FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse reactions listed in this section fall into the following frequency categories: Very common (≥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 svrstavaju se 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: * primary analysis
Croatian: * primarna analiza
English: ● you may develop a severe migraine.
Croatian: ● možete dobiti jaku migrenu.
English: What Zirabev is and what it is used for
Croatian: Što je Zirabev i za što se koristi
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 nije ustanovljena.
English: If you have high blood pressure which is not well controlled with blood pressure medicines, please consult your doctor as it is important to make sure that your blood pressure is under control before starting Zirabev treatment.
Croatian: Ako imate visok krvni tlak koji nije dobro reguliran lijekovima, posavjetujte se sa svojim liječnikom jer je važno osigurati da Vam je krvni tlak reguliran prije početka liječenja lijekom Zirabev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 February 2019
Croatian: Datum prvog odobrenja: 14. veljače 2019
English: Zirabev 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: Zirabev 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: Therefore, caution should be exercised before initiating therapy in these patients.
Croatian: Stoga je potreban oprez prije započinjanja liječenja tih bolesnika.
English: Best overall response - Primary analysis
Croatian: Najbolji ukupni odgovor - Primarna analiza
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: Pojmovi označavaju skup događaja koji opisuju određeni medicinski koncept, a ne pojedinačno stanje ili preferirani pojam prema Medicinskom rječniku za regulatorne poslove (MedDRA).
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, osim ako je razrjeđivanje provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: This does not necessarily mean that these side effects were strictly caused by bevacizumab.
Croatian: To ne mora značiti da su te nuspojave uzrokovane isključivo bevacizumabom.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: According to the two-compartmental model, the elimination half-life is 18 days for a typical female patient and 20 days for a typical male patient.
Croatian: Prema modelu s dva odjeljka, poluvrijeme eliminacije u tipičnog bolesnika ženskog spola iznosi 18 dana, a u tipičnog bolesnika muškog spola 20 dana.
English: The dose of Zirabev needed depends on your body weight and the kind of cancer to be treated.
Croatian: Potrebna doza lijeka Zirabev ovisi o Vašoj tjelesnoj težini i vrsti raka koji se liječi.
English: ● your doctor will decide when you should be given your next dose of Zirabev.
Croatian: Vaš će liječnik odlučiti kada trebate dobiti sljedeću dozu lijeka Zirabev.
English: Other medicines and Zirabev
Croatian: Drugi lijekovi i Zirabev
English: Elderly patients No dose adjustment is required in the elderly.
Croatian: Nije potrebna prilagodba doze u starijih bolesnika.
English: pharmacist or nurse immediately.
Croatian: ljekarniku ili medicinskoj sestri.
English: Zirabev may also cause changes in laboratory tests carried out by your doctor.
Croatian: Zirabev može uzrokovati i promjene u rezultatima laboratorijskih testova na koje Vas šalje liječnik.
English: bevacizumab was combined with two chemotherapy regimens:
Croatian: Bevacizumab je kombiniran s dva režima kemoterapije:
English: There were no complete responses and 2 partial responses (MacDonald criteria).
Croatian: Nije bilo potpunih odgovora na liječenje, a dobivena su 2 djelomična odgovora (kriterij prema MacDonaldu).
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 kliničkim podacima prikupljenim do 31. siječnja 2007. ** primarna analiza prema kliničkim podacima prikupljenim do 31. siječnja 2006. u odnosu na kontrolnu skupinu
English: ● Your doctor should record the brand name and batch number of your medication.
Croatian: Vaš liječnik treba zapisati zaštićeni naziv i broj serije Vašeg lijeka.
English: The addition of bevacizumab to FOLFOX-4 resulted in a statistically significant prolongation of survival.
Croatian: Dodatak bevacizumaba režimu FOLFOX-4 rezultirao je statistički značajnim produljenjem preživljenja.
English: When Zirabev is injected directly into the eye (unapproved use), the following side effects may occur:
Croatian: Kada se lijek Zirabev injicira izravno u oko (neodobrena primjena), mogu se javiti sljedeće nuspojave:
English: Manufacturer Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Ireland
Croatian: Proizvođač Pfizer Ireland Pharmaceuticals, Grange Castle Business Park, Clondalkin, Dublin 22, Irska
English: Observed in pediatric population only
Croatian: Zabilježeno samo u pedijatrijskoj populaciji.
English: The population pharmacokinetics were analysed in adult and pediatric patients to evaluate the effects of demographic characteristics.
Croatian: U odraslih i pedijatrijskih bolesnika analizirana je populacijska farmakokinetika kako bi se procijenili učinci demografskih karakteristika.
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 u dobi od > 65 godina nego u mlađoj dobnoj skupini (< 65 godina).
English: Median overall survival*
Croatian: Medijan ukupnog preživljenja*
English: Median PFS (on treatment)**
Croatian: Medijan PFS-a (tijekom liječenja)**
English: In trial E2100, patients were treated until disease progression.
