FrancophonIA/ELRC3.0 huggingface dataset:
English: A decrease in eltrombopag exposure was observed with co-administration of 200 mg and 600 mg ciclosporin (a BCRP inhibitor).
Croatian: Smanjenje izloženosti eltrombopagu uočeno je kod istodobne primjene s ciklosporinom (BCRP inhibitor) u dozi od 200 mg i 600 mg.
English: • eye problems, including cloudy lens in the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eye
Croatian: • problemi s očima, uključujući zamućenje očne leće (katarakta), suhoću očiju, male žute nakupine na mrežnici, žutilo bjeloočnica
English: The median baseline platelet count was 59,500/µl in both treatment groups: 0.8%, 28% and 72% of the patients recruited had platelet counts <20,000/µl, <50.000/µl and ≥50,000/µl respectively.
Croatian: Medijan početnog broja trombocita bio je 59 500/µl u obje terapijske skupine: 0,8% uključenih bolesnika imalo je broj trombocita <20 000/µl, 28% <50 000/µl, a 72% ≥50 000/µl.
English: If immature or dysplastic cells are observed, peripheral blood smears should be examined for new or worsening morphological abnormalities (e.g. teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
Croatian: Ako se primijete nezrele ili displastične stanice, potrebno je prekontrolirati periferni razmaz krvi radi eventualne pojave novih ili pogoršanja postojećih morfoloških abnormalnosti (npr. pojava eritrocita s jezgrom ili u obliku suze, nezrelih leukocita) ili citopenije.
English: Patients were diagnosed with chronic ITP for at least 1 year and were refractory or relapsed to at least one prior ITP therapy or unable to continue other ITP treatments for a medical reason and had platelet count <30,000/µl.
Croatian: Bolesnicima je dijagnosticiran kronični ITP najmanje 1 godinu i bili su refraktorni ili imali relaps na najmanje jednoj prethodnoj terapiji za ITP ili nisu mogli nastaviti druge terapije za ITP iz medicinskog razloga te su imali broj trombocita <30 000/µl.
English: Take Revolade
Croatian: Uzeti Revolade
English: Co-administration of a single dose of eltrombopag 200 mg with telaprevir 750 mg every 8 hours did not alter plasma telaprevir exposure.
Croatian: Istodobna primjena jedne doze eltrombopaga od 200 mg s telaprevirom u dozi od 750 mg svakih 8 sati nije promijenila izloženost telapreviru u plazmi.
English: Plasma eltrombopag concentration-time data collected in 590 patients with HCV enrolled in phase III studies TPL103922/ENABLE 1 and TPL108390/ENABLE 2 were combined with data from patients with HCV enrolled in the phase II study TPL102357 and healthy adult patients in a population PK analysis.
Croatian: Podaci o koncentraciji eltrombopaga u plazmi tijekom vremena za 590 bolesnika s HCV-om uključenih u fazu III ispitivanja TPL103922/ENABLE 1 i TPL108390/ENABLE 2 bile su združene s podacima bolesnika s HCV-om uključenih u fazu II ispitivanja TPL102357 i zdravih odraslih ispitanika u populaciji za PK analizu.
English: ≤ 35g/l > 35g/l MELD score f a Eltrombopag given in combination with peginterferon alfa-2a (180 μg once weekly for 48 weeks for genotypes 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1200 mg daily in 2 divided doses orally) b Eltrombopag given in combination with peginterferon alfa-2b (1.5 μg/kg once weekly for 48 weeks for genotype 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1400 mg orally in 2 divided doses) c Target platelet count was 90,000/µl for ENABLE 1 and 100,000/µl for ENABLE 2.
Croatian: ≤35 g/l >35 g/l MELD indeks f a Eltrombopag dan u kombinaciji s peginterferonom alfa-2a (180 μg jednom tjedno tijekom 48 tjedana za genotip 1/4/6; 24 tjedna za genotip 2/3) uz ribavirin (800 do 1200 mg dnevno u 2 odvojene peroralne doze) b Eltrombopag dan u kombinaciji s peginterferonom alfa-2b (1,5 μg/kg jednom tjedno tijekom 48 tjedana za genotip 1/4/6; 24 tjedna za genotip 2/3) uz ribavirin (800 do 1400 mg peroralno u 2 odvojene doze) c Ciljni broj trombocita bio je 90 000/µl u ENABLE 1 i 100 000/µl u ENABLE 2.
