natgillin/translations-raw huggingface dataset:
The safety and efficacy of tivozanib in children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost tivozaniba pri otrocih in mladostnikih, mlajših od 18 let, še nista dokazani.
Fotivda must be taken with a glass of water and can be taken either with or without food.
Zdravilo Fotivda je treba vzeti z vodo, jemlje se ga lahko s hrano ali brez nje.
• if you have high blood pressure.
• če imate visok krvni tlak.
The majority of AST and ALT elevations were not accompanied with concomitant elevations of bilirubin.
Večino povišanj AST in ALT ni spremljalo hkratno povišanje bilirubina.
In studies that evaluated the terminal elimination phase, tivozanib had a mean t½ of 4.5 - 5.1 days.
V študijah, v katerih so proučevali fazo končnega izločanja, je imel tivozanib mediani t½ 4,5-5,1 dan.
• If you are allergic to tivozanib or any of the other ingredients of this medicine (listed in section 6);
• Če ste alergični na tivozanib ali katero koli drugo sestavina tega zdravila (navedeno v poglavju
The next dose should be taken at the next scheduled time.
Naslednji odmerek mora vzeti v naslednjem predvidenem času po razporedu.
Gastrointestinal perforation/fistula
Gastrointestinalna perforacija/fistula
common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and not known (cannot be estimated from available data).
Pogostost je določena, kot sledi: zelo pogosti (≥1/10); pogosti (≥1/100 do < 1/10); občasni (≥1/1.000 do < 1/100), redki (≥1/10.000 do < 1/1000) in neznana pogostnost (ni možno oceniti glede na razpoložljive podatke).
In vitro protein binding studies have shown that tivozanib is > 99% bound to plasma proteins.
Rezultati študije in vitro vezave na proteine so pokazali, da je tivozanib > 99 % vezan na plazemske beljakovine.
Clearance is similar between acute and chronic dosing indicating no time dependent changes in PK.
Očistek je med akutnem in kroničnem odmerjanju podoben, kar kaže, da ni časovno odvisnih sprememb v FK.
Tell your doctor who will discuss with you the risks of taking Fotivda to you and your child.
Povejte zdravniku, ki vas bo poučil o tveganju jemanja zdravila Fotivda za vašega otroka.
QT/QTc interval prolongation may lead to an increased risk for ventricular arrhythmias.
Podaljšanje intervala QT/QTc lahko vodi do povečanega tveganja za prekatno aritmijo.
Risk factors for proteinuria include high blood pressure.
Dejavniki tveganja za proteinurijo vključujejo visok krvni tlak.
These may be symptoms of a condition called hand foot skin reaction.
To so lahko simptomi stanja t. i. kožne reakcije roka-noga.
Risk factors for hypothyroidism include prior history of hypothyroidism and use of anti-thyroid medications.
Dejavniki tveganja za hipotiroidizem vključujejo anamnezo hipotiroidizma in uporabo antitiroidnih zdravil.
No more than one dose of Fotivda must be taken per day.
Na dan se sme vzeti samo en odmerek zdravila Fotivda.
Healthcare professions should be aware that elderly patients may be at increased risk of adverse reactions.
Zdravstveni delavci morajo vedeti, da pri starejših bolnikih obstaja večje tveganje za neželene učinke.
It works by blocking the action of a protein called vascular endothelial growth factor (VEGF).
Deluje tako, da zavira delovanje beljakovine, imenovane vaskularni endotelijski rastni faktor (VEGF).
In a controlled clinical study (AV-951-09-301), in which 25% of patients receiving tivozanib were ≥ 65 years of age, no overall differences was observed in efficacy between elderly and younger patients (see section 4.2).
V kontrolirani klinični študiji (AV-951-09-301), v kateri je bilo 25 % bolnikov, ki so prejemali tivozanib, starih ≥65 let, niso zabeležili razlik v učinkovitosti med starejšimi in mlajšimi bolniki (glejte poglavje 4.2).
Before initiating Fotivda, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Pred uvedbo zdravila Fotivda je treba to tveganje skrbno preučiti pri bolnikih z dejavniki tveganja, kot sta hipertenzija ali anamneza anevrizme.
