FrancophonIA/ELRC3.0 huggingface dataset:
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji in redčenju zdravila glejte poglavje 6.3.
English: Potactasol can make you feel tired or weak.
Slovenian: Zdravilo Potactasol lahko povzroči utrujenost in šibkost.
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Slovenian: A tako kot druga citotoksična zdravila je tudi topotekan genotoksičen in vpliva na plodnost (tudi na plodnost samcev) ni mogoče izključiti.
English: Topotecan half-life was increased by about 30 % but no clear change in volume of distribution was observed.
Slovenian: Razpolovna doba topotekana se je podaljšala za 30 %, volumen porazdelitve pa se ni bistveno spremenil.
English: If you are being treated for cervical cancer, you may get side effects from the other medicine (cisplatin) that you will be given along with Potactasol.
Slovenian: Če se zdravite zaradi raka materničnega vratu, se vam lahko neželeni učinki pojavijo tudi zaradi drugega zdravila (cisplatina), ki ga boste dobili skupaj z zdravilom Potactasol.
English: Potactasol is available in cartons containing 1 vial.
Slovenian: Zdravilo Potactasol je na voljo v škatlah, ki vsebujejo 1 vialo.
English: - The active substance is topotecan.
Slovenian: − Učinkovina je topotekan.
English: Median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Slovenian: Mediana časa preživetja je bila 30,3 tedna (95-odstotni interval zaupanja: 27,6; 33,4).
English: In this case Potactasol treatment is combined with medicines containing cisplatin.
Slovenian: V tem primeru se zdravilo Potactasol uporablja skupaj z zdravili, ki vsebujejo cisplatin.
English: An N-desmethyl metabolite, which was shown to have similar or less activity than the parent in a cell-based assay, was found in urine, plasma, and faeces.
Slovenian: Presnovek N-desmetil (za katerega so v celičnem testu dokazali, da ima podobno ali manjšo aktivnost kot matična učinkovina) so odkrili v urinu, plazmi in blatu.
English: Potactasol contains the active substance topotecan which helps to kill tumour cells.
Slovenian: Zdravilo Potactasol vsebuje učinkovino topotekan, ki pomaga uničiti tumorske celice.
English: - Decrease in the number of all blood cells (pancytopenia).
Slovenian: - Zmanjšano število vseh krvnih celic (pancitopenija).
English: This should be taken into account, when prescribing topotecan, e.g. if patients at increased risk of tumour bleeds are considered for therapy.
Slovenian: To je treba upoštevati pri predpisovanju zdravila Potactasol, npr. pri odločanju za zdravljenje bolnikov, pri katerih obstaja večje tveganje za krvavitve tumorja.
English: Cytotoxic, special handling instructions (see package leaflet).
Slovenian: Citotoksično zdravilo, posebna navodila za ravnanje (glejte navodilo za uporabo).
English: Other medicines and Potactasol
Slovenian: Druga zdravila in zdravilo Potactasol
English: (95 % CI)
Slovenian: (95-odstotni IZ)
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, morate odvreči v vreče za shranjevanje nevarnih odpadkov, ki so namenjene sežigu pri visokih temperaturah.
English: This condition can be fatal.
Slovenian: To stanje se lahko konča s smrtjo.
English: What Potactasol is and what it is used for
Slovenian: Kaj je zdravilo Potactasol in za kaj ga uporabljamo
English: In patients refractory to, or relapsing within 3 months after cisplatin therapy (n = 186), the response rate was 10 %.
Slovenian: Pri bolnicah, ki se jim je bolezen po zdravljenju s cisplatinom ponovila v roku 3 mesecev ali ki se niso odzvale na zdravilo (n = 186), je bila stopnja odziva 10 %.
English: - if you are allergic to topotecan or any of the other ingredients of this medicine (listed in section 6); - if you are breast-feeding.
Slovenian: - če ste alergični na topotekan ali katero koli sestavino tega zdravila (navedeno v poglavju - če dojite, - če imate prenizko število krvnih celic.
English: In clinical studies, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Slovenian: V kliničnimi študijah so o izpuščaju poročali pri 4 % bolnikov, o srbenju pa pri 1,5 % bolnikov.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total topotecan-related material accounted for in the urine and faeces.
Slovenian: Presnovek N-desmetil predstavlja v povprečju manj kot 7 % (od 4 do 9 %) vseh s topotekanom povezanih snovi prisotnih v urinu in blatu.
English: 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: Doses should be similarly reduced if the platelet count falls below 25 x 109/l.
Slovenian: Odmerke je treba podobno zmanjšati, če se število trombocitov zniža pod 25 x 109/l.