English: Increase daily dose by 25 mg to a maximum of 75 mg/day*.
Croatian: Povećati dnevnu dozu za 25 mg do maksimalno 75 mg/dan*.
English: Following the administration of a single 50 mg dose, the AUC0- of eltrombopag was 41% higher in patients with mild hepatic impairment and 80% to 93% higher in patients with moderate to severe hepatic impairment compared with healthy volunteers.
Croatian: Nakon jednokratne primjene doze od 50 mg, AUC0- eltrombopaga je bila 41% viša u bolesnika s blagim oštećenjem jetre, i 80% do 93% viša u bolesnika s umjerenim do teškim oštećenjem jetre, u odnosu na zdrave dobrovoljce.
English: The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:
Croatian: Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u kombinaciji s peginterferonom i ribavirinom u bolesnika s hepatitisom C:
English: Common Blood alkaline phosphatase increased Uncommon Blood albumin increased, protein total increased, blood albumin decreased, pH urine increased
Croatian: Pretrage često porast alkalne fosfataze u krvi manje često porast albumina u krvi, povišenje ukupnih proteina, sniženje albumina u krvi, porast pH mokraće
English: CYP1A2 and CYP2C8 inhibitors and inducers
Croatian: Inhibitori i induktori CYP1A2 i CYP2C8
English: On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose reductions should be avoided.
Croatian: Nakon započinjanja antivirusnog liječenja broj trombocita može pasti tako da treba izbjegavati neposredno smanjivanje doze eltrombopaga.
English: Table 1 Dose adjustments of eltrombopag in ITP patients
Croatian: Tablica 1 Prilagodba doze eltrombopaga u bolesnika s ITP-om
English: All events were resolved without sequelae following treatment.
Croatian: Svi navedeni događaji prošli su bez posljedica i bez potrebe za daljnjim liječenjem.
English: On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose adjustments should be avoided (see Table 2).
Croatian: Nakon započinjanja antivirusnog liječenja broj trombocita može pasti tako da treba izbjegavati neposredno prilagođavanje doze eltrombopaga (vidjeti tablicu 2).
English: TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand for the TPO-R. Eltrombopag interacts with the transmembrane domain of the human TPO-R and initiates signalling cascades similar but not identical to that of endogenous thrombopoietin (TPO), inducing proliferation and differentiation from bone marrow progenitor cells.
Croatian: Eltrombopag reagira s transmembranskom domenom humanog TPO-R i započinje signalnu kaskadu sličnu, iako ne i identičnu, djelovanju endogenog trombopoetina, potičući proliferaciju i diferencijaciju iz progenitorskih stanica koštane srži.
English: Higher risk of blood clots
Croatian: Povišeni rizik od stvaranja krvnih ugrušaka
English: In the 3 controlled clinical ITP studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 8% and 8% of the eltrombopag and placebo groups, respectively (see section 4.4).
Croatian: U 3 kontrolirana klinička ispitivanja ITP-a, nakon prekida liječenja zabilježen je prolazni pad broja trombocita na vrijednosti niže od ishodišnih u 8% bolesnika na eltrombopagu i 8% ispitanika na placebu (vidjeti dio 4.4).
English: If platelet counts drop to <30,000/µl, haemoglobin drops to <9 g/dl or absolute neutrophil count (ANC) to <0.5 x 10
Croatian: Ako broj trombocita padne na <30 000/µl, hemoglobin padne na <9 g/dl ili apsolutni broj neutrofila (ABN) na <0,5 x 10
English: The median baseline platelet count was 19,000/l prior to eltrombopag administration.
Croatian: Medijan početnog broja trombocita iznosio je 19 000/l prije primjene eltrombopaga.
English: The most important serious adverse reactions identified were hepatotoxicity and thrombotic/thromboembolic events.
Croatian: Najvažnije uočene ozbiljne nuspojave bile su hepatotoksičnost i trombotični/tromboembolijski događaji.
English: Powder for oral suspension
Croatian: Prašak za oralnu suspenziju.
