FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies 1 and 3 decreased potassium was observed in 5.4% and 9.5% of sorafenib-treated patients compared to 0.7% and 5.9% of placebo patients, respectively.
Slovenian: V študijah 1 in 3 so opazili zmanjšanje vrednosti kalija pri 5,4 % in 9,5 % bolnikov, ki so se zdravili s sorafenibom, oziroma 0,7 % in 5,9 % bolnikov, ki so prejemali placebo.
English: Bayer Oy Puh/Tel: +358 20 785 21
Slovenian: Puh/Tel: +358 20 785 21
English: Study 5 (study 14295) was a Phase III, international, multi-centre, randomised, double blind, placebocontrolled trial in 417 patients with locally advanced or metastatic DTC refractory to radioactive iodine.
Slovenian: Študija 5 (študija 14295) je bilo mednarodno, multicentrično, randomizirano, dvojno slepo, s placebom nadzorovano preskušanje III. faze pri 417 bolnikih z lokalno napredovalim ali metastatskim, diferenciranim karcinomom ščitnice, odpornim na radioaktivni jod.
English: In rats, sorafenib and its metabolites were demonstrated to cross the placenta and sorafenib is anticipated to cause harmful effects on the foetus.
Slovenian: Sorafenib in njegovi presnovki so pri podganah prehajali skozi placento; pričakovati je, da sorafenib škodljivo deluje na plod.
English: This OS analysis showed a statistically significant advantage for sorafenib over placebo for OS (HR: 0.69, p = 0.00058, see table 3).
Slovenian: Kar zadeva celokupno preživetje, je analiza pokazala statistično značilno prednost sorafeniba pred placebom (razmerje ogroženosti: 0,69, p = 0,00058, glejte preglednico 3).
English: The clinical safety and efficacy of sorafenib have been studied in patients with hepatocellular carcinoma (HCC), in patients with advanced renal cell carcinoma (RCC) and in patients with differentiated thyroid carcinoma (DTC).
Slovenian: Klinično varnost in učinkovitost sorafeniba so preučevali pri bolnikih s karcinomom jetrnih celic, bolnikih z napredovalim karcinomom ledvičnih celic in pri bolnikih z diferenciranim karcinomom ščitnice.
English: Nexavar is used to treat thyroid cancer (differentiated thyroid carcinoma).
Slovenian: Zdravilo Nexavar se uporablja za zdravljenje bolnikov z rakom ščitnice (diferencirani karcinom ščitnice).
English: Paclitaxel/carboplatin o Administration of paclitaxel (225 mg/m2) and carboplatin (AUC = 6) with sorafenib (≤ 400 mg twice daily), administered with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration), resulted in no significant effect on the pharmacokinetics of paclitaxel.
Slovenian: Paklitaksel/karboplatin o Uporaba paklitaksela (225 mg/m2) in karboplatina (AUC = 6) s sorafenibom (< 400 mg dvakrat na dan), s 3-dnevnimi prekinitvami v odmerjanju sorafeniba (dva dni pred in na dan aplikacije paklitaksela/karboplatina), ni pokazala pomembnega vpliva na farmakokinetiko paklitaksela.
English: Management of suspected adverse drug reactions may require temporary interruption or dose reduction of sorafenib therapy.
Slovenian: Ob sumu na pojav neželenih učinkov zdravila bo morda treba zdravljenje s sorafenibom začasno prenehati ali zmanjšati odmerek sorafeniba.
English: Study 3 (study 100554) was a Phase III, international, multi-centre, randomised, double blind, placebo-controlled study in 602 patients with hepatocellular carcinoma.
Slovenian: Študija 3 (študija 100554) je bila mednarodna, multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija III. faze pri 602 bolnikih s karcinomom jetrnih celic.
English: Sorafenib accounts for approximately 70 - 85 % of the circulating analytes in plasma at steady state.
Slovenian: V stanju dinamičnega ravnovesja kroži v plazmi približno 70 do 85 % presnovkov sorafeniba.
English: - The other ingredients are: Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
Slovenian: Jedro tablete: premrežen natrijev karmelozat, mikrokristalna celuloza, hipromeloza, natrijev lavrilsulfat, magnezijev stearat.
English: The clinical significance of the increases in sorafenib and paclitaxel exposure, upon co-administration of sorafenib without a break in dosing, is unknown.
