FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the patients who received more than 6 cycles of therapy, 91 % completed the study as planned or were treated until disease progression with only 3 % withdrawn for adverse events.
Croatian: 91% je završilo sa sudjelovanjem u ispitivanju kako je i predviđeno, ili su liječene do progresije bolesti uz samo 3% povučenih iz ispitivanja zbog pojave štetnih događaja.
English: 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.
Croatian: U fazi III randomiziranog ispitivanja u kojem se topotekan primijenjen intravenski (i.v.) uspoređivao s ciklofosfamidom, doksorubicinom i vinkristinom (CAV protokol) u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, ukupna stopa odgovora na topotekan iznosila je 24,3%, u usporedbi s 18,3% za skupinu koja je primala CAV protokol.
English: If cisplatin is discontinued, there are insufficient data regarding continuing monotherapy with topotecan in patients with cervical cancer.
Croatian: U slučaju prekida liječenja cisplatinom, nema dovoljno podataka o nastavku monoterapije samim topotekanom u bolesnica s karcinomom vrata maternice.
English: The experience in children is limited and treatment is therefore not recommended.
Croatian: Budući da je iskustvo u primjeni ovoga lijeka u djece ograničeno, ne preporučuje se njegova primjena u toj dobnoj skupini.
English: 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.
Croatian: Peroralno i intravenski primijenjen topotekan pokazali su slično ublažavanje simptoma u bolesnika s recidivirajućim karcinomom pluća malih stanica osjetljivim na liječenje, standardiziranim upitnicima samih bolesnika na otvorenoj (engl. unblinded) skali procjene simptoma u svakoj od ove dvije studije.
English: Sudden swelling of the skin and mucosa (e.g. throat or tongue) caused by fluid build up (angioedema).
Croatian: Naglo oticanje kože i sluznice (npr. grla ili jezika) uzrokovano nakupljanjem tekućine
English: In the oral topotecan plus BSC group there was a statistically significant improvement in overall survival compared with the BSC alone group (Log- rank p = 0.0104).
Croatian: U skupini koja je primala oralni topotekan uz BSC bilo je statistički značajno poboljšanje u ukupnom preživljenju u odnosu na skupinu koja je liječena samo BSC-om (log-rang p = 0,0104).
English: The use of Topotecan Teva is not recommended in patients with severe liver impairment; if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs (also see section 4 ‘Possible side effects'); if you suffer from unusual bruising or bleeding (also see section 4 ‘Possible side effects'); if you are feeling very ill.
Croatian: Primjena lijeka Topotekan Teva ne preporučuje se bolesnicima koji imaju teško oštećenje jetre; - ako trenutno imate problema s plućima ili ako ste bili podvrgnuti radioterapiji ili uzimali lijekove koji su Vam oštetili pluća (vidjeti također dio 4. „Moguće nuspojave“); - ako imate neuobičajene modrice ili krvarenje (vidjeti također dio 4. „Moguće nuspojave“); - ako se osjećate jako bolesno.
English: Tumour types included were Ewing's sarcoma/primitive neuroectodermal tumour, neuroblastoma, osteoblastoma, and rhabdomyosarcoma.
Croatian: Uključene su bile sljedeće vrste tumora: Ewingov sarkom/primitivni neuroektodermalni tumor, neuroblastom, osteoblastom i rabdomiosarkom.
English: Topotecan is contraindicated during breast-feeding (see section 4.3).
Croatian: Topotekan je kontraindiciran tijekom dojenja (vidjeti dio 4.3).
English: The unadjusted hazard ratio for the oral topotecan plus BSC group relative to the BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Croatian: Neprilagođeni omjer hazarda za skupinu liječenu oralnim topotekanom uz BSC, u odnosu na skupinu koja je liječena samo BSC-om, iznosio je 0,64 (95% CI: 0,45; 0,90).
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.
Croatian: Sveukupno, doprinos N-desmetil metabolita ukupnom materijalu povezanom s topotekanom u urinu i fecesu je bio prosječno manji od 7% (u rasponu od 4 - 9 %).
English: Topotecan Teva is supplied as a concentrate for solution for infusion.