• Inflammation of the pancreas causing severe stomach pain which may spread to your back.
• Vnetje trebušne slinavke, ki povzroči hudo bolečino v trebuhu, ki se lahko razširi na hrbtni del.
• Watery eyes.
• Vodene oči.
As CYP1A1 is primarily expressed in extrahepatic tissues such as the lung and intestine, it was considered unlikely that this isoform would be extensively involved in hepatic metabolism.
Ker je CYP1A1 primarno izražen v ekstrahepatičnih tkivih, kot so pljuča in črevesje, se smatra, da ni verjetno, da bi bila ta izooblika obsežno vključena v jetrno presnovo.
Carcinogenesis Carcinogenicity studies have not been performed with tivozanib.
Študij kancerogenosti s tovzanibom niso opravili.
See the end of section 4 for how to report side effects.
Glejte na koncu poglavja 4, kako poročati o neželenih učinkih
There are no data from the use of tivozanib in pregnant women.
Ni podatkov o uporabi tivozaniba pri nosečnicah.
Urticaria Dermatitis26
Urtikarija Dermatitis26
The efficacy of tivozanib in the treatment of advanced RCC was studied in the following randomised clinical study.
Učinkovitost tivozaniba pri zdravljenju napredovalega RCC so proučevali v naslednji randomizirani klinični študiji.
Albumin is the major tivozanib binding component in human plasma.
Albumin je najpomembnejša komponenta, na katero se veže tivozanib v človeški plazmi.
Moderate CYP3A4 inducers are not expected to have a clinically relevant effect on tivozanib exposure.
Zmerni induktorji CYP3A4 pričakovano nimajo klinično pomembnega učinka na izpostavljenost tivozanibu.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Poročanje o neželenih učinkih Poročanje o domnevnih neželenih učinkih po izdanem dovoljenju za zdravilo je pomembno.
Do not throw away any medicines via wastewater or household waste.
Zdravila ni dovoljeno zavreči v odpadno vodo ali med hišne odpadke.
Printing ink (blue)
Tiskarska barva (modra)
• Do not breast-feed during treatment with Fotivda, as it is not known whether the active ingredient in Fotivda passes into breast-milk.
• Ne dojite, ko jemljete zdravilo Fotivda, saj ni znano, ali učinkovina v zdravilu Fotivda lahko preide v materino mleko.
Clinical studies with tivozanib were conducted in RCC patients with serum creatinine concentration ≤ 2 times the upper limit of normal, including those who may have had a prior nephrectomy.
Klinične študije s tivozanibom so bile opravljene pri bolnikih z RCC, ki so imeli koncentracijo kreatinina v serumu ≤ 2-krat nad zgornjo mejo normalne vrednosti, vključno s tistimi, ki so morda že imeli predhodno nefrektomijo.
One patient died as a result of uncontrolled hypertension in the setting of a suspected overdose.
En bolnik je umrl zaradi neobvladljive hipertenzije v okoliščinah domnevnega prevelikega odmerka.
• Paleness and tiredness from excess bleeding.
• Bledičnost in utrujenost zaradi prekomernih krvavitev.
The most common adverse reactions of any grade include hypertension (47.6%), dysphonia (26.9%), fatigue (25.8%) and diarrhoea (25.5%).
Najpogostejši neželeni učinki katere koli stopnje vključujejo hipertenzijo (47,6 %), disfonijo (26,9 %), utrujenost (25,8 %) in diarejo (25,5 %).
Treatment with Fotivda may increase the risk of bleeding.
Zdravljenje z zdravilom Fotivda lahko poveča tveganje za krvavitve.
In the case of vomiting a replacement dose should not be taken; the next dose should be taken at the next scheduled time.
Po morebitnem bruhanju naj ne vzame nadomestnega odmerka; naslednji odmerek mora vzeti v naslednjem predvidenem času po razporedu.
• if laboratory tests show that there is protein in your urine Your doctor will monitor this at the beginning and during your treatment.
• če rezultati laboratorijski preiskav pokažejo, da imate beljakovine v urinu Zdravnik bo preveril vsebnost beljakovin v urinu pred zdravljenjem in nato redno med zdravljenjem.
