FrancophonIA/ELRC3.0 huggingface dataset:
English: In combining topotecan with other chemotherapy agents, reduction of the doses of each medicinal product may be required to improve tolerability.
Croatian: Kad se topotekan primjenjuje u kombinaciji s drugim kemoterapijskim lijekovima, može biti potrebno smanjiti dozu svakog primijenjenog lijeka u svrhu poboljšanja njihove podnošljivosti.
English: Topotecan Actavis is used to treat: - small cell lung cancer that has come back after chemotherapy, or - advanced cervical cancer if surgery or radiotherapy is not possible.
Croatian: Topotecan Actavis se primjenjuje u liječenju: raka pluća malih stanica koji se ponovno pojavio nakon prethodne kemoterapije ili uznapredovalog raka vrata maternice ako kirurški zahvat ili zračenje nije moguće provesti.
English: In clinical trials, rash was reported in 4 % of patients and pruritus in 1.5 % of patients.
Croatian: U kliničkim ispitivanjima osip je zabilježen u 4% bolesnika, a svrbež u 1,5% bolesnika.
English: The use of topotecan should be confined to units specialised in the administration of cytotoxic chemotherapy and should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Croatian: Topotekan se smije primjenjivati samo na odjelima specijaliziranim za primjenu citotoksične kemoterapije te se smije primjenjivati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije (vidjeti dio 6.6).
English: 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.
Croatian: Ako se cisplatin ili karboplatin primjenjuju prvi dan primjene topotekana, mora se primijeniti manja doza svakog lijeka kako bi se poboljšala njihova podnošljivost, u usporedbi s dozama svakog od pojedinačnih lijekova koje se mogu dati ako se spoj platine primjenjuje petog dana liječenja topotekanom.
English: Median time to onset of severe thrombocytopenia was Day 15 and the median duration was five days.
Croatian: Medijan vremena do pojave teške trombocitopenije bio je 15. dan liječenja, a medijan vremena trajanja iznosio je pet dana.
English: Topotecan Actavis is not recommended in case of severe kidney impairment; - if you have liver problems.
Croatian: Topotecan Actavis se ne preporučuje u slučaju teškog oštećenja bubrega. ako imate problema s jetrom.
English: One study included a dose range of 1.4 mg/m to 2.4 mg/m in children (aged 2 up to
Croatian: U prvom ispitivanju raspon doza bio je od 1,4 mg/m2 do 2,4 mg/m2 u djece (u dobi od 2 do 12
English: As with other cytotoxic medicinal products, topotecan may cause foetal harm and therefore women of child bearing potential should be advised to avoid becoming pregnant during therapy with topotecan.
Croatian: Kao i ostali citotoksični lijekovi, topotekan može uzrokovati fetalna oštećenja te je, stoga, potrebno savjetovati žene u reproduktivnoj dobi da izbjegavaju trudnoću tijekom liječenja topotekanom.
English: 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.
Croatian: Učestalost dolje opisanih hematoloških i nehematoloških štetnih događaja dobivena je iz prijava štetnih događaja koji se smatraju kao povezani/moguće povezani s terapijom topotekanom.
English: 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).
Croatian: U populacijskom ispitivanju intravenske primjene istodobna primjena granisetrona, ondansetrona, morfina ili kortikosteroida nije pokazala značajan učinak na farmakokinetiku ukupnog topotekana (aktivnog i inaktivnog oblika).
English: Combination therapy (Cervical carcinoma)
Croatian: Kombinirana terapija (karcinom vrata maternice)
English: The experience in children is limited, therefore no recommendation for treatment of paediatric patients with Topotecan Actavis can be given (see sections 5.1 and 5.2).
Croatian: Zbog ograničenih iskustava u djece, nije moguće dati preporuke o liječenju pedijatrijskih bolesnika lijekom Topotecan Actavis (vidjeti dijelove 5.1 i 5.2).
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 Actavis.
Croatian: Ako se liječite zbog raka vrata maternice, mogu se pojaviti i nuspojave zbog drugog lijeka (cisplatina) kojeg primate zajedno s lijekom Topotecan Actavis.
English: Reconstitution and dilution prior to administration
Croatian: Rekonstitucija i razrjeđivanje prije primjene
English: Reconstitution and dilution of the medicinal product must be performed by trained personnel.
Croatian: Rekonstituciju i razrjeđivanje lijeka mora provoditi educirano osoblje.
English: Volume for 50 microgram/ml solution
Croatian: Volumen za otopinu od 50 mikrograma/ml
English: topotecan was discontinued if the dose had been reduced to 1.0 mg/m and a further dose reduction was required to manage adverse effects.
