natgillin/translations-raw huggingface dataset:
Increased testis weights were observed at a dose 7-fold higher than the recommended clinical dose.
O povečanih masah mod so poročali pri 7-krat večjem odmerku, kot je priporočeni klinični odmerek.
It is recommended that concomitant administration of tivozanib with strong CYP3A4 inducers, if used, should be undertaken with caution.
Priporočamo, da tivozanib sočasno z močnimi induktorji CYP3A4 uporabljate previdno.
Your doctor will regularly monitor how well your thyroid gland is working before and during treatment with Fotivda (e.g. with blood tests).
Zdravnik bo redno spremljal, kako dobro vam deluje ščitnica, pred in med zdravljenjem z zdravilom Fotivda (npr. s krvnimi testi).
Pancreatitis17 Dysphagia18 Vomiting Gastrooesophageal reflux disease Abdominal distension Glossitis19 Gingivitis20 Dyspepsia Constipation Dry mouth Flatulence
Bruhanje Gastroezofagealna refluksna bolezen Distenzija trebuha Glositis19 Gingivitis20
The printing ink used on the Fotivda 890 microgram capsule contains tartrazine (E102), which may cause allergic reactions.
Tiskarska barva na kapsulah Fotivda 890 mikrogramov vsebuje tartrazin (E102), ki lahko povzroči alergijske reakcije.
In clinical studies with tivozanib, QT/QTc interval prolongation has been reported (see section 4.8 and section 5.1).
Pri kliničnem preskušanju tivozaniba so poročali o podaljšanju intervala QT/QTc (glejte poglavij 4.8 in 5.1).
There were no [14C]-containing metabolites present in faeces at greater than 10% of the dose.
V blatu ni bilo presnovkov s [14C] v količini, večji od 10 % odmerka.
• Dizziness; ringing in the ears; dizziness and a spinning sensation (vertigo).
• Omotica; zvonjenje v ušesih; omotica in občutek vrtenja v glavi (vrtoglavica).
Tartrazine Fotivda 890 microgram hard capsules contain tartrazine (E102) which may cause allergic reactions.
Zdravila Fotivda 890 mikrogramov trde kapsule vsebuje tartrazin (E102), ki lahko povzroči alergijske reakcije.
Because of the potential for tivozanib-mediated adverse reactions in breastfed infants, women should not breast-feed while taking tivozanib.
Ker obstaja verjetnost neželenih učinkov zaradi tivozaniba pri dojenčkih, ženske, ki jemljejo tivozanib, ne smejo dojiti.
In vitro studies have shown that tivozanib is neither a substrate nor an inhibitor of the multidrug efflux pump, P-glycoprotein.
Študije in vitro so pokazale, da tivozanib ni ne substrat ne zaviralec izločevalne črpalke za več zdravil, P-glikoproteina.
• Rashes with pus; fungal infections.
• Gnojni izpuščaji; glivične okužbe.
Table 1: Tabulated list of adverse reactions (presented using frequencies for all-causality adverse events)
Preglednica 1: Seznam neželenih učinkov v obliki preglednice (z informacijo o pogostosti neželenih učinkov ne glede na vzročnost)
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.
Na podlagi in vitro IC50 in in vivo nevezane Cmax ni verjetno, da bi tivozanib v klinično pomembni meri medsebojno deloval z učinkovinami, ki se presnavljajo s temi encimi.
There is no relevant use of tivozanib in the paediatric population in the indication advanced renal cell carcinoma.
Zdravilo Tivozanib ni namenjeno za uporabo pri pediatrični populaciji za indikacijo napredovalega raka ledvičnih celic.
• Fever; chest pain; swelling of feet and legs; chills and low body temperature.
• Vročina; bolečina v prsnem košu; zatekanje stopal in nog; mrzlica in nizka telesna temperatura.
During treatment, patients should be monitored for hypertension and treated as needed with anti-hypertensive therapy according to standard medical practice.
Med zdravljenjem je treba spremljati morebiten pojav hipertenzije ter bolnike po potrebi zdraviti z antihipertenzivi v skladu s standardno medicinsko prakso.
