FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine.
Croatian: Lijekom Avastin u kombinaciji s kapecitabinom ne smiju se liječiti bolesnici koji su u proteklih 12 mjeseci u okviru adjuvantnog liječenja primali taksane ili antracikline.
English: p-Value Hazard ratio (95% CI) (registration form)b
Croatian: Omjer hazarda (95% CI) (registracijski obrazac)
English: The primary efficacy parameter of the trial was the duration of progression-free survival.
Croatian: Primarni parametar djelotvornosti u ispitivanju bilo je preživljenje bez progresije bolesti (engl.
English: Information on foetal malformations observed in the post marketing setting are provided in section 4.6 Fertility, Pregnancy and Lactation and 4.8 Undesirable Effects.
Croatian: 'Trudnoća, dojenje i plodnost' te u dijelu 4.8. 'Nuspojave'.
English: Arm 2
Croatian: 2. tromjesečje
English: Relative to the control arm; stratified hazard ratio.
Croatian: 2 U odnosu na kontrolnu skupinu, stratificirani omjer rizika 3 p-vrijednost jednostranog log-rang testa
English: Summarised below are PFS results for the individual chemotherapy agents included in the indication:
Croatian: Slijedi sažeti pregled rezultata preživljenja bez progresije bolesti za svaki kemoterapijski lijek obuhvaćen indikacijom:
English: Avastin/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 Avastin/IFN) je nakon završetka ispitivanja primao različite nespecificirane antitumorske terapije, uključujući antineoplastičke lijekove, što je moglo utjecati na analizu ukupnog preživljenja.
English: Dyspnoea, Rhinitis
Croatian: mučnina. povraćanje,
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 2 (q3w); or Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 (q3w)
Croatian: 2. dana plus bevacizumab u dozi od 15 mg/kg i.v. 2. dana (svaka 3 tjedna); ili paklitaksel u dozi od 175 mg/m i.v. tijekom 3 sata 1. dana i cisplatin u dozi od 50 mg/m i.v.
English: Patients with a history of hypertension may be at increased risk for the development of proteinuria when treated with Avastin.
Croatian: Kada se liječe lijekom Avastin, bolesnici s hipertenzijom mogu biti izloženi povećanom riziku od razvoja proteinurije.
English: Thromboembolism (see section 4.4)
Croatian: Tromboembolija (vidjeti dio 4.4)
English: Based on a substudy from NSABP C-08 with 295 patients d For additional information refer below within section "Further information on selected serious adverse reactions."
Croatian: c Na temelju podataka iz podispitivanja u okviru ispitivanja NSABP C-08 s 295 bolesnica.
English: Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer.
Croatian: Avastin se koristi i za liječenje odraslih bolesnika s uznapredovalim rakom pluća nemalih stanica.
English: Placebo or Avastin
Croatian: Paklitaksel/ Avastin
English: Responders (Response rate 95% CI for Response Rates3
Croatian: 95% CI za stope odgovora3
English: Progression-free survival Median (months) Hazard ratio
Croatian: Medijan (mjeseci) Omjer hazarda
English: Table 10 Trial E2100 efficacy results
Croatian: Tablica 10 Rezultati djelotvornosti za ispitivanje E2100 Preživljenje bez progresije bolesti
English: * Primary analysis was performed with a data cut-off date of 14 November 2011.
Croatian: * Završni dan prikupljanja podataka za primarnu analizu bio je 14. studenoga 2011. **Randomizirane bolesnice s mjerljivom bolešću na početku ispitivanja.
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Croatian: U bolesnika u kojih dođe do gastrointestinalne perforacije liječenje treba trajno obustaviti.
