FrancophonIA/ELRC3.0 huggingface dataset:
English: Each ml of concentrate contains 25 mg of bevacizumab.
Croatian: Jedan ml koncentrata sadrži 25 mg bevacizumaba.
English: Zirabev therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Croatian: U bolesnika u kojih se razvije nekrotizirajući fasciitis terapiju lijekom Zirabev treba prekinuti i odmah započeti s odgovarajućim liječenjem.
English: In clinical trials with bevacizumab, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
Croatian: U kliničkim ispitivanjima bevacizumaba kongestivno zatajenje srca opaženo je u svim dosad ispitivanim onkološkim indikacijama, no najčešće se javljalo u bolesnica s metastatskim rakom dojke.
English: Cases of non-mandibular osteonecrosis have been observed in bevacizumab treated paediatric patients (see section 4.8, Paediatric population).
Croatian: U pedijatrijskih bolesnika liječenih bevacizumabom zabilježeni su slučajevi osteonekroze koja nije zahvaćala čeljust (vidjeti dio 4.8, „Pedijatrijska populacija“).
English: a 10 mg/kg every 2 weeks b Relative to control arm
Croatian: 10 mg/kg svaka 2 tjedna u odnosu na kontrolnu skupinu
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
Croatian: U tom je kliničkom ispitivanju faze III uspoređeno liječenje kombinacijom lijekova rituksimab/ciklofosfamid/doksorubicin/vinkristin/prednizon (R-CHOP) uz bevacizumab s liječenjem R-CHOP-om bez bevacizumaba.
English: First-line treatment of non-squamous NSCLC in combination with platinum-based chemotherapy Zirabev is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Zirabev as a single agent until disease progression.
Croatian: Lijek Zirabev primjenjuje se uz kemoterapiju na bazi platine do najviše 6 ciklusa liječenja, nakon čega se lijek Zirabev primjenjuje sam do progresije bolesti.
English: Cisplatin/Gemcitabine + bevacizumab 15 mg/kg q 3 weeks
Croatian: Cisplatin/gemcitabin + bevacizumab 15 mg/kg svaka 3 tjedna
English: 55% bevacizumab/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Croatian: Velik udio bolesnika (oko 63 % za IFN/placebo; 55 % za bevacizumab/IFN) je nakon završetka ispitivanja primao različite nespecificirane antitumorske terapije, uključujući antineoplastičke lijekove, što je moglo utjecati na analizu ukupnog preživljenja.
English: Relative to control arm. NR = not reached.
Croatian: ND = nije dostignuto.
English: Grade 3-5 reactions have been observed in up to 2.3% of patients treated with bevacizumab plus chemotherapy as compared with < 1% with chemotherapy alone (NCI-CTCAE v.3).
Croatian: Krvarenja stupnja 3-5 opažena su u do 2,3% bolesnika liječenih kombinacijom bevacizumaba i kemoterapije u usporedbi s < 1% u bolesnika liječenih samo kemoterapijom (NCICTCAE v.3).
English: Do not use Zirabev if you notice any particulate matter or discolouration prior to administration.
Croatian: Lijek Zirabev se ne smije upotrijebiti ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: Placebo + IFNa
Croatian: Placebo + IFN
English: Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja perforacija nosnog septuma (nepoznato) plućna hipertenzija (nepoznato) disfonija (često)
English: Concentrate for solution for infusion 1 vial of 4 ml
Croatian: Koncentrat za otopinu za infuziju 1 bočica od 4 ml 100 mg/4 ml
English: An increased incidence of arterial thromboembolic reactions was observed in patients treated with bevacizumab across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Croatian: U bolesnika liječenih bevacizumabom u svim je indikacijama opažena povećana incidencija arterijskih tromboembolijskih reakcija, uključujući cerebrovaskularne incidente, infarkt miokarda, tranzitorne ishemijske atake i druge arterijske tromboembolijske reakcije.
English: a Interferon alfa-2a 9 MIU 3x/week b Bevacizumab 10 mg/kg q 2 wk
Croatian: Interferon alfa-2a 9 milijuna IU 3 puta tjedno Bevacizumab 10 mg/kg svaka 2 tjedna
English: In these studies, bevacizumab was administered at the following dosing regimens in combination with FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), and fluoropyrimidine/irinotecan and fluoropyrimidine/oxaliplatin:
Croatian: FOLFOX-4 (5-FU/LV/oksaliplatin), XELOX (kapecitabin/oksaliplatin) te fluoropirimidin/irinotekan i fluoropirimidin/oksaliplatin u sljedećim režimima doziranja:
English: One hundred and five patients were randomised to 5-FU/FA + placebo arm and 104 patients to 5-FU/FA + bevacizumab (5 mg/kg every 2 weeks) arm. All treatments were continued until disease progression.