The decision to resume tivozanib therapy after surgery should be based on clinical judgment of adequate wound healing.
Odločitev, kdaj znova začeti z zdravljenjem s tivozanibom po operaciji, mora temeljiti na klinični presoji o ustrezni zaceljenosti ran.
Taking too much Fotivda makes side effects more likely or to become more severe, especially high blood pressure.
Če vzamete preveč zdravila Fotivda, so neželeni učinki verjetnejši ali resnejši, predvsem visok krvni tlak.
Patients should be advised to be cautious when driving or using machines if they experience asthenia, fatigue, and/or dizziness during treatment with tivozanib (see section 4.8).
Bolnikom je treba svetovati, naj bodo previdni pri vožnji in upravljanju strojev, če občutijo astenijo, utrujenost in/ali omotico med zdravljenjem z zdravilom tivozanib (glejte poglavje 4.8).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika alifarmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If you forget to take Fotivda
Če ste pozabili vzeti zdravilo Fotivda
Ask your pharmacist how to throw away medicines you no longer use.
O tem, kako pravilno zavreči zdravila, ki jih ne uporabljajte več, se posvetujte s farmacevtom.
Fotivda may be taken with or without food (see section 5.2).
Zdravilo Fotivda se lahko vzame z ali brez hrane (glejte poglavje 5.2).
In vitro studies conducted in human liver microsomes and hepatocytes evaluating the activity of CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 and CYP3A4 suggested that tivozanib is a weak inhibitor of CYP2B6 and CYP2C8.
Rezultati študij in vitro na mikrosomih in hepatocitih človeških jeter, pri katerih so proučevali delovanje CYP1A2, CYP2B6, CYP2A6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 in CYP3A4, so pokazali, da je tivozanib blag zaviralec CYP2B6 in CYP2C8.
Dysphonia, diarrhoea, fatigue, weight decreased, appetite decreased and hypothyroidism occurred more commonly in patients ≥ 65 years of age.
Disfonija, diareja, utrujenost, zmanjšanje telesne mase, zmanjšan apetit in hipotiroidizem so se pojavili pogosteje pri bolnikih, starih ≥ 65 let.
Experience of tivozanib use in patients with severe renal impairment is limited and caution is advised.
Izkušnje z uporabo tivozaniba pri bolnikih s hudo ledvično okvaro so omejene in svetuje se previdnost.
The primary endpoint of the study was progression-free survival (PFS) by blinded independent radiology review; key secondary endpoints included overall survival (OS) and objective response rate (ORR) by independent radiology review.
Primarni cilj preskušanja je bilo preživetje brez napredovanja bolezni (PFS - progression-free survival) v slepem neodvisnem radiološkem pregledu; ključni sekundarni cilji preskušanja so vključevali celokupno preživetje (OS - overall survival) in delež objektivnega odziva (ORR - objective response rate) v neodvisnem radiološkem pregledu.
Do not stop taking this medicine unless your doctor tells you to.
Če ste prenehali jemati zdravilo Fotivda Ne prekinite jemanja zdravile, razen če vam tako predpiše zdravnik.
The next most potently inhibited kinase is c-kit which is 8-fold less sensitive to inhibition by tivozanib compared to VEGFR 1, 2 and 3.
Naslednja najbolj učinkovito zavrta kinaza je gen c-kit, ki je 8-krat manj občutljiva na tivozanib in zaviranje v primerjavi z VEGFR 1, 2 in 3.
• overactive thyroid gland (which may cause symptoms like increased appetite, loss of weight,
• Prekomerno delovanje ščitnice (ki lahko povzroči simptome, kot so povečan apetit, hujšanje,
• dexamethasone (a corticosteroid to reduce inflammation and treat disorders of the immune system);
• deksametazon (kortikosteroid za zmanjšanje vnetja in zdravljenje motenj imunskega sistema);
Each hard capsule contains trace amounts of tartrazine (E102) (8-12% of the yellow printing ink composition) (see section 4.4).
Ena trda kapsula vsebuje sledi tartrazina (E102) (8-12 % kemične sestave rumenega črnila za tisk) (glejte poglavje 4.4).