English: Thromboembolism (arterial)b,d, Haemorrhageb,d,
Croatian: Krvožilni poremećaji hipertenzijab,d tromboembolija (venska)b,d tromboembolija (arterijska)b,d, krvarenjeb,d, duboka venska tromboza bubrežna trombotska mikroangiopatijaa,b, aneurizme i disekcije arterije
English: • The primary analysis of investigator-assessed PFS (censoring for CA-125 progressions and NPT) shows a stratified hazard ratio of 0.62 (95% CI: 0.52-0.75, 1-sided log-rank p-value < 0.0001) when CPB15+ is compared with CPP, with a median PFS of 12.0 months in the CPP arm and 18.2 months in the CPB15+ arm.
Croatian: • Primarna analiza preživljenja bez progresije bolesti prema procjeni ispitivača (cenzurirana za porast razine CA-125 i terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,52-0,75; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina
English: Overall Survival (OS)
Croatian: Primarna mjera ishoda Ukupno preživljenje (OS)
English: Each vial contains 100 mg bevacizumab in 4 ml of solution or 400 mg bevacizumab in 16 ml of solution.
Croatian: Jedna bočica sadrži 100 mg bevacizumaba u 4 ml otopine ili
English: Addition of Avastin to RT/T did not demonstrate clinical benefit in study BO25041 in 60 evaluable children patients with newly diagnosed supratentorial or infratentorial cerebellar or peduncular highgrade glioma (HGG) (See section 4.2 for information on paediatric use).
Croatian: 60 ocjenjive djece s novodijagnosticiranim supratentorijalnim ili infratentorijalnim cerebelarnim ili pedunkularnim gliomom visokog stupnja (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Two large Phase III trials were designed to investigate the treatment effect of Avastin in combination with two individual chemotherapy agents, as measured by the primary endpoint of PFS. A clinically meaningful and statistically significant improvement in PFS was observed in both trials.
Croatian: Djelotvornost liječenja lijekom Avastin u kombinaciji s dva zasebna kemoterapijska lijeka ispitana je u dva velika ispitivanja faze III, u kojima je primarna mjera ishoda bilo preživljenje bez progresije bolesti.
English: AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment.
Croatian: AVF2107g: tjedna primjena protokola irinotekan/bolus 5-fluorouracila/folne kiseline (IFL) kroz ukupno 4 tjedna tijekom svakog šestotjednog ciklusa (Saltzov protokol) AVF0780g: u kombinaciji s bolusom 5-fluorouracila/folne kiseline (5-FU/FA) kroz ukupno 6 tjedana tijekom svakog osmotjednog ciklusa (Roswell-Park protokol) AVF2192g: u kombinaciji s bolusom 5-FU/FA kroz ukupno 6 tjedana tijekom svakog osmotjednog ciklusa (Roswell-Park protokol) u bolesnika koji nisu bili optimalni kandidati za primjenu irinotekana u prvoj liniji liječenja.
English: This was a phase III randomised, double-blind (for bevacizumab), clinical trial investigating Avastin 7.5 mg/kg in combination with oral capecitabine and IV oxaliplatin (XELOX), administered on a 3weekly schedule; or Avastin 5 mg/kg in combination with leucovorin with 5-fluorouracil bolus, followed by 5-fluorouracil infusional, with IV oxaliplatin (FOLFOX-4), administered on a 2-weekly schedule.
Croatian: NO16966 Riječ je o randomiziranom, dvostruko slijepom (za bevacizumab) kliničkom ispitivanju faze III u kojemu se ispitivala primjena lijeka Avastin u dozi od 7,5 mg/kg svaka 3 tjedna u kombinaciji s peroralno primijenjenim kapecitabinom i intravenski primijenjenim oksalipaltinom (XELOX), odnosno primjena lijeka Avastin u dozi od 5 mg/kg svaka dva tjedna u kombinaciji s leukovorinom i bolusom 5-fluorouracila, nakon čega je slijedila infuzija 5-fluorouracila uz intravensku primjenu oksaliplatina (FOLFOX-4).
