, če spojino platine date na 5. dan odmerjanja topotekana.
English: − All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Slovenian: − Vse predmete, ki so bili uporabljeni pri dajanju zdravila ali čiščenju, vključno z rokavicami, morate odlagati v vreče za sežig nevarnih odpadkov pri visoki temperaturi, tekoče odpadke pa lahko sperete z veliko količino vode.
English: Median overall survival was 62 weeks for topotecan versus 53 weeks for paclitaxel (hazard ratio 0.9 [0.6, 1.3]).
Slovenian: Mediana časa preživetja je bila 62 tednov pri uporabi topotekana in 53 tednov pri zdravljenju s paklitakselom (razmerje tveganja 0,9 [0,6; 1,3]).
English: • patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.
Slovenian: • bolnicah z rakom jajčnika z metastazami, če terapija prve izbire in tudi naslednje terapije niso uspele.
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.
Slovenian: V tej študiji je 46 (43 %) bolnikov prejelo G-CSF v 192 (42,1 %) ciklusih, 65 (60 %) bolnikov je prejelo transfuzije koncentriranih eritrocitov v 139 (30,5 %) ciklusih in 50 (46 %) bolnikov je prejelo transfuzijo trombocitov v 159 (34,9 %) ciklusih.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Slovenian: Pri bolnikih, ki so prejemali topotekan, so utrujenost opazili pri približno 25 % bolnikov in astenijo pri 16 % bolnikov.
English: Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Slovenian: Bolnice, ki so bile predhodno zdravljene s cisplatinom, morajo biti dlje časa brez zdravljenja, da je pri njih upravičeno zdravljenje s to kombinirano terapijo (glejte poglavje 5.1).
English: • Cervical cancer: 0.75 milligrams per m2 of body surface area per day.
Slovenian: • rak materničnega vratu: 0,75 miligrama na kvadratni meter telesne površine na dan.
English: If visible particles are observed, the medicine should not be administered.
Slovenian: Če v raztopini opazite vidne delce, zdravila ne smete dati bolniku.
English: Log rank p-value
Slovenian: P-vrednost log ranka
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Slovenian: Incidenca hude utrujenosti in astenije (3. ali 4. stopnje) se je pojavljala s pogostnostjo 3 % pri obeh.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Slovenian: Uporaba topotekana v monoterapiji in topotekana v kombinaciji s cisplatinom je pogosto povezana s pojavom klinično pomembne trombocitopenije.
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Slovenian: •hude bolečine v trebuhu, občutek slabosti, bruhanje krvi, črno ali krvavo blato (to so lahko simptomi gastrointestinalne perforacije ali predrtja stene prebavil);
English: There were no signs of cumulative haematological or non-haematological toxicity.
Slovenian: Ta toksičnost je bila predvidljiva in reverzibilna in ni bilo nobenih znakov kumulativne hematološke ali nehematološke toksičnosti.
English: Haematological Neutropenia: Severe (neutrophil count <0.5 x 10
Slovenian: Nevtropenija: Hudo nevtropenijo (število nevtrofilcev < 0,5 x 10
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.
Slovenian: Odobrene raztopine za redčenje koncentrata so 0,9 % raztopina natrijevega klorida za injiciranje (9 mg/ml) in 5 % raztopina glukoze za injiciranje (50 mg/ml).
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.
Slovenian: Majhno število bolnikov z jetrno okvaro (vrednost bilirubina v serumu med 1,5 in 10 mg/dl) je prejemalo intravensko odmerek topotekana 1,5 mg/m2/dan po pet dni na vsake tri tedne.
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.
Slovenian: Pri uporabi topotekana v kombinaciji s cisplatinom so opazili dodatne neželene učinke, vendar so le-te opazili že pri monoterapiji s cisplatinom in jih ni bilo mogoče pripisati topotekanu.
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Slovenian: Tudi cisplatin dajte bolniku v obliki intravenske infuzije prvi dan v odmerku 50 mg/m2 na dan, po odmerku topotekana.
