FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies conducted in vitro have shown that tivozanib is not a potent inhibitor of UGT (UDP-glucuronosyltransferase) metabolic activities and clinically relevant drug-drug interactions are unlikely with medicinal products metabolised by these pathways.
Croatian: Ispitivanja provedena in vitro pokazuju da tivozanib nije potentni inhibitor metabolitičkih aktivnosti UGT-a (UDP-glukuronoziltransferaze) i klinički značajne interakcije među lijekovima nisu vjerojatne s lijekovima koji se metaboliziraju ovim putovima.
English: In nonclinical studies assessing mating and fertility parameters in male rats, doses > 2-fold higher than the recommended clinical dose, produced increased epididymis and testis weights associated with infertility.
Croatian: U nekliničkim ispitivanjima kojima su se ocjenjivali parametri parenja i plodnosti kod mužjaka štakora, doze > 2 puta više od preporučenih kliničkih doza uzrokovale su povećanje težine epididimisa i testisa povezano s neplodnošću.
English: median OS was 28.2 months (95% CI 22.5, 33.0) in the tivozanib arm compared to 30.8 months (95% CI 28.4, 33.3) in the sorafenib arm (HR=1.147, p=0.276).
Croatian: Medijan ukupnog preživljenja (OS) bio je 28,2 mjeseca (95% CI: 22,5; 33,0) u skupini s tivozanibom u usporedbi s 30,8 mjeseci (95% CI: 28,4; 33,3) u skupini sa sorafenibom (HR=1,147; p=0,276).
English: There were no deaths due to arterial thromboembolic adverse reactions in those receiving tivozanib as initial therapy but a myocardial infarction in a patient receiving second-line tivozanib had a fatal outcome.
Croatian: Nije bilo smrtnih ishoda zbog arterijskih tromboembolijskih nuspojava u bolesnika koji su primali tivozanib kao inicijalnu terapiju, ali je infarkt miokarda u jednog bolesnika koji je primao tivozanib kao drugu liniju liječenja bio sa smrtnim ishodom.
English: If you are already taking a medicine to treat high blood pressure, and your doctor reduces the dose of Fotivda or interrupts or stops treatment, you will be regularly checked for low blood pressure.
Croatian: Ako već uzimate lijek za snižavanje visokog krvnog tlaka i Vaš liječnik smanji dozu Fotivde ili privremeno ili potpuno prekine terapiju, morate redovito kontrolirati krvni tlak da ne bi bio prenizak.
English: • Tiredness; unusual weakness; pain (including in the mouth, bone, extremities, side of the body,
Croatian: • Umor; neuobičajena slabost; bol (uključujući i bol u ustima, kostima, ekstremitetima, jednoj strani tijela, preponama, tumoru)
English: • if you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Croatian: • ako imate ili ste imali aneurizmu (proširenje i slabljenje stijenke krvne žile) ili rascjep stijenke krvne žile.
English: • Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
Croatian: • Omaglica, zvonjenje u ušima, omaglica i osjećaj vrtoglavice (vertigo)
English: • Rashes with pus; fungal infections.
Croatian: • Gnojni osip; gljivične infekcije
English: OS was a key secondary endpoint in the pivotal study and the analysis included data from all randomized patients, including those who progressed on sorafenib and crossed over to receive tivozanib as part of the extension study.
Croatian: Ukupno preživljenje (OS) bilo je ključna sekundarna mjera ishoda pivotalnog ispitivanja, a analiza je obuhvatila podatke svih randomiziranih bolesnika, uključujući i one kod kojih je primijećena progresija sa sorafenibom i koji su bili prebačeni na tivozanib kao dio nastavka ispitivanja.
English: Hypothyroidism was reported as an adverse reaction for 5.6% of patients during initial therapy and was CTC Grade 2 or lower in all cases.
Croatian: Hipotireoza je prijavljena kao nuspojava u 5,6% bolesnika tijekom inicijalne terapije i u svim slučajevima bila je CTC 2. stupnja ili niža.
English: • Rapid heart rate; tightness of the chest; heart attack/reduced blood flow to heart; blood clot in an artery (blood vessel).
Croatian: • Ubrzan rad srca; stezanje u prsima; srčani udar/smanjen dotok krvi u srce; ugrušak u arteriji
English: QT prolongation was reported in two patients (CTC Grade 2 and Grade 3) in the tivozanib cardiac safety study, neither reaction was considered serious (see section 4.4 and section 5.1).