Slovenian: Klinično pomembno zvečanje izpostavljenosti sorafenibu in paklitakselu, pri sočasni uporabi s sorafenibom brez prekinitev v odmerjanju, ni znana.
English: No data is available on patients with Child Pugh C (severe) hepatic impairment (see sections 4.4 and 5.2).
Slovenian: Podatkov o bolnikih s hudo okvaro jeter (Child Pugh C) ni na voljo (glejte poglavji 4.4
English: Musculoskeletal and connective tissue disorders arthralgia myalgia muscle spasms rhabdomyolysis
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva artralgija mialgija mišični spazmi rabdomioliza
English: Increased plasma concentrations of P-gp substrates such as digoxin cannot be excluded with concomitant treatment with sorafenib.
Slovenian: Pri sočasni uporabi sorafeniba, zvečanja plazemske koncentracije P-gp substrata, kot je digoksin, ni možno izključiti.
English: Endocrine disorders hypothyroidism hyperthyroidism
Slovenian: Bolezni endokrinega sistema hipotiroidizem hipertiroidizem
English: AST increased
Slovenian: stopnja stopnja
English: Cardiac disorders congestive heart failure* myocardial ischaemia and infarction*
Slovenian: Srčne bolezni kongestivno srčno popuščanje* srčna ishemija in infarkt*
English: Sorafenib is metabolised primarily in the liver and undergoes oxidative metabolism, mediated by CYP 3A4, as well as glucuronidation mediated by UGT1A9.
Slovenian: Sorafenib se presnovi predvsem v jetrih, in sicer z oksidacijo, pri kateri posreduje CYP3A4, in glukuronidacijo, pri kateri posreduje UGT1A9.
English: Median PFS time was 10.8 months in the sorafenib group compared to 5.8 months in the placebo group (HR=0.587; 95% Confidence Interval (CI): 0.454, 0.758; one-sided p <0.0001).
Slovenian: Mediani PFS je bil 10,8 mesecev v skupini bolnikov, ki so se zdravili s sorafenibom v primerjavi s 5,8 meseci v skupini bolnikov, ki so prejemali placebo (RO = 0,587; 95-% IZ: 0,454, 0,758; enostranski p < 0,0001).
English: How to take Nexavar The recommended dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
Slovenian: Priporočeni odmerek zdravila Nexavar za odrasle je 2 tableti po 200 mg, dvakrat na dan.
English: Progression-free survival (PFS) as evaluated by a blinded independent radiological review using RECIST criteria was the primary endpoint of the study.
Slovenian: Primarni končni izid študije je bilo preživetje brez napredovanja (PFS), ovrednoteno s slepo neodvisno oceno radioloških posnetkov po kriterijih RECIST.
English: Reproductive system and breast disorders erectile dysfunction gynaecomastia
Slovenian: Motnje reprodukcije in dojk erektilna disfunkcija ginekomastija
English: Nexavar may lead to a higher risk of bleeding.
Slovenian: Med zdravljenjem z zdravilom Nexavar se lahko zveča tveganje za krvavitve.
English: - If you have severe liver impairment.
Slovenian: - če imate hudo okvaro jeter.
English: Co-administration of capecitabine (750-1050 mg/m2 twice daily, Days 1-14 every 21 days) and sorafenib (200 or 400 mg twice daily, continuous uninterrupted administration) resulted in no significant change in sorafenib exposure, but a 15-50% increase in capecitabine exposure and a 0-52% increase in 5-FU exposure.
Slovenian: Sočasna uporaba kapecitabina (750 - 1050 mg/m2 dvakrat na dan, 1 - 14 dni vsakih 21 dni) s sorafenibom (200 mg ali 400 mg dvakrat na dan, kontinuirana neprekinjena uporaba) ne kaže pomembne spremembe v izpostavljenosti sorafenibu, ampak 15 - 50 % zvečanje izpostavljenosti kapacitabinu in 0 - 52 % zvečanje izpostavljenosti 5-FU.
English: Bayer AB Tel: +46 (0) 8 580 223 00
Slovenian: Tel: +46 (0) 8 580 223 00
English: Progression-free survival in patients with RCC was significantly longer in the sorafenib group (163 days) than in the placebo group (41 days) (p = 0.0001, HR = 0.29).