English: If you are given too much Potactasol
Slovenian: Če ste dobili preveč zdravila Potactasol
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 kakršnega koli navodila glede zmanjšanja odmerka cisplatina ali nadaljevanja zdravljenja.
English: Vials may or may not be sheathed in a protective sleeve.
Slovenian: Viale so lahko obdane z zaščitnim ovojem ali so brez njega.
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 pokazala, da so toksični učinki, ki omejujejo odmerek topotekana v monoterapiji, hematološki.
English: Do not use this medicine after the expiry date which is stated on the vial and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na viali in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Anaemia: Moderate to severe (Hb ≤ 8.0 g/dl) in 37 % of patients (14 % of courses).
Slovenian: Anemija: Zmerna do huda oblika (Hb ≤ 8,0 g/dl) se je razvila pri 37 % bolnikov (v 14 % ciklusov zdravljenja).
English: There is no known antidote for topotecan overdose.
Slovenian: Antidota za preveliko odmerjanje s topotekanom ni.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Slovenian: Samonavedbe bolnikov o simptomih, pri katerih je bila uporabljena neslepljena ocena, so pokazale dosleden trend k ugodnim spremembam simptomov s peroralnim topotekanom in NPO.
English: 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.
Slovenian: Bolnike je treba kontrolirati glede pljučnih simptomov, ki kažejo na IBP (npr. kašelj, zvišana telesna temperatura, dispneja in/ali hipoksija); čČe se IBP pojavi na novo in je diagnoza potrjena, je treba zdravljenje s topotekanom prekiniti.
English: Among all patients treated in clinical studies (including both those with severe neutropenia and those who did not develop severe neutropenia), 11 % (4 % of courses) developed fever and 26 % (9 % of courses) developed infection.
Slovenian: 11 % vseh bolnikov (v 4% ciklusov zdravljenja), ki so se zdravili v kliničnih študijah (vključno z bolniki s hudo nevtropenijo in s tistimi, pri katerih se huda nevtropenija ni pojavila), je imelo zvišano telesno temperaturo, pri 26 % (v 9% ciklusov zdravljenja) pa so se pojavile okužbe.
English: In patients with moderate renal impairment topotecan plasma clearance was reduced to 34 % of the value in control patients.
Slovenian: Pri bolnikih z zmerno hudo okvaro ledvic se je plazemski očistek zmanjšal na 34 % vrednosti pri bolnikih v kontrolni skupini.
English: If topotecan is used during pregnancy, or if the patient becomes pregnant during therapy with topotecan, the patient must be warned of the potential hazards to the foetus.
Slovenian: Nosečnost Če je topotekan uporabljen med nosečnostjo ali če bolnica zanosi med zdravljenjem s topotekanom, jo je treba opozoriti na možne nevarnosti za plod.
English: For intravenous use as infusion, after reconstitution and dilution.
Slovenian: Za intravensko uporabo v obliki infuzije, po pripravi in redčenju.
English: - If you have any further questions, ask your doctor or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali s farmacevtom.
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: You must not breast-feed while on treatment with Potactasol.
Slovenian: Med zdravljenjem z zdravilom Potactasol ne smete dojiti.
English: Potactasol 4 mg powder for concentrate for solution for infusion EU/1/10/660/002
Slovenian: Potactosol 4 mg prašek za koncentrat za raztopino za infundiranje EU/1/10/660/002
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: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Slovenian: Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; čas običajno ne sme presegati 24 ur pri temperaturi od 2 do 8 °C, razen če ni priprava/redčenje opravljeno v nadzorovanih in preverjenih aseptičnih pogojih.
English: In a population of patients with refractory SCLC (those not responding to first-line therapy), the response rate to topotecan was 4.0 %.
Slovenian: V skupini bolnikov z neodzivnim drobnoceličnim pljučnim rakom (pri katerih ni prišlo do odziva na zdravljenje prve linije) je bil odziv na topotekan 4,0-odstoten.
English: When given in combination with cisplatin (cisplatin day 1, topotecan days 1 to 5), the clearance of topotecan was reduced on day 5 compared to day 1 (19.1 l/h/m2 compared to 21.3 l/h/m2 [n = 9]) (see section 4.5).
Slovenian: Pri dajanju v kombinaciji s cisplatinom (cisplatin 1. dan, topotekan od 1. do 5. dan) je bil 5. dan očistek topotekana v primerjavi s 1. dnem manjši (19,1 l/uro/m2 v primerjavi z 21,3 l/uro/m2 [n = 9])
English: Underlying risk factors include history of ILD, pulmonary fibrosis, lung cancer, thoracic exposure to radiation and use of pneumotoxic substances and/or colony stimulating factors.
