FrancophonIA/ELRC3.0 huggingface dataset:
English: When used for those adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer whose disease has come back before 6 months after the last time they were treated with a chemotherapy regimen containing a platinum agent, Avastin will be administered in combination with paclitaxel, or topotecan, or pegylated liposomal doxorubicin.
Croatian: Kada se koristi za odrasle bolesnice s uznapredovalim epitelnim rakom jajnika, rakom jajovoda ili primarnim peritonealnim rakom u kojih se bolest vratila manje od 6 mjeseci nakon posljednje primjene kemoterapije koja je sadržavala platinu, Avastin će se davati u kombinaciji s paklitakselom ili topotekanom ili pegiliranim liposomalnim doksorubicinom.
English: 95% CI (0.69; 0.93)
Croatian: 0,80 (p=0,003) 95% CI (0,69; 0,93)
English: The overall incidence of NCI-CTC Grade 3 and 4 hypertension in patients receiving Avastin ranged from 0.4% to 17.9%.
Croatian: kriterijima u bolesnika koji su primali Avastin kretala se od 0,4% do 17,9%.
English: The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 patients in Study BO20924 ((1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in Study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Croatian: Farmakokinetika bevacizumaba dobro je okarakterizirana pedijatrijskim populacijskim farmakokinetičkim modelom za 70 bolesnika u ispitivanju BO20924 (1,4 - 17,6 godina;
English: Very Rare
Croatian: Manje često Rijetko
English: The exploratory PFS and OS analyses by chemotherapy cohort (paclitaxel, topotecan and PLD) are summarized in Table 24.
Croatian: Eksploracijske analize PFS-a i OS-a prema kemoterapijskoj kohorti pokazale su poboljšanja u svim kohortama (paklitaksel, topotekan i PLD) nakon dodavanja bevacizumaba.
English: Avastin (15 mg/kg Day 1) every 3 weeks for 6 and up to 10 cycles followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity
Croatian: dan) svaka 3 tjedna tijekom 6, a najviše 10 ciklusa, a zatim samo Avastin (15 mg/kg svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti.
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 karcinoma jajnika, komplikacije pri zacjeljivanju rana stupnja 3-5 zabilježene su u 1,8% bolesnica u skupini koja je primala bevacizumab u odnosu na 0,1% u kontrolnoj skupini (NCI-CTCAE v.3).
English: NN:
Croatian: uključuju:
English: Therapy should be permanently discontinued in patients who develop arterial thromboembolic reactions.
Croatian: U bolesnika u kojih se razviju arterijske tromboembolijske reakcije liječenje treba trajno obustaviti.
English: • NO16966: Avastin 7.5 mg/kg of body weight every 3 weeks in combination with oral capecitabine and intravenous oxaliplatin (XELOX) or Avastin 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: Avastin u dozi od 7,5 mg/kg tjelesne težine svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksaliplatinom (XELOX), ili Avastin u dozi od 5 mg/kg svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila te zatim infuzijom 5-fluorouracila i intravenski primijenjenim oksaliplatinom (FOLFOX-4).
English: • blocking of the arteries by a blood clot,
Croatian: ● začepljenje arterija zbog krvnog ugruška,
English: The primary analysis of investigator-assessed PFS with a data cut-off date of 28 February 2010 shows an unstratified hazard ratio of 0.79 (95% CI: 0.68-0.91, 2-sided log-rank p-value 0.0010) with a median PFS of 16.0 months in the CP arm and 18.3 months in the CPB7.5+ arm.
Croatian: Primarna analiza preživljenja bez progresije bolesti prema procjeni ispitivača i na temelju podataka prikupljenih do 28. veljače 2010. pokazuje nestratificirani omjer rizika od 0,79 (95% CI: 0,68-0,91; p-vrijednost dvostranog log-rang testa = 0,0010), uz medijan preživljenja bez progresije bolesti od
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 Avastin compared with up to 0.9% of patients in the control arms (NCI-CTCAE v.3).
