FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the dose regimen of 10 mg/kg ramucirumab every 3 weeks, the geometric means of ramucirumab Cmin were 28.3 μg/ml (range of 2.5-108 μg/ml) and 38.4 μg/ml (range of 3.1-128 μg/ml)
Croatian: Nakon režima primjene ramucirumaba u dozi od 10 mg/kg svaka 3 tjedna u kombinaciji s docetakselom, geometrijska srednja vrijednost Cmin ramucirumaba u serumu bolesnika s NSCLC-om iznosila je 28,3 μg/ml (raspon: 2,5-108 μg/ml) prije primjene treće doze te 38,4 μg/ml (raspon:
English: Progression-free survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.635; 95% CI: 0.536 to 0.752; p<0.0001).
Croatian: Preživljenje bez progresije bolesti statistički se značajno poboljšalo u bolesnika liječenih lijekom Cyramza i paklitakselom u odnosu na one koji su primali placebo i paklitaksel (HR 0,635; 95% CI: 0,536 do 0,752; p=0,0001).
English: If a patient experiences a Grade 1 or 2 infusion-related reaction premedication must be given for all subsequent infusions.
Croatian: Ako se u bolesnika pojavi reakcija na infuziju 1. ili 2. stupnja,
English: Severe gastrointestinal haemorrhage, including fatal events, were reported in patients with gastric cancer treated with ramucirumab in combination with paclitaxel, and in patients with mCRC treated with ramucirumab in combination with FOLFIRI.
Croatian: U bolesnika s rakom želuca liječenih ramucirumabom u kombinaciji s paklitakselom te u bolesnika s metastatskim kolorektalnim rakom liječenih ramucirumabom u kombinaciji s protokolom FOLFIRI prijavljeno je teško krvarenje u probavnom sustavu, uključujući slučajeve sa smrtnim ishodom.
English: Stratified CMH p-value
Croatian: Omjer šansi Stratificirana CMH p-vrijednost
English: ORR % (95% CI) p-value Abbreviations: CI = confidence interval, CR = complete response, ORR = objective response rate and PR = partial response
Croatian: Kratice: CI = interval pouzdanosti, CR = potpun odgovor, ORR = stopa objektivnog odgovora,
English: OS was statistically significantly improved in patients receiving Cyramza plus docetaxel compared with those receiving placebo plus docetaxel (HR 0.857; 95% CI: 0.751 to 0.979; p=0.024).
Croatian: OS se statistički značajno poboljšao u bolesnika liječenih lijekom Cyramza plus docetakselom u odnosu na one koji su primali placebo plus docetaksel (HR 0,857; 95% CI: 0,751 do 0,979; p=0,024).
English: Overall survival was statistically significantly improved in patients receiving Cyramza plus paclitaxel compared with those receiving placebo plus paclitaxel (HR 0.807; 95% CI: 0.678 to 0.962; p=0.0169).
Croatian: Ukupno preživljenje statistički se značajno poboljšalo u bolesnika liječenih lijekom Cyramza plus paklitakselom u odnosu na one koji su primali placebo plus paklitaksel (omjer hazarda [engl. hazard ratio, HR] 0,807; 95% CI: 0,678 do 0,962; p=0,0169).
English: A consistent improvement (ramucirumab plus docetaxel vs placebo plus docetaxel) was observed in important subgroups for PFS and OS. OS subgroup results included the following: non-squamous histology (HR 0.83; 95% CI: 0.71 to 0.97; median OS [mOS]: 11.1 vs 9.7 months) and squamous histology (HR 0.88; 95% CI: 0.69 to 1.13; mOS: 9.5 vs 8.2 months); patients with prior maintenance (HR 0.69; 95% CI: 0.51 to 0.93; mOS: 14.4 vs 10.4 months); time since start of prior therapy <9 months (HR 0.75; 95% CI: 0.64 to 0.88; mOS: 9.3 vs 7.0 months); patients <65 years old (HR 0.74, 95% CI: 0.62, 0.87; mOS: 11.3 vs 8.9 months).
Croatian: 95% CI: 0,51 do 0,93; mOS: 14,4 naspram 10,4 mjeseca); vrijeme od početka prethodne terapije < 9 mjeseci (HR 0,75; 95% CI: 0,64 do 0,88; mOS: 9,3 naspram 7,0 mjeseci); bolesnike u dobi od < 65 godina (HR 0,74, 95% CI: 0,62; 0,87; mOS: 11,3 naspram 8,9 mjeseci).