Croatian: Produženje QT intervala prijavljeno je kod dva bolesnika (CTC 2. i 3. stupanj) u ispitivanju sigurnosti tivozaniba za srce; nijedna reakcija nije smatrana ozbiljnom (vidjeti dio 4.4 i dio 5.1).
English: Albumin is the major tivozanib binding component in human plasma.
Croatian: Albumin je glavna komponenta koja veže tivozanib u krvnoj plazmi čovjeka.
English: In vitro studies have shown that tivozanib is neither a substrate nor inhibitor of the transporter proteins MDR1 (P-gp), OCT1, OATP1B1, OATP1B3 and BSEP.
Croatian: In vitro ispitivanja pokazuju da tivozanib nije ni supstrat niti inhibitor transportnih proteina MDR1 (Pgp), OCT1, OATP1B1, OATP1B3 i BSEP.
English: Management of cardiac failure events may require temporary interruption or permanent discontinuation and/or dose reduction of tivozanib therapy, plus treatment of potential underlying causes of cardiac failure e.g. hypertension.
Croatian: Postupanje u slučaju zatajenja srca može zahtijevati privremeni prekid ili trajno obustavljanje i/ili smanjenje doze tivozaniba uz dodatno liječenje potencijalnih podležećih uzroka zatajenja srca, npr. hipertenzije.
English: Herbal preparations containing St. John's wort (Hypericum perforatum) are contraindicated.
Croatian: Biljni preparati koji sadrže gospinu travu (Hypericum perforatum) su kontraindicirani.
English: Furthermore, tivozanib was not an in vitro inhibitor of OAT1, OAT3, OCT2, MATE1 and MATE2-K or substrate of MRP2 and BCRP.
Croatian: Nadalje, tivozanib in vitro nije bio inhibitor OAT1, OAT3, OCT2, MATE1 i MATE2-K niti supstrat proteina MRP2 i BCRP.
English: QT interval prolongation
Croatian: Produženje QT intervala
English: Because of the potential for tivozanib-mediated adverse reactions in breastfed infants, women should not breast-feed while taking tivozanib.
Croatian: Zbog potencijalnih nuspojava uzrokovanih tivozanibom u dojene djece, dok uzimaju tivozanib žene ne smiju dojiti.
English: In clinical studies with tivozanib, QT/QTc interval prolongation has been reported (see section 4.8 and section 5.1).
Croatian: U kliničkim ispitivanjima s tivozanibom, prijavljeno je produženje QT/QTc intervala (vidjeti dio 4.8 i dio 5.1).
English: Signs or symptoms of cardiac failure should be periodically monitored throughout treatment with tivozanib.
Croatian: Znakove ili simptome zatajenja srca potrebno je tijekom trajanja terapije tivozanibom redovito pratiti.
English: • if you suffer or have suffered from any of these symptoms or are treated for heart failure: o Shortness of breath (dyspnoea) when you exert yourself or when you lie down o Feeling weak and tired o Swelling (oedema) in your legs, ankles and feet o Reduced ability to exercise o Persistent cough or wheezing with white or pink blood-tinged phlegm Signs and symptoms of heart failure will be monitored whilst you are taking your medicine.
Croatian: • ako patite ili ste patili od bilo kojih od navedenih simptoma ili se liječite zbog zatajenja srca: o Nedostatak zraka (dispneja) kod naprezanja ili kad legnete o Osjećaj slabosti i umora o Oticanje (edemi) nogu, gležnjeva i stopala o Smanjena sposobnost vježbanja o Uporni kašalj ili piskanje u plućima s bijelim ili crvenkastim (od krvi) iskašljajem Dok uzimate lijek pratit će se znakovi i simptomi zatajenja srca.
English: Tivozanib inhibits the transporter protein BCRP in vitro, at concentrations that are likely to restrict the effect to intestinal BCRP activity in vivo.
Croatian: Tivozanib inhibira transportni protein BCRP in vitro, pri koncentracijama za koje je vjerojatno da će djelovanje tivozaniba biti ograničeno na aktivnost crijevnog BCRP-a in vivo.
English: • Lack of blood flow through the heart blood vessels.
Croatian: • Nedovoljan protok krvi kroz krvne žile u srcu
English: Two patients received excessive doses of tivozanib during the monotherapy studies.
