FrancophonIA/ELRC3.0 huggingface dataset:
English: • Revolade can also be used to treat low platelet count (thrombocytopenia) in adults with hepatitis C virus (HCV) infections, if they have had problems with side effects while on interferon treatment.
Croatian: • Revolade se također može koristiti za liječenje sniženog broja trombocita (trombocitopenija) u odraslih s infekcijom virusom hepatitisa C (HCV), ako su imali problema s nuspojavama dok su bili liječeni interferonom.
English: Thirty-one percent of patients had been treated with prior HCV therapies, primarily pegylated interferon plus ribavirin.
Croatian: Trideset jedan posto bolesnika je ranije liječeno terapijom za HCV, primarno pegiliranim interferonom uz ribavirin.
English: Hypersensitivity to eltrombopag or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na eltrombopag ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Effects of other medicinal products on eltrombopag
Croatian: Učinak drugih lijekova na eltrombopag
English: If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks.
Croatian: Ako Vam on savjetuje da prekinete liječenje, trombocite ćete morati kontrolirati svaki tjedan tijekom naredna 4 tjedna.
English: Revolade contains eltrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Croatian: Revolade sadrži eltrombopag, koji ubrajamo u skupinu lijekova koje zovemo agonisti trombopoetinskih receptora.
English: In the clinical studies there was one report of overdose where the patient ingested 5000 mg of eltrombopag.
Croatian: U kliničkim ispitivanjima prijavljen je jedan slučaj predoziranja u kojem je bolesnik uzeo 5000 mg eltrombopaga.
English: Plasma eltrombopag apparent clearance following oral administration (CL/F) increased with increasing body weight.
Croatian: Prividni klirens eltrombopaga iz plazme nakon peroralne primjene (CL/F) povećao se s povećanjem tjelesne težine.
English: Additional medical management may include cessation of anticoagulant and/or anti-platelet therapy, reversal of anticoagulation, or platelet support.
Croatian: Dodatne medicinske mjere mogu uključivati prestanak primjene antikoagulantnih i/ili antitrombocitnih lijekova, poništavanje učinka antikoagulansa ili potporu trombocitima.
English: During treatment with eltrombopag 59% (23/39) became platelet transfusion independent (28 days without platelet transfusion) and 27% (10/37) became RBC transfusion independent (56 days without RBC transfusion).
Croatian: Tijekom liječenja eltrombopagom 59% (23/39) postalo je neovisno o transfuziji trombocita (28 dana bez transfuzije trombocita), a 27% (10/37) postalo je neovisno o transfuziji eritrocita (56 dana bez transfuzije eritrocita).
English: Some people have bleeding in the digestive system after they stop taking peginterferon, ribavirin, and Revolade.
Croatian: Neke osobe imaju krvarenje u probavnom sustavu nakon prestanka uzimanja lijekova peginterferona, ribavirina i Revolade.
English: Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Croatian: Glaxo Wellcome S.A., Avenida de Extramadura 3, 09400 Aranda de Duero, Burgos, Španjolska Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
English: Concomitant administration of eltrombopag and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution (see section 5.2).
Croatian: Istodobna primjena eltrombopaga i OATP1B1 (npr. metotreksata) i BCRP supstrata (npr. topotekana i metotreksata) mora se provoditi s oprezom (vidjeti dio 5.2).
English: Cohort 2 (6 to 11 years)
Croatian: Kohorta 2 (6 do 11 godina)
English: Reported thrombotic/thromboembolic complications included both venous and arterial events.
Croatian: Zabilježene trombotičke/tromboemboličke komplikacije uključivale su i venske i arterijske događaje.
English: Wash any exposed area immediately with soap and water.
Croatian: Svaku izloženu površinu odmah operite sapunom i vodom.
English: The active substance in Revolade is eltrombopag.
Croatian: Djelatna tvar u lijeku Revolade je eltrombopag.
English: Eltrombopag administration can cause abnormal liver function and severe hepatotoxicity, which might be life-threatening (see section 4.8).
Croatian: Primjena eltrombopaga može poremetiti normalnu funkciju jetre i uzrokovati tešku hepatotoksičnost, koja može biti opasna po život (vidjeti dio 4.8).
