natgillin/translations-raw huggingface dataset:
Reconstitution and dilution prior to administration 
Priprava in razredčenje pred uporabo
Reconstitution and dilution of the medicinal product must be performed by trained personnel. 
Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Median (95 % C.I.) 
Mediana vrednost (95 %
1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml 
1 ml raztopine topotekana 1 mg/ml Dodajte 39 ml, da boste
Talk to your doctor before using Topotecan Actavis: - if you have any kidney problems. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Topotekan Actavis se posvetujte z zdravnikom: - če imate kakšne težave z ledvicami.
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). 
Uporaba zdravila naj vedno poteka pod nadzorom zdravnika z izkušnjami na področju kemoterapije (glejte poglavje 6.6).
In addition, elevated hepatic enzymes have been reported with intravenous topotecan overdose. 
Poleg tega so poročali o zvišanih vrednostih jetrnih encimov v primeru prevelikega odmerjanja z intravensko danim topotekanom.
The volume of reconstituted concentrate corresponding to the calculated individual dose, should be further diluted with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion, to a final concentration of between 25 and 50 microgram per ml in the solution for infusion, for example: 
Količino pripravljenega koncentrata, ki ustreza izračunanemu individualnemu odmerku, je treba dodatno razredčiti bodisi z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje ali raztopino 50 mg/ml (5%) glukoze za infundiranje, do končne koncentracije od 25 do 50 mikrogramov na ml raztopine za infundiranje, na primer:
Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3). 
Predklinične študije so pokazale, da topotekan povzroča smrt in malformacije zarodka oziroma ploda (glejte poglavje 5.3).
Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan. 
Steklene viale (8 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 4 mg topotekana.
You must not breast-feed while on treatment with Topotecan Actavis. 
Med zdravljenjem z zdravilom Topotekan Actavis ne smete dojiti.
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/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary). 
9/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo, ali jim je bilo zdravljenje odloženo zaradi nevtropenije, morate odmerek za naslednje cikluse zmanjšati za 20% na 0,60 mg/m2/dan (ali nato na 0,45 mg/m2/dan,
Precautions to be taken before handling or administering the medicinal product Reconstitution and dilution of the medicinal product must be performed by trained personnel. 
Previdnostni ukrepi pred ravnanjem z zdravilom in njegovo uporabo Zdravilo mora pripraviti in razredčiti usposobljeno osebje.
Topotecan is supplied as a powder for concentrate for solution for infusion. 
Topotekan je na voljo kot prašek za koncentrat za raztopino za infundiranje.
- Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Topotecan Actavis 4 mg with 4 ml water for injections 
Pred infundiranjem je treba Topotekan Actavis prašek za koncentrat za raztopino za infundiranje pripraviti z ustrezno količino vode za injekcije, in sicer takole: - Topotekan Actavis 1 mg z 1,1 ml vode za injekcije (ker vsebuje 10% prepolnjenja) - Topotekan Actavis 4 mg s 4 ml vode za injekcije
Common side effects (may affect up to 1 in 10 people) - Allergic (hypersensitivity) reactions (including rash). 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) - Alergijske (preobčutljivostne) reakcije (vključno z izpuščajem).
Each vial contains 2.07 mg (0.09 mmol) sodium. 
Pomožna snov z znanim učinkom: Ena viala vsebuje 2,07 mg (0,09 mmol) natrija.
Toxicities of topotecan in paediatric patients with recurrent and refractory solid tumours were similar to those historically seen in adult patients. 
Pri otrocih z rekurentnimi in neodzivnimi solidnimi tumorji je bila toksičnost topotekana podobna toksičnosti, ki je že bila opažena pri odraslih bolnikih.
hypersensitivity reaction including rash 
preobčutljivostna reakcija, vključno z izpuščajem
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). 