English: Hepatic impairment
Croatian: Kongestivno zatajenje srca
English: Median (months) Hazard ratio [95% CI]
Croatian: Medijan (mjeseci) Omjer hazarda [95% CI]
English: A total of 484 patients with measurable disease were randomised 1:1 to either: • Carboplatin (AUC4, Day 1) and gemcitabine (1000 mg/m2 on Days 1 and 8) and concurrent placebo every 3 weeks for 6 and up to 10 cycles followed by placebo (every 3 weeks) alone until disease progression or unacceptable toxicity
Croatian: karboplatin (AUC4, 1. dan) i gemcitabin (1000 mg/m2, 1. i 8. dan) uz placebo svaka 3 tjedna tijekom 6, a najviše 10 ciklusa, a zatim samo placebo (svaka 3 tjedna) do progresije bolesti ili razvoja neprihvatljive toksičnosti, ili karboplatin (AUC4, 1. dan) i gemcitabin (1000 mg/m 2, 1. i 8. dan) uz Avastin (15 mg/kg, 1.
English: Paclitaxel (n=243)
Croatian: Paklitaksel (n=243)
English: This was a Phase III randomised, controlled, open-label trial investigating Avastin 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 firstline bevacizumab-containing regimen.
Croatian: Avastin 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: This was a phase II randomised, active-controlled, open-labelled clinical trial investigating Avastin in combination with 5-FU/FA as first-line treatment of metastatic colorectal cancer.
Croatian: AVF0780g Riječ je o randomiziranom, aktivno kontroliranom, otvorenom kliničkom ispitivanju faze II, u kojemu se ispitivala primjena lijeka Avastin u kombinaciji s protokolom 5-FU/FA u prvoj liniji liječenja metastatskog kolorektalnog karcinoma.
English: Pulmonary hypertensionc, Nasal septum perforationc
Croatian: epistaksa, dispneja, hipoksija plućna hipertenzija c, perforacija nosnog septumac
English: Pulmonary embolism, Epistaxis, Dyspnoea, Hypoxia
Croatian: hipoksija, disfonijaa plućna hipertenzijaa,
English: 5 mg/kg every 2 weeks.
Croatian: 15 mg/kg svaka 3 tjedna
English: Pulmonary haemorrhage/ Haemoptysis a,b
Croatian: Poremećaji bubrega i mokraćnog sustava proteinurija a,b
English: Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Croatian: Bevacizumab je u kombinaciji s karboplatinom i gemcitabinom ili u kombinaciji s karboplatinom i paklitakselom indiciran za liječenje odraslih bolesnica s prvim recidivom epitelnog karcinoma jajnika,
English: It should not be administered as an intravenous push or bolus.
Croatian: Lijek se ne smije primijeniti brzom intravenskom injekcijom niti u obliku bolusa.
English: Ireland
Croatian: България
English: Difference in Response Rates 95% CI for Difference in Response Rates4
Croatian: 95% CI za razliku u stopama odgovora p-vrijednost (hi-kvadrat test)
English: The number of infusions that you receive will depend on how you are responding to treatment; you should continue to receive this medicine until Avastin fails to stop your tumour growing.
Croatian: Trebali biste nastaviti primati ovaj lijek sve dok Avastin uspješno sprječava rast tumora.
English: What Avastin looks like and contents of the pack Avastin is a concentrate for solution for infusion.
Croatian: Kako Avastin izgleda i sadržaj pakiranja
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;
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: • tiredness,
Croatian: ● mučnina,
English: Palmar-plantar erythrodysaesthesia syndrome
Croatian: suha koža, promjena boje kože sindrom palmarnoplantarne eritrodizestezije
English: performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Croatian: bolesnika imalo je ECOG funkcionalni status 0, njih 43% status 1, a 0,4% status 2. 15,5% bolesnika prethodno je primilo radioterapiju, a 28,4% kemoterapiju.
