FrancophonIA/ELRC3.0 huggingface dataset:
English: The decision to resume treatment with Stivarga following major surgical intervention should be based on clinical judgment of adequate wound healing.
Croatian: Stoga se odluka da se nastavi liječenje lijekom Stivarga nakon velikog kirurškog zahvata mora temeljiti na kliničkoj procjeni odgovarajućeg cijeljenja rane.
English: If your liver function is severely impaired, you should not be treated with Stivarga, as there are no data on the use of Stivarga in patients with a severely impaired liver function.
Croatian: Ako je Vaša jetra teško oštećena, ne smijete se liječiti lijekom Stivarga jer nema podataka o uporabi lijeka Stivarga u bolesnika s teško oštećenom jetrom.
English: The concentration-time profile indicates that regorafenib and its metabolites may undergo enterohepatic circulation (see section 5.2).
Croatian: Profil odnosa koncentracija-vrijeme pokazuje da regorafenib i njegovi metaboliti mogu ući u enterohepatičku cirkulaciju (vidjeti dio 5.2).
English: Studies on the carcinogenic potential of regorafenib have not been performed.
Croatian: Nisu provedena ispitivanja kancerogenosti regorafeniba.
English: Regorafenib is a uridine diphosphate glucuronosyl transferase (UGT) 1A1 inhibitor (see section 4.5).
Croatian: Regorafenib je inhibitor uridindifosfat glukuronozil transferaze (UGT) 1A1 (vidjeti dio 4.5).
English: Light pink film-coated tablets, oval shaped with a length of 16 mm and a width of 7 mm marked with ‘BAYER' on one side and ‘40' on the other side.
Croatian: Svijetloružičaste filmom obložene tablete ovalnog oblika, duljine 16 mm i širine 7 mm, s oznakom „BAYER“ na jednoj strani i „40“ na drugoj.
English: Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as Stivarga has not been studied in this population and exposure might be increased in these patients.
Croatian: Stivarga se ne preporučuje za primjenu u bolesnika s teškim oštećenjem jetre (Child-Pugh C) jer Stivarga nije ispitivana u ovoj populaciji i izloženost kod tih bolesnika može biti povećana.
English: An effect of regorafenib on intrauterine development was shown in rabbits at exposures below the anticipated human exposure (based on AUC comparison).
Croatian: Učinak regorafeniba na intrauterini razvoj pokazan je na kunićima pri izloženosti manjoj od one koja se očekuje u ljudi (na temelju usporedbe AUC-a).
English: Two major and six minor metabolites of regorafenib have been identified in plasma.
Croatian: U plazmi su utvrđena dva glavna i šest drugih metabolita regorafeniba.
English: Talk to your doctor or pharmacist before taking Stivarga.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Stivarga.
English: Tell your doctor about any missed dose.
Croatian: Obavijestite svog liječnika ako ste propustili uzeti bilo koju dozu.
English: Major human metabolites (M-2 and M-5) exhibited similar efficacies, compared to regorafenib in in vitro and in vivo models.
Croatian: Glavni metaboliti u ljudi (M-2 i M-5) pokazali su sličnu djelotvornost u usporedbi s regorafenibom u in vitro i in vivo modelima.
English: The clinical significance of this neomycin interaction is unknown, but may result in a decreased efficacy of regorafenib.
Croatian: Klinička značajnost ove interakcije s neomicinom nije poznata, ali posljedica može biti smanjena djelotvornost regorafeniba.
English: As medicinal products with anti-angiogenic properties may suppress or interfere with wound healing, temporary interruption of Stivarga is recommended for precautionary reasons in patients undergoing major surgical procedures.
Croatian: Kako lijekovi s antiangiogenim svojstvima mogu usporiti ili ometati cijeljenje rana, preporučuje se privremeni prekid primjene lijeka Stivarga kao mjera opreza u bolesnika koji će se podvrgnuti velikom kirurškom zahvatu.
English: Parent compound found in faeces could be derived from intestinal degradation of glucuronides or reduction of metabolite M-2 (N-oxide), as well as unabsorbed regorafenib.
Croatian: Ishodišna tvar pronađena u stolici mogla je potjecati od intestinalnog raspadanja glukuronida ili smanjenja metabolita M-2 (N-oksida), kao i neapsorbiranog regorafeniba.