Ob hudi nevtropeniji so med prvim ciklom zdravljenja pri 16% bolnikov opazili zvišano telesno temperaturo ali različne okužbe, 23% bolnikov pa je imelo takšne neželene učinke ves čas (6% ciklov zdravljenja).
Topotecan Actavis is for intravenous infusion after reconstitution and dilution. 
Zdravilo Topotekan Actavis je za intravensko infundiranje po rekonstituciji in redčenju.
Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan. 
Steklene viale (5 ml) iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko vsebujejo 1 mg topotekana.
The usual dose is 0.75 mg per m of body surface area once daily for 3 days. 
Rak materničnega vratu Običajen odmerek je 0,75 mg na m telesne površine enkrat na dan 3 dni.
Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033). 
Pri vmesni analizi je imela kombinacija topotekana in cisplatina statistično pomembno korist na skupno preživetje v primerjavi z zdravljenjem s samim cisplatinom (log-rank p = 0,033).
Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %. 
Ocenjeno je, da se z blatom izloči 18% skupnega topotekana in 1,7% N-desmetil topotekana.
Contains mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide. 
Zdravilo vsebuje: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507) in natrijev hidroksid.
interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common: 
intersticijska bolezen pljuč (nekateri primeri s smrtnim
Each vial contains 1 mg or 4 mg topotecan (as hydrochloride). 
Ena viala vsebuje 1 mg ali 4 mg topotekana (v obliki klorida).
Severe (grade 3 or 4) fatigue and asthenia incidence was 3 and 3 % respectively. 
Pojavnost tako hude oblike utrujenosti kot astenije (3. ali 4. stopnje) je bila 3%.
Topotecan monotherapy is indicated for the treatment of 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). 
Pri bolnikih z relapsom drobnoceličnega pljučnega raka, pri katerih ponovno zdravljenje s terapijo prve izbire ni primerno (glejte poglavje 5.1).
Mannitol (E421) Tartaric acid (E334) Sodium hydroxide Hydrochloric acid (E507) 
6.1 Seznam pomožnih snovi manitol (E421) vinska kislina (E334) natrijev hidroksid klorovodikova kislina (E507)
The physico-chemical stability of the drug product solution obtained after dilution in solutions for infusion (NaCl 0.9 % and Glucose 5 %) has been demonstrated for 4 hours at room temperature, in normal lighting conditions, on samples reconstituted and stored for 12 hours and respectively 24 hours at 25 
Fizikalno-kemična stabilnost raztopine zdravila po redčenju v raztopinah za infundiranje (0,9 % NaCl in 5 % glukoza) je dokazana za 4 ure pri sobni temperaturi v normalnih svetlobnih pogojih, na vzorcih pripravljenih in shranjenih za 12 ur oz. 24 ur pri temperaturi 25 ± 2 °C in potem redčenih.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION 
C. DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN UPORABE
Topotecan Actavis is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”. 
- če imate vnetje pljuč z znaki, kot so kašelj, zvišana telesna temperatura in težave z dihanjem; glejte tudi poglavje 4, "Možni neželeni učinki".
CI = Confidence interval. 
n = celotno število zdravljenih bolnikov IZ = interval zaupanja
- Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty in breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.This condition can be fatal. 
Tveganje za pojav te hude bolezni (intersticijske bolezni pljuč) je večje, če imate trenutno kakšne težave s pljuči, če ste bili predhodno obsevani ali ste dobivali kakšna zdravila, ki prizadenejo pljuča; glejte tudi poglavje 2, "Opozorila in previdnostni ukrepi".
Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow. 
5 zaporednih dni pri času infuzije 30 minut visok, in sicer 62 l/h (SD 22), kar pomeni približno 2/3 pretoka krvi skozi jetra.
5.2 mg/m in children (n = 8), adolescents (n = 3), and young adults (n = 3) with leukaemia. 
V drugi študiji so otroci (n = 8), mladostniki (n = 3) in mlajši odrasli (n = 3) z levkemijo prejemali odmerek od 2,0 mg/m do 5,2 mg/m2.