Croatian: Topotekan Teva dostupan je u obliku koncentrata za otopinu za infuziju.
English: However as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Croatian: Međutim, kao i ostali citotoksični lijekovi, topotekan je genotoksičan te se učinci na plodnost muškaraca i žena ne mogu isključiti.
English: Colourless, type I glass vial with bromobutyl rubber stopper, aluminium seal and polypropylene snapcap containing 1 ml or 4 ml of concentrate.
Croatian: I s brombutilnim gumenim čepom, aluminijskim prstenom i polipropilenskom zaštitnom kapicom koja sadrži 1 ml ili 4 ml koncentrata.
English: Cisplatin is administered as an intravenous infusion on day 1 at a dose of 50 mg/m2/day and following the topotecan dose.
Croatian: Cisplatin se primjenjuje prvog dana u obliku intravenske infuzije u dozi od 50 mg/m2 /dan i to nakon doze topotekana.
English: The hazard ratio for survival with IV topotecan relative to CAV was 1.04 (95 % CI 0.78 - 1.40).
Croatian: Omjer hazarda za preživljenje kod intravenski primjenjenog topotekana u odnosu na CAV protokol bio je 1,04 (95% CI: 0,78; 1,40).
English: In patients presenting with fever, neutropenia, and a compatible pattern of abdominal pain, the possibility of neutropenic colitis should be considered.
Croatian: U bolesnika s vrućicom, neutropenijom i odgovarajućim oblikom boli u abdomenu, potrebno je posumnjati na neutropenički kolitis.
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove (EMA) http://www.ema.europa.eu/.
English: The concentrate is pale yellow in colour and contains 1 mg per ml of topotecan.
Croatian: Koncentrat je blijedo žute boje i sadržava 1 mg po ml topotekana.
English: In clinical studies with topotecan in combination with cisplatin for the treatment of cervical cancer, therapy was only initiated in patients with serum creatinine less than or equal to 1.5 mg/dl.
Croatian: U kliničkim ispitivanjima kombinacije topotekana i cisplatine u liječenju karcinoma vrata maternice, terapija je započeta samo u bolesnica s vrijednošću kreatinina u serumu ≤1,5 mg/dl.
English: When topotecan is used in combination with cisplatin, the full prescribing information for cisplatin should be consulted.
Croatian: Kad se topotekan koristi u kombinaciji s cisplatinom potrebno je slijediti detaljne upute za propisivanje cisplatina.
English: Instructions on how to dilute, store and dispose of Topotecan Teva Instructions for dilution
Croatian: Upute za razrjeđivanje, čuvanje i odlaganje lijeka Topotekan Teva Upute za razrijeđivanje
English: Summary of survival, response rate, and time to progression in SCLC patients treated with oral or intravenous topotecan
Croatian: Sažeti prikaz preživljenja, stope odgovora i vremena do progresije bolesti u bolesnika s karcinomom pluća malih stanica liječenih peroralnim ili intravenskim topotekanom
English: patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Croatian: • bolesnika s recidivom karcinoma pluća malih stanica (SCLC, od engl. small cell lung cancer) koji nisu pogodni za ponovno uvođenje prve linije liječenja (vidjeti dio 5.1).
English: - The active substance is topotecan hydrochloride.
Croatian: - Djelatna tvar je topotekanklorid.
English: In addition, 5 % of all patients treated (1 % of courses) developed sepsis (see section 4.4).
Croatian: Nadalje, 5% svih liječenih bolesnika (1%
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m2 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.
Croatian: Nakon intravenske primjene topotekana u dozi od 0,5 do 1,5 mg/m2 u obliku 30-minutne infuzije dnevno tijekom 5 dana, topotekan je pokazao visoki klirens iz plazme u vrijednosti od 62 l/h (SD 22),
English: Talk to your doctor or nurse before using Topotecan Teva: if you have any kidney problems.
Croatian: Obavijestite svog liječnika ili medicinsku sestru prije primjene lijeka Topotekan Teva:
English: Topotecan Teva is available in cartons containing 1 vial and 5 vials.
