FrancophonIA/ELRC3.0 huggingface dataset:
English: • Paleness and tiredness from excess bleeding.
Slovenian: • Bledičnost in utrujenost zaradi prekomernih krvavitev.
English: The most common adverse reactions of any grade include hypertension (47.6%), dysphonia (26.9%), fatigue (25.8%) and diarrhoea (25.5%).
Slovenian: Najpogostejši neželeni učinki katere koli stopnje vključujejo hipertenzijo (47,6 %), disfonijo (26,9 %), utrujenost (25,8 %) in diarejo (25,5 %).
English: Treatment with Fotivda may increase the risk of bleeding.
Slovenian: Zdravljenje z zdravilom Fotivda lahko poveča tveganje za krvavitve.
English: In the case of vomiting a replacement dose should not be taken; the next dose should be taken at the next scheduled time.
Slovenian: Po morebitnem bruhanju naj ne vzame nadomestnega odmerka; naslednji odmerek mora vzeti v naslednjem predvidenem času po razporedu.
English: Oral use.
Slovenian: Oralna uporaba.
English: • if laboratory tests show that there is protein in your urine Your doctor will monitor this at the beginning and during your treatment.
Slovenian: • če rezultati laboratorijski preiskav pokažejo, da imate beljakovine v urinu Zdravnik bo preveril vsebnost beljakovin v urinu pred zdravljenjem in nato redno med zdravljenjem.
English: • Posterior reversible encephalopathy syndrome (PRES).
Slovenian: • Sindrom posteriorne reverzibilne encefalopatije (PRES).
English: The decision to resume tivozanib therapy after surgery should be based on clinical judgment of adequate wound healing.
Slovenian: Odločitev, kdaj znova začeti z zdravljenjem s tivozanibom po operaciji, mora temeljiti na klinični presoji o ustrezni zaceljenosti ran.
English: Taking too much Fotivda makes side effects more likely or to become more severe, especially high blood pressure.
Slovenian: Če vzamete preveč zdravila Fotivda, so neželeni učinki verjetnejši ali resnejši, predvsem visok krvni tlak.
English: 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).
Slovenian: 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).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika alifarmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: If you forget to take Fotivda
Slovenian: Če ste pozabili vzeti zdravilo Fotivda
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O tem, kako pravilno zavreči zdravila, ki jih ne uporabljajte več, se posvetujte s farmacevtom.
English: Fotivda may be taken with or without food (see section 5.2).
Slovenian: Zdravilo Fotivda se lahko vzame z ali brez hrane (glejte poglavje 5.2).
English: 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.
Slovenian: 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.
English: Dysphonia, diarrhoea, fatigue, weight decreased, appetite decreased and hypothyroidism occurred more commonly in patients ≥ 65 years of age.
Slovenian: Disfonija, diareja, utrujenost, zmanjšanje telesne mase, zmanjšan apetit in hipotiroidizem so se pojavili pogosteje pri bolnikih, starih ≥ 65 let.
English: Experience of tivozanib use in patients with severe renal impairment is limited and caution is advised.
Slovenian: Izkušnje z uporabo tivozaniba pri bolnikih s hudo ledvično okvaro so omejene in svetuje se previdnost.
English: 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.
Slovenian: 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.
English: Do not stop taking this medicine unless your doctor tells you to.
Slovenian: Če ste prenehali jemati zdravilo Fotivda Ne prekinite jemanja zdravile, razen če vam tako predpiše zdravnik.
English: 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.
Slovenian: 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.
English: • overactive thyroid gland (which may cause symptoms like increased appetite, loss of weight,
Slovenian: • Prekomerno delovanje ščitnice (ki lahko povzroči simptome, kot so povečan apetit, hujšanje,
English: • dexamethasone (a corticosteroid to reduce inflammation and treat disorders of the immune system);
Slovenian: • deksametazon (kortikosteroid za zmanjšanje vnetja in zdravljenje motenj imunskega sistema);
English: Each hard capsule contains trace amounts of tartrazine (E102) (8-12% of the yellow printing ink composition) (see section 4.4).
Slovenian: Ena trda kapsula vsebuje sledi tartrazina (E102) (8-12 % kemične sestave rumenega črnila za tisk) (glejte poglavje 4.4).
English: Both events were CTC Grade 3 (see section 4.4).
