FrancophonIA/ELRC3.0 huggingface dataset:
English: Avastin may cause damage to your unborn baby as it may stop the formation of new blood vessels.
Croatian: Avastin može naškoditi nerođenom djetetu jer može zaustaviti stvaranje novih krvnih žila.
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis
Croatian: Primarna analiza provedena je na temelju podataka prikupljenih do 12. prosinca 2012. i smatra se završnom analizom
English: Binding of the IgG to the FcRn receptor results in protection from cellular metabolism and the long terminal half-life.
Croatian: Vezivanje IgG-a na FcRn receptor rezultira zaštitom od staničnog metabolizma i dugim terminalnim poluvijekom.
English: Symptoms usually resolve or improve within days after treatment discontinuation, although some patients have experienced some neurologic sequelae.
Croatian: Simptomi se obično povlače ili poboljšavaju u roku od nekoliko dana nakon prekida liječenja, iako su neki bolesnici imali neke neurološke posljedice.
English: If a reaction occurs, the infusion should be discontinued and appropriate medical therapies should be administered.
Croatian: Ako se razvije reakcija, infuziju treba prekinuti i primijeniti odgovarajuće liječenje.
English: Data are unadjusted for the differential time on treatment.
Croatian: Podaci nisu usklađeni s obzirom na različito trajanje liječenja.
English: There were no grade 4 or 5 hypertension events.
Croatian: Nisu zabilježeni slučajevi hipertenzije stupnja 4 ili 5.
English: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Switzerland
Croatian: Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Švicarska
English: Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason.
Croatian: Molimo posavjetujte se sa svojim liječnikom ako Vi ili netko u Vašoj obitelji pati od problema s krvarenjem ili ako iz bilo kojeg razloga uzimate lijekove protiv zgrušavanja krvi.
English: Major or massive pulmonary haemorrhage/haemoptysis can occur suddenly and up to two thirds of the serious pulmonary haemorrhages resulted in a fatal outcome.
Croatian: Jako ili masivno plućno krvarenje/hemoptiza može nastupiti iznenada, a do dvije trećine slučajeva ozbiljnog plućnog krvarenja imalo je smrtni ishod.
English: Metastatic disease progression was inhibited and microvascular permeability was reduced.
Croatian: Inhibirana je metastatska progresija bolesti i smanjena je mikrovaskularna propusnost.
English: ● your doctor will decide when you should be given your next dose of Avastin.
Croatian: Vaš će liječnik odlučiti kada trebate dobiti sljedeću dozu lijeka Avastin.
English: What Avastin contains
Croatian: Što Avastin sadrži
English: Do not use Avastin if you notice any particulate matter or discolouration prior to administration.
Croatian: Ne upotrebljavajte Avastin ako primijetite bilo kakve čestice ili promjenu boje prije primjene.
English: • Increased eye pressure,
Croatian: ● povišen očni tlak,
English: What Avastin is and what it is used for What you need to know before you use Avastin How to use Avastin
Croatian: Što je Avastin i za što se koristi Što morate znati prije nego počnete primati Avastin
English: In trial E2100, patients were treated until disease progression.
Croatian: U ispitivanju E2100 bolesnici su liječeni do progresije bolesti.
English: Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Croatian: Molim obavijestite liječnika ako ste nedavno primali ili sada primate terapiju zračenjem.
English: Avastin should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Croatian: Avastin treba trajno obustaviti ako se medicinski značajna hipertenzija ne može odgovarajuće kontrolirati antihipertenzivima, ili ako se u bolesnika razvije hipertenzivna kriza ili hipertenzivna encefalopatija.
English: If you have an allergic reaction, tell your doctor or a member of the medical staff straight away.
Croatian: Ako razvijete alergijsku reakciju, odmah o tome obavijestite liječnika ili člana medicinskog osoblja.
English: The patient characteristics were similar across the trial arms.
Croatian: Karakteristike bolesnika bile su slične u obje ispitivane skupine.
English: There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly-diagnosed high-grade glioma.
Croatian: Nema dovoljno informacija na temelju kojih bi se utvrdila sigurnost i djelotvornost bevacizumaba u djece s novodijagnosticiranim gliomom visokog stupnja malignosti.
English: Overall Survival* (months)
Croatian: Ukupno preživljenje* (mjeseci)
English: • Bleeding in the eye.
Croatian: ● krvarenje u oku.
English: • abnormally high blood pressure in the blood vessels of the lungs which makes the right side of the heart work harder than normal,
Croatian: ● abnormalno visok krvni tlak u krvnim žilama pluća zbog čega desna strana srca mora raditi više nego inače,
English: (See section 5.1).
