FrancophonIA/ELRC3.0 huggingface dataset:
English: Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Slovenian: Zdravilo Revolade je indicirano za zdravljenje odraslih bolnikov s pridobljeno hudo aplastično anemijo, ki se bodisi niso odzvali na predhodno imunosupresivno zdravljenje ali so že bili obsežno zdravljeni in niso primerni za presaditev krvotvornih matičnih celic (glejte poglavje 5.1).
English: There are no or limited amount of data from the use of eltrombopag in pregnant women.
Slovenian: Podatkov o uporabi eltrombopaga pri nosečnicah ni oziroma so podatki omejeni.
English: In comparison, at Week 12, 55% of placebo patients reported any bleeding.
Slovenian: Za primerjavo, po 12 tednih je pojav katerekoli krvavitve navajalo 55 % bolnikov s placebom.
English: Patients were randomised 2:1 and received Revolade (n=63) or placebo (n=29) for up to 13 weeks in the randomised period of the study.
Slovenian: Bolnike so v razmerju 2:1 randomizirali na prejemanje zdravila Revolade (n=63) oziroma placeba (n=29), kar so do 13 tednov prejemali v randomiziranem obdobju študije.
English: Uridine diphosphoglucuronyl transferase UGT1A1 and UGT1A3 are responsible for glucuronidation, and bacteria in the lower gastrointestinal tract may be responsible for the cleavage pathway.
Slovenian: Encima uridin difosfat-glukuronil transferaze UGT1A1 in UGT1A3 sta odgovorna za glukuronidacijo, za razcepitev pa verjetno bakterije v spodnjih delih prebavil.
English: Pack size of 30 sachets.
Slovenian: Velikost pakiranja: 30 vrečic.
English: If the patient develops new or worsening morphological abnormalities or cytopenia(s), treatment with eltrombopag should be discontinued and a bone marrow biopsy considered, including staining for fibrosis.
Slovenian: Če se pri bolniku pojavijo nove ali poslabšajo že obstoječe morfološke nepravilnosti ali pojavi citopenija, je treba zdravljenje z eltrombopagom prekiniti in razmisliti o biopsiji kostnega mozga, vključno z barvanjem na fibrozo.
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).
Slovenian: Drugi sekundarni rezultati študij so vključevali naslednje: pomembno manjše število bolnikov zdravljenih z eltrombopagom je predčasno končalo protivirusno zdravljenje glede na placebo (45 % v primerjavi s 60 %, p = <0,0001).
English: PETIT (TRA108062) was a 3-part, staggered-cohort, open-label and double-blind, randomised, placebo-controlled study.
Slovenian: Študija PETIT (TRA108062) je bila tridelna, nezaslepljena in dvojno slepa, randomizirana, s placebom kontrolirana študija z nestalnimi kohortami (staggered-cohort).
English: • generally feeling unwell, high temperature, feeling hot
Slovenian: • splošno slabo počutje, zvišana telesna temperatura, občutek vročine
English: • joint pain, back pain, bone pain, pain in the hands or feet, muscle spasms
Slovenian: • bolečine v sklepih, bolečine v hrbtu, bolečine v kosteh, bolečine v rokah ali stopalih, mišični krči
English: Eltrombopag can be administered in addition to other ITP medicinal products.
Slovenian: Eltrombopag se lahko uporablja skupaj z drugimi zdravili za zdravljenje ITP.
English: When treatment is considered appropriate, caution is required when administering eltrombopag to patients with hepatic impairment (see sections 4.2 and 4.8).
Slovenian: Če je zdravljenje ocenjeno kot primerno, je potrebna previdnost, če je eltrombopag uporabljen pri bolnikih z ITP, ki imajo okvaro jeter (glejte poglavji 4.2 in 4.8).
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).
Slovenian: Pri bolnikih z okvaro delovanja ledvic je treba eltrombopag uporabljati previdno in zdravljenje skrbno nadzirati, na primer s preiskavami vrednosti serumskega kreatinina in/ali z analizami urina (glejte poglavje 4.2).
English: Dose adjustment is not required when eltrombopag is co-administered with either telaprevir or boceprevir.
