FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of bevacizumab, in addition to platinum-based chemotherapy, in the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC), was investigated in trials E4599 and BO17704.
Croatian: Sigurnost primjene i djelotvornost bevacizumaba u kombinaciji s kemoterapijom na bazi platine kao prvom linijom liječenja bolesnika koji boluju od neskvamoznog karcinoma pluća nemalih stanica (NSCLC) ispitana je u ispitivanjima E4599 i BO17704.
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).
English: How to store MVASI
Croatian: Kako čuvati MVASI
English: The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Treba izvući potrebnu količinu bevacizumaba i razrijediti je otopinom natrijevog klorida 9 mg/ml (0,9%) za injekciju do volumena potrebnog za primjenu.
English: Hypersensitivity reactions/infusion reactions (see section 4.8)
Croatian: Reakcije preosjetljivosti/infuzijske reakcije (vidjeti dio 4.8)
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after the abbreviation EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake „Rok valjanosti“ ili „EXP“.
English: MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Croatian: MVASI se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica kada stanice raka imaju specifične mutacije proteina koji se zove receptor epidermalnog faktora rasta (engl. epidermal growth factor receptor, EGFR).
English: CT (n = 144)
Croatian: KT (n = 144)
English: MVASI is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Croatian: MVASI je lijek koji se koristi za liječenje odraslih bolesnika s uznapredovalim rakom debelog crijeva, tj. kolona ili rektuma.
English: • an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
Croatian: • u slučaju pojave neuobičajenog spoja ili kanala između dušnika i jednjaka, između unutarnjih organa i kože, između rodnice i bilo kojeg dijela probavnog sustava ili između drugih tkiva koja inače nisu povezana (fistula), a koje Vaš liječnik smatra teškim,
English: Hazard ratio Best overall response ratea
Croatian: Omjer hazarda Najbolja stopa ukupnog odgovoraa
English: • Non-inferiority of the XELOX-containing arms compared with the FOLFOX-4-containing arms in the overall comparison was demonstrated in terms of progression-free survival and overall survival in the eligible per-protocol population.
Croatian: • Neinferiornost protokola XELOX u odnosu na protokol FOLFOX-4 u cjelovitoj je usporedbi dokazana s obzirom na preživljenje bez progresije bolesti i ukupno preživljenje u populaciji bolesnika liječenih prema protokolu koje je bilo moguće ocijeniti.
English: Overall approximately 34% of patients were FIGO stage III optimally debulked with gross residual disease, 40% stage III suboptimally debulked, and 26% were stage IV patients.
Croatian: Približno 34% bolesnica imalo je po FIGO klasifikaciji bolest stadija III uz optimalno odstranjenu tumorsku masu, ali uz velik rezidualni tumor; 40% bolesnica bolest stadija III uz suboptimalno odstranjenu tumorsku masu, a 26% bolesnica bilo je u stadiju IV.
English: FOLFOX-4 or XELOX + bevacizumab (n = 699)
Croatian: FOLFOX-4 ili XELOX + bevacizumab (n = 699)
English: • dry mouth in combination with thirst and/or reduced or darkened urine,
Croatian: • suhoću usta uz osjećaj žeđi i/ili smanjenu količinu mokraće ili tamniju mokraću,
English: Eligible patients had epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed within < 6 months of previous platinum therapy consisting of a minimum of 4 platinum therapy cycles.
Croatian: Bolesnice koje su se mogle uključiti u ispitivanje imale su epitelni karcinom jajnika, karcinom jajovoda ili primarni peritonealni karcinom koji je progredirao unutar < 6 mjeseci od prethodne terapije platinom, koja je obuhvaćala najmanje 4 ciklusa terapije platinom.
English: Permanently discontinue MVASI in patients with tracheoesophageal (TE) fistula or any grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Croatian: Terapiju lijekom MVASI treba trajno obustaviti u bolesnika s traheoezofagealnom fistulom ili bilo kojom fistulom stupnja 4 [prema Općim terminološkim kriterijima za štetne događaje Nacionalnog instituta za rak SAD-a (NCI-CTCAE v.3)].
English: Across clinical trials, the following grade 3 and 4 (NCI-CTCAE v.3) laboratory abnormalities occurred in patients treated with bevacizumab with at least a 2% difference compared to the corresponding control groups: hyperglycaemia, decreased haemoglobin, hypokalaemia, hyponatraemia, decreased white blood cell count, increased international normalised ratio (INR).
