FrancophonIA/ELRC3.0 huggingface dataset:
English: Thrombotic/thromboembolic complications
Croatian: Trombotičke/tromboembolijske komplikacije
English: At Week 12, the proportion of eltrombopag patients reporting any bleeding was decreased to half of baseline (36%).
Croatian: U 12. tjednu udio bolesnika na eltrombopagu koji su prijavili bilo kakvo krvarenje smanjen je na polovicu od početnog (36%).
English: The predominant route of eltrombopag excretion is via faeces (59%) with 31% of the dose found in the urine as metabolites.
Croatian: Glavni put izlučivanja je putem stolice (59%), dok se 31% doze nađe u mokraći u obliku metabolita.
English: What Revolade looks like and contents of the pack Revolade 25 mg powder for oral suspension is available in kits containing 30 sachets; each sachet contains a reddish-brown to yellow powder.
Croatian: Revolade 25 mg prašak za oralnu suspenziju dostupan je u kompletima koji sadrže 30 vrećica; svaka vrećica sadrži crvenkasto-smeđi do žuti prašak.
English: A study in 40 healthy volunteers showed that the co-administration of a single 100 mg dose of eltrombopag with repeat dose lopinavir/ritonavir 400/100 mg twice daily resulted in a reduction in eltrombopag plasma AUCinf by 17% (90% CI: 6.6%, 26.6%).
Croatian: Ispitivanje s 40 zdravih dobrovoljaca pokazalo je da istodobna primjena jedne doze eltrombopaga od 100 mg s ponovljenim dozama lopinavira/ritonavira od 400/100 mg dva puta dnevno rezultira smanjenjem plazmatskog AUCinf eltrombopaga za 17% (90% CI: 6,6%, 26,6%).
English: You may also be checked for the occurrence of any bleeding in or around your retina (the light-sensitive layer of cells at the back of the eye).
Croatian: Liječnik će možda također provjeriti postoji li bilo kakvo krvarenje u i oko mrežnice (sloj stanica osjetljivih na svjetlost na stražnjoj strani oka).
English: Preparation and administration of the powder for oral suspension:
Croatian: Priprema i primjena praška za oralnu suspenziju:
English: In a human radiolabel study, eltrombopag accounted for approximately 64% of plasma radiocarbon AUC0-.
Croatian: U ispitivanju kod kojeg je korišten radioaktivno obilježen lijek u ljudi, eltrombopag je bio odgovoran za otprilike 64% AUC0- radioaktivnog ugljika u plazmi.
English: PETIT2 (TRA115450) was a 2-part, double-blind and open-label, randomised, placebo-controlled study.
Croatian: PETIT2 (TRA115450) je bilo ispitivanje u dva dijela, dvostruko slijepo i otvoreno, randomizirano, placebom kontrolirano.
English: • darkening of the skin
Croatian: • tamnjenje kože
English: In addition, in the RAISE study, 42% of patients with baseline platelet count ≤15,000/μl treated with eltrombopag responded at the end of the 6 month treatment period.
Croatian: Osim toga, u RAISE studiji 42% bolesnika s početnim brojem trombocita ≤15 000/μl liječenih eltrombopagom odgovorilo je na kraju šestomjesečnog perioda ispitivanja.
English: Very common side effects that may show up in blood tests: • increased of liver enzymes (alanine aminotransferase (ALT))
Croatian: Vrlo česte nuspojave koje se vide u krvnim pretragama: porast jetrenih enzima (alanin aminotransferaza (ALT))
English: • antacid medicines to treat indigestion, heartburn or stomach ulcers (see also ‘When to take it' in section 3)
Croatian: • antacidi - lijekovi za liječenje probavnih tegoba, žgaravice ili čira na želucu (također pogledajte „Kada uzeti lijek“ u dijelu 3.)
English: Cohort 1 (12 to 17 years)
Croatian: Kohorta 1 (12 do 17 godina)
English: There are no PK data on the use of eltrombopag in patients ≥75 years.
Croatian: Ne postoje farmakokinetički podatci o korištenju eltrombopaga u bolesnika ≥75 godina.
English: In clinical studies, platelet counts generally increased within 1 to 2 weeks after starting eltrombopag and decreased within 1 to 2 weeks after discontinuation.
