FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: Budući da je CYP1A1 primarno eksprimiran u ekstrahepatalnim tkivima poput pluća i crijeva, ozbiljnije uključivanje ove izoforme u metabolizam jetre nije se smatralo vjerojatnim.
English: The decision to resume tivozanib therapy after surgery should be based on clinical judgment of adequate wound healing.
Croatian: Odluku o nastavku terapije tivozanibom nakon operacije treba temeljiti na kliničkoj procjeni odgovarajućeg zacjeljivanja rane.
English: In the case of persistent hypertension despite use of anti-hypertensive therapy, the tivozanib dose should be reduced, or the treatment interrupted and re-initiated at a lower dose once the blood pressure is controlled, according to clinical judgment (see section 4.2).
Croatian: U slučaju perzistirajuće hipertenzije usprkos primjeni terapije za snižavanje krvnog tlaka, dozu tivozaniba potrebno je smanjiti ili je potrebno privremeno prekinuti terapiju i ponovno je započeti smanjenom dozom jednom kad krvni tlak bude stabilan, u skladu s kliničkom procjenom (vidjeti dio 4.2).
English: Table 2: Efficacy analysis by independent radiology review (ITT population)
Croatian: Tablica 2: Analiza djelotvornosti pomoću neovisne radiološke procjene (ITT populacija) Tivozanib
English: Tivozanib was shown to be teratogenic, embryotoxic and foetotoxic in pregnant rats at dose levels 5 times lower than the recommended clinical dose (based on a 60 kg human).
Croatian: Pokazalo se da je tivozanib teratogen, embriotoksičan i fetotoksičan u gravidnih ženki štakora kod doziranja koje je 5 puta niže od preporučene kliničke doze (na temelju čovjeka težine 60 kg).
English: Talk to your doctor, pharmacist or nurse while taking Fotivda:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri kad uzimate Fotivdu:
English: For the 30% of patients receiving prior treatment, the predominant therapy was interferon alpha as monotherapy which was received by 75 patients in the tivozanib arm and 62 patients in the sorafenib arm.
Croatian: Kod 30% bolesnika koji su prethodno primali terapiju, dominantna terapija bila je interferon alfa kao monoterapija koju je primilo 75 bolesnika u skupini s tivozanibom i 62 bolesnika u skupini sa sorafenibom.
English: • Paleness and tiredness from excess bleeding.
Croatian: • Bljedoća i umor od prekomjernog krvarenja
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).
Croatian: Ako imate problema s jetrom, Vaš liječnik može smanjiti učestalost uzimanja doze na svaki drugi dan (tj. jednu kapsulu od 1340 mikrograma svaki drugi dan).
English: 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.
Croatian: Vaš liječnik će redovito pratiti vaš krvni tlak i ako je previsok, može Vam dati lijek za njegovo snižavanje ili smanjiti dozu Fotivde.
English: Progression-Free Survival [median, months (95% CI)], ITT Population
Croatian: Preživljenje bez progresije [medijan, mjeseci (95% CI)], ITT populacija
English: Moderate CYP3A4 inducers are not expected to have a clinically relevant effect on tivozanib exposure.
Croatian: Za umjerene induktore enzima CYP3A4 ne očekuje se klinički značajan učinak na izloženost tivozanibu.
English: Figure 1: Kaplan-Meier plot of progression free survival, independent radiological review (ITT Population)
Croatian: Slika 1: Kaplan-Meierov prikaz preživljenja bez progresije, neovisna radiološka procjena (ITT populacija)
English: Posterior Reversible Encephalopathy Syndrome (PRES) PRES (also known as reversible posterior leukoencephalopathy syndrome (RPLS)) was confirmed in one non-RCC patient after approximately 8 weeks on tivozanib.
Croatian: Sindrom posteriorne reverzibilne encefalopatije (PRES) PRES (poznat i kao sindrom posteriorne reverzibilne leukoencefalopatije (RPLS)) potvrđen je kod jednog ne-RCC bolesnika nakon otprilike 8 tjedana terapije tivozanibom.
English: In vitro studies have shown that metabolites of tivozanib can undergo UGT mediated biotransformation via the UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9, and UGT1A10 pathways.
Croatian: In vitro ispitivanja pokazuju da metaboliti tivozaniba mogu proći biotransformaciju UGT-om putem UGT1A1, UGT1A3, UGT1A7, UGT1A8, UGT1A9 i UGT1A10.
