FrancophonIA/ELRC3.0 huggingface dataset:
English: Close monitoring is recommended in patients with these risk factors.
Croatian: Preporučuje se pažljivo nadzirati bolesnike s ovim čimbenicima rizika.
English: You need to pay special attention if you get the following side effects during treatment with Ofev:
Croatian: Morate obratiti posebnu pažnju ako dobijete sljedeće nuspojave tijekom liječenja Ofevom:
English: This ensures that a steady amount of nintedanib is maintained in your blood stream.
Croatian: To osigurava održavanje stalne količine nintedaniba u krvotoku.
English: Summary of the safety profile
Croatian: Sažetak profila sigurnosti
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Absorption and bioavailability are decreased by transporter effects and substantial first-pass metabolism.
Croatian: Apsorpcija i bioraspoloživost smanjuju se učincima transportera i znatnim metabolizmom prvog prolaza.
English: The capsules should be taken with food, swallowed whole with water, and should not be chewed or crushed.
Croatian: Kapsule se moraju uzeti s hranom, progutati cijele s vodom i ne smiju se žvakati ili drobiti.
English: Elevations of liver enzymes were reversible and not associated with clinically manifest liver disease.
Croatian: Povišene vrijednosti jetrenih enzima bile su reverzibilne i nisu bile povezane s klinički manifestiranom bolešću jetre.
English: The difference between the treatment groups reached nominal statistical significance (p=0.0136).
Croatian: Razlika između skupina liječenja bila je nominalno statistički značajna (p=0,0136).
English: The robustness of the effect of nintedanib in reducing the annual rate of decline in FVC was confirmed in all pre-specified sensitivity analyses.
Croatian: Robusnost učinka nintedaniba u reduciranju godišnje stope smanjenja FVC-a potvrđena je u svim prethodno specificiranim analizama osjetljivosti.
English: A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of incorrect dosing, with no onset of other reported events.
Croatian: Pojavio se štetni događaj (nazofaringitis) koji nije bio ozbiljan i povukao se tijekom razdoblja nepravilnog doziranja bez pojave drugih prijavljenih događaja.
English: Therefore, hepatic transaminase and bilirubin levels should be investigated before treatment initiation and during the first month of treatment with Ofev.
Croatian: Stoga se razine jetrenih transaminaza i bilirubina moraju ispitati prije početka liječenja i tijekom prvog mjeseca liječenja Ofevom.
English: Figure 1:
Croatian: Slika 1:
English: Women of childbearing potential / Contraception
Croatian: Žene reproduktivne dobi / kontracepcija
English: Body weight
Croatian: Tjelesna težina
English: In such cases, patients should be monitored closely for tolerability of nintedanib.
Croatian: U takvim slučajevima, bolesnike se mora pažljivo nadzirati u smislu podnošljivosti nintedaniba.
English: The pharmacokinetics (PK) of nintedanib can be considered linear with respect to time (i.e. singledose data can be extrapolated to multiple-dose data).
Croatian: Farmakokinetika (PK) nintedaniba može se smatrati linearnom u odnosu na vrijeme (tj. podaci o jednokratnoj dozi mogu se ekstrapolirati na podatke o višekratnim dozama).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Ofev in all subsets of the paediatric population in IPF (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Ofev u svim podskupinama pedijatrijske populacije s IPF-om (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Data from Black individuals were very limited but in the same range as for Caucasians.
Croatian: Podaci o bolesnicima crne rase bili su vrlo ograničeni, ali u istom rasponu kao i podaci o bijelcima.
English: Not all pack-sizes may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP Blister
English: Number of analysed patients
Croatian: Broj analiziranih bolesnika
English: The results of all survival endpoints (such as on-treatment mortality and respiratory mortality) showed a consistent numerical difference in favour of nintedanib.
Croatian: Rezultati svih mjera ishoda za preživljenje (poput smrtnosti tijekom liječenja i respiratorne smrtnosti) pokazali su konzistentnu brojčanu razliku u korist nintedaniba.
English: Reproduction toxicity
Croatian: Reproduktivna toksičnost
English: Vascular endothelial growth factor receptor (VEGFR) inhibition might be associated with an increased risk of bleeding.
Croatian: Inhibicija receptora vaskularnog endotelnog faktora rasta (engl. vascular endothelial growth factor receptor, VEGFR) može biti povezana s povećanim rizikom od krvarenja.
English: Patients at known risk for bleeding including patients with inherited predisposition to bleeding or patients receiving a full dose of anticoagulative treatment were not included in the INPULSIS studies.
