FrancophonIA/ELRC3.0 huggingface dataset:
English: No animal studies have been performed to test ramucirumab for potential of carcinogenicity or genotoxicity.
Croatian: Nisu provedena istraživanja na životinjama kojima bi se ispitao kancerogeni i genotoksični potencijal ramucirumaba.
English: A trend towards less efficacy with increasing age has been observed in patients receiving ramucirumab plus docetaxel for the treatment of advanced NSCLC with disease progression after platinum-based chemotherapy (see section 5.1).
Croatian: Primijećen je trend pada djelotvornosti s porastom dobi u bolesnika koji su primali ramucirumab plus docetaksel za liječenje uznapredovalog NSCLC-a koji je progredirao nakon kemoterapije utemeljene na platini (vidjeti dio 5.1).
English: Hypokalaemiaa,b Hyponatraemiaa Hypoalbuminaemiaa
Croatian: Poremećaji metabolizma i prehrane hipokalijemijaa,b hiponatrijemijaa hipoalbuminemijaa
English: Your doctor will monitor your blood pressure and adjust your blood pressure medicine as needed during treatment with Cyramza.
Croatian: Liječnik će tijekom liječenja lijekom Cyramza nadzirati krvni tlak i po potrebi prilagoditi dozu lijekova za kontrolu krvnog tlaka.
English: Ramucirumab therapy should be permanently discontinued if the urine protein level is >3 g/24 hours or in the event of nephrotic syndrome (see section 4.2).
Croatian: Liječenje ramucirumabom mora se trajno obustaviti ako je razina proteina u mokraći > 3 g/24 sata ili ako se razvije nefrotski sindrom (vidjeti dio 4.2).
English: Cyramza has no or negligible influence on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima Lijek Cyramza ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Discard any unused portion of ramucirumab left in a vial, as the product contains no antimicrobial preservatives.
Croatian: Bacite sav neupotrijebljeni ramucirumab preostao u bočici jer lijek ne sadrži antimikrobne konzervanse.
English: The threshold for the elevated AFP study entry requirement for REACH-2 was determined based on the survival results from a pre-specified subgroup, exploratory analysis from REACH, a previously completed, supportive phase 3 clinical study in 565 HCC patients randomised (1:1) to either Cyramza plus BSC or placebo plus BSC that had disease progression on or after prior sorafenib therapy.
Croatian: određena je na temelju rezultata za preživljenje iz eksploracijske analize unaprijed specificiranih podskupina iz ispitivanja REACH, prethodno završenog, suportivnog kliničkog ispitivanja faze 3 koje je obuhvatilo 565 bolesnika s HCC-om koji su doživjeli progresiju bolesti tijekom ili nakon prethodne terapije sorafenibom i koji su bili randomizirani (1:1) za primanje lijeka Cyramza plus NPL-a ili placeba plus NPL-a.
English: Post discontinuation systemic anticancer therapy was given to 54% of patients receiving Cyramza plus FOLFIRI and 56% of patients receiving placebo plus FOLFIRI.
Croatian: Sistemsku protutumorsku terapiju je nakon prekida liječenja primilo 54% bolesnika liječenih lijekom Cyramza plus protokolom FOLFIRI te 56% onih koji su primali placebo plus FOLFIRI.
English: c Based on study REACH-2 and REACH (single-agent ramucirumab in HCC).
Croatian: Na temelju podataka iz ispitivanja REACH-2 i REACH (ramucirumab u monoterapiji za liječenje HCC-a).
English: The primary endpoint was OS.
Croatian: Primarna mjera ishoda bio je OS.
English: Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure)
Croatian: Odmah razgovarajte sa svojim liječnikom ili medicinskom sestrom ako se nešto od sljedećega odnosi na Vas (ili ako niste sigurni) tijekom liječenja lijekom Cyramza ili u bilo kojem trenutku nakon njega:
English: Patients were randomised in a 1:1 ratio to receive Cyramza plus paclitaxel (n=330) or placebo plus paclitaxel (n=335).
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 da primaju lijek Cyramza plus paklitaksel (n=330) ili placebo plus paklitaksel (n=335).
English: Placebo plus docetaxel N=625
Croatian: Placebo plus docetaksel N=625
English: Table 4: FOLFIRI dose reductions FOLFIRI componenta
Croatian: Tablica 4: Smanjenje doze protokola FOLFIRI Sastavnica protokola FOLFIRIa
English: you should not breast-feed your baby during treatment with Cyramza and for at least 3 months after you receive the last dose.