English: Secondary endpoints were Progression-Free Survival (PFS), Time To Progression (TTP), Objective Tumour Response Rate (ORR) and Disease Control Rate (DCR).
Croatian: Sekundarni ishodi bili su preživljenje bez progresije bolesti (PFS), vrijeme do progresije (TTP), stopa objektivnog odgovora tumora (ORR) i stopa kontrole bolesti (DCR).
English: The main circulating metabolites of regorafenib in human plasma are M-2 (N-oxide) and M-5 (N-oxide and N-desmethyl), which are pharmacologically active and have similar concentrations as regorafenib at steady state.
Croatian: Glavni cirkulirajući metaboliti regorafeniba u ljudskoj plazmi su M-2 (N-oksid) i M-5 (N-oksid i N-dezmetil), koji su farmakološki djelatni i imaju slične koncentracije kao i regorafenib u stanju dinamičke ravnoteže.
English: White opaque HDPE bottle closed with a PP/PP (polypropylene) screw cap with sealing insert and a molecular sieve desiccant.
Croatian: Bijela neprozirna HDPE bočica zatvorena PP/PP (polipropilenskim) navojnim čepom s umetkom za zaštitno zatvaranje i sredstvom za sušenje (molekularno sito).
English: Biochemical and metabolic laboratory test abnormalities Stivarga has been associated with an increased incidence of electrolyte abnormalities (including hypophosphatemia, hypocalcaemia, hyponatraemia and hypokalaemia) and metabolic abnormalities (including increases in thyroid stimulating hormone, lipase and amylase).
Croatian: Poremećaji rezultata biokemijskih i metaboličkih laboratorijskih testova Primjena lijeka Stivarga povezuje se s povećanom incidencijom poremećaja elektrolita (uključujući hipofosfatemiju, hipokalcemiju, hiponatremiju i hipokalemiju) i metaboličkih poremećaja (uključujući povećanje hormona koji stimulira štitnjaču, lipaza i amilaza).
English: The recommended dose of regorafenib is 160 mg (4 tablets of 40 mg) taken once daily for 3 weeks followed by 1 week off therapy.
Croatian: Preporučena doza regorafeniba je 160 mg (4 tablete od 40 mg) jedanput na dan tijekom 3 tjedna nakon čega slijedi 1 tjedan bez terapije.
English: In patients developing PRES, discontinuation of Stivarga, along with control of hypertension and supportive medical management of other symptoms is recommended.
Croatian: U bolesnika koji razviju PRES preporučuje se prekid primjene lijeka Stivarga zajedno s kontrolom hipertenzije i primjenom potpornog liječenja drugih simptoma.
English: Both metabolites, M-2 and M-5, exhibit non-linear accumulation, which might be caused by enterohepatic recycling or saturation of the UGT1A9 pathway.
Croatian: Oba metabolita, M-2 i M-5 iskazuju nelinearnu akumulaciju, koja može biti uzrokovana enterohepatičkom recirkulacijom ili zasićenjem metaboličkog mehanizma UGT1A9.
English: Prior to and during treatment with Stivarga, your doctor will do blood tests to monitor your liver function.
Croatian: Prije i tijekom liječenja lijekom Stivarga liječnik će Vam raditi krvne pretrage radi praćenja funkcije jetre.
English: Inhibitors of P-glycoprotein and BCRP/Inducers of P-glycoprotein and BCRP In vitro studies indicate that the active metabolites M-2 and M-5 are substrates for P-glycoprotein and BCRP.
Croatian: Inhibitori P-glikoproteina i BCRP-a / Induktori P-glikoproteina i BCRP-a In vitro ispitivanja pokazuju da su djelatni metaboliti M-2 i M-5 supstrati P-glikoproteina i BCRP-a.
English: Inhibitors and inducers of BCRP and P-glycoprotein may interfere with the exposure of M-2 and M-5.
Croatian: Inhibitori i induktori BCRP-a i P-glikoproteina mogu utjecati na izloženost metabolitima M-2 i M-5.
English: After repeated dosing to mice, rats and dogs, adverse effects were observed in a number of organs, primarily in the kidneys, liver, digestive tract, thyroid gland, lympho-/haematopoietic system, endocrine system, reproductive system and skin.