Both events were CTC Grade 3 (see section 4.4).
Oba dogodka sta bila 3. stopnje po CTC (glejte poglavje 4.4).
Table 2: Efficacy analysis by independent radiology review (ITT population)
Preglednica 2: Analiza učinkovitosti z neodvisnim radiološkim pregledom (populacija
Caution is advised in patients with severe renal impairment due to limited experience and in patients undergoing dialysis as there is no experience of tivozanib in this patient population.
Svetuje se previdnost pri bolnikih s hudo ledvično okvaro, ker je izkušenj malo, in pri bolnikih, ki so na dializi, ker ni izkušenj s tivozanibom pri teh bolnikih.
In the case of a missed dose a replacement dose must not be taken to make up for a forgotten dose.
Izpuščen odmerek v primeru izpuščenega odmerka bolnik ne sme vzeti nadomestnega odmerka, da bi nadoknadil pozabljeni odmerek.
Continue to take your next dose at the usual time.
Vzemite naslednji odmerek po običajnem razporedu.
Fotivda may work less well when taken with some medicines.
Zdravilo Fotivda morda ne bo delovalo enako učinkovito, če ga jemljete skupaj z določenimi drugimi zdravili.
• Talk to your doctor when planning a baby, as Fotivda may affect the fertility of men and women.
• Če želite zanositi, se o tem pogovorite z zdravnikom, saj zdravilo Fotivda lahko vpliva na plodnost moških in žensk.
The maximum change in QTcF from baseline was 9.3 ms (90% CI: 5, 13.6), which occurred 2.5 hours after dosing on Day 21.
Največja sprememba QTcF od začetka zdravljenja je bila 9,3 ms (90 % CI: 5 13,6), ki je nastala 2,5 ure po odmerjanju 21. dan.
Transporter in vitro studies
In vitro študije prenašalcev
• Very high blood pressure leading to a stroke; flushed skin.
• Zelo visok krvni tlak, ki vodi do možganske kapi; pordela koža.
It is currently unknown whether tivozanib may reduce the effectiveness of hormonal contraceptives and therefore women using hormonal contraceptives should add a barrier method.
Trenutno ni znano, ali tivozanib zmanjša učinkovitost hormonske kontracepcije, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, uporabiti dodatno pregradno metodo.
In the pivotal study, the dose was reduced for grade 3 events and interrupted for grade 4 events.
V ključni študiji so odmerek zmanjšali pri dogodkih 3. stopnje, pri dogodkih 4. stopnje pa so odmerjanje prekinili.
What Fotivda is and what it is used for What you need to know before you take Fotivda How to take Fotivda
Kaj je zdravilo Fotivda in za kaj ga uporabljamo Kaj morate vedeti, preden vzamete zdravilo Fotivda Kako jemati zdravilo Fotivda Možni neželeni učinki
Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours.
Po peroralni uporabi tivozaniba se vzpostavijo najvišje ravni v serumu po približno 2 do 24 urah.
Hand foot skin reaction
Kožna reakcija roka-noga
Tivozanib potently and selectively blocks all 3 Vascular Endothelial Growth Factor receptors (VEGFR) and has been shown to block various VEGF-induced biochemical and biologic responses in vitro, including VEGF-ligand-induced phosphorylation of all three VEGFR 1, 2 and 3, and proliferation of human endothelial cells.
Tivozanib potencialno in selektivno blokira vse 3 receptorje za vaskularni endotelijski rastni faktor (VEGFR) in dokazano je, da in vitro blokira različne biokemične odzive in biološke odzive, ki jih inducira VEGF, vključno s fosforilacijo, ki jo inducira ligand VEGF, vseh treh VEGFR 1, 2 in 3, ter proliferacijo endotelijskih celic pri človeku.
Discontinuation of treatment should be considered in cases of persistent severe hypertension, posterior reversible encephalopathy syndrome (see below), or other complications of hypertension.
O ukinitvi zdravljenja razmislite v primerih vztrajne hude hipertenzije, sindroma posteriorne reverzibilne encefalopatije (glejte spodaj) ali drugih komplikacij, povezanih s hipertenzijo.
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows.