English: • The protocol specified analysis of investigator-assessed PFS (without censoring for CA-125 progression or non-protocol therapy [NPT]) shows a stratified hazard ratio of 0.71 (95% CI:
Croatian: • Analiza preživljenja bez progresije bolesti prema procjeni neovisnog ocjenjivačkog povjerenstva (cenzurirana za terapiju izvan protokola) pokazuje stratificirani omjer rizika od 0,62 (95% CI: 0,50-0,77; p-vrijednost jednostranog log-rang testa < 0,0001) kada se skupina
English: NAME OF THE MEDICINAL PRODUCT Avastin 25 mg/ml concentrate for solution for infusion.
Croatian: Avastin 25 mg/ml koncentrat za otopinu za infuziju.
English: Tel: + 385 1 47 22 333
Croatian: Roche d.o.o. Tel: + 385 1 47 22 333
English: Rectal haemorrhage, Stomatitis, Constipation, Diarrhoea, Nausea, Vomiting, Abdominal pain
Croatian: Poremećaji probavnog sustava rektalno krvarenje, stomatitis, konstipacija, proljev,
English: Median PFS (months) Hazard ratio (95% CI) Median OS (months) Hazard ratio (95% CI)
Croatian: Medijan PFS-a (mjeseci) Omjer hazarda (95% CI)* Medijan OS-a (mjeseci) Omjer hazarda (95% CI)*
English: Reactions (frequency*)
Croatian: Nuspojave (učestalost*)
English: Dehydration
Croatian: Krvarenje
English: Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Croatian: Čini se da ova pedijatrijska populacija dobro podnosi dodavanje bevacizumaba multimodalnom standardnom liječenju.
English: Randomised patients with stage III suboptimally debulked disease3
Croatian: Randomizirane bolesnice sa stadijem III bolesti uz suboptimalno smanjenu tumorsku masu CPP (n = 253)
English: Results are presented in Table 12.
Croatian: Rezultati su prikazani u Tablici 22.
English: HR (95% CI) p-value
Croatian: HR (95% CI)
English: Number of patients Overall survival Median (months) 95% CI
Croatian: Medijan (mjeseci) 95% CI
English: ● A rare neurological side effect named posterior reversible encephalopathy syndrome (PRES) has been associated with Avastin treatment.
Croatian: Liječenje lijekom Avastin, povezano je s rijetkom neurološkom nuspojavom koju nazivamo sindrom reverzibilne posteriorne encefalopatije.
English: • blocking of the veins by a blood clot,
Croatian: ● začepljenje vena zbog krvnog ugruška,
English: Foetal abnormalitiesa,b
Croatian: + Avastin b
English: Metastatic breast cancer (mBC)
Croatian: Metastatski karcinom dojke
English: How to store Avastin
Croatian: Moguće nuspojave Kako čuvati Avastin
English: Median OS (months) HR (95% CI) p-value
Croatian: Medijan PFS-a (mjeseci) HR (95% CI) p-vrijednost
English: The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Croatian: Primarna mjera ishoda ispitivanja bilo je preživljenje bez progresije bolesti po procjeni ispitivača prema RECIST-u.
English: Gallbladder perforation b,c
Croatian: Omjer hazarda b
English: • Median PFS increase 5.6 months, HR 0.421 (p < 0.0001, 95% CI 0.343; 0.516)
Croatian: (p < 0,0001; 95% CI = 0,343; 0,516)
English: The recommended dose of Avastin is 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Croatian: Preporučena doza lijeka Avastin je 7,5 mg/kg ili 15 mg/kg tjelesne težine, primijenjena jednom svaka
English: Roche d.o.o.
Croatian: Roche s. r. o.
English: Median PFS (months) Hazard ratio (95% CI)4
Croatian: Medijan PFS (mjeseci) Omjer hazarda (95% CI) 4
English: Febrile neutropenia, Leucopenia, Neutropeniab, Thrombo-cytopenia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenijab, trombocitopenija anemija, limfopenija
English: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Croatian: Bolesnike s tromboembolijskim reakcijama stupnja ≤ 3 treba pomno nadzirati (NCI-CTCAE v.3).