English: QT/QTc prolongation
Croatian: Produženje QT/QTc intervala
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U
English: In patients receiving tivozanib as initial therapy, there were three adverse reactions with outcome death; one was uncontrolled hypertension in the setting of a suspected overdose (see section 4.9) and two were reported simply as death.
Croatian: Kod bolesnika koji su tivozanib primali kao početnu terapiju pojavile su se tri nuspojave sa smrtnim ishodom; jedna je bila nekontrolirana hipertenzija u okolnostima u kojima postoji sumnja na predoziranje (vidjeti dio 4.9), dok su dvije prijavljene samo kao smrt.
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).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja tivozaniba u svim podskupinama pedijatrijske populacije s uznapredovalim karcinomom bubrežnih stanica (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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.
Croatian: Nepromijenjeni tivozanib glavni je cirkulirajući oblik molekule i kod izloženosti koja je jednaka ili veća od 10% ukupne izloženosti radioaktivnosti u serumu nije otkriven nijedan glavni metabolit.
English: Persistent severe hypertension (‘hypertensive crisis') was an adverse reaction in 1.0%, CTC Grade 3 or higher in 0.9%.
Croatian: Perzistentna teška hipertenzija („hipertenzivna kriza“) bila je nuspojava u 1,0%, a CTC 3. stupnja ili više u 0,9%.
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.
Croatian: Sigurnost ponovnog započinjanja terapije tivozanibom kod bolesnika koji su ranije imali PRES nije poznata i kod takvih bolesnika tivozanib bi trebalo koristiti oprezno.
English: Following oral administration of tivozanib, peak serum levels are achieved after approximately 2 to 24 hours.
Croatian: Nakon peroralne primjene tivozaniba, najviše razine u serumu postižu se nakon otprilike 2 do 24 sata.
English: • Peptic ulcer in the small intestines.
Croatian: • Peptički ulkus u tankom crijevu
English: Exposure is dose proportional between 890 and 1340 microgram and dose related over the wider range of 450 mg and 1790 microgram.
Croatian: Izloženost je proporcionalna dozi za raspon od 890 do 1340 mikrograma i vezana uz dozu u većem rasponu, od 450 do 1790 mikrograma.
English: If the patient develops Grade 4 proteinuria (nephrotic syndrome) tivozanib has to be discontinued.
Croatian: Ako se kod bolesnika razvije proteinurija 4. stupnja (nefrotski sindrom), terapiju tivozanibom treba obustaviti.
English: Fotivda 890 microgram hard capsules EU/1/17/1215/001
Croatian: Fotivda 890 mikrograma tvrde kapsule EU/1/17/1215/001
English: • If you are taking St. John's Wort (also known as Hypericum perforatum, a herbal remedy used for treatment of depression and anxiety).
Croatian: • ako uzimate gospinu travu (poznatu kao Hypericum perforatum, biljni lijek koji se koristi za liječenje depresije i tjeskobe).
English: Myocardial infarction (acute) / ischaemia7 Angina pectoris Tachycardia8
Croatian: (akutni) / ishemija7 Angina pectoris Tahikardija8
English: Get medical help straightaway if you experience confusion, changes in your mental state or headaches.
Croatian: Odmah potražite liječničku pomoć ako primijetite smetenost, promjene mentalnog stanja ili osjetite glavobolju.
English: Your doctor will regularly monitor you for these symptoms during your treatment with Fotivda.
Croatian: Vaš će liječnik redovito pratiti ove simptome tijekom terapije Fotivdom.
English: Accumulation at steady-state is approximately 6- to 7- fold the exposure observed at single-dose levels.
Croatian: Akumulacija u stanju dinamičke ravnoteže iznosi otprilike 6 do 7 puta vrijednosti izloženosti uočenih na razini jedne doze.
English: Mild to severe hypertension may be present.
Croatian: Može biti prisutna blaga do teška hipertenzija.
English: Results from a single dose study to evaluate the pharmacokinetics, safety and tolerability of tivozanib in subjects with hepatic impairment show that across the entire measurement period, tivozanib was eliminated more slowly in subjects with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
Croatian: Rezultati ispitivanja jednokratnog doziranja kako bi se ocijenila farmakokinetika, sigurnost i podnošljivost tivozaniba kod ispitanika s oštećenjem jetre pokazali su da se tijekom čitavog razdoblja mjerenja tivozanib izlučivao sporije kod ispitanika s umjerenim (Child-Pugh stupanj B) ili teškim oštećenjem jetre (Child-Pugh stupanj C).