Small Cell Lung Carcinoma 
Drobnocelični pljučni karcinom Začetni odmerek
OTHER SPECIAL WARNING(S), IF NECESSARY Cytotoxic, special handling instructions (see package leaflet). 
Citotoksično, posebna navodila za ravnanje (glejte navodilo za uporabo)
An O-glucuronidation metabolite of topotecan and N-desmethyl topotecan has been identified in the urine. 
V urinu so odkrili O-glukuronidacijski presnovek topotekana in N-desmetil topotekan.
9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary). 
≥ 100 x 10 9/l, vrednost hemoglobina pa ≥ 9 g/dl (po transfuziji, če je le-ta potrebna).
For more information about cisplatin, please refer to the corresponding package leaflet. 
Za več informacij o cisplatinu glejte navodilo za uporabo cisplatina.
Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion is required to a final concentration of between 25 and 50 microgram/ml. 
Ustrezno količino tako pripravljene raztopine morate še dodatno razredčiti z 9 mg/ml (0,9%) intravensko infuzijsko raztopino natrijevega klorida ali s 50 mg/ml ( 5%) infuzijsko raztopino glukoze, da nastane končni pripravek s koncentracijo med 25 in 50 mikrogramov/ml.
Severe (grade 3 or 4) nausea, vomiting, diarrhoea and mucositis incidence was 4, 3, 2 and 1 % respectively. 
Hude oblike (3. ali 4. stopnje) navzea (4%), bruhanje (3%), driska (2%) in mukozitis (1%).
Mild abdominal pain was also reported amongst 4 % of patients. 
4% bolnikov je imelo blage bolečine v trebuhu.
After reconstitution 1 ml concentrate contains 1 mg topotecan. 
Po pripravi 1 ml koncentrata vsebuje 1 mg topotekana.
If you get any side effects, talk to your doctor or nurse. 
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali farmacevtom.
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 0.25 mg/m 2/day to 1.25 mg/m 2/day (or subsequently down to 1.0 mg/m 2/day if necessary). 
9/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo, ali jim je bilo zdravljenje odloženo zaradi nevtropenije, morate odmerek zmanjšati po 0,25 mg/m2/dan, če je treba).
The integrated safety data for topotecan monotherapy are presented below. 
V nadaljevanju navajamo povzetek podatkov o varnosti topotekana kot samostojnega zdravila.
9/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary). 
9/l, število trombocitov večje ali enako 100 x 10 9/l in vrednost hemoglobina večja ali enaka 9 g/dl (po transfuziji,če je le-ta potrebna).
Cisplatin 50 mg/m d.1 + Topotecan 0,75 mg/ m dx3 
Topotekan 0,75 mg/m2/dan x 3 na 21 dni
- The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide. 
− Pomožne snovi so: manitol (E421), vinska kislina (E334), klorovodikova kislina (E507)
Reconstitution will result in a concentrate containing 1 mg topotecan per ml. 
S pripravo nastane koncentrat, ki vsebuje 1 mg topotekana na ml.
5 x 4 mg vial 
5 x 4 mg viala
Chemical and physical stability of the solution obtained after dilution of the concentrate in sodium chloride 9 mg/ml (0.9 %) solution for injection or 50 mg/ml (5 %) glucose solution for infusion has been demonstrated for 4 hours at 25 ± 2°C, in normal lighting conditions. 
Kemična in fizikalna stabilnost raztopine po razredčenju koncentrata z natrijevim kloridom 9 mg/ml (0,9%) raztopino za infundiranje je dokazana za 4 ure pri temperaturi 25 ± 2°C v normalnih svetlobnih razmerah.
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 10 
Če izberete zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev manj kot 0,5 x 10
5 x 1 mg vial 
5 x 1 mg viala
OTHER CONDITIONS AND REQUIREMENTS OF THE 
DRUGI POGOJI IN ZAHTEVE GLEDE OSKRBE IN
9/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). 
