FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Avastin may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Croatian: Avastin može povećati rizik od stvaranja neuobičajenog spoja ili prolaza između dvaju organa ili krvnih žila.
English: For additional information refer below within section "Further information on selected serious adverse reactions"
Croatian: d Za dodatne informacije vidjeti dio „Dodatne informacije o odabranim ozbiljnim nuspojavama“ u nastavku.
English: Statistically significant improvements in progression-free survival were also observed.
Croatian: Opaženo je i statistički značajno poboljšanje preživljenja bez progresije bolesti.
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG
Croatian: Prosječna ukupna dob iznosila je 59,4 godine; 56,6%
English: ● you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Croatian: ● ako ste alergični (preosjetljivi) na proizvode stanica jajnika kineskog hrčka ili druga rekombinantna ljudska ili humanizirana protutijela.
English: Avastin is a concentrate for solution for infusion.
Croatian: Avastin je koncentrat za otopinu za infuziju.
English: Supraventricular tachycardia
Croatian: supraventrikularna tahikardija
English: The majority of the patients in each treatment arm (74% and 71%) had poorly differentiated (Grade 3) primary tumours at baseline.
Croatian: U većine bolesnica u svakoj skupini (74% odnosno 71%) primarni su tumori na početku liječenja bili slabo diferencirani (stupnja 3).
English: FOLFOX-4 or XELOX + placebo (n=701)
Croatian: FOLFOX-4 ili XELOX + placebo (n=701)
English: Median PFS (months)
Croatian: Medijan PFS (mjeseci)
English: These efficacy data are consistent with the results from trial AVF2107g.
Croatian: Ovi podaci o djelotvornosti podudaraju se s rezultatima iz ispitivanja AVF2107g.
English: • high blood pressure,
Croatian: ● visok krvni tlak,
English: Response rates (for patients with measurable disease)
Croatian: Stopa odgovora (za bolesnike s mjerljivom bolešću)
English: Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal malformations.
Croatian: Opaženo je smanjenje tjelesne težine majke i fetusa, povećan broj fetalnih resorpcija i veća incidencija specifičnih ukupnih i koštanih deformacija fetusa.
English: The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Croatian: Kliničke manifestacije PRES-a su često nespecifične pa stoga dijagnozu PRES-a treba potvrditi snimanjem mozga, najbolje MR-om.
English: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Croatian: a Pojmovi označavaju skup događaja koji opisuju određeni medicinski koncept, a ne pojedinačno stanje ili preferirani termin prema Medicinskom rječniku za regulatorne poslove (MedDRA).
English: Pregnancy (see section 4.6).
Croatian: Trudnoća (vidjeti dio 4.6).
English: Magyarország Roche (Magyarország) Kft. Tel: +36 - 23 446 800
Croatian: Roche (Magyarország) Kft. Tel: +36 - 23 446 800
English: • bleeding from the lower part of the large bowel,
Croatian: ● krvarenje iz donjeg dijela debelog crijeva,
English: Additional endpoints included objective response, duration of response, overall survival and safety.
Croatian: Dodatne mjere ishoda obuhvaćale su objektivni odgovor, trajanje odgovora, ukupno preživljenje i sigurnost primjene.
English: Later infusions may be given to you over 30 minutes.
Croatian: Kasnije infuzije mogu trajati 30 minuta.
English: Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Croatian: Što je Avastin i za što se koristi Avastin sadrži djelatnu tvar bevacizumab, koji je humanizirano monoklonsko protutijelo (vrsta proteina kojeg normalno stvara imunološki sustav kako bi pomogao u obrani organizma od infekcije i raka).
English: Trehalose dihydrate Sodium phosphate Polysorbate 20
Croatian: Trehaloza dihidrat Natrijev fosfat Polisorbat 20
English: * Overall survival analysis at clinical cut-off 31 January 2007 ** Primary analysis at clinical cut-off 31 January 2006 a relative to control arm
Croatian: * analiza ukupnog preživljenja prema podacima do 31. siječnja 2007. ** primarna analiza prema podacima do 31. siječnja 2006.