English: In two placebo-controlled studies in paediatric patients (aged 1 to 17 years) with chronic ITP, ALT 3 x ULN was reported in 4.7% and 0% of the eltrombopag and placebo groups, respectively.
Croatian: U dva placebo kontrolirana ispitivanja u pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s kroničnim ITP-om, povišenje ALT-a 3 x GGN bilo je prijavljeno u 4,7% slučajeva u eltrombopag skupini i 0% slučajeva u placebo skupini.
English: • swelling, pain or tenderness in one leg
Croatian: • oticanje, bol ili osjetljivost u jednoj nozi
English: During the randomised period of the study, patients were randomised by three age cohort strata (2:1) to eltrombopag (n=45) or placebo (n=22).
Croatian: Tijekom randomiziranog razdoblja ispitivanja bolesnici su bili randomizirani prema tri stratuma dobnih kohorti (2:1) na eltrombopag (n=45) ili placebo (n=22).
English: Table 2 Dose adjustments of eltrombopag in HCV patients during antiviral therapy
Croatian: Tablica 2 Prilagodba doze eltrombopaga u bolesnika s HCV-om tijekom antivirusnog liječenja Broj trombocita
English: 1 reusable mixing bottle with lid and cap (notethe mixing bottle may become stained)
Croatian: 1 bočicu za miješanje za višekratnu uporabu s poklopcem i zatvaračem (napomena - bočica za miješanje može potamniti)
English: • 75 mg dose - 3 sachets
Croatian: • Doza od 75 mg - 3 vrećice
English: Cytogenetic abnormalities and progression to MDS/AML in patients with SAA
Croatian: Citogenetske abnormalnosti i progresija u MDS/AML u bolesnika s teškom aplastičnom anemijom
English: Administration of a single 50 mg dose of eltrombopag in tablet form with a standard high-calorie, high-fat breakfast that included dairy products reduced plasma eltrombopag mean AUC0-∞ by 59% and mean Cmax by 65%.
Croatian: Primjena jedne doze od 50 mg eltrombopaga u obliku tablete sa standardnim visoko kaloričnim doručkom s visokim udjelom masnoća koji je uključivao mliječne proizvode smanjila je srednji plazmatski AUC0-∞ eltrombopaga za 59% te srednji Cmax za 65%.
English: Decrease the daily dose by 25 mg.
Croatian: Smanjiti dnevnu dozu za 25 mg.
English: Ninety-two patients were randomised by three age cohort strata (2:1) to eltrombopag (n=63) or placebo (n=29).
Croatian: Devedeset dvoje bolesnika bilo je randomizirano prema tri stratuma dobnih kohorti (2:1) na primanje eltrombopaga (n=63) ili placeba (n=29).
English: The influence of hepatic impairment on the pharmacokinetics of eltrombopag following repeat administration was evaluated using a population pharmacokinetic analysis in 28 healthy adults and 714 patients with hepatic impairment (673 patients with HCV and 41 patients with chronic liver disease of other aetiology).
Croatian: Utjecaj oštećenja jetre na farmakokinetiku eltrombopaga nakon ponovljene primjene procjenjivan je koristeći analize farmakokinetike u populaciji 28 zdravih odraslih osoba i 714 bolesnika s oštećenjem jetre (673 bolesnika s HCV-om i 41 bolesnik s kroničnom bolešću jetre druge etiologije).
English: The dose of eltrombopag was adjusted during the 6-month treatment period based on individual platelet counts.
Croatian: Doza eltrombopaga je prilagođavana tijekom perioda liječenja od 6 mjeseci na temelju individualnog broja trombocita.
English: Do not change the dose or schedule for taking Revolade unless your doctor or pharmacist advises you to.
Croatian: Nemojte mijenjati dozu lijeka Revolade niti raspored njegove primjene ako Vam to ne savjetuju
English: • inflammation of the nasal passages, throat and mouth, flu-like symptoms, dry mouth, sore or inflamed mouth, toothache
Croatian: • upale nosnih kanala, grla i usta, simptomi slični gripi, suha usta, bolna ili upaljena usta,
English: Symptoms patients with ITP may notice include petechiae (pinpointsized flat round red spots under the skin), bruising, nosebleeds, bleeding gums and not being able to control bleeding if they are cut or injured.
