FrancophonIA/ELRC3.0 huggingface dataset:
English: Final overall survival analysis performed when 46.9% of the patients had died.
Croatian: Finalna analiza ukupnog preživljenja izvršena je nakon što je umrlo 46,9% bolesnica.
English: Overall survival - Follow-up analysis7 Median (months)1
Croatian: Ukupno preživljenje -Analiza nakon praćenja7 Medijan (mjeseci)1
English: The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology.
Croatian: Jedine varijable koje su pokazale statistički značajne korelacije s krvarenjem jesu terapija bevacizumabom i histologija skvamoznih stanica.
English: You must not breast-feed your baby during treatment with MVASI and for at least 6 months after the last dose of MVASI, as this medicine may interfere with the growth and development of your baby.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom MVASI i još najmanje 6 mjeseci nakon posljednje doze lijeka MVASI jer ovaj lijek može utjecati na rast i razvoj djeteta.
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-treated patients.
Croatian: Smrtni je ishod prijavljen u približno trećine ozbiljnih slučajeva gastrointestinalnih perforacija, što predstavlja između 0,2% i 1% svih bolesnika liječenih bevacizumabom.
English: Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Croatian: Renalna trombotska mikroangiopatija, koja se klinički može iskazati kao proteinurija (nepoznato), kod istodobne primjene sunitiniba ili bez njega.
English: As bevacizumab may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Croatian: Budući da bevacizumab može nepovoljno utjecati na zacjeljivanje rana, bolesnici koji su bili podvrgnuti opsežnijoj operaciji u prethodnih 28 dana nisu bili uključeni u klinička ispitivanja faze III.
English: • if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Croatian: • ako se morate podvrgnuti invazivnom stomatološkom postupku ili operaciji zuba, recite stomatologu da se liječite lijekom MVASI (bevacizumab), a naročito ako primate ili ste primali injekcije bisfosfonata u krvnu žilu.
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 bevacizumab.
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 bevacizumab.
English: For additional information refer below within section “Description of selected serious adverse reactions”.
Croatian: Za dodatne informacije vidjeti dio „Opis odabranih ozbiljnih nuspojava“ u nastavku.
English: It is recommended that treatment be continued until disease progression or unacceptable toxicity (see section 5.1, study MO22224).
Croatian: Liječenje se preporučuje nastaviti do progresije bolesti ili do pojave neprihvatljive toksičnosti (vidjeti dio 5.1, ispitivanje MO22224).
English: MVASI is contraindicated in pregnancy (see section 4.3).
Croatian: MVASI je kontraindiciran u trudnoći (vidjeti dio 4.3).
English: There are no clinical trial data on the use of bevacizumab in pregnant women.
Croatian: Nema podataka iz kliničkih ispitivanja o primjeni bevacizumaba u trudnica.
English: The majority of patients (CP: 64.6%; CPB: 68.8%) were in the age category < 65 years.
Croatian: Većina je bolesnica (CP: 64,6%; CPB: 68,8%) bila u dobnoj skupini < 65 godina.
English: If you stop treatment with MVASI
Croatian: Ako se prestanete liječiti lijekom MVASI
English: MVASI 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: MVASI 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: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 mL of red blood) should not be treated with bevacizumab.
Croatian: Bolesnici koji su nedavno imali plućno krvarenje/hemoptizu (> 2,5 ml svježe krvi) ne smiju se liječiti bevacizumabom.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Dokazana je kemijska i fizikalna stabilnost pripremljenog lijeka tijekom 48 sati na temperaturi od 2°C do 30°C u otopini natrijevog klorida za injekcije od 9 mg/ml (0,9%).
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Croatian: Da bi se poboljšala sljedivost ovog lijeka, vaš liječnik ili ljekarnik trebaju zabilježiti naziv i broj serije lijeka koji ste dobili, u vaš zdravstveni karton.
English: If you have conditions causing inflammation inside the abdomen (e.g. diverticulitis, stomach ulcers, colitis associated with chemotherapy), please discuss this with your doctor.
Croatian: Ako bolujete od stanja koja uzrokuju upale u trbuhu (npr. divertikulitis, želučani vrijed, kolitis povezan s kemoterapijom), porazgovarajte o tome sa svojim liječnikom.