Slovenian: Prilagoditev odmerka v primeru sočasne uporabe eltrombopaga s telaprevirjem ali boceprevirjem ni potrebna.
English: Revolade is not recommended in women of childbearing potential not using contraception.
Slovenian: Ženske v rodni dobi / Kontracepcija pri moških in ženskah Uporaba zdravila Revolade ni priporočljiva pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: To give a dose to a child
Slovenian: Odmerjanje zdravila otroku
English: Eltrombopag was an inhibitor of a number of UGT enzymes in vitro.
Slovenian: In vitro je eltrombopag zaviral številne UGT encime.
English: In both studies, patients with a platelet count of <75,000/µl were enrolled and stratified by platelet count (<50,000/µl and ≥50,000/µl to <75,000/µl), screening HCV RNA (<800,000 IU/ml and ≥800,000 IU/ml), and HCV genotype (genotype 2/3, and genotype 1/4/6).
Slovenian: V obeh študijah so bili bolniki s številom trombocitov <75.000/µl vključeni in stratificirani glede na število trombocitov (<50.000/µl in ≥50.000/µl do <75,000/µl), presejalna vrednost HCV RNA (<800,000 IU/ml in ≥800,000 IU/ml), in HCV genotip (genotip 2/3, in genotip 1/4/6).
English: Co-administration of a single dose of eltrombopag 200 mg with telaprevir 750 mg every 8 hours did not alter plasma telaprevir exposure.
Slovenian: Sočasna uporaba enkratnega 200 mg odmerka eltrombopaga s 750 mg telaprevirja vsakih 8 ur ni spremenila plazemske izpostavljenosti telaprevirja.
English: 30 sachets and 1 mixing bottle + 30 single-use oral syringes
Slovenian: 30 vrečic in 1 mešalna plastenka + 30 brizg za peroralno odmerjanje za enkratno uporabo
English: All 7 patients had normal cytogenetics at baseline.
Slovenian: Vseh 7 bolnikov je imelo ob izhodišču normalen citogenetski izvid.
English: Patients with bleeding (WHO Grades 2-4) at any time during 6 months, n (%)
Slovenian: Bolniki s krvavitvami (Stopnje 2-4 po SZO) v kateremkoli času med 6 mesečnim obdobjem, n (%)
English: Eltrombopag does not inhibit or induce CYP enzymes based on in vitro and in vivo data (see section 4.5).
Slovenian: Na osnovi in vitro ter in vivo podatkov eltrombopag ne zavira in ne inducira encimov CYP (glejte poglavje 4.5).
English: • decreased levels of calcium
Slovenian: • znižana vrednost kalcija
English: Number of cumulative weeks with platelet counts 50,000-400,000/µl, Mean (SD) Patients with ≥75% of assessments in the target range (50,000 to 400,000/l), n (%)
Slovenian: Ključni sekundarni opazovani dogodki Število kumulativnih tednov s številom trombocitov 50.000-400.000/µl, srednja vrednost (SD) Bolniki z ≥75 % ocen v ciljnem območju (50.000 do 400.000/l) , n (%)
English: If your doctor advises you to stop treatment, your platelet count will then be checked each week for four weeks.
Slovenian: Če vam zdravnik svetuje, da zdravljenje z zdravilom Revolade prekinete, je treba nato še štiri tedne enkrat na teden nadzirati število trombocitov.
English: • increased blood sugar (glucose)
Slovenian: • zvišana vrednost sladkorja v krvi (glukoze)
English: The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
Slovenian: Režim odmerjanja sočasno uporabljenih drugih zdravil za zdravljenje ITP je treba prilagoditi kot je to medicinsko upravičeno, da se med zdravljenjem z eltrombopagom prepreči prekomerno povečanje števila trombocitov.
English: • digestive system problems including frequent bowel movements, food poisoning, blood in stool
Slovenian: • prebavne težave, med drugim pogostejše odvajanje blata, zastrupitev s hrano, kri v blatu
English: Treatment-related cataracts were detected in rodents and were dose and time-dependent.
Slovenian: Pojav katarakte je bil odvisen od odmerka in časa zdravljenja.
English: • Revolade is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.