Croatian: U kliničkim ispitivanjima broj trombocita obično se povisio unutar 1 do 2 tjedna nakon započinjanja liječenja eltrombopagom te se smanjio unutar 1 do 2 tjedna nakon prestanka uzimanja.
English: The following additional side effects have been reported to be associated with treatment with Revolade in children (aged 1 to 17 years) with ITP:
Croatian: Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u djece (u dobi od 1 do 17 godina) s ITP-om:
English: Multilineage responses were reported by 45% of patients.
Croatian: U 45% bolesnika zabilježeni su odgovori u više loza.
English: In 3 controlled and 2 uncontrolled clinical studies among adult ITP patients receiving eltrombopag (n=446), 17 patients experienced a total of 19 TEEs, which included (in descending order of occurrence) deep vein thrombosis (n=6), pulmonary embolism (n=6), acute myocardial infarction (n=2), cerebral infarction (n=2), embolism (n=1) (see section 4.4).
Croatian: U 3 kontrolirana i 2 nekontrolirana klinička ispitivanja, među odraslim bolesnicima s ITP-om koji su primali eltrombopag (n=446), 17 bolesnika je doživjelo ukupno 19 TED, koji su uključivali (navedeni prema padajućem redoslijedu pojavljivanja): duboku vensku trombozu (n=6), plućnu emboliju (n=6), akutni infarkt miokarda (n=2), cerebralni infarkt (n=2), emboliju (n=1) (vidjeti dio 4.4).
English: Platelet count should be monitored at least weekly for 2 to 3 weeks when eltrombopag is co-administered with ciclosporin.
Croatian: Potrebno je praćenje broja trombocita najmanje jednom tjedno tijekom 2 do 3 tjedna kada se eltrombopag istodobno primjenjuje s ciklosporinom.
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%).
Croatian: To smanjenje izloženosti bilo je ublaženo kada je jednokratna doza od 25 mg eltrombopag praška za oralnu suspenziju bila primijenjena 2 sata prije obroka s visokim udjelom kalcija (srednji AUC0-∞ bio je smanjen za 20%, a srednji Cmax za 14%).
English: Statistically fewer eltrombopag patients required rescue treatment during the randomised period compared to placebo patients (19% [12/63] vs. 24% [7/29], p=0.032).
Croatian: Statistički manje bolesnika na eltrombopagu trebalo je simptomatsku terapiju tijekom randomiziranog razdoblja u usporedbi s bolesnicima na placebu (19% [12/63] vs. 24% [7/29], p=0,032).
English: In the pre-antiviral treatment phase, patients received open-label eltrombopag to increase the platelet count to ≥90,000/µl for ENABLE 1 and ≥100,000/µl for ENABLE 2.
Croatian: U fazi prije antivirusnog liječenja, bolesnici su otvoreno primali eltrombopag kako bi povećali broj trombocita na ≥90 000/µl u ENABLE 1 i ≥100 000/µl u ENABLE 2 ispitivanju.
English: • Place the tip of the syringe into the inside of the child's cheek.
Croatian: • Postavite vršak štrcaljke djetetu s unutarnje strane obraza.
English: In contrast, the administration of eltrombopag 2 hours before or 4 hours after a high-calcium meal or with low-calcium food [<50 mg calcium] did not alter plasma eltrombopag exposure to a clinically significant extent (see section 4.2).
Croatian: Nasuprot tome, primjena eltrombopaga 2 sata prije ili 4 sata nakon obroka s visokim udjelom kalcija ili s hranom s niskim udjelom kalcija [< 50 mg kalcija] nije promijenila plazmatsku razinu eltrombopaga u klinički značajnoj mjeri (vidjeti dio 4.2).
English: Based on urinary excretion and metabolites eliminated in faeces, the oral absorption of drug-related material following administration of a single 75 mg eltrombopag solution dose was estimated to be at least 52%.
Croatian: Na temelju izlučivanja mokraćom i metabolita eliminiranih stolicom, oralna apsorpcija lijeka nakon primjene jedne doze otopine eltrombopaga od 75 mg, procijenjena je da iznosi barem 52%.
English: Administration of eltrombopag 75 mg once daily for 7 days to 24 healthy male subjects did not inhibit or induce the metabolism of probe substrates for 1A2 (caffeine), 2C19 (omeprazole), 2C9 (flurbiprofen), or 3A4 (midazolam) in humans.