English: No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).
Croatian: Ne očekuju se klinički značajne interakcije prilikom istodobne primjene eltrombopaga i CYP450 supstrata (vidjeti dio 5.2).
English: Based on your response to Revolade your doctor may recommend that your daily dose is changed.
Croatian: Ovisno o odgovoru Vašeg organizma na lijek, liječnik Vam može preporučiti promjenu doze lijeka Revolade.
English: An open-label, repeat-dose study (3 cycles of 6 weeks of treatment, followed by 4 weeks off treatment) showed that episodic use with multiple courses of eltrombopag has demonstrated no loss of response.
Croatian: Otvoreno ispitivanje s ponavljanim dozama (3 ciklusa po 6 tjedana liječenja, nakon kojih su uslijedila 4 tjedna bez liječenja) pokazalo je da periodična primjena eltrombopaga u višekratnim ciklusima ne pokazuje gubitak odgovora.
English: Excessive platelet count responses (as outlined in Table 3) or important liver test abnormalities also necessitate discontinuation of eltrombopag (see section 4.8).
Croatian: Odgovori s prekomjernim brojem trombocita (kako je navedeno u tablici 3) ili značajne abnormalnosti jetrenih testova također zahtijevaju prekid primjene eltrombopaga (vidjeti dio 4.8).
English: Co-administration of eltrombopag with lopinavir/ritonavir may cause a decrease in the concentration of eltrombopag.
Croatian: Istodobna primjena eltrombopaga s lopinavirom/ritonavirom može uzrokovati smanjenje koncentracije eltrombopaga.
English: In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (<3-fold increase in mutation frequency).
Croatian: U in vitro probi mišjeg limfoma, eltrombopag je bio granično pozitivan (porast učestalosti mutacija <3 puta).
English: Make sure the cap is firmly pushed onto the lid, so it is closed.
Croatian: Provjerite je li zatvarač čvrsto gurnut na poklopac, tako da je zatvoren.
English: 6 to 11 years (n=68)
Croatian: 6 do 11 godina (n=68)
English: Based on a human study with radiolabelled eltrombopag, glucuronidation plays a minor role in the metabolism of eltrombopag.
Croatian: Prema humanim ispitivanjima s radioaktivno obilježenim eltrombopagom, glukuronidacija igra malu ulogu u metabolizmu eltrombopaga.
English: Medicinal products that inhibit or induce a single enzyme are unlikely to significantly affect plasma eltrombopag concentrations, whereas medicinal products that inhibit or induce multiple enzymes have the potential to increase (e.g. fluvoxamine) or decrease (e.g. rifampicin) eltrombopag concentrations.
Croatian: Dok je malo vjerojatno da lijekovi koji inhibiraju ili induciraju jedan enzim značajno utječu na koncentracije eltrombopaga u plazmi, lijekovi koji inhibiraju ili induciraju više enzima imaju sposobnost povećati (npr. fluvoksamin) ili smanjiti (npr. rifampicin) koncentracije eltrombopaga.
English: Unchanged eltrombopag excreted in faeces accounts for approximately 20% of the dose.
Croatian: Nepromijenjeni eltrombopag izlučen stolicom čini otprilike 20% doze.
English: Clinically significant drug interactions involving glucuronidation are not anticipated due to limited contribution of individual UGT enzymes in the glucuronidation of eltrombopag.
Croatian: Klinički značajne interakcije s lijekovima, koje bi uključivale glukuronidaciju, se ne očekuju zbog ograničenog doprinosa pojedinih UGT enzima glukuronidaciji eltrombopaga.
English: • Remove the syringe from the bottle.
Croatian: • Izvucite štrcaljku iz bočice.
English: Get medical help immediately if you have any of these signs of a blood clot:
Croatian: Odmah potražite liječničku pomoć ako primijetite bilo koji od znakova postojanja krvnog ugruška:
English: Revolade should not be used outside of clinical studies for the treatment of thrombocytopenia due to MDS.
Croatian: Revolade se ne smije koristiti izvan kliničkih ispitivanja za liječenje trombocitopenije koja je posljedica MDS-a.