Croatian: Simptomi koje bolesnici s ITP-om mogu primijetiti uključuju petehije (sitne plosnate, okrugle, crvene točkice pod kožom), modrice, krvarenja iz nosa, krvarenja iz desni i otežano zaustavljanje krvarenja iz posjekotina ili kod ozljeda.
English: In addition, patients could taper off concomitant ITP medicinal products and receive rescue treatments as dictated by local standard of care.
Croatian: Uz to, bolesnicima se moglo postupno smanjiti ostale lijekove za ITP, kao i primijeniti dodatno (rescue) liječenje u slučaju potrebe, sve prema lokalnim principima zbrinjavanja takvih bolesnika.
English: The following side effects have been reported to be associated with treatment with Revolade in adult patients with ITP:
Croatian: Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u odraslih bolesnika s ITP-om:
English: Chronic HCV patients and severe aplastic anaemia patients with hepatic impairment should initiate eltrombopag at a dose of 25 mg once daily (see section 5.2).
Croatian: Bolesnici s kroničnim HCV-om i bolesnici s teškom aplastičnom anemijom s oštećenjem jetre trebaju započeti liječenje eltrombopagom u dozi od 25 mg jednom dnevno (vidjeti dio 5.2).
English: Patients were diagnosed with ITP for at least 6 months and were refractory or relapsed to at least one prior ITP therapy with a platelet count <30,000/µl (n=67).
Croatian: Bolesnicima je dijagnosticiran ITP najmanje 6 mjeseci i bili su refraktorni ili imali relaps na najmanje jednoj prethodnoj terapiji za ITP s brojem trombocita <30 000/µl (n=67).
English: For patients of Asian ancestry, eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Croatian: Za bolesnike azijskog podrijetla, eltrombopag treba započeti u smanjenoj dozi od 25 mg jednom dnevno (vidjeti dio 5.2).
English: Common Paraesthesia, hypoaesthesia, somnolence, migraine Uncommon Tremor, balance disorder, dysaesthesia, hemiparesis, migraine with aura, neuropathy peripheral, peripheral sensory neuropathy, speech disorder, toxic neuropathy, vascular headache
Croatian: Poremećaji živčanog sustava često parestezija, hipoestezija, somnolencija, migrena manje često tremor, poremećaji ravnoteže, dizestezija, hemipareza, migrena s aurom, periferna neuropatija, periferna senzorna neuropatija, poremećaji govora, toksična neuropatija, vaskularna glavobolja
English: Unbound eltrombopag (active) concentrations for this highly protein-bound medicinal product were not measured.
Croatian: Koncentracije nevezanog eltrombopaga (aktivan), koji se inače u visokom postotku veže za proteine plazme, nisu bile mjerene.
English: A new single-use oral dosing syringe should be used to prepare each dose of Revolade for oral suspension.
Croatian: Za pripremu svake doze lijeka Revolade za oralnu suspenziju potrebno je koristiti novu dozirnu štrcaljku za usta za jednokratnu uporabu.
English: A greater proportion of patients on eltrombopag did not require any antiviral dose reduction as compared to placebo (45% vs. 27%).
Croatian: U usporedbi s placebom veći udio bolesnika na eltrombopagu nije trebao smanjiti dozu antivirusnog lijeka (45% nasuprot 27%).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE VREĆICA
English: • 50 mg dose - 2 sachets
Croatian: • Doza od 50 mg - 2 vrećice
English: For patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), eltrombopag should be initiated at a reduced dose of 25 mg once daily (see section 5.2).
Croatian: Za bolesnike azijskog podrijetla (kao što su Kinezi, Japanci, Tajvanci, Korejci ili Tajlanđani), eltrombopag treba započeti u smanjenoj dozi od 25 mg jednom dnevno (vidjeti dio 5.2).
English: Overall, a significantly greater proportion of eltrombopag patients (62%) compared with placebo patients (32%) met the primary endpoint (Odds Ratio: 4.3 [95% CI: 1.4, 13.3] p=0.011).
Croatian: Ukupno je značajno veći udio bolesnika na eltrombopagu (62%) u usporedbi s bolesnicima na placebu (32%) ostvario mjeru primarnog ishoda (omjer izgleda: 4,3 [95% CI: 1,4; 13,3] p=0,011).