Slovenian: Oba dogodka sta bila 3. stopnje po CTC (glejte poglavje 4.4).
English: Table 2: Efficacy analysis by independent radiology review (ITT population)
Slovenian: Preglednica 2: Analiza učinkovitosti z neodvisnim radiološkim pregledom (populacija
English: 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.
Slovenian: 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.
English: In the case of a missed dose a replacement dose must not be taken to make up for a forgotten dose.
Slovenian: Izpuščen odmerek v primeru izpuščenega odmerka bolnik ne sme vzeti nadomestnega odmerka, da bi nadoknadil pozabljeni odmerek.
English: Continue to take your next dose at the usual time.
Slovenian: Vzemite naslednji odmerek po običajnem razporedu.
English: Fotivda may work less well when taken with some medicines.
Slovenian: Zdravilo Fotivda morda ne bo delovalo enako učinkovito, če ga jemljete skupaj z določenimi drugimi zdravili.
English: • Talk to your doctor when planning a baby, as Fotivda may affect the fertility of men and women.
Slovenian: • Če želite zanositi, se o tem pogovorite z zdravnikom, saj zdravilo Fotivda lahko vpliva na plodnost moških in žensk.
English: 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.
Slovenian: 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.
English: Transporter in vitro studies
Slovenian: In vitro študije prenašalcev
English: • Very high blood pressure leading to a stroke; flushed skin.
Slovenian: • Zelo visok krvni tlak, ki vodi do možganske kapi; pordela koža.
English: It is currently unknown whether tivozanib may reduce the effectiveness of hormonal contraceptives and therefore women using hormonal contraceptives should add a barrier method.
Slovenian: Trenutno ni znano, ali tivozanib zmanjša učinkovitost hormonske kontracepcije, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, uporabiti dodatno pregradno metodo.
English: In the pivotal study, the dose was reduced for grade 3 events and interrupted for grade 4 events.
Slovenian: V ključni študiji so odmerek zmanjšali pri dogodkih 3. stopnje, pri dogodkih 4. stopnje pa so odmerjanje prekinili.
English: What Fotivda is and what it is used for What you need to know before you take Fotivda How to take Fotivda
Slovenian: Kaj je zdravilo Fotivda in za kaj ga uporabljamo Kaj morate vedeti, preden vzamete zdravilo Fotivda Kako jemati zdravilo Fotivda Možni neželeni učinki
English: Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours.
Slovenian: Po peroralni uporabi tivozaniba se vzpostavijo najvišje ravni v serumu po približno 2 do 24 urah.
English: Hand foot skin reaction
Slovenian: Kožna reakcija roka-noga
English: 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.
Slovenian: 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.
English: Discontinuation of treatment should be considered in cases of persistent severe hypertension, posterior reversible encephalopathy syndrome (see below), or other complications of hypertension.
Slovenian: O ukinitvi zdravljenja razmislite v primerih vztrajne hude hipertenzije, sindroma posteriorne reverzibilne encefalopatije (glejte spodaj) ali drugih komplikacij, povezanih s hipertenzijo.
English: 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.
Slovenian: 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.
English: There is no specific treatment or antidote for tivozanib overdose.
Slovenian: Za prevelik odmerek tivozaniba ni posebnega zdravljenja ali protistrupa.
English: Tivozanib reduces the supply of blood to the cancer, which slows down the growth and spread of cancer cells.
Slovenian: Tivozanib zmanjšuje dovod krvi raku, zaradi česar se upočasnita rast in širjenje rakavih celic.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Hypothyroidism has been observed to occur at any time during treatment with tivozanib, developing as early as within two months of treatment initiation.
Slovenian: Opazili so, da se hipotiroidizem pojavi kadar koli med zdravljenjem z zdravilom tivozanib, razvije se lahko že v dveh mesecih od začetka zdravljenja.
English: In vitro metabolism studies have shown that CYP3A4 and CYP1A1 are capable of metabolising tivozanib.
Slovenian: Rezultati študij presnove in vitro so pokazali, da sta CYP3A4 in CYP1A1 zmožna presnavljati tivozanib.
English: Treatment with Fotivda may cause your thyroid gland to work less well than usual.
Slovenian: Zdravljenje z zdravilom Fotivda lahko povzroči, da začne ščitnica delovati slabše kot normalno.