English: • decrease in blood sugar levels (hypoglycaemia)
Croatian: • smanjenje razine šećera u krvi (hipoglikemija)
English: Most patients receiving eltrombopag in combination with peginterferon / ribavirin therapy will experience indirect hyperbilirubinaemia.
Croatian: Većina bolesnika koji su primali eltrombopag u kombinaciji s terapijom peginterferonom / ribavirinom doživjela je indirektnu hiperbilirubinemiju.
English: If you are also taking medicines to prevent blood clots there is a greater risk of bleeding.
Croatian: Ako uzimate lijekove koji sprječavaju zgrušavanje krvi postoji povišeni rizik od krvarenja.
English: Eltrombopag is primarily metabolised through cleavage, oxidation and conjugation with glucuronic acid, glutathione, or cysteine.
Croatian: Eltrombopag se primarno metabolizira cijepanjem, oksidacijom i konjugacijom s glukuronskom kiselinom, glutationom ili cisteinom.
English: Prior to initiation of eltrombopag, the peripheral blood smear should be examined closely to establish a baseline level of cellular morphologic abnormalities.
Croatian: Prije uvođenja eltrombopaga, potreban je detaljan pregled razmaza periferne krvi radi utvrđivanja početnog stupnja morfoloških abnormalnosti stanica.
English: Your doctor may consider it necessary to monitor your heart during treatment with Revolade and carry out an electrocardiogram (ECG) test.
Croatian: Vaš će liječnik možda smatrati da je neophodno pratiti rad Vašeg srca i provesti EKG snimanja tijekom liječenja lijekom Revolade.
English: The pharmacokinetic parameters of eltrombopag in paediatric patients with ITP are shown in Table 10.
Croatian: Farmakokinetički parametri eltrombopaga u pedijatrijskih bolesnika s ITP-om prikazani su u tablici 10.
English: In a relative bioavailability study in adults, the eltrombopag powder for oral suspension delivered 22% higher plasma AUC(0-) than the film-coated tablet formulation.
Croatian: U ispitivanju relativne bioraspoloživosti u odraslih, eltrombopag prašak za oralnu suspenziju uzrokovao je 22% viši plazmatski AUC(0-) od formulacije filmom obložene tablete.
English: • depression, anxiety, sleep problems, nervousness
Croatian: • depresija, tjeskoba, problemi sa spavanjem, nervoza
English: If you have questions or do not understand the Instructions For Use, talk to your doctor, nurse or pharmacist.
Croatian: Ako imate pitanja ili ne razumijete Upute za uporabu, obratite se svom liječniku, medicinskoj sestri ili ljekarniku.
English: During antiviral therapy, the aim of treatment should be to keep platelet counts at a level that prevents the risk of bleeding complications, normally around 50,000-75,000/µl.
Croatian: Tijekom antivirusnog liječenja, cilj liječenja treba biti održavanje broja trombocita na razini koja sprječava rizik od komplikacija krvarenja, koja je normalno oko 50 000-75 000/µl.
English: Cytochrome P450 substrates
Croatian: Supstrati citokroma P450
English: Carton of 25 mg powder for oral suspension - without blue box - 30 sachets
Croatian: Kutija 25 mg praška za oralnu suspenziju - bez plavog okvira - 30 vrećica
English: Eltrombopag is a substrate for BCRP, but is not a substrate for P-glycoprotein or OATP1B1.
Croatian: Eltrombopag je supstrat BCRP-a, ali ne i P-glikoprotein-a ili OATP1B1.
English: Treatment with eltrombopag in these patients should be initiated only by physicians experienced in the management of advanced HCV, and only when the risks of thrombocytopenia or withholding antiviral therapy necessitate intervention.
Croatian: Liječenje eltrombopagom u tih bolesnika trebaju započinjati samo liječnici koji imaju iskustva u liječenju uznapredovalog HCV-a i to samo onda kada rizik od trombocitopenije ili ustezanja od antivirusnog liječenja zahtijeva intervenciju.