Croatian: Sljedeća odstupanja laboratorijskih nalaza stupnja 3 i 4 (NCI-CTCAE v.3) u svim su se kliničkim ispitivanjima javljala s razlikom od najmanje 2% između bolesnika liječenih bevacizumabom i odgovarajućih kontrolnih skupina: hiperglikemija, snižena razina hemoglobina, hipokalijemija, hiponatrijemija, smanjen broj leukocita, povišena vrijednost INR-a (internacionalni normalizirani omjer).
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: • proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with bevacizumab in combination with chemotherapy compared with up to 0.9% in the control arms.
Croatian: U četiri ispitivanja faze III (AVF2119g, E2100, BO17708 i AVF3694g) u bolesnika s metastatskim karcinomom dojke, kongestivno zatajenje srca stupnja 3 ili višeg stupnja (NCI-CTCAE v.3) prijavljeno je u do 3,5% bolesnika liječenih bevacizumabom u kombinaciji s kemoterapijom, u usporedbi s 0,9% bolesnika u kontrolnim skupinama.
English: There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials.
Croatian: Nema podataka o sigurnosnom profilu bevacizumaba u bolesnika s prirođenom hemoragijskom dijatezom, stečenom koagulopatijom niti u bolesnika koji su prije početka liječenja bevacizumabom primali punu dozu antikoagulanasa za liječenje tromboembolije jer takvi bolesnici nisu bili uključeni u klinička ispitivanja.
English: In addition, in study AVF3694g the incidences of all grade CHF were similar between the anthracycline + bevacizumab (6.2%) and the anthracycline + placebo arms (6.0%).
Croatian: Nadalje, u ispitivanju AVF3694g incidencija kongestivnog zatajenja srca bilo kojeg stupnja bila je podjednaka u skupini koja je primala antraciklin + bevacizumab (6,2%) i skupini koja je primala antraciklin + placebo (6,0%).
English: CT (n = 182)
Croatian: KT (n = 182)
English: At the time of the final primary analysis, the primary endpoint of EFS by independent central review did not show a statistically significant difference between the two treatment arms, with HR of 0.93 (95% CI: 0.61, 1.41; p-value = 0.72).
Croatian: U trenutku završne primarne analize, za primarnu mjeru ishoda - preživljenje bez događaja prema ocjeni neovisnog središnjeg povjerenstva - nije bilo statistički značajne razlike između dvije liječene skupine, uz HR 0,93 (95% CI: 0,61; 1,41; p-vrijednost = 0,72).
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
Croatian: Prema planu ispitivanja uključivanje u treću skupinu prekinuto je čim je utvrđena i prihvatljivom ocijenjena sigurnost primjene bevacizumaba u kombinaciji s protokolom IFL.
English: 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks.
Croatian: 5,0 mg/kg svaka 2 tjedna ili 7,5 mg/kg svaka 3 tjedna.
English: A total of 1,528 patients were randomised in equal proportions to the following two arms:
Croatian: Ukupno je randomizirano 1528 bolesnica u jednakim omjerima u sljedeće dvije skupine:
English: Effect of antineoplastic agents on bevacizumab pharmacokinetics
Croatian: Učinak antineoplastičnih tvari na farmakokinetiku bevacizumaba
English: PFS1 results by disease stage and debulking status from study BO17707 (ICON7) Randomised patients stage III optimally debulked disease2,3 CP (n = 368)
Croatian: Rezultati preživljenja bez progresije bolesti1 prema stadiju bolesti i statusu smanjenja tumorske mase iz ispitivanja BO17707 (ICON7) Randomizirane bolesnice sa stadijem III bolesti uz optimalno smanjenu tumorsku masu2,3 CP (n = 368)
English: Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
Croatian: Bolesnici koji su imali NSCLC s poznatom histologijom skvamoznih stanica ili NSCLC mješovitog staničnog tipa s prevladavajućom histologijom skvamoznih stanica nisu bili uključeni u daljnja ispitivanja faze III, dok su bolesnici s tumorom nepoznate histologije bili uključeni.
