FrancophonIA/ELRC3.0 huggingface dataset:
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Slovenian: Povzetek preživetja, deleža odziva in časa do napredovanja pri bolnikih z drobnoceličnim pljučnim rakom, zdravljenih s peroralnim oziroma intravenskim topotekanom
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10%.
Slovenian: Pri bolnicah, ki se jim je bolezen po zdravljenju s cisplatinom ponovila v roku 3 mesecev ali ki se niso odzvale na zdravilo (n = 186), je bila stopnja odziva 10 %.
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.
Slovenian: Običajna klinična praksa pri obravnavi nevtropenije je aplikacija topotekana skupaj z drugimi zdravili (npr. G-CSF) ali zmanjšanje do odmerka, s katerim lahko vzdržujemo ustrezno število nevtrofilcev.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7% (range 4-9%) of the total topotecan related material accounted for in the urine and faeces.
Slovenian: Presnovek N-desmetil predstavlja v povprečju manj kot 7 % (od 4 do 9 %) vseh s topotekanom povezanih snovi prisotnih v urinu in blatu.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Slovenian: V kliničnih študijah so o izpuščaju poročali pri 4 % bolnikov, o srbenju pa pri 1,5 % bolnikov.
English: There were no signs of cumulative haematological or non- haematological toxicity.
Slovenian: Znakov kumulativne hematološke ali nehematološke toksičnosti niso ugotovili.
English: All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Slovenian: Vse pripomočke, ki jih potrebujete pri dajanju zdravila ali čiščenju, tudi rokavice, je treba odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
English: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Slovenian: Zmerna do huda oblika (Hb ≤ 8,0 g/dl) se je razvila pri 37 % bolnikov (v 14 % ciklusov zdravljenja).
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).
Slovenian: Pri dajanju v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dan) je bil 5. dan očistek topotekana v primerjavi s 1. dnem manjši (19,1 l/uro/m2 v primerjavi z 21,3 l/uro/m2 [n = 9]) (glejte poglavje 4.5).
English: What Topotecan Teva is and what it is used for What you need to know before you use Toptecan Teva How to use Topotecan Teva Possible side effects
Slovenian: Kaj je zdravilo Topotekan Teva in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Topotekan Teva Kako uporabljati zdravilo Topotekan Teva
English: Abnormally low white blood cell count (leucopenia, neutropenia) which may be accompanied with fever and signs of infections (febrile neutropenia).
Slovenian: - Nenormalno majhno število belih krvničk (levkopenija, nevtropenija), ki jo lahko spremlja zvišana telesna temperatura in znaki okužbe (febrilna nevtropenija).
English: Unusual bruising or bleeding, sometimes severe, caused by a decrease in the number of blood clotting cells (platelets).
Slovenian: - Neobičajne modrice ali krvavitve (včasih v hujši obliki), ki so posledica zmanjšanja števila trombocitov (krvnih ploščic).
English: Very common Anorexia (which may be severe)
Slovenian: Presnovne in prehranske motnje zelo pogosti anoreksija (ki je lahko huda)
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.
Slovenian: Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih z jetrno okvaro v primerjavi s kontrolno skupino zmanjšal le za približno 10 %.
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Slovenian: Pri bolnikih z zmerno okvaro ledvic se je plazemski očistek zmanjšal na 34 % vrednosti pri bolnikih v kontrolni skupini.
English: What you need to know before you use Topotecan Teva Do not use Topotecan Teva:
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Topotekan Teva Ne uporabljajte zdravila Topotekan Teva
English: Doses should be similarly reduced if the platelet count falls below 25 x 109/l.
Slovenian: Podobno je treba zmanjšati odmerke, če se število trombocitov zniža pod 25 x 109/l.
English: Other medicines and Topotecan Teva
Slovenian: Druga zdravila in zdravilo Topotekan Teva
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.
Slovenian: V študijah za določitev ustreznega odmerka, v katere je bilo vključenih 523 bolnic s ponovitvijo raka na jajčniku in 631 bolnikov s ponovitvijo drobnoceličnega pljučnega raka, so ugotovili, da pri zdravljenju s topotekanom kot samostojnim zdravilom, odmerek omejuje hematološka toksičnost.
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).
Slovenian: bolnikih s ponovitvijo drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve linije ni primerno (glejte poglavje 5.1).
English: There is no known antidote for topotecan overdose.
