natgillin/translations-raw huggingface dataset:
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). 
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).
95% CI for difference in response rates p-value (Chi-squared test) 
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)
Number of patients Progression-free survival 
Preživljenje bez progresije bolesti
• 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). 
• 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).
Hypertensive encephalopathy c 
, hipertenzivna encefalopatija
MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia. 
Mikroangiopatska hemolitička anemija je hemolitički poremećaj koji se može manifestirati fragmentacijom eritrocita, anemijom i trombocitopenijom.
NAME OF THE MEDICINAL PRODUCT Zirabev 25 mg/ml concentrate for solution for infusion. 
Zirabev 25 mg/ml koncentrat za otopinu za infuziju.
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. 
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.
EGFR monoclonal antibodies should not be administered for the treatment of mCRC in combination with bevacizumab-containing chemotherapy. 
Monoklonska protutijela s djelovanjem na EGFR u liječenju metastatskog karcinoma kolona ili rektuma ne smiju se primjenjivati u kombinaciji s kemoterapijom koja uključuje bevacizumab.
Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + bevacizumab a 
Kemoterapija na bazi fluoropirimidina/irinotekana ili fluoropirimidina/oksaliplatina + bevacizumab
A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zirabev. 
Prije započinjanja liječenja lijekom Zirabev potrebno je razmisliti o pregledu zubi i odgovarajućim preventivnim stomatološkim postupcima.
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). 
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).
Most patients who developed CHF during mBC trials showed improved symptoms and/or left ventricular function following appropriate medical therapy. 
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.
Paclitaxel/ bevacizumab (n=368) 
Paklitaksel/ bevacizumab (n = 368)
1 vial of 16 ml 400 mg/16 ml 
Koncentrat za otopinu za infuziju 1 bočica od 16 ml 400 mg/16 ml
The addition of bevacizumab to IFN-alpha-2a significantly increased PFS and objective tumour response rate. 
Dodavanjem bevacizumaba IFN alfa-2a značajno se produljilo preživljenje bez progresije bolesti i povećala stopa objektivnog tumorskog odgovora.
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. 
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.
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. 
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.
Treatment comparison Other factor 
Usporedba liječenja
Gastrointestinal disorder, Stomatitis, Proctalgia 
gastrointestinalni poremećaj, proktalgija gastrointestinalni ulkus
Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. 
Zirabev je u kombinaciji s paklitakselom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim rakom dojke.
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. 
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.
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. 
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).
Overall survival - follow-up analysis2 Hazard ratio (95% CI) 
Ukupno preživljenje - analiza nakon praćenja Omjer hazarda (95 % CI)
Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3). 
U bolesnika u kojih se razvije nefrotski sindrom (NCI-CTCAE v.3) treba trajno obustaviti liječenje.
Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8) 
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)
Anorexia, Hypomagnesaemia, Hyponatraemia 
Poremećaji metabolizma i prehrane anoreksija, hipomagnezijemija, hiponatrijemija dehidracija
Gastrointestinal (GI) perforations and fistulae (see section 4.8) 
Gastrointestinalne perforacije i fistule (vidjeti dio 4.8)
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. 
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.
Progression-free survival Median time (months) Hazard ratio p-value 
Preživljenje bez progresije bolesti Medijan vremena (mjeseci) Omjer hazarda p-vrijednost
Zirabev is also used for the treatment of adult patients with metastatic breast cancer. 
Zirabev se koristi i za liječenje odraslih bolesnica s metastatskim rakom dojke.
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. 
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.
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. 
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.
Median PFS (months) Hazard ratio [95% CI] 
Medijan PFS-a (mjeseci) Omjer hazarda [95 % CI]
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). 
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,
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. 
(7 mjeseci do 21 godine; 5,9 do 125 kg) u 4 klinička ispitivanja uz pomoć populacijskog farmakokinetičkog modela.
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. 
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.
The primary efficacy parameter of the trial was the duration of progression-free survival. 
Primarni parametar djelotvornosti u ispitivanju bilo je trajanje preživljenja bez progresije bolesti (engl. progression-free survival, PFS).
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. 
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.
Metastatic breast cancer (mBC) 
Metastatski rak dojke
Zirabev is also used for treatment of adult patients with advanced kidney cancer. 
Zirabev se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom bubrega.
4.5 Interaction with other medicinal products and other forms of interaction Effect of antineoplastic agents on bevacizumab pharmacokinetics 
Učinak antineoplastičnih lijekova na farmakokinetiku bevacizumaba
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). 