English: • Blood clot in a deep vein such as in the leg.
Slovenian: • Krvni strdek v globoki veni, kot je vena v nogi.
English: 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.
Slovenian: Zdravnik vas bo redno pregledoval in z jemanjem zdravila Fotivda boste normalno nadaljevali, dokler zdravilo učinkuje in nima nesprejemljivih neželenih učinkov.
English: 2 Peripheral neuropathy including hyperaesthesia, hypoaesthesia, mononeuropathy, neuropathy peripheral, peripheral sensory neuropathy and paraesthesia
Slovenian: 2 Periferna nevropatija vključuje hiperesteziijo, hipoestezijo, mononevropatijo, periferno nevropatijo, periferno senzorno nevropatijo in parestezijo
English: Accumulation at steady-state is approximately 6- to 7- fold the exposure observed at single-dose levels.
Slovenian: Kopičenje v stanju dinamičnega ravnovesja je približno 6- do 7-kratnik izpostavljenosti, ugotovljeni po enkratnem odmerku.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Po enkratnem peroralnem odmerku [14C]-tivozaniba je bilo približno 79 % radioaktivnih snovi zajetih v blatu in približno 12 % v urinu v obliki presnovkov.
English: Blocking the action of VEGF prevents the formation of new blood vessels.
Slovenian: Z zaviranjem delovanja VEGF preprečuje nastajanje novih krvnih žil.
English: • phenobarbital, phenytoin, carbamazepine (used to treat epilepsy);
Slovenian: • fenobarbital, fenitoin, karbamazepin (zdravilo proti epilepsiji);
English: Based on the population pharmacokinetic analysis, there is no clinically relevant effect of age, gender or race on the pharmacokinetics of tivozanib.
Slovenian: Glede na analizo populacijske farmakokinetike starost, spol ali rasa nimajo klinično pomembnega vpliva na farmakokinetiko tivozaniba.
English: Tivozanib should not be used during pregnancy.
Slovenian: Zdravila tivozanib ni dovoljeno uporabljati med nosečnostjo.
English: • If you have or are treated for an abnormal rate and rhythm of the heartbeat (arrhythmia).
Slovenian: • če imate ali če se zdravite zaradi nenormalne hitrosti in ritma srčnega utripa (aritmija).
English: 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.
Slovenian: 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“.
English: 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.
Slovenian: 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.
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).
Slovenian: 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).
English: Fotivda 890 microgram hard capsules EU/1/17/1215/001
Slovenian: Fotivda 890 mikrogramov trde kapsule EU/1/17/1215/001
English: Dry skin
Slovenian: Luščenje kože
English: 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).
Slovenian: Trenutno ni znano, ali tivozanib zmanjša učinkovitost hormonske kontracepcije, zato morajo ženske, ki uporabljajo hormonsko kontracepcijo, uporabiti dodatno pregradno metodo (glejte poglavje 4.6).
English: 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.
Slovenian: Varnost ponovnega začetka jemanja tivozaniba pri bolnikih, ki so predhodno prestali PRES, ni znana, zato je treba tivozanib pri teh bolnikih uporabljati previdno.
English: Persistent severe hypertension (‘hypertensive crisis') was an adverse reaction in 1.0%, CTC Grade 3 or higher in 0.9%.
Slovenian: Vztrajna huda hipertenzija („hipertenzivna kriza“) je bila neželen učinek pri 1,0 %, 3. stopnje ali več po CTC pri 0,9 %.
English: 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).
Slovenian: 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).
English: Tivozanib showed a statistically significant improvement in PFS and ORR over sorafenib by independent radiology review (Table 2 and Figure 1).
Slovenian: Tivozanib je pokazal statistično značilno večje izboljšanje v PFS in ORR kot sorafenib, ocenjeno z neodvisnim radiološkim pregledom (preglednica 2 in slika 1).
English: In repeat-dose toxicity studies in rats, abnormalities were noted in growing incisors (thin brittle teeth, tooth loss, malocclusions) at doses approximately 2-fold greater than the calculated human equivalent dose and growth plate hypertrophy was observed at doses approximately 0.7- to 7-fold greater than the calculated human equivalent dose.