Croatian: U ispitivanju E2100 bolesnice su liječene do progresije bolesti.
English: Bevacizumab is not approved for use in patients under the age of 18 years.
Croatian: Bevacizumab nije odobren za primjenu u bolesnika mlađih od 18 godina.
English: ● It is possible that Zirabev can cause hypersensitivity and/or infusion reactions (reactions related to your injection of the medicine).
Croatian: Zirabev može prouzročiti reakcije preosjetljivosti i/ili reakcije povezane s infuzijom (reakcije povezane s injiciranjem lijeka).
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: 5.5 - NR 6.1 - NR 3.8 - 7.8 5.59 - 9.17 5.88 - 13.01
Croatian: ND 25. - 75. percentila (mjeseci) 5,5 - ND 6,1 - ND 3,8 - 7,8 5,59 - 9,17 5,88 - 13,01
English: I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Croatian: Ibevacizumaba pokazala je da je njegov metabolički profil sličan onome kakav bi se očekivao od prirodne molekule IgG-a koja ne vezuje VEGF.
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: Two of the eight cases did not have radiological confirmation via MRI.
Croatian: U dva od tih osam slučajeva nije bilo radiološke potvrde oslikavanjem magnetskom rezonancijom.
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 režimom FOLFOX-4 koristile su se iste doze i raspored doziranja kao one prikazanima u tablici 6 za ispitivanje NO16966.
English: Zirabev 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: Zirabev 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: The patient characteristics were similar across the trial arms.
Croatian: Karakteristike bolesnica bile su slične u obje ispitivane skupine.
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 bile su terapija bevacizumabom i histologija skvamoznih stanica.
English: Name and address of the manufacturer of the biological active substance Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
Croatian: Wyeth BioPharma Division of Wyeth Pharmaceuticals, LLC 1 Burtt Road
English: For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Croatian: Za dodatne informacije o statusu receptora humanog epidermalnog čimbenika rasta 2 (engl. human epidermal growth factor receptor 2, HER2), vidjeti dio 5.1.
English: No AEs leading to death occurred in either treatment arm; all deaths were attributed to disease progression.
Croatian: Niti u jednoj liječenoj skupini nisu nastupili štetni događaji koji bi doveli do smrti; svi smrtni ishodi bili su pripisani progresiji bolesti.
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: Opaženi učinci uključivali su smanjenja tjelesne težine majke i fetusa, povećan broj fetalnih resorpcija i veću incidenciju specifičnih značajnih i koštanih deformacija fetusa.
English: ● if you have problems with wound healing following surgery,
Croatian: ● u slučaju da imate problema sa zacjeljivanjem rana nakon operacije,
English: The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Croatian: Sigurnost i djelotvornost istodobne primjene radioterapije i bevacizumaba nije ustanovljena.
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 dojenčeta (vidjeti dio 5.3), žene moraju prestati dojiti za vrijeme liječenja te ne smiju dojiti najmanje šest mjeseci nakon posljednje doze bevacizumaba.
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 značajno (HR = 0,91).
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis 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: Primarna analiza provedena je na temelju podataka prikupljenih do 12. prosinca 2012. i smatra se završnom analizom Analiza nakon praćenja provedena je na temelju podataka prikupljenih do 7. ožujka 2014.; sve pvrijednosti navedene su samo u ilustrativne svrhe
English: Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Croatian: Ključni rezultati djelotvornosti za analizu superiornosti (ITT populacija, ispitivanje NO16966)
English: ● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Zirabev, 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 Zirabev, a naročito ako primate ili ste primali injekcije bisfosfonata u krvnu žilu
English: Your doctor should advise you about using contraception during treatment with Zirabev and for at least 6 months after the last dose of Zirabev.
Croatian: Liječnik bi Vas trebao savjetovati o uporabi kontracepcije tijekom liječenja lijekom Zirabev i najmanje 6 mjeseci nakon posljednje doze lijeka Zirabev.
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 većem kirurškom zahvatu u prethodnih 28 dana nisu bili uključeni u klinička ispitivanja faze III.
English: You will be treated with Zirabev once every 2 or 3 weeks.
Croatian: Lijek Zirabev ćete primati jedanput svaka 2 ili 3 tjedna.
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 ishod bio je prijavljen u približno trećine ozbiljnih slučajeva gastrointestinalnih perforacija, što predstavlja između 0,2 % i 1 % svih bolesnika liječenih bevacizumabom.
English: A total of 452 patients were randomised to receive either:
Croatian: Ukupno su randomizirane 452 bolesnice kako bi primale jedan od sljedećih režima:
English: The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in Table 4.
Croatian: Rezultati djelotvornosti bevacizumaba u kombinaciji s IFL kemoterapijom prikazani su u tablici 4.
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 ml of red blood) should not be treated with Zirabev.