English: In addition, patients were either Barcelona Clinic Liver Cancer (BCLC) stage B and no longer amenable to locoregional therapy, or were BCLC stage C. Patients with brain metastases, leptomeningeal disease, uncontrolled spinal cord compression, a history of or current hepatic encephalopathy or clinically meaningful ascites, severe variceal bleeding in the 3 months prior to treatment, or gastric or oesophageal varices at high risk of bleeding were excluded from the study.
Croatian: U ispitivanju nisu mogli sudjelovati bolesnici s moždanim metastazama, leptomeningealnom bolešću, nekontroliranom kompresijom kralježnične moždine, prethodnom ili trenutnom jetrenom encefalopatijom ili klinički značajnim ascitesom, teškim krvarenjem iz varikoziteta unutar 3 mjeseca prije početka liječenja te varikozitetima želuca ili jednjaka kod kojih je postojao visok rizik od krvarenja.
English: Impaired wound healing
Croatian: Otežano cijeljenje rana
English: Patients receiving any kind of therapeutic anticoagulation and/or chronic therapy with non-steroidal anti-inflammatory drugs or anti-platelet agents were excluded from the REVEL NSCLC clinical trial.
Croatian: U ispitivanje nisu bili uključeni ni bolesnici koji su primali bilo kakvu antikoagulantnu terapiju i/ili dugotrajnu terapiju nesteroidnim protuupalnim lijekovima ili drugim antitrombocitima, kao ni bolesnici s neliječenim, klinički nestabilnim metastazama u mozgu/SŽS-u.
English: Paclitaxel at 80 mg/m2 was administered by intravenous infusion on days 1, 8, and 15 of each 28-day cycle.
Croatian: Paklitaksel u dozi od 80 mg/m2 primjenjivao se intravenskom infuzijom 1., 8. i 15. dana svakog 28-dnevnog ciklusa.
English: Includes: fatigue and asthenia.
Croatian: Uključuje: umor i asteniju.
English: 4.4), patients pre-treated with taxanes (HR 0.81; 95% CI:0.62 to 1.07; mOS 10.8 vs 10.4 months) and those with time since start of prior therapy ≥9 months (HR 0.95; 95% CI: 0.75 to 1.2; mOS: 13.7 vs
Croatian: 0,62 do 1,07; mOS: 10,8 naspram 10,4 mjeseci) i podskupini bolesnika u kojih je prethodna terapija počela prije ≥ 9 mjeseci (HR 0,95; 95% CI: 0,75 do 1,2; mOS: 13,7 naspram 13,3 mjeseca).
English: The infusion rate of ramucirumab should be reduced by 50% for the duration of the infusion and all subsequent infusions if the patient experiences a grade 1 or 2 IRR.
Croatian: Ako se u bolesnika pojavi reakcija na infuziju 1. ili 2. stupnja, brzinu infuzije ramucirumaba potrebno je smanjiti za 50% tijekom ostatka infuzije i kod svih sljedećih infuzija.
English: Hazard ratio (95% CI) Stratified log-rank p-value Abbreviations: CI = confidence interval
Croatian: Medijan (95% CI) Omjer hazarda (95% CI) Stratificirana log-rank p-vrijednost Kratice: CI = interval pouzdanosti
English: Patients with HCC should be selected based on a serum AFP concentration of ≥ 400 ng/ml with a validated AFP test prior to ramucirumab treatment (see section 5.1).
Croatian: utvrđene validiranim testom na AFP provedenim prije početka liječenja ramucirumabom (vidjeti dio 5.1).
English: EU/1/14/957/001 - 1 vial of 10 ml.
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/957/001 - 1 bočica od 10 ml
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Croatian: Ako se proljev ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU za 1 razinu.
English: Hypoalbuminaemiaa Hyponatraemiaa
Croatian: Poremećaji metabolizma i prehrane hipoalbuminemijaa hiponatrijemijaa
English: If not used immediately, inuse storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 °C to 8 °C.
Croatian: Ako se ne primijeni odmah, trajanje i uvjeti čuvanja prije uporabe odgovornost su korisnika.