Croatian: Nakon ponovljene doze u miševa, štakora i pasa opažene su nuspojave na mnogim organima, prvenstveno bubrezima, jetri, probavnom sustavu, štitnoj žlijezdi, limfnom/hematopoetskom sustavu, endokrinom sustavu, reproduktivnom sustavu i koži.
English: The pharmacokinetics of regorafenib has not been studied in patients with end-stage renal disease.
Croatian: Farmakokinetika regorafeniba nije ispitivana u bolesnika s terminalnim stadijem bolesti bubrega.
English: Main findings consisted of malformations of the urinary system, the heart and major vessels, and the skeleton.
Croatian: Glavni nalazi sastojali su se od malformacija mokraćnog sustava, srca i velikih krvnih žila te kostura.
English: - if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall)
Croatian: ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
English: The safety and efficacy of Stivarga in children and adolescents in the indication of gastrointestinal stromal tumours (GIST) have not been established.
Croatian: Sigurnost i djelotvornost lijeka Stivarga u djece i adolescenata u indikaciji gastrointestinalnih stromalnih tumora (GIST) nisu ustanovljene.
English: For patients with observed worsening of liver function tests considered related to treatment with Stivarga (i.e. where no alternative cause is evident, such as post-hepatic cholestasis or disease progression), the dose modification and monitoring advice in Table 2 should be followed (see section 4.2).
Croatian: U bolesnika u kojih se opazi pogoršanje testova jetrene funkcije za koje se smatra da su povezani s liječenjem lijekom Stivarga (tj. kad nema drugog očitog uzroka, kao što je posthepatička kolestaza ili progresija bolesti) mora se prilagoditi doza i slijediti savjete o praćenju bolesnika kako je navedeno u tablici 2 (vidjeti dio 4.2).
English: For recommended measures and dose modifications in case of worsening of liver function tests considered related to treatment with Stivarga see Table 2 (see also section 4.4).
Croatian: Preporučene mjere i prilagodbe doze u slučaju pogoršanja rezultata testova jetrene funkcije koji se smatraju povezanima s liječenjem lijekom Stivarga vidjeti u tablici 2 (vidjeti također dio 4.4).
English: Keratoacanthoma/ Squamous cell carcinoma of the skin
Croatian: keratoakantom/ karcinom skvamoznih stanica kože
English: Interrupt therapy for a minimum of 7 days until toxicity resolves to Grade 0-1.
Croatian: Prekinuti terapiju na najmanje 7 dana dok se toksičnost ne smanji na 0.-1. stupanj.
English: Restart: If the potential benefit outweighs the risk of hepatotoxicity, re-start Stivarga treatment, reduce dose by 40 mg (one tablet), and monitor liver function weekly for at least 4 weeks.
Croatian: Ponovno započinjanje liječenja: Ako je moguća korist veća od rizika od hepatotoksičnosti, ponovno započnite liječenje lijekom Stivarga u dozi smanjenoj za 40 mg (jedna tableta) i pratite funkciju jetre svaki tjedan tijekom najmanje 4 tjedna. ponovna pojava Trajno prekinite liječenje lijekom Stivarga.
English: The DCR (complete response or partial response or stable disease) was significantly higher in patients treated with Stivarga (41.0% vs. 14.9%, p<0.000001, 1 sided).
Croatian: Stopa kontrole bolesti (potpuni odgovor ili djelomični odgovor ili stabilna bolest) bila je znatno viša u bolesnika liječenih lijekom Stivarga (41,0% naspram 14,9%, p<0,000001, jednostrana).
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between male and female patients.
Croatian: U kliničkim ispitivanjima nisu opažene značajne razlike u izloženosti, sigurnosti ili djelotvornosti između muških i ženskih bolesnika.
English: The incidence of Grade 3 hypertension was 8.7% (CRC), 28.0% (GIST) and 15.2% (HCC).
Croatian: Incidencija hipertenzije 3. stupnja iznosila je 8,7% (CRC), 28% (GIST) i 15,2% (HCC).
English: PFS**
Croatian: NP**
English: Once the bottle is opened the medicine is to be discarded after 7 weeks.
Croatian: Lijek treba baciti nakon 7 tjedana od otvaranja bočice.
