FrancophonIA/ELRC3.0 huggingface dataset:
English: Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased number of external and visceral malformations.
Croatian: Uočeni učinci uključivali su gubitak na tjelesnoj težini majke i ploda, povećan broj resorpcija ploda, te povećan broj vanjskih i visceralnih malformacija.
English: Nexavar is a so-called multikinase inhibitor.
Croatian: Nexavar je takozvani inhibitor više kinaza.
English: Time to Progression (TTP) [median, weeks (95% CI)]**
Croatian: Vrijeme do progresije [medijan, tjedni (95% CI)]**
English: When administered with irinotecan, whose active metabolite SN-38 is further metabolised by the UGT1A1 pathway, there was a 67 - 120 % increase in the AUC of SN-38 and a 26 - 42 % increase in the AUC of irinotecan.
Croatian: Kad se primijenio s irinotekanom čiji se aktivni metabolit SN-38 dalje metabolizira preko UGT1A1 zabilježeno je 67-120%-tno povećanje AUC SN-38, te 26-42%-tno povećanje AUC irinotekana.
English: DTC refractory to RAI was defined as having a lesion without iodine uptake on a RAI scan, or receiving cumulative RAI ≥ 22.2 GBq, or experiencing a progression after a RAI treatment within 16 months of enrollment or after two RAI treatments within 16 months of each other.
Croatian: DTC refraktoran na RAI bio je definiran kao lezija koja ne preuzima jod na RAI-snimanju ili primanje kumulativne aktivnosti RAI ≥ 22,2 GBq, ili pojava progresije nakon liječenja pomoću RAI unutar 16 mjeseci od uključenja ili nakon dva liječenja pomoću RAI unutar razmaka od 16 mjeseci.
English: Overall Survival (OS) [median, weeks (95%
Croatian: Ukupno preživljenje, [medijan, tjedni (95% CI)]
English: One intermediate in the manufacturing process, which is also present in the final active substance (< 0.15 %), was positive for mutagenesis in an in vitro bacterial cell assay (Ames test).
Croatian: Jedan međuproizvod koji nastaje tijekom proizvodnog procesa, koji je prisutan i u finalnoj djelatnoj tvari (< 0,15%), bio je mutagen prema in vitro testu na bakterijskim stanicama (Amesov test).
English: After improvement of non-haematological adverse reactions, the dose of Nexavar may be increased.
Croatian: Nakon poboljšanja nehematoloških nuspojava, doza lijeka Nexavar može se povisiti.
English: If it is nearly time for the next dose, forget about the missed one and carry on as normal.
Croatian: Ukoliko je vrijeme kada biste trebali uzeti sljedeću dozu, zanemarite propuštenu dozu i nastavite s uzimanjem lijeka na uobičajeni način.
English: You will usually carry on taking this medicine as long as you are getting clinical benefits, and not suffering unacceptable side effects.
Croatian: Uobičajeno je ovaj lijek uzimati tako dugo dok se njime postiže klinička korist, a da pritom nema neprihvatljivih štetnih učinaka.
English: Inducers of metabolic enzymes
Croatian: Induktori metaboličkih enzima
English: In vitro binding of sorafenib to human plasma proteins is 99.5 %.
Croatian: U in vitro uvjetima, vezivanje sorafeniba za bjelančevine ljudske plazme iznosi 99,5%.
English: This study, conducted in China, Korea and Taiwan confirmed the findings of Study 3 with respect to the favourable benefit-risk profile of sorafenib (HR (OS): 0.68, p = 0.01414).
Croatian: Ovo ispitivanje koje se provodilo u Kini, Tajvanu i Koreji potvrdilo je nalaze ispitivanja 3 s obzirom na povoljni profil koristi-rizika sorafeniba (HR (OS): 0,68; p = 0,01414).
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, koja je uključila i pojavu malformacija (vidjeti dio 5.3).
English: - If you get any bleeding problems, or are taking warfarin or phenprocoumon.
Croatian: - ako se javi bilo kakvo krvarenje, ili ako istodobno uzimate varfarin ili fenprokumon.
