FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may temporarily stop your treatment.
Croatian: Vaš liječnik može privremeno prekinuti Vaše liječenje.
English: - if you get chest pain or have any heart problems.
Croatian: ako imate bol u prsima ili bilo kakve probleme sa srcem.
English: A risk to the breast-fed child cannot be excluded.
Croatian: Rizik za dojeno dijete ne može se isključiti.
English: Pharmacokinetic interactions of other antibiotics have not been studied.
Croatian: Farmakokinetičke interakcije drugih antibiotika nisu ispitivane.
English: If you take more Stivarga than you should
Croatian: Ako uzmete više lijeka Stivarga nego što ste trebali
English: Observed elevations of ALT and/or AST Occurrence
Croatian: Opaženo povišenje ALT i/ili AST
English: A pre-planned interim analysis for efficacy was performed when 432 deaths had occurred.
Croatian: Unaprijed planirana međuanaliza djelotvornosti provedena je nakon 432 smrtna slučaja.
English: Once the bottle is opened the medicinal product has shown to be stable for 7 weeks.
Croatian: Nakon što se bočica otvori, pokazalo se da je lijek stabilan kroz 7 tjedana.
English: Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Croatian: Nemojte voziti niti upravljati alatima ili strojevima ako osjetite simptome povezane s liječenjem koji utječu na Vašu sposobnost koncentracije i reagiranja.
English: • Radiotherapy prior to regorafenib treatment: 15%
Croatian: • Radioterapija prije liječenja regorafenibom: 15%
English: Stivarga 40 mg tablets are available in packs containing one bottle or three bottles.
Croatian: Stivarga 40 mg tablete dostupne su u pakiranjima koja sadrže jednu bočicu ili 3 bočice.
English: EU/1/13/858/001 EU/1/13/858/002
Croatian: EU/1/13/858/002
English: This is equivalent to 3% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 3% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Stivarga may reduce fertility in both men and women.
Croatian: Stivarga može smanjiti plodnost i u muškaraca i u žena.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Take Stivarga at the same time each day after a light (low-fat) meal.
Croatian: Uzmite lijek Stivarga svakog dana u isto vrijeme nakon laganog (s niskim udjelom masti) obroka.
English: What Stivarga looks like and contents of the pack
Croatian: Kako Stivarga izgleda i sadržaj pakiranja
English: Most patients (52%) received 3 or fewer previous lines of treatment for metastatic disease.
Croatian: Većina je bolesnika (52%) prethodno primila 3 ili manje linija liječenja metastatske bolesti.
English: <0.000001 1.9 months
Croatian: <0,000001 1,9 mjeseci
English: Frequency groups are defined by the following convention: 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) and not known (cannot be estimated from the available data).
Croatian: Skupine prema učestalosti definirane su na sljedeći način: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Thereafter, periodic monitoring should be continued at least monthly and as clinically indicated.
Croatian: Nakon toga, potrebno je nastaviti s povremenim praćenjem najmanje jedanput mjesečno i kad je to klinički indicirano.
English: Patients with performance status (PS) 2 or higher were excluded from clinical studies.
Croatian: Bolesnici s funkcionalnim stanjem (PS) 2 ili višim bili su isključeni iz kliničkih ispitivanja.
English: • Loco-regional transarterial embolisation or chemoinfusion procedures: 61%
Croatian: • Loko-regionalna transarterijska kemoembolizacija ili kemoinfuzijske procedure: 61%
English: You may need treatment for them and extra tests may be done (see also section 4 ‘Possible side effects').
Croatian: Možda ćete ih trebati liječiti ili napraviti dodatne pretrage (pogledajte također dio 4 „Moguće nuspojave“).
English: However, physiology-based pharmacokinetic modelling does not predict any relevant change in exposure in these patients.
Croatian: No, farmakokinetički modeli koji se temelje na fiziologiji ne predviđaju nikakve relevantne promjene u izloženosti tih bolesnika.
English: You should not take Stivarga together with grapefruit juice (see also section ‘Taking Stivarga with food and drink').
