natgillin/translations-raw huggingface dataset:
Talk to your doctor or nurse before using Topotecan Teva: if you have any kidney problems. 
Pred začetkom uporabe zdravila Topotekan Teva se posvetijte z zdravnikom ali medicinsko sestro: - če imate kakršne koli težave z ledvicami.
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion EU/1/09/552/001- 1vial 
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje EU/1/09/552/001 - 1 viala
Feeling unwell (malaise). 
- Slabo počutje (šibkost).
Severe (platelets < 25 x 109/l) in 25 % of patients (8 % of courses); moderate (platelets between 25.0 and 50.0 x 109/l) in 25 % of patients (15 % of courses). 
Huda oblika (število trombocitov < 25 x 109/l) se je razvila pri 25 % bolnikov (v 8 % ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in 50,0 x 109/l) pa pri 25 % bolnikov (v
Concentrate for solution for infusion 1 vial of 1 ml (1 mg topotecan) 5 vials of 1 ml (1 mg topotecan) 
koncentrat za raztopino za infundiranje 1 viala z 1 ml (1 mg topotekana) 5 vial po 1 ml (1 mg topotekana)
Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
Neporabljeno zdravilo ali odpadni material morate odstraniti v skladu z lokalnimi predpisi.
The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of proteinassociated DNA single-strand breaks. 
Celična posledica zaviranja topoizomeraze I s topotekanom je nastanek prekinitev na enojni verigi DNA, vezani na beljakovino.
tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections. 
Vinska kislina (E334), klorovodikova kislina (E507) (za uravnavanje pH), natrijev hidroksid (E524) (za uravnavanje pH) in voda za injekcije.
Topotecan Teva is supplied as a concentrate for solution for infusion. 
Zdravilo Topotekan Teva je v obliki koncentrata za pripravo raztopine za infundiranje.
Very rare (may affect up to 1 in 10,000 people) 
Zelo redki (pojavijo se lahko pri največ 1 bolniku od 10.000 bolnikov)
1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4). 
1 Pri bolnikih, ki so se zdravili s topotekanom, so poročali o smrti zaradi sepse (glejte poglavje 4.4).
- The active substance is topotecan hydrochloride. 
- Učinkovina je topotekanijev klorid.
Median survival in patients treated with oral topotecan plus BSC was 25.9 weeks (95 % CI 18.3, 31.6) compared to 13.9 weeks (95 % CI 11.1, 18.6) for patients receiving BSC alone (p = 0.0104). 
Mediana časa preživetja bolnikov, ki so bili zdravljeni s peroralnim topotekanom v kombinaciji z NPO, je bila 25,9 tedna (95-odstotni IZ 18,3, 31,6), pri bolnikih, ki so bili zdravljeni z NPO samo, pa 13,9 tedna (95-odstotni IZ 11,1, 18,6) (p = 0,0104).
Topotecan Teva contains sodium 
Zdravilo Topotecan vsebuje natrij
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 hudo okvaro ledvične funkcije (očistek kreatinina < 20 ml/min) ali s hudo okvaro jetrne funkcije, ki je posledica ciroze (bilirubin v serumu ≥ 10 mg/dl), ni na voljo dovolj izkušenj.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder 
Imetnik dovoljenja za promet in izdelovalec
Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
- huda preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 - dojenje (glejte poglavje 4.6)
Based on the doselimiting 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). 
določen največji odmerek, ki so ga bolniki še prenašali, 2,0 mg/m2/dan pri uporabi G-CSF in 1,4 mg/m2/dan brez uporabe G-CSF (glejte poglavje 5.2).
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/m2 given as a 30- minute infusion for 5 days repeated every 3 weeks for up to one year depending on response to therapy. 
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/m2
Mild abdominal pain was reported in 4 % of patients. 
4 % bolnikov je imelo blage bolečine v trebuhu.
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 kreatinina v serumu preseže 1,5 mg/dl, je priporočljivo pregledati navodila za predpisovanje cisplatina glede kakršnega koli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
What Topotecan Teva looks like and contents of the pack 
Izgled zdravila Topotekan Teva in vsebina pakiranja
CYTOTOXIC, special handling instructions (see package leaflet). 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA CITOTOKSIČNO ZDRAVILO, posebna navodila za ravnanje (preberite priloženo navodilo).
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 ciklusom zdravljenja pri 16 % bolnikov opazili zvišano telesno temperaturo ali okužboe, 23 % bolnikovpa je imelo take neželene učinke ves čas (v 6 % ciklusov zdravljenja).
