FrancophonIA/ELRC3.0 huggingface dataset:
English: • ovarian cancer or small cell lung cancer that has come back after chemotherapy.
Slovenian: • raka na jajčniku ali drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji.
English: • Allergic or hypersensitivity reactions (including rash).
Slovenian: • alergijske ali preobčutljivostne reakcije (vključno s pojavom izpuščaja);
English: Intravenous topotecan should be considered in the following clinical situations: uncontrolled emesis, swallowing disorders, uncontrolled diarrhoea, clinical conditions and medication that may alter gastrointestinal motility and drug absorption.
Slovenian: Uporaba intravenskega topotekana pride v poštev v naslednjih kliničnih okoliščinah: pri neobvladanem bruhanju, motnjah požiranja, neobvladani driski ter v kliničnih stanjih ali med uporabo zdravil, ki lahko vplivajo na gibljivost prebavil in absorpcijo zdravil.
English: Personnel handling this medicinal product during reconstitution should wear protective clothing including mask, goggles and gloves.
Slovenian: - Osebje, ki pripravlja zdravilo, mora med rekonstitucijo nositi zaščitna oblačila, masko, zaščitna očala in rokavice.
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: If you get the capsule contents in your eyes, wash them immediately with gently flowing water for at least 15 minutes.
Slovenian: Če zdravilo pride v oči, morate oči takoj vsaj 15 minut izpirati z vodo, ki ne teče premočno.
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: 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.
Slovenian: Tako kot druga citotoksična zdravila lahko tudi topotekan škoduje plodu, zato je ženske v rodni dobi potrebno opozoriti, da med zdravljenjem s topotekanom ne smejo zanositi.
English: Therefore, use of the normal starting dose in patients with a mild decrease in renal function is considered established (see section 4.2).
Slovenian: Zato velja, da je uporaba normalnega začetnega odmerka pri bolnikih z blago ledvično okvaro ustrezno utemeljena (glejte poglavje 4.2).
English: If, during topotecan/cisplatin combination therapy, serum creatinine exceeds 1.5 mg/dl, it is recommended that the full prescribing information be consulted for any advice on cisplatin dose reduction/continuation.
Slovenian: Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnegakoli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
English: The dose of Hycamtin you are given will be worked out by your doctor, based on:
Slovenian: Odmerek zdravila Hycamtin, ki ga boste prejeli, bo zdravnik določil glede na:
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 platinovimi spojinami pride do izrazite interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega, ali bolnik prejme zdravilo s platino na 1. ali 5. dan dajanja topotekana.
English: Moderate to severe anaemia (Grade 3 and 4 - Hb 8.0 g/dl) occurred in 25% of patients (12% of courses).
Slovenian: Zmerna do huda anemija (3. in 4. stopnje - Hb 8,0 g/dl) se je pojavila pri 25 % bolnikov (v 12 % ciklusov).
English: If well tolerated, the dose may be increased to 2.3 mg/m 2/day in subsequent cycles (see section 5.2).
Slovenian: Če zdravilo bolnik dobro prenaša, je mogoče v naslednjih ciklusih odmerek povečati na 2,3 mg/m telesne površine na dan (glejte poglavje 5.2).
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: Complete alopecia related/possibly related to topotecan administration was observed in 9% of patients and partial alopecia related/possibly related to topotecan administration in 11% of patients.
Slovenian: Popolno alopecijo, povezano ali morda povezano z uporabo topotekana, so zabeležili pri 9 % bolnikov, delno alopecijo, povezano ali morda povezano z uporabo topotekana, pa pri 11 %.
English: Topotecan monotherapy is indicated for the treatment of:
Slovenian: Samostojno zdravljenje s topotekanom je indicirano pri:
English: • Weight loss and loss of appetite (anorexia); tiredness; weakness.
Slovenian: • hujšanje in neješčnost (anoreksija), utrujenost, šibkost;
English: Hycamtin is used to treat:
Slovenian: Zdravilo Hycamtin uporabljamo za zdravljenje:
English: • Pregnant staff should be excluded from working with this medicinal product.
Slovenian: • Nosečnice ne smejo rokovati z zdravilom.
English: Infections and infestations Very common Infection Common
Slovenian: Infekcijske in parazitske bolezni zelo pogosti okužba pogosti sepsa
English: Other severe events that were recorded as related or possibly related to topotecan treatment were anorexia (12%), malaise (3%) and hyperbilirubinaemia (1%).
