FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may prescribe treatment to help with the symptoms.
Croatian: Liječnik će Vam možda propisati terapiju koja će pomoći ublažiti simptome.
English: In 32 of the 33 pre-specified sub-group analyses for OS, the HR was < 1.0.
Croatian: U 32 od 33 unaprijed određene analize podskupina za OS, HR je iznosio < 1,0.
English: You should not receive Cyramza for at least 4 weeks before you undergo planned surgery and your doctor will decide when to re-start treatment.
Croatian: Ne smijete primati lijek Cyramza najmanje 4 tjedna prije planirane operacije, a liječnik će odlučiti kada ponovno započeti liječenje.
English: The patient should be monitored during infusion for signs of infusion-related reactions (see section 4.4) and the availability of appropriate resuscitation equipment should be ensured.
Croatian: Bolesnika treba nadzirati tijekom infuzije kako bi se uočili mogući znakovi reakcija na infuziju (vidjeti dio 4.4) te treba osigurati dostupnost odgovarajuće opreme za oživljavanje.
English: Administer via infusion pump.
Croatian: Primijenite infuzijskom pumpom.
English: Other medicines and Cyramza
Croatian: Drugi lijekovi i Cyramza
English: Antibodies are principally cleared by catabolism.
Croatian: Protutijela se prvenstveno uklanjaju katabolizmom.
English: The container should be gently inverted to ensure adequate mixing.
Croatian: Spremnik treba nježno okretati kako bi se omogućilo pravilno miješanje.
English: The amount of paclitaxel or docetaxel needed depends on the surface area of your body.
Croatian: Potrebna količina paklitaksela ili docetaksela ovisi o površini Vašeg tijela.
English: The amount of protein in your urine will be checked regularly during treatment.
Croatian: Tijekom liječenja redovito će se provjeravati količina proteina u Vašoj mokraći.
English: It is not known if the medicine passes into breast milk and could affect a breastfed baby.
Croatian: Nije poznato izlučuje li se lijek u majčino mlijeko i može li utjecati na dojenče.
English: REACH-2 efficacy results are shown in Table 12 and Figure 8.
Croatian: Rezultati za djelotvornost iz ispitivanja REACH-2 prikazani su u Tablici 12 i na Slici 8.
English: What Cyramza is and what it is used for
Croatian: Što je Cyramza i za što se koristi
English: *The 28 day time period begins on day 1 of the cycle subsequent to the ADR.
Croatian: *28-dnevno razdoblje počinje 1. dana ciklusa koji slijedi nakon nastupa nuspojave.
English: Also tell your doctor if you are taking any medicines which may increase the risk of bleeding or which affect blood clotting ability.
Croatian: Obavijestite liječnika i ako uzimate bilo koji lijek koji bi mogao povećati rizik od krvarenja ili koji utječe na sposobnost zgrušavanja krvi.
English: Store in a refrigerator (2 ºC - 8 ºC).
Croatian: Čuvati u hladnjaku (2ºC - 8ºC).
English: Randomisation was stratified by weight loss over the prior 3 months (≥ 10% versus < 10%), geographic region, and location of the primary tumour (gastric versus GEJ).
Croatian: Randomizacija je bila stratificirana prema gubitku tjelesne težine tijekom prethodna 3 mjeseca (≥ 10% naspram < 10%), geografskoj regiji i lokaciji primarnog tumora (želudac naspram gastroezofagealnog spoja).
English: Lilly Hungária Kft.
Croatian: Magyarország Lilly Hungária Kft.
English: The majority of patients (76%) had experienced disease progression within 6 months from the start of first-line therapy.
Croatian: U većine je bolesnika (76%) progresija bolesti nastupila unutar 6 mjeseci nakon početka prvolinijske terapije.
English: This one sub-group is a group which can be considered to have aggressive disease that is relatively refractory to first-line treatment.
Croatian: Ta se jedna podskupina može smatrati skupinom s agresivnom bolešću koja je razmjerno refraktorna na prvolinijsko liječenje.