English: • medicines called statins, to lower cholesterol
Croatian: • statini - lijekovi za snižavanje kolesterola
English: Paediatric population (aged 1 to 17 years)
Croatian: Pedijatrijska populacija (u dobi od 1 do 17 godina)
English: Requiring rescue therapy, n (%) p-value a
Croatian: Potreba za dodatnim (rescue) liječenjem, n (%) p-vrijednost a
English: Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svake klasifikacije organskih sustava, nuspojave na lijek su navedene prema učestalosti, navodeći prvo najčešće nuspojave.
English: Patients did not receive direct acting antiviral agents.
Croatian: Bolesnici nisu primali antivirusne lijekove koji djeluju direktno.
English: • runny nose
Croatian: • curenje nosa
English: Six patients had cytogenetic abnormality at Month 3 of eltrombopag therapy and one patient had cytogenetic abnormality at Month 6.
Croatian: Šest bolesnika imalo je citogenetsku abnormalnost u 3. mjesecu terapije eltrombopagom i jedan bolesnik je imao citogenetsku abnormalnost u 6. mjesecu.
English: Treatment with eltrombopag should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of eltrombopag therapy at 75 mg once daily.
Croatian: Liječenje eltrombopagom treba prekinuti ako broj trombocita ne poraste do razine potrebne za sprečavanje klinički značajnog krvarenja nakon 4 tjedna primjene lijeka u dozi od 75 mg jednom dnevno.
English: Do not re-use the oral dosing syringe.
Croatian: Nemojte ponovno koristiti jednom iskorištenu dozirnu štrcaljku za usta.
English: Unchanged parent compound (eltrombopag) is not detected in urine.
Croatian: Nepromijenjeni eltrombopag se ne nalazi u urinu.
English: 12 to 17 years (n=62)
Croatian: 12 do 17 godina (n=62)
English: If you don't use the medicine within 30 minutes of mixing it, you will need to mix a new dose.
Croatian: Ako ne upotrijebite lijek unutar 30 minuta od kad ste ga zamiješali, morat ćete zamiješati novu dozu.
English: Eltrombopag was administered to 302 ITP patients in the open-label extension study EXTEND (TRA105325), 218 patients completed 1 year, 180 completed 2 years, 107 completed 3 years, 75 completed 4 years, 34 completed 5 years and 18 completed 6 years.
Croatian: Eltrombopag je primijenjen u 302 bolesnika s ITP-om u produžetku otvorenog ispitivanja EXTEND (TRA105325), 218 bolesnika je završilo 1 godinu, 180 je završilo 2 godine, 107 je završilo 3 godine, 75 je završilo 4 godine, 34 je završilo 5 godina i 18 je završilo 6 godina ispitivanja.
English: Across the programme, no patients had evidence of clinically relevant bone marrow abnormalities or clinical findings that would indicate bone marrow dysfunction.
Croatian: Tijekom programa ispitivanja, niti jedan bolesnik nije imao dokazanu klinički značajnu abnormalnost koštane srži ili klinički nalaz koji bi upućivao na disfunkciju koštane srži.
English: Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the study and 53% (8/15) of patients were able to reduce (n=1) or discontinue (n=7) baseline ITP therapy, mainly corticosteroids, without needing rescue therapy.
Croatian: Bolesnici su smjeli smanjiti ili prekinuti početnu terapiju za ITP samo tijekom otvorene faze ispitivanja i 53% (8/15) bolesnika moglo je smanjiti (n=1) ili prekinuti (n=7) početnu terapiju za ITP, uglavnom kortikosteroide, bez potrebe za simptomatskom terapijom.
English: Haemorrhages occurred on the surface of the retina (preretinal), under the retina (subretinal), or within the retinal tissue.
Croatian: Krvarenja su se javljala na površini mrežnice (preretinalno), ispod mrežnice (subretinalno) ili unutar samog tkiva mrežnice.
English: Liver problems (increased enzymes showing up in blood tests) are common and may affect up to 1 in 10 people.
Croatian: Jetrene tegobe (povišeni enzimi koji su vidljivi na krvnim pretragama) česta su nuspojava koja se može javiti u do 1 na 10 osoba.