Slovenian: Pri bolnikih s karcinomom ledvičnih celic, ki so jemali sorafenib, je bilo preživetje brez napredovanja bolezni (PFS) značilno daljše (163 dni), kot pri tistih, ki so prejemali placebo (41 dni) (p = 0,0001, RO = 0,29).
English: Immune system disorders hypersensitivity reactions (including skin reactions and urticaria)
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije (tudi kožne reakcije in koprivnica) anafilaktična reakcija angioedem
English: Female rats showed central necrosis of the corpora lutea and arrested follicular development in the ovaries.
Slovenian: Pri podganjih samicah sta se pojavili centralna nekroza rumenega telesca in zastoj razvoja foliklov v jajčnikih.
English: In clinical trials, certain adverse drug reactions such as hand foot skin reaction, diarrhoea, alopecia, weight decrease, hypertension, hypocalcaemia, and keratoacanthoma/squamous cell carcinoma of skin occurred at a substantially higher frequency in patients with differentiated thyroid compared to patients in the renal cell or hepatocellular carcinoma studies.
Slovenian: Dodatne informacije o posebnih skupinah bolnikov V kliničnih preskušanjih so se nekateri neželeni učinki kot na primer kožne reakcije na dlaneh in podplatih, driska, alopecija, zmanjšanje telesne mase, hipertenzija, hipokalciemija in keratoakantom/ploščatocelični karcinom kože pojavljali pogosteje pri bolnikih z diferenciranim karcinomom ščitnice kot pri bolnikih s karcinomom ledvičnih celic ali karcinomom jetrnih celic.
English: In these studies CTCAE Grade 3 hypokalaemia occurred in 1.1% and 0.4% of sorafenib treated patients and 0.2% and 0.7% of patients in the placebo group.
Slovenian: V teh študijah se je hipokaliemija 3. stopnje po CTCAE pojavila pri 1,1 % in 0,4 % bolnikov, ki so se zdravili s sorafenibom, oziroma pri 0,2 % in 0,7 % bolnikov, ki so prejemali placebo.
English: In study 11213 (RCC) adverse events consistent with congestive heart failure were reported in 1.7% of patients treated with sorafenib and 0.7% receiving placebo.
Slovenian: V študiji 11213 (karcinom ledvičnih celic) so poročali o kongestivnem srčnem popuščanju pri 1,7 % bolnikov, ki so se zdravili s sorafenibom, in 0,7 % bolnikov, ki so prejemali placebo.
English: In study 100554 (HCC), 0.99% of those treated with sorafenib and 1.1% receiving placebo were reported with these events.
Slovenian: V študiji 100554 (karcinom jetrnih celic) so o teh učinkih poročali pri 0,99 % bolnikov, ki so se zdravili s sorafenibom, in pri 1,1 % bolnikov, ki so prejemali placebo.
English: o Co-administration of paclitaxel (225 mg/m2, once every 3 weeks) and carboplatin (AUC=6) with sorafenib (400 mg twice daily, without a break in sorafenib dosing) resulted in a 47% increase in sorafenib exposure, a 29% increase in paclitaxel exposure and a 50% increase in 6OH paclitaxel exposure.
Slovenian: o Sočasna uporaba paklitaksela (225 mg/m2, enkrat na vsake tri tedne) in karboplatina (AUC = 6) s sorafenibom (400 mg dvakrat na dan, brez prekinitev v odmerjanju sorafeniba) zveča izpostavljenost sorafenibu za 47 %, paklitakselu za 29 % in 6-OH paklitakselu za 50 %.
English: Laboratory test abnormalities in HCC (study 3) and RCC (study 1) patients
Slovenian: Nenormalne vrednosti laboratorijskih preiskav pri bolnikih s karcinomom jetrnih celic (študija 3) in karcinomom ledvičnih celic (študija 1)
English: Docetaxel (75 or 100 mg/m2 administered once every 21 days) when co-administered with sorafenib (200 mg twice daily or 400 mg twice daily administered on Days 2 through 19 of a 21-day cycle with a 3-day break in dosing around administration of docetaxel) resulted in a 36-80 % increase in docetaxel AUC and a 16-32 % increase in docetaxel Cmax.
Slovenian: Sočasna uporaba docetaksela (75 ali 100 mg/m2 v enkratnem odmerku vsakih 21 dni) in sorafeniba (200 mg dvakrat na dan ali 400 mg dvakrat na dan od 2. do 19. dne enaindvajset dnevnega ciklusa s tridnevnimi prekinitvami pred uporabo docetaksela) zveča AUC docetaksela za 36 - 80 % in njegov Cmax za 16 - 32 %.