English: Adverse reactions from other sources
Croatian: Nuspojave iz drugih izvora
English: Samples were tested from 956 patients: 527 ramucirumab treated patients and 429 control treated patients.
Croatian: Ispitivani su uzorci prikupljeni od 956 bolesnika: 527 bolesnika liječenih ramucirumabom i 429 bolesnika liječenih kontrolnim lijekom.
English: As Cyramza inhibits the development of new blood vessels, it may decrease the likelihood of you becoming pregnant or maintaining a pregnancy.
Croatian: Budući da Cyramza sprječava nastanak novih krvnih žila, može smanjiti vjerojatnost da ćete zatrudnjeti ili održati trudnoću.
English: Two-thirds of the patients experienced disease progression while still on first-line therapy (66.8%).
Croatian: U dvije trećine bolesnika progresija bolesti nastupila je još tijekom prvolinijskog liječenja (66,8%).
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies ATC code: L01XC21.
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela, ATK oznaka: L01XC21.
English: f Includes one case of nephrotic syndrome
Croatian: f Uključuje jedan slučaj nefrotskog sindroma.
English: Prior to being given any paclitaxel infusion, you will have blood tests to check that your blood counts are high enough and that your liver is functioning well.
Croatian: Prije nego što primite bilo koju infuziju paklitaksela, napravit će se krvne pretrage kako bi se utvrdilo je li broj krvnih stanica dovoljno visok i radi li jetra dobro.
English: Patients who are treated with ramucirumab should have their blood pressure monitored.
Croatian: Bolesnicima koji se liječe ramucirumabom treba nadzirati krvni tlak.
English: If you become pregnant during treatment with Cyramza, your doctor will discuss with you if the benefit of treatment for you is greater than any possible risk to you or your unborn baby.
Croatian: Ako zatrudnite tijekom liječenja lijekom Cyramza, liječnik će razgovarati s Vama o tome nadmašuju li korisni učinci liječenja za Vas sve moguće rizike za Vas ili Vaše nerođeno dijete.
English: Excretion in milk and oral absorption is expected to be low.
Croatian: Očekuje se da će stupanj izlučivanja u majčino mlijeko i stupanj oralne apsorpcije biti nizak.
English: Demographic and baseline characteristics for the ITT population were similar between treatment arms.
Croatian: Demografske i početne značajke ITT populacije bile su slične u obje liječene skupine.
English: Stratified log-rank p-value
Croatian: Stratificirana log-rang p-vrijednost
English: This receptor is needed in the development of new blood vessels.
Croatian: Taj je receptor neophodan za stvaranje novih krvnih žila.
English: Cyramza should only be used if the potential benefit to the mother justifies the potential risk during pregnancy.
Croatian: Cyramza se smije primjenjivati samo ako mogući korisni učinci liječenja za majku opravdavaju mogući rizik tijekom trudnoće.
English: Prepare the infusion solution using aseptic technique to ensure the sterility of the prepared solution.
Croatian: Pripremite otopinu za infuziju primjenom aseptičke tehnike kako biste osigurali sterilnost pripremljene otopine.
English: Before initiating Cyramza, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Cyramza potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Nemojte tresti.
English: Elderly patients with NSCLC
Croatian: Stariji bolesnici s NSCLC-om
English: Cyramza may cause changes in laboratory tests.
Croatian: Cyramza može uzrokovati promjene u nalazima laboratorijskih pretraga.
English: - are going to have planned surgery, if you had recent surgery or if you have poor wound healing after surgery.
Croatian: - idete na ranije dogovorenu operaciju, ako ste nedavno imali operaciju ili ako Vam rana nakon kirurškog zahvata teško cijeli.
English: Terminology Criteria for Adverse Events [NCI
Croatian: National Cancer Institute Common Terminology Criteria for Adverse Events, NCI CTCAE])
English: To grow, cancer needs new blood vessels to develop.
Croatian: Da bi rak rastao, moraju se stvarati nove krvne žile.