Croatian: U ispitivanjima lokalno recidivirajućeg ili metastatskog karcinoma dojke, komplikacije pri zacjeljivanju rana stupnja 3-5 primijećene su u 1,1% bolesnika koji su primali Avastin, u usporedbi s 0,9% bolesnika u kontrolnoj skupini (NCI-CTCAE v.3).
English: Common Uncommon Rare
Croatian: Vrlo rijetko Nepoznata učestalost
English: • Haemorrhage, including pulmonary haemorrhage/haemoptysis, which is more common in non small cell lung cancer patients (see section 4.4).
Croatian: krvarenje, uključujući plućno krvarenje/hemoptizu, koje je češće u bolesnika koji boluju od karcinoma pluća nemalih stanica (vidjeti dio 4.4) arterijska tromboembolija (vidjeti dio 4.4).
English: Wound healing complications (see section 4.8)
Croatian: Komplikacije pri zacjeljivanju rana (vidjeti dio 4.8)
English: In a trial of patients with persistent, recurrent or metastatic cervical cancer, the incidence of GI-vaginal fistulae was 8.3% in Avastin-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 karcinomom cerviksa, incidencija gastrointestinalno-vaginalnih fistula iznosila je 8,3% u bolesnica liječenih lijekom Avastin te 0,9% u kontrolnoj skupini, a u svih njih prethodno je provedeno zračenje zdjelice.
English: Leucovorin 200 mg/m2 IV 2 h 5-Fluorouracil
Croatian: 200 mg/m i.v. 2 h
English: The study did not meet its primary endpoint of demonstrating a significant improvement of EFS (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T
Croatian: Ispitivanje nije postiglo primarnu mjeru ishoda, tj. nije pokazalo značajno poboljšanje preživljenja bez događaja (prema ocjeni središnjeg povjerenstva za radiološku ocjenu) u skupini koja je uz RT/T
English: The primary endpoint was progression-free-survival, with secondary endpoints including objective response rate and overall survival.
Croatian: Primarna mjera ishoda bilo je preživljenje bez progresije bolesti, dok su sekundarne mjere ishoda obuhvaćale stopu objektivnog odgovora i ukupno preživljenje.
English: Progression-free survival Median time (months) Hazard ratio p-value
Croatian: Medijan vremena (mjeseci) Omjer hazarda p-vrijednost
English: Only patients with histologically documented ovarian, primary peritoneal, or fallopian tube carcinoma that had recurred > 6 months after platinum-based chemotherapy and who had not received chemotherapy in the recurrent setting and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents were included in the study.
Croatian: U ispitivanje su uključene samo bolesnice s histološki potvrđenim karcinomom jajnika, primarnim peritonealnim karcinomom ili karcinomom jajovoda koji je recidivirao nakon > 6 mjeseci od kemoterapije utemeljene na platini, a koje nisu primale kemoterapiju za liječenje recidiva i nisu prethodno bile liječene bevacizumabom, drugim VEGF inhibitorima niti lijekovima koji djeluju na VEGF receptore.
English: • E3200: Avastin 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: Avastin u dozi od 10 mg/kg tjelesne težine svaka 2 tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila te zatim infuzijom 5-fluorouracila i intravenski primijenjenim oksaliplatinom (FOLFOX-4) u bolesnika koji prethodno nisu bili liječeni bevacizumabom.
English: Tél/Tel: +32 (0) 2 525 82 11
Croatian: N.V. Roche S.A. Tél/Tel: +32 (0) 2 525 82 11
English: The safety and efficacy of Avastin in the treatment of patients with platinum-sensitive, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who have not received prior chemotherapy in the recurrent setting or prior bevacizumab treatment, was studied in a phase III randomised, double-blind, placebo-controlled trial (AVF4095g).
Croatian: karcinoma jajovoda ili primarnog peritonealnog karcinoma osjetljivih na platinu, koje nisu prethodno primale kemoterapiju za liječenje recidiva i nisu prethodno bile liječene bevacizumabom, ispitivane su u randomiziranom, dvostruko slijepom, placebo kontroliranom ispitivanju (AVF4095g).