English: Patients with stable disease on therapy with sorafenib were randomised to placebo or continued sorafenib therapy.
Slovenian: Bolniki, pri katerih je bilo pri zdravljenju s sorafenibom stanje stabilno so bili randomizirani v skupino bolnikov, ki so prejemali placebo ali skupino, ki je nadaljevala zdravljenje s sorafenibom.
English: Monitoring of fluid balance and electrolytes in patients at risk of renal dysfunction is advised.
Slovenian: Pri bolnikih s tveganjem za motnje v delovanju ledvic se priporoča spremljanje ravnovesja tekočin in elektrolitov.
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.
Slovenian: Izsledki in vitro testov na celicah sesalcev (jajčniki samic kitajskega hrčka) za klastogenost so bili pozitivni (več strukturnih kromosomskih aberacij v navzočnosti aktivacije presnove).
English: Laboratory test abnormalities in DTC patients (study 5)
Slovenian: Nenormalne vrednosti laboratorijskih preiskav pri bolnikih z diferenciranim karcinomom ščitnice (študija 5)
English: No data is available on patients with Child Pugh C (severe) hepatic impairment.
Slovenian: Podatkov o bolnikih s hudo okvaro jeter (Child Pugh C) ni na voljo.
English: Placebo (N=303)
Slovenian: (N = 303)
English: The reason for the increased concentration in DTC patients is unknown.
Slovenian: Razlog za večjo koncentracijo pri bolnikih z diferenciranim karcinomom ščitnice ni znan.
English: Results from animal studies further indicate that sorafenib can impair male and female fertility (see section 5.3).
Slovenian: Izsledki študij na živalih kažejo, da lahko sorafenib vpliva na sposobnost razmnoževanja tako pri samcih kot samicah (glejte poglavje 5.3).
English: Hepatobiliary disorders increase in bilirubin and jaundice, cholecystitis, cholangitis drug induced hepatitis*
Slovenian: Bolezni jeter, žolčnika in žolčevodov zvečanje vrednosti bilirubina in zlatenica holecistitis holangitis hepatitis zaradi zdravil*
English: In clinical studies sorafenib has been administered with a variety of other anti-neoplastic agents at their commonly used dosing regimens including gemcitabine, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabine, doxorubicin, irinotecan, docetaxel and cyclophosphamide.
Slovenian: V kliničnih študijah so sorafenib uporabljali sočasno z več drugimi učinkovinami z delovanjem na novotvorbe (gemcitabin, cisplatin, oksaliplatin, paklitaksel, karboplatin, kapecitabin, doksorubicin, irinotekan, docetaksel in ciklofosfamid), v običajnih odmerkih.
English: Combination with other agents
Slovenian: Medsebojno delovanje z drugimi zdravili
English: When dose reduction is necessary during the treatment of differentiated thyroid carcinoma (DTC), the Nexavar dose should be reduced to 600 mg sorafenib daily in divided doses (two tablets of 200 mg and one tablet of 200 mg twelve hours apart).
Slovenian: Če je treba odmerek zdravila Nexavar zmanjšati med zdravljenjem diferenciranega karcinoma ščitnice, ga je treba zmanjšati na 600 mg sorafeniba na dan in uporabiti v dveh delih (dve tableti po 200 mg in nato po dvanajstih urah ena tableta po 200 mg).
English: Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.5).
Slovenian: Previdnost je potrebna pri sočasni uporabi sorafeniba in docetaksela (glejte poglavje 4.5).
English: No dose adjustment is required in patients with mild, moderate or severe renal impairment.
Slovenian: Bolnikom z blago, zmerno ali hudo okvaro ledvic odmerka zdravila ni treba prilagajati.
English: How to store Nexavar
Slovenian: Kako jemati zdravilo Nexavar
English: dyspepsia dysphagia gastro oesophageal reflux disease pancreatitis gastritis gastrointestinal perforations*
Slovenian: Bolezni prebavil driska navzea bruhanje zaprtje stomatitis (suha usta in glosodinija) dispepsija disfagija gastroezofagealni refluks vnetje trebušne slinavke gastritis gastrointestinalne perforacije*
English: Do not store above 25°C.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 25 °C.