Croatian: Stoga ne smijete dojiti tijekom liječenja lijekom Cyramza niti još najmanje 3 mjeseca nakon što primite posljednju dozu.
English: The recommended dose of ramucirumab is 8 mg/kg on days 1 and 15 of a 28 day cycle, prior to paclitaxel infusion.
Croatian: Preporučena doza ramucirumaba iznosi 8 mg/kg 1. i 15. dana 28-dnevnog ciklusa, a primjenjuje se prije infuzije paklitaksela.
English: Objective response rate [ORR(complete response [CR] + partial response [PR])] was significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (Odds ratio 2.140; 95% CI: 1.499 to 3.160; p=0.0001).
Croatian: Stopa objektivnog odgovora [engl. objective response rate, ORR (potpun odgovor [engl. complete response, CR] + djelomičan odgovor [engl. partial response, PR])] značajno se poboljšala u bolesnika koji su primali lijek Cyramza plus paklitaksel u odnosu na one koji su primali placebo plus paklitaksel (omjer šansi: 2,140; 95% CI: 1,499 do 3,160; p=0,0001).
English: The FOLFIRI regimen was: irinotecan 180 mg/m2 administered over 90 minutes and folinic acid 400 mg/m2 administered, simultaneously over 120 minutes; followed by bolus 5-fluorouracil(5-FU) 400 mg/m2 over 2 to 4 minutes; followed by 5-FU 2400 mg/m2 administered by continuous infusion over 46 to 48 hours.
Croatian: 180 mg/m2 tijekom 90 minuta i folatne kiseline u dozi od 400 mg/m2 tijekom 120 minuta, nakon čega je slijedila bolusna primjena 5-fluorouracila (5-FU) u dozi od 400 mg/m2 tijekom 2 - 4 minute, a zatim i primjena 5-FU u dozi od 2400 mg/m2 kontinuiranom infuzijom tijekom 46 - 48 sati.
English: Eli Lilly Lietuva
Croatian: Eli Lilly Lietuva Tel.
English: The HR of OS was 0.82 (95% CI: 0.67 to 1.0) in patients with a KRAS wild type tumour, and 0.89 (95% CI: 0.73 to 1.09) in patients with a KRAS mutant tumour.
Croatian: HR za OS iznosio je 0,82 (95% CI: 0,67 do 1,0) u bolesnika oboljelih od tumora s divljim tipom gena KRAS te 0,89 (95% CI: 0,73 do 1,09) u bolesnika oboljelih od tumora s mutacijom gena KRAS.
English: NCI CTCAE grade
Croatian: Stupanj prema NCI CTCAE kriterijima
English: The recommended dose of docetaxel is 75 mg/m2 administered by intravenous infusion over approximately 60 minutes on day 1 of a 21 day cycle.
Croatian: Preporučena doza docetaksela je 75 mg/m2, a primjenjuje se intravenskom infuzijom tijekom približno 60 minuta 1. dana 21-dnevnog ciklusa.
English: A treatment effect on PFS was observed for all exposure levels produced by 8 mg/kg ramucirumab given every 2 weeks.
Croatian: Učinak liječenja na PFS zabilježen je kod svih razina izloženosti nakon primjene ramucirumaba u dozi od 8 mg/kg svaka 2 tjedna.
English: 2,000 mg/m2 over 46-48 hours
Croatian: 2000 mg/m2 tijekom 46 - 48 sati
English: Common side effects (may affect up to 1 in 10 people): - fever accompanied by low white blood cell counts - low blood levels of a protein called albumin - infusion-related reactions - rash - redness, swelling, numbness/tingling, or pain and/or skin peeling in hands and/or feet (called hand-foot syndrome) - low blood levels of sodium (hyponatraemia) which can cause tiredness and confusion or muscle twitching - confusion and/or disorientation in patients with chronic liver problems - intestinal blockage; symptoms may include constipation and abdominal pain - abnormal growth of blood vessels - serious infection (sepsis) - low blood levels of potassium (hypokalaemia) which can cause muscle weakness, twitching or abnormal heart rhythm
Croatian: - niske razine albumina (jedne vrste proteina) u krvi - reakcije na infuziju - osip - crvenilo, oticanje, utrnulost/trnci ili bol i/ili ljuštenje kože na šakama i/ili stopalima (što se naziva sindromom šaka-stopalo) - niske razine natrija u krvi (hiponatrijemija), koje mogu uzrokovati umor i smetenost ili trzanje mišića - smetenost i/ili dezorijentiranost u bolesnika s kroničnim jetrenim tegobama - blokada crijeva; simptomi mogu uključivati zatvor i bol u trbuhu
English: Concentrate for solution for infusion 500 mg/50 ml
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 500 mg/50 ml
English: Cyramza at 8 mg/kg or placebo was administered by intravenous infusion every 2 weeks (on days 1 and 15) of a 28-day cycle.