English: Thus, also the risk for a clinically relevant in vivo inhibition of CYP2C9 by sorafenib may be expected to be low.
Croatian: Stoga se također može očekivati da je rizik za klinički značajnu in vivo inhibiciju CYP2C9 nizak.
English: In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%.
Croatian: U zdravih dobrovoljaca koji su liječeni neomicinom tijekom 5 dana, prosječna izloženost sorafenibu smanjila se za 54%.
English: Infections and infestations infection folliculitis
Croatian: Infekcije i infestacije infekcija folikulitis
English: Patients were included in the study if they experienced progression within 14 months of enrollment and had DTC refractory to radioactive iodine (RAI).
Croatian: Bolesnici su bili uključeni u ispitivanje ako su imali progresiju bolesti unutar 14 mjeseci od uključenja i DTC refraktoran na radioaktivni jod (RAI).
English: In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Croatian: U in vitro uvjetima se pokazalo da sorafenib inhibira transportni protein p-glikoprotein (P-gp).
English: Sorafenib is mainly eliminated via the liver, and exposure might be increased in this patient population.
Croatian: Sorafenib se prvenstveno izlučuje putem jetre te izloženost lijeku u ovoj populaciji može biti povećana.
English: Blood sugar levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicine's dosage needs to be adjusted to minimize the risk of low blood sugar.
Croatian: Razinu šećera u krvi u bolesnika s dijabetesom treba redovito provjeravati da bi se procijenilo je li potrebno prilagoditi doziranje antidijabetičkog lijeka kako bi se smanjio rizik od niske razine šećera u krvi.
English: There were no reports of hypokalaemia CTCAE grade 4.
Croatian: Nije bilo izvješća o hipokalemiji CTCAE stupnja 4.
English: When using sorafenib in these patients, periodic monitoring with on-treatment electrocardiograms and electrolytes (magnesium, potassium, calcium) should be considered.
Croatian: Kad se sorafenib primijenjuje u ovih bolesnika treba razmotriti periodičko praćenje elektrokardiograma i elektrolita (magnezija, kalija i kalcija).
English: Administration of rifampicin for 5 days before administration of a single dose of sorafenib resulted in an average 37 % reduction of sorafenib AUC.
Croatian: Primjena rifampicina tijekom 5 dana prije primjene jedne doze sorafeniba rezultirala je prosječnim smanjenjem AUC sorafeniba od 37%.
English: Progression-free survival (PFS) as evaluated by a blinded independent radiological review using RECIST criteria was the primary endpoint of the study.
Croatian: Preživljenje bez progresije bolesti (PFS) procijenjeno slijepim, neovisnim pregledom radioloških podataka prema kriterijima RECIST bilo je primarni ishod ispitivanja.
English: Talk to your doctor or pharmacist before taking Nexavar.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete Nexavar.
English: Lipase increased * Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 ** The aetiology of hypophosphatemia associated with sorafenib is not known.
Croatian: * Zajednički terminološki kriteriji za nuspojave (CTCAE), verzija 3.0 ** Etiologija hipofosfatemije povezane sa sorafenibom nije poznata.
English: 112 film-coated tablets (4 x 28) in transparent (PP/Aluminium) blister packs.
Croatian: 112 (4 x 28) filmom obloženih tableta u prozirnom (PP/aluminij) blisteru.
English: There are no data on the use of sorafenib in pregnant women.
Croatian: Nema podataka o primjeni sorafeniba u trudnica.
English: You must not breast-feed your baby during Nexavar treatment, as this medicine may interfere with the growth and development of your baby.
Croatian: Za trajanja liječenja lijekom Nexavar svoje dijete ne smijete dojiti jer ovaj lijek može negativno utjecati na njegov rast i razvoj.
English: - If you have diabetes.
Croatian: - ako imate dijabetes.
English: In the pre-specified stratification factors (ECOG status, presence or absence of macroscopic vascular invasion and/or extrahepatic tumour spread) of both Study 3 and 4, the HR consistently favoured sorafenib over placebo.
