FrancophonIA/ELRC3.0 huggingface dataset:
English: After one 28-day treatment cycle, at the time of maximum concentration of sorafenib, QTcB was prolonged by 4 ±19 msec and QTcF by 9 ±18 msec, as compared to placebo treatment at baseline.
Croatian: Nakon jednog ciklusa liječenja od 28 dana, u vrijeme najviše koncentracije sorafeniba, QTcB produljen je na 4 ± 19 ms i QTcF za 9 ± 18 ms u usporedbi s liječenjem placebom na početku.
English: After repeated dosing to young and growing dogs effects on bone and teeth were observed at exposures below the clinical exposure.
Croatian: Nakon ponavljanih doza u mladih i pasa u rastu, uočeno je da sorafenib djeluje na kosti i zube pri izloženosti nižoj od predviđene za kliničku uporabu.
English: Laboratory test abnormalities in HCC (study 3) and RCC (study 1) patients
Croatian: Odstupanja u vrijednostima laboratorijskih pretraga kod bolesnika s HCC (ispitivanje 3) i RCC (ispitivanje 1)
English: The standard program of genotoxicity studies was conducted and positive results were obtained as an increase in structural chromosomal aberrations in an in vitro mammalian cell assay (Chinese hamster ovary) for clastogenicity in the presence of metabolic activation was seen.
Croatian: Proveden je i standardni program ispitivanja genotoksičnosti, a pozitivni rezultati očitovali su se kroz povećanje incidencije strukturnih aberacija kromosoma, detektiranih u genomu stanica sisavaca (jajnika kineskog hrčka) in vitro testiranjem klastogenosti u uvjetima metaboličke aktivacije.
English: The median duration of therapy in the double-blind period was 46 weeks (range 0.3-135) for patients receiving sorafenib and 28 weeks (range 1.7-132) for patients receiving placebo.
Croatian: Medijan trajanja terapije u dvostruko slijepom razdoblju iznosio je 46 tjedana (raspon, 0,3-135) u bolesnika koji su primali sorafenib i 28 tjedana (raspon 1,7-132) u bolesnika koji su primali placebo.
English: Hypromellose Macrogol (3350) Titanium dioxide (E 171) Ferric oxide red (E 172)
Croatian: hipromeloza makrogol (3350) titanijev dioksid (E 171) željezov oksid, crveni (E 172) 6.2 Inkompatibilnosti
English: Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in table 1, by system organ class (in MedDRA) and frequency.
Croatian: Nuspojave prijavljene u višestrukim kliničkim ispitivanjima ili nakon stavljanja lijeka u promet navedene su u nastavku u tablici 1, sistematizirane prema klasifikaciji organskih sustava (navedenoj u MedDRA-i) i učestalosti kojom se javljaju.
English: Use sorafenib with caution in patients who have, or may develop prolongation of QTc, such as patients with a congenital long QT syndrome, patients treated with a high cumulative dose of anthracycline therapy, patients taking certain anti-arrhythmic medicines or other medicinal products that lead to QT prolongation, and those with electrolyte disturbances such as hypokalaemia, hypocalcaemia, or hypomagnesaemia.
Croatian: Sorafenib treba primjenjivati s oprezom u bolesnika koji imaju ili bi mogli razviti produljenje QTc intervala, kao što su bolesnici s prirođenim sindromom dugog QT intervala, bolesnici liječeni visokim kumulativnim dozama antraciklina, bolesnici koji uzimaju određene antiaritmike ili druge lijekove koji dovode do produljenja QT intervala, te oni s poremećajem elektrolita poput hipokalijemije, hipokalcemije ili hipomagnezemije.
English: The pharmacokinetics of carboplatin were unaffected.
Croatian: Nije bilo učinka na farmakokinetiku karboplatina.
English: Bayer Vital GmbH Tel: +49 (0)214-30 513 48
Croatian: Deutschland Bayer Vital GmbH Tel: +49 (0)214-30 513 48
English: Nexavar can raise blood pressure, and your doctor will usually monitor your blood pressure and may give you a medicine to treat your high blood pressure.