Croatian: Primjena eltrombopaga u dozi od 75 mg jednom dnevno tijekom 7 dana u 24 zdrava muškarca nije inhibirala niti inducirala metabolizam supstrata za 1A2 (kofein), 2C19 (omeprazol), 2C9 (flurbiprofen) ili 3A4 (midazolam) u ljudi.
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.
Croatian: Uridin difosfoglukuronil transferaze UGT1A1 i UGT1A3 su odgovorne za glukuronidaciju, a bakterije u donjem dijelu probavnog sustava bi mogle biti odgovorne za put odstranjivanja cijepanjem.
English: Dose adjustment is not required when eltrombopag is co-administered with either telaprevir or boceprevir.
Croatian: Nije potrebna prilagodba doze kad se eltrombopag primjenjuje istodobno s telaprevirom ili boceprevirom.
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.
Croatian: Aluminijski blisteri (PA/Al/PVC/Al) u kutiji koji sadrže 14 ili 28 filmom obloženih tableta i višestruko pakiranje koje sadrži 84 (3 pakiranja po 28) filmom obloženih tableta.
English: Minor metabolites due to glucuronidation and oxidation were also detected.
Croatian: Manje značajni metaboliti nastali glukuronidacijom i oksidacijom su također detektirani.
English: Paediatric population (aged 1 to 17 years) The safety and efficacy of eltrombopag in paediatric patients have been investigated in two studies.
Croatian: Pedijatrijska populacija (u dobi od 1 do 17 godina) Sigurnost i djelotvornost eltrombopaga u pedijatrijskih bolesnika bile su istraživane u dva ispitivanja.
English: HCV protease inhibitors
Croatian: Inhibitori HCV proteaze
English: For 4 hours before you take
Croatian: U razdoblju od 4 sata prije uzimanja lijeka
English: During antiviral therapy, the dose of eltrombopag should be adjusted as necessary to avoid dose reductions of peginterferon due to decreasing platelet counts that may put patients at risk of bleeding (see Table 2).
Croatian: Tijekom antivirusnog liječenja treba po potrebi prilagođavati dozu eltrombopaga kako bi izbjegli smanjivanje doze peginterferona zbog smanjenja broja trombocita koje bi moglo bolesnicima predstavljati rizik za krvarenje (vidjeti tablicu 2).
English: • infection in the nose, sinuses, throat and upper airways, common cold (upper respiratory tract infection)
Croatian: • infekcija u nosu, sinusima, grlu i gornjim dišnim putevima, obična prehlada (infekcija gornjeg dijela dišnog sustava)
English: The safety and efficacy of eltrombopag has not been established in children and adolescents (<18 years) with chronic HCV related thrombocytopenia or SAA.
Croatian: Sigurnost i djelotvornost eltrombopaga u djece i adolescenata (<18 godina) s trombocitopenijom povezanom s kroničnim HCV-om ili teškom aplastičnom anemijom nisu ustanovljene.
English: • antacids, a type of medicine for indigestion and heartburn
Croatian: • antacide, vrstu lijekova za probavne tegobe i žgaravicu
English: In clinical studies with a TPO-R agonist in patients with MDS, cases of transient increases in blast cell counts were observed and cases of MDS disease progression to acute myeloid leukaemia (AML) were reported.
Croatian: U kliničkim ispitivanjima s TPO-R agonistima u bolesnika s MDS-om pronađeni su slučajevi s prolaznim povećanjem broja blasta te postoje izvještaji o slučajevima progresije MDS-a u akutnu mijeloičnu leukemiju (AML).
English: In the HCV studies the safety population consisted of all randomised patients who received double-blind study medicinal product during Part 2 of ENABLE 1 (Revolade treatment n=450, placebo treatment n=232) and ENABLE 2 (Revolade treatment n=506, placebo treatment n=253).
Croatian: U ispitivanjima HCV-a sigurnosnu populaciju su činili svi randomizirani bolesnici koji su primali lijek iz dvostruko slijepog ispitivanja tijekom 2. dijela ENABLE 1 (liječenje Revoladeom n=450, liječenje placebom n=232) i ENABLE 2 ispitivanja (liječenje Revoladeom n=506, liječenje placebom n=253).