Croatian: Dva bolesnika su tijekom ispitivanja monoterapije primila prekomjerne doze tivozaniba.
English: The recommended dose is one Fotivda 1340 microgram capsule, taken once daily for 21 days (3 weeks), followed by a 7-day (1-week) period when no capsules are taken.
Croatian: Preporučena doza je jedna kapsula Fotivde od 1340 mikrograma koja se uzima jednom dnevno tijekom 21 dana (3 tjedna), iza čega slijedi stanka od 7 dana (1 tjedan), kada se kapsule ne uzimaju.
English: The clinical effects of strong CYP3A4 inducers on repeated daily dosing of tivozanib has not been studied but potentially the average time to reach steady-state and the average steady-state serum concentration of tivozanib may be reduced, due to the reduction in half-life.
Croatian: Klinički učinci jakih induktora enzima CYP3A4 na ponovljeno svakodnevno doziranje tivozaniba nisu ispitivani, ali postoji mogućnost za skraćivanje prosječnog vremena postizanja stanja dinamičke ravnoteže i smanjenje prosječne koncentracije tivozaniba u serumu u stanju dinamičke ravnoteže, zbog smanjenja poluvijeka.
English: • if you suffer from a disease of the brain, called posterior reversible encephalopathy syndrome (PRES)
Croatian: • ako patite od bolesti mozga poznate kao sindrom posteriorne reverzibilne encefalopatije
English: How to take Fotivda
Croatian: Kako uzimati Fotivdu
English: Single dose AUC0-inf for healthy volunteers dosed with 1340 microgram tivozanib was 1,950 to 2,491 ng.hr/mL.
Croatian: AUC0-inf jedne doze od 1340 mikrograma tivozaniba kod zdravih dobrovoljaca bio je 1,950 do 2,491 ng.hr/mL.
English: Your doctor will regularly monitor how well your liver is working before and during treatment with Fotivda (e.g. with blood tests), and if necessary may need to reduce how often you take Fotivda.
Croatian: Vaš će liječnik redovito pratiti kako Vaša jetra radi prije i tijekom terapije Fotivdom (npr. krvnim pretragama) i, ako je potrebno, smanjiti učestalost uzimanja Fotivde.
English: In a clinical study in healthy volunteers, co-administration of a single 1340 microgram dose of tivozanib with a strong CYP3A4 inducer at steady-state (rifampin 600 mg once daily) decreased the average half-life of tivozanib from 121 to 54 hours which was associated with a decrease in the single dose AUC0-∞ of 48% compared with AUC0-∞ in the absence of rifampin.
Croatian: U kliničkom ispitivanju zdravih dobrovoljnih sudionika, zajednička primjena jedne doze od 1340 mikrograma tivozaniba s jakim induktorom enzima CYP3A4 u stanju dinamičke ravnoteže (rifampin 600 mg jednom dnevno) smanjila je prosječni poluvijek tivozaniba sa 121 na 54 sata, što je bilo povezano sa smanjenjem AUC0-∞ jedne doze od 48% u usporedbi s AUC0-∞ pri izostanku rifampina.
English: Fotivda 890 microgram and Fotivda 1340 microgram are available as packs of 21 capsules in HDPE-bottles with child-resistant closure.
Croatian: Fotivda 890 mikrograma i Fotivda 1340 mikrograma dostupne su u pakiranjima od 21 kapsule u HDPE bočicama za sigurnosnim zatvaračem za djecu.
English: Most events in the five renal cell carcinoma monotherapy studies were CTC Grade 1 or 2 (≥ CTC Grade 3 was observed in < 2% of patients treated with tivozanib) and there were no serious events (see section 4.8).
Croatian: Većina događaja u pet monoterapijskih ispitivanja karcinoma bubrežnih stanica bilo je CTC 1. ili 2. stupnja (≥ CTC 3. stupnja primijećen je kod < 2% bolesnika liječenih tivozanibom), dok ozbiljnih događaja nije bilo (vidjeti dio 4.8).