Slovenian: Drugi močno izraženi neželeni dogodki, ki so jih ocenili kot posledico ali možno posledico zdravljenja s topotekanom, so bili anoreksija (12 %), splošno slabo počutje (3 %) in hiperbilirubinemija (1 %).
English: In vitro, topotecan did not inhibit human P450 enzymes CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A or CYP4A, nor did it inhibit the human cytosolic enzymes dihydropyrimidine or xanthine oxidase.
Slovenian: Topotekan in vitro pri človeku ni zaviral delovanja encimov P450 (CYP1A2, CYP2A6, CYP2C8/9, CYP2C19, CYP2D6, CYP2E, CYP3A ali CYP4A).
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76% of the administered IV dose.
Slovenian: Celokupno izločanje s topotekanom povezanih snovi po petih dnevnih odmerkih topotekana je bilo od 71 do 76 % intravensko prejetega odmerka.
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: 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: • 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: Hycamtin is used to treat small cell lung cancer that has come back after chemotherapy.
Slovenian: Zdravilo Hycamtin uporabljamo za zdravljenje drobnoceličnega pljučnega raka, ki se je ponovil po kemoterapiji.
English: Pancytopenia has been reported.
Slovenian: Poročali so o pancitopeniji.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Slovenian: Predklinične študije kažejo, da se topotekan le malo veže na beljakovine v plazmi (35 %), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
English: Severe neutropenia lasted beyond seven days in 11% of courses overall.
Slovenian: Huda nevtropenija je pri 11 % vseh ciklusov zdravljenja trajala več kot sedem dni.
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: When combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Slovenian: Pri sočasni uporabi topotekana z drugimi kemoterapevtiki je morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
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: Any unused product or waste material should be disposed of in accordance with local requirements for cytotoxic material.
Slovenian: Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi za citotoksične snovi.
English: In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose.
Slovenian: Poleg tega so poročali o povišanih vrednostih jetrnih encimov v primeru prevelikega odmerjanja z intravenskim topotekanom.
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Slovenian: Topotekan zavira topoizomerazo I tako, da stabilizira kovalentni kompleks tega encima in enojne verige DNA, ki je vmesni produkt katalitičnega mehanizma.
English: Dosing recommendations for patients receiving oral topotecan with creatinine clearance less than 30 ml/min have not been established.
Slovenian: Priporočila za odmerjanje peroralnega topotekana pri bolnikih z očistkom kreatinina pod 30 ml/min niso določena.
English: In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Slovenian: V raziskavi in vitro, v kateri so uporabili mikrosome človeških jeter, so opazili nastanek majhne količine N-demetiliranega topotekana.
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/m given as a
Slovenian: V odprti študiji pri otrocih (n = 108, razpon starosti: od dojenčka do 16 let) z rekurentnim ali progresivnim solidnim tumorjem so otroci topotekan prejemali v začetnem odmerku 2,0 mg/m v obliki 30-minutne infuzije 5 dni.
English: Inhibitors of ABCB1 and ABCG2 administered with oral topotecan have been shown to increase topotecan exposure.
Slovenian: Sočasna uporaba zaviralcev ABCB1 in ABCG2 ter peroralnega topotekana poveča izpostavljenost topotekanu.
English: However, as with other cytotoxic medicinal products, topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Slovenian: Ker pa je topotekan - tako kot druga citotoksična zdravilagenotoksičen, ni mogoče izključiti učinkov na plodnost, vključno z učinki na plodnost samcev.
English: • Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood.
Slovenian: • neobičajne modrice ali krvavitve, ki so posledica zmanjšanega števila trombocitov, ki zagotavljajo strjevanje krvi.
English: There is no known antidote for topotecan overdose.
Slovenian: Antidot za preveliko odmerjanje s topotekanom ni znan.
English: For severe cases (CTC Grade 3/4) reported as related/possibly related to topotecan administration the incidence was diarrhoea 5% (see section 4.4), fatigue 4%, vomiting 3%, nausea 3% and anorexia 2%.
Slovenian: Incidenca hudih primerov (3. in 4. stopnja po CTC), ki so bili opisani kot povezani ali morda povezani z uporabo topotekana, je bila: driska 5 % (glejte poglavje 4.4), utrujenost 4 %, bruhanje 3 %, navzea 3 % in anoreksija 2 %.
English: Growth factors were administered to 19% of patients in 8% of courses.
Slovenian: Rastne dejavnike so uporabili pri 19 % bolnikov v 8 % ciklusov.
English: Communication with patients prior to drug administration regarding these side effects and proactive management of early and all signs and symptoms of diarrhoea is important.