Croatian: Ne smijete uzimati lijek Stivarga zajedno sa sokom od grejpa (pogledajte također dio „Stivarga s hranom i pićem“).
English: The median secondary PFS (as measured by the investigator's assessment) were 5.0 and 4.5 months, respectively.
Croatian: Medijan sekundarnog PFS (mjerenog prema procjeni ispitivača) iznosio je 5,0 odnosno 4,5 mjeseci.
English: • Barcelona Clinic Liver Cancer (BCLC) stage B: 13%; BCLC stage C: 87%
Croatian: Barcelona Clinic Liver Cancer, BCLC) faza B: 13%; BCLC faza C: 87%
English: These may be signs of an infection.
Croatian: To mogu biti znakovi infekcije.
English: Stivarga should not be used during pregnancy unless clearly necessary and after careful consideration of the benefits for the mother and the risk to the foetus.
Croatian: Stivarga se ne smije primjenjivati tijekom trudnoće, osim kad je to jasno potrebno i nakon pažljivog razmatranja koristi za majku i rizika za fetus.
English: You may require medical attention and your doctor may tell you to stop taking Stivarga.
Croatian: Možda će Vam trebati medicinski nadzor, a liječnik Vam može reći da prestanete uzimati lijek Stivarga.
English: Other medicines and Stivarga
Croatian: Drugi lijekovi i Stivarga
English: Regorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Croatian: Regorafenib se uglavnom eliminira putem jetre, a izloženost se može povećati u ovoj populaciji bolesnika.
English: Your doctor will usually ask you to take Stivarga for 3 weeks and then to stop for 1 week.
Croatian: Liječnik će Vam obično savjetovati da uzimate lijek Stivarga tijekom tri tjedna te da ga potom ne uzimate 1 tjedan.
English: Randomisation was performed within 10 weeks after the last treatment with sorafenib.
Croatian: Randomizacija je provedena unutar 10 tjedana nakon zadnjeg liječenja sorafenibom.
English: P-value (one-sided)
Croatian: P-vrijednost (jednostrana)
English: All Grades*
Croatian: Svi stupnjevi*
English: The mean elimination half-life for the metabolite M-5 is approximately 60 hours (range from 40 to 100 hours).
Croatian: Srednja vrijednost poluvremena eliminacije metabolita M-5 iznosi približno 60 sati (raspon od 40 do 100 sati).
English: It is recommended to monitor blood pressure and to treat hypertension in accordance with standard medical practice.
Croatian: Preporučuje se pratiti krvni tlak i liječiti hipertenziju u skladu sa standardnom medicinskom praksom.
English: The study was un-blinded after this planned interim analysis of OS had crossed the pre-specified efficacy boundary.
Croatian: Ispitivanje više nije bilo slijepo nakon što je ova planirana međuanaliza ukupnog preživljenja prešla unaprijed određenu granicu djelotvornosti.
English: • Absence of both macroscopic vascular invasion and extra-hepatic tumour spread: 19%
Croatian: • Izostanak i makroskopske žilne invazije i ekstrahepatičkog tumorskog širenja: 19%
English: Grade a
Croatian: Stupanj a
English: In vitro protein binding of regorafenib to human plasma proteins is high (99.5%).
Croatian: In vitro vezanje regorafeniba na proteine humane plazme je visoko (99,5%).
English: The decision to re-start Stivarga therapy should be based on careful consideration of the potential benefits and risks of the individual patient.
Croatian: Odluka da se ponovno počne liječenje lijekom Stivarga mora se temeljiti na pažljivom razmatranju mogućih koristi i rizika u pojedinog bolesnika.
English: The primary site of disease was colon (65%), rectum (29%), or both (6%).
Croatian: Primarno mjesto bolesti bio je kolon (65%), rektum (29%) ili oboje (6%).
English: Your doctor will monitor your blood pressure prior to and during treatment and may give you a medicine to treat high blood pressure.
Croatian: Liječnik će pratiti Vaš krvni tlak prije i tijekom liječenja te Vam može dati lijek za liječenje visokog krvnog tlaka.