Croatian: Nexavar može povisiti krvni tlak, te je uobičajeno da liječnik kontrolira
English: Age, MSKCC prognostic group, ECOG PS and prior therapy did not affect the treatment effect size.
Croatian: Dob, prognostička skupina prema MSKCC-u, PS po ECOG-kriterijima (PS; od engleskog performance status) i ranije provođena terapija, nisu imali nikakva utjecaja na postignuti terapijski učinak.
English: The safety and efficacy of sorafenib in the treatment of advanced renal cell carcinoma (RCC) were investigated in two clinical studies:
Croatian: Sigurnost i djelotvornost sorafeniba u liječenju uznapredovalog raka bubrežnih stanica (RCC; od engleskog renal cell carcinoma), proučavane su u okviru dva klinička ispitivanja:
English: Following oral administration sorafenib reaches peak plasma concentrations in approximately 3 hours.
Croatian: Nakon peroralne primjene, vršna koncentracija sorafeniba u plazmi se dosegne za otprilike 3 sata.
English: A post-hoc subgroup analysis by thyroid carcinoma symptoms at baseline showed a treatment effect for PFS in favour of sorafenib over placebo for both symptomatic and asymptomatic patients.
Croatian: Post-hoc analiza podskupina prema simptomima karcinoma štitnjače na početku liječenja pokazala je terapijski učinak za PFS u korist sorafeniba u odnosu na placebo i kod simptomatskih i asimptomatskih bolesnika.
English: Metabolism and nutrition disorders anorexia hypophosphataemia hypocalcaemia hypokalaemia hyponatraemia hypoglycaemia dehydration
Croatian: Poremećaji metabolizma i prehrane anoreksija hipofosfatemija hipokalcemija hipokalemija hiponatremija hipoglikemija dehidracija
English: - If you are allergic to sorafenib or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Nexavar - ako ste alergični na sorafenib ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: No data is available in patients requiring dialysis.
Croatian: Nisu dostupni podaci za bolesnike na dijalizi.
English: This metabolite comprises approximately 9 - 16 % of circulating analytes at steady state.
Croatian: U stanju dinamičke ravnoteže, ovaj metabolit čini otprilike 9-16% cirkulirajućih analita.
English: Cardiac ischaemia and/or infarction
Croatian: Srčana ishemija i/ili infarkt
English: What do you need to know before you take Nexavar Do not take Nexavar
Croatian: Što morate znati prije nego počnete uzimati Nexavar
English: Approximately half of the patients had an ECOG performance status of 0, and half of the patients were in the low risk MSKCC prognostic group.
Croatian: Prema ljestvici ECOG-a otprilike polovica bolesnika imala je rezultat općeg stanja 0, dok je, prema MKSCC-kriterijima, druga polovica spadala u prognostičku skupinu niskog rizika.
English: Following oral administration of a 100 mg dose of a solution formulation of sorafenib, 96 % of the dose was recovered within 14 days, with 77 % of the dose excreted in faeces, and 19 % of the dose excreted in urine as glucuronidated metabolites.
Croatian: Nakon peroralne primjene sorafeniba u dozi od 100 mg, formulirane u obliku otopine, 96% iste izlučeno je kroz 14 dana, pri čemu se 77% izlučilo stolicom, a 19% mokraćom, u obliku glukuroniziranih metabolita.
English: The clinical significance of these small to modest increases in capecitabine and 5-FU exposure when co-administered with sorafenib is unknown.
Croatian: Klinički značaj ovih malih do umjerenih povećanja izloženosti 5-FU i kapecitabinu kad se primjenjuju istodobno sa sorafenibom, nije poznat.
English: The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Croatian: Najvažniji metabolit sorafeniba koji cirkulira u plazmi je piridin N-oksid, koji u in vitro uvjetima pokazuje potentnost sličnu onoj sorafeniba.
English: In two randomised trials investigating patients with Non-Small Cell Lung Cancer in the subgroup of patients with squamous cell carcinoma treated with sorafenib as add-on to paclitaxel/carboplatin, the HR for overall survival was found to be 1.81 (95% CI 1.19; 2.74) and as add-on to gemcitabine/cisplatin 1.22 (95% CI 0.82; 1.80).