English: Do not use MVASI if you notice any particulate matter or discolouration prior to administration.
Croatian: Ne upotrebljavajte MVASI ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: 5.8% of the overall randomised patient population had stage IIIB disease.
Croatian: 5,8% ukupne populacije randomiziranih bolesnica imalo je stadij bolesti IIIB.
English: The incidence of these reactions in some clinical trials of bevacizumab is common (up to 5% in bevacizumab-treated patients).
Croatian: Incidencija ovih reakcija je u pojedinim kliničkim ispitivanjima bevacizumaba bila česta (do 5% u bolesnika liječenih bevacizumabom).
English: No incompatibilities between MVASI and polyvinyl chloride or polyolefin bags or infusion sets have been observed.
Croatian: Nisu opažene nekompatibilnosti između lijeka MVASI i polivinilkloridnih ili poliolefinskih vrećica ili kompleta za infuziju.
English: Caution should be exercised when bevacizumab and intravenous bisphosphonates are administered simultaneously or sequentially.
Croatian: Potreban je oprez kada se bevacizumab i intravenski bisfosfonat primjenjuju istovremeno ili jedan iza drugoga.
English: Bevacizumab has been associated with serious cases of gastrointestinal perforation.
Croatian: Bevacizumab se povezuje s ozbiljnim slučajevima gastrointestinalne perforacije.
English: Before initiating MVASI, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka MVASI potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: • dry skin, flaking and inflammation of the skin, change in skin colour,
Croatian: • suhu kožu, perutanje i upalu kože, promjenu boje kože,
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: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in table 6 for trial NO16966.
Croatian: U skupinama koje su primale kemoterapiju, u liječenju protokolom FOLFOX-4 koristile su se doze i raspored doziranja jednaki onima prikazanima u Tablici 6 za ispitivanje NO16966.
English: Reactions were reported at various time points during treatment ranging from one week to greater than 1 year from initiation of bevacizumab, 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 bevacizumaba, ali se većina njih pojavila u prvih 6 mjeseci liječenja.
English: • Increased eye pressure,
Croatian: • povišen očni tlak,
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 sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: Of the 722 patients in the trial, the majority of patients had HER2-negative disease (90%), with a small number of patients with unknown (8%) or confirmed HER2-positive status (2%), who had previously been treated with or were considered unsuitable for trastuzumab therapy.
Croatian: Od 722 bolesnika koji su sudjelovali u ispitivanju većina je imala HER2-negativan oblik bolesti (90%), uz mali broj bolesnika u kojih status nije bio poznat (8%) ili su imali potvrđen HER2-pozitivan status (2%), te su prethodno ili bili liječeni trastuzumabom ili nisu bili smatrani pogodnima za liječenje trastuzumabom.
English: Very rare Frequency not known
Croatian: Rijetko Vrlo rijetko Nepoznata učestalost
English: Combination of bevacizumab and sunitinib malate
Croatian: Kombinacija bevacizumaba i sunitinib malata
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensinconverting enzyme inhibitors, diuretics and calcium-channel blockers.
Croatian: Hipertenzija se u načelu dobro kontrolirala primjenom oralnih antihipertenziva poput inhibitora angiotenzin-konvertirajućeg enzima, diuretika i blokatora kalcijskih kanala.
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC07.
Croatian: Farmakoterapijska skupina: pripravci za liječenje zloćudnih bolesti i imunomodulatori, antineoplastici, ostali antineoplastici, monoklonska protutijela, ATK oznaka: L01XC07.
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression-free survival was 8.8 months.
Croatian: Za 110 bolesnika randomiziranih u skupinu 3 (5-FU/FA + bevacizumab) prije prekida uključivanja u tu skupinu medijan ukupnog preživljenja iznosio je 18,3 mjeseca, a medijan preživljenja bez progresije bolesti 8,8 mjeseci.
English: Intravitreal use
Croatian: Intravitrealna primjena
English: After cycle 1, the medicinal product could be delivered as a 1-hour infusion.
Croatian: Nakon 1. ciklusa lijek se mogao primjenjivati u obliku jednosatne infuzije.