English: The addition of Avastin to IFN-alpha-2a significantly increased PFS and objective tumour response rate.
Croatian: Dodavanjem lijeka Avastin interferonu alfa-2a značajno se produljilo preživljenje bez progresije bolesti i stopa objektivnog odgovora tumora.
English: The majority of patients in both arms had an ECOG Performance Status (PS) of 0 (CT: 56.4% vs. CT + BV: 61.2%).
Croatian: 56,4% naspram KT+BV: 61,2%).
English: Each 16 ml vial contains 400 mg of bevacizumab.
Croatian: Jedna bočica od 16 ml sadrži 400 mg bevacizumaba.
English: FOLFOX-4 + Avastina
Croatian: FOLFOX-4 + Avastin a
English: PFS subgroup analyses by disease stage and debulking status are summarised in Table 19.
Croatian: Analize preživljenja bez progresije bolesti po podskupinama prema stadiju bolesti i statusu smanjenja tumorske mase sažeti su u Tablici 19.
English: Hypersensitivity, infusion reactions a,b,c
Croatian: Poremećaji imunološkog sustava preosjetljivost, infuzijske reakcijea,b,c
English: The efficacy results are presented in Table 15 Table 15 Efficacy results for trial BO17705
Croatian: Tablica 15 Rezultati djelotvornosti za ispitivanje BO17705 BO17705
English: • a hole in the stomach or intestines,
Croatian: ● napuknuće želuca ili crijeva,
English: The results of this study are summarised in Table 18.
Croatian: Rezultati ovog ispitivanja sažeti su u Tablici 18.
English: The addition of Avastin 5 mg/kg every two weeks to 5-FU/FA resulted in higher objective response rates, significantly longer progression-free survival, and a trend in longer survival as compared to 5-FU/FA chemotherapy alone.
Croatian: Dodavanjem lijeka Avastin u dozi od 5 mg/kg protokolu 5-FU/FA svaka dva tjedna povećala se stopa objektivnog odgovora, statistički značajno je produljeno preživljenje do progresije bolesti uz tendenciju poboljšanja preživljenja u usporedbi s primjenom samo kemoterapije 5-FU/FA.
English: Arterial thromboembolism (see section 4.8)
Croatian: Arterijska tromboembolija (vidjeti dio 4.8)
English: (p-value = 0.00004)
Croatian: (p-vrijednost = 0,00004)
English: Death of bone tissue (osteonecrosis) in bones other than the jaw have been reported in patients under 18 years old when treated with Avastin.
Croatian: U bolesnika mlađih od 18 godina prijavljeno je odumiranje koštanog tkiva (osteonekroza) u drugim kostima osim čeljusti kada su liječeni lijekom Avastin.
English: • blocking of the blood vessels of the lungs by a blood clot,
Croatian: ● začepljenje krvnih žila u plućima zbog krvnog ugruška,
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 se u liječenju metastatskog karcinoma kolona ili rektuma ne smiju primjenjivati u kombinaciji s kemoterapijom koja uključuje bevacizumab.
English: Limited information is available on the continued use of Avastin in patients with other fistulae.
Croatian: Podaci o nastavku primjene lijeka Avastin u bolesnika s drugim fistulama su ograničeni.
English: Pulmonary haemorrhage/ Haemoptysisb,d,
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurijab,d
English: Hypertension (see section 4.4)
Croatian: Hipertenzija (vidjeti dio 4.4)
English: Randomised patients with stage III suboptimally debulked disease
Croatian: Randomizirane bolesnice sa stadijem III bolesti uz suboptimalno smanjenu tumorsku masu
English: % pts with objective response p-value
Croatian: % bolesnica s objektivnim odgovorom p-vrijednost
English: Avastin is administered in addition to platinum-based chemotherapy for up to 6 cycles of treatment followed by Avastin as a single agent until disease progression.