Croatian: U dva randomizirana ispitivanja u bolesnika s karcinomom ne-malih stanica pluća u podgrupi bolesnika s karcinomom skvamoznih stanica liječenih sorafenibom kao dodatak paklitakselu/karboplatinu, omjer hazarda za ukupno preživljenje iznosio je 1,81 (95% CI 1,19; 2,74), a kao dodatak gemcitabinu/cisplatinu 1,22 (95% CI 0,82; 1,80).
English: Your doctor will monitor your fluid and electrolyte balance.
Croatian: Liječnik će pratiti ravnotežu tekućine i elektrolita u Vašem tijelu. - plodnost.
English: The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand foot skin reaction (corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA) and rash.
Croatian: Najčešće nuspojave bile su proljev, umor, alopecija, infekcija, kožna reakcija na šakama i stopalima (odgovara sindromu palmarno-plantarne eritrodisestezije po MedDRA-i) te osip.
English: The overall response rate (CR + partial response (PR) per independent radiological assessment was higher in the sorafenib group (24 patients, 12.2%) than in the placebo group (1 patient, 0.5%), one-sided p<0.0001.
Croatian: Ukupna stopa odgovora (potpuni odgovor + djelomični odgovor) prema neovisnoj radiološkoj procjeni bila je viša u skupini koja je primala sorafenib (24 bolesnika, 12,2%) nego u skupini koja je primala placebo (1 bolesnik, 0,5%), jednostrani p< 0,0001.
English: This OS analysis showed a statistically significant advantage for sorafenib over placebo for OS (HR: 0.69, p = 0.00058, see table 3).
Croatian: Ova analiza ukupnog preživljenja je pokazala statistički značajnu prednost sorafeniba u odnosu na placebo za OS (od engleskog: overall survival), (HR: 0,69, p = 0,00058, vidjeti tablicu 3).
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake od spomenutih skupina, nuspojave prikazane su prema ozbiljnosti opadajućim redoslijedom.
English: The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Croatian: Preporučena doza lijeka Nexavar u odraslih iznosi 400 mg sorafeniba (dvije tablete od 200 mg) dvaput na dan (što odgovara ukupnoj dnevnoj dozi od 800 mg).
English: Co-administration of neomycin, a non-systemic antimicrobial agent used to eradicate gastrointestinal flora, interferes with the enterohepatic recycling of sorafenib (see section 5.2, Metabolism and Elimination), resulting in decreased sorafenib exposure.
Croatian: Istodobna primjena neomicina, nesistemskog antimikrobnog lijeka koji se koristio za eradikaciju flore probavnog sustava interferira s enterohepatičkim recikliranjem sorafeniba (vidjeti dio 5.2, Metabolizam i eliminacija) što uzrokuje smanjeno izlaganje sorafenibu.
English: Higher mortality has been reported in patients with squamous cell carcinoma of the lung treated with sorafenib in combination with platinum-based chemotherapies.
Croatian: Viša stopa mortaliteta prijavljena je u bolesnika s karcinomom skvamoznih stanica pluća koji su liječeni sorafenibom u kombinaciji s kemoterapijom na bazi platine.
English: The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis.
Croatian: Najvažnije ozbiljne nuspojave bile su infarkt/ishemija miokarda, perforacija u probavnom sustavu, hepatitis izazvan lijekovima, krvarenje i hipertenzija/hipertenzivna kriza.
English: Sorafenib has been shown to be embryotoxic and teratogenic when administered to rats and rabbits at exposures below the clinical exposure.
Croatian: Sorafenib se pokazao embriotoksičnim i teratogenim u štakora i kunića pri izloženostima nižim od onih koje se koriste u kliničkoj praksi.
English: Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Croatian: Bolesnike koji istodobno uzimaju varfarin ili fenprokumon valja redovito nadzirati, kako bi se uočile promjene protrombinskog vremena i INR-a, odnosno klinički očitovane epizode krvarenja (vidjeti dijelove 4.5 i 4.8).
English: Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.
Croatian: Nexavar je indiciran za liječenje bolesnika s uznapredovalim karcinomom bubrežnih stanica, u kojih prethodna terapija, temeljena na primjeni interferona-alfa ili interleukina-2, nije bila uspješna, odnosno za koje takva terapija nije primjerena.