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]).
Slovenian: •razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic]).
English: The normal procedures for proper handling and disposal of anti-tumour medicinal products should be adopted:
Slovenian: Ravnanje z zdravilom in njegovo odstranjevanje Uporabiti je treba uveljavljene postopke za pravilno ravnanje s protitumorskimi zdravili in njihovo odstranjevanje:
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma and rhabdomyosarcoma.
Slovenian: Zastopane so bile naslednje vrste tumorjev: Ewingov sarkom oz. primitivni nevroektodermalni tumor, nevroblastom, osteoblastom in rabdomiosarkom.
English: Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients.
Slovenian: Pri otrocih s ponavljajočimi se in neodzivnimi solidnimi tumorji so bili toksični učinki topotekana podobni toksičnim učinkom, ki so jih v preteklosti opažali pri odraslih bolnikih.
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).
Slovenian: zvišana telesna temperatura, resno poslabšanje vašega splošnega zdravstvenega stanja oz. zdravja, lokalni simptomi, na primer vnetje žrela ali težave s sečili (na primer pekoč občutek med odvajanjem seča, ki je lahko znak okužbe sečil).
English: Topotecan Hospira is available in two pack sizes, containing either 1 vial or 5 vials.
Slovenian: Zdravilo Topotecan Hospira je na voljo v dveh velikostih pakiranja z 1 vialo ali 5 vialami.
English: Topotecan Hospira is available in pack sizes of 1 vial and 5 vials.
Slovenian: Zdravilo Topotecan Hospira je na voljo v velikostih pakiranj z 1 vialo ali 5 vialami.
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).
Slovenian: • Občasne hude trebušne bolečine, zvišana telesna temperatura in morda driska (redko z navzočnostjo krvi v blatu) so lahko znaki vnetja črevesja (kolitisa).
English: Intravenous topotecan
Slovenian: Intravenski topotekan
English: Median (95% CI.)
Slovenian: Mediana vrednost (95 % IZ)
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).
Slovenian: Zgoraj navedeni neželeni dogodki so lahko pogostejši pri bolnikih v slabšem stanju (glejte poglavje
English: Ovarian and small cell lung carcinoma
Slovenian: Karcinom jajčnika in drobnocelični pljučni karcinom
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.
Slovenian: Kombinirana terapija (karcinom materničnega vratu) V kliničnih študijah uporabe topotekana v kombinaciji s cisplatinom za zdravljenje raka materničnega vratu je bilo zdravljenje uvedeno le pri tistih bolnicah, ki so imele vrednost kreatinina v serumu ≤ 1,5 mg/dl.
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).
Slovenian: Ob hudi nevtropeniji so med prvim ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužbo, 23 % bolnikov pa ju je imelo pri vseh ciklusih (6 % ciklusov zdravljenja).
English: Parenteral products should be visually inspected for particulate matter and discolouration prior to administration.
Slovenian: Zdravila za parenteralno uporabo je treba pred uporabo vizualno pregledati, da ugotovite, ali vsebujejo delce in ali so obarvana.
English: 9/l and/or a platelet count of < 100 x 10
Slovenian: 9/l in/ali števila trombocitov < 100 x 10 9/l.
English: Mild abdominal pain was reported in 4 % of patients.
Slovenian: Pri 4 % bolnikov so poročali o blagih trebušnih bolečinah.
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Slovenian: Uporaba topotekana je bila povezana tudi s poročili o nastanku intersticijske pljučne bolezni (IPB), ki je v nekaterih primerih vodila do smrti bolnika (glejte poglavje 4.8).
English: Also contains: tartaric acid (E334), water for injections, and hydrochloric acid (E507) or sodium hydroxide (for pH adjustment).
Slovenian: Zdravilo vsebuje tudi: vinsko kislino (E334), vodo za injekcije in klorovodikovo kislino (E507) ali natrijev hidroksid (za uravnavanje pH).
