FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-small cell lung cancer (NSCLC)
Croatian: Rak pluća nemalih stanica (engl. non-small cell lung cancer, NSCLC)
English: ● Zirabev can increase the incidence of high blood pressure.
Croatian: Zirabev može povećati učestalost visokog krvnog tlaka.
English: Zirabev should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Croatian: Potrebno je trajno obustaviti primjenu lijeka Zirabev ako se medicinski značajna hipertenzija ne može na odgovarajući način kontrolirati antihipertenzivnom terapijom ili ako se u bolesnika razvije hipertenzivna kriza ili hipertenzivna encefalopatija.
English: ● if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Croatian: ● u slučaju izrazitog povišenja Vašeg krvnog tlaka koje je potrebno liječiti lijekovima za krvni tlak,
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Croatian: Ako bolesnici imaju simptome koji utječu na njihov vid, koncentraciju ili sposobnost reakcije, mora ih se upozoriti da ne upravljaju vozilima i ne rade sa strojevima dok se simptomi ne povuku.
English: Results are presented in Table 11.
Croatian: Rezultati su prikazani u tablici 11.
English: No incompatibilities between Zirabev and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Croatian: Nisu opažene nekompatibilnosti između lijeka Zirabev i polivinilkloridnih ili poliolefinskih vrećica ili kompleta za infuziju.
English: Best overall response ratea
Croatian: Najbolja stopa ukupnog odgovora
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Croatian: Farmakoterapijska skupina: pripravci za liječenje zloćudnih bolesti imunomodulatori, antineoplastici, ostali antineoplastici, monoklonska protutijela, ATK oznaka: L01X C07
English: In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
Croatian: U većini slučajeva hipertenzija je bila dobro kontrolirana primjenom standardnog liječenja antihipertenzivima, prilagođenog stanju pojedinog bolesnika.
English: Zirabev may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Croatian: Lijek Zirabev može naškoditi nerođenom djetetu jer može zaustaviti stvaranje novih krvnih žila.
English: Zirabev is for single-use only, as the product contains no preservatives.
Croatian: Zirabev je namijenjen samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: The safety and efficacy of bevacizumab, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Croatian: Sigurnost i djelotvornost bevacizumaba u kombinaciji s kemoterapijom na bazi platine kao prvom linijom liječenja bolesnika koji boluju od neskvamoznog raka pluća nemalih stanica (NSCLC) ispitana je u ispitivanjima E4599 i BO17704.
English: Very rare cases of hypertensive encephalopathy have been reported, some of which were fatal.
Croatian: Vrlo rijetko zabilježeni su slučajevi hipertenzivne encefalopatije, od kojih su neki imali smrtni ishod.
English: In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Croatian: U tom su ispitivanju arterijske tromboembolijske reakcije opažene u 11 % (11/100) bolesnika u usporedbi s 5,8 % (6/104) u kontrolnoj skupini liječenoj kemoterapijom.
English: The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Croatian: Odgovarajuća učestalost u kontrolnoj skupini koja je primala samo kemoterapiju iznosila je 1,1 % odnosno 0,8 %.
English: Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT-11).
Croatian: Antitumorska aktivnost nije opažena u dva ranija ispitivanja među ukupno 30 djece u dobi od > 3 godine s relapsnim ili progresivnim gliomom visokog stupnja malignosti, kada su bila liječena bevacizumabom i irinotekanom (CPT-11).
English: ● if you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Croatian: ● ste alergični (preosjetljivi) na bevacizumab ili neki drugi sastojak ovog lijeka
English: Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications.
Croatian: U tablicama 1 i 2 navedene su nuspojave povezane s primjenom bevacizumaba u kombinaciji s različitim režimima kemoterapije u većem broju indikacija.
English: In most clinical trials urine protein levels of ≥ 2 g/24 hrs led to the holding of bevacizumab until recovery to < 2 g/24 hrs.
Croatian: U većini kliničkih ispitivanja razine proteina u mokraći ≥ 2 g/24 h dovele su do prekida primjene bevacizumaba dok se razina nije vratila na < 2 g/24 h.
English: Assessment of bevacizumab metabolism in rabbits following a single intravenous dose of
Croatian: Procjena metabolizma bevacizumaba u kunića nakon jednokratne intravenske doze
English: Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Croatian: U tablicama u nastavku nuspojave su razvrstane u odgovarajuću kategoriju učestalosti na osnovi najveće zabilježene incidencije u bilo kojoj indikaciji.
English: Monitoring of blood pressure is generally recommended during therapy.
Croatian: Općenito se tijekom liječenja preporučuje kontrolirati krvni tlak.