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
Number of patients Overall survival Median (months) 95% CI 
Ukupno preživljenje Medijan (mjeseci) 95 % CI
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. 
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.
Aneurysms and artery dissections, Renal thrombotic microangiopathy b,c 
a,b duboka venska tromboza aneurizme i disekcije arterije, bubrežna trombotička mikroangiopatij b,c
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. 
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.
Paclitaxel/ bevacizumab (n=252) 
Paklitaksel/ bevacizumab (n = 252)
Zirabev is also used for the treatment of adult patients with advanced non-small cell lung cancer. 
Zirabev se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica.
EGFR monoclonal antibodies in combination with bevacizumab chemotherapy regimens 
Monoklonska protutijela s djelovanjem na EGFR u kombinaciji s režimom kemoterapije koji uključuje bevacizumab
Paclitaxel/ bevacizumab (n=229) 
Paklitaksel/ bevacizumab (n = 229)
Name and address of the manufacturer responsible for batch release Pfizer Ireland Pharmaceuticals 
Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by intravenous infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or 
Bolesnici su randomizirani u skupinu koja je primala kemoterapiju na bazi platine (paklitaksel 200 mg/m2) i karboplatin AUC = 6,0, oba intravenskom infuzijom (PK) 1. dana svakog trotjednog ciklusa u trajanju do najviše šest ciklusa ili u skupinu koja je primala isti kemoterapijski protokol na bazi platine (PK) u kombinaciji s bevacizumabom u dozi od 15 mg/kg primijenjen intravenskom infuzijom 1. dana svakog trotjednog ciklusa.
From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (GOG-240), 1.8% of bevacizumab-treated patients and 1.4% of control patients were reported to have had nongastrointestinal vaginal, vesical, or female genital tract fistulae. 
U kliničkom ispitivanju u bolesnica s perzistentnim, recidivirajućim ili metastatskim rakom cerviksa (ispitivanje GOG-240), fistule izvan gastrointestinalnog sustava, i to vaginalne, vezikalne ili fistule u ženskom genitalnom traktu, prijavljene su u 1,8 % bolesnica liječenih bevacizumabom te u 1,4 % bolesnica u kontrolnoj skupini.
The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Preporučena doza lijeka Zirabev iznosi 10 mg/kg tjelesne težine jednom svaka 2 tjedna ili 15 mg/kg tjelesne težine jednom svaka 3 tjedna, primijenjeno putem intravenske infuzije.
The secondary endpoint of Overall Survival (OS) was not mature. 
Podaci za sekundarnu mjeru ishoda, ukupno preživljenje, nisu bili spremni.
Number of patients Overall survival Median time (months) 95% CI 
Ukupno preživljenje Medijan vremena (mjeseci) 95 % CI
5-fluorouracil intravenous bolus/infusion, each on days 1 and 2 
22 h oksaliplatin 1. dana leukovorin 1. i 2. dana 5-fluorouracil intravenski bolus/infuzija, oboje 1. i 2. dana placebo ili bevacizumab
The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + Erlotinib arm (median PFS 8.5 versus 9.9 months). 
+ erlotinib (medijan PFS-a 8,5 naspram 9,9 mjeseci).
• comparative incidences noted between clinical trial treatment arms (with at least a 10% difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2% difference compared to the control arm for NCI-CTCAE Grade 3-5 reactions, 
NCI-CTCAE ili s razlikom od najmanje 2 % u odnosu na kontrolnu skupinu za nuspojave stupnja 3-5 prema NCI-CTCAE),
This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating bevacizumab 7.5 mg/kg in combination with oral capecitabine and intravenous oxaliplatin (XELOX), administered on a 3- weekly schedule; or bevacizumab 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with intravenous oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule. 
Riječ je o randomiziranom, dvostruko slijepom (za bevacizumab) kliničkom ispitivanju faze III u kojemu se ispitivala primjena bevacizumaba u dozi od 7,5 mg/kg svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksalipaltinom (XELOX), odnosno primjena bevacizumaba u dozi od 5 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila, nakon čega je slijedila infuzija 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4).
An increased incidence of hypertension was observed in bevacizumab-treated patients. 
U bolesnika liječenih bevacizumabom opažena je povećana incidencija hipertenzije.
Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. 
Lijekove za parenteralnu primjenu potrebno je prije primjene vizualno pregledati na moguću prisutnost čestica i promjenu boje.