Croatian: (vidjeti dio 5.1).
English: ● The risk of developing blood clots in your arteries (a type of blood vessel) can increase if you are over 65 years old, if you have diabetes, or if you have had previous blood clots in your arteries.
Croatian: Rizik od nastanka krvnih ugrušaka u arterijama (vrsta krvnih žila) može se povećati ako ste stariji od 65 godina, ako imate šećernu bolest ili ako ste u prošlosti imali krvne ugruške u arterijama.
English: NR 25-75 percentile (months) 5.5 − NR 6.1 − NR 3.8 - 7.8 5.59 - 9.17 5.88 - 13.01
Croatian: 5,5 - ND 6,1 - ND 3,8 - 7,8 5,59 - 9,17 5,88 - 13,01
English: Each pack of Avastin contains one vial.
Croatian: Svako pakiranje lijeka Avastin sadrži jednu bočicu.
English: Radiotherapy
Croatian: Radioterapija
English: • CT+BV Arm (chemotherapy plus bevacizumab):
Croatian: • Skupina KT+BV (kemoterapija i bevacizumab):
English: ● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Avastin, 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 Avastin, a naročito ako primate ili ste primali injekcije bisfosfonata u krvnu žilu.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za savjet prije nego uzmete bilo koji lijek.
English: Roche farmacevtska družba d.o.o.
Croatian: Slove nija Roche farmacevtska družba d.o.o.
English: ● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Croatian: Ovaj lijek može izazvati infekcije i smanjenje broja neutrofila (vrsta krvnih stanica koja je važna u zaštiti od bakterija).
English: The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Croatian: Sigurnost i djelotvornost bevacizumaba u djece mlađe od 18 godina nisu ustanovljene.
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Croatian: Nuspojave navedene u ovom dijelu mogu se svrstati u sljedeće kategorije učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Non-small cell lung cancer (NSCLC)
Croatian: Karcinom pluća nemalih stanica (NSCLC)
English: HR (95% CI) p-value # A total of 154 patients (ECOG Performance Status 0 or 1) were randomized.
Croatian: HR (95% CI) p-vrijednost # Ukupno su randomizirana 154 bolesnika (ECOG funkcionalni status 0 ili 1).
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Croatian: Brzina infuzije ovisila je o podnošljivosti, a početna infuzija trajala je 90 minuta.
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući i malformacije (vidjeti dio 5.3).
English: For further information on proteinuria see section 4.4 and Proteinuria in section 4.8.
Croatian: Za dodatne informacije o proteinuriji vidjeti dio 4.4 i Proteinurija u dijelu 4.8.
English: Objective Response Rate**
Croatian: Stopa objektivnog odgovora**
English: CT+BV
Croatian: KT+BV
English: Patients should have had a life expectancy of ≥ 12 weeks and no prior radiotherapy to the pelvis or abdomen.
Croatian: Bolesnice su morale imati očekivan životni vijek od ≥ 12 tjedana i prethodno nisu smjele biti liječene radioterapijom zdjelice ili abdomena.
English: Systemic effects following intravitreal use
Croatian: Sistemski učinci nakon intravitrealne primjene
English: After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Croatian: Nakon prekida liječenja bevacizumabom, funkcija jajnika se oporavila u 86,2% tih žena koje je bilo moguće ocijeniti.
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Croatian: Farmakokinetika bevacizumaba bila je linearna pri dozama od 1 do 10 mg/kg.
English: ● It is possible that Avastin can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Croatian: Avastin može prouzročiti reakcije preosjetljivosti i/ili infuzijske reakcije (reakcije povezane s injiciranjem lijeka).
English: After correcting for body weight, male patients had a larger Vc (+ 20%) than female patients.
Croatian: Uz korekciju s obzirom na tjelesnu težinu, muškarci su imali veći Vc (+20%) od žena.
English: Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
Croatian: Liječnik bi Vas trebao savjetovati o uporabi kontracepcije tijekom liječenja lijekom Avastin i najmanje 6 mjeseci nakon posljednje doze lijeka Avastin.
English: • shortness of breath or low levels of oxygen in the blood,
Croatian: ● nedostatak zraka ili nisku razinu kisika u krvi,
English: Time from last platinum therapy to recurrence
Croatian: Vrijeme od posljednje terapije platinom do recidiva
English: Any unused medicinal product or waste material should be disposed in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: a Interferon alfa-2a 9 MIU 3x/week b
Croatian: Interferon alfa-2a 9 milijuna IU 3 puta tjedno b
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (<65 years).