22 Erythema including erythema, generalised erythema and palmar erythema 23 Pruritus including generalised pruritus and pruritus
22 Eritem vključuje eritem, generalizirani eritem in palmarni eritem23 Pruritus vključuje generalizirani pruritus in pruritus
• St. John's Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety) as this herbal remedy should not be used at the same time as Fotivda.
• šentjanževka (Hypericum perforatum, zeliščno zdravilo iz šentjavževke za zdravljenje depresije in tesnobe), saj tega zeliščnega zdravila ni dovoljeno jemati istočasno z zdravilom Fotivda.
The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy (see section 4.4).
Zaradi pojava neželenih učinkov bo morda treba začasno prekiniti zdravljenje s tivozanibom ali zmanjšati odmerek tega zdravila (glejte poglavje 4.4).
• Loss of appetite; weight loss.
• Izguba apetita; hujšanje • Glavobol.
0.520e a Hazard ratio for tivozanib arm vs. sorafenib arm, based on stratified Cox proportional hazards model.
0,520e a Razmerje ogroženosti za krak s tivozanibom proti kraku s sorafenibom, ki temelji na stratificiranem modelu sorazmernih tveganj Cox.
Your doctor will check your blood pressure regularly during treatment with Fotivda.
Zdravnik bo med zdravljenjem z zdravilom Fotivda redno meril krvni tlak.
Your doctor will monitor your blood pressure regularly and, if it is too high, may either give you a medicine to lower it, or reduce your dose of Fotivda.
Zdravnik vam bo redno preverjal krvni tlak in če je previsok, lahko predpiše zdravilo proti visokem krvnem tlaku ali zmanjša odmerek zdravila Fotivda.
If PRES is diagnosed, your doctor will stop treatment with Fotivda.
Če vam diagnosticirajo PRES, se lahko zdravnik odloči zaustaviti zdravljenje z zdravilom Fotivda.
Female partners of male patients taking tivozanib should also avoid pregnancy.
Tudi partnerke bolnikov, ki jemljejo tivozanib, morajo paziti, da ne zanosijo.
In the core RCC studies some adverse reaction occurred more commonly in the elderly (see section
V osrednjih študijah RCC so bili nekateri neželeni učinki pogostejši pri starejših (glejte poglavje 4.4).
• Difficult breathing; shortness of breath during exercise; coughing.
• Oteženo dihanje; zasoplost med vadbo; kašljanje.
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.
Priporočeni odmerek je ena kapsula zdravila Fotivda po 1340 mikrogramov, ki jo vzamete enkrat na dan 21 dni (3 tedne), sledi 7-dnevni premor (1 teden), ko ne vzamete nobene kapsule.
• Coughing up blood; vomiting up blood.
• Izkašljevanje krvi; bljuvanje krvi.
Symptoms include severe headaches, blurred vision, shortness of breath, changes in your mental state, such as feeling anxious, confused or disorientated
Simptomi vključujejo hude glavobole, zamegljen vid, zasoplost, spremembe v duševnem stanju, kot so občutek tesnobe, zmedenosti ali dezorientiranost.
• if you have problems with your thyroid gland or use medicines to treat thyroid disease.
• če imate težave s ščitnico ali če se zdravite z zdravili proti bolezni ščitnice.
The central tendency change for all measured days and across all time points was 2.2 ms. No subjects had a new > 500 ms change in QTcF; 2 patients (4%) had QTcF values > 480 ms. One subject (2%) had a > 60 ms change from baseline in QTcF and 6 subjects (12%) had a 30 ms to 60 ms change from baseline (see section 4.4 and section 4.8).
Centralna tendenca spremembe za vse merjene dni in prek vseh časovnih točk je bila 2,2 ms. Noben testiranec ni imel nove spremembe QTcF na > 500 ms; 2 bolnika (4 %) sta imela vrednosti QTcF >480 ms.
The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor.
Učinkovina v zdravilu Fotivda je tivozanib, ki je zaviralec protein kinaze.
3 Dysgeusia including ageusia, dysgeusia and hypogeusia 4 Memory impairment including amnesia and memory impairment 5 PRES was not observed in patients treated with tivozanib in the five RCC monotherapy studies.
