FrancophonIA/ELRC3.0 huggingface dataset:
English: CTCAE grade 3 hypocalcaemia (6.0 - 7.0 mg /dL) occurred in 1.1% and 1.8% of sorafenib treated patients and 0.2% and 1.1% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia (< 6.0 mg/dL) occurred in 1.1% and 0.4% of sorafenib treated patients and 0.5% and 0% of patients in the placebo group in study 1 and 3, respectively.
Croatian: Hipokalcemija CTCAE stupnja 3 (6,0-7,0 mg/dl) zabilježena je u 1,1% i 1,8% bolesnika liječenih sorafenibom te u 0,2% i 1,1% bolesnika u skupini koja je primala placebo, a hipokalcijemija CTCAE stupnja 4 (< 6,0 mg/dl) u 1,1% i 0,4% bolesnika liječenih sorafenibom te kod 0,5% i 0% bolesnika u skupini koja je primala placebo u ispitivanjima 1 odnosno 3.
English: Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patients compared to 12 % and 11 % of placebo patients in study 1 and study 3, respectively.
Croatian: Hipofosfatemija je bila vrlo česti laboratorijski nalaz, primijećen u 45% odnosno 35% bolesnika liječenih sorafenibom u usporedbi s 12% odnosno 11% bolesnika koji su primali placebo u ispitivanju 1 odnosno 3.
English: - The other ingredients are: Tablet core: croscarmellose sodium, microcrystalline cellulose, hypromellose, sodium laurilsulfate, magnesium stearate.
Croatian: Jezgra tablete: umrežena karmelozanatrij, mikrokristalična celuloza, hipromeloza, natrijev laurilsulfat, magnezijev stearat.
English: CTCAE Grade 3 or 4 lipase elevations occurred in 11 % and 9 % of patients in the sorafenib group in study 1 (RCC) and study 3 (HCC), respectively, compared to 7 % and 9 % of patients in the placebo group.
Croatian: Povišenje lipaze CTCAE stupnja 3 ili 4 zabilježeno je u 11% odnosno 9% bolesnika u skupini liječenoj sorafenibom u ispitivanju 1 (RCC) odnosno ispitivanju 3 (HCC), u usporedbi sa 7% i 9% bolesnika u skupini koja je primala placebo.
English: Demographics and baseline disease characteristics were comparable between the sorafenib and the placebo group with regard to ECOG status (status 0: 54 % vs. 54 %; status 1: 38 % vs. 39 %; status 2: 8 % vs. 7 %), TNM stage (stage I: <1 % vs. <1 %; stage II: 10.4 % vs. 8.3 %; stage III: 37.8 % vs. 43.6 %; stage IV: 50.8 % vs. 46.9 %), and BCLC stage (stage B: 18.1 % vs. 16.8 %; stage C: 81.6 % vs. 83.2 %; stage D: < 1 % vs. 0 %).
Croatian: Demografske i karakteristike osnovne bolesti bile su usporedive između grupe koja je uzimala sorafenib i placebo grupe s obzirom na ECOG (Eastern Cooperative Oncology Group) status (status 0: 54% naspram 54%; status 1. 38% naspram 39%; status 2:8% naspram 7%), TNM stadiju (stadij I: < 1% naspram < 1%; stadij II 10,4% naspram 8,3%; stadij III:
English: Hand foot skin reaction (palmar-plantar erythrodysaesthesia) and rash represent the most common adverse drug reactions with sorafenib.
Croatian: Reakcija kože šaka i stopala (palmarno-plantarna eritrodizestezija) i osip najčešće su nuspojave izazvane sorafenibom.
English: In study 5 (see section 5.1), increases in TSH levels above 0.5mU/L were observed in sorafenib treated patients.
Croatian: U ispitivanju 5 (vidjeti dio 5.1), u bolesnika liječenih sorafenibom bilo je opaženo povećanje koncentracije TSH iznad 0,5 mU/l.
English: Hepatobiliary disorders increase in bilirubin and jaundice, cholecystitis, cholangitis drug induced hepatitis*
Croatian: Poremećaji jetre i žuči povišenje razina bilirubina i žutica, kolescistitis, kolangitis hepatitis izazvan lijekovima*
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).