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Croatian: Klinička korist u bolesnika koji boluju od karcinoma pluća nemalih stanica dokazana je i uz dozu od 7,5 mg/kg i uz dozu od 15 mg/kg (vidjeti dio 5.1).
English: Arm 2 IFL + bevacizumaba
Croatian: Skupina 2 IFL + bevacizumaba
English: In one clinical trial evaluating bevacizumab in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Croatian: U jedno kliničko ispitivanje AVF2192g, u kojem se bevacizumab ispitivao u kombinaciji s 5-fluorouracilom/ folnom kiselinom, uključeni su bolesnici s metastatskim kolorektalnim karcinomom koji nisu bili kandidati za liječenje irinotekanom.
English: With or without gross residual disease.
Croatian: Uz veliki rezidualni tumor ili bez njega.
English: • AVF0780g: In combination with bolus 5-fluorouracil/folinic acid (5-FU/FA) for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen).
Croatian: • AVF0780g: u kombinaciji s bolusom 5-fluorouracila/folne kiseline (5-FU/FA) kroz ukupno 6 tjedana tijekom svakog osmotjednog ciklusa (Roswell-Park protokol).
English: CT + BV (n = 179)
Croatian: KT+BV (n = 179)
English: Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p = 0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm.
Croatian: Nakon prilagodbe za navedene ishodišne čimbenike dobiven je omjer rizika liječenja od 0,78 (95% CI [0,63;0,96]; p = 0,0219), koji ukazuje da je rizik od smrti u skupini bevacizumab + IFN alfa-2a bio 22% manji nego u bolesnika koji su primali IFN alfa-2a.
English: 5 mg/kg every 2 weeks.
Croatian: 5 mg/kg svaka 2 tjedna.
English: An increased incidence of CHF has been observed in a clinical trial of patients with diffuse large B-cell lymphoma when receiving bevacizumab with a cumulative doxorubicin dose greater than 300 mg/m2.
Croatian: 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.
English: MVASI 25 mg/mL concentrate for solution for infusion bevacizumab
Croatian: MVASI 25 mg/ml koncentrat za otopinu za infuziju bevacizumab
English: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see table 9).
Croatian: Dodavanje bevacizumaba kemoterapiji na bazi fluoropirimidina dovelo je do statistički značajnog produljenja preživljenja u bolesnika s metastatskim karcinomom kolona ili rektuma u kojih je došlo do progresije bolesti nakon prve linije liječenja koja je sadržavala bevacizumab (ITT = 819) (vidjeti Tablicu 9).
English: In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
Croatian: U dva kasnija ispitivanja u bolesnika s liječenim metastazama na mozgu (koja su obuhvaćala približno 800 bolesnika) u vrijeme međuanalize sigurnosti primjene u 83 bolesnika liječenih bevacizumabom prijavljen je jedan slučaj krvarenja u SŽS-u stupnja 2 (1,2%) (NCI-CTCAE v.3).
English: Patients treated for persistent, recurrent, or metastatic cervical cancer with bevacizumab are at increased risk of fistulae between the vagina and any part of the GI tract (Gastrointestinal-vaginal fistulae).
Croatian: Bolesnice koje se liječe bevacizumabom zbog perzistentnog, recidivirajućeg ili metastatskog karcinoma cerviksa izložene su povećanom riziku od nastanka fistula između rodnice i bilo kojeg dijela gastrointestinalnog trakta (gastrointestinalno-vaginalne fistule).
English: The clinical benefit of bevacizumab as measured by PFS was seen in all pre-specified subgroups tested (including disease-free interval, number of metastatic sites, prior receipt of adjuvant chemotherapy and oestrogen receptor (ER) status).
Croatian: Klinička korist bevacizumaba, određena prema preživljenju bez progresije bolesti, uočena je u svim unaprijed definiranim ispitanim podskupinama (uključujući razdoblje bez bolesti, broj metastatskih sijela, prethodno liječenje adjuvantnom kemoterapijom i status estrogenskih receptora (ER)).
English: CT + BV (n = 142)
Croatian: KT+BV (n = 142)
English: Overall survival3
Croatian: Ukupno preživljenje3
English: 10 mg/kg every 2 weeks.
Croatian: 10 mg/kg svaka 2 tjedna.