4 Motnje spomina vključujejo amnezijo in motnje spomina 5 PRES niso opazili pri bolnikih, zdravljenih s tivozanibom v petih študijah monoterapije RCC.
Symptoms include cough, chest pain, sudden shortness of breath or coughing up blood.
Simptomi vključujejo: kašelj, bolečino v prsnem košu, nenadno zadihanost ali izkašljevanje krvi.
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%).
Arterijski trombembolični neželeni učinki pri bolnikih, ki so prejemali tivozanib kot začetno zdravljenje, so bili ishemična možganska kap (1,0 %), miokardni infarkt (0,7 %), prehodni ishemični napad (0,7 %) in akutni miokardni infarkt (0,4 %), večina je bila vsaj 3. stopnje po CTC, ter tromboza iliakalne arterije (0,1 %).
According to the population pharmacokinetic analysis of tivozanib exposure, no dose adjustment is required in patients with mild or moderate renal impairment.
Glede na populacijsko farmakokinetično analizo izpostavljenosti tivozanibu pri bolnikih z blago ali zmerno ledvično okvaro ni potrebna prilagoditev odmerka.
20 Gingivitis including gingival bleeding, gingival disorder, gingival pain and gingivitis 21 Alanine aminotransferase (ALT) increased / Aspartate aminotransferase (AST) increased including ALT increased and AST increased
20 Gingivitis vključuje krvavitve iz dlesni, bolezni dlesni, bolečino v dlesnih in gingivitis 21 Povišana raven alanin aminotresferaze (ALT) / Povišana raven aspartat aminotrasferaze (AST) vključuje povišano raven ALT in povišano raven AST
Thyroid function should be monitored before initiation of, and periodically throughout treatment with tivozanib.
Delovanje ščitnice je treba nadzorovati pred začetkom zdravljenja in redno ves čas zdravljenja s tivozanibom.
reduced vision, or changes in your mental state) o a stroke, or signs and symptoms of a ‘mini-stroke' (transient ischaemic attack) o a heart attack o high blood pressure o diabetes o major surgery o multiple injuries such as broken bones and damage to internal organs o inability to move for a long period o heart failure which can cause shortness of breath or ankle swelling o inability to breathe, bluish colour on your skin, fingertips or lips, restlessness, anxiety,
motnjo vida ali spremembami duševnega stanja) o možgansko kap ali znake in simptome „male kapi“ (prehodni ishemični napad) o srčni infarkt o visok krvni tlak o sladkorno bolezen o večjo operacijo o več poškodb, kot so zlomljene kosti in poškodbe notranjih organov o nezmožnost premikanja dalj časa o srčno popuščanje, ki lahko povzroči sopenje ali zatekanje gležnjev o nezmožnost dihati, modrikasta koža, modrikaste konice prstov ali ustnice, nemirnost,
In vitro studies have shown that metabolites of tivozanib can undergo UGT mediated biotransformation via the UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9, and UGT1A10 pathways.
UGT prek poti UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9 in UGT1A10.
Tivozanib inhibits the transporter protein BCRP in vitro, at concentrations that are likely to restrict the effect to intestinal BCRP activity in vivo.
Tivozanib zavira prenašalno beljakovino BCRP in vitro pri koncentracijah, pri katerih je vpliv na delovanje BCRP v črevesju in vivo verjetno omejen.
A patient with a history of hypertension experienced aggravated uncontrolled hypertension that was fatal after taking 3 doses of 1340 microgram tivozanib in one day (total 4020 microgram).
Bolnik z anamnezo hipertenzije je doživel poslabšano neobvladljivo hipertenzijo, ki je bila zanj usodna po 3 odmerkih tivozaniba po 1340 mikrogramov v enem dnevu (skupaj 4020 mikrogramov).
Tell your doctor straightaway if you have taken more than your prescribed dose of 1 capsule per day.
Če ste vzeli večji odmerek zdravila Fotivda, kot bi smeli Takoj povejte zdravniku, če ste vzeli več kot predpisano 1 kapsulo na dan.
Adverse reactions from clinical studies are presented using frequencies for all-causality adverse events.