English: Dyspnoea14 Dysphonia Cough
Croatian: Dispneja14 Disfonija Kašalj
English: 2 Peripheral neuropathy including hyperaesthesia, hypoaesthesia, mononeuropathy, neuropathy peripheral, peripheral sensory neuropathy and paraesthesia
Croatian: 1 Struma uključujući strumu i toksičnu nodularnu strumu 2 Periferna neuropatija uključujući hiperesteziju, hipoesteziju, mononeuropatiju, perifernu neuropatiju, perifernu senzornu neuropatiju i paresteziju
English: Pancreatitis17 Dysphagia18 Vomiting Gastrooesophageal reflux disease Abdominal distension Glossitis19 Gingivitis20 Dyspepsia Constipation Dry mouth Flatulence
Croatian: Distenzija abdomena Glositis19 Gingivitis20 Dispepsija Konstipacija Suha usta Flatulencija
English: Arterial thromboembolic adverse reactions in the patients receiving tivozanib as initial therapy were ischaemic stroke (1.0%), myocardial infarction (0.7%), transient ischaemic attack (0.7%) and acute myocardial infarction (0.4%), the majority of which were at least CTC Grade 3, plus iliac artery thrombosis (0.1%).
Croatian: Arterijske tromboembolijske nuspojave u bolesnika koji su primali tivozanib kao inicijalnu terapiju bile su ishemijski moždani udar (1,0%), infarkt miokarda (0,7%), tranzistorna ishemijska ataka (0,7%) i akutni infarkt miokarda (0,4%), od kojih je većina bila najmanje CTC 3. stupanj, plus tromboza ilijačne arterije (0,1%).
English: • if you have symptoms of gastrointestinal perforation or fistula formation (developing a hole in the stomach or intestine or abnormal passages forming between parts of the intestine) such as severe stomach pain, chills, fever, nausea, vomiting or painful bowel obstruction, diarrhoea or rectal bleeding.
Croatian: • ako primijetite simptome gastrointestinalne perforacije ili formiranja fistula (nastanak rupe u želucu ili crijevu ili abnormalnih prolaza koji se formiraju između dijelova crijeva) poput jake boli u trbuhu, zimice, vrućice, mučnine, povraćanja ili bolnog začepljenja crijeva, proljeva ili krvarenja iz anusa.
English: If a patient is already taking St John's wort, this should be stopped before starting tivozanib treatment.
Croatian: Ako bolesnik već uzima gospinu travu, uzimanje je potrebno prekinuti prije početka liječenja tivozanibom.
English: The inducing effect of St John's wort may persist for at least 2 weeks after cessation of treatment with St John's wort (see section 4.3).
Croatian: Inducirajući učinak gospine trave može trajati barem još 2 tjedna nakon prestanka terapije gospinom travom (vidjeti dio 4.3).
English: It is recommended that concomitant administration of tivozanib with strong CYP3A4 inducers, if used, should be undertaken with caution.
Croatian: Preporučuje se oprez kod istodobne primjene tivozaniba s jakim induktorima enzima CYP3A4, ako se koriste.
English: Although the impact of further impairment of renal function on the overall disposition of tivozanib is unknown, a clinical study has shown that no unchanged tivozanib is excreted in the urine indicating that tivozanib does not undergo renal excretion..
Croatian: Iako je utjecaj daljnjeg oštećenja bubrežne funkcije na ukupno raspoređivanje tivozaniba nepoznat, kliničko ispitivanje je pokazalo da se nepromijenjeni tivozanib ne izlučuje putem urina što upućuje na činjenicu da se tivozanib ne izlučuje kroz bubrege.
English: Tivozanib must be used with caution in patients who are at risk for, or who have a history of bleeding.
Croatian: Tivozanib se mora primjenjivati pažljivo kod bolesnika kod kojih postoji rizik ili povijest krvarenja.
English: Co-administration with herbal preparations containing St. John's wort (Hypericum perforatum) (see section 4.5).
Croatian: Zajednička primjena s biljnim preparatima koji sadrže gospinu travu (Hypericum perforatum) (vidjeti dio 4.5).
English: One Fotivda capsule taken once daily
Croatian: 21 dan (tri tjedna) Jedna kapsula Fotivda jednom dnevno
English: Risk factors for VTEs include major surgery, multiple trauma, prior VTEs, advanced age, obesity, cardiac or respiratory failure, and prolonged immobility.
Croatian: Faktori rizika za VTE uključuju težu operaciju, višestruku traumu, ranije VTE-ove, stariju dob, pretilost, zatajenje srca ili disanja te dugo razdoblje nepokretnosti.