English: The lower platelet count may increase the risk of bleeding or bruising.
Croatian: Niže vrijednosti trombocita u krvi mogu povisiti rizik od krvarenja ili stvaranja modrica.
English: Each sachet contains a powder for reconstitution that delivers 32 mg eltrombopag olamine, equivalent to 25 mg of eltrombopag free acid.
Croatian: Jedna vrećica sadrži prašak za rekonstituciju koji daje 32 mg eltrombopagolamina, u količini koja odgovara 25 mg eltrombopag slobodne kiseline.
English: Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dose regimen of eltrombopag modified based on platelet counts as outlined in Table 1.
Croatian: Klinički hematološki i jetreni testovi trebaju biti redovito praćeni tijekom cijelog liječenja eltrombopagom i režim njegova doziranja korigiran prema broju trombocita, kako je navedeno u tablici 1.
English: Decrease the daily dose by 50 mg.
Croatian: Smanjiti dnevnu dozu za 50 mg.
English: Human liver microsome studies identified CYP1A2 and CYP2C8 as the enzymes responsible for eltrombopag oxidation.
Croatian: Ispitivanja na humanim jetrenim mikrosomima identificirala su CYP1A2 i CYP2C8 kao enzime odgovorne za oksidaciju eltrombopaga.
English: Data presented as geometric mean (95% CI).
Croatian: Podaci predstavljeni kao geometrijska srednja vrijednost (95% CI).
English: Patients with impaired renal function should use eltrombopag with caution and close monitoring, for example by testing serum creatinine and/or urine analysis (see section 4.2).
Croatian: Bolesnici s oštećenom bubrežnom funkcijom moraju uzimati eltrombopag s oprezom i biti detaljno praćeni, npr. kontrolom kreatinina u krvi i/ili analizom urina (vidjeti dio 4.2).
English: Eltrombopag does not inhibit or induce CYP enzymes based on in vitro and in vivo data (see section 4.5).
Croatian: Na temelju in vitro i in vivo podataka, eltrombopag ne inhibira niti inducira CYP enzime (vidjeti dio 4.5).
English: Eltrombopag should be taken at least two hours before or four hours after any products such as antacids, dairy products or mineral supplements containing polyvalent cations to avoid significant reduction in eltrombopag absorption due to chelation (see sections 4.2 and 5.2).
Croatian: Eltrombopag treba uzeti najmanje dva sata prije ili četiri sata nakon bilo kojeg pripravka kao što su antacidi, mliječni proizvodi ili nadomjesci minerala koji sadrže polivalentne katione kako bi se izbjeglo značajno smanjenje apsorpcije eltrombopaga uslijed stvaranja kelata (vidjeti dijelove 4.2 i 5.2).
English: • sudden shortness of breath especially together with sharp pain in the chest or rapid breathing
Croatian: • nagli nedostatak zraka naročito ako je praćen oštrom boli u prsnom košu ili ubrzanim disanjem
English: Table 10 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in paediatric patients with ITP (50 mg once daily dosing regimen)
Croatian: Tablica 10 Geometrijska srednja vrijednost (95% CI) farmakokinetičkih parametara plazmatskog eltrombopaga u stanju dinamičke ravnoteže u pedijatrijskih bolesnika s ITP-om (režim doziranja 50 mg jednom dnevno)
English: Multipack containing 84 (3 packs of 28) film-coated tablets
Croatian: Višestruko pakiranje koje sadrži 84 (3 pakiranja po 28) filmom obloženih tableta
English: Do not use this medicine after the expiry date which is stated on the carton and the sachet.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i vrećici.
English: • skin changes, including rash, dry skin, eczema, redness of the skin, itching, excessive sweating,
Croatian: • kožne promjene, uključujući osip, suhu kožu, ekcem, crvenilo kože, svrbež, pojačano znojenje, neuobičajene izrasline na koži
English: Table 3 Dose adjustments of eltrombopag in patients with severe aplastic anaemia
Croatian: Tablica 3 Prilagodbe doze eltrombopaga u bolesnika s teškom aplastičnom anemijom Broj trombocita
English: A loss of response or failure to maintain a platelet response with eltrombopag treatment within the recommended dosing range should prompt a search for causative factors, including an increased bone marrow reticulin.