English: Patients with unstable angina or new onset angina (within 3 months of starting Stivarga therapy), recent myocardial infarction (within 6 months of starting Stivarga therapy) and those with cardiac failure New York Heart Association (NYHA) Classification 2 or higher were excluded from the clinical studies.
Croatian: Bolesnici s nestabilnom anginom pektoris ili novim napadom angine pektoris (unutar tri mjeseca od početka liječenja lijekom Stivarga), nedavnim infarktom miokarda (unutar 6 mjeseci od početka liječenja lijekom Stivarga) i oni sa zatajenjem srca NYHA 2 klasifikacije ili višom (eng.
English: Other strong CYP3A4 inducers (e.g. phenytoin, carbamazepine, phenobarbital and St. John's wort) may also increase metabolism of regorafenib.
Croatian: I drugi jaki induktori CYP3A4 (npr. fenitoin, karbamazepin, fenobarbital i gospina trava) mogu pojačati metabolizam regorafeniba.
English: CYP isoform-selective substrates
Croatian: Selektivni supstrati izoenzima CYP-a
English: • ECOG Performance Status (PS) of 0: 66% or ECOG PS of 1: 34%
Croatian: Eastern Cooperative Oncology Group, ECOG) status 0: 66% ili ECOG status 1:
English: - dry mouth - decreased appetite - high blood pressure (hypertension) - excessive tiredness (fatigue).
Croatian: suha usta smanjen apetit povišen krvni tlak (hipertenzija) pretjeran umor
English: The safety profile of Stivarga plus BSC in the CONCUR study was consistent with the safety profile observed in the CORRECT study.
Croatian: Sigurnosni profil lijeka Stivarga uz najbolju potpornu njegu u ispitivanju CONCUR bio je sukladan sigurnosnom profilu opaženom u ispitivanju CORRECT.
English: This medicine contains 1.68 mg of lecithin (derived from soya) per daily dose (4 tablets).
Croatian: Ovaj lijek sadrži 1,68 mg lecitina (dobivenog iz soje) po dnevnoj dozi (4 tablete).
English: Treatment with Stivarga may also lead to a higher risk of fungal infections of the mucous membrane, skin or the body.
Croatian: Liječenje lijekom Stivarga može također dovesti do povišenog rizika za nastanak gljivičnih infekcija sluznice, kože ili tijela.
English: Contains sodium and lecithin (derived from soya).
Croatian: POPIS POMOĆNIH TVARI Sadrži natrij i lecitin (dobiven iz soje).
English: Subgroup analyses for OS and PFS according to age (<65; ≥65), gender, ECOG PS, primary site of disease, time from first diagnosis of metastatic disease, prior anticancer treatment, prior treatment lines for metastatic disease, and KRAS mutation status showed a treatment effect favouring the regorafenib regimen over the placebo regimen.
Croatian: Analize podgrupe na ukupno preživljenje i preživljenje bez progresije bolesti prema dobi (<65; ≥65), spolu, ECOG PS, primarnom mjestu bolesti, vremenu od postavljanja dijagnoze metastatske bolesti, prethodnom antineoplastičnom liječenju, prethodnoj liniji liječenja metastatske bolesti i statusu KRAS mutacije, pokazale su prednost učinka liječenja regorafenibom u odnosu na placebo.
English: Fatal outcome in patients treated with Stivarga was uncommon (0.7%), and included cerebral, respiratory, gastrointestinal and genitourinary events.
Croatian: Smrtni ishod u bolesnika liječenih lijekom Stivarga bio je manje čest (0,7%) i uključivao je moždane, dišne, probavne i mokraćno-spolne događaje.
English: - if you have high blood pressure Stivarga can raise your blood pressure.
Croatian: ako imate visoki krvni tlak.
English: Across all clinical trials, cardiac disorder events (all grades) have been more often (13.7% vs. 6.5%) reported in Stivarga-treated patients aged 75 years or older (N=410), compared to Stivarga-treated patients below 75 years (N=4108).
Croatian: U svim kliničkim ispitivanjima, slučajevi srčanih poremećaja (svih stupnjeva) bili su češće (13,7% naspram 6,5%) zabilježeni u bolesnika liječenih lijekom Stivarga koji su bili u dobi od 75 godina ili stariji (N=410) nego u bolesnika liječenih lijekom Stivarga koji su bili mlađi od 75 godina (N=4108).