English: There was substantial variability and significant overlap in exposures between patients with hepatic impairment and healthy volunteers.
Croatian: Postojala je i značajna varijabilnost i preklapanje u izloženostima između bubrežnih bolesnika i zdravih dobrovoljaca.
English: For TPO-R agonists there is a concern that they may stimulate the progression of existing haematopoietic malignancies such as MDS.
Croatian: Za agoniste TPO-R postoji zabrinutost da bi mogli stimulirati progresiju postojećih hematopoetskih zloćudnih bolesti poput MDS-a.
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation (see section 4.4).
Croatian: Bolesnike s tim karakteristikama treba pažljivo motriti zbog moguće pojave znakova i simptoma jetrene dekompenzacije (vidjeti dio 4.4).
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).
Croatian: Nisu identificirani specifični čimbenici rizika u bolesnika koji su doživjeli tromboembolijski događaj s iznimkom broja trombocita ≥200 000/µl (vidjeti dio 4.4).
English: Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration.
Croatian: Apsorbirani eltrombopag doseže vršnu koncentraciju 2-6 sati nakon peroralne primjene.
English: A dose of 100 mg eltrombopag once daily must not be exceeded.
Croatian: Ne smije se prekoračiti doza od 100 mg eltrombopaga jednom dnevno.
English: In vitro studies also demonstrated that eltrombopag is a breast cancer resistance protein (BCRP) substrate and inhibitor (IC50 value of 2.7 μM (1.2 μg/ml).
Croatian: In vitro ispitivanja su također pokazala da je eltrombopag supstrat i inhibitor proteina rezistencije raka dojke (BCRP) (IC50 vrijednost od 2,7 μM (1,2 μg/ml).
English: In the controlled clinical studies in chronic ITP with eltrombopag, increases in serum ALT, AST and bilirubin were observed (see section 4.4).
Croatian: U kontroliranim kliničkim ispitivanjima kroničnog ITP-a s eltrombopagom, opažena su povišenja serumskog ALT-a, AST-a i bilirubina (vidjeti dio 4.4).
English: Make sure the lid is not on the mixing bottle.
Croatian: Provjerite da poklopac nije na boci za miješanje.
English: Eltrombopag must not be used to normalise platelet counts.
Croatian: Eltrombopag se ne smije koristiti za normalizaciju broja trombocita.
English: • increase of liver enzymes (aspartate aminotransferase (AST))
Croatian: • porast jetrenih enzima (aspartat aminotransferaza (AST))
English: Platelet counts must be monitored weekly for 4 weeks following discontinuation of eltrombopag.
Croatian: Broj trombocita je neophodno pratiti jednom tjedno tijekom 4 tjedna nakon prestanka uzimanja eltrombopaga.
English: In case of an overdose, consideration should be given to oral administration of a metal cation-containing preparation, such as calcium, aluminium, or magnesium preparations to chelate eltrombopag and thus limit absorption.
Croatian: U slučaju predoziranja potrebno je razmotriti peroralnu primjenu preparata koji sadrže katione metala kao što su kalcij, aluminij ili magnezij, koji će kelirati eltrombopag i tako smanjiti njegovu apsorpciju.
English: Additional adverse reactions observed in paediatric studies (aged 1to 17 years).
Croatian: Dodatne nuspojave uočene u pedijatrijskim ispitivanjima (u dobi od 1 do 17 godina).
English: Cataracts were observed in toxicology studies of eltrombopag in rodents (see section 5.3).
Croatian: Pojava katarakte zamijećena je u toksikološkim studijama eltrombopaga na glodavcima (vidjeti dio 5.3).
English: Two phase III, randomised, double-blind, placebo-controlled studies RAISE (TRA102537) and TRA100773B and two open-label studies REPEAT (TRA108057) and EXTEND (TRA105325) evaluated the safety and efficacy of eltrombopag in adult patients with previously treated ITP.
Croatian: Dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III, RAISE (TRA102537) i TRA100773B, i dvije otvorene studije REPEAT (TRA108057) i EXTEND (TRA105325), procjenjivale su djelotvornost i sigurnost eltrombopaga u odraslih bolesnika s prethodno liječenim ITP-om.