≥ 9 g/dl (po transfuziji, če je potrebna).
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN
Based on the dose-limiting toxicity of myelosuppression, the maximum tolerated dose (MTD) was established at 2.0 mg/m2/day 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). 
Pri otrocih z neodzivnimi solidnimi tumorji je bil v farmakokinetični študiji na osnovi od odmerka pogojene toksičnosti za mielosupresijo določen največji tolerantni odmerek 2,0 mg/m2/dan pri uporabi G-CSF i
However, caution should be observed when driving or operating machines if fatigue and asthenia persist. 
Če utrujenost in astenija ne mineta, je pri vožnji ali upravljanju s stroji potrebna previdnost.
Topotecan Actavis can make you feel tired or weak. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Topotekan Actavis lahko povzroči utrujenost in šibkost.
Topotecan Actavis 1 mg powder for concentrate for solution for infusion Topotecan Actavis 4 mg powder for concentrate for solution for infusion topotecan 
Topotekan Actavis 1 mg prašek za koncentrat za raztopino za infundiranje Topotekan Actavis 4 mg prašek za koncentrat za raztopino za infundiranje topotekan
Adequate care and precautions should be taken in the disposal of items (syringes, needles etc) used to reconstitute and/or dilute cytotoxic medicinal products. 
Pri odstranjevanju predmetov (brizg, igel itn.), uporabljenih za pripravo in/ali razredčenje citotoksičnih zdravil, sta potrebna ustrezna skrb in upoštevanje previdnostnih ukrepov.
No in vivo human pharmacokinetic interaction studies have been performed. 
Farmakokinetične študije medsebojnega delovanja zdravila z drugimi zdravili in vivo pri ljudeh niso bile izvedene.
- If you get any side effects, talk to your doctor or nurse. 
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
After reconstitution, 1 ml concentrate contains 1 mg topotecan. 
Po pripravi vsebuje 1 ml koncentrata 1 mg topotekana.
Oral topotecan plus BSC group had a statistically significant improvement in overall survival compared with the BSC alone group (Log-rank p = 0.0104). 
Celotno preživetje v skupini, ki je dobivala peroralni topotekan in NPO, je bilo statistično značilno boljše kot v skupni, ki je bila deležna le NPO (vrednost p za lograng = 0,0104).
A phase III trial (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 + BSC, 90 days for BSC) and for whom retreatment with intravenous chemotherapy was not considered appropriate. 
Raziskava je bila opravljena pri bolnikih, pri katerih je po zdravljenju s terapijo prve izbire prišlo do relapsa (srednji čas do progresije, ki je minil od zdravljenja s terapijo prve izbire: 84 dni za zdravljenje s peroralnim topotekanom v kombinaciji z NPO; 90 dni za zdravljenje z NPO samo) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
Dosage in renally impaired patients 
Odmerjanje pri bolnikih z ledvično okvaro
Patients with prior cisplatin chemoradiotherapy Cisplatin 
Bolniki s predhodno cisplatinsko kemoradioterapijo topotecan/cisplatin (n = 69)
Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8). 
Pri bolnikih, ki so se zdravili s topotekanom, so poročali o mielosupresiji, ki je povzročila sepso in smrti zaradi sepse (glejte poglavje 4.8).
One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1). 
Za oceno učinkovitosti peroralnega topotekana v primerjavi z intravenskim topotekanom pri bolnikih, ki se jim je pojavil recidiv ≥ 90 dni po dokončanju ene predhodne sheme kemoterapije, je bila opravljena ena študija 2. faze (študija 065) in ena študija 3. faze (študija 396) (glejte preglednico 1).
The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan. 