Croatian: Cyramza u dozi od 8 mg/kg ili placebo primjenjivani su intravenskom infuzijom svaka 2 tjedna (1. i 15. dana) u sklopu 28-dnevnog ciklusa.
English: Symptoms may include: extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Croatian: Simptomi mogu uključivati: izrazit umor, slabost, omaglicu ili promjene u boji stolice.
English: Patients were required to have experienced disease progression during, or within 4 months after the last dose of first-line therapy and with ECOG PS 0-1.
Croatian: Bolesnici su morali imati progresiju bolesti tijekom ili unutar 4 mjeseca nakon posljednje doze prvolinijske terapije te su morali imati funkcionalni ECOG status od 0-1.
English: If Grade 4 diarrhoea does not resolve to Grade ≤1, withhold 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1.
Croatian: Ako se proljev 4. stupnja ne ublaži do ≤ 1. stupnja, odgoditi primjenu 5-FU i irinotekana za najviše 28* dana, dok se nuspojava ne ublaži do ≤ 1. stupnja.
English: REACH-2 was a global, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC that randomised (2:1) 292 patients with HCC who had a serum AFP ≥ 400 ng/ml at study entry.
Croatian: Ispitivanje REACH-2 bilo je globalno, randomizirano, dvostruko slijepo ispitivanje lijeka Cyramza u kombinaciji s najboljim potpornim liječenjem (NPL) u odnosu na placebo plus NPL, u kojem su randomizirana (2:1) 292 bolesnika s HCC-om kojima je pri uključivanju u ispitivanje AFP u serumu iznosio ≥ 400 ng/ml.
English: The metabolism of ramucirumab has not been studied.
Croatian: Nisu provedena ispitivanja metabolizma ramucirumaba.
English: Cases of gastrointestinal perforation have been reported in patients treated with ramucirumab.
Croatian: Prijavljeni su slučajevi perforacija u probavnom sustavu u bolesnika liječenih ramucirumabom.
English: Do not dilute with other solutions or co-infuse with other electrolytes or medicinal products.
Croatian: Ne smijete je razrjeđivati s drugim otopinama niti infundirati istodobno s drugim elektrolitima ili lijekovima.
English: Symptoms may include: increased muscle tension, back pain, chest pain and/or tightness, chills, flushing, difficulty in breathing, wheezing, and feeling of tingling or numbness in hands or feet.
Croatian: Simptomi mogu uključivati: pojačanu napetost mišića, bol u leđima, bol i/ili stezanje u prsima, zimicu, crvenilo praćeno osjećajem vrućine, otežano disanje, piskanje pri disanju te trnce ili utrnulost u šakama ili stopalima.
English: Concentrate for solution for infusion 100 mg/10 ml
Croatian: OBLIK I SADRŽAJ Koncentrat za otopinu za infuziju 100 mg/10 ml
English: Aseptically transfer the calculated volume of ramucirumab to the intravenous container.
Croatian: Aseptičkom tehnikom prebacite izračunati volumen ramucirumaba u spremnik za intravensku infuziju.
English: Do not administer the solution if you notice any particulate matter or discolouration.
Croatian: Nemojte primijeniti otopinu ako primijetite da sadrži čestice ili da je promijenila boju.
English: Cyramza monotherapy is indicated for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma who have a serum alpha fetoprotein (AFP) of ≥ 400 ng/ml and who have been previously treated with sorafenib.
Croatian: Monoterapija lijekom Cyramza indicirana je za liječenje uznapredovalog ili neresektabilnog hepatocelularnog karcinoma u odraslih bolesnika kojima je vrijednost alfa-fetoproteina (AFP) u serumu ≥ 400 ng/ml i koji su prethodno bili liječeni sorafenibom.