English: Elderly Age did not affect the regorafenib pharmacokinetics over the studied age range (29 - 85 years).
Croatian: Stariji Dob nije utjecala na farmakokinetiku regorafeniba u ispitivanom dobnom rasponu (29-85 godina).
English: Do not take two doses of Stivarga on the same day to make up for a missed dose from the previous day.
Croatian: Nemojte uzeti dvostruku dozu lijeka Stivarga istog dana kako biste nadoknadili propuštenu dozu od prethodnog dana.
English: Take the dose of Stivarga that your doctor prescribes for you.
Croatian: Uzmite dozu lijeka Stivarga koju Vam je propisao liječnik.
English: Only 59.5 % of patients enrolled in the CONCUR study were also previously treated with VEGF- or EGFR-targeted agents.
Croatian: Samo je 59,5 % bolesnika uključenih u ispitivanje CONCUR prethodno također bilo liječeno lijekovima usmjerenima na VEGF ili EGFR.
English: A KRAS mutation was reported in 57% of patients at study entry.
Croatian: Mutacija KRAS bila je zabilježena u 57% bolesnika na ulasku u ispitivanje.
English: Your doctor will discuss with you the potential risks of taking Stivarga during pregnancy.
Croatian: Liječnik će Vam objasniti moguće rizike uzimanja lijeka Stivarga tijekom trudnoće.
English: The abnormalities are generally of mild to moderate severity, not associated with clinical manifestations, and do not usually require dose interruptions or reductions.
Croatian: Poremećaji su općenito blagi do umjereno teški, nisu povezani s kliničkim manifestacijama i obično ne zahtijevaju privremeni prekid primjene ili smanjenje doze.
English: These events are also known to be common disease-related complications in patients with intra-abdominal malignancies.
Croatian: Poznato je i da su ti događaji uobičajene komplikacije bolesti u bolesnika s intraabdominalnom zloćudnom bolesti.
English: The clinical significance of these findings is unknown (see also section 5.2).
Croatian: Klinički značaj ovih nalaza nije poznat (vidjeti također dio 5.2).
English: Thereafter, the medicinal product is to be discarded.
Croatian: Nakon toga lijek treba baciti.
English: Overall approximately 4.6% of patients treated with Stivarga developed hypothyroidism requiring hormonal replacement treatment.
Croatian: Sveukupno, približno 4,6% bolesnika liječenih lijekom Stivarga razvilo je hipotireozu koja je zahtijevala hormonsko nadomjesno liječenje.
English: StevensJohnson syndrome Toxic epidermal necrolysis
Croatian: StevensJohnsonov sindrom toksična epidermalna nekroliza
English: This 4-week period is considered a treatment cycle.
Croatian: To razdoblje od 4 tjedna čini ciklus liječenja.
English: There are no data on the use of regorafenib in pregnant women.
Croatian: Nema podataka o primjeni regorafeniba u trudnica.
English: It is a medicine used to treat cancer by slowing down the growth and spread of cancer cells and cutting off the blood supply that keeps cancer cells growing.
Croatian: To je lijek koji se primjenjuje u liječenju raka usporavajući rast i širenje stanica raka i prekidajući opskrbu krvlju koja omogućuje rast stanica raka.
English: These may be signs of bleeding.
Croatian: To mogu biti znakovi krvarenja.
English: The exposure of regorafenib in various Asian populations (Chinese, Japanese, Korean) is within the same range as seen in Caucasians.
Croatian: Izloženost regorafenibu u različitim populacijama azijskog podrijetla (Kinezi, Japanci, Korejci) u istom je rasponu kao i izloženost bijelaca.
English: Laboratory parameter, (in % of samples investigated)
Croatian: Laboratorijski parametar, (u % ispitivanih uzoraka)
English: If you get this side effect, your doctor may change your dose or stop your treatment until your condition improves.
Croatian: Ako razvijete ovu nuspojavu, liječnik može promijeniti Vašu dozu ili prekinuti liječenje sve dok Vam se stanje ne poboljša.
