natgillin/translations-raw huggingface dataset:
In the unlikely event of an overdose, your doctor will monitor you for side effects. 
V primeru prevelikega odmerka bo vaš zdravnik nadzoroval morebitne neželene učinke.
Frequently reported non-haematological effects were gastrointestinal such as nausea (52 %), vomiting (32 %), and diarrhoea (18 %), constipation (9 %) and mucositis (14 %). 
Pogostejši nehematološki učinki so bile gastrointestinalne težave, kot so navzea (52%), bruhanje (32%), driska (18%), zaprtje (9%) in mukozitis (14%).
Very common side effects (may affect more than 1 in 10 people) - Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia). 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Občutek splošne šibkosti in utrujenosti, kar sta lahko simptoma zmanjšanega števila rdečih krvnih celic (anemije).
Pregnant staff should not handle the cytotoxic preparation. 
Noseče članice osebja ne smejo delati s citotoksičnimi pripravki.
Median time to onset of severe thrombocytopenia was Day 15 and the median duration was five days. 
Mediana časa do pojava hude trombocitopenije je bila 15. dan, mediana trajanja trombocitopenije pa pet dni.
- Severe allergic (anaphylactic) reactions (rare; may affect up to 1 in 1,000 people), with signs such as: - swelling of the face, lips, tongue or throat, difficulty breathing, low blood pressure, dizziness and itchy rash. 
- Hude alergijske (anafilaktične) reakcije (redko; pojavijo se lahko pri največ 1 od 1.000 bolnikov) z znaki, kot so npr.: otekanje obraza, ustnic, jezika ali žrela, oteženo dihanje, nizek krvni tlak, omotičnost ali srbeč izpuščaj.
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. 
Če med zdravljenjem s kombinacijo topotekan/cisplatin vrednost serumskega kreatinina preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnegakoli zmanjšanja odmerka cisplatina ali nadaljevanju zdravljenja.
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. 
Plazemski očistek celotnega topotekana (aktivne in neaktivne oblike) se je pri teh bolnikih v primerjavi s kontrolno skupino zmanjšal le za približno 10%.
In a randomised, comparative phase III trial conducted by the Gynaecological Oncology Group (GOG 0179), topotecan plus cisplatin (n = 147) was compared with cisplatin alone (n = 146) for the treatment of histologically confirmed persistent, recurrent or Stage IVB carcinoma of the cervix where curative treatment with surgery and/or radiation was not considered appropriate. 
Randomizirano primerjalno preskušanje III. faze, ki ga je izvedla ginekološka onkološka skupina (GOG 0179), je primerjalo topotekan in cisplatin (n = 147) s cisplatinom samim (n = 146) pri zdravljenju histološko potrjenega persistentnega rekurentnega karcinoma materničnega vratu ali karcinoma materničnega vratu v stadiju IVB, kjer kurativno zdravljenje s kirurškim posegom in/ali radiacijo ni bilo primerno.
extravasation 
ekstravazacija
Comparison of pharmacokinetic parameters did not suggest any change in pharmacokinetics over the 5 days of dosing. 
Med primerjavo farmakokinetičnih parametrov nismo ugotavljali razlik med farmakokinetičnimi podatki v 5 dneh uporabe topotekana.
Rarely, it can lead to more severe bleeding (haemorrhage). 
Redko lahko to povzroči hujše krvavitve.
Other side effects with Topotecan Actavis include: 
Med drugimi neželenimi učinki zdravila Topotekan Actavis so:
In an intravenous population study, the coadministration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form). 
V populacijski študiji po intravenski aplikaciji niso zasledili, da bi sočasno dajanje granisetrona, ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celokupnega topotekana (aktivne in neaktivne oblike).
Topotecan is contraindicated during breast-feeding (see section 4.3). 
Topotekan je kontraindiciran med obdobjem dojenja (glejte poglavje 4.3).
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. 
V tej študiji je šestinštirideset (43%) bolnikov po 192 (42,1%) ciklih prejelo G-CSF, petinšestdeset (60%) bolnikov je po 139 (30,5%) ciklih prejelo transfuzijo eritrocitov, petdeset (46 ) bolnikov pa po 159 (34,9 ) ciklih transfuzijo trombocitov.
Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks respectively). 
Srednji čas do progresije je bil v obeh skupinah podoben, in sicer pri topotekanu 13,3 tedna, pri kombinaciji CAV pa 12,3 tedna.
In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients. 
Pri bolnikih z zmerno hudo ledvično okvaro se je plazemski očistek zmanjšal na 34 % vrednosti pri bolnikih v kontrolni skupini.
- Inflammation of the lining of the mouth and digestive tract. 
- Vnetje sluznice v ustih in prebavilih.
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis. 
Z uporabo topotekana za zdravljenje bolnikov s hudimi motnjami delovanja ledvic (očistek kreatinina < 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (serumski bilirubin ≥ 10 mg/dl), nimamo dovolj izkušenj.
- Weight loss and loss of appetite (anorexia); tiredness; weakness. 
- Hujšanje in izguba teka (neješčnost), utrujenost, šibkost.
nausea, vomiting and diarrhoea (all of which may be severe) 
navzea, bruhanje in driska (vsi so lahko hudi), zaprtje
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). 
Poročali so o prevelikem odmerjanju pri bolnikih, ki so bili zdravljeni z intravenskim topotekanom (do 10-kratni priporočeni odmerek) in topotekanom v kapsulah (do 5-kratni priporočeni odmerek).
Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo. 
Topotekan je zaradi svojega mehanizma delovanja genotoksičen za celice sesalcev (celice limfoma pri miših in človeške limfocite) in vitro, in celice kostnega mozga pri miših in vivo.
The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted. 
Koncentrati, ki so bili testirani, so bili shranjenih pri temperaturi 25 ± 2°C za 12 ur in 24 ur in potem razredčeni.
Effective contraception methods should be used to avoid becoming pregnant/fathering a child while on treatment. 
Uporabljati morate učinkovito kontracepcijo zaščito, da v času zdravljenja ne zanosite oz. zaplodite otroka.
Topotecan Actavis contains the active substance topotecan which helps to kill tumour cells. 
Zdravilo Topotekan Actavis vsebuje zdravilno učinkovino topotekan, ki pomaga uničiti tumorske celice.
febrile neutropenia neutropenia (see Gastrointestinal disorders below) thrombocytopenia anaemia leukopenia 
febrilna nevtropenija nevtropenija (glejte Bolezni prebavil, spodaj) trombocitopenija anemija levkopenija
The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI: 0.45, 0.90). 
Nekorigirano razmerje ogroženosti za skupino s peroralnim topotekanom in NPO glede na skupino s samo NPO je bilo 0,64 (95% IZ: 0,45, 0,90).
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 10 
Pred prvim ciklom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev ≥ 1,5 x 10
Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent. 
Poročila o resnih zapletih, povezanih s trombocitopenijo, vključno s smrtnimi primeri in krvavitvami tumorjev, so bila redka.
What Topotecan Actavis is and what it is used for 
Kaj je zdravilo Topotekan Actavis in za kaj ga uporabljamo
In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability. 
Pri sočasni uporabi topotekana z drugimi kemoterapevtiki bo morda zaradi boljšega prenašanja potrebno zmanjšati odmerek vsakega zdravila.
Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1). 
Pri bolnicah, ki so se predhodno zdravile s cisplatinom mora preteči daljše obdobje brez zdravljenja, da se opraviči zdravljenje s kombinacijo (glejte poglavje 5.1).
- Feeling sick (nausea), vomiting; diarrhoea; stomach pain; constipation. 
- Siljenje na bruhanje (navzea), bruhanje, driska, bolečine v trebuhu, zaprtje.
A small number of hepatically impaired patients (serum bilirubin between 1.5 and 10 mg/dl) were given intravenous topotecan at 1.5 mg/m for five days every three weeks. 
Le manjše število bolnikov z jetrno okvaro (vrednost serumskega bilirubina med 1,5 in 10 mg/dl) je prejelo intravenski odmerek 1,5 mg/m2 po pet dni na vsake tri tedne.