English: No formal studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of ramucirumab.
Croatian: Nisu provedena službena ispitivanja kojima bi se ocijenio učinak oštećenja jetrene funkcije na farmakokinetiku ramucirumaba.
English: Ramucirumab should be immediately and permanently discontinued in the event of a grade 3 or 4 IRR (see section 4.4).
Croatian: Primjena ramucirumaba mora se odmah i trajno obustaviti u slučaju reakcije na infuziju 3. ili 4. stupnja (vidjeti dio 4.4).
English: Haematological criteria in Table 2 are not met
Croatian: Nisu zadovoljeni hematološki kriteriji iz Tablice 2
English: REVEL, a randomised, double-blind study of Cyramza plus docetaxel versus placebo plus docetaxel, was conducted in 1253 patients with locally advanced or metastatic squamous or non-squamous NSCLC with disease progression on or after one platinum-based therapy.
Croatian: REVEL, randomizirano, dvostruko slijepo ispitivanje lijeka Cyramza plus docetaksela napram placeba plus docetaksela, provedeno je u 1253 bolesnika s lokalno uznapredovalim ili metastatskim planocelularnim ili neplanocelularnim NSCLC-om kojima je bolest progredirala tijekom ili nakon jedne terapije utemeljene na platini.
English: during treatment with Cyramza or anytime thereafter: - Blocking of the arteries by a blood clot (‘arterial thromboembolic events'):
Croatian: - začepljenje arterija zbog krvnog ugruška („arterijski tromboembolijski događaji“):
English: Package leaflet: Information for the user Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Croatian: Uputa o lijeku: Informacije za korisnika Cyramza 10 mg/ml koncentrat za otopinu za infuziju ramucirumab
English: Table 6: ADRs reported in patients treated with ramucirumab as monotherapy in phase 3 clinical trials (REGARD, REACH-2 and REACH patients with alpha fetoprotein ≥ 400 ng/ml)
Croatian: Tablica 6: Nuspojave na lijek prijavljene u bolesnika liječenih ramucirumabom u monoterapiji u sklopu kliničkih ispitivanja faze 3 (REGARD, REACH-2 i REACH [bolesnici kojima je vrijednost alfa-fetoproteina bila ≥ 400 ng/ml])
English: 13.3 months).
Croatian: 3 tjedna.
English: Pack of 1 vial of 10 ml.
Croatian: Pakiranje s 1 bočicom od 10 ml.
English: Gastric cancer
Croatian: Rak želuca
English: 50 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Croatian: 50 ml otopine u bočici (staklo tipa I) s čepom od klorobutilne gume, aluminijskim zaštitnim zatvaračem i polipropilenskim zatvaračem.
English: Premedication is recommended with a histamine H1 antagonist (for example diphenhydramine) prior to infusion of ramucirumab.
Croatian: Preporučuje se premedikacija antagonistom histaminskog H1 receptora (primjerice, difenhidraminom)
English: The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.
Croatian: Istodobna primjena ramucirumaba nije utjecala na farmakokinetiku paklitaksela, a istodobna primjena paklitaksela nije utjecala na farmakokinetiku ramucirumaba.
English: Hazard ratio (95% CI) Stratified log-rank p-value Progression free survival, months Median (95% CI)
Croatian: Omjer hazarda (95% CI) Stratificirana log-rank p-vrijednost Preživljenje bez progresije bolesti, mjeseci Medijan (95% CI)
English: Few between-arm differences were reported after the first month of treatment.
Croatian: Nakon prvih mjesec dana liječenja prijavljene su tek malobrojne razlike između dviju skupina.
English: Cyramza is used for the treatment of advanced stomach cancer (or cancer of the junction between the oesophagus and the stomach) in adults whose disease has worsened after treatment with medicines to treat cancer and for whom treatment of Cyramza in combination with paclitaxel is not suitable.
Croatian: Cyramza se primjenjuje za liječenje uznapredovalog raka želuca (ili raka na spoju između jednjaka i želuca) u odraslih osoba kod kojih se bolest pogoršala nakon terapije lijekovima za liječenje raka, a za koje nije prikladno liječenje lijekom Cyramza u kombinaciji s paklitakselom.
English: The recommended dose of ramucirumab is 8 mg/kg every 2 weeks administered by intravenous infusion, prior to FOLFIRI administration.