An O-glucuronidation metabolite of topotecan and Ndesmethyl topotecan has been identified in the urine. 
V urinu so odkrili O-glukuronidacijski presnovek topotekana in N-desmetil topotekan.
Platelet transfusions were given in 4 % of courses. 
V 4 % ciklusov zdravljenja so bolniki prejeli transfuzije trombocitov.
Topotecan monotherapy is indicated for the treatment of: patients with metastatic carcinoma of the ovary after failure of first line or subsequent therapy. 
bolnikih z metastatskim karcinomom jajčnikov po neuspehu z zdravili prvega linije ali naslednjega izbora.
• Lung inflammation (rare (may affect up to 1 in 1,000 people)), with signs such as: difficulty breathing, cough fever. 
• Vnetje pljuč (redko (pojavijo se lahko pri največ 1 od 1.000 bolnikov)) z znaki, kot so:
Severe (neutrophil count < 0.5 x 109/l) during course 1 in 55 % of patients, with duration ≥ seven days in 20 % and overall in 77 % of patients (39 % of courses). 
Med prvim ciklusom zdravljenja je imelo 55 % bolnikov hudo obliko nevtropenije (število nevtrofilcev < 0,5 x 109/l), ki je pri 20 % bolnikov trajala najmanj sedem dni, pri 77 % pa ves čas (v 39 % ciklusov zdravljenja).
For more information about cisplatin, please refer to the corresponding Package Leaflet. 
Za več podatkov o cisplatinu preberite ustrezno navodilo za uporabo.
Each vial contains 1 ml of the concentrate for solution for infusion. 
Ena viala vsebuje 1 ml koncentrata za raztopino za infundiranje.
A doctor or nurse will give you the diluted Topotecan Teva solution as an infusion (a drip) usually into your arm over about 30 minutes. 
Zdravnik ali medicinska sestra vam bosta dala razredčeno raztopino Topotekana Teva v obliki kapljične infuzije.
In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form). 
ondansetrona, morfina ali kortikosteroidov pomembneje vplivalo na farmakokinetiko celotnega topotekana (aktivne in neaktivne oblike).
Storage of the diluted solution 
Shranjevanje razredčene raztopine
Mouth sores, difficulty swallowing, abdominal pain, nausea, vomiting, diarrhoea, bloody stools (possible signs and symptoms of inflammation of the inner lining of the mouth, stomach and/or gut [mucosal inflammation]). 
• razjede v ustih, oteženo požiranje, bolečine v trebuhu, občutek slabosti, bruhanje, driska, kri v blatu (to so lahko znaki in simptomi vnetja sluznice v ustih, želodcu in/ali črevesu [vnetje sluznic]).
Median (95% CI) 
Mediana vrednost (95-odstotni IZ)
How to use Topotecan Teva 
Kako uporabljati zdravilo Topotekan Teva
Preclinical studies indicate plasma protein binding of topotecan is low (35 %) and distribution between blood cells and plasma was fairly homogeneous. 
(35 %), precej enakomerno pa se razporedi med krvnimi celicami in plazmo.
Clinical efficacy and safety 
Klinična učinkovitost in varnost Ponovitev raka jajčnikov
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 % CI: 2,6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23). 
Pri bolnicah (n = 39) s ponovitvijo v 180 dneh po kemoterapiji s cisplatinom je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 4,6 meseca (95-odstotniIZ: 2,6, 6,1), v skupini, ki je prejemala cisplatin, pa 4,5 meseca (95-odstotni IZ: 2,9, 9,6), razmerje ogroženosti 1,15 (0,59, 2,23).
(95% CI) Hazard ratio (95% CI) 
(95-odstotni IZ) Razmerje tveganja (95-odstotni IZ)
There is insufficient experience with the use of topotecan in patients with severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis. 
Z uporabo topotekana pri bolnikih, ki imajo zaradi ciroze hudo okvaro jetrne funkcije (z vrednostmi bilirubina v serumu ≥ 10 mg/dl), ni na voljo dovolj izkušenj.
A Phase III study (Study 478) compared oral topotecan plus best supportive care (BSC) (n=71) with BSC alone (n=70) in patients who had relapsed following first line therapy (median time to progression [TTP] from first-line therapy: 84 days for oral topotecan plus BSC, 90 days for BSC alone) and for whom re-treatment with intravenous chemotherapy was not considered appropriate. 
