FrancophonIA/ELRC3.0 huggingface dataset:
English: Duration of response Median time (months)
Croatian: Trajanje odgovora Medijan vremena (mjeseci)
English: ● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Croatian: Ovaj lijek može povećati rizik od krvarenja ili problema sa zacjeljivanjem rana poslije operacije.
English: If you experience symptoms that affect your vision or concentration, or your ability to react, do not drive and use machines until symptoms disappear.
Croatian: Ako primijetite simptome koji Vam utječu na vid, koncentraciju ili sposobnost reakcije, nemojte voziti ni raditi sa strojevima dok simptomi ne prestanu.
English: Patients with recent pulmonary haemorrhage/ haemoptysis (> 2.5 ml of red blood) should not be treated with Avastin.
Croatian: Bolesnici koji su nedavno imali plućno krvarenje/hemoptizu (> 2,5 ml svježe krvi) ne smiju se liječiti lijekom Avastin.
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Croatian: Zbog toga rizik od krvarenja u SŽS-u u takvih bolesnika nije prospektivno ocijenjen u randomiziranim kliničkim ispitivanjima (vidjeti dio 4.8).
English: Caution should be exercised when Avastin and intravenous bisphosphonates are administered simultaneously or sequentially.
Croatian: Potreban je oprez kada se Avastin i intravenski bisfosfonat primjenjuju istovremeno ili jedan iza drugoga.
English: Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer.
Croatian: Obavijestite svog liječnika ako primate terapiju koja se temelji na platini ili taksanima za liječenje raka pluća ili metastatskog raka dojke.
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anticancer therapies, which may have impacted the analysis of overall survival.
Croatian: Visok udio bolesnika (oko 62%) je u nastavku liječenja primao različite antitumorske lijekove koji nisu navedeni u protokolu, a koji su mogli utjecati na analizu ukupnog preživljenja.
English: The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Croatian: Najveća doza ispitana u ljudi (20 mg/kg tjelesne težine, primijenjena intravenski svaka 2 tjedna) u nekoliko je bolesnika bila povezana s teškom migrenom.
English: However, the increase in the primary endpoint of overall survival by 2 months was not significant (HR= 0.91).
Croatian: Međutim, produljenje ukupnog preživljenja, kao primarne mjere ishoda, za 2 mjeseca nije bilo statistički značajno (HR= 0,91).
English: Avastin was combined with two chemotherapy regimens:
Croatian: Avastin je kombiniran s dva kemoterapijska protokola:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001 - 100 mg/4 ml vial EU/1/04/300/002 - 400 mg/16 ml vial
Croatian: EU/1/04/300/001 - 100 mg/4 ml bočica EU/1/04/300/002 - 400 mg/16 ml bočica
English: The efficacy results of Avastin in combination with IFL-chemotherapy are displayed in Table 4.
Croatian: Rezultati djelotvornosti lijeka Avastin u kombinaciji s IFL kemoterapijom prikazani su u Tablici 4.
English: In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Croatian: U odraslih rezultati nisu pokazali značajne razlike u farmakokinetici bevacizumaba s obzirom na dob.
English: Overall survival
Croatian: Ukupno preživljenje
English: As maternal IgG is excreted in milk and bevacizumab could harm infant growth and development (see section 5.3), women must discontinue breast-feeding during therapy and not breast-feed for at least six months following the last dose of Avastin.
Croatian: Budući da se majčin IgG izlučuje u mlijeko, a bevacizumab može naškoditi rastu i razvoju djeteta (vidjeti dio 5.3), žene moraju prestati dojiti za vrijeme liječenja te ne smiju dojiti najmanje šest mjeseci nakon posljednje doze lijeka
English: 3 One-sided log-rank p-value Subject to a p-value boundary of 0.0116.
Croatian: 4 Ovisno o graničnoj p-vrijednosti od 0,0116
English: The concentrate is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Croatian: Koncentrat je bistra, bezbojna do blijedosmeđa tekućina u staklenoj bočici s gumenim čepom.