English: • Redness of the eye, small particles or spots in your vision (floaters), eye pain,
Croatian: ● crvenilo oka, male čestice ili mrlje u vidnom polju (plutajuće čestice), bol u oku,
English: In addition, hypertension (including hypertensive crisis), elevated creatinine, and neurological symptoms were observed in some of these patients.
Croatian: Uz to su u nekih od ovih bolesnika opaženi hipertenzija (uključujući hipertenzivne krize), povišena razina kreatinina i neurološki simptomi.
English: In an exploratory analysis, the extent of Avastin benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Croatian: U eksploracijskoj analizi je utvrđeno da je opseg koristi liječenja lijekom Avastin u pogledu ukupnog preživljenja bio manje izražen u podskupini bolesnika koji histološki nisu imali adenokarcinom.
English: The primary outcome measure was overall survival defined as the time from randomisation until death from any cause.
Croatian: Primarna mjera ishoda bilo je ukupno preživljenje, definirano kao vrijeme od randomizacije do smrti zbog bilo kojeg razloga.
English: Patients with untreated CNS metastases were routinely excluded from clinical trials with Avastin, based on imaging procedures or signs and symptoms.
Croatian: Bolesnici s neliječenim metastazama u središnjem živčanom sustavu (SŽS) bili su rutinski isključeni iz kliničkih ispitivanja lijeka Avastin na temelju dijagnostičkih snimaka ili znakova i simptoma.
English: Arm 1 IFL + placebo
Croatian: Skupina 1 IFL + placebo
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen),
Croatian: One uključuju: smanjen broj bijelih krvnih stanica, naročito neutrofila (vrsta bijelih krvnih stanica koja pomaže u zaštiti od infekcija); prisutnost proteina u mokraći; smanjenu razinu kalija, natrija ili fosfora (mineral) u krvi; povišenu razinu šećera u krvi; povišenu razinu alkalne fosfataze (enzim); povišenu serumsku razinu kreatinina (protein čija se razina određuje krvnom pretragom kako bi se utvrdilo kako
English: Presentation may include seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Croatian: On se može manifestirati konvulzijama, glavoboljom, promjenom psihičkog stanja, poremećajem vida ili kortikalnim sljepilom, sa ili bez hipertenzije.
English: • a negative effect on a woman's ability to have children (see the paragraphs below the list of side effects for further recommendations),
Croatian: ● negativan učinak na ženinu plodnost (daljnje preporuke vidjeti u odjeljcima iza popisa nuspojava),
English: Post-marketing adverse reactions are included in both Tables 1 and 2, where applicable.
Croatian: Nuspojave prijavljene nakon stavljanja lijeka u promet uključene su u Tablice 1 i 2 (kako je odgovarajuće).
English: Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.
Croatian: Neke od ovih reakcija imale su za posljedicu gubitak vida različitog stupnja,
English: ● Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the below measures: Description
Croatian: Nositelj odobrenja dužan je unutar navedenog vremenskog roka, provesti niže navedene mjere:
English: Front-line treatment of ovarian cancer
Croatian: Prva linija liječenja karcinoma jajnika
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of postoperative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting Avastin.
Croatian: U kliničkim ispitivanjima u indikaciji metastatskog karcinoma kolona ili rektuma nije zabilježen povećan rizik od postoperativnog krvarenja ili komplikacija pri zacjeljivanju rana u bolesnika koji su bili podvrgnuti većem kirurškom zahvatu 28 do 60 dana prije početka liječenja lijekom Avastin.
English: Table 24: Exploratory PFS and OS analyses by chemotherapy cohort CT
Croatian: Tablica 24: Eksploracijske analize PFS-a i OS-a prema kemoterapijskoj kohorti
English: Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Croatian: Bol u ustima, zubima i/ili čeljusti, otekline ili ranice u usnoj šupljini, utrnulost ili osjećaj težine u čeljusti ili klimanje zuba.
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of Avastin and 21.1% (89/422) of patients received 13 or more administrations of Avastin.