Študija je bila opravljena pri bolnikih, pri katerih je po zdravljenju prve linije prišlo do ponovitve (mediana časa do napredovanja od zdravljenja prve linije: 84 dni za peroralni topotekan in NPO, 90 dni za samo NPO) in pri katerih zdravljenje z intravensko obliko kemoterapije ni bilo primerno.
The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan. 
Koncentrat je bledo rumena tekočina, ki vsebuje 1 mg/ml topotekana.
Serious side effects 
Resni neželeni učinki:
Each vial contains 1 mg topotecan (as hydrochloride) in 1 ml concentrate. 
Vsaka viala vsebuje 1 mg topotekana (v obliki topotekanijevega klorida) v 1 ml koncentrata.
N = total number of patients treated. 
Razmerje tveganja (95-odstotni IZ) n = celotno število zdravljenih bolnikov IZ = interval zaupanja
Each vial contains 4 mg topotecan (as hydrochloride) in 4 ml concentrate. 
Vsaka viala vsebuje 4 mg topotekana (v obliki topotekanijevega klorida) v 4 ml koncentrata.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
Prior to administration of the first course of topotecan, patients must have a baseline neutrophil count of ≥ 1.5 x 109/l, a platelet count of ≥ 100 x 109/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary). 
Pred prvim ciklusom zdravljenja s topotekanom morajo imeti bolniki izhodiščno število nevtrofilcev ≥ 1,5 x 109/l, število trombocitov ≥ 100 x 109/l ter raven hemoglobina ≥ 9 g/dl (po prejemu transfuzije, če je ta potrebna).
Feeling generally weak and tired, which can be symptoms of a decrease in the number of red blood cells (anaemia). 
Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov) - Občutek splošne oslabelosti in utrujenosti, ki sta lahko znaka zmanjšanega števila rdečih krvničk (anemija).
Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 on days 1-3, every 21 days 
1. dan vsakih 21 dni cisplatin 50 mg/m2 na 1. dan +
Your dose of Topotecan Teva will depend on: the disease being treated your body surface area (m2) the results of blood tests carried out before and during treatment how well you tolerate treatment. 
Vaš odmerek zdravila Topotekan Teva bo odvisen od: - bolezni, zaradi katere se zdravite, - vaše telesne površine (m2),
How Topotecan Teva is prepared 
Kako se zdravilo Topotekan Teva pripravi
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje
Very common Nausea, vomiting and diarrhoea (all of which may be severe), constipation, abdominal pain2, mucositis 
Bolezni prebavil zelo pogosti navzea, bruhanje in driska (vse lahko v hudi obliki), zaprtje, bolečine v trebuhu2, vnetje ustne sluznice pogostnost neznana gastrointestinalna perforacija
Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %). 
bruhanje (32 %), driska (18 %), zaprtje (9 %) in vnetje ustne sluznice (14 %).
In those patients (n = 102) with recurrence after 180 days, median survival in the topotecan plus cisplatin arm was 9.9 months (95 % CI: 7, 12.6) versus 6.3 months (95 % CI: 4.9, 9.5) for the cisplatin arm with a hazard ratio of 0.75 (0.49, 1.16). 
Pri bolnicah (n = 102) s ponovitvijo po 180 dneh je bila mediana preživetja v skupini, ki je prejemala topotekan in cisplatin, 9,9 meseca (95-odstotni IZ: 7, 12,6) v skupini, ki je prejemala cisplatin, pa 6,3 meseca (95-odstotni IZ: 4,9, 9,5), razmerje ogroženosti 0,75 (0,49, 1,16).
ovarian cancer or small cell lung cancer that has come back after chemotherapy advanced cervical cancer if surgery or radiotherapy treatment is not possible. 
- napredovalega raka materničnega vratu, če zdravljenje z operacijo ali obsevanjem ni možno.
Tell a doctor if any of these becomes troublesome. 
→ Zdravniku morate povedati, če menite, da kaj od tega velja za vas.
Women of childbearing potential / Contraception in males and females Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3). 
Predklinične raziskave so pokazale, da topotekan povzroča smrt in deformacije zarodka oziroma ploda (glejte poglavje 5.3).
Colourless, type I glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snapcap containing 1 ml or 4 ml of concentrate. 
Brezbarvana viala iz stekla tipa I z zamaškom iz brombutilne gume, aluminijasto zaporko in polipropilenskim natičnim pokrovom.