English: The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Croatian: Dodatak bevacizumaba IFL-u rezultirao je statistički značajnim porastom ukupnog preživljenja, preživljenja bez progresije bolesti i ukupne stope odgovora (vidjeti tablicu 4).
English: Cisplatin/Gemcitabine + placebo
Croatian: Cisplatin/gemcitabin + placebo
English: Patients were nephrectomised for primary renal cell carcinoma.
Croatian: Bolesnicima je prethodno učinjena nefrektomija zbog primarnog raka bubrežnih stanica.
English: In all clinical trials, bevacizumab was administered as an intravenous infusion.
Croatian: U svim je kliničkim ispitivanjima bevacizumab primijenjen u obliku intravenske infuzije.
English: 878 patients were randomised to the two arms.
Croatian: U te je dvije skupine bilo randomizirano 878 bolesnika.
English: Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Croatian: Bevacizumab u kombinaciji s interferonom alfa-2a u prvoj liniji liječenja uznapredovalog i/ili metastatskog raka bubrežnih stanica (BO17705)
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with bevacizumab (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Croatian: Sekundarne analize PFS-a, temeljene na procjeni odgovora tijekom liječenja, potvrdile su značajno superiorniju kliničku korist za bolesnike liječene bevacizumabom (analize su prikazane u tablici 7), što je u skladu sa statistički značajnom koristi opaženom u analizi objedinjenih podataka.
English: Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents
Croatian: Učinak bevacizumaba na farmakokinetiku drugih antineoplastičnih lijekova
English: A high proportion of patients (approximately 62%) went on to receive a variety of nonprotocol specified anti- cancer therapies, which may have impacted the analysis of overall survival.
Croatian: Visok udio bolesnika (oko 62 %) je u nastavku liječenja primao različite antitumorske lijekove koji nisu navedeni u protokolu, a koji su mogli utjecati na analizu ukupnog preživljenja.
English: An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Croatian: Međutim, može se očekivati štetan učinak na plodnost žena jer su ispitivanja toksičnosti ponovljenih doza na životinjama pokazala inhibiciju sazrijevanja folikula u jajnicima i smanjenje/odsutnost žutog tijela te s time povezano smanjenje težine jajnika i maternice kao i smanjenje broja menstrualnih ciklusa.
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „EXP“.
English: Presentation may include seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Croatian: On se može manifestirati napadajima, glavoboljom, promjenom psihičkog stanja, poremećajem vida ili kortikalnim sljepilom, sa ili bez povezane hipertenzije.
English: In the majority of the occasions the necessary amount of Zirabev can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Croatian: U većini slučajeva potrebna količina lijeka Zirabev se može razrijediti s 0,9%-tnom otopinom natrijevog klorida za injekciju do ukupnog volumena od 100 ml.
English: In an exploratory analysis, the extent of bevacizumab benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Croatian: U eksploracijskoj analizi je utvrđeno da je opseg koristi liječenja bevacizumabom u pogledu ukupnog preživljenja bio manje izražen u podskupini bolesnika koji histološki nisu imali adenokarcinom.
English: Gastrointestinal ulcer (not known)
Croatian: Poremećaji probavnog sustava gastrointestinalni ulkus (nepoznato)
English: In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
Croatian: U ispitivanjima na cynomolgus (makaki) majmunima u trajanju od najdulje 26 tjedana, u mladih životinja s otvorenim pločama rasta opažena je epifizna displazija, pri čemu su prosječne koncentracije bevacizumaba u serumu bile niže od očekivanih prosječnih terapijskih koncentracija u serumu u ljudi.
English: Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance.
Croatian: Ne može se donijeti definitivan zaključak o omjeru koristi i rizika dok ne budu dostupni spremni podaci o rezultatima ukupnog preživljenja i sigurnosti.
English: Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 8).
Croatian: Uočeno je i statistički značajno produljenje preživljenja bez progresije bolesti i povećanje stope objektivnog odgovora (vidjeti tablicu 8).
English: The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen.
Croatian: Primjena diuretika za regulaciju hipertenzije ne preporučuje se u bolesnika koji primaju režim kemoterapije na bazi cisplatina.
English: Depending on the dose prescribed for you, some or all of the contents of the Zirabev vial will be diluted with sodium chloride solution before use.
Croatian: Ovisno o dozi koja Vam je propisana, dio sadržaja ili cijeli sadržaj bočice lijeka Zirabev bit će prije primjene razrijeđen otopinom natrijevog klorida.
English: Before you are given Zirabev or while you are being treated with Zirabev:
Croatian: Prije nego primite Zirabev ili tijekom liječenja lijekom Zirabev:
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post-operative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting bevacizumab.