English: Increased Amylase a Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0 b Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0
Croatian: Common Terminology Criteria for Adverse Events (CTCAE)), verzija 3.0 b Zajednički terminološki kriteriji za štetne događaje (engl.
English: In case of hypertensive crisis, Stivarga should be discontinued.
Croatian: U slučaju hipertenzivne krize, liječenje lijekom Stivarga mora se prekinuti.
English: For recommended dose modifications and measures in case of hand-foot skin reaction (HFSR)/palmar-plantar erythrodysesthesia syndrome see Table 1.
Croatian: Preporučene prilagodbe doze i mjere koje treba poduzeti u slučaju kožne reakcije na šakama i stopalima (engl. hand-foot skin reaction, HFSR) / sindroma palmarno-plantarne eritrodizestezije vidjeti u tablici 1.
English: Bile saltsequestering agents such as cholestyramine and cholestagel may interact with regorafenib by forming insoluble complexes which may impact absorption (or reabsorption), thus resulting in potentially decreased exposure.
Croatian: Može doći do interakcije lijekova za odjeljivanje žučnih soli kao što su kolestiramin i kolestipol sa regorafenibom sa stvaranjem netopljivih kompleksa koji mogu utjecati na apsorpciju (ili reapsorpciju), odnosno potencijalno dovesti do smanjenja izloženosti.
English: Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with Stivarga.
Croatian: Probir i kasnije liječenje varikoziteta jednjaka u bolesnika s cirozom jetre treba provoditi kao standardnu skrb prije početka liječenja lijekom Stivarga.
English: A clinical probe substrate study was performed to evaluate the effect of 14 days of dosing with 160 mg regorafenib on the pharmacokinetics of probe substrates of CYP2C8 (rosiglitazone) CYP2C9 (S-warfarin), CYP 2C19 (omeprazole) and CYP3A4 (midazolam).
Croatian: Provedeno je kliničko ispitivanje probe supstrata zbog procjene učinka primjene regorafeniba u dozi od 160 mg tijekom 14 dana na farmakokinetiku probe supstrata CYP2C8 (rosiglitazona), CYP2C9 (S-varfarina), CYP2C19 (omeprazola) te CYP3A4 (midazolama).
English: If a dose is missed, then it should be taken on the same day as soon as the patient remembers.
Croatian: Ako bolesnik propusti uzeti dozu onda ju mora uzeti istog dana čim se sjeti.
English: Each bottle contains 28 film-coated tablets.
Croatian: Svaka bočica sadrži 28 filmom obloženih tableta.
English: In vitro data indicate that regorafenib as well as its active metabolite M-2 inhibit glucuronidation mediated by UGT1A1 and UGT1A9 whereas M-5 only inhibits UGT1A1 at concentrations which are achieved in vivo at steady state.
Croatian: In vitro podaci pokazuju da regorafenib i njegov djelatni metabolit M-2 inhibiraju glukuronidaciju putem UGT1A1 i UGT1A9, dok M-5 inhibira samo UGT1A1 pri koncentracijama koje se postižu in vivo u stanju dinamičke ravnoteže.
English: If you have a mildly or moderately impaired liver function while you are being treated with Stivarga, your doctor should monitor you closely.
Croatian: Ako imate blago ili umjereno oštećenu funkciju jetre za vrijeme liječenja lijekom Stivarga, liječnik Vas mora pažljivo nadzirati.
English: The overall incidence of hand-foot skin reaction (74.8%, CRC, 88.2%, GIST and 67.1%, HCC) was higher in Stivarga-treated Asian patients, compared to other ethnicities.
Croatian: Ukupna incidencija kožne reakcije na šakama i stopalima (74,8% bolesnika s CRC-om, 88,2% bolesnika s GIST-om i 67,1% bolesnika s HCC-om) bila je viša u bolesnika azijskog podrijetla liječenih lijekom Stivarga u odnosu na bolesnike drugih rasa.
English: Bayer HealthCare Tél: +33-(0)800 87 54 54
Croatian: Tél: +33-(0)800 87 54 54
English: Get medical help immediately if you get the following symptoms, as they may be signs of a heart attack or decreased blood flow to the heart: chest discomfort or pain which may spread beyond your chest to your shoulders, arms, back, neck, teeth, jaw or stomach and may come and go; shortness of breath; sudden outbreak into a sweat with cold, clammy skin, feeling dizzy or fainting.