English: In both studies, bevacizumb exposure trended lower as body weight decreased.
Croatian: U oba se ispitivanja izloženost bevacizumabu obično smanjivala sa smanjenjem tjelesne težine.
English: • high blood pressure.
Croatian: ● visok krvni tlak.
English: 19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
Croatian: 19% bolesnika prethodno je primilo kemoterapiju, a 14% radioterapiju.
English: The use of diuretics to manage hypertension is not advised in patients who receive a cisplatin-based chemotherapy regimen.
Croatian: Uporaba diuretika za regulaciju hipertenzije ne preporučuje se u bolesnika koji primaju kemoterapiju na bazi cisplatina.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 January 2005
Croatian: Datum prvog odobrenja: 12. siječnja 2005.
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and young adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Croatian: Farmakokinetički podaci pokazuju da su klirens i volumen distribucije bevacizumaba u pedijatrijskih i mlađih odraslih bolesnika usporedivi kada se normaliziraju za tjelesnu težinu, uz trend smanjenja izloženosti sa smanjenjem tjelesne težine.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD <Sadrži 2D barkod s jedinstvenim identifikatorom.>
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Croatian: Nisu poznati dugoročni učinci liječenja bevacizumabom na plodnost.
English: Congenital, familial, and genetic disorder
Croatian: Prirođeni, obiteljski i genetski poremećaji
English: Your doctor will prescribe a dose of Avastin that is right for you.
Croatian: Liječnik će propisati dozu lijeka Avastin koja je primjerena za Vas.
English: • change in the sense of taste,
Croatian: ● promjene osjeta okusa,
English: Reactions were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of Avastin, with most reactions occurring within the first 6 months of therapy.
Croatian: Fistule su prijavljene u različitim razdobljima tijekom liječenja, od prvog tjedna do više od godine dana nakon početka primjene lijeka Avastin, ali se većina njih pojavila u prvih 6 mjeseci liječenja.
English: Rate (n) p-value
Croatian: Stopa (n) p-vrijednost
English: Infusion solutions should be used immediately after dilution.
Croatian: Otopine za infuziju moraju se upotrijebiti odmah nakon razrjeđivanja.
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 Avastin + FOLFOX-4 and 244 Avastin monotherapy).
Croatian: Randomizirano je 829 bolesnika (292 za protokol FOLFOX-4, 293 za Avastin + FOLFOX-4 i 244 za monoterapiju lijekom Avastin).
English: ● Avastin may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
Croatian: Avastin može povećati rizik od razvoja ozbiljnih infekcija kože ili dubljih potkožnih slojeva, osobito ako ste imali napuknuća u stijenci crijeva ili probleme sa zacjeljivanjem rana.
English: The value for clearance is, on average, equal to 0.188 and 0.220 L/day for female and male patients, respectively.
Croatian: Vrijednost klirensa iznosi u prosjeku 0,188 l/dan za žene i 0,220 l/dan za muškarce.
English: In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Croatian: U tom su ispitivanju arterijske tromboembolijske reakcije opažene u 11% (11/100) bolesnika u usporedbi s 5,8% (6/104) u kontrolnoj skupini liječenoj kemoterapijom.
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Croatian: Farmakoterapijska skupina: pripravci za liječenje zloćudnih bolesti i imunomodulatori, antineoplastici, ostali antineoplastici, monoklonska protutijela, ATK oznaka: L01X C07
English: Gastrointestinal (GI) perforations and Fistulae (see section 4.4) Avastin has been associated with serious cases of gastrointestinal perforation.
Croatian: Gastrointestinalne perforacije i fistule (vidjeti dio 4.4) Avastin se povezuje s ozbiljnim slučajevima gastrointestinalne perforacije.
English: A cross-trial comparison of the efficacy and safety data is limited by differences between these studies, most notably in patient populations, previous bevacizumab exposure and chemotherapy regimens.
Croatian: Usporedba podataka o djelotvornosti i sigurnosti između ta dva ispitivanja ograničena je razlikama prije svega u populacijama bolesnika, prethodnoj izloženosti bevacizumabu i kemoterapijskim protokolima.