Croatian: U oboljelih od RCC-a liječenih sorafenibom, preživljenje tijekom kojeg osnovna bolest nije napredovala bilo je značajno dulje (163 dana), nego u skupini liječenoj placebom (41 dan) (p = 0,0001, HR = 0,29).
English: An adverse effect on male and female fertility can however be expected because repeat-dose studies in animals have shown changes in male and female reproductive organs at exposures below the anticipated clinical exposure (based on AUC).
Croatian: Može se očekivati štetni učinak na mušku i žensku plodnost, budući da su ispitivanja primjene ponavljanih doza na životinjama pokazala promjene na reproduktivnim organima mužjaka i ženki pri izloženosti nižoj od predviđene za kliničku primjenu (na temelju AUC-a) . U tipične promjene su spadali znaci degeneracije i zastoja u rastu sjemenika, pasjemenika, prostate i sjemenih vesikula u štakora.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05 Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and antiangiogenic properties in vitro and in vivo.
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE05
English: There were no cases of CTCAE Grade 4 hypophosphataemia (< 1 mg/dl) reported in either sorafenib or placebo patients in study 1, and 1 case in the placebo group in study 3.
Croatian: Nije bilo slučajeva hipofosfatemije CTCAE stupnja 4 (< 1 mg/dl) bilo kod bolesnika liječenih sorafenibom niti u bolesnika koji su primali placebo u ispitivanju 1, no zabilježen je jedan slučaj u skupini koja je primala placebo u ispitivanju
English: MedDRA. ° Cases have been reported in the post marketing setting.
Croatian: ° Slučajevi su bili zabilježeni nakon stavljanja lijeka u promet.
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.
Croatian: Istodobna primjena kapecitabina (750-1050 mg/m2 dvaput dnevno, u trajanju od 14 dana sa 7 dana pauze) i sorafeniba (200 ili 400 mg dvaput dnevno, kontinuirana, neprekinuta primjena) nije dovela do značajne promjene izloženosti sorafenibu, ali je došlo do porasta od 15-50% u izloženosti kapecitabinu te porastu od 0-52% u izloženosti 5-FU.
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.
Croatian: o Istodobna primjena paklitaksela (225 mg/m2, jednom svaka 3 tjedna) i karboplatina (AUC = 6) sa sorafenibom (400 mg dva puta dnevno bez prekida u doziranju sorafeniba) dovela je do 47%-tnog povećanja izloženosti sorafenibu, do 29%-tnog povećanja izloženosti paklitakselu, te do 50%tnog sniženja izloženosti 6-OH paklitakselu.
English: Combination with other anti-neoplastic agents
Croatian: Kombinacija s drugim antineoplasticima
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.
Croatian: Hipokalcemija 3. stupnja prema CTCAE nastala je u 6,8% bolesnika liječenih sorafenibom i 1,9% bolesnika u skupini koja je primala placebo, dok je hipokalcemija 4. stupnja prema CTCAE nastala u 3,4% bolesnika liječenih sorafenibom i 1,0% bolesnika u skupini koja je primala placebo.
English: No specific studies with sorafenib have been conducted in animals to evaluate the effect on fertility.
Croatian: Ispitivanja na životinjama, specifično usmjerene na vrednovanje učinka sorafeniba na plodnost, nisu provedena.
English: Multiple dosing of sorafenib for 7 days resulted in a 2.5- to 7-fold accumulation compared to single dose administration.
Croatian: U usporedbi s jednokratnom primjenom sorafeniba, njegova višekratna primjena u trajanju od 7 dana rezultirala je 2,5 do 7 puta većim nakupljanjem lijeka u organizmu.
English: The median OS was not reached in the sorafenib arm and was 36.5 months in the placebo arm. One hundred fifty seven (75%) patients randomised to placebo and 61 (30%) patients randomised to sorafenib received open-label sorafenib.
Croatian: Sto pedeset sedam bolesnika (75%) bilo je randomizirano u skupinu koja je primala placebo i 61 (30%) bolesnik bio je randomiziran u skupinu koja je otvoreno primala sorafenib.