English: It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Croatian: Primjenjuje se zajedno s drugim lijekovima koji se nazivaju „kemoterapijom FOLFIRI“, a uključuju „5-fluorouracil“, „folatnu kiselinu“ i „irinotekan“.
English: Ramucirumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Croatian: Ramucirumab je humano IgG1 monoklonsko protutijelo proizvedeno u mišjim (NS0) stanicama tehnologijom rekombinantne DNK.
English: Improvements in OS and PFS were consistently observed in pre-specified subgroups based on age, sex, race and in most other pre-specified subgroups.
Croatian: PFS-a dosljedno su opažena u podskupinama koje su bile unaprijed određene na temelju dobi, spola i rase, kao i u većini drugih unaprijed određenih podskupina.
English: It is recommended that treatment be continued until disease progression or until unacceptable toxicity has occurred.
Croatian: Trajanje liječenja Preporučuje se nastaviti liječenje do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: The correct amount of Cyramza needed to treat your disease will be calculated by your doctor or hospital pharmacist depending on your body weight.
Croatian: Točnu količinu lijeka Cyramza potrebnu za liječenje bolesti izračunat će liječnik ili bolnički ljekarnik na temelju
English: Cyramza has been administered in a Phase 1 study up to 10 mg/kg every two weeks without reaching a maximum tolerated dose.
Croatian: Cyramza se primjenjivala u ispitivanju faze 1 u dozi do 10 mg/kg svaka dva tjedna, a da nije dosegnuta maksimalna podnošljiva doza.
English: Vascular Endothelial Growth Factor (VEGF) Receptor 2 is the key mediator of VEGF induced angiogenesis.
Croatian: Receptor 2 vaskularnog endotelnog faktora rasta (engl. vascular endothelial growth factor, VEGF) je ključni posrednik u angiogenezi koju inducira VEGF.
English: Your doctor will discuss with you if the potential benefits of treatment are judged to outweigh the potential risks for you.
Croatian: Liječnik će razgovarati s Vama o tome smatra li da mogući korisni učinci liječenja nadmašuju moguće rizike.
English: - if there is X-ray evidence that the lung cancer has a cavity or hole in it or if the lung cancer is close to major blood vessels.
Croatian: - ako rendgenska snimka pokazuje da rak pluća u sebi ima šupljinu ili rupu ili da se nalazi blizu velikih krvnih žila
English: Cyramza is a concentrate for solution for infusion (also called “sterile concentrate”).
Croatian: Cyramza je koncentrat za otopinu za infuziju (naziva se i 'sterilnim koncentratom').
English: As angiogenesis is critical to maintenance of pregnancy and to foetal development, the inhibition of angiogenesis following ramucirumab administration may result in adverse effects on pregnancy, including the foetus.
Croatian: Budući da je angiogeneza ključna za održanje trudnoće i razvoj ploda, inhibicija angiogeneze nakon primjene ramucirumaba može dovesti do štetnih učinaka na trudnoću, uključujući plod.
English: If you experience any symptoms affecting your ability to concentrate and react, do not drive or use machines until the effect goes away.
Croatian: Ako primijetite bilo koji simptom koji utječe na Vašu sposobnost koncentracije i reagiranja, nemojte upravljati vozilima niti raditi sa strojevima sve dok se taj učinak ne povuče.
English: d Includes: blood pressure increased and hypertension.
Croatian: d Uključuje: povišen krvni tlak i hipertenziju.
English: Ramucirumab therapy must be initiated and supervised by physicians experienced in oncology.
Croatian: Liječenje ramucirumabom moraju započeti i nadzirati liječnici s iskustvom na području onkologije.
English: Depending on the protein level measured, Cyramza may be temporarily discontinued.
Croatian: Ovisno o izmjerenoj razini proteina, liječenje lijekom Cyramza možda će se privremeno prekinuti.
English: Time and dose dependency
Croatian: Ovisnost o vremenu i dozi
English: Tell your doctor immediately if you experience any of the following serious side effects that have been observed during Cyramza treatment (see also What you need to know before you are given
Croatian: Odmah obavijestite svog liječnika ako se pojavi bilo koja od sljedećih ozbiljnih nuspojava koje su primijećene tijekom liječenja lijekom Cyramza (pogledajte i dio „Što morate znati prije nego počnete primati lijek Cyramza“):
English: It should not be administered as an intravenous bolus or push.