Croatian: Od bolesnika koji su tijekom ispitivanja primali ispitivani lijek, njih 32,2% (136/422) je primilo 7-12 aplikacija lijeka Avastin, a 21,1% (89/422) 13 ili više aplikacija lijeka Avastin.
English: Do not stop treatment with Avastin unless you have discussed this with your doctor.
Croatian: Nemojte prekinuti liječenje lijekom Avastin bez prethodnog savjetovanja s liječnikom.
English: Pregnancy, breast feeding and fertility
Croatian: Trudnoća, dojenje i plodnost
English: Serious wound healing complications, including anastomotic complications, have been reported, some of which had a fatal outcome.
Croatian: Prijavljene su ozbiljne komplikacije pri zacjeljivanju rana, uključujući anastomotske komplikacije, od kojih su neke imale smrtni ishod.
English: Tables 1 and 2 list adverse reactions associated with the use of Avastin in combination with different chemotherapy regimens in multiple indications.
Croatian: U Tablicama 1 i 2 navedene su nuspojave povezane s primjenom lijeka Avastin u kombinaciji s različitim kemoterapijskim protokolima u većem broju indikacija.
English: The incidence of each histologic sub-type of EOC was similar between the treatment arms; 69% of patients in each treatment arm had serous adenocarcinoma histologic type.
Croatian: Incidencija svake histološke podvrste epitelnog karcinoma jajnika bila je slična u obje skupine; 69% bolesnica u svakoj skupini bolovalo je od seroznog adenokarcinoma.
English: • decreased number of red cells in the blood,
Croatian: ● smanjen broj crvenih krvnih stanica,
English: The risk of developing connections between the vagina and any parts of the gut can increase if you have persistent, recurrent or metastatic cervical cancer.
Croatian: Rizik od stvaranja spojeva između rodnice i bilo kojeg dijela probavnog sustava može biti veći ako imate perzistentni, recidivirajući ili metastatski rak vrata maternice.
English: Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.
Croatian: Neutralizacijom biološke aktivnosti VEGF-a smanjuje se vaskularizacija tumora, normalizira preostala tumorska krvožilna mreža i smanjuje stvaranje novih krvnih žila tumora, a time i inhibira njegov rast.
English: Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of Avastin.
Croatian: Klinička su ispitivanja pokazala da su prolazna povećanja serumske razine kreatinina (u rasponu od 1,5 do 1,9 puta iznad početne vrijednosti), koja su se javljala i uz istodobnu proteinuriju kao i bez nje, povezana s primjenom lijeka Avastin.
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Croatian: Venske tromboembolijske reakcije uključuju duboku vensku trombozu, plućnu emboliju i tromboflebitis.
English: Grade 3 proteinuria was reported in up to 10.9% of treated patients.
Croatian: Proteinurija stupnja 3 prijavljena je u najviše 10,9% liječenih bolesnika.
English: Objective response rate (%) in Patients with measurable disease
Croatian: Stopa (%) objektivnog odgovora u bolesnika s mjerljivom bolešću
English: ● If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: Ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, za trajanje i uvjete čuvanja do primjene lijeka odgovoran je korisnik te ono obično ne smije biti dulje od 24 sata na temperaturi od 2°C do 8°C,
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Croatian: Prijavljene su sistemske nuspojave, uključujući neokularna krvarenja i arterijske tromboembolijske reakcije nakon intravitrealne injekcije VEGF inhibitora.
English: In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
Croatian: U ispitivanjima na makaki majmunima u trajanju od najdulje 26 tjedana, u mladih životinja s otvorenom pločom rasta opažena je epifizna displazija, pri čemu su prosječne koncentracije bevacizumaba u serumu bile niže od očekivanih prosječnih terapijskih koncentracija u serumu u ljudi.
English: • Seeing flashes of light with floaters, progressing to a loss of some of your vision,
Croatian: ● pojava bljeskanja u vidnom polju s plutajućim česticama, koje napreduje do djelomičnog gubitka vida,
English: b stratified by the duration of treatment free-interval prior to enrolling onto this study per the registration form, and secondary surgical debulking status Yes/No.