Croatian: U kliničkim ispitivanjima metastatskog karcinoma kolona ili rektuma nije zabilježen povećan rizik od postoperativnog krvarenja ili komplikacija pri zacjeljivanju rana u bolesnika koji su bili podvrgnuti većem kirurškom zahvatu 28 do 60 dana prije početka primjene bevacizumaba.
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Croatian: Eksploracijski multivarijatni Coxov regresijski model sa selekcijom unatrag (engl. backward selection) pokazao je da su sljedeći ishodišni prognostički čimbenici izrazito povezani s preživljenjem, neovisno o liječenju: spol, broj bijelih krvnih stanica, trombociti, gubitak tjelesne težine tijekom 6 mjeseci prije uključenja u ispitivanje, broj metastatskih mjesta, zbroj najdužeg promjera ciljnih lezija i rezultat prema Motzeru.
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Croatian: Klinička korist u bolesnika s NSCLC-om dokazana je i uz primjenu doze od 7,5 mg/kg i uz primjenu doze od 15 mg/kg (vidjeti dio 5.1).
English: The concentrate is a clear to slightly opalescent, colourless to pale brown liquid in a glass vial with a rubber stopper.
Croatian: Koncentrat je bistra do blago opalescentna, bezbojna do blijedosmeđa tekućina u staklenoj bočici s gumenim čepom.
English: ● It is possible that Zirabev may cause bleeding in and around your brain.
Croatian: Može se dogoditi da Zirabev uzrokuje krvarenje u mozgu i oko mozga.
English: Common Uncommon Rare Very rare Frequency not known
Croatian: Manje često Rijetko Vrlo rijetko Nepoznata učestalost
English: Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Croatian: Rezultati djelotvornosti za ispitivanja AVF0780g i AVF2192g
English: ● Zirabev may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
Croatian: Zirabev može povećati rizik od razvoja ozbiljnih infekcija kože ili dubljih potkožnih slojeva, osobito ako ste imali napuknuća u stijenci crijeva ili probleme sa zacjeljivanjem rana.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab.
Croatian: Opaženo povećanje serumske razine kreatinina nije bilo povezano s većom incidencijom kliničkih manifestacija oštećenja bubrežne funkcije u bolesnika liječenih bevacizumabom.
English: These clinically significant reactions have therefore been included in Table 2 within the column entitled “Frequency Not Known.”
Croatian: Te su klinički značajne nuspojave zato u tablici 2 uvrštene u stupac s naslovom „Nepoznata učestalost“.
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 and 244 bevacizumab monotherapy).
Croatian: Randomizirano je 829 bolesnika (292 za režim FOLFOX-4, 293 za bevacizumab + FOLFOX-4 i 244 za monoterapiju bevacizumabom).
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Croatian: Dodavanje erlotiniba bevacizumabu nije poboljšalo ukupno preživljenje (HR = 1,764; p = 0,1789), trajanje objektivnog odgovora (6,7 naspram 9,1 mjeseci) niti vrijeme do progresije simptoma (HR = 1,172; p = 0,5076).
English: FOLFOX-4 or XELOX + placebo (n=701)
Croatian: FOLFOX-4 ili XELOX + placebo (n = 701)
English: Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Croatian: Karakteristična vrijednost volumena raspodjele u središnjem odjeljku (Vc) bila je 2,73 l za bolesnike ženskog spola i 3,28 l za bolesnike muškog spola, što je u rasponu opisanom za IgG i druga monoklonska protutijela.
English: Objective response rate (%) in Patients with measurable disease N Response rate
Croatian: Stopa (%) objektivnog odgovora u bolesnika s mjerljivom bolešću
English: Results from the primary analysis and the follow-up analysis are presented by bevacizumab Treatment and by Trial Treatment in Table 14 and Table 15, respectively.
Croatian: Rezultati primarne analize i analize nakon praćenja su prikazani prema liječenju bevacizumabom i prema ispitivanom liječenju u tablici 14 odnosno tablici 15.
English: Zirabev is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Croatian: Lijek Zirabev primjenjuje se u kombinaciji s jednim od sljedećih režima kemoterapije: paklitaksel i cisplatin ili paklitaksel i topotekan.
English: Combinations of Zirabev with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Croatian: Kombinacija lijeka Zirabev i drugog lijeka koji se zove sunitinibmalat (propisuje se za liječenje raka bubrega i raka probavnog sustava) može izazvati teške nuspojave.
English: Patients with thromboembolic reactions ≤ Grade 3 need to be closely monitored (NCI-CTCAE v.3).