Croatian: Prema prethodno određenim čimbenicima procjene (ECOG status, prisutnost ili odsutnost makroskopske vaskularne invazije i/ili širenje tumora izvan jetre) u oba ispitivanja, 3 i 4, omjer hazarda dosljedno je bio povoljniji za sorafenib u odnosu na placebo.
English: The effect of sorafenib on PFS was consistent independent of geographic region, age above or below 60 years, gender, histological subtype, and presence or absence of bone metastasis.
Croatian: Učinak sorafeniba na PFS bio je dosljedan neovisno o geografskoj regiji, dobi većoj ili manjoj od 60 godina, spolu, histološkom podtipu i prisutnosti ili odsutnosti metastaza u kostima.
English: In vitro studies of CYP enzyme induction
Croatian: In vitro ispitivanja indukcije enzima CYP-a
English: You may need treatment for them, or your doctor may decide to change your dose of Nexavar, or stop treatment altogether (see also section 4: Possible side effects).
Croatian: Moguće je da će nuspojave trebati liječiti, ili će liječnik odlučiti smanjiti dozu lijeka Nexavar koju uzimate, odnosno posve prekinuti liječenje (vidjeti također dio 4: Moguće nuspojave).
English: This is equivalent to a daily dose of 800 mg or four tablets a day.
Croatian: Ovo odgovara dnevnoj dozi od 800 mg, odnosno četiri tablete na dan.
English: In case of symptomatic hypoglycaemia, sorafenib should be temporarily interrupted.
Croatian: U slučaju simptomatske hipoglikemije liječenje sorafenibom treba privremeno prekinuti.
English: If the patient intends to have a high-fat meal, sorafenib tablets should be taken at least 1 hour before or 2 hours after the meal.
Croatian: Ako bolesnik želi pojesti obrok s visokim sadržajem masnoća, tablete sorafeniba potrebno je uzeti najmanje 1 sat prije ili 2 sata nakon obroka.
English: Unchanged sorafenib, accounting for 51 % of the dose, was found in faeces but not in urine, indicating that biliary excretion of unchanged active substance might contribute to the elimination of sorafenib.
Croatian: Nepromijenjeni sorafenib, koji čini 51% izlučene doze, nađen je u stolici, ali ne i u mokraći, što upućuje na mogućnost da bilijarna ekskrecija nepromijenjene djelatne tvari doprinosi eliminaciji sorafeniba iz organizma.
English: Swallow Nexavar tablets with a glass of water, either without food or with a low-fat or moderate fat meal.
Croatian: Tablete lijeka Nexavar progutajte s čašom vode, natašte ili uz posni ili umjereno masni obrok.
English: Differentiated thyroid cancer (DTC)
Croatian: Diferencirani karcinom štitnjače (DTC)
English: The clinical significance of these findings is unknown (see section 4.4).
Croatian: Klinički značaj ovih nalaza nije poznat (vidjeti dio 4.4).
English: Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2.
Croatian: Druga klinički važna odstupanja u nalazima laboratorijskih pretraga opažena u ispitivanju 5 prikazana su u tablici 2.
English: If you become pregnant while being treated with Nexavar, immediately tell your doctor who will decide if the treatment should be continued.
Croatian: Ukoliko ste tijekom liječenja lijekom Nexavar ostali u drugom stanju, bez odlaganja to priopćite svom liječniku, koji će odlučiti treba li liječenje nastaviti.
English: Your doctor may tell you to stop taking this medicine.
Croatian: U ovakvom slučaju, Vaš Vam liječnik može reći da prestanete uzimati lijek.
English: - If you have thyroid cancer.
Croatian: - ako imate rak štitnjače.
English: Nexavar may increase the effects and, in particular, the side effects of these medicines.
Croatian: Nexavar može pojačati učinke ovih lijekova, a posebno nuspojave koje one uzrokuju.
English: Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Croatian: Preporučuje se praćenje ravnoteže tekućine i elektrolita u bolesnika s rizikom za razvoj poremećaja funkcije bubrega.
English: RAF kinases are serine/threonine kinases, whereas c-KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFR-ß are receptor tyrosine kinases.