Croatian: U jednom je kliničkom ispitivanju incidencija hipertenzije stupnja ≥ 3 bila dvostruko veća u bolesnika starijih od 65 godina nego u mlađoj dobnoj skupini (< 65 godina).
English: Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
Croatian: Liječenje se ne smije započinjati barem 28 dana nakon veće operacije ili dok rana od operacije ne zacijeli u potpunosti.
English: Further details of each study and the results are provided below.
Croatian: Dodatne pojedinosti i rezultati svakoga od ispitivanja navedeni su u nastavku.
English: Overall Survival 3
Croatian: Ukupno preživljenje3
English: Avastin use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Croatian: Djeca i adolescenti Avastin se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina jer sigurnost i korist liječenja nisu ustanovljeni u toj populaciji bolesnika.
English: Please talk to your doctor since blood clots can lead to heart attack and stroke.
Croatian: Porazgovarajte o tome sa svojim liječnikom jer krvni ugrušci mogu izazvati srčani i moždani udar.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Croatian: PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Randomised patients with stage IV disease
Croatian: Randomizirane bolesnice sa stadijem IV bolesti
English: It rarely resulted in discontinuation of Avastin treatment or hospitalisation.
Croatian: Rijetko je došlo do prekida liječenja lijekom Avastin ili hospitalizacije.
English: If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
Croatian: Ako imate glavobolju, promjene vida, smeteni ste ili imate konvulzije sa ili bez povišenog krvnog tlaka, molimo obratite se svom liječniku.
English: Effects on wound healing were shown to be fully reversible.
Croatian: Učinci na zacjeljivanje rana bili su u potpunosti reverzibilni.
English: No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Croatian: Nisu opažene nekompatibilnosti između lijeka Avastin i polivinilkloridnih ili poliolefinskih vrećica ili kompleta za infuziju.
English: The signs may include: difficulty in breathing or chest pain.
Croatian: Znakovi mogu obuhvaćati otežano disanje ili bol u prsima.
English: Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see section 5.3).
Croatian: Ispitivanja toksičnosti ponovljenih doza provedena na životinjama pokazala su da bevacizumab može imati štetan učinak na žensku plodnost (vidjeti dio 5.3).
English: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
Croatian: (Voir/siehe Belgique/Belgien)
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: 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: You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Avastin i još najmanje 6 mjeseci nakon posljednje doze lijeka Avastin jer ovaj lijek može utjecati na rast i razvoj djeteta.
English: Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Croatian: Nisu provedena istraživanja koja bi ocijenila mutageni i kancerogeni potencijal bevacizumaba.
English: The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.
Croatian: Nisu ustanovljene sigurnost i djelotvornost istodobne primjene radioterapije i lijeka Avastin.
English: No AEs leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Croatian: Niti u jednoj skupini nisu nastupili štetni događaji koji bi doveli do smrti; svi smrtni ishodi pripisani su progresiji bolesti.
English: Please let your doctor, pharmacist or nurse know if you have previously experienced problems after injections, such as dizziness/feeling of fainting, breathlessness, swelling or skin rash.
Croatian: Molimo obavijestite liječnika, ljekarnika ili medicinsku sestru ako ste ranije imali tegobe nakon primanja injekcije, poput omaglice/osjećaja nesvjestice, nedostatka zraka, oticanja ili osipa kože.
English: The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Croatian: Dostupni su farmakokinetički podaci o bevacizumabu iz deset kliničkih ispitivanja u bolesnika sa solidnim tumorima.
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Croatian: *Bevacizumab je rekombinantno humanizirano monoklonsko protutijelo proizvedeno DNK tehnologijom u stanicama jajnika kineskog hrčka.
English: Please discuss with your doctor if you noticed this previously.
Croatian: Molimo porazgovarajte sa svojim liječnikom ako ste već primijetili te simptome.
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Croatian: Karakteristična vrijednost za volumen središnjeg odjeljka (Vc) bila je 2,73 l za žene i 3,28 l za muškarce, što je u rasponu opisanom za IgG i druga monoklonska protutijela.
English: Avastin is not approved for use in patients under the age of 18 years.
Croatian: Avastin nije odobren za primjenu u bolesnika mlađih od 18 godina.
English: The first infusion will be given to you over 90 minutes.
Croatian: Prvu ćete infuziju primati tijekom 90 minuta.
English: ● This medicine may cause bleeding, especially tumour-related bleeding.
Croatian: Ovaj lijek može izazvati krvarenje, naročito ono povezano s tumorom.