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below)
Croatian: Reakcije preosjetljivosti/infuzijske reakcije (vidjeti dio 4.4 i Iskustvo nakon stavljanja lijeka u promet u daljnjem tekstu)
English: MVASI in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.
Croatian: MVASI je u kombinaciji s kemoterapijom na bazi fluoropirimidina indiciran za liječenje odraslih bolesnika s metastatskim karcinomom kolona ili rektuma.
English: In patients developing PRES, treatment of specific symptoms including control of hypertension is recommended along with discontinuation of MVASI.
Croatian: U bolesnika u kojih se razvije PRES, uz prekid primjene lijeka MVASI preporučuje se i liječenje specifičnih simptoma uključujući kontrolu hipertenzije.
English: PFS1 results by disease stage and debulking status from study GOG-0218
Croatian: Rezultati preživljenja bez progresije bolesti1 prema stadiju bolesti i statusu smanjenja tumorske mase iz ispitivanja GOG-0218
English: MVASI may impair female fertility.
Croatian: MVASI može štetno djelovati na plodnost žena.
English: Immune system disorders Hypersensitivity reactions and infusion reactions (not known); with the following possible co-manifestations: dyspnoea/difficulty breathing, flushing/redness/rash, hypotension or hypertension, oxygen desaturation, chest pain, rigors and nausea/vomiting (see also section 4.4 and Hypersensitivity reactions/infusion reactions above)
Croatian: Reakcije preosjetljivosti i infuzijske reakcije (nepoznato), sa sljedećim mogućim pratećim znakovima: dispneja/otežano disanje, navale vrućine/crvenilo/osip, hipotenzija ili hipertenzija, smanjena saturacija kisikom, bol u prsištu, tresavica i mučnina/povraćanje (vidjeti i dio 4.4 i Reakcije preosjetljivosti/infuzijske reakcije u prethodnom tekstu)
English: Randomised patients stage III optimally debulked disease2,3
Croatian: Randomizirane bolesnice sa stadijem III bolesti uz optimalno smanjenu tumorsku masu2,3
English: A total of 673 patients were randomised in equal proportions to the following two treatment arms:
Croatian: Ukupno su 673 bolesnice randomizirane u jednakim udjelima u sljedeće dvije liječene skupine:
English: Nasal septum perforation (not known) Pulmonary hypertension (not known) Dysphonia (common)
Croatian: Perforacija nosnog septuma (nepoznato) Plućna hipertenzija (nepoznato) Disfonija (često)
English: Posterior Reversible Encephalopathy Syndrome (PRES) (rare) (see also section 4.4)
Croatian: Sindrom reverzibilne posteriorne encefalopatije (PRES) (rijetko) (vidjeti i dio 4.4)
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline.
Croatian: Bolesnice i postotak bolesnica s najboljim ukupnim odgovorom koji uključuje potvrđeni djelomičan ili potpun odgovor; postotak izračunat na temelju bolesnica s mjerljivom bolešću na početku ispitivanja.
English: Hazard ratio (95% CI) (registration form)b
Croatian: Omjer hazarda (95% CI) (registracijski obrazac)b
English: MVASI will be administered together with a chemotherapy regimen containing platinum.
Croatian: MVASI će se davati zajedno s kemoterapijom koja sadrži platinu.
English: Chemotherapy (n = 225)
Croatian: Kemoterapija (n = 225)
English: Very common (may affect more than 1 in 10 people) side effects, which were not severe, include:
Croatian: Vrlo česte (mogu se javiti u više od 1 na 10 osoba) nuspojave koje nisu teške uključuju:
English: • Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
Croatian: • Preosjetljivost na produkte stanica jajnika kineskog hrčka ili druga rekombinantna humana ili humanizirana protutijela.
English: In the bevacizumab-containing arms, patients could receive bevacizumab as a single agent every 3 weeks until disease progression or unacceptable toxicity.
Croatian: U skupinama koje su primale bevacizumab bolesnici su mogli dobivati bevacizumab i kao jedini lijek svaka tri tjedna do progresije bolesti ili razvoja neprihvatljive toksičnosti.
English: • infections of the skin or deeper layers under the skin,
Croatian: • infekcije kože ili dubljih potkožnih slojeva,
English: In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Croatian: Bolesnici s postojećim kongestivnim zatajenjem srca NYHA (New York Heart Association) stupnja II-IV nisu bili uključeni u većinu kliničkih ispitivanja bevacizumaba pa stoga nema dostupnih informacija o riziku za razvoj kongestivnog zatajenja srca u toj populaciji bolesnika.