Slovenian: Antidota za preveliko odmerjanje s topotekanom ni znan.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Slovenian: 11 % vseh bolnikov (v 4 % ciklusov zdravljenja), ki so se zdravili v kliničnih študijah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se huda nevtropenija ni pojavila), je imelo zvišano telesno temperaturo, pri 26 % (v 9 % ciklusov zdravljenja) pa so se pojavile okužbe.
English: Red cell transfusions were given in 52 % of patients (21 % of courses).
Slovenian: 52 % bolnikov je prejelo transfuzijo eritrocitov (v 21 % ciklusov zdravljenja).
English: Hypersensitivity reactions including rash, urticaria, angioedema and anaphylactic reactions have been reported rarely.
Slovenian: O preobčutljivostnih reakcijah, vključno z izpuščajem, urtikarijo, angioedemom in anafilaktičnimi reakcijami so poročali redko.
English: Topotecan Teva is a clear pale yellow liquid in a colourless glass vial with bromobutyl rubber stopper, aluminium seal and snap-cap.
Slovenian: Topotekan Teva je bistra, bledo rumena tekočina v brezbarvni stekleni viali, z zamaškom iz bromobutilne gume, aluminijasto zaporko in natičnim pokrovom.
English: Subsequent doses
Slovenian: Naslednji odmerki
English: Topotecan Teva helps to kill tumour cells.
Slovenian: Zdravilo Topotekan Teva pomaga uničiti rakave celice.
English: If you experience this, do not drive or use machines.
Slovenian: Če se počutite utrujeno ali slabotno, ne vozite avtomobila in ne upravljajte s stroji.
English: In vitro data using human liver microsomes indicate the formation of small amounts of N-demethylated topotecan.
Slovenian: V raziskavi in vitro, v kateri so uporabili mikrosome človeških jeter, so opazili nastanek majhne količine N-demetiliranega topotekana.
English: The response rate in the whole ovarian carcinoma programme (n = 392, all previously treated with cisplatin or cisplatin and paclitaxel) was 16 %.
Slovenian: Stopnja odziva na zdravilo za celoten program študij raka na jajčnikih (n = 392, pri bolnicah, ki so se pred tem zdravile s cisplatinom ali cisplatinom in paklitakselom) je bila 16 %.
English: Weight loss and loss of appetite (anorexia), tiredness, weakness.
Slovenian: - Hujšanje in neješčnost (anoreksija), utrujenost; šibkost.
English: Sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema).
Slovenian: - Nenadno otekanje kože in sluznic (npr. grla ali jezika) zaradi kopičenja tekočine (angioedem).
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Slovenian: Razmerje ogroženosti za preživetje z intravenskim topotekanom relativno glede na kombinacijo CAV je bilo 1,04 (95-odstotni IZ: 0,78-1,40).
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: V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (pri katerih ni prišlo do odziva na zdravljenje prve linije) je bil odziv na topotekan 4,0-odstoten.
English: Severe neutropenia lasted beyond seven days in 11 % of courses overall.
Slovenian: Huda nevtropenija je pri 11 % vseh ciklusov zdravljenja trajala več kot 7 dni.
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 %.
Slovenian: Odstotek odziva na topotekan po združenih podatkih programa zdravljenja drobnoceličnega pljučnega raka (n = 480) pri bolnikih s ponovitvijo bolezni, ki je bila dovzetna za zdravljenje prve linije, je bil 20,2 %.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
English: Topotecan Teva can make you feel tired or weak.
Slovenian: Zdravilo Topotekan Teva lahko povzroči utrujenost ali slabotnost.
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Zdravilo je potrebno z mikrobiološkega stališča uporabiti takoj.
English: The experience in children is limited and treatment is therefore not recommended.
Slovenian: Izkušnje pri otrocih so omejene, zato se zdravljenje z zdravilom Topotekan Teva ne priporoča.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively).
Slovenian: Mediana časa do napredovanja je bila v obeh skupinah podobna, in sicer pri topotekanu 13,3 tedna, pri kombinaciji CAV pa 12,3 tedna.
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted, namely:
Slovenian: Upoštevati morate običajne postopke za ustrezno ravnanje s protitumorskimi zdravili in njihovo odstranjevanje, in sicer:
English: Severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness).
Slovenian: - Hude alergijske (anafilaktične) reakcije, ki povzročijo otekanje ustnic, obraza ali vratu, kar vodi v hude težave z dihanjem, izpuščaj ali koprivnica, anafilaktični šok (močan padec krvnega tlaka, bledica, nemir, pospešen srčni utrip, zožanje zavesti).