Severe neutropenia lasted beyond seven days in 11 % of courses overall. 
Huda nevtropenija je pri 11% vseh ciklov zdravljenja trajala več kot sedem dni.
The hazard ratio for survival of IV topotecan relative to CAV was 1.04 (95 % CI 0.78 -1.40). 
Razmerje tveganja za preživetje z intravenskim topotekanom relativno glede na kombinacijo CAV je bilo 1,04 (95% interval zaupanja: 0,78-1,40).
In a population of patients with refractory SCLC (those not responding to first line therapy), the response rate to topotecan was 4.0 %. 
V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (obliko, ki se ne odziva na zdravljenje s terapijo prve izbire) je bil odziv na topotekan 4,0%.
However, in 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. 
Pri sočasni uporabi s platinovimi spojinami pride do izrazite interakcije, ki je odvisna od zaporedja dajanja zdravil, in sicer od tega ali damo pripravek s platino na 1. ali 5. dan dajanja topotekana.
9/l) in 25 % of patients (8 % of courses); 
9/l) pri 25% bolnikov (8%
9/l, a platelet count of ≥ 100 x 10 
9/l, število trombocitov ≥ 100 x 10
Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2). 
Hematološka toksičnost je odvisna od odmerka, zato je treba bolnikom redno nadzorovati celotno krvno sliko, vključno s trombociti (glejte poglavje 4.2).
25 microgram/ml solution 
50 mikrogramov/ml
Patients without prior cisplatin chemoradiotherapy Cisplatin 
Bolniki brez predhodne cisplatinske kemoradioterapije cisplatin topotecan/cisplatin
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. 
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 mg/m do 2,4 mg/m 2.
The incidence of adverse reactions listed above have the potential to occur with a higher frequency in patients who have a poor performance status (see section 4.4). 
Pojavnost zgoraj navedenih neželenih učinkov je lahko pogostejša pri bolnikih s slabšim telesnim stanjem (glejte poglavje 4.4).
Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan. 
Med zdravljenjem s topotekanom so pri približno 25% bolnikov opazili utrujenost, pri 16% pa astenijo.
Topotecan Actavis 1 mg vials must be reconstituted with 1.1 ml water for injections. 
Topotekan Actavis 1 mg viale morate rekonstituirati z 1,1 ml vode za injekcije.
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. 
Če dajemo cisplatin ali karboplatin na 1. dan dajanja topotekana, je potrebno zaradi boljšega prenašanja zmanjšati odmerek teh zdravil v primerjavi z odmerki, ki jih lahko dajemo, kadar damo platinove spojine na 5. dan uporabe topotekana.
Red cell transfusions were given in 52 % of patients (21 % of courses). 
52% bolnikov je prejelo transfuzijo eritrocitov (21% ciklov zdravljenja).
- Infections (very common; may affect more than 1 in 10 people), with signs such as: - fever - serious decline of your general condition - local symptoms, such as sore throat or burning sensation when urinating - severe stomach pain, fever and possibly diarrhoea (rarely with blood) can be signs of bowel inflammation (neutropenic colitis) Topotecan Actavis may reduce your ability to fight infections. 
- Okužbe (zelo pogosto; pojavijo se lahko pri več kot 1 od 10 bolnikov) z znaki, kot so lokalni simptomi, npr. vnetje žrela ali pekoč občutek pri uriniranju hude bolečine v trebuhu, zvišana telesna temperatura in driska (ki je v redkih primerih krvava) so lahko znaki vnetja črevesa (nevtropeničnega kolitisa) Zdravilo Topotekan Actavis lahko zmanjša vašo sposobnost za premagovanje okužb.
Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10 
Naslednji odmerki Bolnica topotekana ne sme prejeti, če število nevtrofilcev ni večje ali enako 1,5 x 10
The frequencies associated with the haematological and non-haematological adverse events listed below represent the adverse event reports considered to be related/possibly related to topotecan therapy. 
V nadaljevanju navedena pogostnost hematoloških in nehematoloških neželenih učinkov se nanaša na poročila o neželenih učinkih, ki so bili ali bi lahko bili povezani z zdravljenjem s topotekanom.