Slovenian: • Zdravilo Revolade uporabljamo za zdravljenje motnje hemostaze, imenovane imunska (primarna) trombocitopenija (ITP), pri bolnikih, ki so stari 1 leto ali več in so se pred tem že zdravili z drugimi zdravili (kortikosteroidi ali imunoglobulini), vendar pa je bilo zdravljenje neuspešno.
English: Use lowest dose of eltrombopag to maintain platelet counts.
Slovenian: Uporabite najmanjši odmerek eltrombopaga za vzdrževanje števila trombocitov.
English: • decrease in blood sugar levels (hypoglycaemia)
Slovenian: • znižana vrednost sladkorja v krvi (hipoglikemija)
English: • digestive wind/gas
Slovenian: • prisotnost plinov v črevesu/vetrovi
English: ENABLE 1 (TPL103922 n=716) and ENABLE 2 (TPL108390 n=805) were randomised, double-blind, placebo-controlled, multicentre studies to assess the efficacy and safety of Revolade in thrombocytopenic patients with HCV infection who were otherwise eligible to initiate antiviral therapy.
Slovenian: Študiji ENABLE 1 (TPL103922, n=716) in ENABLE 2 (TPL108390, n=805) sta bili randomizirani, dvojno slepi, s placebom kontrolirani, multicentrični študiji za oceno učinkovitosti in varnosti zdravila Revolade pri trombocitopeničnih bolnikih z okužbo s HCV, ki so bili sicer primerni za uvedbo protivirusnega zdravljenja.
English: The long-term safety of eltrombopag should be considered prior to starting therapy.
Slovenian: Pred začetkom zdravljenja je treba pretehtati dolgoročno varnost zdravljenja z eltrombopagom.
English: Patients receiving ITP therapy at baseline (n) Patients who attempted to reduce or discontinue baseline therapy, n (%)
Slovenian: Bolniki, ki so se v izhodišču že zdravili zaradi ITP (n) Bolniki pri katerih so izhodiščno obliko zdravljenja poskušali zmanjšati ali ukiniti, n (%)
English: Ciclosporin
Slovenian: Ciklosporin
English: • Give the entire contents of the bottle to the patient using the same oral syringe.
Slovenian: • Bolniku dajte celotno vsebino plastenke z isto brizgo za peroralno odmerjanje.
English: • increased number of white blood cells (leukocytosis)
Slovenian: • zvišano število levkocitov (levkocitoza)
English: Frequency Adverse reaction Infections and infestations Very common
Slovenian: Infekcijske in parazitske bolezni zelo pogosti nazofaringitis
English: The active substance in Revolade is eltrombopag.
Slovenian: Zdravilna učinkovina zdravila Revolade je eltrombopag.
English: Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Slovenian: Zdravilo Revolade je indicirano za zdravljenje bolnikov, ki so stari 1 leto ali več, imajo primarno imunsko trombocitopenijo (ITP) s trajanjem 6 mesecev ali več od postavitve diagnoze in se niso odzvali na zdravljenje z drugimi zdravili (npr. kortikosteroidi, imunoglobulini) (glejte poglavji 4.2 in
English: The administration of eltrombopag tablet or powder for oral suspension formulations with a highcalcium meal (e.g. a meal that included dairy products) significantly reduced plasma eltrombopag AUC0-∞ and Cmax.
Slovenian: Odmerjanje eltrombopaga v obliki tablet ali praška za peroralno suspenzijo skupaj z obrokom z veliko vsebnostjo kalcija (na primer z obrokom, ki je vključeval mlečne izdelke) je pomembno zmanjšalo vrednosti AUC0-∞ in Cmax eltrombopaga v plazmi.
English: If you are taking corticosteroids, danazol, and/or azathioprine you may need to take a lower dose or to stop taking them while you are taking Revolade.
Slovenian: Če ste pred uvedbo zdravljenja z zdravilom Revolade jemali kortikosteroide, danazol in/ali azatioprin, bo po začetku zdravljenja z zdravilom Revolade njihov odmerek morda treba zmanjšati ali zdravljenje z njimi prekiniti.