Croatian: U kliničkim se ispitivanjima primjena topotekana obustavljala ako je njegova doza smanjena na 1,0 mg/m2 i ukoliko je postojala potreba za daljnjim smanjenjem doze u svrhu kontrole štetnih učinaka lijeka.
English: 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).
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) osjećaj opće slabosti i umora, što mogu biti simptomi smanjenja broja crvenih krvnih stanica (anemija).
English: In the event of contact with the eyes, irrigate with large amounts of water.
Croatian: U slučaju kontakta s očima, isperite s obilnom količinom vode.
English: Storage after reconstitution and dilution
Croatian: Čuvanje nakon rekonstitucije i razrjeđivanja
English: The incidence of side effects is more frequent in patients who are in poor general health.
Croatian: Učestalost nuspojava je češća u bolesnika čije je opće zdravstveno stanje loše.
English: Following intravenous administration of topotecan at doses of 0.5 to 1.5 mg/m as a 30 minute infusion daily for five days, topotecan demonstrated a high plasma clearance of 62 l/h (SD 22), corresponding to approximately 2/3 of liver blood flow.
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), koji odgovara približno 2/3 protoka krvi kroz jetru.
English: - Topotecan Actavis 1 mg with 1.1 ml water for injections (as it contains 10 % overage of fill) - Topotecan Actavis 4 mg with 4 ml water for injections
Croatian: Topotecan Actavis 1 mg s 1,1 ml vode za injekcije (jer sadrži 10% suviška u punjenju) Topotecan Actavis 4 mg s 4 ml vode za injekcije
English: Pregnant staff should not handle the cytotoxic preparation.
Croatian: Trudnice ne smiju rukovati citotoksičnim pripravcima.
English: There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Croatian: Postoji zanemarivo nakupljanje ili nema nakupljanja topotekana nakon primjene ponovljenih dnevnih doza te nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Vanjska kutija
English: A. Potamitis Medicare Ltd Τηλ: +357 22583333
Croatian: Potamitis Medicare Ltd Τηλ: +35722583333
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan + BSC.
Croatian: Standardizirani upitnici o simptomima koje su ispunjavali sami bolesnici nakon otvorene (engl. unblinded) procjene pokazali su konzistentan trend u poboljšanju simptoma za oralni topotekan + BSC.
English: The hazard ratio for survival of 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: Topotecan Actavis is for intravenous infusion after reconstitution and dilution.
Croatian: Topotecan Actavis je namijenjen za intravensku infuziju nakon rekonstitucije i razrjeđivanja.
English: Fatigue was observed in approximately 25 % and asthenia in 16 % of patients whilst receiving topotecan.
Croatian: Umor je primijećen u otprilike 25%, a astenija u 16% bolesnika koji su primali topotekan.
English: One Phase 2 study (Study 065) and one Phase 3 study (Study 396) were conducted to evaluate the efficacy of oral topotecan versus intravenous topotecan in patients who had relapsed ≥ 90 days after completion of one prior regimen of chemotherapy (see Table 1).
Croatian: Faza II jednog ispitivanja (studija 065) i faza III drugog (studija 396) provedene su radi procjene djelotvornosti peroralno i intravenski primijenjenog topotekana u bolesnika koji su imali recidiv nakon 90 ili više dana po završetku prethodnog kemoterapijskog protokola (vidjeti Tablicu 1).
English: Topotecan Actavis should not be used in pregnant women, unless clearly necessary.
Croatian: Topotecan Actavis se ne smije koristiti tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje.
English: In dose-finding trials 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.
Croatian: U ispitivanjima u kojima se utvrđuje doza lijeka, provedenim u 523 bolesnice s recidivom karcinoma jajnika i 631 bolesnika s recidivom karcinoma pluća malih stanica, hematološka toksičnost se pokazala čimbenikom ograničenja doze u monoterapiji topotekanom.
English: Each vial contains 2.07 mg (0.09 mmol) sodium.
Croatian: Jedna bočica sadrži 2,07 mg (0,09 mmol) natrija.
English: Approximately 51 % was excreted as total topotecan and 3 % was excreted as N-desmethyl topotecan in the urine.
Croatian: Oko 51% bilo je izlučeno urinom kao ukupni topotekan, a 3% kao N-desmetil topotekan.
English: In case of skin contact, thoroughly wash the affected area with large amount of water.
Croatian: U slučaju kontakta s kožom, temeljito isperite zahvaćeno područje s obilnom količinom vode.