Rare side effects (may affect up to 1 in 1,000 people) - Swelling caused by fluid build-up (angioedema) e.g. around the eyes and lips as well as hands, 
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - Oteklost zaradi kopičenja tekočine (angioedema), npr. okrog oči in ustnic ter v dlaneh,
The primary complications of overdose are bone marrow suppression and mucositis. 
Primarna zapleta prevelikega odmerjanja sta predvsem supresija kostnega mozga in mukozitis.
Very rare side effects (may affect up to 1 in 10,000 people) - Mild pain and inflammation at the site of injection due to accidental administration of the medicinal product into the surrounding tissue (extravasation) e.g. by leakage. 
Zelo redki neželeni učinki (pojavijo se lahko pri največ 1 od 10.000 bolnikov) - Blage bolečine in vnetje na mestu injiciranja zaradi naključnega prehajanja zdravila v okoliško tkivo (ekstravazacija), npr. zaradi iztekanja.
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 %. 
Odstotek odziva na topotekan pri kombiniranem režimu zdravljenja drobnoceličnega pljučnega raka (n = 480) pri bolnikih z relapsom bolezni, dovzetne na zdravljenje s terapijo prve izbire je bil 20,2%.
Topotecan Actavis may cause a decrease in the number of blood clotting cells (platelets). 
Zdravilo Topotekan Actavis lahko povzroči zmanjšanje števila krvnih ploščic (trombocitov), potrebnih za strjevanje krvi.
9/l) in 25 % of patients (15 % of courses). 
9/l) pa pri 25% bolnikov (15% ciklov zdravljenja).
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. 
Plazemski očistek pri bolnikih z jetrno okvaro (serumski bilirubin med 1.5 in 10 mg/dl) se je v primerjavi s kontrolno skupino znižal na približno 67%.
Small cell lung cancer The usual dose is 1.5 mg per m of body surface area once daily for 5 days. 
Drobnocelični pljučni rak Običajen odmerek je 1,5 mg na m telesne površine enkrat na dan 5 dni.
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. 
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 serumskega kreatinina manjšo ali enako 1,5 mg/dl.
In case of skin contact, thoroughly wash the affected area with large amount of water. 
Če zdravilo pride v stik s kožo, je treba prizadeti predel sprati z veliko količino vode.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodiumfree'. 
Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar pomeni, da je praktično "brez natrija".
Tumour types included were Ewing's Sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma. 
Vključene so bile naslednje vrste tumorjev: Ewingov sarkom/primitivni nevroektodermalni tumor, nevroblastom, osteoblastom in rabdomiosarkom.
Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine. 
Z urinom se izloči približno 51% skupnega topotekana in 3% N-desmetil topotekana.
9/l) during course 1 was seen in 55 % of the patients and with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses). 
9/l), ki je pri 20% bolnikov trajala ≥ sedem dni, pri 77% pa ves čas (39% ciklov zdravljenja).
A reduction in topotecan clearance was observed. 
Pri tem so opazili manjši očistek topotekana.
The anti-tumour activity of topotecan involves the inhibition of topoisomerase-I, an enzyme intimately involved in DNA replication as it relieves the torsional strain introduced ahead of the moving replication fork. 
Protitumorsko delovanje topotekana vključuje zaviranje encima topoizomeraze I, tesno povezanega s podvojevanjem DNA, saj sprošča torzijsko napetost, ki nastopa pred napredujočimi replikacijskimi vilicami.
Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8). 
Med uporabo topotekana so opisani primeri intersticijske bolezni pljuč (ILD - interstitial lung disease), nekateri s smrtnim izidom (glejte poglavje 4.8).
In an open-label trial 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 
Med odprtim preskušanjem pri otrocih (n = 108, razpon starosti: dojenčki 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.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. 
Če ste dobili preveč zdravila Topotekan Actavis Ker vam bo to zdravilo dal vaš zdravnik ali medicinska sestra je malo verjetno, da boste dobili prevelik odmerek.