English: Hand foot skin reaction
Croatian: Reakcija kože šaka i stopala
English: Risk factors for ATE include malignant disease, age > 65 years, hypertension, diabetes mellitus, smoking, hypercholesterolaemia, and prior thromboembolic disease.
Croatian: Faktori rizika za ATE uključuju malignu bolest, dob višu od 65 godina, hipertenziju, dijabetes melitus, pušenje, hiperkolesterolemiju i raniju tromboembolijsku bolest.
English: Women of childbearing potential/contraception in males and females Women of childbearing potential should avoid becoming pregnant while on tivozanib.
Croatian: Žene u reproduktivnoj dobi/kontracepcija kod žena i muškaraca Žene u reproduktivnoj dobi trebale bi izbjegavati trudnoću dok uzimaju tivozanib.
English: It is recommended that tivozanib be used with caution in patients with a history of QT interval prolongation or other relevant pre-existing cardiac disease and those receiving other medications known to increase the QT interval.
Croatian: Preporučuje se oprezna primjena tivozaniba kod bolesnika koji imaju povijest produženja QT intervala ili drugih relevantnih srčanih bolesti koje su otprije prisutne i kod onih bolesnika koji primaju druge lijekove za koje se zna da produžuju QT interval.
English: Alternatively, a statin not subject to restriction of intestinal absorption by BCRP should be considered.
Croatian: Potrebno je razmotriti i primjenu alternativnog statina koji ne podliježe ograničenju apsorpcije u crijeva BCRP-om.
English: If you get bleeding problems (with painful swollen stomach (abdomen), vomiting blood, coughing up blood, black stools, blood in your urine, headache or changes in your mental state), tell your doctor right away.
Croatian: Ako Vam se jave problemi s krvarenjem (uz bol i nadutost u trbuhu (abdomenu), povraćanje krvi, iskašljavanje krvi, crnu stolicu, krv u mokraći, glavobolju ili promjene mentalnog stanja), odmah obavijestite liječnika.
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).
Croatian: Trenutačno nije poznato može li tivozanib smanjiti učinkovitost hormonskih kontracepcijskih sredstava, pa žene koje koriste hormonska kontracepcijska sredstva trebaju koristiti i dodatnu mehaničku metodu kontracepcije (vidjeti dio 4.6).
English: In clinical studies with tivozanib, hand foot skin reaction (palmar-plantar erythrodysaesthesia) has been reported.
Croatian: U kliničkim ispitivanjima s tivozanibom prijavljena je reakcija kože šaka i stopala (palmoplantarna eritrodizestezija).
English: • Posterior reversible encephalopathy syndrome (PRES).
Croatian: • Sindrom posteriorne reverzibilne encefalopatije (PRES).
English: Direct N-glucoronidation of tivozanib was a minor pathway of metabolism in vitro.
Croatian: Direktna N-glukuronidacija tivozaniba predstavljala je manje bitan metabolički put in vitro.
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.
Croatian: Trenutačno nije poznato može li tivozanib smanjiti učinak hormonskih kontracepcijskih sredstava, pa žene koje koriste hormonska kontracepcijska sredstva trebaju koristiti i dodatnu mehaničku metodu kontracepcije.
English: Fotivda 1340 microgram hard capsules EU/1/17/1215/002
Croatian: Fotivda 1340 mikrograma tvrde kapsule EU/1/17/1215/002
English: Proteinuria Blood creatinine increased
Croatian: Proteinurija Povišeni kreatinin u krvi
English: Contraindication of concomitant use
Croatian: Kontraindikacija za istodobnu primjenu
English: There are no data from the use of tivozanib in pregnant women.
Croatian: Nema podataka o primjeni tivozaniba kod trudnica.
English: According to the population pharmacokinetic analysis of tivozanib exposure, no dose adjustment is required in patients with mild or moderate renal impairment.