English: Cellulitis, Infection, Urinary tract infection
Croatian: Infekcije i infestacije sepsa apscesb,d, celulitis, infekcija, infekcija mokraćnih putova nekrotizirajući fascitisa
English: Median PFS (months) Hazard Ratio (95% CI) 2
Croatian: Medijan PFS (mjeseci) Omjer hazarda (95% CI) 2
English: No increase in the incidence of other reactions, including gastrointestinal perforation, wound healing complications, congestive heart failure, and haemorrhage was observed in elderly patients (> 65 years)
Croatian: ≤ 65 godina liječene Avastinom, nije primijećen porast incidencije drugih reakcija, uključujući gastrointestinalne perforacije, komplikacije pri zacjeljivanju rana, kongestivno zatajenje srca i krvarenje.
English: Pre-existing hypertension should be adequately controlled before starting Avastin treatment.
Croatian: Prije početka liječenja lijekom Avastin postojeću hipertenziju treba odgovarajuće regulirati.
English: Peripheral sensory neuropathyb, Dysarthria, Headache, Dysguesia
Croatian: Poremećaji živčanog sustava periferna senzorna neuropatijab dizartrija, glavobolja, disgeuzija cerebrovaskularni incident, sinkopa, somnolencija sindrom reverzibilne posteriorne encefalopatije a,b,d hipertenzivna encefalopatijaa
English: Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.
Croatian: Za dodatne informacije o statusu HER2, molimo vidjeti dio 5.1. Bevacizumab je u kombinaciji s kemoterapijom na bazi spojeva platine indiciran za prvu liniju liječenja odraslih bolesnika s neresektabilnim uznapredovalim, metastatskim ili recidivirajućim karcinomom pluća nemalih stanica u kojemu histološki ne prevladavaju skvamozne stanice.
English: EGFR mutation status was determined for each patient prior to patient screening and 154 patients were randomised to receive either erlotinib + Avastin (erlotinib 150 mg oral daily + Avastin [15 mg/kg IV every 3 weeks]) or erlotinib monotherapy (150 mg oral daily) until disease progression (PD) or unacceptable toxicity.
Croatian: + Avastin (erlotinib 150 mg na dan, peroralno + Avastin [15 mg/kg i.v. svaka 3 tjedna]) ili u skupinu koja je primala monoterapiju erlotinibom
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the kidneys are not a major organ for bevacizumab metabolism or excretion.
Croatian: Budući da bubrezi nisu glavni organ metaboliziranja i izlučivanja bevacizumaba, nisu provedena ispitivanja farmakokinetike bevacizumaba u bolesnika s oštećenjem bubrežne funkcije.
English: Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Croatian: u bolesnica s mjerljivom bolešću na početku ispitivanja Analiza preživljenja bez progresije bolesti po procjeni ispitivača, prema podacima do 30. studenog 2010.
English: Arterial thromboembolism: An increased incidence of arterial thromboembolic reactions was observed in patients treated with Avastin across indications, including cerebrovascular accidents, myocardial infarction, transient ischaemic attacks, and other arterial thromboembolic reactions.
Croatian: U bolesnika liječenih lijekom Avastin u svim je indikacijama opažena povećana incidencija arterijskih tromboembolijskih reakcija, uključujući cerebrovaskularne incidente,
English: Relative to the control arm.
Croatian: 4 U odnosu na kontrolnu skupinu.
English: Hypertensionb,d, Thrombo-embolism (venous)b,d
Croatian: a,b krvarenjea,b, tromboembolija (venska)a,b, duboka venska tromboza bubrežna trombotska mikroangiopatijab,c, aneurizme i disekcije arterije
English: Censored for NPT Median PFS (months) Hazard ratio (95% CI) p -value
Croatian: Cenzurirano za terapiju izvan protokola Medijan PFS (mjeseci) Omjer hazarda (95% CI) p -vrijednost
English: Osteonecrosis of the jaw (ONJ) (see section 4.8)
Croatian: Osteonekroza čeljusti (vidjeti dio 4.8)
English: Grade 4 proteinuria (nephrotic syndrome) was seen in up to 1.4% of patients treated with Avastin.