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.
Slovenian: - huda depresija kostnega mozga že pred začetkom prvega ciklusa, kar je razvidno iz izhodiščnega števila nevtrofilcev < 1,5 x 109/l in/ali števila trombocitov < 100 x 109/l
English: 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Slovenian: 2 O nevtropeničnem kolitisu, vključno z nevtropeničnim kolitisom s smrtnim izidom, so poročali kot o zapletu s topotekanom povzročene nevtropenije (glejte poglavje 4.4).
English: The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Slovenian: Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnikov s karcinomom jajčnika in drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/min, je 0,75 mg/m2/dan, pet zaporednih dni.
English: uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: Contents of the pack and other information What Topotecan Teva contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Topotekan Teva
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 ogroženosti med skupino s peroralnim topotekanom in NPO ter skupino s samo NPO je bilo 0,64 (95-odstotni IZ: 0,45, 0,90).
English: Approximately 51 % was excreted as total topotecan and 3% was excreted as N-desmethyl topotecan in the urine.
Slovenian: Z urinom se izloči približno 51 % celotnega topotekana in 3 % N-desmetil topotekana.
English: Personnel should be trained to dilute the medicinal product.
Slovenian: - Osebje mora biti ustrezno izurjeno za redčenje zdravila.
English: Topotecan Teva is available in cartons containing 1 vial and 5 vials.
Slovenian: Topotekan Teva je na voljo v škatlah z 1 vialo ali 5 vialami.
English: The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
Slovenian: - Druge sestavine zdravila so: vinska kislina (E334), klorovodikova kislina (E507), natrijev hidroksid (E524) in voda za injekcije.
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 1.5 mg/dl.
Slovenian: Kombinirano zdravljenje (karcinom materničnega vratu) Med kliničnimi študijami zdravljenja raka materničnega vratu je bilo zdravljenje s topotekanom v kombinaciji s cisplatinom uvedeno le pri bolnicah, ki so imele vrednost kreatinina v serumu manjšo ali enako 1,5 mg/dl.
English: For cervical cancer it will be used together with another anticancer medicine containing cisplatin.
Slovenian: Pri zdravljenju raka materničnega vratu se uporablja skupaj z drugim zdravilom, ki vsebuje cisplatin.
English: Pregnant staff should be excluded from working with this medicinal product.
Slovenian: Pri rokovanju z zdravilom ne smejo sodelovati nosečnice.
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Slovenian: Huda oblika (3. ali 4. stopnje) tako utrujenosti kot astenije se je pojavljala s pogostnostjo 3 %.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Slovenian: Vključene so bile naslednje vrste tumorjev: Ewingov sarkom/primitivni nevroektodermalni tumor, nevroblastom, osteoblastom in rabdomiosarkom.
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 pri bolnikih z jetrno okvaro (bilirubin v serumu med 1,5 in 10 mg/dl) se je v primerjavi s kontrolno skupino znižal na približno 67 %.
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.
Slovenian: V eni študiji so otroci (stari od 2 do 12 let, n = 18), mladostniki (stari od 12 do 16 let, n = 9) in mlajši odrasli (stari od 16 do 21 let, n = 9) z neodzivnim solidnim tumorjem prejemali odmerek od 1,4 do 2,4 mg/m2.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Slovenian: Pri bolnicah, ki so se predhodno zdravile s cisplatinom, mora preteči daljše obdobje brez zdravljenja, da bi bilo zdravljenje s kombinacijo smiselno (glejte poglavje 5.1).
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.
Slovenian: Madžarska V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca,
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 celokupnega preživetja je bila 62 tednov pri uporabi topotekana in 53 tednov pri zdravljenju s paklitakselom (razmerje ogroženosti 0,9 [0,6, 1,3]).
English: Ovarian and small cell lung carcinoma Initial dose
Slovenian: Drobnocelični pljučni karcinom in karcinom jajčnikov Začetni odmerek
English: Median time to onset of severe thrombocytopenia was day 15 and the median duration was five days.
Slovenian: Mediana časa do pojava hude trombocitopenije je bila 15. dan,
English: When treating cervical cancer, Topotecan Teva is combined with another medicine called cisplatin.
Slovenian: Pri zdravljenju raka materničnega vratu se zdravilo Topotekan Teva kombinira z zdravilom, imenovanim cisplatin.
English: Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).
Slovenian: - Vnetje in razjede v ustih, grlu, na jeziku ali dlesnih (vnetje ustne sluznice).
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.