English: In study BO25041 of bevacizumab added to post-operative radiation therapy (RT) with concomitant and adjuvant temozolomide in paediatric patients with newly diagnosed supratentorial, infratentorial, cerebellar, or peduncular high-grade glioma, the safety profile was comparable with that observed in other tumour types in adults treated with bevacizumab.
Croatian: U ispitivanju BO25041, u kojem se ocjenjivao bevacizumab kao dodatak poslijeoperacijskoj radioterapiji (RT) uz istodobnu i adjuvantnu primjenu temozolomida u pedijatrijskih bolesnika s novodijagnosticiranim supratentorijalnim, infratentorijalnim, cerebelarnim ili pedunkularnim gliomom visokog stupnja, sigurnosni profil bio je usporediv s onim opaženim kod drugih vrsta tumora u odraslih liječenih bevacizumabom.
English: Results are presented in table 22.
Croatian: Rezultati su prikazani u Tablici 22.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon razrjeđivanja.
English: Ninety-seven (97) patients in the IFN alfa-2a arm and 131 patients in the bevacizumab arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Croatian: U 97 bolesnika koji su primali IFN alfa-2a i 131 bolesnika koji je primao bevacizumab doza interferona alfa-2a smanjena je s 9 milijuna IU na 6 ili 3 milijuna IU tri puta tjedno, kako je prethodno utvrđeno u protokolu ispitivanja.
English: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Croatian: Mogući čimbenici rizika obuhvaćaju histološki tip tumora skvamoznih stanica, liječenje antireumatskim/protuupalnim lijekovima, liječenje antikoagulansima, prethodnu radioterapiju, terapiju bevacizumabom, anamnezu ateroskleroze te središnju lokalizaciju i kavitacije tumora prije ili tijekom liječenja.
English: Both the 5 mg/kg/week and 2.5 mg/kg/week equivalent doses of bevacizumab provided a statistically significant benefit with regards to OS (HR 0.751 in study E3200; HR 0.81 in study ML18147) and PFS (HR 0.518 in study E3200; HR 0.68 in study ML18147).
Croatian: I doze bevacizumaba ekvivalentne dozi od 5 mg/kg na tjedan i one ekvivalentne dozi od 2,5 mg/kg na tjedan pružile su statistički značajnu korist s obzirom na ukupno preživljenje (HR 0,751 u ispitivanju E3200; HR 0,81 u ispitivanju ML18147) i preživljenje bez progresije bolesti (HR 0,518 u ispitivanju E3200; HR 0,68 u ispitivanju ML18147).
English: The most frequently observed adverse reactions across clinical trials in patients receiving bevacizumab were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Croatian: Najčešće zabilježene nuspojave u svim kliničkim ispitivanjima u bolesnika koji su primali bevacizumab bile su hipertenzija, umor ili astenija, proljev i bol u abdomenu.
English: Grade 3 hypertension was 60.0% in patients treated with bevacizumab in combination with erlotinib compared to 11.7% in patients treated with erlotinib alone.
Croatian: Hipertenzija stupnja 3 zabilježena je u 60,0% bolesnika liječenih bevacizumabom u kombinaciji s erlotinibom u usporedbi s 11,7% bolesnika liječenih samo erlotinibom.
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurological disorder.
Croatian: U bolesnika liječenih bevacizumabom rijetko je prijavljena pojava znakova i simptoma povezanih s PRES-om, rijetkim neurološkim poremećajem.
English: Treatment of platinum-sensitive recurrent disease: MVASI is administered in combination with either carboplatin and gemcitabine for 6 cycles and up to 10 cycles or in combination with carboplatin and paclitaxel for 6 cycles and up to 8 cycles, followed by continued use of MVASI as single agent until disease progression.
Croatian: Liječenje rekurentne bolesti osjetljive na platinu: MVASI se primjenjuje u kombinaciji s karboplatinom i gemcitabinom tijekom 6, a najviše 10 ciklusa, ili u kombinaciji s karboplatinom i paklitakselom tijekom 6, a najviše 8 ciklusa, nakon čega se MVASI primjenjuje sam do progresije bolesti.