Croatian: Prema populacijskoj farmakokinetičkoj analizi izloženosti tivozanibu, dozu nije potrebno prilagođavati kod bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Gastrointestinal perforation/fistula
Croatian: Želučano-crijevna perforacija/fistula
English: If you forget to take Fotivda
Croatian: Ako ste zaboravili uzeti Fotivdu
English: • Bleeding, e.g. in the brain, from the mouth, gums, lungs, stomach, gut ulcers, female genitals,
Croatian: • Krvarenje, npr. u mozgu, iz usta, desni, pluća, želuca, crijevnih čireva, ženskih genitalija, anusa,
English: 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.
Croatian: U kliničkom ispitivanju zdravih dobrovoljnih sudionika, zajednička primjena tivozaniba s potentnim inhibitorom enzima CYP3A4, ketokonazolom (400 mg jednom dnevno), nije imala nikakav učinak na koncentracije tivozaniba u serumu (Cmax ili AUC); stoga nije vjerojatno da se izloženost tivozanibu može mijenjati inhibitorima enzima CYP3A4.
English: Hazard Ratio (95% CI)
Croatian: (95% CI)
English: Experience of tivozanib use in patients with severe renal impairment is limited and caution is advised.
Croatian: Iskustvo primjene tivozaniba kod bolesnika s teškim oštećenjem bubrega je ograničeno pa se preporučuje oprez.
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.
Croatian: Pretpostavljajući proporcionalne hazarde, omjer hazarda manji od 1 upućuje na smanjenje stope hazarda u korist tivozaniba; e p-vrijednost za analize podskupina temeljena na nestratificiranom log-rang testu.
English: 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).
Croatian: Kod bolesnika s poviješću hipertenzije nastupila je pogoršana nekontrolirana hipertenzija koja je imala smrtni ishod nakon uzimanja 3 doze od 1340 mikrograma tivozaniba u jednom danu (ukupno 4020 mikrograma).
English: The active substance in Fotivda is tivozanib, which is a protein kinase inhibitor.
Croatian: Djelatna tvar u Fotivdi je tivozanib, inhibitor proteinske kinaze.
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).
Croatian: Bolesnike je potrebno uputiti na oprez tijekom upravljanja vozilima i rada sa strojevima ako za vrijeme liječenja tivozanibom osjete asteniju, umor i/ili omaglicu (vidjeti dio 4.8).
English: The occurrence of undesirable effects may require temporary interruption and/or dose reduction of tivozanib therapy (see section 4.4).
Croatian: Pojava nuspojava može zahtijevati privremeni prekid i/ili smanjenje doze tivozaniba (vidjeti dio 4.4).
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).
Croatian: Lijekovi čija je apsorpcija u crijevu ograničena proteinom rezistencije raka dojke (BCRP) Tivozanib inhibira transportni protein BCRP in vitro, ali klinički značaj ovog nalaza nije poznat (vidjeti dio 5.2).
English: After once daily dosing of 1340 microgram tivozanib for 21 or 28 days in RCC patients, Cmax was 67.5 to 94.3 ng/mL and AUC0-24 was 1,180 to 1,641 ng.hr/mL.
Croatian: Nakon primjene 1340 mikrograma tivozaniba na dan tijekom 21 ili 28 dana kod bolesnika s karcinomom bubrežnih stanica (RCC), Cmax je bio od 67,5 do 94,3 ng/mL, a AUC0-24 je bio od 1,180 do 1,641 ng.hr/mL.
English: 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.
Croatian: Pri ocjenjivanju tivozaniba u ispitivanju učinka hrane, obrok bogat mastima smanjio je vršnu koncentraciju (Cmax) u serumu za 23,4% u usporedbi sa stanjem na tašte.
English: The active substance is tivozanib.
Croatian: Djelatna tvar je tivozanib.
English: No more than one dose of Fotivda must be taken per day.
Croatian: U jednom danu smije se uzeti samo jedna doza Fotivde.
English: Stratification factors are number of prior treatments (0 or 1) and number of metastatic sites/organs involved (1 or ≥2).
Croatian: Faktori stratifikacije su broj prethodnih terapija (0 ili 1) i broj mjesta s metastazama/zahvaćenih organa (1 ili ≥2).
English: 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.
Croatian: Klinička ispitivanja s tivozanibom provodila su se s bolesnicima s karcinomom bubrežnih stanica (RCC) čija je koncentracija kreatinina u serumu bila ≤2 puta vrijednosti gornje granice normalne vrijednosti, uključujući i one koji su prethodno bili podvrgnuti nefrektomiji.