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥1.5 x 10
Slovenian: Pred dajanjem prvega ciklusa topotekana mora imeti bolnik začetno število nevtrofilcev ≥ 1,5 x 10
English: The safety profile of topotecan when given in combination with cisplatin in the cervical cancer clinical studies is consistent with that seen with topotecan monotherapy.
Slovenian: Varnostni profil topotekana v kliničnih študijah kombinirane terapije raka materničnega vratu s cisplatinom je bil enak kot pri monoterapiji s topotekanom.
English: The usual dose • Ovarian and small cell lung cancer: 1.5 milligrams per m2 of body surface area per day.
Slovenian: • rak jajčnika in drobnocelični pljučni rak: 1,5 miligrama na kvadratni meter telesne površine na dan.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Slovenian: Farmakokinetičnih študij medsebojnega delovanja z drugimi zdravili pri človeku in vivo niso izvedli.
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of protein-associated DNA single-strand breaks.
Slovenian: Celična posledica zaviranja topoizomeraze I s topotekanom je razpad posameznih enojnih verig DNA, vezanih na beljakovine.
English: The integrated safety data for topotecan monotherapy are presented below.
Slovenian: V nadaljevanju navajamo združene podatke o varnosti topotekana v monoterapiji.
English: 9/l, the platelet count is ≥ 100 x 10
Slovenian: 9/l, število trombocitov ni ≥ 100 x 10
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).
Slovenian: Pomožne snovi so: vinska kislina (E334), voda za injekcije in klorovodikova kislina (E507) ali natrijev hidroksid (za uravnavanje pH raztopine).
English: Oral topotecan
Slovenian: Peroralni topotekan
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Slovenian: Predklinične študije so pokazale, da topotekan povzroča smrt in deformacije zarodka oziroma ploda (glejte poglavje 5.3).
English: The overall haematological toxicity is lower in patients treated with topotecan in combination with cisplatin compared to topotecan monotherapy, but higher than with cisplatin alone.
Slovenian: Pri bolnikih, ki so jih zdravili s topotekanom v kombinaciji s cisplatinom, je bila skupna hematološka toksičnost manjša kot pri monoterapiji s topotekanom, vendar še vedno večja kot pri monoterapiji s cisplatinom.
English: After opening, the product should be used immediately.
Slovenian: Zdravilo je namenjeno samo za enkratno uporabo in ga je treba po odprtju takoj uporabiti.
English: • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
Slovenian: • občutek slabosti (navzea), bruhanje (vomitus), driska, trebušne bolečine, zaprtje,
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.
Slovenian: Preden aplicirate zdravilo Topotecan Hospira 4 mg/4 ml koncentrat za raztopino za infundiranje bolniku, ga je treba razredčiti do končne koncentracije 25 do 50 mikrogramov/ml.
English: Infections and infestations Very common
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužba pogosti sepsa
English: Platelet transfusions were given in 4 % of courses.
Slovenian: V 4 % ciklusov zdravljenja so bolnikom dali transfuzijo trombocitov.
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Slovenian: Z blatom se ga je 18 % izločilo v obliki samega topotekana, 1,7 % pa v obliki N-desmetil topotekana.
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).
Slovenian: Skupno preživetje v skupini, ki je prejemala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupini, ki je prejemala samo NPO (vrednost p log ranga = 0,0104).
English: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Slovenian: Za primere, ko je pri bolnicah z rakom materničnega vratu ukinjeno zdravljenje s cisplatinom, pa ni zadostnih podatkov o nadaljevanju zdravljenja s topotekanom v monoterapiji.
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n=9) and Cmax (23%, n=11) was noted on day 5.
Slovenian: mg/m2 na dan prvi dan) 13 bolnicam z rakom jajčnikov so 5. dan opazili rahlo povečanje vrednosti AUC (12 %, n = 9) in Cmax (23 %, n = 11).