English: * if specified, the frequency has been derived from clinical trial data
Croatian: * ako je učestalost navedena, preuzeta je iz podataka prikupljenih tijekom kliničkih ispitivanja
English: The addition of Avastin to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Croatian: Dodatak lijeka Avastin protokolu FOLFOX-4 rezultirao je statistički značajnim produljenjem preživljenja.
English: Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility.
Croatian: U žena u predmenopauzi (žena koje imaju menstrualni ciklus) mjesečnica može postati neredovita ili čak izostati te se može smanjiti njihova plodnost.
English: The incidence of these reactions in some clinical trials of Avastin is common (up to 5% in bevacizumabtreated patients).
Croatian: Incidencija ovih reakcija je u pojedinim kliničkim ispitivanjima lijeka Avastin bila česta (do 5% u bolesnika liječenih bevacizumabom).
English: Please consult your doctor for more information.
Croatian: Za više informacija molimo obratite se svom liječniku.
English: There is no information on the effect of Avastin in patients with uncontrolled hypertension at the time of initiating therapy.
Croatian: Nema informacija o učinku lijeka Avastin na bolesnike s nekontroliranom hipertenzijom u vrijeme početka liječenja.
English: There are no clinical trial data on the use of Avastin in pregnant women.
Croatian: Nema podataka iz kliničkih ispitivanja o primjeni lijeka Avastin u trudnica.
English: In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
Croatian: U većini slučajeva hipertenzija je bila dobro kontrolirana standardnom antihipertenzivnom terapijom, sukladnom potrebama pojedinog bolesnika.
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: The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Croatian: Farmakokinetika u posebnim populacijama U odraslih i pedijatrijskih bolesnika analizirana je populacijska farmakokinetika kako bi se procijenili učinci demografskih karakteristika.
English: In the majority of the occasions the necessary amount of Avastin 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 Avastin se može razrijediti s 0,9% otopinom natrijevog klorida za injekciju do ukupnog volumena od 100 ml.
English: Avastin is for single-use only, as the product contains no preservatives.
Croatian: Avastin je namijenjen samo za jednokratnu primjenu jer ne sadrži konzervanse.
English: Patients were nephrectomised for primary renal cell carcinoma.
Croatian: Bolesnicima je prethodno učinjena nefrektomija zbog primarnog karcinoma bubrežnih stanica.
English: Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Croatian: Nadalje, 65% bolesnika je primilo adjuvantnu kemoterapiju, od toga u 19% slučajeva taksane, a u 49% antracikline.
English: Patients were stratified according to country and Motzer score and the treatment arms were shown to be well balanced for the prognostic factors.
Croatian: Bolesnici su bili stratificirani po zemljama i rezultatu po Motzeru, a terapijske skupine su bile dobro uravnotežene u pogledu prognostičkih faktora.
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: Other medicines and Avastin
Croatian: Drugi lijekovi i Avastin
English: Objective Response Rate (ORR) Patients included in analysis Rate
Croatian: Stopa objektivnog odgovora (ORR) Bolesnici obuhvaćeni analizom
English: Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Croatian: Tablica 7 Ključni rezultati djelotvornosti za analizu superiornosti (ITT populacija, ispitivanje NO16966)
English: Adverse foetal outcomes were observed at all tested doses, of which the lowest dose resulted in average serum concentrations approximately 3 times larger than in humans receiving 5 mg/kg every 2 weeks.
Croatian: Štetni ishodi za fetus opaženi su pri svim ispitivanim dozama, pri čemu je najniža doza rezultirala prosječnim koncentracijama u serumu otprilike 3 puta većima od onih u ljudi koji su primali 5 mg/kg svaka 2 tjedna.
English: United Kingdom Roche Products Ltd.
Croatian: Roche Products Ltd.
English: In Part II, treatment assignment was double-blind with respect to Avastin.
Croatian: U dijelu II je randomizacija bolesnika bila dvostruko slijepa s obzirom na Avastin.
English: Avastin will be administered in combination with erlotinib.
Croatian: Avastin će se primjenjivati u kombinaciji s erlotinibom.
English: The only variables that showed statistically significant correlations with bleeding were Avastin therapy and squamous cell histology.
Croatian: Jedine varijable koje su pokazale statistički značajne korelacije s krvarenjem jesu terapija lijekom Avastin i histologija skvamoznih stanica.
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: • 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: Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
Croatian: Ne mogu se donijeti zaključci o utjecaju bevacizumaba na farmakokinetiku gemcitabina.
English: The median age of patients was 61.0 (range: 25−84) years.
Croatian: Medijan dobi bolesnica bio je 61,0 godinu (raspon 25-84 godine).
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting 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: • increase in heart rate (pulse),
Croatian: ● ubrzane otkucaje srca (puls),