English: Most reports of hypokalaemia were low grade (CTCAE Grade 1).
Croatian: U većini izvješća hipokalemija je bila niskog stupnja (CTCAE stupanj 1).
English: Nexavar treatment should be supervised by a physician experienced in the use of anticancer therapies.
Croatian: Liječenje lijekom Nexavar mora nadzirati liječnik koji ima iskustva u provođenju terapije antineoplasticima.
English: In a clinical pharmacology study (single dose of 400 mg sorafenib), no relationship was observed between sorafenib exposure and renal function in subjects with normal renal function, mild, moderate or severe renal impairment.
Croatian: U kliničkom farmakološkom ispitivanju (jedna doza od 400 mg sorafeniba), nije zamijećena povezanost između izloženosti sorafenibu i bubrežne funkcije u bolesnika s normalnom bubrežnom funkcijom, blagim, umjerenim ili teškim bubrežnim oštećenjem.
English: When using sorafenib in patients with DTC, close monitoring of blood calcium level is recommended.
Croatian: Kad se sorafenib primjenjuje u bolesnika s DTC, preporučuje se pažljivo praćenje koncentracije kalcija u krvi.
English: In company sponsored clinical trials congestive heart failure was reported as an adverse event in 1.9% of patients treated with sorafenib (N= 2276).
Croatian: U kliničkim ispitivanjima koje je naručila tvrtka kongestivno zatajenje srca prijavljeno je kao nuspojava u 1,9% bolesnika liječenih sorafenibom (N = 2276).
English: Sorafenib had no clinically relevant effect on the pharmacokinetics of gemcitabine, cisplatin, carboplatin, oxaliplatin or cyclophosphamide.
Croatian: Sorafenib nije imao klinički značajan učinak na farmakokinetiku gemcitabina, cisplatina, karboplatina, oksaliplatina ili ciklofosfamida.
English: Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Croatian: Nexavar je indiciran za liječenje bolesnika s progresivnim, lokalno uznapredovalim ili metastatskim diferenciranim (papilarnim/folikularnim/Hürthleovih stanica) karcinomom štitnjače, koji je refraktoran na radioaktivni jod.
English: The primary endpoints were overall survival and progression-free survival (PFS).
Croatian: Primarni pokazatelji ishoda bili su ukupno preživljenje i preživljenje tijekom kojeg nije došlo do napredovanja osnovne bolesti (PFS; od engleskog progression-free survival).
English: Endocrine disorders hypothyroidism hyperthyroidism
Croatian: Endokrini poremećaji hipotireoza hipertireoza
English: Not known: frequency cannot be estimated from the available data - impaired brain function that can be associated with e.g. drowsiness, behavioural changes, or confusion (encephalopathy) - an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka - oštećenje funkcije mozga koje može biti povezano s npr. omamljenošću, promjenama ponašanja ili smetenošću (encefalopatija) - proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: Sorafenib accounts for approximately 70 - 85 % of the circulating analytes in plasma at steady state.
Croatian: U stanju dinamičke ravnoteže, sorafenib čini otprilike 70-85% analita koji cirkuliraju plazmom.
English: Since sorafenib is mainly eliminated via the hepatic route exposure might be increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Croatian: Kako se sorafenib uglavnom eliminira putem jetre, u bolesnika s teškim oštećenjem funkcije jetre može doći do povećane izloženosti sorafenibu (vidjeti dijelove 4.2 i 5.2).
English: However, in clinical pharmacokinetic studies, concomitant administration of sorafenib 400 mg twice daily with cyclophosphamide, a CYP2B6 substrate, or paclitaxel, a CYP2C8 substrate, did not result in a clinically meaningful inhibition.
Croatian: Ipak, u kliničkim ispitivanjima farmakokinetike, istodobna primjena 400 mg sorafeniba dvaput dnevno s ciklofosfamidom, supstratom CYP2B6 ili paklitakselom, supstratom CYP2C8 nije uzrokovala klinički značajnu inhibiciju.