English: Do not take Revolade
Croatian: Nemojte uzimati Revolade
English: There are no or limited amount of data from the use of eltrombopag in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni eltrombopaga u trudnica ograničeni.
English: Revolade 12.5 mg and 25 mg film-coated tablets also contain polysorbate 80 (E433).
Croatian: Revolade 12,5 mg i 25 mg filmom obložene tablete također sadrže i polisorbat 80 (E433).
English: Empty water into open mixing bottle • Slowly pushing the plunger all the way into the syringe.
Croatian: Ispraznite vodu u otvorenu bočicu za miješanje • Polako gurnite klip do kraja u štrcaljku.
English: Key primary endpoints
Croatian: Ključni primarni ishodi ispitivanja
English: Tell your doctor if any of these apply to you.
Croatian: Recite liječniku ako se nešto od navedenog odnosi na Vas.
English: In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates.
Croatian: U ispitivanjima na humanim jetrenim mikrosomima eltrombopag (do 100 M) nije pokazao in vitro inhibiciju CYP450 enzima 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5 i 4A9/11, ali je bio inhibitor CYP2C8 i CYP2C9, mjereno paklitakselom i diklofenakom kao supstratima.
English: Hepatic decompensation (use with interferon)
Croatian: Jetrena dekompenzacija (primjena s interferonom)
English: HCV study population (in combination with anti-viral interferon and ribavirin therapy)
Croatian: Ispitivana populacija s HCV-om (u kombinaciji s antivirusnim liječenjem interferonom i ribavirinom)
English: TRA108062 (PETIT): The primary endpoint was the proportion of patients achieving platelet counts ≥50,000/µl at least once between weeks 1 and 6 of the randomised period.
Croatian: TRA108062 (PETIT): Mjera primarnog ishoda bila je udio bolesnika koji su postigli broj trombocita ≥50 000/µl najmanje jedanput između 1. i 6. tjedna randomiziranog razdoblja.
English: It is not known whether Revolade passes into breast-milk.
Croatian: Nije poznato izlučuje li se Revolade majčinim mlijekom.
English: The profile of adverse reactions was comparable to that seen in adults with some additional adverse reactions, marked ♦ in the table below.
Croatian: Profil nuspojava bio je usporediv s onim uočenim u odraslih, a bile su uočene i neke dodatne nuspojave navedene u tablici u nastavku i označene znakom ♦.
English: • swelling of the lower limbs due to the accumulation of fluids
Croatian: • oticanje donjih udova zbog nakupljanja tekućina
English: • liver problems, including blood clot, tumour in the liver (see ‘Liver problems' earlier in section 4)
Croatian: • jetreni problemi, uključujući krvne ugruške, tumor u jetri (pogledajte „Jetrene tegobe“ ranije u dijelu 4)
English: Eltrombopag should be discontinued if ALT levels increase (3 times the upper limit of normal [x ULN] in patients with normal liver function, or ≥3 x baseline or >5 x ULN, whichever is the lower, in patients with pre-treatment elevations in transaminases) and are:
Croatian: Eltrombopag treba prekinuti ako razina ALT poraste (3 puta iznad gornje granice normale [x GGN] u bolesnika s normalnom funkcijom jetre, ili 3 x od početne vrijednosti ili >5 x GGN, koja god je niža, u bolesnika koji su prije započinjanja terapije imali povišene vrijednosti transaminaza) i ako je porast:
English: Heart monitoring
Croatian: Praćenje rada srca
English: 30 sachets and 1 mixing bottle + 30 single-use oral syringes
Croatian: 30 vrećica i 1 bočica za miješanje + 30 štrcaljki za usta za jednokratnu uporabu
English: AUC (0-) and Cmax based on population PK post-hoc estimates at the highest dose in the data for each patient.
Croatian: AUC (0-) i Cmax temeljeni na populacijskoj PK post-hoc procjeni pri najvišoj dozi u podacima za svakog bolesnika.
English: After initiating eltrombopag, the dose must be adjusted to achieve and maintain a platelet count ≥50,000/µl as necessary to reduce the risk for bleeding.