Croatian: Prva linija liječenja neskvamoznog NSCLC-a u kombinaciji s kemoterapijom na bazi platine Avastin se primjenjuje uz kemoterapiju na bazi spojeva platine do najviše 6 ciklusa liječenja, nakon čega se Avastin primjenjuje sam do progresije bolesti.
English: Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with Avastin.
Croatian: U bolesnika liječenih lijekom Avastin rijetko je prijavljen nekrotizirajući fasciitis, uključujući slučajeve sa smrtnim ishodom.
English: The results of this study are summarised in Table 16.
Croatian: Rezultati ovog ispitivanja sažeti su u Tablici 16.
English: receiving Avastin as compared to those aged ≤ 65 years treated with Avastin.
Croatian: U starijih bolesnika (> 65 godina) koji su primali Avastin, u odnosu na bolesnike u dobi od
English: België/Belgique/Belgien N.V. Roche S.A.
Croatian: B e lgië/Belgique/Belgien
English: Hazard ratio (95% CI)
Croatian: Omjer hazarda (95% CI)
English: Paclitaxel/ Avastin (n=252)
Croatian: Paklitaksel/ Avastin (n=252)
English: Hypertension (see section 4.8)
Croatian: Hipertenzija (vidjeti dio 4.8)
English: Avastin is also used for the treatment of adult patients with metastatic breast cancer.
Croatian: Avastin se koristi i za liječenje odraslih bolesnika s metastatskim rakom dojke.
English: Diluted medicinal product
Croatian: Razrijeđeni lijek
English: Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer.
Croatian: Bevacizumab je u kombinaciji s paklitakselom indiciran za prvu liniju liječenja odraslih bolesnika s metastatskim karcinomom dojke.
English: Hazard ratio Best overall response ratea
Croatian: Omjer hazarda Najbolja stopa ukupnog odgovora a
English: Each 4 ml vial contains 100 mg of bevacizumab.
Croatian: Jedna bočica od 4 ml sadrži 100 mg bevacizumaba.
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: mjeseci do 21 godine; 5,9 do 125 kg) u 4 klinička ispitivanja uz pomoć populacijskog farmakokinetičkog modela.
English: 0.61-0.83, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 10.4 months in the CPP arm and 14.1 months in the CPB15+ arm.
Croatian: kada se skupina CPB15+ usporedi sa skupinom CPP, uz medijan preživljenja bez progresije bolesti od 10,4 mjeseca u skupini CPP te 14,1 mjesec u skupini CPB15+.
English: Clear to slightly opalescent, colourless to pale brown liquid.
Croatian: Bistra do blago opalescentna, bezbojna do blijedosmeđa tekućina.
English: Rectal haemorrhage
Croatian: Prijavljivanje nuspojava
English: This was a randomised, double-blind, phase II clinical trial investigating Avastin 10 mg/kg in a 2 weekly schedule with the same dose of Avastin 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 Avastin 10 mg/kg every 2 weeks plus placebo and 51 to Avastin 10 mg/kg every 2 weeks plus erlotinib 150 mg daily.
Croatian: U ovom su ispitivanju ukupno 104 bolesnika randomizirana u dvije terapijske skupine: 53 za liječenje lijekom Avastin u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s placebom, a 51 za liječenje lijekom Avastin u dozi od 10 mg/kg svaka 2 tjedna u kombinaciji s erlotinibom u dozi od 150 mg na dan.
English: The results of this study are summarised in Table 20.
Croatian: Rezultati ovog ispitivanja sažeti su u Tablici 20.
English: Post-marketing experience Table 3 Adverse reactions reported in post-marketing setting System organ class (SOC)
Croatian: Tablica 3 Nuspojave prijavljene nakon stavljanja lijeka u promet
English: • allergic reactions (the signs may include difficulty breathing, facial redness, rash, low blood pressure or high blood pressure, low oxygen in your blood, chest pain, or nausea/vomiting),
Croatian: ● ozbiljne infekcije kože ili dubljih potkožnih slojeva, osobito ako ste imali napuknuća u stijenci crijeva ili probleme sa zacjeljivanjem rana, ● alergijske reakcije (znakovi mogu uključivati otežano disanje, crvenilo lica, osip, visok ili nizak krvni tlak, niske razine kisika u krvi, bol u prsištu ili mučninu/povraćanje),
English: • CPB arm: Carboplatin (AUC5) and paclitaxel (175 mg/m2 IV) and concurrent Avastin (15 mg/kg) every 3 weeks for 6 and up to 8 cycles, followed by Avastin (15 mg/kg every 3 weeks) alone until disease progression or unacceptable toxicity.