Slovenian: pljučna fibroza, pljučni rak, izpostavljenost prsnega koša obsevanju in uporaba pnevmotoksičnih snovi in/ali kolonije stimulirajočih faktorjev.
English: Potactasol 1 mg powder for concentrate for solution for infusion EU/1/10/660/001
Slovenian: Potactosol 1 mg prašek za koncentrat za raztopino za infundiranje EU/1/10/660/001
English: Volume for 25 microgram/ml solution
Slovenian: Količina za raztopino 25 mikrogramov/ml
English: Each vial contains 0.52 mg (0.0225 mmol) sodium.
Slovenian: Ena viala vsebuje 0,52 mg (0,0225 mmol) natrija.
English: Volume for 50 microgram/ml solution
Slovenian: Količina za raztopino 50 mikrogramov/ml
English: Each vial contains 2.07 mg (0.09 mmol) sodium.
Slovenian: Ena viala vsebuje 2,07 mg (0,09 mmol) natrija.
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: Reconstituted and diluted solution
Slovenian: Rekonstituirane in razredčene raztopine
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common:
Slovenian: hiperbilirubinemija Bolezni kože in podkožja Zelo pogosti:
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: 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Slovenian: 1 ml raztopine topotekana 1 mg/ml Dodajte 39 ml, da boste dobili 40 ml
English: Talk to your doctor before using Potactasol: - if you have any kidney problems.
Slovenian: Pred začetkom jemanja zdravila Potactasol se posvetujte z zdravnikom: - če imate kakršne težave z ledvicami.
English: The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Slovenian: Koncentrati, ki so bili testirani, so bili shranjenih pri temperaturi 25 ± 2 °C za 12 ur in 24 ur in potem razredčeni.
English: Patients with prior exposure to cisplatin require a sustained treatment free interval to justify treatment with the combination (see section 5.1).
Slovenian: Pri bolnicah, ki so se predhodno zdravile s cisplatinom mora preteči daljše obdobje brez zdravljenja, da bi bilo zdravljenje s kombinacijo smiselno (glejte poglavje 5.1).
English: The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days.
Slovenian: Običajen odmerek je 1,5 mg na m2 telesne površine enkrat na dan 5 dni.
English: The recommended monotherapy dose of topotecan in patients with ovarian or small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Slovenian: Priporočeni odmerek topotekana kot samostojnega zdravila pri zdravljenju bolnic s karcinom jajčnika in bolnikov z drobnoceličnim pljučnim karcinomom, ki imajo očistek kreatinina med 20 in 39 ml/min je 0,75 mg/m2/dan, pet zaporednih dni.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin
Slovenian: Bolniki brez predhodne cisplatinske kemoradioterapije cisplatin topotekan/cisplatin
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/m2 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/m2 v obliki 30-minutne infuzije 5 dni.
English: Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Slovenian: Z urinom se izloči približno 51 % celotnega topotekana in 3 % N-desmetil topotekana.
English: What Potactasol looks like and contents of the pack
Slovenian: Izgled zdravila Potactasol in vsebina pakiranja
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Potactasol Vsebina pakiranja in dodatne informacije
English: Difference in response rate (95 % CI)
Slovenian: Razlika v deležu odziva (95-odstotni IZ)
English: Rarely, it can lead to more severe bleeding (haemorrhage).
Slovenian: Redko lahko to povzroči zelo hude krvavitve.
English: Other side effects with Potactasol include: Very common side effects (may affect more than 1 in 10 people)
Slovenian: Med drugimi neželenimi učinki zdravila Potactasol so: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov)
English: Ovarian cancer and small cell lung cancer
Slovenian: Rak jajčnika in drobnocelični pljučni rak
English: - Feeling unwell.
Slovenian: - Slabo počutje.
English: Vials contain either 1 mg or 4 mg of topotecan.
Slovenian: Viala vsebuje 1 mg ali 4 mg topotekana.
English: The signs and symptoms observed following overdose were consistent with the known undesirable events associated with topotecan (see section 4.8).
Slovenian: ki so jih opažali po prevelikem odmerjanju, so bili v skladu z znanimi neželenimi učinki topotekana (glejte poglavje 4.8).
English: Monotherapy (ovarian and small cell lung carcinoma) There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Slovenian: Monoterapija (karcinom jajčnika in drobnocelični pljučni karcinom) Z uporabo topotekana pri bolnikih s hudo okvaro ledvične funkcije (z očistkom kreatinina < 20 ml/min) ni na voljo dovolj izkušenj.
