FrancophonIA/ELRC3.0 huggingface dataset:
English: have abnormal liver test results as this may be related to a serious and potentially fatal liver injury (hepatotoxicity).
Croatian: - imate odstupanja u jetrenim nalazima, jer to može biti povezano s ozbiljnim i potencijalno smrtonosnim oštećenjem jetre (hepatotoksičnost).
English: Adcetris is used to treat CTCL where a specific type of protein is present on the cells' surface.
Croatian: Adcetris se koristi za liječenje CTCL-a u kojemu se na površini stanice nalazi specifična vrsta proteina.
English: Instructions for reconstitution
Croatian: Upute za rekonstituciju
English: The primary endpoint of PFS was met and showed a difference in median PFS of 18.8 months in favour of the treatment arm.
Croatian: Primarni ishod PFS-a je dosegnut i pokazala se razlika medijana PFS-a od 18,8 mjeseci u korist skupine s liječenjem.
English: Progression Free Survival (PFS) per IRF Median (months)
Croatian: Preživljenje bez progresije bolesti (PFS) po IRF-u Medijan (mjeseci)
English: In clinical trials, the majority of patients had resolution or improvement of their symptoms (see section 4.8).
Croatian: U kliničkim ispitivanjima, simptomi su se u većine bolesnika povukli ili poboljšali (vidjeti dio 4.8).
English: At the time of the primary analysis, the median follow-up time for both arms was 30 months (range, 0 to 50).
Croatian: U vrijeme primarne analize medijan vremena praćenja za obje skupine bio je 30 mjeseci (raspon, 0 do 50).
English: However, any patient who experiences an event of hyperglycaemia should have their serum glucose closely monitored.
Croatian: Međutim, kod svakog bolesnika koji je imao epizodu hiperglikemije treba pažljivo pratiti glukozu u serumu.
English: Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out.
Croatian: Iako nije utvrđena uzročna povezanost s lijekom ADCETRIS, rizik od plućne toksičnosti ne može se isključiti.
English: Of the 329 patients, 165 patients were randomised to the treatment arm and 164 patients were randomised to the placebo arm.
Croatian: Od 329 bolesnika, njih 165 randomizirano je u skupinu liječenja, a 164 u skupinu primanja placeba.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Croatian: Europska agencija za lijekove će barem jednom godišnje procjenjivati sve nove informacije o ovom lijeku te će se ova uputa obnavljati prema potrebi.
English: Reduce dose to 0.9 mg/kg up to a maximum of 90 mg every 2 weeks
Croatian: Dozu smanjite na 0,9 mg/kg, do maksimalnih 90 mg svaka 2 tjedna
English: Frequencies of adverse reactions described below and in Table 3 have been determined based on data generated from clinical studies.
Croatian: Učestalost nuspojava koje su opisane niže i u tablici 3 određena je na temelju podataka prikupljenih u kliničkim ispitivanjima.
English: • Extranodal involvement at time of pre-ASCT relapse, including extranodal extension of nodal masses into adjacent vital organs
Croatian: • Ekstranodularna zahvaćenost u vrijeme relapsa prije ASCT-a, uključujući ekstranodularno širenje nodularnih tvorbi u susjedne vitalne organe
English: More serious adverse events and dose modifications (including dose delays, reductions, and discontinuations) were reported in the older patients compared with the overall study population.
Croatian: Ozbiljniji štetni događaji i prilagodbe doziranja (uključujući odgodu doze, smanjenje doze i prekid liječenja) bile su češće prijavljene u starijih osoba u usporedbi s ukupnom ispitivanom populacijom.
English: Complete remission (CR) was 33% (34 of 102 patients in the ITT set).
Croatian: Potpuna remisija (CR) postignuta je u 33% (34 od 102 bolesnika u grupi ITT).
English: The upper 90% confidence interval (CI) around the mean effect on QTc was < 10 msec at each of the Cycle 1 and Cycle 3 post-baseline time points.
Croatian: Gornji 90%-tni interval pouzdanosti (CI) srednje vrijednosti učinka na QTc interval iznosio je < 10 ms u svakom ciklusu 1 i ciklusu 3 nakon početne vremenske točke.