Neželeni učinki iz kliničnih študij so navedeni s pogostnostmi ne glede na vzročnost.
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.
Za obvladovanje dogodkov srčnega popuščanja bo morda treba začasno prekiniti ali trajno ukiniti zdravljenje in/ali zmanjšati odmerek tivozaniba ter zdraviti morebitne druge obstoječe vzroke srčnega popuščanja, npr. hipertenzijo.
The active substance is tivozanib.
Učinkovina je tivozanib.
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.
Neželeni učinki pri bolnikih, ki so nadaljevali s prejemanjem tivozaniba kot začetnega zdravila v petih preskušanjih zdravila v monoterapiji RCC, so zbrani in navedeni v seznamu spodaj po organskih sistemih po MedDRA in pogostosti.
Women of childbearing potential/contraception in males and females Women of childbearing potential should avoid becoming pregnant while on tivozanib.
Ženske v rodni dobi/kontracepcija za moške in ženske Ženske v rodni dobi morajo paziti, da ne zanosijo, medtem ko se zdravijo z zdravilom tivozanib.
If a patient is already taking St John's wort, this should be stopped before starting tivozanib treatment.
Če bolnik že jemlje šentjanževko, mora z jemanjem prenehati, preden začne jemati tivozanib.
Tivozanib exposure was increased in patients with severe hepatic impairment (mean AUC0-∞ by 4.0-fold) and in patients with moderate hepatic impairment (mean AUC0-∞ by 2.6-fold).
Izpostavljenost tivozanibu je bila povečana pri bolnikih s hudo jetrno okvaro (povprečna AUC0-∞ za 4,0-krat) in pri bolnikih z zmerno jetrno okvaro (povprečna
• Nerve damage including numbness, pins and needles, sensitive skin or numbness and weakness in the arms and legs.
• Okvara živcev, vključno z otrplo, mravljinčasto, občutljivo kožo ali otrplostjo in šibkostjo v rokah in nogah.
No concentration dependence of plasma protein binding was observed over the range of 0.1 to 5 µmol/L tivozanib.
V območju od 0,1 do 5 µmol/l tivozaniba niso opazili odvisnosti vezave na plazemske beljakovine od koncentracije.
Fotivda is for oral use.
Zdravilo Fotivda je za peroralno uporabo.
Tivozanib is not recommended in patients with severe hepatic impairment.
Tivozanib se ne priporoča za bolnike s hudo okvaro jeter.
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.
1340 mikrogramov tivozaniba z močnim induktorjem CYP3A4 v stanju dinamičnega ravnovesja (rifampin 600 mg enkrat na dan) skrajšala povprečni razpolovni čas z 121 na 54 ur, hkrati se je zmanjšala AUC0-∞ enkratnega odmerka za 48 % v primerjavi z AUC0-∞ v odsotnosti rifampina.
In clinical studies, one case of posterior reversible encephalopathy syndrome (PRES) was confirmed after treatment with tivozanib (see section 4.8).
V kliničnih študijah so potrdili en primer sindroma posteriorne reverzibilne encefalopatije (PRES) po zdravljenju s tivozanibom (glejte poglavje 4.8).
Fotivda 890 microgram and Fotivda 1340 microgram are available as packs of 21 capsules in HDPE-bottles with child-resistant closure.
Zdravili Fotivda 890 mikrogramov in Fotivda 1340 mikrogramov sta pakirani po 21 kapsul v plastični steklenici HDPE z zapiralom, varnim za otroke.
Mild to severe hypertension may be present (see section 4.4).
Prisotna je lahko blaga ali huda hipertenzija (glejte poglavje 4.4).
There was no unchanged tivozanib recovered in the urine indicating that tivozanib does not undergo renal excretion.
V urinu ni bilo nespremenjenega tivozaniba, kar kaže, da se tivozanib ne izloča skozi ledvice.
When tivozanib was evaluated in a food effect study in healthy subjects, a high fat meal decreased the peak serum concentrations (Cmax) by 23.4% compared to the fasted state.