Croatian: Ne smije se primijeniti kao intravenski bolus ili brza injekcija.
English: It is recommended to reduce the docetaxel dose by 10 mg/m2 for all following cycles.
Croatian: Preporučuje se smanjiti dozu docetaksela za 10 mg/m2 u svim sljedećim ciklusima.
English: 1,200 mg/m2 over 46-48 hours a 5-FU = 5-fluorouracil.
Croatian: 1200 mg/m2 tijekom 46 - 48 sati a 5-FU = 5-fluorouracil.
English: Eligible patients were Child Pugh A (score < 7), had creatinine clearance ≥ 60 ml/min, and ECOG PS of 0 or 1.
Croatian: Bolesnici pogodni za sudjelovanje u ispitivanju imali su Child Pugh stadij A (rezultat < 7), klirens kreatinina ≥ 60 ml/min i funkcionalni ECOG status 0 ili 1.
English: Exposure-response analyses indicated that efficacy was correlated with ramucirumab exposure across pivotal studies.
Croatian: Analize odgovora u odnosu na izloženost pokazale su da je djelotvornost bila u korelaciji s izloženošću ramucirumabu u svim pivotalnim ispitivanjima.
English: If you experience an infusion-related reaction during treatment, the time taken to give your infusion will be increased for the rest of that infusion and for all future infusions.
Croatian: Ako se tijekom liječenja razvije reakcija na infuziju, vrijeme primjene infuzije će se produljiti i za ostatak te infuzije kao i za sve sljedeće infuzije.
English: Progression free survival, months
Croatian: Preživljenje bez progresije bolesti, mjeseci
English: The primary endpoint was OS and secondary endpoints included PFS.
Croatian: Primarna mjera ishoda bio je OS, a sekundarne mjere ishoda uključivale su PFS.
English: Patients were required to have adequate hepatic, renal and coagulation function.
Croatian: Bolesnici su morali imati odgovarajuću jetrenu, bubrežnu i koagulacijsku funkciju.
English: Dose modification at day 1 of cycle subsequent to ADR
Croatian: Prilagodba doze 1. dana ciklusa nakon nastupa nuspojave
English: Women of childbearing potential should use effective contraception during and up to 3 months after the last dose of ramucirumab treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do 3 mjeseca nakon posljednje doze ramucirumaba.
English: - have severe liver disease (‘cirrhosis') and associated conditions, such as excessive accumulation of fluid in your abdomen (‘ascites').
Croatian: - imate tešku bolest jetre („cirozu“) i s njome povezane poremećaje, poput prekomjernog nakupljanja tekućine u trbuhu („ascites“).
English: In severe cases symptoms included bronchospasm, supraventricular tachycardia, and hypotension.
Croatian: U teškim su slučajevima simptomi uključivali bronhospazam, supraventrikularnu tahikardiju i hipotenziju.
English: This medicine is given by infusion via a drip over a period of approximately 60 minutes.
Croatian: Ovaj se lijek daje infuzijom (ukapavanjem) tijekom razdoblja od približno 60 minuta.
English: The median relative dose intensity of Cyramza was 98.6% and of placebo was 99.6%.
Croatian: Medijan relativnog intenziteta doze lijeka Cyramza iznosio je 98,6%, a placeba 99,6%.
English: Prior to chemotherapy, patients should have a complete blood count.
Croatian: Prije kemoterapije bolesnicima je potrebno odrediti kompletnu krvnu sliku.
English: All medicinal products were administered intravenously.
Croatian: Svi su se lijekovi primjenjivali intravenski.
English: - Infusion-related reaction: Infusion-related reactions may happen during treatment because Cyramza is given as an intravenous infusion via a drip (see section 3).