Croatian: RAF kinaze su serin/treonin kinaze, dok su c-KIT, FLT-3, VEGFR-2, VEGFR-3 i PDGFR-ß receptorske tirozin kinaze.
English: Therefore, clinical pharmacokinetic interactions of sorafenib with substrates of these enzymes are unlikely.
Croatian: Stoga kliničke farmakokinetičke interakcije sorafeniba sa supstratima tih enzima nisu vjerojatne.
English: Your doctor will monitor blood calcium and thyroid hormone levels.
Croatian: Liječnik će Vam nadzirati razinu kalcija i hormona štitnjače u krvi.
English: Patients with unstable coronary artery disease or recent myocardial infarction were excluded from these studies.
Croatian: Bolesnici s nestabilnom bolesti koronarnih arterija, kao i bolesnici koji su nedavno preboljeli infarkt miokarda, isključeni su iz ovih ispitivanja.
English: Do not take this medicine with high fat meals, as this may make Nexavar less effective.
Croatian: Ne uzimajte ovaj lijek s punomasnim obrocima jer mu to smanjuje djelotvornost.
English: Respiratory, thoracic and mediastinal disorders rhinorrhoea dysphonia interstitial lung disease-like events* (pneumonitis, radiation pneumonitis, acute respiratory distress, etc. )
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja rinoreja disfonija događaji nalik intersticijskoj bolesti pluća* (pneumonitis, radijacijski pneumonitis, akutni respiratorni distres itd.)
English: These data suggest that sorafenib at the recommended dose of 400 mg twice daily may not be an in vivo inhibitor of CYP2B6 or CYP2C8.
Croatian: Ti podaci ukazuju da je moguće da sorafenib pri preporučenoj dozi od 400 mg dvaput dnevno nije in vivo inhibitor enzima CYP2B6 ili CYP2C8.
English: Nexavar 200 mg film-coated tablets are red and round with the Bayer cross on one side and “200” on the other side.
Croatian: Nexavar 200 mg filmom obložene tablete su crvene i okrugle s Bayerovim znakom križa na jednoj strani i oznakom “200” na drugoj strani tablete.
English: High Risk Patients, according to MSKCC (Memorial Sloan Kettering Cancer Center) prognostic group, were not included in the phase III clinical study in renal cell carcinoma (see study 1 in section 5.1), and benefit-risk in these patients has not been evaluated.
Croatian: Bolesnici, koji su sukladno kriterijima prognostičke skupine MSKCC-a (Memorial Sloan Kettering Cancer Center) svrstani u grupu visokorizičnih, nisu bili uključeni u kliničko ispitivanje III. faze karcinoma bubrežnih stanica, (vidjeti ispitivanje 1 u dijelu 5.1) te omjer koristi i rizika u takvih bolesnika nije procijenjen.
English: No studies have been conducted to investigate the pharmacokinetics of sorafenib in paediatric patients.
Croatian: Nisu provedena ispitivanja kojima bi se istražilo farmakokinetiku sorafeniba u pedijatrijskih bolesnika.
English: Study 2 was a Phase II, discontinuation study in patients with metastatic malignancies, including RCC.
Croatian: Ispitivanje 2 bilo je ispitivanje II. faze a istraživalo je posljedice prekida liječenja sorafenibom u oboljelih od metastatskih malignih bolesti, uključujući i RCC.
English: There is no evidence that Nexavar will affect the ability to drive or to operate machines.
Croatian: Nema dokaza da bi Nexavar utjecao na sposobnost upravljanja vozilima i rukovanja strojevima.
English: Steady state plasma sorafenib concentrations are achieved within 7 days, with a peak to trough ratio of mean concentrations of less than 2.
Croatian: Stanje dinamičke ravnoteže koncentracija sorafeniba u plazmi postiže se unutar 7 dana, pri čemu je omjer vršnih i najnižih koncentracija manji od 2.
English: Exploratory subgroup analyses suggested that patients with distant metastases at baseline derived a less pronounced treatment effect.
Croatian: Istraživačkom analizom podgrupe ukazale su da bolesnici s udaljenim metastazama na početku liječenja, imaju manje izražen učinak liječenja.