Croatian: 105 bolesnika je bilo randomizirano u skupinu 5-FU/FA + placebo, a 104 bolesnika u skupinu 5-FU/FA + bevacizumab (5 mg/kg svaka 2 tjedna).
English: Zirabev is also used for the treatment of adult patients with persistent, recurrent or metastatic cervical cancer.
Croatian: Zirabev se koristi i za liječenje odraslih bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom vrata maternice.
English: Hazard ratio [95% CI]
Croatian: Omjer hazarda (95 % CI)
English: • E3200: Bevacizumab 10 mg/kg of body weight every 2 weeks in combination with leucovorin and 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4) in bevacizumab-naïve patients.
Croatian: • E3200: Bevacizumab u dozi od 10 mg/kg tjelesne težine svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila nakon čega slijedi infuzija 5-fluorouracila i intravenski primijenjen oksaliplatin (FOLFOX-4) u bolesnika koji prethodno nisu bili liječeni bevacizumabom.
English: Myocardial infarction was reported in up to 1.4% of patients treated with bevacizumab in combination with chemotherapy compared to up to 0.7% of patients treated with chemotherapy alone.
Croatian: Infarkt miokarda prijavljen je u najviše 1,4 % bolesnika koji su primali bevacizumab u kombinaciji s kemoterapijom u usporedbi s najviše 0,7 % bolesnika liječenih samo kemoterapijom.
English: • post-authorisation safety studies,
Croatian: ● iz ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja,
English: The recommended dose of Zirabev, administered as an intravenous infusion, is either 5 mg/kg or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks.
Croatian: Preporučena doza lijeka Zirabev, primijenjenog putem intravenske infuzije, iznosi bilo 5 mg/kg ili 10 mg/kg tjelesne težine jednom svaka 2 tjedna, odnosno 7,5 mg/kg ili 15 mg/kg tjelesne težine jednom svaka 3 tjedna.
English: In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in bevacizumab-treated patients and 0.9% in control patients, all of whom had a history of prior pelvic radiation.
Croatian: U ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom cerviksa, incidencija gastrointestinalno-vaginalnih fistula iznosila je 8,3 % u bolesnica liječenih bevacizumabom te 0,9 % u kontrolnoj skupini, a u svih njih prethodno je provedeno zračenje zdjelice.
English: Zirabev 25 mg/ml concentrate for solution for infusion bevacizumab
Croatian: Zirabev 25 mg/ml koncentrat za otopinu za infuziju bevacizumab
English: In locally recurrent and metastatic breast cancer trials, Grade 3-5 wound healing complications were observed in up to 1.1% of patients receiving bevacizumab compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
Croatian: U ispitivanjima lokalno recidivirajućeg ili metastatskog raka dojke, komplikacije pri zacjeljivanju rana stupnja 3-5 primijećene su u do 1,1 % bolesnika koji su primali bevacizumab, u usporedbi s do 0,9 % bolesnika u kontrolnoj skupini (NCI-CTCAE v.3).
English: 95% CI for difference in response rates p-value (Chi-squared test)
Croatian: Bolesnice s odgovorom (Stopa odgovora 95 % CI za stope odgovora Razlika u stopama odgovora 95 % CI za razliku u stopama odgovora p-vrijednost (hi-kvadrat test)
English: Number of patients Progression-free survival
Croatian: Preživljenje bez progresije bolesti
English: • NO16966: Bevacizumab 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or bevacizumab 5 mg/kg every 2 weeks in combination with leucovorin plus 5-fluorouracil bolus, followed by 5-fluorouracil infusion, with intravenous oxaliplatin (FOLFOX-4).
Croatian: • NO16966: Bevacizumab u dozi od 7,5 mg/kg tjelesne težine svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksaliplatinom (XELOX), ili bevacizumab u dozi od 5 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila nakon čega slijedi infuzija 5-fluorouracila i intravenski primijenjen oksaliplatin (FOLFOX-4).