English: The other ingredients are: mannitol, sucralose and xanthan gum.
Croatian: Drugi sastojicu su: manitol, sukraloza i ksantanska guma.
English: Eye examinations
Croatian: Pregled očiju
English: In both HCV studies, a significantly greater proportion of patients treated with eltrombopag (n=201, 21%) achieved SVR compared to those treated with placebo (n=65, 13%) (see Table 7).
Croatian: U oba HCV ispitivanja, značajno veći udio bolesnika koji je liječen eltrombopagom (n=201, 21%), postigao je SVR u odnosu na bolesnike koji su primali placebo (n=65, 13%) (vidjeti tablicu 7).
English: Patients with bleeding (WHO Grades 2-4) at any time during 6 months, n (%)
Croatian: Bolesnici s krvarenjem (WHO stupanj 2-4) u bilo koje vrijeme tijekom 6 mjeseci, n (%)
English: PETIT (TRA108062) was a 3-part, staggered-cohort, open-label and double-blind, randomised, placebo-controlled study.
Croatian: PETIT (TRA108062) je bilo ispitivanje od tri dijela, raspoređena kohorta, otvoreno i dvostruko slijepo, randomizirano, placebom kontrolirano.
English: Following discontinuation of eltrombopag, platelet counts return to baseline levels within 2 weeks in the majority of patients, which increases the bleeding risk and in some cases may lead to bleeding.
Croatian: Nakon prekida, u većine bolesnika broj trombocita se vraća na početnu razinu unutar 2 tjedna, što povećava rizik od krvarenja, a u nekim slučajevima može dovesti i do manifestnog krvarenja.
English: During therapy with eltrombopag full blood counts (FBCs), including platelet count and peripheral blood smears, should be assessed weekly until a stable platelet count (≥50,000/µl for at least 4 weeks) has been achieved.
Croatian: Tijekom liječenja eltrombopagom, kompletnu krvnu sliku (KKS), uključujući i broj trombocita i razmaz periferne krvi, treba kontrolirati jednom tjedno do postizanja stabilnog broja trombocita (≥50 000/µl tijekom barem 4 tjedna).
English: Revolade 12.5 mg, 25 mg, 50 mg and 75 mg film-coated tablets:
Croatian: Revolade 12,5 mg, 25 mg, 50 mg i 75 mg filmom obložene tablete:
English: You may be at higher risk of blood clots: as you get older if you have had to stay in bed for a long time if you have cancer if you are taking the contraceptive birth control pill or hormone replacement therapy if you have recently had surgery or received a physical injury if you are very overweight (obese) if you are a smoker if you have advanced chronic liver disease If any of these apply to you, tell your doctor before starting treatment.
Croatian: Rizik od krvnih ugrušaka povećava se: što ste stariji ako ste morali duže vrijeme boraviti u krevetu ako bolujete od raka ako uzimate oralne kontraceptive ili hormonsko nadomjesno liječenje ako ste nedavno bili operirani ili ste se ozlijedili ako imate povećanu tjelesnu težinu (pretilost) ako ste pušač ako imate uznapredovalu kroničnu bolest jetre Recite liječniku prije nego započnete liječenje ako mislite da se nešto od navedenog odnosi na Vas.
English: • increased levels of liver enzymes (aspartate aminotransferase (AST))
Croatian: • povećane razine jetrenih enzima (aspartat aminotransferaza (AST))
English: Eltrombopag may increase the risk for development or progression of reticulin fibres within the bone marrow.
Croatian: Eltrombopag može povisiti rizik od razvoja ili progresivnog umnažanja retikulinskih niti u koštanoj srži.
English: Initial dose regimen
Croatian: Početni režim doziranja
English: There are no findings in juvenile rats to suggest a greater risk of toxicity with eltrombopag treatment in paediatric vs. adult ITP patients.
Croatian: Nema nalaza u juvenilnih štakora koji bi upućivali na veći rizik od toksičnosti uz liječenje eltrombopagom u pedijatrijskih u odnosu na odrasle bolesnike s ITP-om.
English: Absorption and bioavailability
Croatian: Apsorpcija i bioraspoloživost
English: In clinical studies with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
Croatian: U kliničkim ispitivanjima s eltrombopagom kod teške aplastične anemije, u 4% bolesnika (5/133) dijagnosticiran je MDS.