English: There is no known antidote for overdose of ADCETRIS.
Croatian: Nema poznatog antidota za predoziranje lijekom ADCETRIS.
English: Stratification factors at randomisation.
Croatian: Čimbenici stratifikacije prilikom randomizacije.
English: Progressive multifocal leukoencephalopathy
Croatian: Progresivna multifokalna leukoencefalopatija
English: Medical resource utilization (MRU) analysis showed that hospitalizations and outpatient visits, as well as working days/other activities missed by patients and caregivers were lower with ADCETRIS compared with placebo in patients with HL at increased risk of relapse.
Croatian: Medical resource utilization, MRU) pokazala je da je broj hospitalizacija i ambulantnih posjeta, kao i radnih dana/ostalih aktivnosti propuštenih od strane bolesnika i njegovatelja bio niži kod lijeka ADCETRIS u usporedbi s placebom u bolesnika s HL-om s povećanim rizikom od relapsa.
English: Interaction with medicinal products metabolised through CYP3A4 route (CYP3A4 inhibitors/inducers)
Croatian: Interakcije s lijekovima koji se metaboliziraju putem CYP3A4 (inhibitori/induktori CYP3A4)
English: Keep the vial in the original carton in order to protect from light.
Croatian: Bočicu čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Store in a refrigerator (2 °C-8 °C).
Croatian: Čuvati u hladnjaku (2 °C-8 °C).
English: Fatigue, pyrexia, infusion-related reactions
Croatian: Umor, pireksija, reakcije povezane s infuzijom
English: Each vial contains approximately 13.2 mg of sodium.
Croatian: Jedna bočica sadrži približno 13,2 mg natrija.
English: The most commonly reported opportunistic infections were herpes viral infections.
Croatian: Najčešće prijavljivane oportunističke infekcije bile su infekcije herpes virusom.
English: At the time of analysis, the median modified PFS follow-up time for both arms was 24.6 months Data from an interim OS analysis
Croatian: U vrijeme analize, medijan mPFS razdoblja praćenja za oba terapijska režima je bio 24,6 mjeseci Podaci iz interim OS analize
English: Response to treatment with ADCETRIS was assessed by Independent Review Facility (IRF) using the Revised Response Criteria for Malignant Lymphoma (Cheson, 2007).
Croatian: Odgovor na liječenje lijekom ADCETRIS procijenila je Skupina za neovisnu procjenu (IRF) pomoću revidiranih kriterija odgovora na terapiju (Cheson, 2007).
English: Response assessments were performed at cycles 2, 4, 7, 10, 13 and 16 with PET at cycles 4 and 7.
Croatian: Procjene odgovora napravljene su u 2., 4., 7., 10., 13. i 16. ciklusu te PET u 4. i 7. ciklusu.
English: All patients had a histologically confirmed CD30-expressing disease.
Croatian: Svi bolesnici imali su histološki potvrđenu CD30 pozitivnu bolest.
English: Keep out of the sight and reach of children
Croatian: Čuvati izvan pogleda i dohvata djece.
English: See Table 6 for patient characteristics.
Croatian: Vidjeti tablicu 6 za karakteristike bolesnika.
English: In vitro studies using human liver microsomes indicate that MMAE inhibits only CYP3A4/5 at concentrations much higher than was achieved during clinical application.
Croatian: In vitro ispitivanja pomoću mikrosoma ljudske jetre pokazuju da MMAE inhibira samo CYP3A4/5 pri koncentracijama puno višima od onih postignutih tijekom kliničke primjene.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed Risk Management Plan presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: See Table 1 below for appropriate dosing recommendations (see also section 4.4).
Croatian: U tablici 1 ispod navedene su preporuke za adekvatno doziranje (vidjeti također dio 4.4).
English: Grade 4 (sensory neuropathy which is disabling or motor neuropathy that is life threatening or leads to paralysis)
Croatian: Stupanj 4 (onesposobljavajuća senzorna neuropatija ili motorička neuropatija koja je opasna po život ili uzrokuje paralizu)
English: Infection a, upper respiratory tract infection Infection a, upper respiratory tract infection
Croatian: Infekcija a, infekcija gornjih dišnih puteva Infekcija a, infekcija gornjih dišnih puteva
English: MMAE has been shown to have aneugenic properties (see section 5.3).