English: CYP2B6, CYP2C8 and CYP2C9 substrates
Croatian: Supstrati CYP2B6, CYP2C8 i CYP2C9
English: CYP1A2 and CYP3A4 activities were not altered after treatment of cultured human hepatocytes with sorafenib, indicating that sorafenib is unlikely to be an inducer of CYP1A2 and CYP3A4.
Croatian: Nakon tretiranja kultura humanih jetrenih stanica sorafenibom, aktivnost CYP1A2 i CYP3A4 nije se promijenila, što ukazuje na to da sorafenib vjerojatno nije induktor CYP1A2 i CYP3A4.
English: CYP3A4, CYP2D6 and CYP2C19 substrates
Croatian: Supstrati CYP3A4, CYP2D6 i CYP2C19
English: Coadministration of neomycin has been shown to interfere with this process, decreasing the mean bioavailability of sorafenib by 54%.
Croatian: Pokazalo se da istodobna primjena neomicina interferira s ovim procesom te tako smanjuje prosječnu bioraspoloživost sorafeniba za 54%.
English: A second Phase III, international, multi-centre, randomised, double blind, placebo-controlled study (Study 4, 11849) evaluated the clinical benefit of sorafenib in 226 patients with advanced hepatocellular carcinoma.
Croatian: Drugim ispitivanjem III. faze, međunarodnim, multicentričnim, randomiziranim, dvostruko-slijepim, placebom kontroliranim (ispitivanje 4, 11849) ispitivala se klinička korist sorafeniba u 226 bolesnika s uznapredovalim hepatocelularnim karcinomom.
English: Additionally, concomitant treatment with sorafenib and warfarin, a CYP2C9 substrate, did not result in changes in mean PT-INR compared to placebo.
Croatian: Dodatno, u usporedbi s placebom, istodobno liječenje sorafenibom i varfarinom, supstratom CYP2C9, nije uzrokovalo promjene u srednjoj vrijednosti PV-INR u odnosu na placebo.
English: At the time of this analysis, about 200 patients had crossed-over to sorafenib from the placebo group.
Croatian: U vrijeme provođenja analize, oko 200 bolesnika liječenih placebom je prešlo na sorafenib.
English: P-gp-substrates
Croatian: Supstrati P-gp-a
English: The highest dose of sorafenib studied clinically is 800 mg twice daily.
Croatian: Najviša klinički ispitivana doza sorafeniba je 800 mg dva puta na dan.
English: A post-hoc subgroup analysis by maximum tumour size showed a treatment effect for PFS in favour of sorafenib over placebo for patients with maximum tumour size of 1.5 cm or larger (HR 0.54 (95% CI: 0.41 - 0.71)) whereas a numerically lower effect was reported in patients with a maximum tumour size of less than 1.5 cm (HR 0.87 (95% CI: 0.40 - 1.89).
Croatian: Post-hoc analiza podskupina prema maksimalnoj veličini tumora pokazala je terapijski učinak za PFS u korist sorafeniba u odnosu na placebo u bolesnika s maksimalnom veličinom tumora od 1,5 cm ili većom (HR 0,54 (0,41-0,71)), dok je numerički niži učinak bio zabilježen u bolesnika s maksimalnom veličinom tumora manjom od 1,5 cm (HR 0,87 (0,40-1,89)).
English: No data is available on patients with Child Pugh C (severe) hepatic impairment (see sections 4.4 and 5.2).
Croatian: Nema podataka o primjeni u bolesnika s oštećenjem funkcije jetre stadija Child-Pugh C (teško oštećenje) (vidjeti dijelove 4.4 i 5.2).
English: Clinical pancreatitis was reported in 2 of 451 sorafenib treated patients (CTCAE Grade 4) in study 1, 1 of 297 sorafenib treated patients in study 3 (CTCAE Grade 2), and 1 of 451 patients (CTCAE Grade 2) in the placebo group in study 1.
Croatian: Klinički pankreatitis prijavljen je u 2 od 451 bolesnika liječenih sorafenibom (CTCAE stupanj 4) u ispitivanju 1, kod 1 od 297 bolesnika liječenih sorafenibom u ispitivanju 3 (CTCAE stupanj 2) te kod 1 od 451 bolesnika (CTCAE stupanj 2) u placebo skupini u ispitivanju 1.