English: Progression-Free Survival, No prior treatment for Metastatic RCC Subgroup [median, months (95% CI)]
Croatian: Preživljenje bez progresije, podskupina bez prethodnog liječenja metastatskog karcinoma bubrežnih stanica (RCC) [medijan, mjeseci (95% CI)]
English: Based on the in vitro IC50 and in vivo unbound Cmax, tivozanib was unlikely to interact in a clinically relevant manner with active substances that are metabolised by these enzyme pathways.
Croatian: Na temelju in vitro IC50 i in vivo Cmax nevezanog tivozaniba, nije vjerojatno da će tivozanib stupiti u klinički značajnu interakciju s djelatnim tvarima koje se metaboliziraju ovim enzimskim putovima.
English: Tartrazine Fotivda 890 microgram hard capsules contain tartrazine (E102) which may cause allergic reactions.
Croatian: Fotivda tvrde kapsule od 890 mikrograma sadrže tartrazin (E102) koji može izazvati alergijske reakcije.
English: There were no [14C]-containing metabolites present in faeces at greater than 10% of the dose.
Croatian: U stolici nisu bili prisutni metaboliti koji bi sadržavali [14C] u količini većoj od
English: Animal studies indicate that male and female fertility may be affected by treatment with tivozanib (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da liječenje tivozanibom može utjecati na plodnost ženki i mužjaka (vidjeti dio 5.3).
English: Tell your doctor right away if you have symptoms such as headache, seizure (fit), lack of energy, confusion, blindness or other visual and neurologic disturbances such as weakness in an arm or a leg.
Croatian: Odmah obavijestite liječnika ako primijetite simptome poput glavobolje, konvulzije (napadaja), pada energije, smetenosti, sljepoće ili drugih poremećaja vida i neuroloških poremećaja poput slabosti u ruci ili nozi.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU OZNAKA NA BOČICI
English: Management of patients experiencing HFSR may include topical therapies for symptomatic relief with consideration of temporary interruption and/or reduction in treatment dose or, in severe or persistent cases, permanent discontinuation of treatment.
Croatian: Liječenje bolesnika s reakcijom kože šaka i stopala (engl. hand foot skin reaction, HFSR) može uključivati topikalnu primjenu lijekova za ublažavanje simptoma, uz razmatranje privremenog prekida i/ili smanjenja terapijske doze ili, kod težih ili perzistentnih slučajeva, trajni prekid liječenja.
English: By blocking VEGF-induced VEGFR activation, tivozanib inhibits angiogenesis and vascular permeability in tumour tissues, leading to inhibition of tumour growth in vivo.
Croatian: Blokiranjem aktiviranja VEGFR-a izazvanog VEGF-om tivozanib inhibira angiogenezu i vaskularnu propusnost tumorskih tkiva, što dovodi do inhibicije rasta tumora in vivo.
English: Mild to severe hypertension may be present (see section 4.4).
Croatian: Može biti prisutna blaga do teška hipertenzija (vidjeti dio 4.4).
English: After a single 1340 microgram dose, mean Cmax was 10.2 to 25.2 ng/mL across healthy subject and patient studies.
Croatian: Nakon jedne doze od 1340 mikrograma, srednja vrijednost Cmax bila je od 10,2 do 25,2 ng/mL u ispitivanjima sa zdravim sudionicima i bolesnicima.
English: However, if your blood pressure remains too high, your doctor may decide to interrupt or to stop treatment with Fotivda.
Croatian: Međutim, ako Vaš krvni tlak bude i dalje previsok, Vaš liječnik može odlučiti privremeno ili potpuno prekinuti terapiju Fotivdom.
English: Adverse reactions from clinical studies are presented using frequencies for all-causality adverse events.
Croatian: Nuspojave iz kliničkih ispitivanja prikazane su korištenjem učestalosti za nuspojave izazvane svim uzrocima.
English: In the five core RCC monotherapy studies tivozanib was discontinued in a total of 20 patients (3%) owing to adverse reactions, most commonly due to hypertension (0.4%), persistent severe hypertension (0.3%), or acute myocardial infarction (0.3%).
Croatian: U pet ključnih ispitivanja monoterapije kod karcinoma bubrežnih stanica (RCC) terapija tivozanibom prekinuta je kod ukupno 20 bolesnika (3%) zbog nuspojava, najčešće zbog hipertenzije (0,4%), perzistentne teške hipertenzije (0,3%) ili akutnog infarkta miokarda (0,3%).
English: 0.520e a Hazard ratio for tivozanib arm vs. sorafenib arm, based on stratified Cox proportional hazards model.