English: The risk of TEEs has been found to be increased in patients with chronic liver disease (CLD) treated with 75 mg eltrombopag once daily for 2 weeks in preparation for invasive procedures.
Croatian: Nađen je povećani rizik za TED kod bolesnika s kroničnom bolešću jetre liječenih dozom od 75 mg eltrombopaga jednom na dan tijekom 2 tjedna priprema za invazivne zahvate.
English: The safety of Revolade was assessed using the pooled double-blind, placebo-controlled studies TRA100773A and B, TRA102537 (RAISE) and TRA113765, in which 403 patients were exposed to Revolade and 179 to placebo, in addition to data from the completed open-label studies TRA108057, TRA105325 (EXTEND) and TRA112940.
Croatian: Sigurnost Revoladea procijenjena je pomoću udruženih dvostruko slijepih, placebom kontroliranih ispitivanja TRA100773A i B, TRA102537 (RAISE) i TRA113765, u kojima su 403 bolesnika bila izložena Revoladeu i 179 placebu, uz podatke iz završenih otvorenih ispitivanja TRA108057, TRA105325 (EXTEND) i TRA112940.
English: Side effects with frequency not known Frequency cannot be estimated from the available data
Croatian: Učestalost se ne može procijeniti iz dostupnih podataka
English: Co-administration of a single dose of eltrombopag 200 mg with boceprevir 800 mg every 8 hours did not alter plasma boceprevir AUC(0-), but increased Cmax by 20%, and decreased Cmin by 32%.
Croatian: Istodobna primjena jedne doze eltrombopaga od 200 mg s boceprevirom u dozi od 800 mg svakih 8 sati nije promijenila AUC(0-) boceprevira u plazmi, ali mu je povećala Cmax za 20% i smanjila Cmin za 32%.
English: In RAISE and TRA100773B studies, in the subgroup of ITP patients with baseline platelet count ≤15,000/μl the median platelet counts did not reach the target level (>50,000/l), although in both studies 43% of these patients treated with eltrombopag responded after 6 weeks of treatment.
Croatian: U ispitivanjima RAISE i TRA100773B, u podgrupi bolesnika s ITP-om s početnim brojem trombocita ≤15 000/μl, medijan broja trombocita nije dosegao ciljnu vrijednost (>50 000/l), iako je u obje studije 43% od bolesnika liječenih eltrombopagom odgovorilo na liječenje nakon 6 tjedana.
English: Eltrombopag is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease in preparation for invasive procedures.
Croatian: Eltrombopag nije indiciran za liječenje trombocitopenije u bolesnika s kroničnom bolešću jetre kao priprema za invazivne postupke.
English: The risk-benefit balance should be considered in patients at risk of TEEs of any aetiology.
Croatian: Treba razmotriti omjer rizika i koristi kod bolesnika koji imaju povećani rizik za TED-ove bilo koje etiologije.
English: At baseline the median platelet count was 20,000/µl, haemoglobin was 8.4 g/dl, ANC was 0.58 x 10
Croatian: Na početku je medijan broja trombocita bio 20 000/μl, hemoglobin je bio 8,4 g/dl, ABN je bio 0,58 x 10
English: At baseline, 71% of patients in the eltrombopag group and 69% in the placebo group reported any bleeding (WHO Grades 1-4).
Croatian: Na početku je 71% bolesnika u eltrombopag skupini te 69% u placebo skupini prijavilo bilo kakvo krvarenje (WHO stupanj 1-4).
English: When treatment is considered appropriate, caution is required when administering eltrombopag to patients with hepatic impairment (see sections 4.2 and 4.8).
Croatian: Kada se liječenje smatra prikladnim, potreban je oprez kod primjene eltrombopaga kod bolesnika s oštećenjem jetre (vidjeti dijelove 4.2 i 4.8).
English: If you forget to take Revolade Take the next dose at the usual time.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: The other ingredients are: hypromellose, macrogol 400, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, titanium dioxide (E171).
Croatian: Drugi sastojci su: hipromeloza, makrogol 400, magnezijev stearat, manitol (E421), mikrokristalična celuloza, povidon, natrijev škroboglikolat, titanijev dioksid (E171).