Croatian: Preporučena doza ramucirumaba iznosi 8 mg/kg svaka 2 tjedna, a primjenjuje se intravenskom infuzijom prije primjene protokola FOLFIRI.
English: There was an increase in median survival of 1.4 months in favour of the Cyramza plus docetaxel arm:
Croatian: Primijećeno je produljenje medijana preživljenja za 2,3 mjeseca u korist skupine liječene lijekom Cyramza plus paklitakselom:
English: The concentrate for solution for infusion (or sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow solution in a glass vial with a rubber stopper.
Croatian: Kako Cyramza izgleda i sadržaj pakiranja Koncentrat za otopinu za infuziju (ili sterilni koncentrat) je bistra do blago opalescentna te bezbojna do blijedo žuta otopina u staklenoj bočici s gumenim čepom.
English: Cyramza is available in packs of: - 1 vial of 10 ml - 2 vials of 10 ml - 1 vial of 50 ml
Croatian: - 1 bočice od 10 ml - 2 bočice od 10 ml - 1 bočice od 50 ml
English: The ECOG PS was 1 for 72% of patients.
Croatian: 72% bolesnika.
English: If a patient develops wound healing complications during therapy, ramucirumab should be discontinued until the wound is fully healed (see section 4.2).
Croatian: Ako tijekom liječenja u bolesnika nastupe komplikacije s cijeljenjem rane, primjenu ramucirumaba treba prekinuti dok rana u potpunosti ne zacijeli (vidjeti dio 4.2).
English: How to store Cyramza
Croatian: Kako čuvati lijek Cyramza
English: Patients with squamous histology are at higher risk of developing serious pulmonary bleeding, however, no excess of Grade 5 pulmonary haemorrhage was observed in ramucirumab treated patients with squamous histology in REVEL.
Croatian: Bolesnici s planocelularnim histološkim tipom tumora imaju veći rizik od razvoja ozbiljnog plućnog krvarenja; međutim, u bolesnika s planocelularnim histološkim tipom liječenih ramucirumabom u ispitivanju REVEL nije primijećena povećana stopa plućnog krvarenja 5. stupnja.
English: Comorbidities associated with advanced age, performance status and the likely tolerability to chemotherapy should therefore be thoroughly evaluated prior to the initiation of treatment in the elderly (see sections 4.2 and 5.1).
Croatian: Stoga je prije započinjanja liječenja u starijih osoba potrebno detaljno ocijeniti popratne bolesti povezane sa starijom dobi, funkcionalni status i vjerojatnu podnošljivost kemoterapije (vidjeti dijelove 4.2 i 5.1).
English: In this case, East Asian patients with a starting dose of 60 mg/m² should have docetaxel treatment discontinued (see Posology).
Croatian: U tom slučaju se liječenje docetakselom mora potpuno prekinuti u bolesnika istočnoazijskog podrijetla koji su liječenje započeli dozom od 60 mg/m2 (vidjeti odlomak „Doziranje“).
English: 10 ml solution in a vial (Type I glass) with a chlorobutyl rubber stopper, an aluminium seal and a polypropylene cap.
Croatian: 10 ml otopine u bočici (staklo tipa I) s čepom od klorobutilne gume, aluminijskim zaštitnim zatvaračem i polipropilenskim zatvaračem.
English: Ramucirumab is an antiangiogenic therapy and may increase the risk of gastrointestinal perforations.
Croatian: Ramucirumab je antiangiogeni lijek i kao takav može povećati rizik od perforacija u probavnom sustavu.
English: The recommended dose of ramucirumab as a single agent is 8 mg/kg every 2 weeks.
Croatian: Preporučena doza ramucirumaba u monoterapiji iznosi 8 mg/kg svaka 2 tjedna.
English: (12.5%), thrombocytopenia (4.2%), diarrhoea (2.3%) and stomatitis (2.3%).
Croatian: Najčešće nuspojave (≥ 1%) koje su dovele do prekida primjene jedne ili više sastavnica protokola FOLFIRI bile su: neutropenija (12,5%), trombocitopenija (4,2%), proljev (2,3%) i stomatitis (2,3%).