Croatian: skupina CP: karboplatin (AUC5) i paklitaksel (175 mg/m i.v.) svaka 3 tjedna tijekom 6, a najviše 8 ciklusa. skupina CPB: karboplatin (AUC5) i paklitaksel (175 mg/m i.v.) uz Avastin (15 mg/kg) svaka 3 tjedna tijekom 6, a najviše 8 ciklusa, a zatim samo Avastin (15 mg/kg svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti.
English: Trial BO17704 has demonstrated that both 7.5 mg/kg/q3wk and 15 mg/kg/q3wk bevacizumab doses increase progression free survival and response rate.
Croatian: Ispitivanje BO17704 pokazalo je da bevacizumab i u dozi od 7,5 mg/kg svaka 3 tjedna i u dozi od 15 mg/kg svaka 3 tjedna produljuje preživljenje bez progresije bolesti te povećava stopu odgovora na liječenje.
English: The administration of Avastin should be permanently discontinued if you develop
Croatian: Primjenu lijeka Avastin treba trajno obustaviti
English: • CPP arm: Five cycles of placebo (started cycle 2) in combination with carboplatin (AUC 6) and paclitaxel (175 mg/m2) for 6 cycles followed by placebo alone, for a total of up to 15 months of therapy
Croatian: • skupina CPP: pet ciklusa placeba (počevši od 2. ciklusa) u kombinaciji sa 6 ciklusa karboplatina (AUC 6) i paklitaksela (175 mg/m2), nakon čega je slijedio samo placebo u ukupnom trajanju do 15 mjeseci liječenja
English: Proteinuria (see section 4.4)
Croatian: Proteinurija (vidjeti dio 4.4)
English: Proteinuria (see section 4.8)
Croatian: Proteinurija (vidjeti dio 4.8)
English: Four patients had objective (partial) response, and all of these had received the 10 mg/kg dose bevacizumab; the ORR for the 10 mg/kg dose was 10%.
Croatian: (djelomičan) odgovor, a stopa ukupnog odgovora na liječenje za dozu od 10 mg/kg iznosila je 10%.
English: Patients were randomised to platinum-based chemotherapy (paclitaxel 200 mg/m2) and carboplatin AUC = 6.0, both by IV infusion (PC) on day 1 of every 3-week cycle for up to 6 cycles or PC in combination with Avastin at a dose of 15 mg/kg IV infusion day 1 of every 3-week cycle.
Croatian: Bolesnici su randomizirani u skupinu koja je primala kemoterapiju na bazi platinskog spoja (paklitaksel 200 mg/m2) i karboplatin AUC = 6,0, oba i.v. 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) uz Avastin u dozi od 15 mg/kg primijenjen intravenskom infuzijom 1. dana svakog trotjednog ciklusa.
English: The trial met its primary objective of OS improvement.
Croatian: Ispitivanje je postiglo svoj primarni cilj - produljenje ukupnog preživljenja.
English: Soft tissue sarcoma
Croatian: Sarkom mekog tkiva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/002
Croatian: EU/1/04/300/002
English: Comparison Other Factor
Croatian: Drugi čimbenik
English: Grade 3-5 (NCI-CTCAE v.3) venous thromboembolic reactions have been reported in up to 7.8% of patients treated with chemotherapy plus bevacizumab compared with up to 4.9% in patients treated with chemotherapy alone (across indications, excluding persistent, recurrent, or metastatic cervical cancer).
Croatian: bolesnika liječenih kemoterapijom i bevacizumabom u usporedbi s 4,9% u bolesnika liječenih samo kemoterapijom (u svim indikacijama osim perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa).