English: Laboratory Parameter (in % of samples investigated)
Croatian: Laboratorijski parametar (u % ispitivanih uzoraka)
English: Before you take Stivarga tell your doctor if any of these conditions apply to you.
Croatian: Prije nego uzmete lijek Stivarga obavijestite svog liječnika ako se neko od navedenih stanja odnosi na Vas.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor; ATC Code: L01XE21
Croatian: Farmakoterapijska skupina: antineoplastici, inhibitori protein-kinaze; ATK oznaka: L01XE21
English: What Stivarga is and what it is used for What you need to know before you take Stivarga How to take Stivarga
Croatian: Što je Stivarga i za što se koristi Što morate znati prije nego počnete uzimati lijek Stivarga Kako uzimati lijek Stivarga
English: Hazard ratio* (95% CI)
Croatian: Omjer hazarda* (95% CI)
English: Treatment should continue as long as benefit is observed or until unacceptable toxicity occurs (see section 4.4).
Croatian: Liječenje mora trajati sve dok je vidljiva korist ili do pojave neprihvatljive toksičnosti (vidjeti dio 4.4).
English: The patient should not take two doses on the same day to make up for a missed dose.
Croatian: Bolesnik ne smije uzeti dvije doze istog dana kako bi nadoknadio propuštenu dozu.
English: M-5 is finally excreted via M-4 as M-6 (carboxylic acid) in faeces.
Croatian: M-5 se konačno izlučuje putem M-4 kao M-6 (karboksilna kiselina) u fecesu.
English: Arterial hypertension
Croatian: Arterijska hipertenzija
English: An example of a light (low-fat) meal would include 1 portion of cereal (about 30 g), 1 glass of skimmed milk, 1 slice of toast with jam, 1 glass of apple juice, and 1 cup of coffee or tea (520 calories, 2 g fat).
Croatian: Primjer laganog obroka (s niskim sadržajem masti) uključuje jednu porciju žitarica (oko 30 g), jednu čašu obranog mlijeka, jednu šnitu tosta s džemom, jednu čašu soka od jabuke i jednu šalicu kave ili čaja (520 kalorija, 2 g masti).
English: If you have any questions about how Stivarga works or why this medicine has been prescribed for you, please ask your doctor.
Croatian: Ako imate dodatnih pitanja o načinu djelovanja lijeka Stivarga ili razlozima zbog kojih Vam je propisan ovaj lijek, molimo obratite se svom liječniku.
English: These may be signs of severe stomach or bowel problems.
Croatian: To mogu biti znakovi teških problema sa želucem ili crijevima.
English: Alterations of teeth and bones and adverse effects in the reproductive system were more pronounced in young and growing animals as well as in juvenile rats and indicate a potential risk for children and adolescents.
Croatian: Promjene na zubima i kostima te štetni učinci na reproduktivni sustav bili su izraženiji u mladunčadi životinja koja se još razvijala kao i u mladih štakora te ukazuju na mogući rizik za djecu i adolescente.
English: The Asian patients treated with Stivarga in clinical studies were primarily from East Asia (~90%).
Croatian: Bolesnici azijskog podrijetla liječeni lijekom Stivarga u kliničkim ispitivanjima bili su prvenstveno iz Istočne Azije (~90%).
English: Close monitoring of overall safety is recommended in these patients (see sections 4.4 and 5.2).
Croatian: Preporučuje se pažljivo pratiti ukupnu sigurnost u ovih bolesnika (vidjeti dijelove 4.4 i 5.2).
English: Before initiating Stivarga, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Stivarga potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: To manage your symptoms, your doctor may recommend the use of creams and/or the use of shoe cushions and gloves.
Croatian: Za liječenje tih simptoma liječnik može preporučiti primjenu krema i/ili nošenje jastučića za obuću i rukavica.
English: In vitro protein binding of M-2 and M-5 is higher (99.8% and 99.95%, respectively) than that of regorafenib.