Croatian: Bolesnici s poznatim rizikom od krvarenja, uključujući bolesnike s naslijeđenom predispozicijom za krvarenje ili bolesnike koji primaju punu dozu antikoagulantnog liječenja, nisu bili uključeni u ispitivanja INPULSIS.
English: For the interaction potential of nintedanib with this transporter, see section 4.5.
Croatian: Za interakcijski potencijal nintedaniba s tim transporterom vidjeti dio 4.5.
English: p-value
Croatian: p-vrijednost
English: Based on the high inter-individual variability of exposure observed moderate effects are considered not clinically relevant (see section 4.4).
Croatian: Na temelju visoke interindividualne varijabilnosti u izloženosti, opaženi umjereni učinci ne smatraju se klinički značajnima (vidjeti dio 4.4).
English: Nintedanib binds competitively to the adenosine triphosphate (ATP) binding pocket of these receptors and blocks the intracellular signalling.
Croatian: Nintedanib se kompetitivno veže na vezno mjesto za adenozin-trifosfat (ATP) ovih receptora i blokira unutarstanični prijenos signala.
English: In patients with missing data, the primary analysis assumes that the decline in FVC after the last observed value would be similar to the decline in other patients in the same treatment group.
Croatian: Primarna analiza pretpostavlja da će, u bolesnika za koje nedostaju podaci, smanjenje FVC-a nakon posljednje opažene vrijednosti biti slično smanjenju u drugih bolesnika iste skupine liječenja.
English: A pre-specified sensitivity analysis of the time to first 'confirmed' or 'suspected' adjudicated acute IPF exacerbation was performed on the pooled data.
Croatian: Prethodno specificirana analiza osjetljivosti za utvrđivanje vremena do prve „potvrđene“ ili „sumnje na“ procijenjenu akutnu egzacerbaciju IPF-a bila je provedena na združenim podacima.
English: Diarrhoea may lead to dehydration: a loss of fluid and important salts (electrolytes, such as sodium or potassium) from your body.
Croatian: Proljev može dovesti do dehidracije: gubitka tekućine i važnih soli (elektrolita, poput natrija ili kalija) iz Vašeg tijela.
English: Based on data collected up to 372 days (52 weeks + 7 day margin).
Croatian: Temeljeno na podacima prikupljenim u razdoblju do 372 dana (52 tjedna + 7 rubnih dana).
English: Effects on the development of the axial skeleton and on the development of the great arteries were also noted at subtherapeutic exposure levels.
Croatian: Učinci na razvoj aksijalnog skeleta i na razvoj velikih arterija također su bili zamijećeni pri razinama izloženosti ispod terapijskih.
English: PopPK analyses indicated moderate effects on exposure to nintedanib depending on age, body weight, and race (see below).
Croatian: Analize PopPK pokazale su umjerene učinke na izloženost nintedanibu ovisno o dobi, tjelesnoj težini i rasi (vidjeti niže).
English: Therefore treatment with Ofev is not recommended in such patients (see section 4.2).
Croatian: Stoga, liječenje Ofevom nije preporučeno u takvih bolesnika (vidjeti dio 4.2).
English: SGRQ total score measuring health related quality of life (HRQoL) was analysed at 52 weeks.
Croatian: Ukupni rezultat upitnika SGRQ, koji mjeri kvalitetu života povezanu sa zdravljem (engl. health related quality of life, HRQoL), bio je analiziran nakon 52 tjedna.
English: A study of male fertility and early embryonic development up to implantation in rats did not reveal effects on the male reproductive tract and male fertility.
Croatian: Ispitivanje muške plodnosti i ranog embrionalnog razvoja do implantacije zametka na štakorima nije otkrilo učinke na muški reproduktivni sustav i mušku plodnost.
English: Take the capsules 12 hours apart at about the same time every day, for example one capsule in the morning and one capsule in the evening.
Croatian: Kapsule uzimajte u razmaku od 12 sati otprilike u isto vrijeme svakog dana, primjerice jednu kapsulu ujutro i jednu kapsulu navečer.
English: Before initiating Ofev, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Croatian: Prije početka primjene lijeka Ofev potrebno je pažljivo razmotriti ovaj rizik u bolesnika s čimbenicima rizika kao što su hipertenzija ili aneurizma u anamnezi.
English: CI: confidence interval
Croatian: CI: interval pouzdanosti (engl. confidence interval)
English: Annual rate of decline in FVC
Croatian: Godišnja stopa smanjenja FVC-a
English: Do not store above 25°C.
Croatian: Ne čuvati na temperaturi iznad 25°C.
English: Therefore these patients should only be treated with Ofev if the anticipated benefit outweighs the potential risk.