English: If stomatitis/mucositis has recovered to Grade ≤1, reduce by 1 dose level for 5-FU.
Croatian: Ako se stomatitis/mukozitis ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU za 1 razinu.
English: Ramucirumab should be permanently discontinued in the event of hepatic encephalopathy or hepatorenal syndrome (see section 4.2).
Croatian: U slučaju razvoja jetrene encefalopatije ili hepatorenalnog sindroma primjena ramucirumaba mora se trajno obustaviti (vidjeti dio 4.2).
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 1 level for 5-FU and irinotecan.
Croatian: Odgoditi primjenu 5-FU i irinotekana za najviše 28* dana, dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU i irinotekana za 1 razinu.
English: Name and address of the manufacturers of the biological active substance ImClone Systems LLC
Croatian: Naziv i adresa proizvođača biološke djelatne tvari
English: Severe gastrointestinal haemorrhage (see section 4.4) Arterial thromboembolic events (see section 4.4)
Croatian: Teških arterijskih tromboembolijskih događaja (vidjeti dio 4.4).
English: Table 12: Summary of efficacy data in REACH-2 - Intent to treat (ITT) population Cyramza N=197
Croatian: Tablica 12: Sažetak rezultata za djelotvornost u ispitivanju REACH-2 - populacija predviđena za liječenje (ITT)
English: Reduce by 1 dose level for 5-FU and irinotecan.
Croatian: Smanjiti doze 5-FU i irinotekana za 1 razinu.
English: If the urine protein is ≥2+ on a dipstick, a 24 hour urine collection should be performed.
Croatian: Ako se testnim trakicama utvrdi da je razina proteina u mokraći ≥ 2+, treba prikupiti svu mokraću tijekom 24 sata.
English: Reduce by 2 dose levels for 5-FU and irinotecan.
Croatian: Smanjiti dozu 5-FU i irinotekana za 2 razine.
English: f Based on study RAINBOW (ramucirumab plus paclitaxel) and study RAISE (ramucirumab plus FOLFIRI).
Croatian: f Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel) i RAISE (ramucirumab plus
English: The median duration of docetaxel therapy was 14.1 weeks for the ramucirumab plus docetaxel arm (with a median of 4.0 infusions received) and 12.0 weeks for the placebo plus docetaxel arm (with a median of 4.0 infusions received).
Croatian: 14,1 tjedan u skupini liječenoj ramucirumabom plus docetakselom (medijan primljenih infuzija: 4,0) te
English: Delay 5-FU and irinotecan for a maximum of 28* days until resolution to Grade ≤1, then dose reduce by 2 levels for 5-FU and irinotecan.
Croatian: Odgoditi primjenu 5-FU i irinotekana za najviše 28* dana, dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU i irinotekana za 2 razine.
English: The median relative dose intensity of paclitaxel was 87.7% for the Cyramza plus paclitaxel arm and 93.2% for the placebo plus paclitaxel arm. A similar percentage of patients discontinued treatment due to adverse events: 12% of patients treated with Cyramza plus paclitaxel compared with 11% of patients treated with placebo plus paclitaxel.
Croatian: Medijan relativnog intenziteta doze paklitaksela iznosio je 87,7% u skupini koja je primala lijek Cyramza plus paklitaksel te 93,2% u skupini koja je primala placebo plus paklitaksel.
English: In REVEL, the incidences of Grade ≥3 febrile neutropenia and hypertension were increased with higher ramucirumab exposure.
Croatian: U ispitivanju REVEL se s povećanjem izloženosti ramucirumabu povećavala i incidencija febrilne neutropenije i hipertenzije ≥ 3. stupnja.
English: - Each 50 ml vial contains 500 mg of ramucirumab.
Croatian: - Jedna bočica od 50 ml sadrži 500 mg ramucirumaba.
English: Grade ≤1, then dose reduce by 2 levels for 5-FU.
Croatian: dok se nuspojava ne ublaži do ≤ 1. stupnja, a zatim smanjiti dozu 5-FU za 2 razine.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 100 mg/10 ml
English: Gastrointestinal perforationa
Croatian: Tablični prikaz nuspojava
English: Not known (frequency cannot be estimated from the available data): - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba): - poremećaj zgrušavanja krvi u malim krvnim žilama Nepoznato (ne može se procijeniti iz dostupnih podataka) - proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: Patients treated with Cyramza experienced a statistically significant improvement in OS, compared to placebo (Table 12).