What Topotecan Actavis is and what it is used for What you need to know before you use Topotecan Actavis How to use Topotecan Actavis Possible side effects 
Kaj je zdravilo Topotekan Actavis in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Topotekan Actavis
Initial dose The recommended dose of topotecan is 1.5 mg/m body surface area/day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course. 
Priporočeni odmerek topotekana je 1,5 mg/m telesne površine na dan, z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklih po pet zaporednih dni in s tritedenskimi presledki med začetki vsakega cikla zdravljenja.
What Topotecan Actavis looks like and contents of the pack Topotecan Actavis is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps. 
Izgled zdravila Topotekan Actavis in vsebina pakiranja Zdravilo Topotekan Actavis je na voljo v vialah iz brezbarvnega stekla tipa I s sivim brombutilnim zamaškom in aluminijsko zaporo s plastično snemno zaporko.
Topotecan Actavis 4 mg vials must be reconstituted with 4 ml water for injections. 
Topotekan Actavis 4 mg viale morate rekonstituirati s 4 ml vode za injekcije.
Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism. 
Topotekan zavira delovanje topoizomeraze I, tako da stabilizira kovalentni kompleks tega encima in ene verige DNA, ki je vmesni produkt katalitičnega mehanizma.
Platelet transfusions were given in 4 % of courses. 
V 4% ciklov zdravljenja so bile uporabljene transfuzije trombocitov.
Topotecan in combination with cisplatin is indicated for patients with carcinoma of the cervix recurrent after radiotherapy and for patients with Stage IVB disease. 
Topotekan v kombinaciji s cisplatinom je indiciran pri bolnicah s ponovitvijo karcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
Topotecan monotherapy and topotecan in combination with cisplatin are commonly associated with clinically relevant thrombocytopenia. 
Uporaba samega topotekana in topotekana v kombinaciji s cisplatinom je pogosto povezana s pojavom klinično pomembne trombocitopenije.
Add 19 ml to give 20 ml 4 ml of 1 mg/ml topotecan solution Add 156 ml to give 160 ml Add 76 ml to give 80 ml 
4 ml raztopine topotekana 1 mg/ml Dodajte 156 ml, da boste dobili 160 ml
When used in combination with cisplatin, the full prescribing information for cisplatin should be consulted. 
Pri uporabi zdravila v kombinaciji s cisplatinom je treba upoštevati tudi navodila za predpisovanje cisplatina.
The recommended monotherapy dose of topotecan in patients with small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days. 
Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnikov z drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/min je 0,75 mg/m na dan, pet zaporednih dni.
Doses should be similarly reduced if the platelet count falls below 25 x 10 9/l. 
Odmerke je treba podobno zmanjšati, če število trombocitov pade pod 25 x 10
Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light. 
Kemična in fizikalna stabilnost koncentrata sta dokazani za 24 ur pri temperaturi 25 ± 2 °C v normalnih svetlobnih pogojih in za 24 ur pri temperaturi od 2°C do 8°C, če je zaščiten pred svetlobo.
Marketing Authorisation Holder Actavis Group PTC ehf. 
Imetnik dovoljenja za promet z zdravilom: Actavis Group PTC ehf.
Thrombocytopenia: Severe (platelets less than 25 x 10 
Trombocitopenija: Huda oblika (število trombocitov manjše od 25 x 10
Each vial contains 0.52 mg (0.0225 mmol) sodium. 
Pomožna snov z znanim učinkom: Ena viala vsebuje 0,52 mg (0,0225 mmol) natrija.
In the event of contact with the eyes, irrigate with large amounts of water. 
Če zdravilo pride v oči, jih je treba sprati z veliko količino vode.
moderate (platelets between 25.0 and 50.0 x 10 
ciklov zdravljenja); zmerna (število trombocitov med 25,0 in 50,0 x 10
Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and not attributable to topotecan. 
Pri dajanju topotekana v kombinaciji s cisplatinom so opazili dodatne neželene učinke, vendar pa so bili ti neželeni učinki opaženi tudi pri samostojnem zdravljenju s cisplatinom in jih niso pripisali topotekanu.