V študiji učinka hrane na tivozanib pri zdravih prostovoljcih so ugotovili, da obrok z visoko vsebnostjo maščob zmanjša najvišje ravni seruma (Cmax) za 23,4 % v primerjavi s temi ravnimi v stanju na tešče.
The intent-to-treat (ITT) population included 517 patients, 260 randomised to tivozanib and 257 randomised to sorafenib.
260 randomiziranih na tivozanib in 257 naključno randomiziranih na sorafenib.
Persistent severe hypertension12
Vztrajna huda hipertenzija12 Pordevanje13
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.
O hipertenziji so poročali kot o neželenem učinku pri 47,6 % bolnikov, ki so prejemali tivozanib kot začetno zdravljenje; pri 23,0 % je bila hipertenzija ≥ 3. stopnje po skupnih kriterijih toksičnosti (CTC).
Risk factors for VTEs include major surgery, multiple trauma, prior VTEs, advanced age, obesity, cardiac or respiratory failure, and prolonged immobility.
Dejavniki tveganja za VTE vključujejo večjo operacijo, predhodne VTE, starost, debelost, srčno ali dihalno popuščanje in dolgotrajna nepremičnost.
Alternatively, a statin not subject to restriction of intestinal absorption by BCRP should be considered.
Razmislite o uporabi drugega statina, katerega absorpcije v črevesju ne zavira BCRP.
• Rapid heart rate; tightness of the chest; heart attack/reduced blood flow to heart; blood clot in an artery (blood vessel).
• Hiter srčni utrip; stiskanje v prsnem košu; srčni infarkt/zmanjšan dotok krvi v srce; krvni strdek ali izkašljevanje krvi.
The other ingredients are: - Capsule content: mannitol, magnesium stearate.
- Vsebina kapsule: manitol, magnezijev stearat.
In vitro studies suggest that tivozanib is an inhibitor of intestinal BCRP.
Rezultati študij in vitro kažejo, da je tivozanib lahko zaviralec intestinalnega BCRP.
No significant increase in exposure was observed in patients with mild (Child-Pugh Class A) hepatic impairment (mean AUC0-∞ by 1.2-fold).
Pri izpostavljenosti bolnikov z blago (Child-Pugh razred A) jetrno okvaro niso poročali o pomembnem povečanju (povprečna AUC0-∞ za 1,2-krat).
Your doctor may recommend that you temporarily stop taking Fotivda if you have an operation or surgery, as it could affect wound healing.
• če potrebujete operacijo ali drugo obliko kirurškega posega Zdravnik lahko priporoči, da začasno prekinete jemanje zdravila Fotivda, če morate imeti operacijo ali kirurški poseg, ker lahko zdravilo vpliva na celjenje.
EUSA Pharma (Netherlands) B.V.
Imetnik dovoljenja za promet z zdravilom EUSA Pharma (Netherlands) B.V.
In clinical studies with tivozanib as monotherapy for the treatment of patients with RCC, cardiac failure has been reported (see section 4.8).
Pri kliničnem preskušanju tivozaniba kot monoterapije za zdravljenje bolnikov z RCC so poročali o srčnem popuščanju (glejte poglavje 4.8).
In female rats, an increase in non-viable foetuses was noted at a dose 0.7-fold the recommended clinical dose, while dose levels ≥ 2 fold the recommended clinical dose produced infertility.
Pri samicah podgan so zabeležili povečanje števila neviabilnih plodov pri 0,7-kratniku priporočenega kliničnega odmerka, medtem ko so ≥2-krat večji odmerki, kot je priporočen klinični odmerek, povzročili neplodnost.
• Tiredness; unusual weakness; pain (including in the mouth, bone, extremities, side of the body,
• Utrujenost; nenavadna šibkost; bolečina (vključno z bolečino v ustih, kosteh, udih, ob strani telesa, dimljah, bolečino zaradi tumorja)
In a clinical study in healthy volunteers, co-administration of tivozanib with a potent CYP3A4 inhibitor, ketoconazole (400 mg once daily), had no influence on tivozanib serum concentrations (Cmax or AUC); therefore, tivozanib exposure is unlikely to be altered by CYP3A4 inhibitors.