Slovenian: Pomembno je takojšnje ukrepanje v primeru zgodnjih in vseh znakov in simptomov driske.
English: • Accidental contact with the skin or eyes should be treated immediately with copious amounts of water.
Slovenian: • Ob naključnem stiku zdravila s kožo ali z očmi jih morate takoj sprati z veliko količino vode.
English: Signs include: fever serious deterioration of your general condition local symptoms such as sore throat or urinary problems (for example, a burning sensation when urinating, which may be a urinary infection).
Slovenian: Med znaki so: zvišana telesna temperatura, resno poslabšanje splošnega zdravstvenega stanja, lokalni simptomi, npr. vnetje žrela ali težave s sečili (npr. pekoč občutek pri uriniranju, ki je lahko znak okužbe sečil).
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Slovenian: Topotekan se sme uporabljati le v ustanovah, ki so specializirane za uporabo citotoksičnih kemoterapevtikov.
English: 9/l) in 25% of patients (8% of courses); moderate (platelets between 25.0 and
Slovenian: 9/l) se je razvila pri 25 % bolnikov (v 8 % ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in 50,0 x 10
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Slovenian: Bolnice brez predhodne kemoterapije s cisplatinom cisplatin topotekan/cisplatin
English: Hycamtin 0.25 mg and 1 mg capsules are available in packs containing 10 capsules.
Slovenian: 0,25-miligramske in 1-miligramske kapsule zdravila Hycamtin so na voljo v pakiranjih, ki vsebujejo po 10 kapsul.
English: • High body temperature (fever).
Slovenian: • zvišana telesna temperatura;
English: Therapeutic interventions associated with non-haematological effects included anti-emetic agents, given to 47% of patients in 38% of courses and anti-diarrhoeal agents, given to 15% of patients in 6% of courses.
Slovenian: Med terapevtskimi ukrepi zaradi nehematoloških učinkov je bila uporaba antiemetikov (dobilo jih je 47 % bolnikov v 38 % ciklusov) in antidiaroikov (dobilo jih je 15 % bolnikov v 6 % ciklusov).
English: Skin and subcutaneous tissue disorders Very common Alopecia Common
Slovenian: Bolezni kože in podkožja zelo pogosti alopecija pogosti srbenje
English: This can lead to severe bleeding from relatively small injuries such as a small cut.
Slovenian: Že pri relativno blagi poškodbi, npr. manjši vreznini, se lahko pojavi obilna krvavitev.
English: In 18% of courses with severe thrombocytopenia the duration was >7 days.
Slovenian: V 18 % ciklusov s hudo trombocitopenijo je ta trajala >7 dni.
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 s slabšo telesno zmogljivostjo (glejte poglavje 4.4).
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: WARNING: Cytotoxic agents, special handling instructions (see Package Leaflet).
Slovenian: OPOZORILO: Citotoksično zdravilo, posebna navodila za ravnanje (glejte Navodilo za uporabo).
English: Median survival (weeks) (95% CI) Hazard ratio (95% CI) Response rate (%) (95% CI) Difference in response rate (95% CI) Median time to progression (weeks) (95% CI) Hazard ratio (95% CI) N = total number of patients treated CI = confidence interval
Slovenian: Mediano preživetje (tedni) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) Delež odziva (%) (95-odstotni IZ) Razlika v deležu odziva (95-odstotni IZ) Mediani čas do napredovanja (tedni) (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
English: In 34% of courses with severe neutropenia, the duration was >7 days.
Slovenian: V 34 % ciklusov s hudo nevtropenijo je ta trajala >7 dni.
English: The pharmacokinetics of oral topotecan have not been studied in patients with hepatic impairment (see section 4.2 and 4.4).
Slovenian: Farmakokinetika peroralnega topotekana ni raziskana pri bolnikih z okvaro jeter (glejte poglavji 4.2 in 4.4).
English: • Ovarian and small cell lung cancer: 1.5 mg per square metre of body surface area per day.
Slovenian: • rak jajčnika in drobnocelični pljučni rak: 1,5 mg na kvadratni meter telesne površine na dan.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Slovenian: Neslepljeno ocenjene navedbe bolnikov samih o simptomih so pokazale dosleden trend k boljšemu simptomatskemu stanju v skupini, zdravljeni s peroralnim topotekanom in NPO.
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: Diarrhoea related to oral topotecan can occur at the same time as drug-related neutropenia and its sequelae.