English: Each film-coated tablet contains 200 mg sorafenib (as tosylate).
Slovenian: Ena filmsko obložena tableta vsebuje 200 mg sorafeniba (v obliki sorafenibijevega tosilata).
English: CTCAE grade 3 hypocalcaemia occurred in 6.8% of sorafenib treated patients and 1.9% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia occurred in 3.4% of sorafenib treated patients and 1.0% of patients in the placebo group.
Slovenian: Hipokalciemija 3. stopnje po CTCAE se je pojavila pri 6,8 % bolnikov, ki so se zdravili s sorafenibom, in pri 1,9 % bolnikov v skupini bolnikov, ki so prejemali placebo, hipokalciemija 4. stopnje po CTCAE pa se je pojavila pri 3,4 % bolnikov, ki so se zdravili s sorafenibom, in pri 1,0 % bolnikov v skupini, ki je prejemala placebo.
English: CTCAE Grade 3 hypophosphataemia (1 - 2 mg/dl) in study 1 occurred in 13 % of sorafenib treated patients and 3 % of patients in the placebo group, in study 3 in 11 % of sorafenib treated patients and 2 % of patients in the placebo group.
Slovenian: Hipofosfatemija 3. stopnje po CTCAE (1 do 2 mg/dl) se je v študiji 1 pojavila pri 13 % bolnikov, ki so se zdravili s sorafenibom, in 3 % bolnikov, ki so prejemali placebo, v študiji 3 pa pri 11 % bolnikov, ki so se zdravili s sorafenibom, in 2 % bolnikov, ki so prejemali placebo.
English: fever asthenia influenza like illness mucosal inflammation
Slovenian: zvišana telesna temperatura astenija gripi podobno bolezensko stanje vnetje sluznice
English: If you are taking warfarin or phenprocoumon, medicines which thin the blood to prevent blood clots, there may be a greater risk of bleeding.
Slovenian: To se zveča tudi pri tistih bolnikih, ki jemljejo varfarin ali fenprokumon, zdravili, ki redčita kri in tako preprečujeta nastanek krvnih strdkov.
English: There is no evidence that Nexavar will affect the ability to drive or to operate machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Dokazov o vplivu zdravila Nexavar na sposobnost vožnje ali upravljanja strojev ni.
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).
Slovenian: V in vitro bakterijskem testu (Amesov test) je bil eden od vmesnih produktov sinteze sorafeniba, ki se nahaja tudi v končni učinkovini (< 0,15 %) pozitiven na mutagenost.
English: There is no evidence that sorafenib affects the ability to drive or to operate machinery.
Slovenian: Dokazov o vplivu sorafeniba na sposobnost vožnje ali upravljanja strojev ni.
English: No dose adjustment is required in patients with Child Pugh A or B (mild to moderate) hepatic impairment.
Slovenian: Bolnikom z blago do zmerno hudo okvaro jeter (Child Pugh A ali B) odmerka zdravila ni treba prilagajati.
English: - Holes in the gut wall (gastrointestinal perforation) may occur during treatment (see section 4:
Slovenian: - Med zdravljenjem lahko pride do predrtja želodčne/črevesne stene (gastrointestinalna perforacija) (glejte poglavje 4, Možni neželeni učinki).
English: Renal impairment
Slovenian: - odpoved ledvic
English: The median PFS was 167 days for patients randomised to sorafenib compared to 84 days for placebo patients (HR = 0.44; 95 % CI: 0.35 - 0.55; p < 0.000001).
Slovenian: Mediana PFS je bila pri bolnikih, ki so se zdravili s sorafenibom 167 dni in pri tistih, ki so prejemali placebo 84 dni (RO = 0,44; 95-% IZ: 0,350,55; p < 0,000001).
English: The aetiology of hypocalcaemia associated with sorafenib is not known.
Slovenian: Vzrok hipokalciemije, povezane z uporabo sorafeniba, ni znan.
English: Bayer, spol.
Slovenian: Slovenská republika Bayer spol.
English: CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphopenia and neutropenia.
Slovenian: Nenormalne vrednosti laboratorijskih preiskav 3. ali 4. stopnje po CTCAE (limfopenija in nevtropenija) so se pojavile pri ≥ 5 % bolnikov, ki so se zdravili s sorafenibom.
English: The aetiology of hypophosphataemia associated with sorafenib is not known.