English: The signs may include: difficulty in breathing or chest pain.
Croatian: Znakovi mogu obuhvaćati otežano disanje ili bol u prsnom košu.
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 bevacizumab 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 bevacizumabom.
English: These clinically significant reactions have therefore been included in table 2 within the column entitled “Frequency not known”.
Croatian: Te su klinički značajne nuspojave zato u Tablici 2 uključene u kolonu „Nepoznata učestalost“.
English: Therefore fertility preservation strategies should be discussed with women of childbearing potential prior to starting treatment with bevacizumab.
Croatian: Stoga kod žena reproduktivne dobi treba razmotriti strategije za očuvanje plodnosti prije početka liječenja bevacizumabom.
English: One-sided log-rank p-value.
Croatian: p-vrijednost jednostranog log-rang testa.
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Croatian: Novi slučajevi zatajenja jajnika prijavljeni su u 2,6% bolesnica u skupini mFOLFOX-6 u usporedbi s 39% njih u skupini mFOLFOX-6 + bevacizumab.
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: • any severe bleeding.
Croatian: • u slučaju bilo kojeg teškog krvarenja.
English: In the majority of the occasions the necessary amount of MVASI can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Croatian: U većini slučajeva potrebna količina lijeka MVASI se može razrijediti s 0,9% otopinom natrijevog klorida za injekciju do ukupnog volumena od 100 ml.
English: • blood clot in the arteries which can lead to a stroke or a heart attack,
Croatian: • krvni ugrušci u arterijama koji mogu izazvati moždani ili srčani udar,
English: Sodium phosphate
Croatian: Natrijev fosfat
English: • pain, including headache, back pain and pain in the pelvis and anal regions,
Croatian: • bol, uključujući glavobolju, bol u leđima i bol u zdjelici i području anusa,
English: • if you develop severe high blood pressure requiring treatment with blood pressure medicines,
Croatian: • u slučaju izrazitog povišenja krvnog tlaka koje je potrebno liječiti lijekovima za krvni tlak,
English: These therapies in combination with MVASI may increase the risk of severe side effects.
Croatian: Ovi lijekovi u kombinaciji s lijekom MVASI mogu povećati rizik od teških nuspojava.
English: Bevacizumab was combined with two chemotherapy regimens:
Croatian: Bevacizumab je kombiniran s dva kemoterapijska protokola:
English: Talk to your doctor, pharmacist or nurse before using MVASI
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite MVASI
English: The median age was 60.0 years in the CP arm and 59.0 years in the CPB arm.
Croatian: Medijan dobi iznosio je 60,0 godina u skupini CP te 59,0 godina u skupini CPB.
English: High-grade glioma
Croatian: Gliom visokog stupnja
English: Efficacy results for study ML18147 (ITT population)
Croatian: Tablica 9. Rezultati djelotvornosti za ispitivanje ML18147 (ITT populacija) ML18147
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Croatian: Konačna analiza ukupnog preživljenja izvršena nakon što je umrlo 46,7% bolesnica, prema podacima do 31. ožujka 2013.
English: • MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Croatian: • MVASI može izazvati infekcije i smanjenje broja neutrofila (vrsta krvnih stanica koja je važna u zaštiti od bakterija).
English: Nervous system disorders Hypertensive encephalopathy (very rare) (see also section 4.4 and Hypertension in section 4.8)
Croatian: Poremećaji živčanog sustava Hipertenzivna encefalopatija (vrlo rijetko) (vidjeti i dio 4.4 i Hipertenzija u dijelu 4.8)
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Croatian: Analiza nakon praćenja provedena je na temelju podataka prikupljenih do 7. ožujka 2014.; sve p-vrijednosti navedene su samo u ilustrativne svrhe.
English: Depending on the dose prescribed for you, some or all of the contents of the MVASI 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 MVASI bit će prije primjene razrijeđen otopinom natrijevog klorida.
English: The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see table 4).
Croatian: Dodatak bevacizumaba IFL protokolu rezultiralo je statistički značajnim porastom ukupnog preživljenja, preživljenja bez progresije bolesti i ukupne stope odgovora (vidjeti Tablicu 4).