Croatian: Pokazalo se da MMAE ima aneugenična svojstva (vidjeti dio 5.3).
English: Doxorubicin, vinblastine and dacarbazine (AVD)
Croatian: Doksorubicin, vinblastin i dakarbazin (AVD)
English: Adcetris is also used to lower the likelihood of classical Hodgkin Lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors.
Croatian: Adcetris se također primjenjuje za smanjenje vjerojatnosti povratka klasičnog Hodgkinovog limfoma nakon transplantacije autolognih matičnih stanica u bolesnika s određenim čimbenicima rizika.
English: Severity grade of neutropenia (signs and symptoms [abbreviated description of CTCAE a])
Croatian: Stupanj težine neutropenije (znakovi i simptomi [skraćeni opis CTCAE a])
English: The recommended dose of ADCETRIS is infused over 30 minutes.
Croatian: Preporučena doza lijeka ADCETRIS daje se infuzijom u trajanju od 30 minuta.
English: No patients required dose reduction or discontinued treatment for neutropenia.
Croatian: Ni u jednog bolesnika nije bilo potrebno smanjenje doze ili prekid liječenja zbog neutropenije.
English: If Grade 3 or Grade 4 neutropenia develops, refer to section 4.2.
Croatian: Ako se razvije neutropenija 3. stupnja ili 4. stupnja, pogledajte dio 4.2.
English: Table 1: Dosing recommendations for neutropenia
Croatian: Tablica 1: Preporuke za doziranje kod neutropenije
English: Overall Survival Number of deaths (%)
Croatian: Ukupno preživljenje Broj smrtnih ishoda (%)
English: If your infusion is restarted, your doctor may increase the time over which your infusion is given so that you may be able to tolerate it better.
Croatian: Ako se ponovno započne s infuzijom, liječnik može produljiti vrijeme trajanja infuzije, tako je možete lakše podnijeti.
English: DO NOT SHAKE.
Croatian: NEMOJTE TRESTI.
English: Results from these phase 1 studies and from the NPP experience showed, that in patients with relapsed or refractory HL without prior ASCT, clinically meaningful responses can be achieved as evidenced by an investigator-assessed, objective response rate of 54% and a complete remission rate of 22% after a median of 5 cycles of ADCETRIS.
Croatian: Rezultati ovih ispitivanja faze 1 i iskustva iz NPP pokazali su da se u bolesnika s relapsom ili refraktornim HL bez prethodne ASCT mogu postići klinički značajni odgovori, kako je dokazano objektivnom stopom odgovora prema procjeni ispitivača od 54% i stopom potpune remisije od 22% nakon medijana od 5 primljenih ciklusa lijeka ADCETRIS.
English: Infections and infestations Very common:
Croatian: Infekcije i infestacije Vrlo često:
English: In humans, the mean steady state volume of distribution was approximately 6-10 l for ADC.
Croatian: Kod ljudi srednja vrijednost volumena distribucije u stanju dinamičke ravnoteže iznosila je 6-10 l za ADC.
English: Pharmacotherapeutic group: Antineoplastic agents; other antineoplastic agents; monoclonal antibodies, ATC code: L01XC12
Croatian: Farmakoterapijska skupina: antineoplastički lijekovi; drugi antineoplastički lijekovi; monoklonska protutijela, ATK oznaka: L01XC12
English: Febrile neutropenia reported in < 1% of the patients (see section 4.2).
Croatian: Febrilna neutropenija prijavljena je u < 1% bolesnika (vidjeti dio 4.2).
English: Overall response rates for MF were 54-66%; pcALCL, 67%; SS, 50%; LyP, 92%; and mixed CTCL histology, 82-85%.
Croatian: Ukupna stopa odgovora za MF bila je 54-66%; pcALCL, 67%; SS, 50%; LyP, 92% i CTCL miješane histologije,
English: 3.6 vials a.