English: Elderly population No dose adjustment is required in the elderly (patients above 65 years of age).
Croatian: U starijih bolesnika (starijih od 65 godina) dozu lijeka nije potrebno prilagođavati.
English: België / Belgique / Belgien
Croatian: België/Belgique/Belgien Bayer SA-NV
English: Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Croatian: Ketokonazol, snažan inhibitor CYP3A4, primjenjivan u zdravih dragovoljaca muškog spola jedanput dnevno tijekom 7 dana, nije promijenio srednju AUC, koja se bilježi pri jednokratnoj primjeni doze od 50 mg sorafeniba.
English: Co-administration of neomycin or other antibiotics that cause major ecological disturbances of the gastrointestinal microflora may lead to a decrease in sorafenib bioavailability (see section 4.5).
Croatian: Istodobna primjena neomicina ili drugih antibiotika koji uzrokuju veći poremećaj gastrointestinalne mikroflore može dovesti do smanjenja bioraspoloživosti sorafeniba (vidjeti dio 4.5).
English: Hypertension was usually mild to moderate, occurred early in the course of treatment, and was amenable to management with standard antihypertensive therapy.
Croatian: Obično se radilo o blagoj do umjerenoj hipertenziji, koja se javljala na samom početku liječenja, i uspješno zbrinjavala standardnim antihipertenzivima.
English: In an overall survival analysis conducted 9 months after the data cut-off for the final PFS analysis there was no statically significant difference in overall survival between the treatment groups (HR=0.884; 95% CI: 0.633, 1.236, one-sided p value of 0.236).
Croatian: U analizi ukupnog preživljenja provedenoj 9 mjeseci nakon završetka prikupljanja podataka za završnu analizu PFS, nije bilo statistički značajne razlike u ukupnom preživljenju između terapijskih skupina (HR je bio 0,884; 95% CI:0,633, 1,236, jednostrana p-vrijednost od 0,236).
English: Bayer Hungária KFT Tel.:+36 14 87-41 00
Croatian: Magyarország Bayer Hungária KFT Tel:+36 14 87-41 00
English: Environmental Risk assessment studies have shown that sorafenib tosylate has the potential to be persistent, bioaccumulative and toxic to the environment.
Croatian: Ispitivanja procjene rizika za okoliš pokazala su da sorafenibtosilat ima potencijal perzistencije, bioakumulacije i toksičnosti za okoliš.
English: No complete response (CR) according to RECIST was observed.
Croatian: Nije bio opažen potpuni odgovor prema RECIST-u.
English: Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see section 4.8).
Croatian: Hipokalcemija 3. i 4. stupnja nastala je u 6,8% odnosno 3,4% bolesnika s DTC liječenih sorafenibom (vidjeti dio 4.8).
English: Sorafenib conjugates may be cleaved in the gastrointestinal tract by bacterial glucuronidase activity, allowing reabsorption of unconjugated active substance.
Croatian: Konjugati sorafeniba mogu se cijepati u probavnom sustavu djelovanjem bakterijske glukuronidaze, čime se omogućuje reapsorpcija nekonjugirane djelatne tvari.
English: Blood glucose levels in diabetic patients should be checked regularly in order to assess if anti-diabetic medicinal product's dosage needs to be adjusted.
Croatian: Razinu glukoze u krvi u bolesnika s dijabetesom treba redovito provjeravati kako bi se procijenilo je li potrebno prilagoditi doziranje antidijabetičkog lijeka.
English: Neomycin
Croatian: Neomicin
English: Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-ß).
Croatian: Sorafenib inhibira aktivnost ciljnih mjesta unutar stanice tumora (CRAF, BRAF, V600E BRAF, c-KIT, i FLT-3) i u krvnim žilama tumora CRAF, VEGFR-2, VEGFR-3 i PDGFR-ß).
English: These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Croatian: Ovi podaci upućuju na to da kliničke farmakokinetičke interakcije sorafeniba i inhibitora CYP3A4 nisu vjerojatne.