English: No single cause of death dominated, but higher incidence of respiratory failure, hemorrhages and infectious adverse events were observed in patients treated with sorafenib as add-on to platinum-based chemotherapies.
Croatian: Nije prevladavao jedan uzrok smrti, već je u bolesnika liječenih sorafenibom kao dodatkom kemoterapijama na bazi platine uočena viša incidencija nuspojava zatajenja disanja, krvarenja i infekcija.
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.
Croatian: U ovim ispitivanjima hipokalemija CTCAE stupnja 3 zabilježena je u 1,1 % odnosno 0,4 % u bolenika liječenih sorafenibom i u 0,2 % odnosno 0,7 % bolesnika koji su primali placebo.
English: There is no evidence that sorafenib affects the ability to drive or to operate machinery.
Croatian: Nema nikakvih dokaza da sorafenib djeluje na sposobnost upravljanja vozilima, odnosno rukovanja strojevima.
English: There are no data for patients with Child-Pugh C (severe) hepatic impairment.
Croatian: Nema podataka za bolesnike s oštećenjem jetrene funkcije stadija Child-Pugh C (teško).
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.
Croatian: Hipofosfatemija CTCAE stupnja 3 (1-2 mg/dl) u ispitivanju 1 pojavila se u 13% bolesnika liječenih sorafenibom i 3% bolesnika u skupini koja je primala placebo te u ispitivanju 3 u 11% bolesnika liječenih sorafenibomte u 2% bolesnika u skupini koja je primala placebo.
English: The aetiology of hypophosphataemia associated with sorafenib is not known.
Croatian: 3. Etiologija hipofosfatemije povezane sa sorafenibom nije poznata.
English: Musculoskeletal and connective tissue disorders arthralgia myalgia muscle spasms rhabdomyolysis
Croatian: Poremećaji mišićnokoštanog sustava i vezivnog tkiva artralgija mijalgija mišićni grčevi rabdomioliza
English: In hepatocellular carcinoma (HCC) patients with Child-Pugh A or B (mild to moderate) hepatic impairment, exposure values were comparable and within the range observed in patients without hepatic impairment.
Croatian: U oboljelih od hepatocelularnog karcinoma s oštećenjem jetrene funkcije stadija Child-Pugh A ili B (blago do umjereno), izloženost lijeku nakon terapijske primjene je bila usporediva i kretala se u istom rasponu kao i u bolesnika uredne jetrene funkcije.
English: The median survival was 19.3 months for patients randomised to sorafenib compared to 15.9 months for placebo patients (HR = 0.77; 95 % CI: 0.63 - 0.95; p = 0.015).
Croatian: U bolesnika randomiziranih u skupinu koja je primala sorafenib, medijan preživljenja iznosio je 19,3 mjeseca, a u bolesnika randomiziranih u skupinu koja je primala placebo 15,9 mjeseci (HR = 0,77; 95%-ni CI: 0,63-0,95; p = 0,015).
English: Nexavar 200 mg tablets sorafenib
Croatian: Nexavar 200 mg tablete sorafenib
English: (drug induced hepatitis) - a sunburn-like rash that may occur on skin that has previously been exposed to radiotherapy and can be severe (radiation recall dermatitis) - serious reactions of the skin and/or mucous membranes which may include painful blisters and fever, including extensive detachment of the skin (Stevens-Johnson syndrome and toxic epidermal necrolysis) - abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis) - damage of the kidney causing them to leak large amounts of protein (nephrotic syndrome) - inflammation of the vessels in the skin which may result in rash (leucocytoclastic vasculitis)
Croatian: - osip nalik opeklinama od sunca koji se može javiti na koži koja je prethodno bila izložena radioterapiji i može biti težak (recidiv radijacijskog dermatitisa) - ozbiljne kožne reakcije i/ili reakcije na sluznici koje mogu uključiti bolne mjehure i vrućicu, uključujući i opsežno odvajanje kože (Stevens-Johnsonov sindrom i toksična epidermalna nekroliza)
English: CTCAE Grade 3 or 4 amylase elevations were reported in 1 % and 2 % of patients in the sorafenib group in study 1 and study 3, respectively, compared to 3 % of patients in each placebo group.