English: Hypertensive encephalopathy c
Croatian: , hipertenzivna encefalopatija
English: MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Croatian: Mikroangiopatska hemolitička anemija je hemolitički poremećaj koji se može manifestirati fragmentacijom eritrocita, anemijom i trombocitopenijom.
English: NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion.
Croatian: Zirabev 25 mg/ml koncentrat za otopinu za infuziju.
English: Study E3200 used a 5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-naïve patients, while study ML18147 used a 2.5 mg/kg/week equivalent dose of bevacizumab in bevacizumab-pretreated patients.
Croatian: U ispitivanju E3200 je u bolesnika koji prethodno nisu bili liječeni bevacizumabom primijenjena doza bevacizumaba ekvivalentna dozi od 5 mg/kg na tjedan, dok je u ispitivanju ML18147 u bolesnika prethodno liječenih bevacizumabom primijenjena doza bevacizumaba ekvivalentna dozi od 2,5 mg/kg na tjedan.
English: EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy.
Croatian: Monoklonska protutijela s djelovanjem na EGFR u liječenju metastatskog karcinoma kolona ili rektuma ne smiju se primjenjivati u kombinaciji s kemoterapijom koja uključuje bevacizumab.
English: Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + bevacizumab a
Croatian: Kemoterapija na bazi fluoropirimidina/irinotekana ili fluoropirimidina/oksaliplatina + bevacizumab
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zirabev.
Croatian: Prije započinjanja liječenja lijekom Zirabev potrebno je razmisliti o pregledu zubi i odgovarajućim preventivnim stomatološkim postupcima.
English: In clinical trials of ovarian cancer, Grade 3-5 wound healing complications were observed in up to 1.8% of patients in the bevacizumab arm versus 0.1% in the control arm (NCI-CTCAE v.3).
Croatian: U kliničkim ispitivanjima raka jajnika, komplikacije pri zacjeljivanju rana stupnja 3-5 primijećene su u do 1,8 % bolesnica u skupini koja je primala bevacizumab u odnosu na 0,1 % u kontrolnoj skupini (NCI-CTCAE v.3).
English: Most patients who developed CHF during mBC trials showed improved symptoms and/or left ventricular function following appropriate medical therapy.
Croatian: U većine bolesnica koje su za vrijeme kliničkog ispitivanja metastatskog raka dojke razvile kongestivno zatajenje srca je nakon odgovarajućeg liječenja došlo do poboljšanja simptoma i/ili poboljšanja funkcije lijeve klijetke.
English: Paclitaxel/ bevacizumab (n=368)
Croatian: Paklitaksel/ bevacizumab (n = 368)
English: 1 vial of 16 ml 400 mg/16 ml
Croatian: Koncentrat za otopinu za infuziju 1 bočica od 16 ml 400 mg/16 ml
English: The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Croatian: Dodavanjem bevacizumaba IFN alfa-2a značajno se produljilo preživljenje bez progresije bolesti i povećala stopa objektivnog tumorskog odgovora.
English: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating bevacizumab in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Croatian: Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze II, u kojemu se ispitivala primjena bevacizumaba u kombinaciji s režimom 5-FU/FA u prvoj liniji liječenja metastatskog kolorektalnog raka.
English: This was a phase III randomised, active-controlled, open-label trial investigating bevacizumab 10 mg/kg in combination with leucovorin with 5-fluorouracil bolus and then 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule in previously-treated patients (second line) with advanced colorectal cancer.
Croatian: Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze III u kojemu se ispitivao bevacizumab u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluororuracila, a zatim infuzijom 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4) u prethodno liječenih bolesnika (druga linija) s uznapredovalim kolorektalnim rakom.
English: Treatment comparison Other factor
Croatian: Usporedba liječenja
English: Gastrointestinal disorder, Stomatitis, Proctalgia
Croatian: gastrointestinalni poremećaj, proktalgija gastrointestinalni ulkus
English: Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Croatian: Zirabev je u kombinaciji s paklitakselom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim rakom dojke.
English: This was a Phase III randomised, controlled, open-label trial investigating bevacizumab 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in combination with fluoropyrimidine-based chemotherapy versus fluoropyrimidine-based chemotherapy alone in patients with mCRC who have progressed on a first- line bevacizumab-containing regimen.