Croatian: b stratificirano prema duljini razdoblja bez primjene liječenja prije uključivanja u ovo ispitivanje sukladno navodima u registracijskim obrascima i statusu sekundarnog smanjenja tumorske mase kirurškim putem: Da/Ne
English: Results from the primary analysis and the follow-up analysis are presented by Avastin Treatment and by Trial Treatment in Table 25 and Table 26, respectively.
Croatian: Rezultati primarne analize i analize nakon praćenja su prikazani prema terapiji lijekom Avastin i prema ispitivanom liječenju u Tablici 25 odnosno Tablici 26.
English: Secondary PFS analyses, based on ‘on-treatment'-based response assessments, confirmed the significantly superior clinical benefit for patients treated with Avastin (analyses shown in Table 7), consistent with the statistically significant benefit observed in the pooled analysis.
Croatian: Sekundarne analize preživljenja bez progresije bolesti, na temelju procjene odgovora tijekom liječenja, potvrdile su značajno superiorniju kliničku korist za bolesnike liječene lijekom Avastin (analize prikazane u Tablici 7), što je u skladu sa statistički značajnom koristi opaženom u analizi objedinjenih podataka.
English: • redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Croatian: ● crvenilo, ljuštenje, osjetljivost, bol ili plikovi na prstima ili stopalima,
English: An increased incidence of post-operative bleeding or wound healing complication occurring within 60 days of major surgery was observed if the patient was being treated with Avastin at the time of surgery.
Croatian: Zabilježena je povećana incidencija postoperativnog krvarenja ili komplikacija pri zacjeljivanju rana unutar 60 dana od većeg kirurškog zahvata ako je bolesnik primao Avastin u vrijeme zahvata.
English: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were White.
Croatian: Većina bolesnica i u skupini CP (80,4%) i u skupini CPB (78,9%) bila je bijele rase.
English: This does not necessarily mean that these side effects were strictly caused by Avastin.
Croatian: To ne mora značiti da su te nuspojave uzrokovane isključivo lijekom Avastin.
English: Before you are given Avastin or while you are being treated with Avastin:
Croatian: Prije nego primite Avastin ili tijekom liječenja lijekom Avastin:
English: Patients were treated until disease progression.
Croatian: Bolesnici su liječeni do progresije bolesti.
English: ● if you have or have had pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth tell your doctor and dentist immediately.
Croatian: ● ako osjećate ili ste osjećali bol u ustima, zubima i/ili čeljusti, ako imate otekline ili ranice u usnoj šupljini, ako osjećate utrnulost ili težinu u čeljusti, ili Vam se klima zub, odmah obavijestite svog liječnika i stomatologa.
English: Uncommon Rare Very Rare
Croatian: Manje često Rijetko Vrlo rijetko
English: The occurrence of those events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Croatian: Pojava tih događaja razlikovala se po obilježjima i težini, u rasponu od slobodnog zraka vidljivog na rendgenskoj snimci abdomena, koji nije trebalo liječiti, do perforacije crijeva s razvojem abdominalnog apscesa i smrtnim ishodom.
English: Avastin is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Croatian: Avastin se primjenjuje u kombinaciji s jednim od sljedećih kemoterapijskih protokola: paklitakselom i cisplatinom ili paklitakselom i topotekanom.
English: There was no exclusion criterion for prior anti-angiogenic therapy.
Croatian: Prethodna antiangiogena terapija nije bila isključni kriterij.
English: After discontinuation of bevacizumab treatment, ovarian function recovered in the majority of patients.
Croatian: Nakon prekida liječenja bevacizumabom, u većine se ispitanica funkcija jajnika oporavila.
English: Avastin will be administered in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy.
Croatian: Avastin će se davati u kombinaciji s paklitakselom i cisplatinom ili, alternativno, paklitakselom i topotekanom u bolesnica koje ne mogu primiti terapiju platinom.
English: Avastin may adversely affect the wound healing process.
Croatian: Avastin može imati nepovoljan utjecaj na proces zacjeljivanja rana.
English: The overall rates of discontinuation due to adverse events were 8.8% in the CT arm and 43.6% in the CT + BV arm (mostly due to Grade 2-3 adverse events) and the median time to discontinuation in the CT + BV arm was 5.2 months compared with 2.4 months in the CT arm.