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 arcinoma materničnega vratu po zdravljenju z obsevanjem in bolnicah s stadijem IVB karcinoma materničnega vratu.
English: n = 18), adolescents (aged 12 up to 16 years, n = 9) and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Slovenian: V eni študiji so otroci (stari od 2 do 12 let, n = 18), mladostniki (stari od 12 do 16 let, n = 9) in mlajši odrasli (stari od 16 do 21 let, n = 9) z neodzivnim solidnim tumorjem prejemali odmerek od 1,4 do 2,4 mg/m2.
English: 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]).
Slovenian: 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]).
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Slovenian: Bolniki s predhodno cisplatinsko kemoradioterapijo cisplatin topotekan/cisplatin
English: (n = 8), adolescents (n = 3) and young adults (n = 3) with leukaemia.
Slovenian: V drugi študiji so otroci (n = 8), mladostniki (n = 3) in mlajši odrasli (n = 3) z levkemijo prejemali odmerek od 2,0 do 5,2 mg/m2.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 0.25 mg/m2/day to 1.25 mg/m2/day (or subsequently down to 1.0 mg/m2/day if necessary).
Slovenian: Pri odločitvi za zmanjšanje odmerka za bolnike, ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev < 0,5 x 109/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo ali jim je bilo zdravljenje odloženo zaradi nevtropenije, je treba odmerek zmanjšati po 0,25 mg/m2/dan do 1,25 mg/m2/dan (ali kasneje nato do 1,0 mg/m2/dan, če je treba).
English: Thrombocytopenia: 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).
Slovenian: Trombocitopenija: Huda oblika (število trombocitov < 25 x 109/l) se je razvila pri 25 % bolnikov (v 8% ciklusov zdravljenja), zmerna (število trombocitov med 25,0 in50,0 x 109/l) pa pri 25 % bolnikov
English: Topotecan has been associated with reports of interstitial lung disease (ILD), some of which have been fatal (see section 4.8).
Slovenian: Med uporabo topotekana so opisani primeri intersticijske bolezni pljuč (IBP), nekateri s smrtnim izidom (glejte poglavje 4.8).
English: Potactasol may cause a decrease in the number of blood clotting cells (platelets).
Slovenian: Zdravilo Potactasol lahko povzroči zmanjšanje števila krvnih ploščic (trombocitov), potrebnih za strjevanje krvi.
English: Initial dose The recommended dose of topotecan is 1.5 mg/m2 body surface area per day administered by intravenous infusion over 30 minutes daily for five consecutive days with a three week interval between the start of each course.
Slovenian: Priporočeni odmerek topotekana je 1,5 mg/m2 telesne površine na dan, z intravensko infuzijo, ki traja po 30 minut dnevno, v ciklusih po pet zaporednih dni in s tritedenskimi presledki med začetki posameznih ciklusov zdravljenja.
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count < 0.5 x 109/l) for seven days or more, or severe neutropenia associated with fever or infection or who have had treatment delayed due to neutropenia, the dose should be reduced by 20 % to 0.60 mg/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Slovenian: Pri odločitvi za zmanjšanje odmerka pri bolnicah , ki se jim pojavi huda, sedem ali več dni trajajoča nevtropenija (število nevtrofilcev manj kot 0,5 x 109/l), huda nevtropenija z zvišano telesno temperaturo ali okužbo ali pri bolnicah, ki jim je bilo zdravljenje odloženo zaradi nevtropenije, je treba odmerek za naslednje cikluse zmanjšati za 20 % na 0,60 mg/m2/dan (ali ga po potrebi kasneje še dodatno zmanjšati na 0,45 mg/m2/dan).
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium-free'.
Slovenian: Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na vialo, kar pomeni, da je praktično "brez-natrija".
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Slovenian: Običajen odmerek je 0,75 mg na m2 telesne površine enkrat na dan 3 dni.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy.
Slovenian: 4.2 Odmerjanje in način uporabe Topotekan se sme uporabljati le v ustanovah, ki so specializirane za uporabo citotoksičnih kemoterapevtikov.
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 pvrednost
English: The physico-chemical stability of the medicinal 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 25oC ± 2oC and then diluted.
Slovenian: 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.
English: of patients (6 % of courses).
Slovenian: (v 15% ciklusov zdravljenja).
English: Faecal elimination of total topotecan accounted for 18 % while faecal elimination of N-desmethyl topotecan was 1.7 %.
Slovenian: Ocenjeno je, da se z blatom izloči 18% celotnega topotekana in 1,7 % N-desmetil topotekana.
English: - Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty 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”.
Slovenian: 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''.