Croatian: 0,520e a Omjer hazarda za skupinu s tivozanibom u usporedbi sa skupinom sa sorafenibom na temelju stratificiranog Coxovog modela proporcionalnih hazarda.
English: Symptoms include cough, chest pain, sudden shortness of breath or coughing up blood.
Croatian: Simptomi uključuju kašalj, bol u prsima, iznenadan nedostatak zraka ili iskašljavanje krvi
English: In a cardiac safety study of 50 patients with advanced solid tumours treated with tivozanib at 1340 microgram daily for 21 days, the mean change from baseline in QTcF was 6.8 ms on day 21 of dosing.
Croatian: U ispitivanju sigurnosti za srce na 50 bolesnika s uznapredovalim solidnim tumorima liječenih tivozanibom od 1340 mikrograma dnevno tijekom 21 dana, srednja vrijednost promjene u usporedbi s početnom vrijednošću QTcF-a bila je 6,8 ms na 21. dan doziranja.
English: The printing ink used on the Fotivda 890 microgram capsule contains tartrazine (E102), which may cause allergic reactions.
Croatian: Tinta koja se koristi za označavanje na kapsuli Fotivde od 890 mikrograma sadrži tartrazin (E102), koji može izazvati alergijske reakcije.
English: Tivozanib should not be used in patients with severe hepatic impairment (see section 4.2 and section 4.4).
Croatian: Tivozanib ne smiju uzimati bolesnici s teškim oštećenjem jetre (vidjeti dio 4.2 i 4.4).
English: Clearance is similar between acute and chronic dosing indicating no time dependent changes in PK.
Croatian: Klirens je sličan kod akutnog i kroničnog doziranja i ne ukazuje na promjene farmakokinetičkih svojstava u ovisnosti o vremenu.
English: Blood pressure should be well controlled prior to initiating tivozanib and patients should be monitored for hypertension during treatment (see section 4.4).
Croatian: Prije početka uzimanja tivozaniba potrebno je dobro kontrolirati krvni tlak, a bolesnike je potrebno pratiti kako im se tlak ne bi povećao tijekom terapije (vidjeti dio 4.4).
English: • An enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Croatian: • Proširenje i slabljenje stijenke krvne žile ili rascjep stijenke krvne žile (aneurizme i disekcije arterije).
English: Adverse reactions occurring in patients who continued to receive tivozanib as their initial on trial therapy in the five RCC monotherapy studies were pooled and are listed below by MedDRA body system organ class (SOC) and frequency.
Croatian: Nuspojave koje se javljaju kod bolesnika koji su nastavili primati tivozanib kao inicijalnu ispitivanu terapiju u pet monoterapijskih ispitivanja RCC-a prikupljene su i navedene u nastavku prema MedDRA klasifikaciji organskih sustava (SOC) i učestalosti.
English: Hypertension was reported as an adverse reaction in 47.6% of patients receiving tivozanib as initial therapy; in 23.0% the hypertension was CTC ≥Grade 3.
Croatian: Hipertenzija je kao nuspojava prijavljena kod 47,6% bolesnika koji su primali tivozanib kao početnu terapiju; kod 23,0% hipertenzija je bila CTC ≥ 3. stupanj.
English: • Red, swollen and sore skin; blistering skin; excessive sweating; hives.
Croatian: • Crvena, otečena i bolna koža; mjehuri; prekomjerno znojenje; koprivnjača
English: In clinical studies, one case of posterior reversible encephalopathy syndrome (PRES) was confirmed after treatment with tivozanib (see section 4.8).
Croatian: U kliničkim ispitivanjima potvrđen je jedan slučaj sindroma posteriorne reverzibilne encefalopatije (PRES) nakon liječenja tivozanibom (vidjeti dio 4.8).
English: Symptoms include severe headaches, blurred vision, shortness of breath, changes in your mental state, such as feeling anxious, confused or disorientated
Croatian: Simptomi uključuju jake glavobolje, zamagljen vid, nedostatak zraka, promjene mentalnog stanja poput osjećaja tjeskobe, smetenosti ili dezorijentiranosti.
English: • Underactive thyroid gland which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, weight gain.
Croatian: • Nedovoljno aktivna štitnjača, što može uzrokovati simptome poput umora, letargije, slabosti mišića, usporenog rada srca, povećanja tjelesne mase