English: • Blood clot in a deep vein such as in the leg.
Croatian: • Ugrušak u dubokoj veni, primjerice onoj u nozi
English: Monitoring for proteinuria before initiation of, and periodically throughout treatment is recommended.
Croatian: Praćenje proteinurije preporučuje se prije početka te redovito tijekom liječenja.
English: Increased testis weights were observed at a dose 7-fold higher than the recommended clinical dose.
Croatian: Povećanje težine testisa uočeno je kod doze koja je bila 7 puta viša od preporučene kliničke doze.
English: 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).
Croatian: Početne demografske značajke i značajke bolesti bile su općenito dobro uravnotežene po skupini s tivozanibom i skupini sa sorafenibom što se tiče dobi bolesnika (srednja vrijednost dobi 58,2 godine u prvoj i 58,4 godina u drugoj), spolu (71,2% muškaraca u prvoj i 73,5% u drugoj), rasi (95,8% bijelaca u prvoj i 96,9% u drugoj), geografskoj regiji (88,1% iz srednje i istočne Europe u prvoj i 88,7 % u drugoj) i prethodnom liječenju metastatskog karcinoma bubrežnih stanica (RCC) (69,6% bolesnika u prvoj skupini nisu primali prethodnu terapiju i 70,8% njih u drugoj).
English: The efficacy of tivozanib in the treatment of advanced RCC was studied in the following randomised clinical study.
Croatian: Djelotvornost tivozaniba u liječenju uznapredovalog karcinoma bubrežnih stanica (RCC) ispitivana je u sljedećim randomiziranim kliničkim ispitivanjima.
English: Progression-Free Survival, One Prior Therapy for Metastatic Disease Subgroup [median, months (95% CI)]
Croatian: Preživljenje bez progresije, podskupina s jednom prethodnom terapijom za metastatsku bolest [medijan, mjeseci (95% CI)]
English: There is no relevant use of tivozanib in the paediatric population in the indication advanced renal cell carcinoma.
Croatian: Nema relevantne primjene tivozaniba u pedijatrijskoj populaciji kod indikacije uznapredovalog karcinoma bubrežnih stanica.
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.
Croatian: U ispitivanjima toksičnosti ponovljenih doza provedenima na štakorima uočene su anomalije u rastu sjekutića (tanki lomljivi zubi, gubitak zuba, nepravilan zagriz) kod doza otprilike 2 puta većih od izračunatog ekvivalenta doziranja kod ljudi, dok je hipertrofija zona rasta kosti uočena kod doza koje su bile od 0,7 do 7 puta veće od izračunatog ekvivalenta doziranja kod ljudi.
English: Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Croatian: Fotivda je indicirana za prvu liniju liječenja odraslih bolesnika s uznapredovalim karcinomom bubrežnih stanica (engl. renal cell carcinoma, RCC) i za liječenje odraslih bolesnika koji do sada nisu primali inhibitore VEGFR i mTOR putova, kod kojih je došlo do progresije bolesti nakon jedne prethodne terapije citokinima kod uznapredovalog RCC-a.
English: Elderly patients No dose adjustment is required in patients 65 years of age or older (see sections 4.4 and 5.1).
Croatian: Kod bolesnika starih 65 godina ili starijih nije potrebno prilagođavati doziranje (vidjeti dio 4.4 i 5.1).
English: Hypothyroidism has been observed to occur at any time during treatment with tivozanib, developing as early as within two months of treatment initiation.
Croatian: Primjećeno je da se hipotireoza javlja u bilo kojem trenutku tijekom liječenja tivozanibom, već unutar prva dva mjeseca nakon početka liječenja.
English: • Difficult breathing; shortness of breath during exercise; coughing.
Croatian: • Teškoće s disanjem; nedostatak zraka tijekom aktivnosti; kašalj
English: Patients taking an oral BCRP substrate with a clinically-relevant efflux interaction in the gut should ensure that a suitable time window (e.g. 2 hours) is applied between administration of tivozanib and the BCRP substrate.
Croatian: Bolesnici koji peroralno uzimaju supstrat BCRP-a s klinički značajnom interakcijom efluksa u crijevu trebali bi osigurati odgovarajući vremenski razmak (npr. 2 sata) između primjene tivozaniba i BCRP supstrata.