Croatian: Proteinurija stupnja 4 (nefrotski sindrom) primijećena je u najviše 1,4% bolesnika liječenih lijekom Avastin.U bolesnika u kojih se razvije nefrotski sindrom (NCICTCAE v.3) treba trajno obustaviti liječenje.
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Croatian: Kod istodobne primjene bevacizumaba i antineoplastičkih lijekova, karakteristična vrijednost volumena perifernog odjeljka (Vp) iznosila je 1,69 l za žene i 2,35 l za muškarce.
English: Paclitaxel (n=273)
Croatian: Paklitaksel (n=273)
English: Hypersensitivity reactions/infusion reactions (see section 4.4 and Post-marketing experience below) In some clinical trials anaphylactic and anaphylactoid-type reactions were reported more frequently in patients receiving Avastin in combination with chemotherapy than with chemotherapy alone.
Croatian: U nekim su kliničkim ispitivanjima anafilaktičke i anafilaktoidne reakcije prijavljene češće u bolesnika koji su u kombinaciji s kemoterapijom primali Avastin nego u bolesnika koji su primali samo kemoterapiju.
English: Precautions to be taken before handling or administering the medicinal product
Croatian: Prije uporabe pročitajte uputu o lijeku
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Croatian: Skupina 1 Karboplatin/ Paklitaksel
English: ● a hole in your gut wall,
Croatian: ● u slučaju napuknuća u stijenci crijeva,
English: difference compared to the control arm for NCI-CTCAE Grade 1-5 reactions or at least a 2%
Croatian: (s razlikom od barem 10% u odnosu na kontrolnu skupinu za nuspojave stupnja 1-5 prema NCI-CTCAE ili s razlikom od barem 2% u odnosu na kontrolnu skupinu za nuspojave stupnja 3-5 prema NCI-CTCAE), iz ispitivanja sigurnosti primjene lijeka nakon dobivanja odobrenja, iz spontanih prijava,
English: 400 mg/m2 IV bolus, 600 mg/m2 IV 22 h
Croatian: 400 mg/m i.v. bolus,
English: Hypersensitivity reactions/infusion reactions (see section 4.8) Patients may be at risk of developing infusion/hypersensitivity reactions.
Croatian: Reakcije preosjetljivosti/infuzijske reakcije (vidjeti dio 4.4 i Iskustvo nakon stavljanja lijeka u promet u daljnjem tekstu)
English: Overall survival Median (months) Hazard ratio 95% CI
Croatian: Medijan (mjeseci) Omjer hazarda 95% CI
English: Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed in patients treated with some myelotoxic chemotherapy regimens plus Avastin in comparison to chemotherapy alone.
Croatian: U bolesnika liječenih nekim mijelotoksičnim kemoterapijskim protokolima u kombinaciji s lijekom Avastin su, u usporedbi s primjenom samo kemoterapije, opažene povećane stope teške neutropenije, febrilne neutropenije te infekcije praćene teškom neutropenijom ili bez nje (s nekoliko smrtnih ishoda).
English: • a brain condition with symptoms including seizures (fits), headache, confusion, and changes in vision (Posterior Reversible Encephalopathy Syndrome or PRES),
Croatian: glavobolja, smetenost i promjene vida (sindrom posteriorne reverzibilne encefalopatije),
English: Sepsis, Cellulitis, Abscess a,b
Croatian: Infekcije i infestacije sepsa, celulitis, apsces a,b infekcija, infekcija mokraćnih putova nekrotizirajući fascitisc
English: Reactions consistent with CHF were reported in clinical trials.
Croatian: U kliničkim su ispitivanjima prijavljene reakcije koje odgovaraju kongestivnom zatajenju srca.
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014 8 p-value displayed for descriptive purpose only
Croatian: Analiza nakon praćenja provedena je na temelju podataka prikupljenih do 7. ožujka 2014.