Croatian: Topotekan Teva je dostupan u kutijama s 1 i 5 bočica.
English: When treating cervical cancer, Topotecan Teva is combined with another medicine called cisplatin.
Croatian: liječenju raka vrata maternice Topotekan Teva se kombinira s drugim lijekom koji se zove cisplatin.
English: In a randomised, comparative Phase III study conducted by the Gynecologic 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.
Croatian: (ispitivanje GOG 0179), uspoređivana je kombinacija topotekana i cisplatina (n = 147) s monoterapijom cisplatinom (n=146) u liječenju histološki potvrđenog perzistentnog recidivirajućeg karcinoma vrata maternice ili karcinoma vrata maternice stadija IVB koji nije bio pogodan za kurativno kirurško liječenje i/ili radioterapiju.
English: Severe allergic (anaphylactic) reactions causing swelling of the lips, face or neck leading to severe difficulty in breathing, skin rash or hives, anaphylactic shock (a severe reduction in blood pressure, paleness, agitation, weak pulse, decreased consciousness).
Croatian: - Teške alergijske (anafilaktičke) reakcije, uključujući oticanje usana, lica ili vrata koje dovodi do velikih teškoća kod disanja, kožni osip ili koprivnjača, anafilaktički šok (teško sniženje krvnog tlaka, bljedilo, uznemirenost, slab puls, smanjena svijest).
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 Topotecan Teva.
Croatian: Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka, cisplatina, kojeg primate zajedno s lijekom Topotekan Teva.
English: Breast-feeding (see section 4.6).
Croatian: − Dojenje (vidjeti dio 4.6).
English: Ovarian and small cell lung cancer The usual dose is 1.5 mg per m2 of body surface area once daily for 5 days.
Croatian: Rak jajnika i rak pluća malih stanica Uobičajena doza je 1,5 mg/m² površine tijela na dan tijekom 5 dana.
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4).
Croatian: 1 Smrtni ishodi zbog sepse prijavljeni su u bolesnika koji su liječeni topotekanom (vidjeti dio 4.4).
English: 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 (also see section 2 ‘What you need to know before you use Topotecan Teva').
Croatian: Pod povišenim ste rizikom od te teške bolesti (intersticijske bolesti pluća) ako već imate bolest pluća, bili ste liječeni zračenjem pluća, ili ako ste prije uzimali lijekove koji mogu oštetiti pluća (vidjeti također dio 2. „Što morate znati prije nego što počnete primjenjivati Topotekan Teva“).
English: Inflammation and ulcers of the mouth, throat, tongue or gums (mucositis).
Croatian: - Upala sluznice i stvaranje rana (ulceracija) usne šupljine, grla, jezika ili desni (mukozitis).
English: Severe bleeding (associated with thrombocytopenia)
Croatian: Nepoznato jako krvarenje (povezano s trombocitopenijom)
English: Overall recovery of topotecan-related material following five daily doses of topotecan was 71 to 76 % of the administered IV dose.
Croatian: Ukupni povrat materijala povezanog s topotekanom nakon pet dnevnih doza topotekana iznosio je 71
English: 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).
Croatian: Teška neutropenija (broj neutrofila < 0,5 x 109/1) tijekom prvog ciklusa zabilježena je u 55% bolesnika, od kojih je 20% bolesnika imalo neutropeniju u trajanju sedam dana ili dulje, a tijekom čitavog liječenja ukupno 77% bolesnika (39% ciklusa).
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).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila < 0,5 x 109/1) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti za 0,25 mg/m2/dan na 1,25 mg/m2/dan (ili ukoliko je potrebno, nadalje smanjiti dozu na 1,0 mg/m2/dan).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: 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,
Croatian: U komparativnom ispitivanju topotekana i paklitaksela u bolesnica s karcinomom jajnika prethodno liječenih kemoterapijom baziranom na platini (n = 112 i n = 114 po istom redoslijedu), postotak odgovora na lijek (95% CI) iznosio je 20,5% (13%, 28%) u odnosu na 14% (8%, 20%), a medijan vremena do progresije iznosio je 19 tjedana u odnosu na 15 tjedana (omjer hazarda 0,7 [0,6, 1,0]) za topotekan i paklitaksel.