Slovenian: V raziskavah toksičnosti pri ponavljajočih odmerkih na podganah so poročali o nenormalnostih na rastočih sekalcih (tanki lomljivi zobje, izguba zob, malokluzija) pri odmerkih, približno 2-krat večjih kot izračunani ekvivalentni odmerek za človeka, in hipertrofijo rastnega hrustanca pri odmerkih, približno 0,7- do 7-krat večjih, kot je izračunani ekvivalentni odmerek za človeka.
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.
Slovenian: Če že jemljete zdravilo za zdravljenje visokega krvnega tlaka in zdravnik zmanjša odmerek zdravila Fotivda ali prekine ali zaustavi zdravljenje, vas bodo redno pregledovali, če imate morda nizek krvni tlak.
English: It is recommended that symptoms of gastrointestinal perforation or fistula should be periodically monitored throughout treatment with tivozanib and that tivozanib should be used with caution in patients at risk for GI perforation or fistula.
Slovenian: Priporočamo, da redno spremljate simptome gastrointestinalne perforacije ali fistule ves čas zdravljenja s tivozanibom in da pri bolnikih s tveganjem za gastrointestinalno perforacijo ali fistulo tivozanib uporabljate previdno.
English: 1 Goitre including goitre and toxic nodular goitre
Slovenian: 1 Golšavost vključuje golšo in toksično nodozno golšo
English: Figure 1: Kaplan-Meier plot of progression free survival, independent radiological review (ITT Population)
Slovenian: Slika 1: Kaplan-Meierjev postopek za preživetje brez napredovanja bolezni, neodvisni radiološki pregled (populacija ITT)
English: Fotivda should be supervised by a physician experienced in the use of anticancer therapies.
Slovenian: Zdravljenje z zdravilom Fotivda mora nadzorovati zdravnik, ki ima zadostne izkušnje z zdravili proti raku.
English: Medicinal products for which intestinal absorption is restricted by BCRP Tivozanib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown (see section 5.2).
Slovenian: Zdravila, pri katerih absorpcijo v črevesju preprečuje BCRP Tivozanib zavira prenašalno beljakovino BCRP in vitro, vendar klinična pomembnost te ugotovitve ni znana (glejte poglavje 5.2).
English: If you vomit after taking Fotivda, do not take a replacement capsule.
Slovenian: Če bruhate po zaužitju zdravila Fotivda, ne vzemite nadometne kapsule.
English: What Fotivda looks like and contents of the pack
Slovenian: Izgled zdravila Fotivda in vsebina pakiranja
English: Increased lacrimation
Slovenian: Povečano solzenje
English: Elderly patients No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).
Slovenian: Starejši bolniki Za bolnike, stare 65 let in več, ni treba prilagoditi odmerka (glejte poglavji 4.4 in 5.1).
English: Furthermore, tivozanib was not an in vitro inhibitor of OAT1, OAT3, OCT2, MATE1 and MATE2-K or substrate of MRP2 and BCRP.
Slovenian: Tivozanib nadalje ni bil in vitro zaviralec OAT1, OAT3, OCT2, MATE1 in MATE2-K niti substrat MRP2 in BCRP.
English: The study included patients who had all undergone prior nephrectomy, and who had received either no prior therapy or no more than one prior systemic therapy in the metastatic setting (immunotherapy/chemotherapy); prior treatment with VEGF or mechanistic Target of Rapamycin (mTOR) targeted therapy was not allowed.
Slovenian: V študijo so bili vključeni bolniki, ki so opravili nefrektomijo in predhodno niso prejeli zdravljenja ali so prejeli samo eno sistemsko zdravljenje metastatskega raka (imunoterapija ali kemoterapija); predhodno zdravljenje z VEGF ali zdravljenje z delovanjem na signalne potmi tarče rapamicina (mTOR) ni bilo dovoljeno.
English: • Lack of blood flow through the heart blood vessels.
Slovenian: • Pomanjkljiv pretok krvi skozi krvne žile.
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).
Slovenian: O podaljšanju QT so poročali pri dveh bolnikih (2. stopnje in 3. stopnje po CTC) v študiji varnosti tivozaniba za srce, nobena reakcija ni štela za resno (glejte poglavji 4.4 in 5.1).
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.
Slovenian: Zdravnik bo redno preverjal, kako dobro delujejo jetra, pred in med zdravljenjem z zdravilom Fotivda (npr. s krvnimi testi) ter po potrebi zmanjšal pogostost jemanja zdravila Fotivda.