English: CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphopenia and neutropenia.
Croatian: Odstupanja u nalazima laboratorijskih pretraga CTCAE stupnja 3 ili 4 koje se javljaju u ≥ 5% bolesnika liječenih sorafenibom uključivale su limfopeniju i neutropeniju.
English: - If you have poor kidney function.
Croatian: - ako imate teško oštećenje jetrene funkcije.
English: The preclinical safety profile of sorafenib was assessed in mice, rats, dogs and rabbits.
Croatian: U nekliničkim ispitivanjima, sigurnost primjene lijeka utvrđena je u miševa, štakora, pasa i kunića.
English: How to store Nexavar
Croatian: Kako čuvati Nexavar
English: However, patients taking warfarin or phenprocoumon should have their INR checked regularly (see section 4.4).
Croatian: Ipak bolesnicima koji uzimaju varfarin ili fenprokumon valja redovito kontrolirati INR (vidjeti dio 4.4).
English: Laboratory test abnormalities in DTC patients (study 5)
Croatian: Odstupanja u nalazima laboratorijskih pretraga u bolesnika s DTC (ispitivanje 5)
English: In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the foetus.
Croatian: U štakora se pokazalo da sorafenib i njegovi metaboliti prolaze posteljicu, te se pretpostavlja da štetno djeluje na plod.
English: When dose reduction is necessary during the treatment of hepatocellular carcinoma (HCC) and advanced renal cell carcinoma (RCC), the Nexavar dose should be reduced to two tablets of 200 mg sorafenib once daily (see section 4.4).
Croatian: Ukoliko je dozu lijeka nužno sniziti tijekom liječenja hepatocelularnog karcinoma (HCC; eng. hepatocellular carcinoma) i uznapredovalog karcinoma bubrežnih stanica (RCC; eng. renal cell carcinoma), dozu lijeka Nexavar potrebno je smanjiti na dvije tablete od 200 mg sorafeniba jedanput na dan (vidjeti dio 4.4).
English: Study 1 (study 11213) was a Phase III, multi-centre, randomised, double blind, placebo-controlled study in 903 patients.
Croatian: Ispitivanje 1 (ispitivanje 11213) bilo je ispitivanje III. faze, multicentrično, dvostruko-slijepo, placebom kontrolirano i randomizirano ispitivanje provedeno na 903 bolesnika.
English: ** Hand foot skin reaction corresponds to palmar plantar erythrodysaesthesia syndrome in
Croatian: ** Kožna reakcija na šakama i stopalima odgovara sindromu palmarno-plantarne eritrodizestezije po MedDRA-i.
English: The highest mean concentration was observed in DTC patients (approximately twice that observed in patients with RCC and HCC), though variability was high for all tumour types.
Croatian: Najviša srednja vrijednost koncentracije bila je opažena u bolesnika s diferenciranim karcinomom štitnjače (približno dvaput veća od one opažene u bolesnika s karcinomom bubrežnih stanica i hepatocelularnim karcinomom), iako je varijabilnost bila velika kod svih vrsta tumora.
English: Sorafenib is metabolised primarily in the liver and undergoes oxidative metabolism, mediated by CYP 3A4, as well as glucuronidation mediated by UGT1A9.
Croatian: Sorafenib se uglavnom metabolizira u jetri, podliježući metaboličkoj oksidaciji posredovanoj CYP-om 3A4, te glukuronidaciji posredovanoj UGT-om1A9.
English: Rash and hand foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with sorafenib.
Croatian: Common Toxicity Criteria), navedene se reakcije rangiraju kao toksični učinci 1. i 2. stupnja, i u načelu se javljaju u prvih šest tjedana liječenja sorafenibom.
English: If you intend to have a high fat meal, take the tablets at least 1 hour before or 2 hours after the meal.
Croatian: Namjeravate li konzumirati punomasni obrok, tablete lijeka Nexavar uzmite sat vremena prije ili 2 sata nakon obroka.
English: Nexavar may lead to a higher risk of bleeding.
Croatian: Liječenje lijekom Nexavar može povisiti rizik od pojave krvarenja.