Croatian: CTCAE povišenja amilaze stupnja 3 ili 4 prijavljena su u 1% odnosno 2% bolesnika u skupini koja je primala sorafenib u ispitivanju 1 odnosno ispitivanju 3, u usporedbi s 3% bolesnika u svakoj od placebo skupina.
English: aneurysms and artery dissections
Croatian: Aneurizme i disekcije arterije
English: Aneurysms and artery dissections
Croatian: aneurizme i disekcije arterije
English: Your doctor will decide when to start with Nexavar again.
Croatian: O tome kada treba ponovno započeti s primjenom lijeka Nexavar, odlučit će Vaš liječnik.
English: An increased incidence of arterial hypertension was observed in sorafenib-treated patients.
Croatian: U bolesnika liječenih sorafenibom uočeno je povećanje incidencije arterijske hipertenzije.
English: Female rats showed central necrosis of the corpora lutea and arrested follicular development in the ovaries.
Croatian: U ženki štakora došlo je do središnje nekroze žutog tijela i zastoja u razvoju folikula u jajnicima.
English: Further information on selected adverse drug reactions
Croatian: Dodatne informacije o odabranim nuspojavama
English: Luxembourg / Luxemburg
Croatian: Luxembourg/Luxemburg Bayer SA-NV
English: Metabolism and nutrition disorders
Croatian: Poremećaji metabolizma i prehrane Hipokalemija
English: Each film-coated tablet contains 200 mg sorafenib (as tosylate).
Croatian: Jedna filmom obložena tableta sadrži 200 mg sorafeniba (u obliku sorafenibtosilata).
English: In the event of suspected overdose sorafenib should be withheld and supportive care instituted where necessary.
Croatian: Posumnja li se na predoziranje, uzimanje sorafeniba treba prekinuti, te po potrebi provesti suportivnu terapiju.
English: Posology adjustments
Croatian: Prilagodbe doze
English: Placebo (N=303)
Croatian: (N = 303)
English: Taking too much Nexavar makes side effects more likely or more severe, especially diarrhoea and skin reactions.
Croatian: Nakon uzimanja prekomjerne količine lijeka Nexavar, nuspojave, a posebno proljev i reakcije na koži, postaju vjerojatnije, odnosno teže.
English: Hypokalemia
Croatian: Hipoglikemija
English: Bilirubin increased
Croatian: Povišena lipaza
English: m. b. H. Tel: +43-(0)1-711 46-0
Croatian: Bayer Austria Ges.m.b.H. Tel: +43-(0)1-711 46-0
English: Temporary or permanent discontinuation of sorafenib should be considered in patients who develop cardiac ischaemia and/or infarction (see section 4.8).
Croatian: U bolesnika koji razviju srčanu ishemiju i/ili infarkt miokarda, treba razmotriti privremeni ili trajni prestanak liječenja sorafenibom (vidjeti dio 4.8).
English: Sorafenib inhibits tumour growth of a broad spectrum of human tumour xenografts in athymic mice accompanied by a reduction of tumour angiogenesis.
Croatian: U miševa kojima je odstranjen timus, sorafenib inhibira rast širokog spektra humanih tumorskih ksenotransplantata i smanjuje angiogenezu u tumorskom tkivu.
English: Cases of renal failure have been reported.
Croatian: Prijavljeni su slučajevi zatajenja bubrega.
English: The median duration of response was 309 days (95% CI: 226,505 days) in sorafenib treated patients who experienced a PR.
Croatian: U bolesnika liječenih sorafenibom koji su imali djelomični odgovor, medijan trajanja odgovora iznosio je 309 dana (95% CI:226, 505 dana).
English: No dose adjustment is required in patients with Child Pugh A or B (mild to moderate) hepatic impairment.
Croatian: U bolesnika s oštećenjem funkcije jetre stadija Child-Pugh A ili B (blago do umjereno oštećenje) dozu lijeka nije potrebno prilagođavati.