Croatian: In vitro vezanje proteina M-2 i M-5 je više (99,8% odnosno 99,95%) nego kod regorafeniba.
English: If you notice any changes contact your doctor.
Croatian: Ako primijetite ikakve promjene, obratite se svom liječniku.
English: If you miss a dose, take it as soon as you remember on that day.
Croatian: Ako ste propustili uzeti dozu, uzmite je čim se sjetite tog istog dana.
English: Exception: patients with Gilbert's syndrome who develop elevated transaminases should be managed as per the above outlined recommendations for the respective observed elevation of ALT and/or AST.
Croatian: Iznimka: bolesnike s Gilbertovim sindromom u kojih nastupi povišenje transaminaza mora se liječiti prema gore navedenim preporukama za opaženo povišenje ALT i/ili AST.
English: Metastatic colorectal cancer (CRC)
Croatian: Metastatski kolorektalni karcinom (CRC)
English: Therefore, it is recommended to monitor patients closely for signs and symptoms of increased exposure to BCRP substrates.
Croatian: Stoga se u bolesnika preporučuje pažljivo praćenje znakova i simptoma povišenog izlaganja supstratima BCRP-a.
English: This includes medicines obtained without a prescription or even over-the-counter medicines, such as vitamins, dietary supplements or herbal medicines.
Croatian: To uključuje lijekove koje ste nabavili bez recepta ili lijekove u slobodnoj prodaji, kao što su vitamini, dodaci prehrani ili biljni lijekovi.
English: The lowest recommended daily dose is 80 mg.
Croatian: Najniža preporučena dnevna doza je 80 mg.
English: A slightly increased incidence of thickening of the atrioventricular valves of the heart was seen in the 26 week repeat-dose toxicity study in rats.
Croatian: Blagi porast pojavnosti zadebljanja atrioventrikularnih zalistaka srca uočeno je u studijama toksičnosti ponovljene doze tijekom 26 tjedana u štakora.
English: - if you had or have any bleeding problems and if you are taking warfarin, phenprocoumon or another medicine that thins the blood to prevent blood clots.
Croatian: ako ste imali ili imate bilo kakve probleme s krvarenjem i ako uzimate varfarin, fenprokumon ili neki drugi lijek koji razrjeđuje krv kako bi se spriječilo nastajanje krvnih ugrušaka.
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between elderly (aged 65 years and above) and younger patients (see also section 5.2).
Croatian: U kliničkim ispitivanjima nisu opažene značajne razlike u izloženosti, sigurnosti ili djelotvornosti između starijih (u dobi od 65 ili više godina) i mlađih bolesnika (vidjeti također dio 5.2).
English: Women of childbearing potential/Contraception in males and females Women of childbearing potential must be informed that regorafenib may cause foetal harm.
Croatian: Žene reproduktivne dobi / Kontracepcija u muškaraca i žena Žene reproduktivne dobi moraju biti obaviještene da regorafenib može uzrokovati oštećenje fetusa.
English: Maintain dose level and immediately institute supportive measures for symptomatic relief.
Croatian: Zadržati istu dozu i odmah uvesti potporne mjere za ublažavanje simptoma.
English: The tablets should be swallowed whole with water after a light meal that contains less than 30% fat.
Croatian: Tablete se moraju progutati cijele s vodom nakon laganog obroka koji sadrži manje od 30% masti.
English: It is recommended to monitor biochemical and metabolic parameters during Stivarga treatment and to institute appropriate replacement therapy according to standard clinical practice if required.
Croatian: Preporučuje se pratiti biokemijske i metaboličke parametre tijekom liječenja lijekom Stivarga i po potrebi uvesti odgovarajuću zamjensku terapiju sukladno standardnoj kliničkoj praksi.
English: Decrease dose by 40 mg (one tablet) and immediately institute supportive measures.
Croatian: Smanjiti dozu za 40 mg (jedna tableta) i odmah uvesti potporne mjere.
English: Metabolite M-5 is a weak BCRP-substrate.
Croatian: Metabolit M-5 je slabi BCRP supstrat.