Croatian: Riječ je o randomiziranom, kontroliranom, otvorenom ispitivanju faze III u kojemu se ispitivao bevacizumab u dozi od 5,0 mg/kg svaka 2 tjedna ili 7,5 mg/kg svaka 3 tjedna u kombinaciji s kemoterapijom na bazi fluoropirimidina u usporedbi s primjenom samo kemoterapije na bazi fluoropirimidina u bolesnika s metastatskim karcinomom kolona ili rektuma u kojih je došlo do progresije bolesti nakon prve linije liječenja koja je obuhvaćala bevacizumab.
English: Addition of bevacizumab to standard of care did not demonstrate clinical benefit in clinical trial BO20924, in 71 evaluable children (from age 6 months to less than 18 years old) patients with metastatic Rhabdomyosarcoma and non-Rhabdomyosarcoma Soft Tissue Sarcoma.
Croatian: U kliničkom ispitivanju BO20924, dodavanje bevacizumaba standardnom liječenju nije pokazalo kliničku korist kod 71 pedijatrijskog bolesnika kojeg se moglo ocijeniti (u dobi od 6 mjeseci do manje od 18 godina) s metastatskim rabdomiosarkomom i sarkomom mekog tkiva koji nije rabdomiosarkom. (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Overall survival - follow-up analysis2 Hazard ratio (95% CI)
Croatian: Ukupno preživljenje - analiza nakon praćenja Omjer hazarda (95 % CI)
English: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Croatian: U bolesnika u kojih se razvije nefrotski sindrom (NCI-CTCAE v.3) treba trajno obustaviti liječenje.
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Croatian: Poremećaji živčanog sustava hipertenzivna encefalopatija (vrlo rijetko) (vidjeti i dio 4.4 i „Hipertenzija“ u dijelu 4.8) sindrom posteriorne reverzibilne encefalopatije (PRES) (rijetko) (vidjeti i dio 4.4)
English: Anorexia, Hypomagnesaemia, Hyponatraemia
Croatian: Poremećaji metabolizma i prehrane anoreksija, hipomagnezijemija, hiponatrijemija dehidracija
English: Gastrointestinal (GI) perforations and fistulae (see section 4.8)
Croatian: Gastrointestinalne perforacije i fistule (vidjeti dio 4.8)
English: In patients with NSCLC excluding predominant squamous histology, all Grade reactions were seen with a frequency of up to 9.3% when treated with bevacizumab plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Croatian: U bolesnika s rakom pluća nemalih stanica, osim u slučaju prevladavajuće histologije skvamoznih stanica, krvarenja svih stupnjeva zabilježena su s učestalošću do 9,3 % kada su bili liječeni bevacizumabom i kemoterapijom, u usporedbi s najviše 5 % u bolesnika liječenih samo kemoterapijom.
English: Progression-free survival Median time (months) Hazard ratio p-value
Croatian: Preživljenje bez progresije bolesti Medijan vremena (mjeseci) Omjer hazarda p-vrijednost
English: Zirabev is also used for the treatment of adult patients with metastatic breast cancer.
Croatian: Zirabev se koristi i za liječenje odraslih bolesnica s metastatskim rakom dojke.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 bleeding reactions have been reported in up to 8.3% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 4.6% of patients treated with paclitaxel and topotecan.
Croatian: U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom cerviksa (ispitivanje GOG-0240), reakcije krvarenja stupnja 3-5 prijavljene su u do 8,3 % bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i topotekanom u usporedbi s do 4,6 % bolesnica liječenih paklitakselom i topotekanom.
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 venous thromboembolic events have been reported in up to 15.6% of patients treated with bevacizumab in combination with paclitaxel and cisplatin compared with up to 7.0% of patients treated with paclitaxel and cisplatin.
Croatian: U kliničkom ispitivanju u bolesnica s perzistirajućim, perzistentnim, recidivirajućim ili metastatskim rakom cerviksa (ispitivanje GOG-0240), venski tromboembolijski događaji stupnja 3-5 prijavljeni su u do 15,6 % bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i cisplatinom u usporedbi s do7,0 % bolesnica liječenih paklitakselom i cisplatinom.
English: Median PFS (months) Hazard ratio [95% CI]
Croatian: Medijan PFS-a (mjeseci) Omjer hazarda [95 % CI]
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Croatian: Nije bilo ni statistički ni klinički značajnih razlika u klirensu bevacizumaba između bolesnika koji su primali samo bevacizumab i bolesnika koji su primali bevacizumab u kombinaciji s interferonom alfa-2a,
English: The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies using a population pharmacokinetic model.
Croatian: (7 mjeseci do 21 godine; 5,9 do 125 kg) u 4 klinička ispitivanja uz pomoć populacijskog farmakokinetičkog modela.