English: These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the Avastin treatment regimen.
Croatian: Najčešće se radilo o epistaksi stupnja 1 prema NCI-CTCAE v.3, koja je trajala manje od 5 minuta i povukla se bez medicinske intervencije te nije zahtijevala promjene u režimu liječenja lijekom Avastin.
English: Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Croatian: Hipertenzivna encefalopatija (vrlo rijetko) (vidjeti i dio 4.4 i Hipertenzija u dijelu 4.8)
English: Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Croatian: U sljedećim su tablicama nuspojave razvrstane u odgovarajuću kategoriju učestalosti na osnovu najveće zabilježene incidencije u bilo kojoj indikaciji.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
Croatian: POSEBNE MJERE ČUVANJA Čuvati u hladnjaku (2°C - 8°C).
English: Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Croatian: Kombinacija lijeka Avastin i drugog lijeka koji se zove sunitinib malat (propisuje se za liječenje raka bubrega i raka probavnog sustava) može izazvati teške nuspojave.
English: ● It is possible that Avastin may cause bleeding in and around your brain.
Croatian: Može se dogoditi da Avastin uzrokuje krvarenje u mozgu i oko mozga.
English: In patients who have previously received or are receiving intravenous bisphosphonates invasive dental procedures should be avoided, if possible.
Croatian: U bolesnika koji su primali ili primaju intravenske bisfosfonate po mogućnosti treba izbjegavati invazivne stomatološke zahvate.
English: Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with sodium chloride solution before use.
Croatian: Ovisno o dozi koja Vam je propisana, dio sadržaja ili cijeli sadržaj bočice lijeka Avastin bit će prije primjene razrijeđen otopinom natrijevog klorida.
English: You should discuss this with your doctor.
Croatian: porazgovarajte o tome sa svojim liječnikom.
English: The addition of Avastin to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Croatian: Dodatak lijeka Avastin IFL protokolu rezultiralo je statistički značajnim porastom ukupnog preživljenja, preživljenja bez progresije bolesti i ukupne stope odgovora (vidjeti Tablicu 4).
English: 3.7% of the overall randomised patient population had Stage IIIB disease.
Croatian: 3 3,7% ukupne populacije randomiziranih bolesnica bilo je u stadiju bolesti IIIB.
English: If you stop treatment with Avastin
Croatian: Ako se prestanete liječiti lijekom Avastin
English: In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
Croatian: U bolesnika koji su tijekom liječenja imali komplikacije pri zacjeljivanju rana treba privremeno prekinuti liječenje dok rana u potpunosti ne zacijeli.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all Avastin treated patients.
Croatian: Smrtni je ishod prijavljen u približno trećine ozbiljnih slučajeva gastrointestinalnih perforacija, što predstavlja između 0,2% i 1% svih bolesnika liječenih lijekom Avastin.
English: Most patients were FIGO Stage IIIC or Stage IV.
Croatian: Većina bolesnica imala je bolest stadija IIIC ili stadija IV prema FIGO klasifikaciji.
English: Low albumin and high tumour burden are generally indicative of disease severity.
Croatian: Općenito, niske vrijednosti albumina i visoko tumorsko opterećenje pokazuju težinu bolesti.
English: The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Croatian: Odgovarajuća učestalost u kontrolnoj skupini koja je primala samo kemoterapiju iznosila je 1,1% odnosno 0,8%.
English: The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Croatian: Većina je bolesnica po histološkom tipu imala serozni adenokarcinom (85% u skupinama CPP i CPB15 te 86% u skupini CPB15+).
English: FOLFOX-4 or XELOX + bevacizumab (n=699)
Croatian: FOLFOX-4 ili XELOX + bevacizumab (n=699)
English: IgGs are known to cross the placenta, and Avastin is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
Croatian: Poznato je da molekule IgG-a mogu proći kroz posteljicu, a pretpostavlja se da Avastin može spriječiti angiogenezu u fetusa te se stoga sumnja da bi mogao izazvati teške urođene mane ako se primjenjuje tijekom trudnoće.