Croatian: OS-a u odnosu na one koji su primali placebo (Tablica 12).
English: If diarrhoea has recovered to Grade ≤1, reduce by 2 dose levels for 5-FU and irinotecan.
Croatian: Ako se proljev ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU i irinotekana za 2 razine.
English: Randomisation was stratified by geographic region, gender, prior maintenance, and ECOG PS. Cyramza at 10 mg/kg or placebo and docetaxel at 75 mg/m2 were each administered by intravenous infusion on day 1 of a 21-day cycle.
Croatian: Cyramza u dozi od 10 mg/kg ili placebo te docetaksel u dozi od 75 mg/m2 primjenjivali su se svaki intravenskom infuzijom 1. dana 21-dnevnog ciklusa.
English: In RAISE, the incidence of Grade ≥3 neutropenia was increased with higher ramucirumab exposure.
Croatian: U ispitivanju RAISE se s povećanjem izloženosti ramucirumabu povećavala i incidencija neutropenije
English: Table 10: Summary of efficacy data - ITT population Cyramza plus FOLFIRI N=536
Croatian: Tablica 9: Sažetak podataka o djelotvornosti - ITT populacija Cyramza N=238
English: Patients were also excluded if they had experienced any of: an ATE, Grade 4 hypertension, Grade 3 proteinuria, a grade 3-4 bleeding event, or bowel perforation during first-line bevacizumab therapy.
Croatian: U ispitivanje nisu bili uključeni ni bolesnici koji su tijekom prvolinijske terapije bevacizumabom imali bilo što od sljedećega: arterijski tromboembolijski događaj, hipertenziju 4. stupnja, proteinuriju 3. stupnja,
English: Irinotecan
Croatian: Imunogenost
English: Table 5 provides details of dose delays or dose reductions of components of FOLFIRI at the next cycle based on maximum grade of specific adverse drug reactions.
Croatian: Prilagodbe doze svake pojedine sastavnice protokola FOLFIRI treba provoditi neovisno o drugim sastavnicama, sukladno napucima u Tablici 4. U Tablici 5 navode se pojedinosti o odgodi primjene ili smanjenju doze pojedinačnih sastavnica protokola FOLFIRI u sljedećem ciklusu na temelju najvišeg stupnja specifične nuspojave.
English: If diarrhoea has recovered to Grade ≤1, reduce by 1 dose level for 5-FU and irinotecan.
Croatian: Ako se proljev ublaži do ≤ 1. stupnja, smanjiti dozu 5-FU i irinotekana za 1 razinu.
English: Ramucirumab treatment should be discontinued in patients who develop fistula (see section 4.2).
Croatian: U bolesnika u kojih dođe do stvaranja fistule mora se prekinuti liječenje ramucirumabom (vidjeti dio 4.2).
English: Post discontinuation systemic anti-cancer therapy was given to 47.9% of patients receiving Cyramza plus paclitaxel and 46.0% of patients receiving placebo plus paclitaxel.
Croatian: Sistemsku protutumorsku terapiju nakon prekida liječenja primilo je 47,9% bolesnika liječenih lijekom Cyramza plus paklitakselom te
English: Cyramza 10 mg/ml sterile concentrate ramucirumab
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Cyramza 10 mg/ml sterilni koncentrat ramucirumab
English: Cyramza treatment will be permanently stopped if you:
Croatian: Trajno obustavljanje liječenja Liječenje ramucirumabom mora se trajno obustaviti u slučaju:
English: Cyramza, in combination with FOLFIRI (irinotecan, folinic acid, and 5-fluorouracil), is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) with disease progression on or after prior therapy with bevacizumab, oxaliplatin and a fluoropyrimidine.
Croatian: FOLFIRI naspram placeba plus protokola FOLFIRI, provedeno u bolesnika s metastatskim kolorektalnim rakom koji su doživjeli progresiju bolesti tijekom ili nakon prvolinijske terapije bevacizumabom, oksaliplatinom i fluoropirimidinom.
English: An increased incidence of proteinuria was reported in patients receiving ramucirumab as compared to placebo.
Croatian: U bolesnika koji su primali ramucirumab prijavljena je povećana incidencija proteinurije u odnosu na one koji su primali placebo.