English: Nervous system disorders peripheral sensory neuropathy dysgeusia reversible posterior leukoencephalopathy*
Croatian: Poremećaji živčanog sustava periferna senzorička neuropatija disgeuzija reverzibilna posteriorna leukoencefalopatija*
English: These data indicate no need for dose adjustments when paclitaxel and carboplatin are co-administered with sorafenib with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration).
Croatian: Ovi podaci pokazuju da nema potrebe za prilagodbom doze kad se paklitaksel i karboplatin primjenjuju istodobno sa sorafenibom uz trodnevni prekid u doziranju sorafeniba (dva dana prije i na dan primjene paklitaksela/karboplatina).
English: Mean Cmax and AUC increased less than proportionally beyond doses of 400 mg administered twice daily.
Croatian: Porast prosječne Cmax i AUC-a manji je od proporcionalnog nakon primjene doza većih od 400 mg primjenjenih dvaput dnevno.
English: Disease specific warnings
Croatian: Upozorenja posebno vezana uz bolest
English: Children and adolescents have not yet been tested with Nexavar.
Croatian: Nexavar nije ispitan na djeci i adolescentima.
English: Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of sorafenib, or in severe or persistent cases, permanent discontinuation of sorafenib (see section 4.8).
Croatian: Zbrinjavanje dermatoloških toksičnosti može uključivati simptomatsko liječenje topičkim pripravcima, privremeni prekid terapije i/ili prilagodbu doze sorafeniba, odnosno, u teškim ili ustrajnim slučajevima, trajni prekid liječenja sorafenibom (vidjeti dio 4.8).
English: No data is available in patients requiring dialysis (see section 5.2).
Croatian: Nema podataka o primjeni u bolesnika kojima je potrebna dijaliza (vidjeti dio 5.2).
English: Most reports of hypocalcaemia were low grade (CTCAE Grade 1 and 2).
Croatian: U većini izvješća hipokalcemija je bila niskog stupnja (CTCAE stupanj 1 ili 2).
English: Tablet coating: hypromellose, macrogol, titanium dioxide (E 171), ferric oxide red (E 172).
Croatian: Ovojnica tablete: hipromeloza, makrogol, titanijev dioksid (E 171), crveni željezov oksid (E 172).
English: Red, round, biconvex film-coated tablets, debossed with Bayer cross on one side and "200" on the other side.
Croatian: Crvene, okrugle, bikonveksne, filmom obložene tablete, na kojima je s jedne strane utisnut Bayerov znak križa, a s druge strane oznaka “200”.
English: Dogs showed tubular degeneration in the testes and oligospermia.
Croatian: U pasa je došlo do tubularne degeneracije sjemenika i oligospermije.
English: Nexavar is also used to treat kidney cancer (advanced renal cell carcinoma) at an advanced stage when standard therapy has not helped to stop your disease or is considered unsuitable.
Croatian: Nexavar se također primjenjuje za liječenje raka bubrega (uznapredovalog karcinoma bubrežnih stanica) u uznapredovalom stadiju, kada se standardnim liječenjem ne uspijeva zaustaviti bolest, odnosno kada se takvo liječenje smatra neprikladnim.
English: There are limited data from this study in patients with Child Pugh B liver impairment and only one patient with Child Pugh C had been included.
Croatian: Ovo ispitivanje daje ograničene podatke u bolesnika s Child-Pugh B stadijem jetrenog oštećenja, a samo je jedan bolesnik sa Child-Pugh stadijem C bio uključen u ispitivanje.
English: If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of sorafenib should be considered (see section 4.8).
Croatian: Javi li se bilo kakvo krvarenje koje iziskuje medicinsku intervenciju, preporučuje se razmotriti mogućnost trajnog prestanka liječenja sorafenibom (vidjeti dio 4.8).
English: In a clinical pharmacology study, QT/QTc measurements were recorded in 31 patients at baseline (pre-treatment) and post-treatment.
Croatian: U kliničkom farmakološkom ispitivanju, zabilježene su vrijednosti QT/QTc intervala u 31 bolesnika prije početka uzimanja lijeka i nakon liječenja.