Croatian: Ove bolesnike se stoga smije liječiti Ofevom samo ukoliko je očekivana korist liječenja veća od potencijalnog rizika.
English: As a result, scarring reduces the ability to transfer oxygen from the lungs into the bloodstream and it becomes difficult to breathe deeply.
Croatian: Stvaranje ožiljaka posljedično smanjuje sposobnost prijenosa kisika iz pluća u krvotok, a duboko disanje postaje otežano.
English: Therefore your treatment with Ofev will usually be stopped for a while if you are having a surgery.
Croatian: Stoga će se liječenje Ofevom u pravilu privremeno prekinuti ako idete na operaciju.
English: Take the capsules twice daily approximately 12 hours apart at about the same time every day, for example one capsule in the morning and one capsule in the evening.
Croatian: Kapsule uzimajte dvaput dnevno u razmaku od približno 12 sati otprilike u isto vrijeme svakog dana, primjerice jednu kapsulu ujutro i jednu kapsulu navečer.
English: Nonserious epistaxis was the most frequent bleeding event.
Croatian: Blaga epistaksa je bila najčešći oblik krvarenja.
English: If a dose is missed, administration should resume at the next scheduled time at the recommended dose.
Croatian: Ako se doza propusti uzeti, primjenu treba nastaviti u sljedeće predviđeno vrijeme i u preporučenoj dozi.
English: There is no information on the use of Ofev in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Croatian: Nema podataka o primjeni Ofeva u trudnica, ali pretklinička ispitivanja na životinjama pokazala su reproduktivnu toksičnost ove djelatne tvari (vidjeti dio 5.3).
English: If symptoms persist despite appropriate supportive care (including anti-emetic therapy), dose reduction or treatment interruption may be required.
Croatian: Ukoliko simptomi traju unatoč odgovarajućim suportivnim mjerama (uključujući antiemetičku terapiju), potrebno je smanjiti dozu ili prekinuti liječenje.
English: Overall, the effect of nintedanib on health-related quality of life as measured by the SGRQ total score is modest, indicating less worsening compared to placebo.
Croatian: Sveukupno, učinak nintedaniba na kvalitetu života povezanu sa zdravljem, procijenjen ukupnim rezultatom upitnika SGRQ je skroman, ukazujući na manje pogoršanje u usporedbi s placebom.
English: Placebo Ofev 150 mg twice daily
Croatian: Placebo Ofev 150 mg dvaput dnevno
English: Patients with known allergy to peanut protein carry an enhanced risk for severe reactions to soya preparations.
Croatian: Bolesnici s poznatom alergijom na protein kikirikija imaju povećani rizik od teških reakcija na sojine pripravke.
English: Steady state plasma concentrations were achieved within one week of dosing at the latest.
Croatian: Koncentracije u plazmi u stanju dinamičke ravnoteže postižu se najkasnije unutar jednog tjedna doziranja.
English: Nintedanib has been studied in clinical trials of 1,529 patients suffering from IPF.
Croatian: Nintedanib je ispitivan u kliničkim ispitivanjima na 1529 bolesnika koji boluju od IPF-a.
English: Nausea and vomiting were frequently reported gastrointestinal adverse reactions (see section 4.8).
Croatian: Mučnina i povraćanje bile su često prijavljene gastrointestinalne nuspojave (vidjeti dio 4.8).
English: Treatment interruption should be considered in patients who develop signs or symptoms of acute myocardial ischemia.
Croatian: Privremeni prekid liječenja mora se razmotriti u bolesnika koji razviju znakove ili simptome akutne ishemije miokarda.
English: In case of overdose, treatment should be interrupted and general supportive measures initiated as appropriate.
Croatian: U slučaju predoziranja, liječenje se mora privremeno prekinuti i prema potrebi, započeti opće potporne mjere.
English: The major CYP-dependent metabolite could not be detected in plasma in the human ADME study.
Croatian: Glavni metabolit ovisan o CYP-u nije se mogao detektirati u plazmi u ispitivanju ADME na ljudima.
English: Nintedanib exposure increased linearly with patient age, which may also result in a higher risk of developing liver enzyme elevations (see section 5.2).
Croatian: Izloženost nintedanibu linearno se povećava s dobi bolesnika, što bi također moglo povećati rizik razvoja povišenih vrijednosti jetrenih enzima (vidjeti dio 5.2).
English: Two patients in the oncology programme had an overdose of maximum 600 mg twice daily up to eight days.
Croatian: U dva bolesnika u onkološkom programu došlo je do predoziranja od maksimalno 600 mg dvaput dnevno u trajanju do osam dana.
English: AUCτ,ss decreased by 16% for a 45-year old patient and increased by 13% for a 76-year old patient relative to a patient with the median age of 62 years.