English: Neutropeniaa Leukopeniaa,c Thrombocytopeniaa
Croatian: Poremećaji krvi i limfnog sustava neutropenijaa leukopenijaa,c trombocitopenijaa febrilna neutropenijad
English: The recommended dose of ramucirumab is 10 mg/kg on day 1 of a 21 day cycle, prior to docetaxel infusion.
Croatian: Preporučena doza ramucirumaba iznosi 10 mg/kg, a primjenjuje se 1. dana 21-dnevnog ciklusa, prije infuzije docetaksela.
English: The most frequent component of FOLFIRI to be discontinued was the 5-FU bolus.
Croatian: Od svih sastavnica protokola FOLFIRI, najčešće se prekidalo liječenje bolusnom dozom 5-FU.
English: Cyramza will be permanently stopped if you develop a blood clot in your arteries.
Croatian: Primjena lijeka Cyramza trajno će se obustaviti ako nastane krvni ugrušak u arterijama.
English: Haematological criteria in Table 2 are not met and fever resolved
Croatian: Nisu zadovoljeni hematološki kriteriji iz Tablice 2, a vrućica se povukla
English: Read the paclitaxel or docetaxel package leaflet for further information.
Croatian: Za dodatne informacije pročitajte uputu o lijeku za paklitaksel ili docetaksel.
English: Symptoms may include a burning sensation in the mouth, ulceration, blisters or swelling.
Croatian: Simptomi mogu uključivati osjećaj žarenja u ustima, vrijedove, mjehuriće ili oticanje.
English: Abbreviations: CI = confidence interval, CR= complete response, PR= partial response, CMH= Cochran-Mantel-Haenszel
Croatian: Kratice: CI = interval pouzdanosti, CR= potpun odgovor, PR= djelomičan odgovor, CMH=
English: Cyramza 10 mg/ml concentrate for solution for infusion ramucirumab
Croatian: Cyramza 10 mg/ml koncentrat za otopinu za infuziju ramucirumab
English: REGARD, a multinational, randomised, double-blind study of Cyramza plus BSC versus placebo plus BSC, was conducted in 355 patients with locally recurrent and unresectable, or metastatic gastric cancer (including GEJ adenocarcinoma) following platinum- or fluoropyrimidine-containing chemotherapy.
Croatian: REGARD REGARD, multinacionalno, randomizirano, dvostruko slijepo ispitivanje lijeka Cyramza plus NPL-a napram placeba plus NPL-a, provedeno je u 355 bolesnika s lokalno recidivirajućim i neoperabilnim ili metastatskim rakom želuca (uključujući adenokarcinom gastroezofagealnog spoja) nakon kemoterapije koja je sadržavala platinu ili fluoropirimidin.
English: gemcitabine (25%), taxane (24%), and bevacizumab (14%); 22% of patients received prior maintenance therapy.
Croatian: Najčešće prethodne terapije uključivale su pemetreksed (38%), gemcitabin (25%), taksan (24%) i bevacizumab (14%); 22%
English: Cyramza is for intravenous use.
Croatian: Lijek Cyramza primjenjuje se intravenski.
English: Haematological criteria in Table 2 are met
Croatian: Zadovoljeni su hematološki kriteriji iz Tablice 2
English: EORTC QLQ-C30, patients in the ramucirumab plus FOLFIRI treatment arm reported a transient decrease in QoL compared to the patients in the placebo plus FOLFIRI treatment arm in most of the scales.
Croatian: S obzirom na upitnik EORTC QLQ-C30, bolesnici u skupini koja je primala ramucirumab plus FOLFIRI na većini su ljestvica prijavili prolazno smanjenje kvalitete života u odnosu na bolesnike u skupini koja je primala placebo plus FOLFIRI.
English: 1,600 mg/m2 over 46-48 hours
Croatian: 1600 mg/m2 tijekom 46 - 48 sati
English: In HCC patients, hepatic encephalopathy was reported at a higher rate in the ramucirumab-treated patients compared to the placebo-treated patients (see section 4.8).
Croatian: Među bolesnicima s hepatocelularnim karcinomom prijavljena je veća stopa jetrene encefalopatije u bolesnika liječenih ramucirumabom nego u onih koji su primali placebo (vidjeti dio 4.8).
English: - Fever or infection: You may develop a temperature of 38 ºC or greater during treatment (since you might have fewer white blood cells than normal which is very common).
Croatian: - vrućica ili infekcija: Tjelesna temperatura Vam tijekom liječenja može porasti na 38°C ili više