Croatian: - reakcija na infuziju: Tijekom liječenja mogu nastupiti reakcije na infuziju jer se Cyramza daje infuzijom (ukapavanjem) u venu (pogledajte dio 3.).
English: EU/1/14/957/002 - 2 vials of 10 ml.
Croatian: EU/1/14/957/002 - 2 bočice od 10 ml
English: Randomisation was stratified by geographic region, time to progression from the start of first-line therapy (<6 months versus ≥6 months) and disease measurability.
Croatian: Randomizacija je bila stratificirana prema geografskoj regiji, vremenu od početka prvolinijske terapije do progresije bolesti (< 6 mjeseci naspram ≥ 6 mjeseci) i mjerljivosti bolesti.
English: Calculate the dose and volume of ramucirumab needed to prepare the infusion solution.
Croatian: Izračunajte dozu i volumen ramucirumaba potreban za pripremu otopine za infuziju.
English: These and other factors investigated had < 20 % effect on ramucirumab disposition.
Croatian: Učinak tih i drugih ispitivanih faktora na raspoloživost ramucirumaba bio je < 20%.
English: Once the urine protein level has decreased to a certain level, treatment may be restarted with a lower dose.
Croatian: Nakon što se vrijednost proteina u mokraći spusti na određenu razinu, liječenje se može ponovno započeti nižom dozom.
English: Blood counts and coagulation parameters should be monitored in patients with conditions predisposing to bleeding, and in those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding.
Croatian: Potrebno je pratiti krvnu sliku i koagulacijske parametre u bolesnika sa stanjima koja su predispozicija za krvarenje te u onih koji se liječe antikoagulansima ili drugim istodobno primjenjivanim lijekovima koji povećavaju rizik od krvarenja.
English: Objective Response Rate (CR + PR)
Croatian: Stopa objektivnog odgovora (CR + PR)
English: There was no clear deviation from dose proportionality in pharmacokinetics of ramucirumab from 6 mg/kg to 20 mg/kg.
Croatian: Nisu primijećena vidljiva odstupanja od proporcionalnosti dozi u farmakokinetici ramucirumaba u rasponu doza od 6 mg/kg do 20 mg/kg.
English: Patients who discontinued one or more components of treatment because of an adverse event were permitted to continue therapy with the other treatment component(s) until disease progression or unacceptable toxicity.
Croatian: Bolesnicima koji su zbog nuspojave prestali primjenjivati jednu ili više sastavnica terapije bio je dopušten nastavak liječenja preostalim sastavnicama do progresije bolesti ili pojave neprihvatljive toksičnosti.
English: The decision to resume ramucirumab following surgical intervention should be based on clinical judgment of adequate wound healing.
Croatian: Odluku o nastavku liječenja ramucirumabom nakon kirurške intervencije treba temeljiti na kliničkoj procjeni uspješnosti cijeljenja rane.
English: Includes: leukopenia and white blood cell count decreased.
Croatian: Uključuje: leukopeniju i smanjen broj bijelih krvnih stanica.
English: Reproductive toxicity studies with ramucirumab have not been performed, however, animal models link angiogenesis, VEGF and VEGF Receptor 2 to critical aspects of female reproduction, embryo-foetal development, and postnatal development.
Croatian: Iako nisu provedena ispitivanja reproduktivne toksičnosti ramucirumaba, životinjski modeli povezuju angiogenezu, VEGF i VEGF receptor 2 s ključnim aspektima reprodukcije ženki, embriofetalnim razvojem i postnatalnim razvojem.
English: Criteria to be met prior to each paclitaxel infusion are provided in Table 1.
Croatian: Kriteriji koji moraju biti zadovoljeni prije svake infuzije paklitaksela navedeni su u Tablici 1.
English: If you have liver cancer your doctor will monitor you for signs and symptoms of confusion and/or disorientation associated with chronic liver problems and will stop treatment with Cyramza if you develop these signs and symptoms.
Croatian: Ako imate rak jetre, liječnik će Vas nadzirati zbog moguće pojave znakova i simptoma smetenosti i/ili dezorijentiranosti koji su povezani s kroničnim jetrenim tegobama te će u slučaju razvoja tih znakova i simptoma prekinuti liječenje lijekom Cyramza.