Croatian: AUCτ,ss se smanjio za 16% u 45-godišnjeg bolesnika, a povećao za 13% u 76-godišnjeg bolesnika u odnosu na bolesnika s medijanom dobi od 62 godine.
English: If any liver test elevations are associated with clinical signs or symptoms of liver injury, e.g. jaundice, treatment with Ofev should be permanently discontinued.
Croatian: Ako su bilo koja povišenja jetrenih testova povezana s kliničkim znakovima ili simptomima oštećenja jetre, npr. žuticom, liječenje Ofevom mora se trajno prekinuti.
English: Exposure to nintedanib increased linearly with age.
Croatian: Izloženost nintedanibu linearno se povećala s dobi.
English: Vomiting led to discontinuation in 0.8% of the patients.
Croatian: Povraćanje je dovelo do prekida liječenja u 0,8% bolesnika.
English: If the patient becomes pregnant while receiving Ofev, she should be apprised of the potential hazard to the foetus.
Croatian: Ako bolesnica zatrudni tijekom primjene Ofeva, mora je se obavijestiti o potencijalnoj opasnosti za fetus.
English: Since the effect of nintedanib on the metabolism and efficacy of hormonal contraceptives has not been investigated, barrier methods should be applied as a second form of contraception, to avoid pregnancy.
Croatian: Budući da učinak nintedaniba na metabolizam i djelotvornost hormonskih kontraceptiva nije istražen, kao dodatan oblik kontracepcije mora se primjenjivati metoda mehaničke kontracepcije kako bi se izbjegla trudnoća.
English: Caution should be used when treating patients at higher cardiovascular risk including known coronary artery disease.
Croatian: Nužan je oprez u liječenju bolesnika s višim kardiovaskularnim rizikom uključujući poznatu koronarnu arterijsku bolest.
English: For the management of selected adverse reactions please also refer to section 4.4.
Croatian: Za zbrinjavanje odabranih nuspojava molimo također vidjeti dio 4.4.
English: Serious bleeding events occurred with low and similar frequencies in the 2 treatment groups (placebo: 1.4%; Ofev: 1.3%).
Croatian: Učestalost ozbiljnih krvarenja bila je niska i slična u 2 skupine liječenja (placebo: 1,4%; Ofev: 1,3%).
English: Post-marketing bleeding events include but are not limited to gastrointestinal, respiratory and central nervous organ systems, with the most frequent being gastrointestinal.
Croatian: Slučajevi krvarenja nakon stavljanja lijeka u promet uključuju, ali nisu ograničeni samo na probavni, dišni i središnji živčani sustav, s time da su najučestaliji bili slučajevi gastrointestinalnog krvarenja.
English: Cases of gastrointestinal perforations, some of which were fatal, have been reported in the post-marketing period.
Croatian: Slučajevi gastrointestinalnih perforacija, od kojih su neki imali smrtni ishod, prijavljeni su u razdoblju nakon stavljanja lijeka u promet.
English: Patients should be advised to be cautious when driving or using machines during treatment with Ofev.
Croatian: Potrebno je savjetovati bolesnike da budu oprezni pri upravljanju vozilima ili radu sa strojevima tijekom liječenja Ofevom.
English: An inverse correlation between body weight and exposure to nintedanib was observed.
Croatian: Uočena je obrnuta povezanost između tjelesne težine i izloženosti nintedanibu.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE31
Croatian: Farmakoterapijska skupina: Antineoplastici, inhibitori protein kinaze, ATK oznaka: L01XE31
English: Printing ink:
Croatian: Tinta za označivanje:
English: The use of VEGF pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Croatian: Primjena inhibitora VEGF puta u bolesnika s hipertenzijom ili bez nje može potaknuti stvaranje aneurizama i/ili disekcija arterije.
English: Diarrhoea and vomiting accompanied by reduced food consumption and loss of body weight were observed in toxicity studies in non-rodents.
Croatian: Proljev i povraćanje praćeni smanjenim unosom hrane i gubitkom tjelesne težine opaženi su u ispitivanjima toksičnosti u neglodavaca.
English: ANNEX II A. MANUFACTURER 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: PRILOG II. A. PROIZVOĐAČ ODGOVORAN 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 PROMET D.
English: All adverse events of acute IPF exacerbation reported by the investigator were adjudicated by a blinded adjudication committee.
Croatian: Svi štetni događaji akutne egzacerbacije IPF-a koje je prijavio ispitivač bili su procijenjeni od strane „slijepog“ povjerenstva za prosudbu.