English: The safety of eltrombopag in severe aplastic anaemia was assessed in a single-arm, open-label study (N=43) in which 11 patients (26%) were treated for >6 months and 7 patients (16%) were treated for >1 year.
Slovenian: Varnost eltrombopaga pri zdravljenju hude aplastične anemije so ocenjevali v nezaslepljeni študiji z eno samo skupino bolnikov (N=43), v kateri so 11 bolnikov (26 %) zdravili več kot 6 mesecev, 7 bolnikov (16 %) pa so zdravili več kot 1 leto.
English: • foamy, frothy or bubbly-looking urine (signs of protein in urine)
Slovenian: • penast ali mehurčkast urin (znak beljakovin v urinu)
English: Table 3 Dose adjustments of eltrombopag in patients with severe aplastic anaemia
Slovenian: Preglednica 3 Prilagoditve odmerka eltrombopaga pri bolnikih s hudo aplastično anemijo
English: Before you start taking Revolade, your doctor will carry out blood tests to check your blood cells, including platelets.
Slovenian: Pred začetkom zdravljenja z zdravilom Revolade bo zdravnik s krvnimi preiskavami preveril število krvnih celic, vključno s trombociti.
English: No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).
Slovenian: Pri sočasni uporabi eltrombopaga in substratov za CYP450, klinično pomembnih interakcij ne pričakujemo (glejte poglavje 5.2).
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation.
Slovenian: Bolnike s temi lastnostmi je potrebno skrbno spremljati glede znakov in simptomov jetrne dekompenazcije.
English: Unbound eltrombopag (active) concentrations for this highly protein-bound medicinal product were not measured.
Slovenian: Koncentracij nevezanega (aktivnega) eltrombopaga, učinkovine, ki se v veliki meri veže na proteine, niso ovrednotili.
English: In a placebo-controlled study (n=288, Safety population), following 2 weeks' treatment in preparation for invasive procedures, 6 of 143 (4%) adult patients with chronic liver disease receiving eltrombopag experienced 7 TEEs of the portal venous system and 2 of 145 (1%) patients in the placebo group experienced 3 TEEs.
Slovenian: V s placebom kontrolirani študiji (n = 288, varnostna populacija), se je po 2-tedenskem zdravljenju v sklopu priprav na invazivne posege pri 6 od143 (4 %) odraslih bolnikov s kronično boleznijo jeter, ki so prejemali eltrombopag, pojavilo 7 trombemboličnih dogodkov v portalnem venskem sistemu in pri 2 od 145 (1 %) bolnikov v skupini s placebom 3 trombembolični dogodki.
English: Your doctor will review the medicines you are taking, and suggest suitable replacements if necessary.
Slovenian: Zdravnik bo presodil, če zdravila, ki jih že jemljete lahko jemljete skupaj z zdravilom Revolade in po potrebi predpisal zdravljenje z ustreznim drugim zdravilom.
English: Patients with bleeding (WHO Grades 1-4) at any time during 6 months, n (%)
Slovenian: Bolniki s krvavitvami (stopnje 1-4 po SZO) v kateremkoli času med 6 mesečnim obdobjem, n (%)
English: The dose of eltrombopag should be adjusted in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy.
Slovenian: Odmerek eltrombopaga se prilagaja po potrebi v odmerku za 25 mg vsake 2 tedna, da se doseže ciljno število trombocitov, ki je potrebno za uvedbo protivirusnega zdravljenja.
English: Approximately 21% of an eltrombopag dose could undergo oxidative metabolism.
Slovenian: Oksidativni presnovi lahko podleže približno 21 % odmerka eltrombopaga.
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.
Slovenian: Zbrani podatki koncentracija-čas plazemskega eltrombopaga pri 590 bolnikih s HCV vključenih v Fazo III študije TPL103922/ENABLE 1 in TPL108390/ENABLE 2 so bili združeni s podatki bolnikov s HCV, ki so bili vključeni v Fazo II študije PL102357 in zdravih odraslih osebah iz farmakokinetične analize populacije.
English: 75 mg a AUC(0-) and Cmax based on population PK post-hoc estimates.