English: ● Avastin can increase the incidence of high blood pressure.
Croatian: Avastin može povećati učestalost visokog krvnog tlaka.
English: Very rare cases of hypertensive encephalopathy have been reported, some of which were fatal.
Croatian: Vrlo su rijetko zabilježeni slučajevi hipertenzivne encefalopatije, od kojih su neki imali smrtan ishod.
English: Table 23 Efficacy Results from Study MO22224
Croatian: Tablica 23 Rezultati djelotvornosti za ispitivanje MO22224
English: b 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: b Pojmovi označavaju skup događaja koji opisuju određeni medicinski koncept, a ne pojedinačno stanje ili preferirani termin prema Medicinskom rječniku za regulatorne poslove (MedDRA).
English: When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.
Croatian: Kada se koristi za bolesnike s rakom bubrega, primjenjuje se zajedno s drugim lijekom koji se zove interferon.
English: Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 8).
Croatian: Uočeno je i statistički značajno produljenje preživljenja bez progresije bolesti i povećanje stope objektivnog odgovora (vidjeti Tablicu 8).
English: Topotecan n=120
Croatian: Topote kan n=120
English: ● severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
Croatian: ● u slučaju izrazito povišenog krvnog tlaka koji se ne može kontrolirati lijekovima ili naglog značajnog povišenja krvnog tlaka,
English: Efficacy Results for Study ML18147 (ITT population)
Croatian: Tablica 9 Rezultati djelotvornosti za ispitivanje ML18147 (ITT populacija)
English: • bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
Croatian: ● krvarenje, uključujući krvarenje u plućima u bolesnika s rakom pluća nemalih stanica,
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Croatian: ● oštećenja zubnog mesa s izloženom čeljusnom kosti koja ne zarastaju i mogu biti povezana s boli i upalom okolnog tkiva (daljnje preporuke vidjeti u odjeljcima iza popisa nuspojava),
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Croatian: Dijagnozu PRES-a treba potvrditi snimanjem mozga, najbolje oslikavanjem magnetskom rezonancijom (MR).
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to the holding of Avastin until recovery to < 2g/24 hrs.
Croatian: U većini kliničkih ispitivanja razine proteina u mokraći ≥ 2 g/24 h dovele su do prekida primjene lijeka Avastin dok se razina nije vratila na < 2 g/24 h.
English: • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
Croatian: ● simptomi koji upućuju na promjene u normalnom radu mozga (glavobolje, promjene vida, smetenost ili konvulzije) i visok krvni tlak,
English: First-line treatment of non-squamous NSCLC with EGFR activating mutations in combination with erlotinib
Croatian: Prva linija liječenja neskvamoznog NSCLC-a s aktivirajućim mutacijama EGFR-a u kombinaciji s erlotinibom
English: CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Croatian: Podaci o rasi na raspolaganju su za 29,3% bolesnica i gotovo sve su bile bijele rase.
English: • localised pus collection,
Croatian: ● lokalizirano nakupljanje gnoja,
English: • abnormal urine test (protein in the urine),
Croatian: ● poremećen nalaz mokraće (proteini u mokraći),
English: Secondary endpoints included overall survival, response rate, disease control rate, duration of response, and safety.
Croatian: Sekundarne mjere ishoda uključivale su ukupno preživljenje, stopu odgovora, stopu kontrole bolesti, trajanje odgovora i sigurnost.
English: The administration of Avastin should be temporarily discontinued
Croatian: Primjenu lijeka Avastin treba privremeno prekinuti
English: Investigations Weight decreased
Croatian: Pretrage smanjenje težine
English: The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/ml to 16.5 mg/ml.
Croatian: Krajnja koncentracija otopine s bevacizumabom treba biti unutar raspona od 1,4 mg/ml do 16,5 mg/ml.
English: On documented disease progression, patients who entered the optional open-label phase could receive open-label Avastin together with a wide-range of second line therapies.