English: Not known
Croatian: Nepoznato
English: The in vitro protein binding of nintedanib in human plasma was high, with a bound fraction of 97.8%.
Croatian: In vitro vezanje nintedaniba za proteine u ljudskoj plazmi bilo je visoko, s udjelom vezanja od 97,8%.
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Croatian: POSEBNE MJERE ČUVANJA Ne čuvati na temperaturi iznad 25°C.
English: Drug-drug interactions between nintedanib and CYP substrates, CYP inhibitors, or CYP inducers are therefore not expected.
Croatian: Stoga se ne očekuju interakcije lijekova, između nintedaniba i CYP supstrata, CYP inhibitora ili CYP induktora.
English: Given the similarity in safety profiles for both medicinal products, additive adverse events, including gastrointestinal and hepatic adverse events, may be expected.
Croatian: Zbog sličnosti sigurnosnih profila ta dva lijeka, mogu se očekivati aditivni štetni događaji, uključujući gastrointestinalne i jetrene štetne događaje.
English: BIBF 1202 is subsequently glucuronidated by uridine 5'-diphosphoglucuronosyltransferase enzymes (UGT) enzymes, namely UGT 1A1, UGT 1A7, UGT 1A8, and UGT 1A10 to BIBF 1202 glucuronide.
Croatian: BIBF 1202 se potom glukuronidira pomoću enzima uridin 5'-difosfo-glukuronozil-transferaze (UGT), i to UGT 1A1, UGT 1A7, UGT 1A8 i UGT 1A10, u BIBF 1202 glukuronid.
English: The most frequently reported adverse reactions associated with the use of nintedanib included diarrhoea, nausea and vomiting, abdominal pain, decreased appetite, weight decreased and hepatic enzyme increased.
Croatian: Najčešće prijavljene nuspojave povezane s primjenom nintedaniba uključivale su proljev, mučninu i povraćanje, bol u abdomenu, smanjen apetit, smanjenje težine i povišene vrijednosti jetrenih enzima.
English: What you need to know before you take Ofev
Croatian: Što morate znati prije nego počnete uzimati Ofev
English: Observed adverse reactions were consistent with the known safety profile of nintedanib, i.e. increased liver enzymes and gastrointestinal symptoms.
Croatian: Opažene nuspojave odgovarale su poznatom profilu sigurnosti nintedaniba, tj. povišenim vrijednostima jetrenih enzima i gastrointestinalnim simptomima.
English: Mild liver enzyme increases, which were not due to serious adverse effects such as diarrhoea were only observed in Rhesus monkeys.
Croatian: Blaga povećanja jetrenih enzima, koja nisu bila povezana s ozbiljnim štetnim učincima poput proljeva, opažena su samo u Rhesus majmuna.
English: Alternative causes of the liver enzyme elevations should be investigated.
Croatian: Moraju se istražiti drugi uzorci povišenja jetrenih enzima.
English: In addition to symptomatic treatment if applicable, the management of adverse reactions to Ofev (see sections 4.4 and 4.8) could include dose reduction and temporary interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.
Croatian: Osim simptomatskog liječenja, ako je primjenjivo, zbrinjavanje nuspojava Ofeva (vidjeti dijelove 4.4 i 4.8) može uključivati smanjenje doze i privremeni prekid liječenja sve dok se specifična nuspojava ne smanji do razine koje dozvoljava nastavak terapije.
English: In case of renal impairment/failure, therapy adjustment should be considered (see section 4.2 Dose adjustments).
Croatian: U slučaju oštećenja/zatajenja bubrega, potrebno je razmotriti prilagodbu terapije (vidjeti dio 4.2 Prilagodbe doze).
English: The same applies for nintedanib being a substrate of OCT-1.
Croatian: Isto se odnosi na nintedanib kao supstrat OCT-1.
English: Population pharmocokinetic analysis in special populations The PK properties of nintedanib were similar in healthy volunteers, patients with IPF, and cancer patients.
Croatian: Populacijska farmakokinetička analiza u posebnim skupinama bolesnika Farmakokinetička svojstva nintedaniba bila su slična u zdravih dobrovoljaca, bolesnika s IPF-om i bolesnika s rakom.
English: The majority of hepatic events occur within the first three months of treatment.
Croatian: Većina jetrenih događaja javila se unutar prva tri mjeseca liječenja.
English: Estimated based on a random coefficient regression model.
Croatian: Procijenjeno na temelju modela regresije nasumičnog koeficijenta.
English: Hypersensitivity to nintedanib, to peanut or soya, or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na nintedanib, kikiriki ili soju, ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Nintedanib was also not a substrate of BCRP.
Croatian: Nintedanib ujedno nije bio supstrat BCRP-a.