Koncentrat je bledo rumen in ima koncentracijo 1 mg topotekana na ml.
oC ± 2 
1. dan +
How to use Topotecan Actavis 
Kako se uporablja zdravilo Topotekan Actavis
If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 10 
Če izberete zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev < 0,5 x 10
severe bleeding (associated with thrombocytopenia) Immune system disorders 
Ni znano hude krvavitve (povezane s trombocitopenijo)
Topotecan is not recommended to be used in these patient groups. 
Pri teh skupinah bolnikov zdravljenje s topotekanom ni priporočljivo.
Ελλάδα Specifar ABEE 
Potem je potreben pregled pri
Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan. 
Med kliničnimi preskušanji s topotekanom so poročali o smrtnih izidih zaradi nevtropeničnega kolitisa.
anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare: 
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
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. 
13 bolnicam z rakom jajčnika so 5. dan opazili rahlo povečanje vrednosti AUC (12%, n=9) in Cmax (23%, n=11).
Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose. 
30 minutne intravenske infuzije enkrat na dan. 1. dan po prejemu odmerka topotekana bolnica prejme še intravensko infuzijo cisplatina v odmerku 50 mg/m2/dan.
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. 
Mediana vrednost (95 % interval zaupanja) Razmerje tveganja (95 % interval zaupanja)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 July 2009 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z
Median survivals for the two groups were 25.0 and 24.7 weeks respectively. 
Srednji čas preživetja bolnikov v skupini, ki je prejemala topotekan je bil 25,0 tednov, v skupini, ki je prejemala kombinacijo CAV pa 24,7 tedna.
Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies. 
Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih v obeh študijah sta peroralni in intravenski topotekan pri bolnikih z recidivom občutljivega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
Median (95 % C.I) Hazard ratio (95 % C.I.) 
Razmerje tveganja (95 % interval zaupanja) Log rank p-vrednost
Insufficient data are available to make a recommendation for patients with a creatinine clearance <20 ml/min. 
Samostojno zdravljenje (drobnocelični pljučni karcinom) Za zdravljenje bolnikov z očistkom kreatinina < 20 ml/min ne moremo priporočiti ustreznih odmerkov, saj imamo premalo izkušenj.
Initial dose The recommended dose of topotecan is 0.75 mg/m2/day administered as 30 minute intravenous infusion daily on days 1, 2 and 3. 
Začetni odmerek Priporočeni odmerek topotekana je 0,75 mg/m2/dan.
How to store Topotecan Actavis 
Dajanje zdravila Topotekan Actavis
The mean metabolite:parent AUC ratio was less than 10 % for both total topotecan and topotecan lactone. 
Tako za skupni topotekan kot topotekan lakton je srednje razmerje AUC-jev presnovek: izvorna učinkovina manjše od 10 %.
In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % C.I. 
Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoradioterapiji s cisplatinom je bila mediana vrednost preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95% interval zaupanja: 2,6; 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95% intervala zaupanja: 2,9; 9,6), razmerje tveganja 1,15 (0,59; 2,23).
The prescribing information for cisplatin should be consulted for a full list of adverse events associated cisplatin use. 
Za celoten seznam neželenih učinkov, povezanih s cisplatinom, glejte podatke za predpisovanje cisplatina.
ITT population Cisplatin 50 mg/m d.1 q21 d. 
Vključene bolnice (ITT populacija) cisplatin 50 mg/m
Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 10 
Nadaljevalni odmerki Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1 x 10
malaise 
Dojenje
9/l and/or a platelet count of < 100 x 10 
9/l in/ali števila
In another randomised phase III trial which compared 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. 
Pri bolnikih z relapsom dovzetnega drobnoceličnega pljučnega raka je bil celoten odstotek odziva na topotekan 24,3%, na kombinacijo CAV pa 18,3%.
The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate. 
V glavnem se presnavlja s hidrolizo laktonskega obroča do karboksilata z odprtim obročem.
Guidelines for the safe handling and disposal of antineoplastic agents Reconstitution and dilution of the medicinal product must be performed by trained personnel. 
Smernice za varno ravnanje in odlaganje antineoplastičnih zdravil