Croatian: 3,6 bočica a.
English: Any portion left in the vial, after withdrawal of the volume to be diluted, must be disposed of in accordance with local requirements.
Croatian: Dio koji preostane u bočici, nakon što se izvuče volumen koji će se razrijediti, mora se zbrinuti sukladno lokalnim propisima.
English: There were no relevant differences in the patient and disease characteristics between the two arms.
Croatian: Nije bilo značajnih razlika u karakteristikama bolesnika i bolesti između dva kraka ispitivanja.
English: To perform a single-arm study in a similar patient population as the sALCL population investigating response rate, duration of response, rate of (second) ASCT and data in subpopulations (including but not necessarily restricted to ALK status and age) based on a CHMP agreed protocol (Study C25006).
Croatian: Provesti ispitivanje s jednim krakom u populaciji bolesnika sličnoj populaciji bolesnika s sALCL ispitujući stopu odgovora, trajanje odgovora, brzinu (drugog) ASCT i podatke u podpopulacijama (što uključuje, ali nije nužno ograničeno na ALK status i dob) na temelju protokola dogovorenog s CHMP-om (ispitivanje C25006).
English: Adcetris is a white to off-white cake or powder for concentrate for solution for infusion provided in a glass vial.
Croatian: Adcetris je bijeli do gotovo bijeli kolačić ili prašak za koncentrat za infuziju u staklenoj bočici.
English: Patients should be monitored for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paraesthesia, discomfort, a burning sensation, neuropathic pain or weakness.
Croatian: Bolesnike treba nadzirati zbog simptoma neuropatije, kao što su hipoestezija, hiperestezija, parestezija, nelagoda, osjećaj žarenja, neuropatska bol ili slabost.
English: Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%).
Croatian: Ozbiljne nuspojave zabilježene u ≥ 3% bolesnika uključuju febrilnu neutropeniju (17%), pireksiju (6%) i neutropeniju (3%).
English: The exposure of MMAE (as assessed by AUC14D between Cycle 1 and Cycle 3) appeared to decrease with time by approximately 50%.
Croatian: Izloženost MMAE (prema analizi AUC14D između 1. i 3. ciklusa) se s vremenom smanjivala za oko 50%.
English: Not reached
Croatian: Nije dosegnuto
English: In the physician's choice arm, the median duration of treatment (number of cycles) for patients receiving bexarotene was approximately 16 weeks (5.5 cycles) and 11 weeks (3 cycles) for patients receiving methotrexate.
Croatian: U skupini koja je liječena po liječnikovom izboru, medijan trajanja liječenja (broj ciklusa) za bolesnike koji su primali beksaroten bio je oko 16 tjedana (5,5 ciklusa), odnosno 11 tjedana (3 ciklusa) za bolesnike koji su primali metotreksat.
English: Patients also had a higher incidence of arthralgia, Grade 3 anaemia, and back pain compared to patients observed in the combined pivotal phase 2 studies.
Croatian: Također, bolesnici su imali višu incidenciju artralgije, anemije 3. stupnja te bolova u leđima u usporedbi s bolesnicima u kombiniranim pivotalnim ispitivanjima faze 2.
English: Number of deaths (%)
Croatian: Broj smrtnih slučajeva (%)
English: No meaningful differences in quality of life (assessed by the EuroQol five dimensions questionnaire [EQ-5D] and Functional Assessment of Cancer Therapy-General [FACT-G]) were observed between the treatment arms.
Croatian: Između dvije liječene skupine nisu primijećene značajne razlike u kvaliteti života (po procjeni EuroQol-ovog upitnika s pet dimenzija [EQ-5D] i Funkcionalne procjene liječenja raka - Opće [FACT-G]).
English: Binding of the ADC to CD30 on the cell surface initiates internalisation of the ADC-CD30 complex, which then traffics to the lysosomal compartment.
Croatian: Vezanjem ADC za CD30 na površini stanice započinje internalizacija ADC-CD30 kompleksa, koji se zatim prenosi u lizosomski odjeljak.