English: Overall, the N-desmethyl metabolite contributed a mean of less than 7 % (range 4-9 %) of the total medicinal product related material accounted for in the urine and faeces.
Croatian: Sveukupno, doprinos N-desmetil metabolita ukupnom materijalu povezanom s lijekom u urinu i fecesu je bio prosječno manji od 7% (u rasponu od 4-9%).
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 23% bolesnika (6% ciklusa).
English: Monotherapy (Small cell lung carcinoma)
Croatian: Monoterapija (karcinom pluća malih stanica)
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 %.
Croatian: Stopa odgovora na topotekan u kombiniranom liječenju karcinoma pluća malih stanica (n=480) za bolesnike s recidivirajućom bolešću osjetljivom na prvu liniju liječenja iznosila je 20,2%.
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/m compared to 21.3 l/h/m
Croatian: Kad se primjenjuje u kombinaciji s cisplatinom (cisplatin 1. dan, topotekan 1. do 5. dan), klirens topotekana 5. dan smanjen je u odnosu na 1. dan (19,1 l/h/m2 u odnosu na 21,3 l/h/m2 [n=9]) (vidjeti dio 4.5).
English: 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.
Croatian: Preporučena doza topotekana u monoterapiji bolesnika s karcinomom pluća malih stanica koji imaju klirens kreatinina između 20 i 39 ml/min iznosi 0,75 mg/m2/dan tijekom pet uzastopnih dana.
English: The median survival was 30.3 weeks (95 % CI: 27.6, 33.4).
Croatian: Medijan vremena preživljenja bio je 30,3 tjedana (95% CI: 27,6; 33,4).
English: Each vial contains 0.52 mg (0.0225 mmol) sodium.
Croatian: Jedna bočica sadrži 0,52 mg (0,0225 mmol) natrija.
English: You must not breast-feed while on treatment with Topotecan Actavis.
Croatian: Ne smijete dojiti za vrijeme liječenja lijekom Topotecan Actavis.
English: Topotecan monotherapy is indicated for the treatment of patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Croatian: Topotekan u monoterapiji indiciran je za liječenje bolesnika s recidivom karcinoma pluća malih stanica kod kojih se ponovno liječenje lijekovima prve linije ne smatra primjerenim (vidjeti dio 5.1).
English: Danmark Actavis A/S Tlf: +45 72 22 30 00
Croatian: Actavis A/S Tlf: +45 72 22 30 00
English: The primary complications of overdose are bone marrow suppression and mucositis.
Croatian: Osnovne komplikacije predoziranja topotekanom su očekivana supresija koštane srži i mukozitis.
English: Τηλ: +30 210 5401500
Croatian: Specifar SA Τel: + 30 210 5401500
English: 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.
Croatian: Nedovoljno je iskustva s primjenom topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥10 mg/dl).
English: Topotecan plus cisplatin had a statistically significant benefit in overall survival relative to cisplatin monotherapy after adjusting for interim analyses (Log-rank p = 0.033).
Croatian: Kombinacija topotekana i cisplatina pokazala je statistički značajnu korist u ukupnom preživljenju u odnosu na monoterapiju cisplatinom nakon prilagodbe rezultata za međuanalizu (log-rank p =0,033).
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light.
Croatian: POSEBNE MJERE ČUVANJA Bočicu čuvati u vanjskoj kutiji radi zaštite od svjetlosti.
English: 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.
Croatian: Kako Topotecan Actavis izgleda i sadržaj pakiranja Topotecan Actavis je pakiran u bezbojne bočice od stakla tipa I, sa sivim bromobutilnim čepom i aluminijskim pokrovom s plastičnim flip-off zatvaračem.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
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 (unblinded) skali procjene simptoma u svakoj od ove dvije studije.
English: The mean metabolite:parent AUC ratio was less than 10 % for both total topotecan and topotecan lactone.
Croatian: Prosječan omjer AUC metabolita i ishodišnog spoja bio je manji od 10% i za ukupni topotekan i za topotekan lakton.
English: 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.
Croatian: Međutim, kada se topotekan kombinira sa spojevima platine, postoji različita interakcija, ovisna o rasporedu primjene lijekova, koja ovisi o tome je li spoj platine primijenjen prvi ili peti dan primjene topotekana.
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, a 50 njih (46%) tijekom 159 (34,9%) ciklusa transfuziju trombocita.
English: Topotecan Actavis may cause a decrease in the number of blood clotting cells (platelets).