The use of Topotecan Teva is not recommended in patients with severe renal impairment; if you have liver problems. 
Uporaba zdravila Topotekan Teva pri bolnikih s hudo okvaro ledvic se ne priporoča.
Patients with renal impairment 
Posebne skupine bolnikov Bolniki z okvaro ledvic
The incidence of severe (Grade 3 or 4) nausea, vomiting, diarrhoea and mucositis was 4, 3, 2 and 1 % respectively. 
Hude oblike (3. ali 4. stopnje) motenj so ugotavljali z naslednjimi pogostnostmi: navzea 4 %, bruhanje 3 %, driska 2 %, vnetje ustne sluznice 1 %.
Relapsed ovarian cancer 
Rak jajčnikov in drobnocelični pljučni rak
However there are insufficient data available to make a dose recommendation for this patient group (see section 4.2). 
Pri tem so opažali zmanjšan očistek topotekana, vendar ni na voljo dovolj podatkov, da bi lahko oblikovali priporočila za odmerjanje za to skupino bolnikov (glejte poglavje 4.2).
How to store Topotecan Teva 
Kako dajati zdravilo Topotekan Teva
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). 
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje 1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana (v obliki topotekanijevega klorida).
if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section if you are breast-feeding; if your blood cells count is too low. 
- če ste alergični na topotekan ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
EXP Read the leaflet for the shelf life of the diluted product. 
EXP Za rok uporabnosti pripravljenega zdravila preberite priložena navodila.
Topotecan Teva 4 mg/4 ml concentrate for solution for infusion 1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). 
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje 1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana (v obliki topotekanijevega klorida).
One Phase II study (Study 065) and one Phase III 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, pri katerih je prišlo do ponovitve ≥ 90 dni po koncu ene predhodne sheme kemoterapije, so izvedli eno študijo faze II (Študija 065) in eno študijo faze III (Študija 396) (glejte preglednico 1).
Hydrochloric acid (E507) (for pH adjustment) Sodium hydroxide (E524) (for pH adjustment) Water for injections 
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi vinska kislina (E334) klorovodikova kislina (E507) (za uravnavanje pH) natrijev hidroksid (E524) (za uravnavanje pH) voda za injekcije
Very common Febrile neutropenia, neutropenia (see “Gastrointestinal disorders”), thrombocytopenia, anaemia, leucopenia 
Bolezni krvi in limfatičnega sistema zelo pogosti febrilna nevtropenija, nevtropenija (glejte "Bolezni prebavil"), trombocitopenija, anemija, levkopenija pogosti pancitopenija pogostnost neznana huda krvavitev (v povezavi s trombocitopenijo)
Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient self reports on an unblinded symptom scale assessment in each of these two studies. 
Na podlagi neslepljene ocene lestvice simptomov po navedbi bolnikov samih sta peroralni in intravenski topotekan v obeh navedenih študijah pri bolnikih s ponovitvijo dovzetnega drobnoceličnega pljučnega raka dosegla podobno ublažitev simptomov.
Instructions for dilution 
Navodilo za redčenje
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. 
Glavna pot razgradnje je hidroliza laktonskega obroča, s katero nastane karboksilat z odprtim obročem.
EU/1/09/552/001 - 1 vial EU/1/09/552/002 - 5 vials 
EU/1/09/552/001 - 1 viala EU/1/09/552/002 - 5 vial
EU/1/09/552/003 - 1 vial EU/1/09/552/004 - 5 vials 
EU/1/09/552/003 - 1 viala EU/1/09/552/004 - 5 vial
Median survivals for the two groups were 25.0 and 24.7 weeks respectively. 
Mediana časa preživetja bolnikov v skupini, ki je prejemala topotekan, je bila 25,0 tedna, v skupini, ki je prejemala kombinacijo CAV pa 24,7 tedna.
One vial of 1 ml of concentrate contains 1 mg topotecan (as hydrochloride). 
1 viala z 1 ml koncentrata vsebuje 1 mg topotekana (v obliki topotekanijevega klorida).
Decrease in the number of all blood cells (pancytopenia ) Allergic or hypersensitivity reactions (including rash). 
- Alergijske ali preobčutljivostne reakcije (vključno z izpuščajem).
Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan 
Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje topotekan
Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan 
Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje topotekan
Ovarian and small cell lung cancer The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days. 
Običajni odmerek je 1,5 mg na m2 telesne površine enkrat na dan pet dni.