English: (p-value = 0.0062)
Croatian: (p-vrijednost = 0,0062)
English: Venous thromboembolism (see section 4.8)
Croatian: Venska tromboembolija (vidjeti dio 4.8)
English: Caution should be taken when treating these patients with Avastin.
Croatian: Kad se takvi bolesnici liječe lijekom Avastin, potreban je oprez.
English: OTHER SPECIAL WARNING(S), IF NECESSARY This medicinal product does not contain any preservative
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO
English: The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Croatian: bolesnica imalo je ECOG funkcionalni status 1, dok je 7% bolesnica u svakoj skupini imalo ECOG status 2. Većina bolesnica bolovala je od epitelnog karcinoma jajnika (87,7%), nakon kojega po učestalosti slijede primarni peritonealni karcinom (6,9%) i karcinom jajovoda (3,7%) ili kombinacija tih triju bolesti (1,7%).
English: Roche s. r. o. Tel: +420 - 2 20382111
Croatian: Roche Slovensko, s.r.o. Tel: +421 - 2 52638201
English: 3 or clear cell histology only; n = 142), or FIGO stage IIB - IV (all Grades and all histological types,
Croatian: FIGO stadija IIB - IV (svih stupnjeva i svih histoloških tipova, n = 1386) nakon kirurškog zahvata
English: The primary endpoint was overall survival, with secondary endpoints for the trial including progression-free survival.
Croatian: Primarna mjera ishoda bila je ukupno preživljenje, dok su sekundarne mjere ishoda obuhvaćale i preživljenje bez progresije bolesti.
English: Patients may be at increased risk for the development of fistulae when treated with Avastin.
Croatian: Bolesnici mogu biti izloženi povećanom riziku od nastanka gastrointestinalnih perforacija i perforacija žučnog mjehura tijekom liječenja lijekom Avastin.
English: Progression-Free Survival*
Croatian: Preživljenje bez progresije bolesti*
English: no CNS metastases and adequate organ function.
Croatian: ≥ 70%, bez metastaza u središnjem živčanom sustavu i sa zadovoljavajućom funkcijom organa.
English: b 10 mg/kg every 2 weeks.
Croatian: Bevacizumab 10 mg/kg svaka 2 tjedna
English: ● a blood clot in the blood vessels of your lungs,
Croatian: ● u slučaju krvnog ugruška u venama u plućima,
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 Avastin plus chemotherapy compared with up to 5% in the patients treated with chemotherapy alone.
Croatian: U bolesnika s karcinomom pluća nemalih stanica, osim u slučaju prevladavajuće histologije skvamoznih stanica, krvarenja svih stupnjeva zabilježena su s učestalošću do 9,3% kada su liječeni lijekom Avastin i kemoterapijom, u usporedbi s najviše 5% u bolesnika liječenih samo kemoterapijom.
English: The recommended dose of Avastin when used in addition to erlotinib is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Avastin kada se primjenjuje kao dodatak erlotinibu je 15 mg/kg tjelesne težine, a primjenjuje se jednom svaka 3 tjedna u obliku intravenske infuzije.
English: Median OS (months) Hazard ratio (95% CI) (eCRF)a
Croatian: Medijan OS (mjeseci) Omjer hazarda (95% CI) (eCRF)
English: BO17707 was a Phase III, two arm, multicentre, randomised, controlled, open-label study comparing the effect of adding Avastin to carboplatin plus paclitaxel in patients with FIGO stage I or IIA (Grade
Croatian: BO17707 bilo je multicentrično, randomizirano, kontrolirano, otvoreno ispitivanje faze III, s dvije skupine, koje je uspoređivalo učinak dodavanja lijeka Avastin terapiji karboplatinom i paklitakselom u bolesnica s epitelnim karcinomom jajnika, karcinomom jajovoda ili primarnim peritonealnim karcinomom FIGO stadija I ili IIA (samo stupnja 3 ili s histologijom svijetlih stanica, n = 142) ili