Neželeni učinki, o katerih niso poročali v kliničnih preskušanjih zdravila, vendar so jih opazili pri živalih, ki so bile izpostavljene ravnem, podobnim kliničnim ravnem izpostavljenosti in možno pomembnih za klinično uporabo, so bili, kot sledi.
There is no specific treatment or antidote for tivozanib overdose.
Za prevelik odmerek tivozaniba ni posebnega zdravljenja ali protistrupa.
Tivozanib reduces the supply of blood to the cancer, which slows down the growth and spread of cancer cells.
Tivozanib zmanjšuje dovod krvi raku, zaradi česar se upočasnita rast in širjenje rakavih celic.
The European Medicines Agency has waived the obligation to submit the results of studies with tivozanib in all subsets of the paediatric population in advanced renal cell carcinoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s tivozanibom za vse podskupine pediatrične populacije z napredovalim rakom ledvičnih celic (za informacije o pediatrični uporabi glejte poglavje 4.2).
Unchanged tivozanib is the major circulating form of the molecule, and there were no major metabolites detected in serum at exposure equal to or greater than 10% of the total radioactivity exposure.
Nespremenjeni tivozanib je najpogostejša oblika molekule v obtoku, zaznali niso nobenih pomembnih presnovkov v serumu pri izpostavljenosti, enaki ali večji kot 10 % skupne izpostavljenosti radioaktivnim snovem.
It is used where other treatments such as interferon-alpha or interleukin-2 have either not yet been used or have not helped to stop your disease.
To zdravilo uporabimo pri bolnikih, ki se še niso zdravili z drugimi zdravili, kot so inteferon alfa ali interlevkin-2, ali pri bolnikih, pri katerih ta zdravila niso pomagala zaustaviti bolezni.
Hypothyroidism has been observed to occur at any time during treatment with tivozanib, developing as early as within two months of treatment initiation.
Opazili so, da se hipotiroidizem pojavi kadar koli med zdravljenjem z zdravilom tivozanib, razvije se lahko že v dveh mesecih od začetka zdravljenja.
In vitro metabolism studies have shown that CYP3A4 and CYP1A1 are capable of metabolising tivozanib.
Rezultati študij presnove in vitro so pokazali, da sta CYP3A4 in CYP1A1 zmožna presnavljati tivozanib.
Treatment with Fotivda may cause your thyroid gland to work less well than usual.
Zdravljenje z zdravilom Fotivda lahko povzroči, da začne ščitnica delovati slabše kot normalno.
• Blood clot in a deep vein such as in the leg.
• Krvni strdek v globoki veni, kot je vena v nogi.
Your doctor will check you regularly, and you will normally continue to take Fotivda as long as it is working, and you do not suffer unacceptable side effects.
Zdravnik vas bo redno pregledoval in z jemanjem zdravila Fotivda boste normalno nadaljevali, dokler zdravilo učinkuje in nima nesprejemljivih neželenih učinkov.
2 Peripheral neuropathy including hyperaesthesia, hypoaesthesia, mononeuropathy, neuropathy peripheral, peripheral sensory neuropathy and paraesthesia
2 Periferna nevropatija vključuje hiperesteziijo, hipoestezijo, mononevropatijo, periferno nevropatijo, periferno senzorno nevropatijo in parestezijo
Accumulation at steady-state is approximately 6- to 7- fold the exposure observed at single-dose levels.
Kopičenje v stanju dinamičnega ravnovesja je približno 6- do 7-kratnik izpostavljenosti, ugotovljeni po enkratnem odmerku.
For patients who develop Grade 2 (> 1.0-3.4 g/24 hours) or Grade 3 (≥ 3.5 g/24 hours) proteinuria (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE]), the dose of tivozanib has to be reduced or the treatment temporarily interrupted.
Pri bolnikih, pri katerih se razvije proteinurija 2. stopnje (>1,0-3,4 g/24 ur) ali 3. stopnje (≥3,5 g/24 ur) (enotna terminološka merila za poimenovanje neželenih dogodkov nacionalnega inštituta za rakava obolenja [NCI CTCAE]), je treba zmanjšati odmerek tivozaniba ali začasno prekiniti zdravljenje s tem zdravilom.