Croatian: Čim bi se potvrdila progresija bolesti, bolesnici koji su ušli u neobaveznu otvorenu fazu ispitivanja mogli su primati Avastin u kombinaciji sa širokim izborom lijekova druge linije.
English: Intravitreal use Avastin is not formulated for intravitreal use.
Croatian: Intravitrealna primjena Avastin nije namijenjen za intravitrealnu primjenu.
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedljivost bioloških lijekova, zaštićeno ime primijenjenog lijeka i broj serije moraju se jasno zabilježiti (navesti) u bolesničkom kartonu.
English: Vascular disorders Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Croatian: Krvožilni poremećaji Renalna trombotska mikroangiopatija, koja se klinički može iskazati kao proteinurija (nepoznato), kod istodobne primjene sunitiniba ili bez njega.
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: 6 - 12 months (n=202) Median
Croatian: 6 - 12 mjeseci (n=202) Me dijan
English: Before initiating Avastin, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka <naziv lijeka> potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: Singapore
Croatian: Singapur
English: Avastin in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Croatian: Avastin u kombinaciji s interferonom alfa-2a u prvoj liniji liječenja uznapredovalog i/ili metastatskog karcinoma bubrežnih stanica (BO17705)
English: For the posology and method of administration of erlotinib, please refer to the full erlotinib prescribing information.
Croatian: Za informacije o doziranju i načinu primjene erlotiniba pročitajte cjelovite informacije o lijeku za erlotinib.
English: Table 11 Efficacy results for study AVF3694g: - Capecitabinea and Avastin/Placebo (Cap + Avastin/Pl)
Croatian: Tablica 11 Rezultati djelotvornosti za ispitivanje AVF3694g: - kapecitabin a i Avastin/placebo
English: There have also been less common reactions of minor mucocutaneous haemorrhage in other locations, such as gingival bleeding or vaginal bleeding.
Croatian: Bilo je i manje čestih slučajeva blažeg mukokutanog krvarenja na drugim mjestima, poput krvarenja iz desni ili vaginalnog krvarenja.
English: Table 8 Efficacy results for trial E3200
Croatian: Tablica 8 Rezultati djelotvornosti za ispitivanje E3200
English: In the absence of PD, discontinuation of one component of study treatment in the erlotinib + Avastin arm did not lead to discontinuation of the other component of study treatment as specified in the study protocol.
Croatian: Ako nije došlo do progresije bolesti, prekid primjene jednog od lijekova uključenih u ispitivanje u skupini liječenoj erlotinibom + lijekom Avastin nije uzrokovao prekid primjene drugog lijeka uključenog u ispitivanje kao što je specificirano u protokolu ispitivanja.
English: Anti-tumour activity was not observed in two earlier studies among a total of 30 children aged > 3 years old with relapsed or progressive high-grade glioma when treated with bevacizumab and irinotecan (CPT-11).
Croatian: Antitumorska aktivnost nije opažena u dva ranija ispitivanja među ukupno 30 djece starije od 3 godine s relapsnim ili progresivnim gliomom visokog stupnja malignosti, kada su liječena bevacizumabom i irinotekanom (CPT-11).
English: After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Croatian: Uz korekciju s obzirom na tjelesnu težinu, muškarci su imali veći klirens bevacizumaba (+17%) od žena.
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Croatian: Ako bolesnici imaju simptome koji im djeluju na vid, koncentraciju ili sposobnost reakcije, mora ih se upozoriti da ne upravljaju vozilima i ne rade sa strojevima dok se simptomi ne povuku.
English: Gastrointestinal ulcer (not known)
Croatian: Ulkus u gastrointestinalnom traktu (nepoznato)
English: An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Croatian: Može se, međutim, očekivati nepovoljan utjecaj na plodnost žena jer su ispitivanja toksičnosti ponovljenih doza na životinjama pokazala inhibiciju sazrijevanja folikula u jajnicima i smanjenje/odsutnost žutog tijela te s time povezano smanjenje mase jajnika i maternice kao i smanjenje broja menstrualnih ciklusa.