English: 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).
Croatian: U farmakokinetičkom ispitivanju djece s refraktornim solidnim tumorima, ustanovljena je maksimalna podnošljiva doza od 2,0 mg/m2/dan uz primjenu G-CSF, odnosno 1,4 mg/m2/dan bez primjene G-CSF (vidjeti dio 5.2) na temelju toksičnosti u obliku mijelosupresije koja je bila ograničavajuća za dozu.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na vanjskom pakiranju i bočici iza oznake „Rok valjanosti“ ili „EXP“.
English: Topotecan Teva contains sodium
Croatian: Topotekan Teva sadrži natrij
English: Cisplatin 50 mg/m2 on day 1 + Topotecan 0.75 mg/m2 on days 1-3, every 21 days
Croatian: topotekan 0,75 mg/m2 1.-3. dana svakih 21 dan
English: Frequently reported non-haematological effects were gastrointestinal, such as nausea (52 %), vomiting (32 %), diarrhoea (18 %), constipation (9 %) and mucositis (14 %).
Croatian: povraćanja (32%), proljeva (18%), konstipacije (9%) i mukozitisa (14%).
English: Plasma clearance in patients with hepatic impairment (serum bilirubin between 1.5 and 10 mg/dl) decreased to about 67 % when compared with a control group of patients.
Croatian: Oštećenje bubrega Klirens plazme u bolesnika s oštećenjem bubrega (klirens kreatinina 41-60 ml/min) smanjio se na približno 67% u usporedbi s kontrolnom skupinom bolesnika.
English: Severe (Grade 3 or 4) fatigue and asthenia both occurred with an incidence of 3 %.
Croatian: Incidencija pojave teškog (stupanj 3 ili 4) umora i astenije iznosila je 3%.
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]).
Croatian: - Ranice u ustima, otežano gutanje, bol u trbuhu, mučnina, povraćanje, proljev, krvave stolice (mogući znakovi i simptomi upale sluznice usta, želuca i/ili crijeva [upala sluznice]).
English: 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).
Croatian: Teška trombocitopenija (broj trombocita < 25 x 109/l) zabilježena je u 25% bolesnika (8% ciklusa), a umjerena (broj trombocita između 25,0 i 50,0 x 109/l) u 25% bolesnika (15% ciklusa).
English: The cellular sequela of inhibition of topoisomerase-I by topotecan is the induction of proteinassociated DNA single-strand breaks.
Croatian: Posljedica inhibicije topoizomeraze-I topotekanom na staničnoj razini je indukcija cijepanja jednog lanca DNK povezanih s proteinom.
English: However there are insufficient data available to make a dose recommendation for this patient group (see section 4.2).
Croatian: Međutim, nema dovoljno dostupnih podataka za preporuku za doziranje u ovoj skupini bolesnika (vidjeti dio 4.2).
English: ovarian cancer or small cell lung cancer that has come back after chemotherapy advanced cervical cancer if surgery or radiotherapy treatment is not possible.
Croatian: - uznapredovalog raka vrata maternice ako kirurški zahvat ili zračenje nije moguće provesti.
English: Use of topotecan in these patient groups is not recommended (see section 4.2).
Croatian: Primjena topotekana u tih skupina bolesnika se ne preporučuje (vidjeti dio 4.2).
English: 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).
Croatian: Tijekom prvog ciklusa vrućica ili infekcija povezana s teškom neutropenijom javila se u 16% bolesnika, a tijekom čitavog liječenja u ukupno
English: Cervical cancer The usual dose is 0.75 mg per m2 of body surface area once daily for 3 days.
Croatian: Uobičajena doza je 0,75 mg/m² površine tijela na dan tijekom 3 dana.
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.
Croatian: Preporučena doza topotekana u monoterapiji bolesnica s karcinomom jajnika i bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 20 i 39 ml/min iznosi 0,75
English: 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.