English: - Severe bleeding: Cyramza may increase the risk of severe bleeding.
Croatian: - teško krvarenje: Cyramza može povećati rizik od teškog krvarenja.
English: Based on PopPK, there was no difference in ramucirumab exposure in patients ≥65 years of age compared to patients <65 years old.
Croatian: Na temelju populacijske farmakokinetike, nije postojala razlika u izloženosti ramucirumabu između bolesnika u dobi od ≥ 65 godina i onih u dobi od < 65 godina.
English: Body weight is considered a significant co-variate of ramucirumab pharmacokinetics supporting the dosing based on body weight.
Croatian: Tjelesna težina smatra se značajnom kovarijatom za farmakokinetiku ramucirumaba, što podupire doziranje na temelju tjelesne težine.
English: Patients should be monitored during the infusion for signs of hypersensitivity.
Croatian: Bolesnike treba nadzirati tijekom infuzije kako bi se uočili mogući znakovi preosjetljivosti.
English: Cyramza can increase the incidence of high blood pressure.
Croatian: Cyramza može povećati učestalost visokog krvnog tlaka.
English: From the side effects listed above, these are: low white blood cell counts; low platelet count in the blood; low blood levels of albumin, potassium or sodium; presence of protein in the urine.
Croatian: Među gore navedenim nuspojavama, te promjene uključuju: nizak broj bijelih krvnih stanica; nizak broj krvnih pločica; niske razine albumina, kalija ili natrija u krvi; prisutnost proteina u mokraći.
English: Chemical and physical in-use stability of Cyramza in sodium chloride 9 mg/ml (0.9%) solution for injection has been demonstrated for 24 hours at 2 ºC to 8 ºC or for 4 hours at 25 ºC.
Croatian: Kemijska i fizikalna stabilnost lijeka Cyramza u otopini natrijeva klorida za injekcije od 9 mg/ml (0,9%) dokazana je tijekom 24 sata na temperaturi od 2ºC do 8ºC ili tijekom 4 sata na temperaturi od 25ºC.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Symptoms of a stroke may include sudden numbness or weakness of the arm, leg and face, feeling confused, difficulty speaking or understanding others, sudden difficulty in walking or loss of balance or coordination or sudden dizziness.
Croatian: Simptomi moždanog udara mogu uključivati iznenadnu utrnulost ili slabost ruke, noge i lica, smetenost, otežan govor ili otežano razumijevanje drugih osoba, iznenadne poteškoće s hodanjem ili gubitak ravnoteže ili koordinacije ili iznenadnu omaglicu.
English: For NCI CTCAE Grade 4 haematological toxicity or Grade 3 paclitaxel-related non-haematological toxicity, it is recommended to reduce the paclitaxel dose by 10 mg/m2 for all following cycles.
Croatian: slučaju hematološke toksičnosti 4. stupnja prema NCI CTCAE kriterijima ili nehematološke toksičnosti 3. stupnja povezane s paklitakselom, preporučuje se smanjiti dozu paklitaksela za 10 mg/m2 u svim sljedećim ciklusima.
English: The most serious adverse reactions associated with ramucirumab treatment (as a single agent or in combination with cytotoxic chemotherapy) were:
Croatian: Najozbiljnije nuspojave povezane s liječenjem ramucirumabom (u monoterapiji ili u kombinaciji s citotoksičnom kemoterapijom) bile su:
English: If patients experience symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Croatian: Ako bolesnici primijete simptome koji utječu na njihovu sposobnost koncentracije i reagiranja, preporučuje se da ne upravljaju vozilima i ne rade sa strojevima sve dok se ti učinci ne povuku.
English: By attaching to ‘VEGF receptor 2' and blocking it the medicine cuts off the blood supply to the cancer cells.
Croatian: Ovaj lijek se vezuje za „VEGF receptor 2“ i blokira ga te tako prekida dotok krvi u stanice raka.