English: This was a randomised, double-blind, phase II clinical trial investigating bevacizumab 10 mg/kg in a 2 weekly schedule with the same dose of bevacizumab in combination with 150 mg daily erlotinib, in patients with metastatic clear cell RCC. A total of 104 patients were randomised to treatment in this trial, 53 to bevacizumab 10 mg/kg every 2 weeks plus placebo and 51 to bevacizumab 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Croatian: U ovom su ispitivanju randomizirana ukupno 104 bolesnika: 53 za liječenje bevacizumabom u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s placebom, a 51 za liječenje bevacizumabom u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s erlotinibom u dozi od 150 mg na dan.
English: The primary efficacy parameter of the trial was the duration of progression-free survival.
Croatian: Primarni parametar djelotvornosti u ispitivanju bilo je trajanje preživljenja bez progresije bolesti (engl. progression-free survival, PFS).
English: From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (study GOG-0240), grade 3-5 infections have been reported in up to 24% of patients treated with bevacizumab in combination with paclitaxel and topotecan compared with up to 13% of patients treated with paclitaxel and topotecan.
Croatian: U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom cerviksa (ispitivanje GOG-0240), infekcije stupnja 3-5 prijavljene su u do 24 % bolesnica liječenih bevacizumabom u kombinaciji s paklitakselom i topotekanom u usporedbi s do 13 % bolesnica liječenih paklitakselom i topotekanom.
English: Metastatic breast cancer (mBC)
Croatian: Metastatski rak dojke
English: Zirabev is also used for treatment of adult patients with advanced kidney cancer.
Croatian: Zirabev se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom bubrega.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics
Croatian: Učinak antineoplastičnih lijekova na farmakokinetiku bevacizumaba
English: Zirabev should be discontinued permanently in patients who experience Grade 3 or 4 bleeding during Zirabev therapy (NCI-CTCAE v.3) (see section 4.8).
Croatian: Potrebno je trajno obustaviti primjenu lijeka Zirabev u bolesnika u kojih tijekom terapije lijekom Zirabev nastupi krvarenje stupnja 3 ili 4 (NCI-CTCAE v.3) (vidjeti dio
English: Number of patients Overall survival Median (months) 95% CI
Croatian: Ukupno preživljenje Medijan (mjeseci) 95 % CI
English: Patients were randomised to platinum-based chemotherapy, cisplatin 80 mg/m2 intravenous infusion on day 1 and gemcitabine 1250 mg/m2 intravenous infusion on days 1 and 8 of every 3-week cycle for up to 6 cycles (CG) with placebo or CG with bevacizumab at a dose of 7.5 or 15 mg/kg intravenous infusion day 1 of every 3-week cycle.
Croatian: 1250 mg/m2 primijenjen intravenskom infuzijom 1. i 8. dana svakog trotjednog ciklusa u trajanju do najviše 6 ciklusa (CG) i placebo ili u skupinu koja je primala CG u kombinaciji s bevacizumabom u dozi od 7,5 ili 15 mg/kg, primijenjenim intravenskom infuzijom 1. dana svakog trotjednog ciklusa.
English: Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c
Croatian: a,b duboka venska tromboza aneurizme i disekcije arterije, bubrežna trombotička mikroangiopatij b,c
English: The median overall survival was 20.3 months in placebo and 21.2 months in bevacizumab treated patients in the FOLFOX treatment subgroup, HR=0.94, 97.5% CI = [0.75; 1.16]; p-value = 0.4937, the corresponding results in the XELOX, treatment subgroup being 19.2 vs. 21.4 months, HR = 0.84, 97.5% CI = [0.68; 1.04]; p-value = 0.0698.
Croatian: Medijan ukupnog preživljenja iznosio je 20,3 mjeseca u bolesnika u podskupini liječenoj režimom FOLFOX koji su primali placebo, a 21,2 mjeseca u onih liječenih bevacizumabom: HR = 0,94; 97,5 % CI = [0,75; 1,16]; p-vrijednost = 0,4937.
English: Paclitaxel/ bevacizumab (n=252)
Croatian: Paklitaksel/ bevacizumab (n = 252)
English: Zirabev is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Croatian: Zirabev se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica.
English: EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens
Croatian: Monoklonska protutijela s djelovanjem na EGFR u kombinaciji s režimom kemoterapije koji uključuje bevacizumab