Slovenian: Priporočeni odmerek topotekana je 1,5 mg/m2 telesne površine na dan z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklusih po pet zaporednih dni in s tritedenskimi presledki med začetki posameznih ciklusov zdravljenja.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients receiving topotecan.
Slovenian: Pri bolnikih, ki so prejemali topotekan, so v približno 25 % opazili utrujenost, v 16 % pa astenijo.
English: Your doctor will tell you whether this is the case, based on the results of your last blood test; →Tell your doctor if you think any of these could apply to you.
Slovenian: To vam bo povedal zdravnik na podlagi izvida vaše zadnje preiskave krvi.
English: Do not use Topotecan Teva if you notice any visible particles or if the solution is unclear.
Slovenian: Zdravila Tepotekan Teva ne smete uporabiti, če so v njem vidni delci ali če je raztopina motna.
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).
Slovenian: Uporaba topotekana naj vedno poteka pod nadzorom zdravnika z izkušnjami na področju kemoterapije (glejte poglavje 6.6).
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 šestinštirideset (43 %) bolnikov v 192 ciklusih (42,1 %) prejelo G-CSF, petinšestdeset (60 %) bolnikov je v 139 ciklusih (30,5 %) prejelo transfuzijo eritrocitov, petdeset (46 %) bolnikov pa v 159 ciklusih (34,9 %) transfuzijo trombocitov.
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Slovenian: Običajni odmerek je 0,75 mg na m2 telesne površine enkrat na dan tri dni.
English: Staff handling this medicinal product during dilution should wear protective clothing including mask, goggles and gloves.
Slovenian: Osebje, ki pripravlja zdravilo, mora med redčenjem nositi zaščitna oblačila, masko, zaščitna očala in rokavice.
English: The use of Topotecan Teva is not recommended in patients with severe liver impairment; if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 4 ‘Possible side effects'); if you suffer from unusual bruising or bleeding (also see section 4 ‘Possible side effects'); if you are feeling very ill.
Slovenian: - če imate trenutno težave s pljuči ali ste se v preteklosti zdravili z obsevanjem ali pa ste prejeli zdravila, ki lahko vplivajo na delovanje pljuč (glejte poglavje 4 »Neželeni učinki«); - če imate nenavadne modrice ali krvavitve (glejte poglavje 4 »Neželeni učinki«); - če se počutite precej bolni;
English: Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation.
Slovenian: - Siljenje na bruhanje (slabost), bruhanje, driska, bolečine v trebuhu, zaprtje.
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 dajanju topotekana v kombinaciji s cisplatinom so opazili dodatne neželene učinke, vendar pa so te neželene učinke opažali tudi pri samostojnem zdravljenju s cisplatinom in jih ni mogoče pripisati topotekanu.
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.
Slovenian: V drugi študiji so otroci (n = 8), mladostniki (n = 3) in mlajši odrasli (n = 3) z levkemijo prejemali odmerek od 2,0 do 5,2 mg/m2.
English: Combination therapy (cervical carcinoma)
Slovenian: Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom)
English: Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Slovenian: Ustrezen volumen koncentrata se redči z 9 mg/ml (0,9 %) injekcijsko raztopino natrijevega klorida ali 50 mg/ml (5 %) injekcijsko raztopino glukoze, da se doseže končno koncentracijo topotekana v raztopini za infundiranje med
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: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/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/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Slovenian: Pri odločitvi za zmanjšanje odmerka pri bolnicah s hudo nevtropenijo (število nevtrofilcev < 0,5 x 109/l), ki traja sedem ali več dni, ali s hudo nevtropenijo z zvišano telesno temperaturo ali okužbo ali pri bolnicah, ki jim je bilo treba zdravljenje odložiti zaradi nevtropenije, je trebaodmerek pri naslednjih ciklusih zmanjšati za 20 % na 0,60 mg/m2/dan (ali ga po potrebi kasneje še dodatno zmanjšati na 0,45 mg/m2/dan).
English: Overdoses have been reported in patients being treated with intravenous topotecan (up to 10 fold of the recommended dose) and topotecan capsules (up to 5 fold of the recommended dose).
Slovenian: 10-kratni priporočeni odmerek) in topotekan v kapsulah (do 5-kratni priporočeni odmerek).
English: The topotecan-O-glucuronide andN-desmethyl topotecan-O-glucuronide in the urine were less than 2.0%.
Slovenian: Topotekan-O-glukuronid in N-desmetil topotekan-O-glukuronid v urinu predstavljata manj kot