English: Each 50 ml vial contains 500 mg of ramucirumab.
Croatian: Jedna bočica od 50 ml sadrži 500 mg ramucirumaba.
English: ≥65 years old (OS HR 1.10, 95% CI: 0.89, 1.36; median OS [mOS]: 9.2 vs 9.3 months, see section
Croatian: Nisu primijećene razlike u djelotvornosti između liječenih skupina u podskupini bolesnika u dobi od ≥ 65 godina (HR za OS 1,10; 95% CI: 0,89; 1,36; medijan OS-a [mOS]: 9,2 naspram
English: - Inflammation of the mouth (‘stomatitis'): Cyramza, when given in combination with chemotherapy may increase the risk of developing inflammation of the mouth.
Croatian: - upala usne šupljine („stomatitis“): Kada se primjenjuje u kombinaciji s kemoterapijom,
English: Figure 6: Kaplan-Meier curves of overall survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Croatian: Slika 6: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus docetaksela naspram placeba plus docetaksela u ispitivanju REVEL
English: Febrile neutropeniad
Croatian: Kriterij neutrofili
English: Figure 3: Kaplan-Meier curves of overall survival for Cyramza versus placebo in REGARD
Croatian: Slika 3: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza naspram placeba u ispitivanju REGARD
English: The pharmacokinetics of docetaxel were not affected when co-administered with ramucirumab.
Croatian: Istodobna primjena ramucirumaba nije utjecala na farmakokinetiku docetaksela.
English: Cyramza will be permanently stopped if you develop a hole in the wall of your gut.
Croatian: Primjena lijeka Cyramza trajno će se obustaviti ako nastane pukotina u stijenci crijeva.
English: - Each 10 ml vial contains 100 mg of ramucirumab.
Croatian: - Jedna bočica od 10 ml sadrži 100 mg ramucirumaba.
English: An increased incidence of severe hypertension was reported in patients receiving ramucirumab as compared to placebo.
Croatian: U bolesnika koji su primali ramucirumab prijavljena je povećana incidencija teške hipertenzije u odnosu na one koji su primali placebo.
English: Figure 1: Kaplan-Meier curves of overall survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Croatian: Slika 1: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus paklitaksela naspram placeba plus paklitaksela u ispitivanju RAINBOW
English: Figure 2: Kaplan-Meier curves of progression-free survival for Cyramza plus paclitaxel versus placebo plus paclitaxel in RAINBOW
Croatian: Slika 2: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus paklitaksela naspram placeba plus paklitaksela u ispitivanju RAINBOW
English: If you experience an infusion-related reaction during Cyramza therapy, you will be given premedication for all future infusions.
Croatian: Ako se tijekom liječenja lijekom Cyramza razvije reakcija na infuziju,
English: If particulate matter or discolouration is identified, discard the vial.
Croatian: Ako primijetite čestice ili promjenu boje, bacite bočicu.
English: Respiratory, thoracic, and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja epistaksa
English: Figure 7: Kaplan-Meier curves of progression-free survival for Cyramza plus docetaxel versus placebo plus docetaxel in REVEL
Croatian: Slika 7: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus docetaksela naspram placeba plus docetaksela u ispitivanju REVEL
English: 61% of patients; 81% of patients had measurable disease and 79% had gastric cancer; 21% had GEJ adenocarcinoma.
Croatian: 61 godinu; 71% bolesnika bili su muškarci; 61% bolesnika bili su bijelci, a 35% njih Azijati; funkcionalni ECOG status iznosio je 0 u 39% bolesnika, te 1 u 61% bolesnika; 81% bolesnika imalo je mjerljivu bolest; 79% imalo je rak želuca, a 21% adenokarcinom gastroezofagealnog spoja.
English: c Based on study RAINBOW (ramucirumab plus paclitaxel).
Croatian: c Na temelju podataka iz ispitivanja RAINBOW (ramucirumab plus paklitaksel).
English: Figure 4: Kaplan-Meier curves of overall survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Croatian: Slika 4: Kaplan-Meierove krivulje ukupnog preživljenja uz primjenu lijeka Cyramza plus protokola FOLFIRI naspram placeba plus protokola FOLFIRI u ispitivanju RAISE
English: There was an increase in median PFS of 1.2 months in favour of the Cyramza plus FOLFIRI arm: 5.7 months in the Cyramza plus FOLFIRI arm and 4.5 months in the placebo plus FOLFIRI arm. Efficacy results are shown in Table 10 and Figures 4 and 5.