Croatian: Topotecan Actavis može uzrokovati smanjenje broja krvnih stanica koje omogućavaju zgrušavanje krvi (trombociti).
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Croatian: Topotekan inhibira topoizomerazu-I na način da stabilizira kovalentni kompleks enzima i jednostrukog lanca DNK što je međuproizvod katalitičkog mehanizma.
English: 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.
Croatian: U fazi III randomiziranog komparativnog ispitivanja Ginekološke onkološke grupe istraživača (studija 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: For more information about cisplatin, please refer to the corresponding package leaflet.
Croatian: Za više informacija o cisplatinu, molimo pogledajte uputu o lijeku za taj lijek.
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 topotekanom u bolesnica s karcinomom vrata maternice.
English: The unadjusted hazard ratio for oral topotecan plus BSC group relative to BSC alone group was 0.64 (95 % CI: 0.45, 0.90).
Croatian: Neprilagođeni omjer hazarda za skupinu liječenu topotekanom peroralno uz BSC, u odnosu na skupinu koja je liječena samo BSC-om, iznosio je 0,64 (95% CI: 0,45; 0,90).
English: In another randomised phase III trial which compared IV topotecan to cyclophosphamide, doxorubicin and vincristine (CAV) in patients with relapsed, sensitive SCLC, the overall response rate was 24.3 % for topotecan compared to 18.3 % for the CAV group.
Croatian: U fazi III randomiziranog ispitivanja u kojem se topotekan primijenjen intravenski 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: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on Day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12 %, n=9) and Cmax (23 %, n=11) was noted on day 5.
Croatian: Prilikom primjene topotekana (0,75 mg/m2/dan tijekom 5 uzastopnih dana) i cisplatina (60 mg/m2/dan 1. dana) u 13 bolesnica s karcinomom jajnika, 5. dan je zabilježen blagi porast vrijednosti AUC-a (12%, n=9) i Cmax (23%, n=11).
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: Tell you doctor if you think any of these could apply to you.
Croatian: Obavijestite svog liječnika ako mislite da se nešto od gore navedenog odnosi na Vas.
English: Other side effects with Topotecan Actavis include:
Croatian: Ostale nuspojave lijeka Topotecan Actavis su:
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.
Croatian: Ako se tijekom terapije kombinacijom topotekana i cisplatina vrijednost kreatinina u serumu poveća iznad 1,5 mg/dl, preporučuje se proučiti detaljne upute za propisivanje cisplatina radi savjeta o smanjenju doze ili nastavku liječenja cisplatinom.
English: Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
Croatian: Hematološka toksičnost je ovisna o dozi te je stoga potrebna redovita kontrola kompletne krvne slike, uključujući trombocite (vidjeti dio 4.2).
English: 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.
Croatian: Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba) blaga bol i upala na mjestu injekcije zbog slučajne primjene lijeka u okolno tkivo (ekstravazacija), npr. uslijed curenja otopine.
English: - 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.
Croatian: Infekcije (vrlo često; mogu se javiti u više od 1 na 10 osoba) sa znakovima poput: - vrućice - ozbiljnog pogoršanja Vašeg općeg stanja - lokalnih simptoma kao što su grlobolja ili osjećaj pečenja pri mokrenju - jake boli u području trbuha, vrućice i mogućeg proljeva (rijetko uz krv) što mogu biti simptomi upale crijeva (neutropenijski kolitis)
English: However, as with other cytotoxic medicinal products topotecan is genotoxic and effects on fertility, including male fertility, cannot be excluded.
Croatian: Međutim, topotekan je genotoksičan, kao i ostali citotoksični lijekovi, te se ne mogu isključiti učinci na plodnost muškaraca i žena.
English: 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.
Croatian: Zbog mehanizma djelovanja topotekan je genotoksičan za stanice sisavaca (stanice mišjeg limfoma i ljudske limfocite) in vitro i za stanice mišje koštane srži in vivo.
English: The concentrates tested were stored at 25 ± 2°C for 12 hours and 24 hours respectively after reconstitution, and then diluted.
Croatian: Ispitani koncentrati su bili pohranjeni na temperaturi od 25 ± 2°C u trajanju od 12 sati, odnosno 24 sata nakon otapanja i potom razrijeđeni.
English: 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).
Croatian: Incidencija navedenih nuspojava potencijalno je veća u bolesnika slabog funkcionalnog stanja (vidjeti dio 4.4).
English: Then seek medical evaluation by a physician.
Croatian: Potom potražite pomoć liječnika.
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 bolova u abdomenu potrebno je posumnjati na neutropenični kolitis.