English: dyspepsia dysphagia gastro oesophageal reflux disease pancreatitis gastritis gastrointestinal perforations*
Croatian: Poremećaji probavnog sustava proljev mučnina povraćanje konstipacija stomatitis (uključujući suhoću u ustima i glosodiniju) dispepsija disfagija gastroezofagealna refluksna bolest pankreatitis gastritis gastrointestinalne perforacije*
English: - If you have a heart disorder, such as an abnormal electrical signal called "prolongation of the QT interval".
Croatian: Liječnik može odlučiti privremeno prekinuti liječenje, ili ga posve obustaviti. - ako imate poremećaj u radu srca, poput poremećenog električnog signala koji se zove „produljenje QT intervala“.
English: Croscarmellose sodium Microcrystalline cellulose Hypromellose Sodium laurilsulfate Magnesium stearate
Croatian: Jezgra tablete: karmelozanatrij, umrežena celuloza, mikrokristalična hipromeloza natrijev laurilsulfat magnezijev stearat
English: There is no specific treatment for sorafenib overdose.
Croatian: Dođe li do predoziranja sorafenibom, specifičnog liječenja nema.
English: may affect up to 1 in 10 people - flu-like illness - indigestion (dyspepsia) - difficulty swallowing (dysphagia) - inflamed or dry mouth, tongue pain (stomatitis and mucosal inflammation) - low calcium levels in the blood (hypocalcaemia) - low potassium levels in the blood (hypokalaemia) - low blood sugar level (hypoglycaemia) - muscle pain (myalgia) - disturbed sensations in fingers and toes, including tingling or numbness (peripheral sensory neuropathy) - depression - erection problems (impotence) - altered voice (dysphonia) - acne - inflamed, dry or scaly skin that sheds (dermatitis, skin desquamation) - heart failure - heart attack (myocardial infarction) or chest pain - tinnitus (ringing sound in the ear) - kidney failure - abnormally high levels of protein in the urine (proteinuria) - general weakness or loss of strength (asthenia) - decrease in the number of white blood cells (leucopenia and neutropenia) - decrease in the number of red blood cells (anaemia) - low number of platelets in the blood (thrombocytopenia) - inflammation of hair follicles (folliculitis) - underactive thyroid gland (hypothyroidism) - low sodium levels in the blood (hyponatraemia) - distortion of the sense of taste (dysgeusia) - red in the face and often other areas of the skin (flushing) - runny nose (rhinorrhoea) - heartburn (gastro oesophageal reflux disease) - skin cancer (keratoacanthomas/squamous cell cancer of the skin) - a thickening of the outer layer of the skin (hyperkeratosis) - a sudden, involuntary contraction of a muscle (muscle spasms)
Croatian: - depresija - problemi s erekcijom (impotencija) - promijenjen glas (disfonija) - akne - upaljena, suha ili ljuskava koža koja se ljušti (dermatitis, deksvamacija kože) - zatajenje srca - srčani udar (infarkt miokarda) ili bol u prsištu - šum u ušima (tinitus) - zatajenje bubrega - abnormalno visoke razine proteina u mokraći (proteinurija) - opća slabost ili gubitak snage (astenija) - smanjenje broja bijelih krvnih stanica (leukopenija i neutropenija) - smanjenje broja crvenih krvnih stanica (anemija) - nizak broj krvnih pločica u krvi (trombocitopenija) - upala folikula dlake (folikulitis) - smanjena aktivnost štitne žlijezde (hipotireoza) - niske razine natrija u krvi (hiponatremija) - promijenjen osjet okusa (disgeuzija) - crvenilo lica i često drugih područja kože (navale crvenila) - curenje iz nosa (rinoreja)
English: Bayer plc Tel: +44 (0) 118 206 3000
Croatian: Tel: +44-(0) 118 206 3000
English: In four Phase I clinical trials, steady state exposure to sorafenib was similar in patients with mild or moderate renal impairment compared to the exposures in patients with normal renal function.