English: The median time from onset to resolution or improvement of peripheral neuropathy events was 10 weeks (ranged from 0 weeks to 139 weeks).
Croatian: Medijan vremena od pojave do povlačenja ili poboljšanja simptoma periferne neuropatije je iznosio 10 tjedana (u rasponu od 0 do 139 tjedana).
English: The pharmacokinetics of ADCETRIS in combination with AVD were evaluated in a single phase 3 study in 661 patients.
Croatian: Farmakokinetika lijeka ADCETRIS u kombinaciji sa AVD procijenjena je u jednom ispitivanju faze 3 u 661 bolesnika.
English: Less than half of the patients in the pivotal phase 2 population with Grade 3 or Grade 4 neutropenia had temporally associated infections, and the majority of temporally associated infections were Grade 1 or Grade 2.
Croatian: Manje od polovice bolesnika iz populacije u pivotalnim ispitivanjima faze 2 s neutropenijom 3. stupnja ili 4. stupnja imalo je vremenski povezane infekcije, a većina vremenski povezanih infekcija bila je 1. stupnja ili 2. stupnja.
English: ADCETRIS-induced peripheral neuropathy is typically an effect of cumulative exposure to this medicinal product and is reversible in most cases.
Croatian: Periferna neuropatija uzrokovana lijekom ADCETRIS obično je posljedica kumulativne izloženosti lijeku i u većini je slučajeva reverzibilna.
English: Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma.
Croatian: Klasični Hodgkinov limfom izražava posebne bjelančevine na površini stanica po kojima se razlikuju od neklasičnog Hodgkinovog limfoma.
English: NOT DONE
Croatian: NIJE UČINJENO
English: The median observation time (time to death or last contact) from first dose was 71.4 months.
Croatian: Medijan trajanja motrenja (vrijeme proteklo do smrti ili zadnjeg kontakta) od prve doze bio je 71,4 mjeseci.
English: Women of childbearing potential should be using two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment.
Croatian: Žene reproduktivne dobi trebaju koristiti dvije učinkovite metode kontracepcije tijekom liječenja lijekom ADCETRIS i do 6 mjeseci nakon liječenja.
English: A monoclonal antibody is a protein which recognises certain cancer cells.
Croatian: Monoklonsko protutijelo je bjelančevina koja prepoznaje određene stanice raka.
English: The other chemotherapy medicines are doxorubicin, vinblastine and dacarbazine.
Croatian: Drugi kemoterapijski lijekovi su doksorubicin, vinblastine i dakarbazin.
English: The pharmacokinetics of brentuximab vedotin were evaluated in phase 1 studies and in a population pharmacokinetic analysis of data from 314 patients.
Croatian: Farmakokinetika brentuksimab vedotina bila je procijenjena u ispitivanjima faze 1 i u analizi populacijske farmakokinetike na 314 bolesnika.
English: Binding of MMAE to tubulin disrupts the microtubule network within the cell, induces cell cycle arrest and results in apoptotic death of the CD30-expressing tumour cell.
Croatian: Vezanje MMAE za tubulin narušava mrežu mikrotubula unutar stanice, izaziva zastoj staničnog ciklusa i dovodi do apoptoze tumorskih stanica koje izražavaju CD30.
English: General precautions
Croatian: Opće mjere opreza
English: Tell your doctor if you have kidney or liver problems as your doctor may lower your starting dose to 0.9 mg/kg or may not recommend Adcetris.
Croatian: Recite liječniku ako imate problema s bubrezima ili jetrom, jer bi u tom slučaju liječnik mogao propisati nižu početnu dozu od 0,9 mg/kg, ili bi mogao Adcetris smatrati neprikladnim za vase liječenje.
English: For further efficacy results see Table 10.
Croatian: Za dodatne rezultate o djelotvornosti, pogledajte tablicu 10.
English: The following side effects have been reported with Adcetris in combination with chemotherapy medicines:
Croatian: Sljedeće nuspojave su prijavljene pri korištenju lijeka Adcetris u kombinaciji s kemoterapijskim lijekovima:
English: Median
Croatian: Medijan
English: Hodgkin lymphoma and systemic anaplastic large cell lymphoma are both types of cancer of the white blood cells.