130 mg/m2 intravenous 2 h 
130 mg/m 2 intravenski
Gastrointestinal (GI) perforations and fistulae (see section 4.4) 
Gastrointestinalne perforacije i fistule (vidjeti dio 4.4)
Other special populations Elderly patients 
Ostale posebne populacije
The recommended dose of Zirabev is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion. 
Preporučena doza lijeka Zirabev iznosi 7,5 mg/kg ili 15 mg/kg tjelesne težine, primijenjeno jednom svaka 3 tjedna putem intravenske infuzije.
Myalgia, Arthralgia, Muscular weaknes s, Back pain 
mialgija, artralgija, mišićna slabost, bol u leđima osteonekroza čeljusti b,c
In the FOLFOX treatment subgroup, the median PFS was 8.6 months in placebo and 9.4 months in bevacizumab treated patients, HR = 0.89, 97.5% CI = [0.73; 1.08]; p-value = 0.1871, the corresponding results in the XELOX treatment subgroup being 7.4 vs. 9.3 months, HR = 0.77, 97.5% CI = [0.63; 0.94]; p-value = 0.0026. 
U podskupini bolesnika liječenih režimom XELOX medijan preživljenja bez progresije bolesti je iznosio 7,4 mjeseca u bolesnika koji su primali placebo, u usporedbi s 9,3 mjeseca u bolesnika liječenih bevacizumabom: HR = 0,77; 97,5 % CI = [0,63; 0,94]; pvrijednost = 0,0026.
Paclitaxel 135 mg/m2 intravenous over 24 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m2 intravenous over 3 hours on Day 1 and cisplatin 50 mg/m2 intravenous on Day 2 plus bevacizumab 15 mg/kg intravenous on Day 2 (q3w); or Paclitaxel 175 mg/m intravenous over 3 hours on Day 1 and cisplatin 50 mg/m intravenous on Day 1 plus bevacizumab 15 mg/kg intravenous on Day 1 (q3w) 
paklitaksel u dozi od 135 mg/m2 intravenski tijekom 24 sata 1. dana i cisplatin u dozi od 50 mg/m2 intravenski 2. dana u kombinaciji s bevacizumabom u dozi od 15 mg/kg intravenski 2. dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m 2 intravenski tijekom 3 sata 1. dana i cisplatin u dozi od
In a randomized phase II study (BO20924) a total of 154 patients aged ≥ 6 months to <18 years with newly diagnosed metastatic rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma were treated with standard of care (Induction IVADO/IVA+/- local therapy followed by Maintenance Vinorelbine and cyclophosphamide) with or without bevacizumab (2.5 mg/kg/week) for a total duration of treatment of approximately 18 months. 
U randomiziranom ispitivanju faze II (BO20924) ukupno su 154 bolesnika u dobi od ≥ 6 mjeseci do < 18 godina s novodijagnosticiranim metastatskim rabdomiosarkomom ili sarkomom mekog tkiva koji nije rabdomiosarkom bila liječena standardnom terapijom (uvodno liječenje režimom IVADO/IVA
After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients. 
U većine se bolesnica funkcija jajnika oporavila nakon prekida liječenja bevacizumabom.
The administration of Zirabev should be permanently discontinued if you develop 
Primjenu lijeka Zirabev treba trajno obustaviti
Gallbladder perforation b,c 
Poremećaji jetre i žuči perforacija žučnog mjehura b,c
The recommended dose of Zirabev is 10 mg/kg of body weight given once every 2 weeks as an intravenous infusion. 
Preporučena doza lijeka Zirabev iznosi 10 mg/kg tjelesne težine, primijenjeno jednom svaka 2 tjedna putem intravenske infuzije.
Some of the adverse reactions are reactions commonly seen with chemotherapy; however, bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents. 
Međutim, bevacizumab može pogoršati te reakcije kada se primjenjuje u kombinaciji s kemoterapeuticima.
Congestive heart failure b,d 
Srčani poremećaji kongestivno zatajenje srca b,d supraventrikularna tahikardija
Objective response rate (ORR) Patients included in analysis Rate 
Stopa objektivnog odgovora (ORR)
B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2. 
Opažena je povećana incidencija kongestivnog zatajenja srca u kliničkom ispitivanju bolesnika s difuznim velikostaničnim limfomom B-limfocita kada su primali bevacizumab s doksorubicinom u kumulativnoj dozi višoj od 300 mg/m2.
Each vial contains 400 mg bevacizumab. 
Jedna bočica sadrži 400 mg bevacizumaba.
Zirabev may impair female fertility. 
Lijek Zirabev može štetno djelovati na plodnost žena.