In a comparative study of topotecan and paclitaxel in patients previously treated for ovarian carcinoma with platinum based chemotherapy (n = 112 and 114, respectively), the response rate (95 % CI) was 20.5 % (13 %, 28 %) versus 14 % (8 %, 20 %) and median time to progression 19 weeks versus 15 weeks (hazard ratio 0.7 [0.6, 1.0]), for topotecan and paclitaxel, 
Stopnja odzivnosti na zdravljenje (95-odstotni interval zaupanja) je znašala 20,5 % (13 %, 28 %) oziroma 14 % (8 %, 20 %), mediana časa do napredovanja pa 19 tednov za topotekan in 15 tednov za paklitaksel (razmerje ogroženosti 0,7 [0,6, 1,0]).
Relapsed SCLC 
Log rank p-vrednost
One vial of 4 ml of concentrate for solution for infusion contains 4 mg topotecan (as hydrochloride). 
Ena viala s 4 ml koncentrata za raztopino za infundiranje vsebuje 4 mg topotekana (v obliki topotekanijevega klorida).
EU/1/09/552/004- 5 vials 
EU/1/09/552/004 - 5 vial
One vial of 4 ml of concentrate contains 4 mg topotecan (as hydrochloride). 
1 viala s 4 ml koncentrata vsebuje 4 mg topotekana (v obliki topotekanijevega klorida).
Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary). 
Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1 x 109/l, število trombocitov ≥ 100 x 109/l, vrednost hemoglobina pa ≥ 9 g/dl (po prejemu transfuzije, če je ta potrebna).
EU/1/09/552/002- 5 vials 
EU/1/09/552/002 - 5 vial
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the pharmacokinetics after multiple doses. 
Prav tako ni znakov, da bi se farmakokinetika spremenila po večkratnem odmerjanju.
Itchy rash (or hives). 
dispneja in/ali hipoksija).
1 ml of concentrate for solution for infusion contains 1 mg topotecan (as hydrochloride). 
1 ml koncentrata za raztopino za infundiranje vsebuje 1 mg topotekana (v obliki topotekanijevega klorida).
Hazard ratio (95% CI) 
Razmerje tveganja (95-odstotni IZ)
Very common Infection Common 
Infekcijske in parazitske bolezni zelo pogosti okužba pogosti sepsa1
Topotecan should not be re-administered unless the neutrophil count is ≥ 1.5 x 109/l, the platelet count is ≥100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary). 
Pred naslednjo uporabo topotekana mora biti število nevtrofilcev ≥ 1,5 x 109/l, število trombocitov ≥ 100 x 109/l in vrednost hemoglobina ≥ 9 g/dl (po prejemu transfuzije, če je ta potrebna).
Patients should be monitored for pulmonary symptoms indicative of ILD (e.g. cough, fever, dyspnoea and/or hypoxia), and topotecan should be discontinued if a new diagnosis of ILD is confirmed. 
Pri bolnikih je potrebno spremljati morebitne pljučne znake IBP (npr. kašelj, vročina,
In another randomised Phase III study which compared intravenous (IV) topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group. 
V drugi randomizirani študiji faze III so primerjali intravenski topotekan s ciklofosfamidom, doksorubicinom in vinkristinom (CAV).
Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.) 
Plazemski očistek pri bolnikih z ledvično okvaro (očistek kreatinina 41−60 ml/min) se je v primerjavi s kontrolno skupino zmanjšal na približno 67 %.
Package leaflet: Information for the user Topotecan Teva 4 mg/4 ml concentrate for solution for infusion topotecan 
Navodilo za uporabo Topotekan Teva 4 mg/4 ml koncentrat za raztopino za infundiranje topotekan
You must tell your doctor immediately if you experience any of the following serious side effects. 
Resni neželeni učinki: Če se pojavi kateri koli izmed navedenih resnih neželenih učinkov, morate nemudoma obvestiti zdravnika.
Respiratory, thoracic and mediastinal disorders 
Bolezni jeter, žolčnika in žolčevodov pogosti hiperbilirubinemija
Difference in response rate (95% CI) 
Razlika v deležu odziva (95-odstotni IZ) Mediani čas do napredovanja (tedni)
Package leaflet: Information for the user Topotecan Teva 1 mg/1 ml concentrate for solution for infusion topotecan 
Navodilo za uporabo Topotekan Teva 1 mg/1 ml koncentrat za raztopino za infundiranje topotekan