Croatian: Bolesnike s tromboembolijskim reakcijama stupnja ≤ 3 treba pomno nadzirati (NCI-CTCAE v.3).
English: The occurrence of those events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Croatian: Pojava tih događaja razlikovala se po obilježjima i težini, u rasponu od slobodnog zraka vidljivog na rendgenskoj snimci abdomena, koji se povukao bez liječenja, do perforacije crijeva s abdominalnim apscesom i smrtnim ishodom.
English: Stopping your treatment with Zirabev may stop the effect on tumour growth.
Croatian: Prekidom liječenja lijekom Zirabev može prestati njegov učinak na rast tumora.
English: Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Croatian: Bevacizumab se primjenjivao u dozi od 10 mg/kg svaka 2 tjedna do progresije bolesti.
English: Combination with platinum- or taxane-based therapies (see sections 4.4 and 4.8)
Croatian: Kombinacija s kemoterapijom na bazi platine ili taksana (vidjeti dijelove 4.4 i 4.8)
English: Zirabev is a biosimilar medicinal product.
Croatian: Zirabev je biosličan lijek.
English: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through:
Croatian: U tablici 1 navedene su prema učestalosti sve nuspojave za koje je utvrđena uzročna povezanost s primjenom bevacizumaba:
English: Patients with untreated CNS metastases were routinely excluded from clinical trials with bevacizumab, based on imaging procedures or signs and symptoms.
Croatian: Bolesnici s neliječenim metastazama u središnjem živčanom sustavu bili su rutinski isključeni iz kliničkih ispitivanja bevacizumaba, na temelju dijagnostičkih snimaka ili znakova i simptoma.
English: Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Croatian: Informacije o malformacijama fetusa primijećenima nakon stavljanja lijeka u promet navode se u dijelu 4.6 „Plodnost, trudnoća i dojenje“ te u dijelu 4.8. „Nuspojave“.
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Croatian: Stoga rizik od krvarenja u središnjem živčanom sustavu u takvih bolesnika nije prospektivno ocijenjen u randomiziranim kliničkim ispitivanjima (vidjeti dio 4.8).
English: The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Croatian: Klinička korist, mjerena ukupnim preživljenjem, uočena je u svim unaprijed definiranim podskupinama bolesnika, uključujući i one određene dobi, spolom, funkcionalnim statusom, lokacijom primarnog tumora, brojem zahvaćenih organa i trajanjem metastatske bolesti.
English: Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Croatian: Krvožilni poremećaji bubrežna trombotička mikroangiopatija, koja se klinički može manifestirati kao proteinurija (nepoznato), kod istodobne primjene sunitiniba ili bez njega
English: ● serious infections of the skin or deeper layers under the skin,
Croatian: ● u slučaju ozbiljne infekcije kože ili dubljih potkožnih slojeva,
English: ● Zirabev may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Croatian: Zirabev može povećati rizik od stvaranja neuobičajenog spoja ili prolaza između dvaju organa ili krvnih žila.
English: Caution should be taken when treating these patients with Zirabev.
Croatian: Potreban je oprez prilikom liječenja takvih bolesnika lijekom Zirabev.
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Mjere opreza koje je potrebno poduzeti prije rukovanja lijekom ili primjene lijeka.
English: The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Croatian: Klinička manifestacija PRES-a je često nespecifična pa stoga dijagnozu PRES-a treba potvrditi snimanjem mozga, najbolje oslikavanjem magnetskom rezonancijom.
English: Table 6 Treatment regimens in trial NO16966 (mCRC)
Croatian: Tablica 6. Režimi liječenja u ispitivanju NO16966 (metastatski karcinom kolona ili rektuma)
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
Croatian: Ovo je ispitivanje imalo dva primarna cilja: pokazati neinferiornost režima XELOX u odnosu na režim FOLFOX-4 i pokazati da je primjena bevacizumaba u kombinaciji s kemoterapijskim režimima FOLFOX-4 ili XELOX superiornija od liječenja samo kemoterapijom.
English: A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Croatian: Razgradnja bevacizumaba ovisna o koncentraciji primijećena je pri razrjeđivanju otopinama glukoze (5 %).
English: In clinical trials, proteinuria has been reported within the range of 0.7% to 54.7% of patients receiving bevacizumab.
Croatian: U kliničkim je ispitivanjima proteinurija prijavljena u rasponu od 0,7 % do 54,7 % bolesnika koji su primali bevacizumab.
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Croatian: Novi slučajevi zatajenja jajnika prijavljeni su u 2,6 % bolesnica u skupini mFOLFOX-6 u usporedbi s 39 % njih u skupini mFOLFOX-6 u kombinaciji s bevacizumabom.