Croatian: U okviru četiri ispitivanja I. faze, izloženost sorafenibu u stanju dinamičke ravnoteže, u bolesnika čija je bubrežna funkcija blago do umjereno poremećena, bila je podjednaka izloženosti u bolesnika s normalnom bubrežnom funkcijom.
English: Patients with stable disease on therapy with sorafenib were randomised to placebo or continued sorafenib therapy.
Croatian: Bolesnici liječeni sorafenibom, čija je osnovna bolest bila klinički stabilna, randomizirani su u skupinu koju će se nadalje liječiti placebom, odnosno u skupinu koju će se nastaviti liječiti sorafenibom.
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).
Croatian: U bolesnika randomiziranih u skupinu koju će se liječiti sorafenibom, medijan PFS-a iznosio je 167 dana, a u onih randomiziranih u skupinu koja je primala placebo 84 dana (omjer hazarda [HR] = 0,44; 95%-ni CI: 0,35-0,55; p< 0,000001).
English: Nexavar 200 mg film-coated tablets sorafenib
Croatian: Nexavar 200 mg filmom obložene tablete sorafenib
English: No formal studies of the effect of sorafenib on wound healing have been conducted.
Croatian: Ciljana ispitivanja učinka sorafeniba na cijeljenje rana nisu provedena.
English: Renal and urinary disorders renal failure proteinuria nephrotic syndrome
Croatian: Poremećaji bubrega i mokraćnog sustava zatajenje bubrega proteinurija nefrotski sindrom
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
Croatian: - mučnina - osjećaj slabosti, odnosno umora - bol (uključujući bol u ustima, bol u trbuhu, glavobolju, bol u kostima, bol prouzročenu tumorom) - ispadanje kose (alopecija) - zacrvenjeli ili bolni dlanovi i tabani (kožna reakcija na šakama i stopalima) - svrbež ili osip - povraćanje - krvarenje (uključujući krvarenje u mozgu, stijenci crijeva, te dišnom sustavu) - visok krvni tlak, ili povišenje krvnog tlaka (hipertenzija) - infekcije - gubitak apetita (anoreksija) - zatvor - bol u zglobovima (artralgija) - vrućica - gubitak na tjelesnoj težini - suha koža
English: Therefore, the decision to resume sorafenib therapy following a major surgical intervention should be based on clinical judgement of adequate wound healing.
Croatian: Stoga takvu odluku valja temeljiti na kliničkoj prosudbi primjerenog cijeljenja rane.
English: Each tablet contains 200 mg of sorafenib (as tosylate).
Croatian: TVARI Jedna tableta sadrži 200 mg sorafeniba (u obliku sorafenibtosilata).
English: may affect up to 1 in 100 people - inflamed stomach lining (gastritis) - pain in the tummy (abdomen) caused by pancreatitis, inflammation of the gall bladder and/or bile ducts - yellow skin or eyes (jaundice) caused by high levels of bile pigments (hyperbilirubinaemia) - allergic like reactions (including skin reactions and hives) - dehydration - enlarged breasts (gynaecomastia) - breathing difficulty (lung disease) - eczema - overactive thyroid gland (hyperthyroidism) - multiple skin eruptions (erythema multiforme) - abnormally high blood pressure - holes in the gut wall (gastrointestinal perforation) - reversible swelling in the rear part of the brain that can be associated with headache, altered consciousness, fits and visual symptoms including visual loss (reversible posterior leukoencephalopathy) - a sudden, severe allergic reaction (anaphylactic reaction)
Croatian: Manje često: mogu se javiti u do 1 na 100 osoba - upala želučane sluznice (gastritis) - bol u trbuhu (abdomenu) uzrokovana upalom gušterače, upalom žučnog mjehura i/ili žučovoda - žuta koža i oči (žutica) uzrokovane visokim razinama žučnog pigmenta (hiperbilirubinemija) - reakcije slične alergijskima (uključujući kožne reakcije i koprivnjaču) - dehidracija - povećanje dojki (ginekomastija) - poteškoće disanja (bolest pluća) - ekcem - pojačana aktivnost štitne žlijezde (hipertireoza) - višestruko izbijanje kožnih promjena (multiformni eritem) - abnormalno visoki krvni tlak