Croatian: Odmah potražite liječničku pomoć ako razvijete sljedeće simptome jer oni mogu biti znak srčanog udara ili smanjenog protoka krvi kroz srce: nelagoda u prsima ili bol u prsima koja se može širiti izvan Vaših prsa u ramena, ruke, leđa, vrat, zube, čeljust ili želudac te može biti prolazna; nedostatak zraka; iznenadni napadaji znojenja s hladnom, ljepljivom kožom, vrtoglavica ili nesvjestica.
English: In clinical studies, no relevant differences in exposure, safety or efficacy were observed between patients with mild hepatic impairment (Child-Pugh A) and normal hepatic function.
Croatian: U kliničkim ispitivanjima nisu opažene značajne razlike u izloženosti, sigurnosti ili djelotvornosti između bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh A) i onih s normalnom funkcijom jetre.
English: Increased AST
Croatian: Povišen AST
English: No dose adjustment is necessary based on ethnicity (see section 5.2).
Croatian: Nije potrebna prilagodba doze s obzirom na etničko podrijetlo (vidjeti dio 5.2).
English: Whereas plasma concentrations of M-2 and M-5 after a single dose of regorafenib are much lower than those of parent compound, steady-state plasma concentrations of M-2 and M-5 are comparable to those of regorafenib.
Croatian: Dok su plazmatske koncentracije M-2 i M-5 nakon pojedinačne doze regorafeniba puno niže od doza ishodišne tvari, plazmatske koncentracije metabolita M-2 i M-5 u stanju dinamičke ravnoteže usporedive su s onim regorafeniba.
English: Metabolites may be reduced or hydrolysed in the gastrointestinal tract by microbial flora, allowing reabsorption of the unconjugated active substance and metabolites (enterohepatic circulation).
Croatian: Metabolite može reducirati ili hidrolizirati mikroflora u probavnom sustavu, što omogućuje ponovnu apsorpciju nekonjugirane djelatne tvari i metabolita (enterohepatička cirkulacija).
English: Most infections in patients treated with Stivarga were mild to moderate in severity (Grades 1 and 2: 23.0%), and included urinary tract infections (5.7%), nasopharyngitis (4.0%), mucocutaneous and systemic fungal infections (3.3%) as well as pneumonia (2.6%).
Croatian: Većina infekcija u bolesnika liječenih lijekom Stivarga bila je blage do umjerene težine (1. i 2. stupnja: 23,0%), a uključivale su infekcije mokraćnog sustava (5,7%), nazofaringitis (4,0%), mukokutane i sistemske gljivične infekcije (3,3%), kao i upalu pluća (2,6%).
English: It is unknown whether regorafenib or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se regorafenib ili njegovi metaboliti u majčino mlijeko u ljudi.
English: Monitor liver function weekly until transaminases return to <3 times ULN (Grade 1) or baseline.
Croatian: Funkciju jetre treba provjeravati svaki tjedan sve dok se transaminaze ne vrate na vrijednosti < 3 puta GGN (1. stupanj) ili na početne vrijednosti.
English: Stivarga is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) as Stivarga has not been studied in this population.
Croatian: Stivarga se ne preporučuje za primjenu u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C) jer Stivarga nije ispitivana u ovoj populaciji.
English: Specific studies on fertility have not been performed.
Croatian: Nisu provedena posebna ispitivanja utjecaja na plodnost.
English: 0.9 months
Croatian: 0,9 mjeseci
English: The concentrations of regorafenib and its major pharmacologically active metabolites (M-2 and M-5) were highest when given after a low-fat (light) breakfast, compared to either a high-fat breakfast or fasting condition.
Croatian: Koncentracije regorafeniba i njegovih glavnih farmakološki aktivnih metabolita (M-2 i M-5) bile su najviše kad se regorafenib davao nakon doručka s niskim udjelom masti (laganog doručka), u usporedbi kad se davao nakon doručka bogatog mastima ili natašte.
English: No dose adjustment is required in patients with mild, moderate or severe renal impairment (see also section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije bubrega (vidjeti također dio 5.2).