Croatian: Nakon uvođenja eltrombopaga, doza lijeka mora biti prilagođena kako bi se postigao i održao broj trombocita ≥50 000/µl, koliko je potrebno da bi se smanjio rizik od nastupa krvarenja.
English: TPO-R agonists are growth factors that lead to thrombopoietic progenitor cell expansion, differentiation and platelet production.
Croatian: Agonisti TPO-R su faktori rasta koji uzrokuju ekspanziju progenitorskih trombopoetskih stanica, njihovu diferencijaciju i stvaranje trombocita.
English: • Give the entire contents of the bottle to the patient using the same oral syringe.
Croatian: • Dajte cijeli sadržaj bočice bolesniku pomoću iste štrcaljke za usta.
English: Key secondary endpoints Patients with a Day 43 bleeding assessment, n Bleeding (WHO Grades 1-4) n (%)
Croatian: Ključni sekundarni ishodi ispitivanja Bolesnici s procjenom krvarenja 43. dana, n Krvarenje (WHO stupanj 1-4), n (%)
English: Eltrombopag treatment should be terminated when antiviral therapy is discontinued unless otherwise justified.
Croatian: Liječenje eltrombopagom treba prekinuti nakon prekidanja antivirusnog liječenja, osim ako drugačije nije opravdano.
English: • some mineral and vitamin supplements including iron, calcium, magnesium, aluminium,
Croatian: • nadomjesne preparate minerala i vitamina koji uključuju željezo, kalcij, magnezij, aluminij,
English: The diagnosis of ITP or SAA in adults and elderly patients should be confirmed by the exclusion of other clinical entities presenting with thrombocytopenia, in particular the diagnosis of MDS must be excluded.
Croatian: Dijagnoza ITP-a ili teške aplastične anemije u odraslih i starijih bolesnika treba biti potvrđena isključivanjem drugih kliničkih stanja koja se prezentiraju trombocitopenijom, a posebno se mora isključiti dijagnozu MDS-a.
English: The most common adverse reactions occurring in at least 10% of patients included nausea, diarrhoea and increased alanine aminotransferase.
Croatian: Najčešće nuspojave koje su se pojavile u najmanje 10% bolesnika uključivale su mučninu, proljev i povišenu alanin aminotransferazu.
English: Platelet count should be closely monitored in order to ensure appropriate medical management of the dose of eltrombopag when lopinavir/ritonavir therapy is initiated or discontinued.
Croatian: Potrebno je pažljivo praćenje broja trombocita kako bi se osigurala primjena odgovarajuće doze eltrombopaga kada se započinje ili prekida liječenje lopinavirom/ritonavirom.
English: Don't stop taking Revolade without talking to your doctor.
Croatian: Nemojte prekinuti uzimanje lijeka Revolade ako se o tome niste posavjetovali sa svojim liječnikom.
English: 30 sachets of powder
Croatian: 30 vrećica praška
English: Severe aplastic anaemia in adult patients
Croatian: Teška aplastična anemija u odraslih bolesnika
English: Other secondary findings of the studies included the following: significantly fewer patients treated with eltrombopag prematurely discontinued antiviral therapy compared to placebo (45% vs. 60%, p=<0.0001).
Croatian: Druga sekundarna otkrića ispitivanja uključivala su sljedeće: značajno manje bolesnika koji su primali terapiju eltrombopagom je ranije prekinulo antivirusno liječenje u usporedbi s placebom (45% nasuprot 60%, p=<0,0001).
English: In vitro studies demonstrate that eltrombopag is an inhibitor of the OATP1B1 transporter and an inhibitor of the BCRP transporter and eltrombopag increased exposure of the OATP1B1 and BCRP substrate rosuvastatin in a clinical drug interaction study (see section 4.5).
Croatian: In vitro ispitivanja pokazuju da je eltrombopag inhibitor OATP1B1 transportera i inhibitor BCRP transportera i da je eltrombopag povećao izloženost supstrata OATP1B1 i BCRP rosuvastatina u kliničkom ispitivanju interakcije lijekova (vidjeti dio 4.5).
English: • yellowing of the skin and eyes, tenderness around the liver
Croatian: • žutilo kože i očiju, osjetljivost (na dodir) oko jetre