Croatian: Izostanak odgovora na liječenje eltrombopagom ili neuspjeh održavanja broja trombocita u preporučenim dozama nalaže potrebu traženja uzroka navedenog, uključujući i pojavu eventualnog umnažanja retikulinskih niti u koštanoj srži.
English: Grouped term with preferred terms acute kidney injury and renal failure
Croatian: Grupni pojam s preporučenim pojmovima akutna ozljeda bubrega i zatajenje bubrega
English: Table 6 Sustained platelet response rates by age cohort in paediatric patients with chronic ITP
Croatian: Tablica 6 Stope održanog trombocitnog odgovora prema dobnoj kohorti u pedijatrijskih bolesnika s kroničnim ITP-om
English: Patients were randomised 2:1 and received Revolade (n=44) or placebo (n=21), for up to 7 weeks.
Croatian: Bolesnici su bili randomizirani u omjeru 2:1 i primali su Revolade (n=44) ili placebo (n=21), do 7 tjedana.
English: Increase daily dose by 50 mg to a maximum of 150 mg/day.
Croatian: Povećati dnevnu dozu za 50 mg do maksimalno 150 mg/dan.
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc.
Croatian: Eltrombopag stvara kelate s polivalentnim kationima poput željeza, kalcija, magnezija, aluminija, selenija i cinka.
English: If you are of Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) you will start on the same 25 mg dose.
Croatian: Ako ste porijeklom iz Azije (Kinez, Japanac, Tajvanac, Tajlanđanin ili Korejac), liječenje ćete započeti istom tom početnom dozom od 25 mg.
English: Clinical haematology and liver tests should be monitored regularly throughout therapy with eltrombopag and the dosage regimen of eltrombopag modified based on platelet counts as outlined in Table 3.
Croatian: Klinički hematološki i jetreni testovi trebaju se redovito pratiti tijekom cijelog liječenja eltrombopagom i korigirati režim njegova doziranja prema broju trombocita, kako je navedeno u tablici 3.
English: In the single-arm phase II monotherapy refractory SAA study, concurrent ALT or AST >3 x ULN with total (indirect) bilirubin >1.5 x ULN were reported in 5% of patients.
Croatian: U ispitivanju refraktorne teške aplastične anemije faze II s jednom skupinom, istovremeni ALT ili AST >3 x GGN s ukupnim (indirektnim) bilirubinom >1,5 x GGN bio je prijavljen u 5% bolesnika.
English: The lowest dose of eltrombopag to achieve and maintain a platelet count ≥50,000/µl should be used.
Croatian: Mora se koristiti najniža doza eltrombopaga kojom se postiže i održava broj trombocita ≥50 000/µl.
English: • increased levels of bilirubin (a substance produced by the liver)
Croatian: • povećana razina bilirubina (tvar koju proizvodi jetra)
English: Based on model estimate, elderly (≥65 years) patients had approximately 41% higher plasma eltrombopag AUC(0-) as compared to younger patients (see section 4.2).
Croatian: Temeljem procijenjenog modela, stariji (≥65 godina) bolesnici imali su približno 41% veće vrijednosti AUC(0-) eltrombopaga u plazmi u usporedbi s mlađim bolesnicima (vidjeti dio 4.2).
English: Chronic HCV patients with cirrhosis may be at risk of hepatic decompensation when receiving alfa interferon therapy.
Croatian: Kronični bolesnici s HCV-om i cirozom tijekom primanja terapije interferonom alfa mogu imati rizik od razvoja jetrene dekompenzacije.
English: This risk is increased if eltrombopag treatment is discontinued in the presence of anticoagulants or anti-platelet agents.
Croatian: Ovaj se rizik još više povećava ukoliko bolesnik istodobno prima antikoagulanse ili antitrombocitne lijekove.
English: Uncommon Tachycardia, acute myocardial infarction, cardiovascular disorder, cyanosis, sinus tachycardia, electrocardiogram QT prolonged
Croatian: Srčani poremećaji manje često tahikardija, akutni infarkt miokarda, kardiovaskularni poremećaj, cijanoza, sinusna tahikardija, produženje QT intervala u EKG-u