If you have liver problems, your doctor may reduce how often you take your dose to every other day (i.e. one 1340 microgram capsule every other day).
Pri morebitnih težavah z jetri vam zdravnik lahko zmanjša pogostost jemanja odmerka na vsak drugi dan (tj. ena kapsula po 1340 mikrogramov vsak drugi dan).
After a single dose oral dose of [14C] tivozanib, approximately 79% of the radioactivity was recovered in the faeces and approximately 12% was found in the urine as metabolites.
Po enkratnem peroralnem odmerku [14C]-tivozaniba je bilo približno 79 % radioaktivnih snovi zajetih v blatu in približno 12 % v urinu v obliki presnovkov.
Blocking the action of VEGF prevents the formation of new blood vessels.
Z zaviranjem delovanja VEGF preprečuje nastajanje novih krvnih žil.
• phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
• fenobarbital, fenitoin, karbamazepin (zdravilo proti epilepsiji);
Based on the population pharmacokinetic analysis, there is no clinically relevant effect of age, gender or race on the pharmacokinetics of tivozanib.
Glede na analizo populacijske farmakokinetike starost, spol ali rasa nimajo klinično pomembnega vpliva na farmakokinetiko tivozaniba.
Tivozanib should not be used during pregnancy.
Zdravila tivozanib ni dovoljeno uporabljati med nosečnostjo.
• If you have or are treated for an abnormal rate and rhythm of the heartbeat (arrhythmia).
• če imate ali če se zdravite zaradi nenormalne hitrosti in ritma srčnega utripa (aritmija).
Assuming proportional hazards, a hazard ratio less than 1 indicates a reduction in hazard rate in favour of tivozanib; e p-value for subgroup analyses based on unstratified log-rank test.
Če predpostavljamo proporcionalna tveganja, razmerje tveganja manj kot 1 označuje zmanjšanje razmerje tveganja v korist tivozanibu; e p-vrednost za analizo podskupine, ki temelji na nestratificiranem „log rank testu“.
Your doctor will monitor the effect of Fotivda on your heart by recording the electrical activity of your heart (an electrocardiogram) or by measuring your blood calcium, magnesium and potassium levels during your treatment.
Zdravnik bo spremljal delovanje zdravila Fotivda na srce tako, da bo beležil električno dejavnost srca (elektrokardiogram) ali meril vsebnost kalcija, magnezija in kalija v krvi med zdravljenjem.
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).
Povprečni OS je bil 28,2 meseca (95 % CI 22,5 33,0) v kraku s tivozanibom v primerjavi s 30,8 meseca (95 % CI 28,4 33,3) v kraku s sorafenibom (HR=1,147 p=0,276).
Fotivda 890 microgram hard capsules EU/1/17/1215/001
Fotivda 890 mikrogramov trde kapsule EU/1/17/1215/001
Dry skin
Luščenje kože
It is currently unknown whether tivozanib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method (see section 4.6).
Trenutno ni znano, ali tivozanib zmanjša učinkovitost hormonske kontracepcije, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, uporabiti dodatno pregradno metodo (glejte poglavje 4.6).
The safety of re-initiating tivozanib therapy in patients previously experiencing PRES is not known and tivozanib should only be used with caution in these patients.
Varnost ponovnega začetka jemanja tivozaniba pri bolnikih, ki so predhodno prestali PRES, ni znana, zato je treba tivozanib pri teh bolnikih uporabljati previdno.
Persistent severe hypertension (‘hypertensive crisis') was an adverse reaction in 1.0%, CTC Grade 3 or higher in 0.9%.
Vztrajna huda hipertenzija („hipertenzivna kriza“) je bila neželen učinek pri 1,0 %, 3. stopnje ali več po CTC pri 0,9 %.
AST, ALT, bilirubin, and AP should be monitored before initiation of and periodically throughout treatment with tivozanib because of the potential risk of hepatotoxicity (see section 4.2).
Vrednosti AST, ALT, bilirubina in AP je treba spremljati pred začetkom zdravljenja in nato redno ves čas zdravljenja s tivozanibom, ker obstaja nevarnost hepatotoksičnosti (glejte poglavje 4.2).