Croatian: U ovom je ispitivanju 46 bolesnika (43%) tijekom 192 (42,1%) ciklusa primilo G-CSF; 65 bolesnika (60%) je tijekom 139 (30,5 %) ciklusa primilo transfuziju koncentrata eritrocita,
English: Topotecan Teva 1 mg/1 ml concentrate for solution for infusion EU/1/09/552/001- 1vial
Croatian: Topotekan Teva 1 mg/1 ml koncentrat za otopinu za infuziju EU/1/09/552/001 - 1 bočica
English: (95% CI) Hazard ratio (95% CI)
Croatian: (95% CI) Omjer hazarda (95% CI)
English: The normal procedures for proper handling and disposal of anticancer medicinal products should be adopted:
Croatian: Opće mjere opreza Potrebno je slijediti uobičajena pravila za ispravno rukovanje i odlaganje lijekova za liječenje karcinoma, tj.:
English: The other ingredients are: tartaric acid (E334), hydrochloric acid (E507), sodium hydroxide (E524) and water for injections.
Croatian: - Drugi sastojci su: tartaratna kiselina (E334), kloridna kiselina (E507), natrijev hidroksid (E524) i voda za injekcije.
English: 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.
Croatian: (n = 70) u bolesnika s recidivom karcinoma nakon prve linije liječenja (medijan vremena do progresije od prve linije liječenja iznosio je 84 dana za oralni topotekan plus BSC, a 90 dana za sam BSC) i u bolesnika koji nisu bili pogodni za ponovno liječenje intravenski primijenjenom kemoterapijom.
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.
Croatian: N-desmetil metabolit koji je pokazao sličnu ili manju aktivnost od ishodišnog spoja u testu koji koristi stanice (engl. cell-based assay).
English: Topotecan Teva 4 mg/4 ml concentrate for solution for infusion EU/1/09/552/003- 1 vial
Croatian: Topotekan Teva 4 mg/4 ml koncentrat za otopinu za infuziju EU/1/09/552/003 - 1 bočica
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds have been infrequent.
Croatian: Rijetko su zabilježene ozbiljne posljedice povezane s trombocitopenijom, uključujući smrtne slučajeve zbog krvarenja povezanog s tumorom.
English: The active substance is topotecan hydrochloride.
Croatian: • Djelatna tvar je topotekanklorid.
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).
Croatian: Ukoliko se u bolesnika s teškom neutropenijom (broj neutrofila < 0,5 x 109/1) koja traje sedam dana ili dulje ili s teškom neutropenijom praćenom vrućicom ili infekcijom, ili u onih kojima je zbog neutropenije liječenje odgođeno izabere smanjenje doze, istu je potrebno smanjiti u sljedećim ciklusima za 20 %, na 0,60 mg/m2/dan (ukoliko je potrebno nadalje smanjiti dozu na 0,45 mg/m2/dan).
English: Futher dilution of the appropriate volume of the concentrate with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection to reach a final topotecan concentration of between 25 and 50 microgram/ml in the solution for infusion.
Croatian: Kako bismo dobili konačnu koncentraciju topotekana od 25 do 50 mikrograma/ml u otopini za infuziju, potrebno je dodatno razrijediti odgovarajući volumen koncentrata ili pomoću 9 mg/ml (0,9%) otopine za injekciju natrijeva klorida ili pomoću 50 mg/ml (5%) otopine glukoze.
English: Very rare (may affect up to 1 in 10,000 people)
Croatian: Vrlo rijetke nuspojave (mogu se javiti do 1 na 10 000 osoba)
English: Your dose of Topotecan Teva may need to be adjusted.
Croatian: Možda će Vam biti potrebna prilagodba doze lijeka Topotekan Teva.
English: Feeling sick (nausea), vomiting, diarrhoea, stomach pain, constipation.
Croatian: - Mučnina, povraćanje; proljev; bol u trbuhu; zatvor (konstipacija).
English: tartaric acid (E334), hydrochloric acid (E507) (for pH adjustment), sodium hydroxide (E524) (for pH adjustment) and water for injections.
Croatian: Tartaratna kiselina (E334), kloridna kiselina (E507) (za podešavanje pH), natrijev hidroksid (E524) (za podešavanje pH) i voda za injekcije.