Slovenian: Driska zaradi peroralnega topotekana se lahko pojavi hkrati z nevtropenijo, povezano s tem zdravilom, in njenimi posledicami.
English: • Swelling caused by fluid build-up (angioedema).
Slovenian: • otekanje zaradi kopičenja tekočine (angioedem);
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: The mean metabolite: parent plasma AUC ratio was less than 10% for both total topotecan and topotecan lactone.
Slovenian: Povprečno razmerje med AUC presnovka in matične snovi v plazmi je bilo manjše od 10 % tako za celotni topotekan kot za topotekanov lakton.
English: Median (95% CI) Hazard ratio (95% CI) Log rank p-value
Slovenian: Mediana vrednost (95-odstotni IZ) Razmerje tveganja (95-odstotni IZ) Log rank p-vrednost
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: The capsule(s) must be swallowed whole, and must not be chewed, crushed or divided.
Slovenian: Kapsule morate pogoltniti cele in jih ne smete žvečiti, drobiti ali deliti.
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 bolnikom redno pregledovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4.2).
English: Moderate thrombocytopenia (Grade 3 - platelets between 10.0 and 50.0 x 10
Slovenian: Zmerna trombocitopenija (3. stopnje - število trombocitov med 10,0 in 50,0 x 10
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Slovenian: Topotekan je med dojenjem kontraindiciran (glejte poglavje 4.3).
English: Infection, sepsis and febrile neutropenia occurred in 17%, 2%, and 4% of patients, respectively.
Slovenian: Okužbe so se pojavile pri 17 % bolnikov, sepsa pri 2 % in febrilna nevtropenija pri 4 %.
English: Cancer treatment-induced diarrhoea (CTID) is associated with significant morbidity and may be life-threatening.
Slovenian: Drisko zaradi zdravil proti raku spremlja velika obolevnost in je lahko smrtno nevarna.
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: Side effects with frequency not known
Slovenian: Neželeni učinki z neznano pogostnostjo
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.
Slovenian: Topotekan je v kombinaciji s cisplatinom indiciran pri bolnicah s ponovitvijo karcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
English: Hard capsule.
Slovenian: trda kapsula
English: 9/l) in 25% of patients (15% of courses).
Slovenian: 9/l) pa pri 25 % bolnikov (v 15 % ciklusov zdravljenja).
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 navodila za predpisovanje cisplatina.
English: Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of 1.5 x 10
Slovenian: Pred prvim ciklusom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev 1,5 x 10
English: Anaemia
Slovenian: Anemija
English: Those effects are described in the cisplatin patient leaflet.
Slovenian: Ti neželeni učinki so navedeni v navodilu za uporabo cisplatina.
English: Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia.
Slovenian: Uporaba samega topotekana in topotekana v kombinaciji s cisplatinom je pogosto povezana s pojavljanjem klinično pomembne trombocitopenije.
English: VIAL
Slovenian: VIALA
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Slovenian: Bolnice s predhodno kemoterapijo s cisplatinom cisplatin topotekan/cisplatin
English: Peel back the outer layer: starting at the coloured corner, lift and peel over the pocket.
Slovenian: Odlepite zadnjo plast: začnite na obarvanem vogalu ter jo dvignite in odlepite s celotnega žepa.
English: No in vivo human pharmacokinetic interaction studies have been performed.
Slovenian: Farmakokinetičnih študij medsebojnega delovanja in vivo pri ljudeh niso izvedli.
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52%), vomiting (32%), diarrhoea (18%), constipation (9%) and mucositis (14%).
Slovenian: Pogostejši nehematološki učinki so bile gastrointestinalne težave, kot so navzea (52 %), bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
English: The pharmacokinetics of topotecan after oral administration have been evaluated in cancer patients following doses of 1.2 to 3.1 mg/m2/day and 4 mg/m2/day administered daily for 5 days.
Slovenian: Farmakokinetiko peroralnega topotekana so ocenili pri bolnikih z rakom po odmerkih od 1,2 do 3,1 mg/m2/dan in 4 mg/m2/dan, uporabljenih vsak dan pet dni.
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 linije in tudi naslednje terapije niso uspele,
English: If reconstitution is performed under strict aseptic conditions Hycamtin infusion may be completed within 12 hours at room temperature (or 24 hours if stored at 2-8oC).
Slovenian: Če je priprava potekala v strogo aseptičnih pogojih, lahko infundiranje zdravila Hycamtin končate v 12 urah, če raztopino hranite pri sobni temperaturi (ali v 24 urah, če jo hranite pri temperaturi od 2 do 8 °C).