English: In both studies, bevacizumab exposure trended lower as body weight decreased.
Croatian: U oba se ispitivanja izloženost bevacizumabu obično smanjivala sa smanjenjem tjelesne težine.
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and 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 odraslih bolesnika usporedivi kada se normaliziraju za tjelesnu težinu, uz trend smanjenja izloženosti sa smanjenjem tjelesne težine.
English: For further information please refer to table 3 “Adverse reactions reported in post-marketing setting”.
Croatian: Za dodatne informacije vidjeti Tablicu 3 „Nuspojave prijavljene nakon stavljanja lijeka u promet“.
English: Efficacy results for trial BO17705
Croatian: Rezultati djelotvornosti za ispitivanje BO17705
English: MVASI will be administered in combination with erlotinib.
Croatian: MVASI će se primjenjivati u kombinaciji s erlotinibom.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 25 mg of bevacizumab*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedan ml koncentrata sadrži 25 mg bevacizumaba*.
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: Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Croatian: Kombinacija lijeka MVASI i drugog lijeka koji se zove sunitinib malat (propisuje se za liječenje raka bubrega i raka probavnog sustava) može izazvati teške nuspojave.
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: 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), which may be severe.
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 Vam rade bubrezi); smanjenu razinu hemoglobina (nalazi se u crvenim krvnim stanicama koje prenose kisik), koja može biti ozbiljna.
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Croatian: Riječ je o randomiziranom ispitivanju faze II u kojem se uspoređivala djelotvornost i sigurnost primjene bevacizumaba u odnosu na placebo.
English: Duration of response Median time (months)
Croatian: pvrijednost Trajanje odgovora Medijan vremena (mjeseci)
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anti-cancer 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: • MVASI may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Croatian: • MVASI može povećati rizik od stvaranja neuobičajenog spoja ili prolaza između dvaju organa ili krvnih žila.
English: The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Croatian: Metabolizam i eliminacija bevacizumaba slični su endogenom IgG-u, tj. primarno se odvijaju putem proteolitičkog katabolizma u čitavom tijelu, uključujući endotelne stanice, te se primarno ne oslanjaju na eliminaciju putem bubrega i jetre.
English: Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be exercised when treating these patients.
Croatian: Intraabdominalni upalni proces može biti čimbenik rizika za gastrointestinalne perforacije u bolesnika s metastatskim karcinomom kolona ili rektuma, stoga je prilikom liječenja takvih bolesnika potreban oprez.
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to stopping treatment with bevacizumab until recovery to < 2g/24 hrs.
Croatian: U većini kliničkih ispitivanja razine proteina u mokraći ≥ 2 g/24 h dovele su do prekida primjene bevacizumaba dok se razina nije vratila na < 2 g/24 h.
English: Bevacizumab use has been associated with serious cases of fistulae including reactions resulting in death.
Croatian: Primjena bevacizumaba povezuje se s ozbiljnim slučajevima fistula, uključujući reakcije sa smrtnim ishodom.
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: • high blood pressure,
Croatian: • visok krvni tlak,
English: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through:
Croatian: Tablici 1 navedene su sve nuspojave prema učestalosti za koje je utvrđena uzročna povezanost s primjenom bevacizumaba:
English: • MVASI can increase the incidence of high blood pressure.
Croatian: • MVASI može povećati učestalost visokog krvnog tlaka.
English: • increase in heart rate (pulse),
Croatian: • ubrzane otkucaje srca (puls),
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Croatian: Eksploracijski multivarijatni Coxov regresijski model sa selekcijom unatrag (engl. “backward selection”) pokazao je da su sljedeći ishodišni prognostički čimbenici izrazito povezani s preživljenjem, neovisno o liječenju: spol, broj bijelih krvnih stanica, trombociti, gubitak tjelesne težine tijekom 6 mjeseci prije uključenja u ispitivanje, broj metastatskih sijela, zbroj najdužeg promjera ciljnih lezija i procjena po Motzeru.
English: Effect of bevacizumab on the pharmacokinetics of other antineoplastic agents
Croatian: Učinak bevacizumaba na farmakokinetiku drugih antineoplastičnih tvari