Pri kliničnem preskušanju zdravila pri zdravih prostovoljcih sočasna uporaba zaviralca CYP3A4, ketokonazola (400 mg enkrat na dan) ni imela vpliva na serumske koncentracije tivozaniba (Cmax ali
Pulmonary oedema was reported in two patients (0.3%) receiving tivozanib as initial therapy in the five core RCC monotherapy studies.
O pljučnem edemu so poročali pri dveh bolnikih (0,3 %), ki sta prejemala tivozanib kot začetno zdravljenje, v petih osrednjih raziskavah RCC v monoterapiji.
In clinical studies with tivozanib, venous thromboembolic events (VTEs) have been reported including pulmonary embolism and deep vein thrombosis (see section 4.8).
Pri kliničnem preskušanjem tivozaniba so poročali o venskih trombemboličnih dogodkih (VTE), vključno s pljučno embolijo in globoko vensko trombozo (glejte poglavje 4.8).
Fotivda is used to treat adults with advanced kidney cancer.
Z zdravilom Fotivda zdravimo odrasle z napredovalim rakom ledvic.
• Peptic ulcer in the small intestines.
• Peptična razjeda v tankem črevesju.
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).
Indukcijski učinek lahko vztraja še najmanj 2 tedna po prekinitvi zdravljenja s šentjanževko (glejte poglavje 4.3).
Treatment decision, especially in patients who are at risk for VTEs, should be based on individual patient benefit/risk assessment.
Odločitev o zdravljenju, predvsem pri bolnikih s tveganjem za VTE,
Myocardial infarction (acute) / ischaemia7 Angina pectoris Tachycardia8
Miokardni infarkt (akutni)/ishemija7
Musculoskeletal and connective tissue disorders
Motnje mišično skeletnega sistema in vezivnega tkiva
ischaemic stroke, myocardial infarction and transient ischaemic attack 11 Venous thromboembolism including deep vein thrombosis, embolism venous and pulmonary embolism 12 Persistent severe hypertension including hypertensive crisis 13 Flushing including flushing and hot flush
ishemično možgansko kap, miokardni infarkt in prehodni ishemični napad 11 Venska tromboembolija vključuje globoko vensko trombozo, vensko embolijo in pljučno embolijo 12 Vztrajna huda hipertenzija vključuje hiperetenzivno krizo 13 Pordevanje vključuje pordevanje in vročinske oblive
In cases of suspected overdose, tivozanib should be discontinued and the patient monitored for hypertension and treated as needed with standard anti-hypertensive therapy.
Če sumit ena prevelik odmerek, je treba prekiniti uporabo tivozaniba in bolnika opazovati, če pri njem nastopi hipertenzija, ter ga po potrebi zdraviti s standardno antihipertenzivno terapijo.
Package leaflet: Information for the patient Fotivda 890 microgram hard capsules Fotivda 1340 microgram hard capsules tivozanib This medicine is subject to additional monitoring.
Navodila za uporabo Fotivda 890 mikrogramov trde kapsule Fotivda 1340 mikrogramov trde kapsule tivozanib Za to zdravilo se izvaja dodatno spremljanje varnosti.
Caution should be exercised if tivozanib is co-administered with rosuvastatin.
Previdno uporabljajte tivozanib sočasno z rosuvastatinom.
The baseline demographic and disease characteristics were generally well balanced across the tivozanib and sorafenib arms with regard to age (mean age 58.2 vs 58.4 years respectively), gender (71.2% vs 73.5% male respectively), race (95.8% vs 96.9% white respectively), geographic region (88.1% vs 88.7% from Central/Eastern Europe respectively) and prior treatment for metastatic RCC (69.6% vs 70.8% treatment naïve respectively).
73,5 % moških), raso (95,8 % proti 96,9 % belcev), geografsko regijo (88,1 % proti 88,7 % iz centralne/vzhodne Evrope) in predhodno zdravljenje metastatskega RCC (69,6 % proti 70,8 % še ne zdravljenih).
4.7 Effects on ability to drive and use machines
4.7 Vpliv na sposobnost vožnje in upravljanje strojev Tivozanib ima lahko blag vpliv na sposobnost vožnje in upravljanje strojev.