Slovenian: 75 mg a vrednosti AUC(0-) in Cmax na osnovi naknadne ocene populacijske farmakokinetike
English: Make sure the plunger is pushed all the way into the syringe.
Slovenian: Poskrbite, da bo bat potisnjen v brizgo do konca.
English: • feeling very tired (fatigue)
Slovenian: • huda utrujenost (izčrpanost)
English: Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets.
Slovenian: Pretisni omoti iz aluminija (PA/Alu/PVC/Alu) v škatli, ki vsebuje 14 ali 28 filmsko obloženih tablet in pakiranje po več enot, ki vsebuje 84 filmsko obloženih tablet (3 pakiranja po 28 filmsko obloženih tablet).
English: People who have low platelet counts as well as advanced chronic (long-term) liver disease are more at risk of side effects, including life-threatening liver damage and blood clots.
Slovenian: Ljudje, ki imajo znižano število trombocitov in napredovalo kronično (dolgotrajno) bolezen jeter, imajo povečano tveganje za neželene učinke, med katerimi so lahko življenjsko nevarna okvara jeter in nastanek krvnih strdkov.
English: When eltrombopag is given in combination with antivirals reference should be made to the full summary of product characteristics of the respective coadministered medicinal products for comprehensive details of relevant safety information or contraindications.
Slovenian: Trombocitopenija povezana s kroničnim hepatitisom C (HCV) Ko se eltrombopag uporablja v kombinaciji s protivirusnimi zdravili, je potrebno upoštevati celoten povzetek glavnih značilnosti sočasno uporabljenih zdravil za podrobnejše informacije o varnosti in kontraindikacijah.
English: If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate.
Slovenian: Če se pri bolniku ugotovi nove citogenetske nepravilnosti, je treba oceniti, ali je zdravljenje z eltrombopagom primerno nadaljevati.
English: Excessive platelet count responses (as outlined in Table 3) or important liver test abnormalities also necessitate discontinuation of eltrombopag (see section 4.8).
Slovenian: Tudi v primeru prekomernega trombocitnega odziva (kot je navedeno v preglednici 3) ali v primeru pomembnih nepravilnostih izvidov testov jetrne funkcije je treba zdravljenje z eltrombopagom prekiniti (glejte poglavje 4.8).
English: How to give a dose of medicine
Slovenian: Kako je treba odmerjati zdravilo
English: Median platelet counts at 1, 2, 3, 4, 5, 6 and 7 years on study were 85,000/l, 85,000/l, 105,000/l, 64,000/l, 75,000/l, 119,000/l and 76,000/l, respectively.
Slovenian: Mediana vrednost števila trombocitov pri bolnikih v študiji je bila po enem letu 85.000/l, po 2 letih 85.000/l, po 3 letih 105.000/l, po 4 letih 64.000/l, po 5 letih 75.000/l, po 6 letih 119.000/l in po 7 letih 76.000/l.
English: EU/1/10/612/013 (30 sachets of powder for oral suspension)
Slovenian: EU/1/10/612/013 (30 vrečic s praškom za peroralno suspenzijo)
English: The influence of age on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 28 healthy subjects, 673 patients with HCV, and 41 patients with chronic liver disease of other aetiology ranging from 19 to 74 years old.
Slovenian: Vpliv starosti na farmakokinetiko eltrombopaga je bil ovrednoten z analizo populacijske farmakokinetike pri 28 zdravih osebah, 673 bolnikih s HCV in 41 bolnikih s kronično boleznijo jeter druge etiologije, v starosti od 19 do 74 let.
English: Bone marrow reticulin formation and risk of bone marrow fibrosis
Slovenian: Tvorba retikulina v kostnem mozgu in tveganje za fibrozo kostnega mozga
English: Platelet counts should be monitored weekly during antiviral therapy until a stable platelet count is achieved, normally around 50,000-75,000/µl.
Slovenian: Med protivirusnim zdravljenjem je potrebno število trombocitov spremljati tedensko dokler se ne doseže stabilno število trombocitov, običajno okoli 50.000-75.000/µl.
English: In the pre- and post-natal development study in rats, there were no undesirable effects on pregnancy, parturition or lactation of F0 female rats at maternally non-toxic doses (10 and 20 mg/kg/day) and no effects on the growth, development, neurobehavioural or reproductive function of the offspring (F1).