Croatian: Primijećeno je produljenje medijana PFS-a za 1,2 mjeseca u korist skupine liječene lijekom Cyramza plus protokolom FOLFIRI: 5,7 mjeseci u skupini koja je primala lijek Cyramza plus FOLFIRI te 4,5 mjeseci u skupini koja je primala placebo plus FOLFIRI.
English: Pre-specified subgroup analyses for both PFS and OS according to age (<65 and ≥65 years), gender, race, ECOG PS (0 or ≥1), number of organs involved, liver metastases only, site of primary tumour (colon or rectum), carcinoembryonic antigen levels (<200 μg/L, ≥200 μg/L), all showed a treatment effect favouring Cyramza plus
Croatian: Sve unaprijed određene analize podskupina za PFS i OS - prema dobi (< 65 i ≥ 65 godina), spolu, rasi, funkcionalnom ECOG statusu
English: 5-FU bolus
Croatian: bolus 5-FU 400 mg/m2
English: In the RAISE study, in mCRC patients treated with ramucirumab plus FOLFIRI, the most frequent (≥1%) ADR that led to the discontinuation of ramucirumab was proteinuria (1.5%).
Croatian: Ramucirumab u kombinaciji s FOLFIRI protokolom Najčešća nuspojava (≥ 1%) koja je dovela do prekida primjene ramucirumaba u bolesnika s metastatskim kolorektalnim rakom liječenih ramucirumabom plus protokolom FOLFIRI u ispitivanju
English: Each 10 ml vial contains 100 mg of ramucirumab.
Croatian: Jedna bočica od 10 ml sadrži 100 mg ramucirumaba.
English: Cyramza plus paclitaxel arm was 27.9% and in the placebo plus paclitaxel arm was 16.1%.
Croatian: Stopa objektivnog odgovora (engl. objective response rate, ORR) iznosila je 27,9% u skupini liječenoj lijekom Cyramza plus paklitakselom te 16,1% u skupini koja je primala placebo plus paklitaksel.
English: A second reduction of 10 mg/m2 is recommended if these toxicities persist or reoccur.
Croatian: preporučuje se dodatno smanjiti dozu za 10 mg/m2.
English: Patients may be at increased risk for the development of fistula when treated with Cyramza.
Croatian: Kada se liječe lijekom Cyramza, bolesnici mogu biti izloženi povećanom riziku za nastanak fistule.
English: Patients with a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders, a recent history of severe (Grade ≥3) bleeding or who had experienced an arterial thrombotic event (ATE) in the 12 months
Croatian: U ispitivanje nisu bili uključeni bolesnici koji su u anamnezi imali nekontrolirane nasljedne ili stečene poremećaje krvarenja ili trombotske poremećaje, koji su nedavno imali teško krvarenje
English: FOLFIRI dose adjustments
Croatian: Prilagodba doze protokola FOLFIRI
English: What Cyramza looks like and contents of the pack
Croatian: Što Cyramza sadrži
English: There was an increase in median survival of 2.3 months in favour of the Cyramza plus paclitaxel arm: 9.63 months in the Cyramza plus paclitaxel arm and 7.36 months in the placebo plus paclitaxel arm.
Croatian: 9,63 mjeseca u skupini liječenoj lijekom Cyramza plus paklitakselom te 7,36 mjeseci u skupini koja je primala placebo plus paklitaksel.
English: EU/1/14/957/003
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/957/003
English: For recurrent Grade 2 diarrhoea, reduce by 1 dose level for 5-FU and irinotecan.
Croatian: U slučaju rekurentnog proljeva 2. stupnja, smanjiti dozu 5-FU i irinotekana za 1 razinu.
English: Proteinuriaa,f
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurijaa,f
English: Figure 5: Kaplan-Meier curves of progression -free survival for Cyramza plus FOLFIRI versus placebo plus FOLFIRI in RAISE
Croatian: Slika 5: Kaplan-Meierove krivulje preživljenja bez progresije bolesti uz primjenu lijeka Cyramza plus protokola FOLFIRI naspram placeba plus protokola FOLFIRI u ispitivanju RAISE