Croatian: Hodgkinov limfom i sistemski anaplastični velikostanični limfom su vrste raka bijelih krvnih stanica.
English: Adcetris is used to treat patients with advanced classical Hodgkin lymphoma who have not had treatment before.
Croatian: Adcetris se koristi za liječenje bolesnika s uznapredovalim klasičnim Hodgkinovim limfomom koji nisu prethodno liječeni.
English: Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations (see section 5.2).
Croatian: Dostupni podaci pokazuju da klirens MMAE može biti narušen kod teškog oštećenja bubrega, oštećenja jetre i niskih koncentracija albumina u serumu (vidjeti dio 5.2).
English: In vitro data indicate that the MMAE metabolism that occurs is primarily via oxidation by CYP3A4/5.
Croatian: In vitro podaci pokazuju da se metabolizam nastalog MMAE odvija prvenstveno putem oksidacije pomoću CYP3A4/5.
English: ADCETRIS may have a moderate influence on the ability to drive and use machines (e.g. dizziness), see section 4.8.
Croatian: ADCETRIS može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima (npr. omaglica),vidjeti dio 4.8.
English: Patients with known cerebral/meningeal disease, including history of PML were excluded from the study.
Croatian: Bolesnici s poznatom cerebralnom/meningealnom bolesti, uključujući anamnezu PML-a, bili su isključeni iz ispitivanja.
English: Patient characteristics n = 58
Croatian: Karakteristike bolesnika n = 58
English: Cardiac electrophysiology
Croatian: Srčana elektrofiziologija
English: The median time to best overall response, defined as the time from first dose to the clinical best response of CR or PR, was 11 weeks (range, 5 to 60 weeks).
Croatian: Medijan vremena do najboljeg ukupnog odgovora, definiran kao vrijeme od prve doze do kliničkog najboljeg odgovora CR-a ili PR-a, bio je 11 tjedana (u rasponu od 5 do 60 tjedana).
English: A best overall response of CR was reported for 7 patients (12%); PR was reported for 23 patients (38%).
Croatian: Najbolji ukupni odgovor CR prijavljen je u 7 bolesnika (12%); PR je prijavljen u 23 bolesnika (38%).
English: The maximal recommended dose is 180 mg.
Croatian: Maksimalna preporučena doza je 180 mg.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADCETRIS in one or more subsets of the paediatric population in the treatment of Hodgkin lymphoma and treatment of anaplastic large cell lymphoma (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja lijeka ADCETRIS u u jednoj ili više podskupina pedijatrijske populacije u liječenju Hodgkinovog limfoma i liječenju anaplastičnog velikostaničnog limfoma (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: In case of overdose, the patient should be closely monitored for adverse reactions, particularly neutropenia, and supportive treatment should be administered (see section 4.4).
Croatian: U slučaju predoziranja, bolesnika je potrebno pažljivo nadzirati zbog nuspojava, osobito neutropenije, i potrebno je primijeniti potporno liječenje (vidjeti dio 4.4).
English: Piramal Healthcare UK Ltd. Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG United Kingdom
Croatian: Earls Road, Grangemouth Stirlingshire, Scotland FK3 8XG Ujedinjeno Kraljevstvo
English: However, results of repeat-dose toxicity studies in rats indicate the potential for brentuximab vedotin to impair male reproductive function and fertility.
Croatian: Međutim, rezultati ispitivanja toksičnosti ponovljene doze u štakora pokazuju da brentuksimab vedotin može oštetiti mušku reproduktivnu funkciju i plodnost.
English: The recommended diluent volume is 150 mL.
Croatian: Volumen preporučene otopine za razrjeđivanje je 150 ml.
English: Patients who achieve stable disease or better should receive a minimum of 8 cycles and up to a maximum of 16 cycles (approximately 1 year) (see section 5.1).
Croatian: Bolesnici u kojih se postigne stabilizacija bolesti ili poboljšanje trebaju primiti najmanje 8 ciklusa do najviše 16 ciklusa (približno 1 godinu) (vidjeti dio 5.1).