Slovenian: Pri študijah prenatalnega in postnatalnega razvoja pri podganah niso zasledili neželenih vplivov na brejost, porod ali dojenje F0 samic pri odmerkih, ki niso bili toksični za matere (10 in 20 mg/kg/dan).
English: In clinical studies, platelet counts generally began to increase within 1 week of starting eltrombopag.
Slovenian: V kliničnih študijah, se po uvedbi eltrombopaga, ševilo trombocitov na splošno začne dvigovati v 1 tednu.
English: This decrease of exposure was attenuated when a single 25 mg dose of eltrombopag powder for oral suspension was administered 2 hours before a high-calcium meal (mean AUC0-∞ was decreased by 20% and mean Cmax by 14%).
Slovenian: Zmanjšanje izpostavljenosti eltrombopagu je bilo manjše, kadar so bolniki 25-miligramski odmerek eltrombopaga v obliki praška za peroralno suspenzijo prejeli 2 uri pred obrokom z veliko vsebnostjo kalcija (povprečna vrednost AUC0-∞ se je zmanjšala za 20 %, povprečna vrednost Cmax pa za 14 %).
English: Additional medical management may include cessation of anticoagulant and/or anti-platelet therapy, reversal of anticoagulation, or platelet support.
Slovenian: Dodatno bo morda treba opustiti tudi zdravljenje z antikoagulanti in/ali antiagregacijskimi zdravili, uvesti ustrezno antihemoragično zdravljenje ali podporo trombocitom.
English: Carcinogenicity and mutagenicity
Slovenian: Kancerogenost in mutagenost
English: It is recommended that, if treatment with eltrombopag is discontinued, ITP treatment be restarted according to current treatment guidelines.
Slovenian: V primeru prekinitve zdravljenja z eltrombopagom je priporočljivo, da se uvede zdravljenje ITP v skladu s trenutnimi smernicami zdravljenja.
English: The lower platelet count may increase the risk of bleeding or bruising.
Slovenian: Zaradi zmanjšanja števila trombocitov se lahko poveča tveganje za pojav krvavitev ali modric.
English: Pharmacokinetics
Slovenian: Farmakokinetika
English: • liver problems, including blood clot, tumour in the liver (see ‘Liver problems' earlier in section 4)
Slovenian: • težave z jetri, med drugim krvni strdek, tumor v jetrih (glejte začetni del poglavja 4 "Težave z jetri")
English: Contents of the pack and other information Instructions for use
Slovenian: Shranjevanje zdravila Revolade Vsebina pakiranja in dodatne informacije Navodila za uporabo
English: No specific risk factors were identified in those patients who experienced a TEE with the exception of platelet counts ≥200,000/µl (see section 4.4).
Slovenian: Pri bolnikih, ki so se jim pojavili trombembolični dogodki, niso ugotovili specifičnih dejavnikov tveganja razen števila trombocitov ≥200.000/µl (glejte poglavje 4.4).
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc (see sections 4.2 and 4.5).
Slovenian: Eltrombopag tvori kelate s polivalentnimi kationi, kot so železo, kalcij, magnezij, aluminij, selen in cink (glejte poglavji 4.2 in 4.5).
English: • decreased vision
Slovenian: • poslabšanje vida
English: Administration of eltrombopag 75 mg once daily for 5 days with a single 10 mg dose of the OATP1B1 and BCRP substrate rosuvastatin to 39 healthy adult subjects increased plasma rosuvastatin Cmax 103% (90% confidence interval [CI]: 82%, 126%) and AUC0- 55% (90% CI: 42%, 69%).
Slovenian: Pri 39 zdravih odraslih osebah se je pri petdnevni uporabi eltrombopaga v odmerku 75 mg enkrat na dan z enim 10 mg odmerkom rosuvastatina, ki je substrat za OATP1B1 in BCRP, plazemska vrednost Cmax rosuvastatina povečala za 103 % (90 % interval zaupanja: 82 %, 126 %), vrednost AUC0- pa za 55 % (90 % interval zaupanja: 42 %, 69 %).