Slovenian: Vzrok hipofosfatemije, povezane z uporabo sorafeniba, ni znan.
English: Blood and lymphatic system disorders lymphopenia leucopenia neutropenia anaemia thrombocytopenia
Slovenian: Bolezni krvi in limfatičnega sistema limfopenija levkopenija nevtropenija anemija trombocitopenija
English: In study 3 (see section 5.1) the incidence of treatmentemergent cardiac ischaemia/infarction events was 2.7 % in sorafenib patients compared with 1.3 % in the placebo group.
Slovenian: V študiji 3 (glejte poglavje 5.1) je bila incidenca srčne ishemije/infarkta, ki se je pojavila med zdravljenjem, 2,7 % pri bolnikih, ki so se zdravili s sorafenibom, in 1,3 % pri bolnikih, ki so prejemali placebo.
English: The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Slovenian: In vitro sta si učinka glavnega presnovka sorafeniba v plazmi, piridin N-oksida in sorafeniba, podobna.
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.
Slovenian: Tako zdravnik oceni, ali je treba odmerke zdravil za zdravljenje sladkorne bolezni prilagoditi, da se zmanjša tveganje za nizke vrednosti sladkorja v krvi.
English: Nexavar 200 mg tablets sorafenib
Slovenian: Nexavar 200 mg tablete sorafenib
English: No specific studies with sorafenib have been conducted in animals to evaluate the effect on fertility.
Slovenian: Posebnih študij za oceno vpliva na sposobnost razmnoževanja pri živalih niso izvedli.
English: Hypocalcaemia was reported in 12% and 26.5% of sorafenib treated patients compared to 7.5% and 14.8% of placebo patients in study 1 and study 3, respectively.
Slovenian: O hipokalciemiji so v študiji 1 poročali pri 12 % bolnikov, ki so se zdravili s sorafenibom v primerjavi s 7,5 % bolnikov, ki so prejemali placebo, v študiji 3 pa pri 26,5 % bolnikov, ki so se zdravili s sorafenibom v primerjavi s 14,8 % bolnikov, ki so prejemali placebo.
English: Bayer plc Tel: +44 (0) 118 206 3000
Slovenian: Tel: +44-(0) 118 206 3000
English: Hypokalemia
Slovenian: Hipoglikemija
English: Nexavar is used to treat liver cancer (hepatocellular carcinoma).
Slovenian: Zdravilo Nexavar se uporablja za zdravljenje bolnikov z rakom jeter (karcinom jetrnih celic).
English: Renal and urinary disorders renal failure proteinuria nephrotic syndrome
Slovenian: Bolezni sečil odpoved ledvic proteinurija nefrotski sindrom
English: Croscarmellose sodium Microcrystalline cellulose Hypromellose Sodium laurilsulfate Magnesium stearate
Slovenian: Jedro tablete: premrežen natrijev karmelozat mikrokristalna celuloza hipromeloza natrijev lavrilsulfat magnezijev stearat
English: Icepharma hf. Sími: +354 540 8000
Slovenian: Sími: +354 540 8000
English: may affect more than 1 in 10 people - diarrhoea - feeling sick (nausea) - feeling weak or tired (fatigue) - pain (including mouth pain, abdominal pain, headache, bone pain, tumour pain) - hair loss (alopecia) - flushed or painful palms or soles (hand foot skin reaction) - itching or rash - throwing up (vomiting) - bleeding (including bleeding in the brain, gut wall and respiratory tract; haemorrhage) - high blood pressure, or increases in blood pressure (hypertension) - infections - loss of appetite (anorexia) - constipation - joint pain (arthralgia) - fever - weight loss - dry skin
Slovenian: - občutek slabosti (navzea) - občutek oslabelosti ali utrujenosti (izčrpanost) - bolečine (tudi bolečine v ustih, trebuhu, glavobol, bolečine v kosteh, bolečine v predelu tumorja) - izpadanje las (alopecija) - pordele ali boleče dlani ali podplati (kožne reakcije na dlaneh in podplatih) - srbenje ali izpuščaji - bruhanje - krvavitev (tudi krvavitve v možganih, črevesni steni in dihalih; hemoragija) - visok krvni tlak ali zvišanje krvnega tlaka (hipertenzija) - okužbe - izguba apetita (anoreksija) - zaprtje - bolečine v sklepih (artralgija)