Croatian: Bolesnici koji su nedavno imali plućno krvarenje/hemoptizu (> 2,5 ml svježe krvi) ne smiju se liječiti lijekom Zirabev.
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, s tim da se većina njih pojavila u prvih 6 mjeseci liječenja.
English: Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
Croatian: Ne smije se započinjati s liječenjem najmanje 28 dana nakon veće operacije ili dok rana od operacije u potpunosti ne zacijeli.
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 prethodno primali ili primaju intravenske bisfosfonate po mogućnosti treba izbjegavati invazivne stomatološke zahvate.
English: Common (may affect up to 1 in 10 people) side effects, which were not severe, include: • voice changes and hoarseness.
Croatian: Česte (mogu se javiti u do 1 na 10 osoba) nuspojave koje nisu bile teške uključuju: promjene glasa i promuklost.
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 napadaje sa ili bez povišenog krvnog tlaka, molimo obratite se svom liječniku.
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, zaštićeni naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u bolesnikovom zdravstvenom kartonu.
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: Konačna koncentracija otopine s bevacizumabom treba biti unutar raspona od 1,4 mg/ml do 16,5 mg/ml.
English: If this happens you should talk to your doctor,
Croatian: Ako se to dogodi, morate se odmah obratiti liječniku,
English: Hypertension was generally adequately controlled with oral anti-hypertensives such as angiotensin-converting enzyme inhibitors, diuretics and calcium-channel blockers.
Croatian: Hipertenzija se uglavnom dobro kontrolirala primjenom oralnih antihipertenziva poput inhibitora angiotenzin-konvertirajućeg enzima, diuretika i blokatora kalcijskih kanala.
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: Furthermore, 65% of patients had received adjuvant chemotherapy including 19% prior taxanes and 49% prior anthracyclines.
Croatian: Nadalje, 65% bolesnica je primilo adjuvantnu kemoterapiju, od toga u 19% slučajeva taksane, a u 49% antracikline.
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 injekciju od 9 mg/ml (0,9 %).
English: After correcting for body weight, male patients had a larger Vc (+ 20%) than female patients.
Croatian: Uz korekciju s obzirom na tjelesnu težinu, bolesnici muškog spola su imali veći Vc (+ 20 %) od bolesnika ženskog spola.
English: The results of this trial are presented in Table 10.
Croatian: Rezultati ovog ispitivanja prikazani su u tablici 10.
English: % pts with objective response p-value
Croatian: % bolesnika s objektivnim odgovorom p-vrijednost
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 prema Motzeru, a terapijske skupine su bile dobro uravnotežene u pogledu prognostičkih čimbenika.
English: Table 11 Efficacy results for trial E4599
Croatian: Tablica 11. Rezultati djelotvornosti za ispitivanje E4599
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: Bevacizumab is contraindicated in pregnancy (see section 4.3).
Croatian: Bevacizumab je kontraindiciran u trudnoći (vidjeti dio 4.3).
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 bolesnica u kojih status nije bio poznat (8 %) ili su imale potvrđen HER2-pozitivan status (2 %), te su prethodno ili bile liječene trastuzumabom ili nisu bile smatrane pogodnima za liječenje trastuzumabom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1344/001 100 mg/4 ml vial EU/1/18/1344/002 400 mg/16 ml vial
Croatian: EU/1/18/1344/001 100 mg/4 ml bočica EU/1/18/1344/002 400 mg/16 ml bočica
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 režimima.
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: c Based on a substudy from NSABP C-08 with 295 patients d
Croatian: Na temelju podataka iz podispitivanja u okviru ispitivanja NSABP C-08 s 295 bolesnica.
English: Caution should be exercised when Zirabev and intravenous bisphosphonates are administered simultaneously or sequentially.
Croatian: Potreban je oprez kada se lijek Zirabev i intravenski bisfosfonati primjenjuju istovremeno ili jedan iza drugoga.
English: You must not breast-feed your baby during treatment with Zirabev and for at least 6 months after the last dose of Zirabev, as this medicine may interfere with the growth and development of your baby.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Zirabev i još najmanje 6 mjeseci nakon posljednje doze lijeka Zirabev jer ovaj lijek može utjecati na rast i razvoj djeteta.
English: 19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
Croatian: 19 % bolesnika prethodno je primilo kemoterapiju, a 14 % radioterapiju.
English: ● presence of protein in your urine accompanied by swelling of your body,
Croatian: ● u slučaju pojave proteina u Vašoj mokraći uz oticanje tijela,
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 upravljati vozilima ni strojevima dok simptomi ne prestanu.
English: Before initiating Zirabev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Zirabev potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: A doctor or nurse will give you this diluted Zirabev solution by intravenous infusion (a drip into your vein).
Croatian: Liječnik ili medicinska sestra će Vam tu razrijeđenu otopinu lijeka Zirabev dati infuzijom u venu (kapanjem u venu).