English: If patients experience symptoms affecting their ability to concentrate and react during treatment with Stivarga, it is recommended that they do not drive or use machines until the effect subsides.
Croatian: Ako bolesnik iskusi simptome koji utječu na njegovu sposobnost koncentracije i reagiranja tijekom liječenja lijekom Stivarga, preporučuje se da ne vozi i da ne upravlja strojevima sve dok se učinci ne povuku.
English: In case of vomiting after regorafenib administration, the patient should not take additional tablets.
Croatian: U slučaju povraćanja nakon primjene regorafeniba, bolesnik ne smije uzimati dodatne tablete.
English: You will usually take Stivarga as long as you are benefiting and not suffering unacceptable side effects.
Croatian: Obično ćete uzimati lijek Stivarga dokle god Vam to koristi i dok nemate neprihvatljive nuspojave.
English: A diagnosis of PRES requires confirmation by brain imaging.
Croatian: Dijagnozu PRES-a potrebno je potvrditi metodom oslikavanja mozga.
English: In case of vomiting after regorafenib administration, you should not take additional tablets and you should inform your doctor.
Croatian: U slučaju povraćanja nakon primjene regorafeniba, ne smijete uzimati dodatne tablete i morate o tome obavijestiti svog liječnika.
English: Following single doses of 60 mg or 100 mg, the average relative bioavailability of tablets compared to an oral solution was 69% and 83%, respectively.
Croatian: Nakon pojedinačne doze od 60 mg ili 100 mg, prosječna relativna bioraspoloživost tableta u usporedbi s oralnom otopinom iznosila je 69% odnosno 83%.
English: Avoid becoming pregnant while being treated with Stivarga, as this medicine may harm your unborn baby.
Croatian: Izbjegavajte trudnoću dok se liječite lijekom Stivarga jer ovaj lijek može naškoditi Vašem nerođenom djetetu.
English: If you forget to take Stivarga
Croatian: Ako ste zaboravili uzeti lijek Stivarga
English: Since only limited data are available for patients with moderate hepatic impairment (Child Pugh B), no dose recommendation can be provided.
Croatian: Budući da su dostupni samo ograničeni podaci za bolesnike s umjerenim oštećenjem funkcije jetre (Child-Pugh B), ne mogu se dati preporuke za doziranje.
English: The majority of patients with PS ≥2 discontinued treatment for progressive disease.
Croatian: Većina bolesnika s PS ≥ 2 prekinula je liječenje zbog napredovanja bolesti.
English: Demographics and baseline disease characteristics were comparable between the Stivarga- and placebo-treated groups and are shown below for all 573 randomised patients:
Croatian: Demografske i početne značajke bolesti bile su usporedive između skupina koje su primale lijek Stivarga i placebo te su prikazane niže za sva 573 randomizirana bolesnika:
English: Some medicines may affect the way Stivarga works or Stivarga may affect how other medicines work and cause serious side effects.
Croatian: Neki lijekovi mogu utjecati na djelovanje lijeka Stivarga ili Stivarga može utjecati na djelovanje drugih lijekova i prouzročiti ozbiljne nuspojave.
English: You must not breast-feed your baby during Stivarga treatment, as this medicine may interfere with the growth and development of your baby.
Croatian: Ne smijete dojiti dijete tijekom liječenja lijekom Stivarga, jer ovaj lijek može ometati rast i razvoj Vašeg djeteta.
English: Strong inducers of CYP3A4 should be avoided, or selection of an alternate concomitant medicinal product, with no or minimal potential to induce CYP3A4 should be considered.
Croatian: Mora se izbjegavati jake induktore CYP3A4 ili odabrati alternativni lijek za istodobnu primjenu, ili se mora razmotriti primjena lijeka koji nema ili ima minimalan potencijal za indukciju CYP3A4.
English: Dermatological toxicity
Croatian: Dermatološka toksičnost
English: There is no specific antidote for Stivarga overdose.
Croatian: Nema specifičnog antidota za predoziranje lijekom Stivarga.