Croatian: Ukupna stopa prekida ispitivanja zbog nuspojava iznosila je 8,8% u skupini KT te 43,6% u skupini KT+BV (uglavnom zbog nuspojava stupnja 2-3), a medijan vremena do prekida ispitivanja u skupini KT+BV bio je 5,2 mjeseca u usporedbi s 2,4 mjeseca u skupini KT.
English: • PLD 40 mg/m2 as a 1 mg/min IV infusion on Day 1 only every 4 weeks.
Croatian: • PLD 40 mg/m2 u obliku i.v. infuzije brzinom od 1 mg/min samo 1. dana svaka 4 tjedna.
English: This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Croatian: Ovo se stanje obično javlja kao posljedica komplikacija pri zacjeljivanju rana, gastrointestinalne perforacije ili nastanka fistule.
English: IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Croatian: Interferon alfa-2a se primjenjivao najdulje 52 tjedna ili do progresije bolesti u preporučenoj početnoj dozi od 9 milijuna IU tri puta tjedno, uz mogućnost postupnog (u dva koraka) smanjenja doze na 3 milijuna IU tri puta tjedno.
English: Avastin infusions should not be administered or mixed with glucose solutions.
Croatian: Infuzije lijeka Avastin ne smiju se primjenjivati niti miješati s otopinama glukoze.
English: Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Croatian: Klinički podaci o sigurnosti primjene upućuju na to da incidencija hipertenzije vjerojatno ovisi o dozi.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with Avastin.
Croatian: Primijećeno povećanje serumske razine kreatinina nije bilo povezano s većom incidencijom kliničkih manifestacija oštećenja bubrežne funkcije u bolesnika liječenih lijekom Avastin.
English: This leaflet was last revised in
Croatian: Ova uputa je zadnji puta revidirana u Ostali izvori informacija
English: In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Croatian: U kunića se pokazalo da bevacizumab inhibira zacjeljivanje rana pri dozama nižima od predložene kliničke doze.
English: GI-vaginal Fistulae in study GOG-0240
Croatian: Gastrointestinalno-vaginalne fistule u ispitivanju GOG-0240
English: The safety and efficacy of the recommended dose (5 mg/kg of body weight every two weeks) in metastatic carcinoma of the colon or rectum were studied in three randomised, active-controlled clinical trials in combination with fluoropyrimidine-based first-line chemotherapy.
Croatian: Sigurnost primjene i djelotvornost preporučene doze (5 mg/kg tjelesne težine svaka dva tjedna) u liječenju metastatskog karcinoma kolona ili rektuma ispitane su u tri randomizirana, aktivno kontrolirana klinička ispitivanja u kombinaciji s kemoterapijom prve linije baziranom na fluoropirimidinu.
English: At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
Croatian: Na početku ispitivanja, većina bolesnica u obje liječene skupine imala je GOG funkcionalni status 0 (CP: 82,4%; CPB: 80,7%) ili 1 (CP: 16,7%; CPB:
English: Cisplatin/Gemcitabine + placebo
Croatian: Cisplatin/Gemcitabin + placebo
English: Patients receiving Avastin plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Croatian: Bolesnici koji primaju Avastin zajedno s kemoterapijom i koji u anamnezi imaju arterijsku tromboemboliju, dijabetes ili su stariji od 65 godina, imaju povećan rizik za razvoj arterijskih tromboembolijskih reakcija tijekom liječenja.
English: The initial dose should be delivered over 90 minutes as an intravenous infusion.
Croatian: Početna se doza mora primijeniti u obliku intravenske infuzije tijekom 90 minuta.
English: It is recommended that the treatment with Avastin in addition to erlotinib is continued until disease progression.
Croatian: Liječenje lijekom Avastin uz erlotinib preporučuje se nastaviti do progresije bolesti.
English: A total of 1528 patients were randomised in equal proportions to the following two arms:
Croatian: Ukupno je randomizirano 1528 bolesnica u jednakim omjerima u sljedeće dvije skupine: