FrancophonIA/ELRC3.0 huggingface dataset:
English: Following discontinuation of therapy, patients should be monitored for any signs or symptoms of gastrointestinal bleeding.
Croatian: Nakon prestanka liječenja bolesnike treba pratiti zbog moguće pojave znakova ili simptoma krvarenja u probavnom sustavu.
English: At non-tolerated doses in pre-weaning rats, ocular opacities were observed.
Croatian: U štakora prije odbijanja od sise, pri dozama koje se ne podnose dobro bili su uočeni opaciteti oka.
English: Eltrombopag dosing requirements must be individualised based on the patient's platelet counts.
Croatian: Režim doziranja eltrombopaga mora biti individualiziran i temeljen na broju trombocita svakog pojedinog bolesnika.
English: Table 9 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in patients with chronic HCV
Croatian: Tablica 9 Geometrijska srednja vrijednost (95% CI) stanja dinamičke ravnoteže farmakokinetičkih parametara eltrombopaga u plazmi u bolesnika s kroničnim HCV-om
English: • abdominal (stomach) pain, enlarged abdomen, blood in your stools.
Croatian: • bol u abdomenu (trbuhu), povećan opseg trbuha, krv u stolici.
English: In addition, the benefits of treatment in terms of the proportion achieving SVR compared with placebo were modest in these patients (especially for those with baseline albumin ≤35 g/l) compared with the group overall.
Croatian: Dodatno, koristi od liječenja prema udjelu postignutog SVR-a u tih bolesnika su bile skromne u usporedbi s placebom (pogotovo za one čija je početna vrijednost albumina ≤35 g/l) kada je uspoređeno s cijelom skupinom.
English: For patients taking 25 mg once daily, increase the dose to 50 mg daily before increasing the dose amount by 50 mg.
Croatian: Za bolesnike koji uzimaju 25 mg jednom dnevno, povećati dozu na 50 mg dnevno prije povećanja doze za 50 mg.
English: • unusual hair loss
Croatian: • neuobičajena boja mokraće
English: AUC(0-) and Cmax based on population PK post-hoc estimates
Croatian: AUC(0-) i Cmax temeljeni na post-hoc procjenama populacijske farmakokinetike
English: All patients initiated treatment with eltrombopag 50 mg. From Day 29 to the end of treatment, 15 to 28% of eltrombopag treated patients were maintained on ≤25 mg and 29 to 53% received 75 mg.
Croatian: Od 29. dana do kraja liječenja 15 do 28% bolesnika koji su primali eltrombopag bilo je na dozi održavanja ≤25 mg, a 29 do 53% je primalo 75 mg.
English: The co-administration of 600 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 39% and 24%, respectively.
Croatian: Istodobna primjena 600 mg ciklosporina smanjila je Cmax eltrombopaga za 39% i AUCinf eltrombopaga za 24%.
English: • weakness (asthenia)
Croatian: • slabost (astenija)
English: Patients with these characteristics should be closely monitored for signs and symptoms of hepatic decompensation.
Croatian: Bolesnike s takvim parametrima treba pozorno pratiti zbog moguće pojave znakova i simptoma dekompenzacije jetre.
English: ♦ For patients taking 25 mg eltrombopag once daily, consideration should be given to dosing at 12.5 mg once daily or alternatively a dose of 25 mg once every other day.
Croatian: ♦ Za bolesnike koji uzimaju 25 mg eltrombopaga jednom dnevno, potrebno je razmotriti primjenu 12,5 mg jednom dnevno ili dozu od 25 mg svaki drugi dan.
English: * For patients taking 25 mg eltrombopag once daily, consideration should be given to reinitiating dosing at 25 mg every other day.
Croatian: * U bolesnika koji uzimaju 25 mg eltrombopaga jednom dnevno, treba razmotriti ponovno uvođenje liječenja dozom od 25 mg svakog drugog dana.
English: • digestive system problems, including being sick (vomiting), stomach pain, indigestion,
Croatian: • problemi probavnog sustava, uključujući povraćanje, bol u želucu, probavne tegobe, zatvor,
English: In HCV clinical studies, a higher incidence of gastrointestinal bleeding, including serious and fatal cases, was reported following discontinuation of peginterferon, ribavirin, and eltrombopag.
Croatian: U kliničkim ispitivanjima HCV-a, nakon prestanka uzimanja peginterferona, ribavirina i eltrombopaga ustanovljena je povećana incidencija krvarenja iz probavnog sustava, uključujući ozbiljne i slučajeve opasne po život.
English: In 2 controlled clinical studies in patients with HCV, ALT or AST 3 x ULN was reported in 34% and 38% of the eltrombopag and placebo groups, respectively.
Croatian: U 2 kontrolirana klinička ispitivanja u bolesnika s HCV-om, povišenje ALT-a ili AST-a od 3 x GGN bilo je prijavljeno u 34% slučajeva u eltrombopag skupini i 38% slučajeva u placebo skupini.
English: Common side effects that may show up in the blood tests
Croatian: Česte nuspojave koje se mogu vidjeti u krvnim pretragama
English: For patients with HCV initiate eltrombopag at a dose of 25 mg once daily (see section 4.2).
Croatian: Za bolesnike sa HCV-om treba započeti terapiju eltrombopagom dozom od 25 mg jednom dnevno (vidjeti dio 4.2).
English: No dosage adjustment is necessary for HCV patients of Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s HCV-om azijskog podrijetla ili bolesnika s blagim oštećenjem jetre (vidjeti dio 5.2).
English: Each pack contains 30 sachets, one 40 ml reusable mixing bottle with lid and cap, and 30 single-use oral dosing syringes.
Croatian: Jedno pakiranje sadrži 30 vrećica, jednu bočicu za miješanje od 40 ml za višekratnu uporabu s poklopcem i zatvaračem, te 30 dozirnih štrcaljki za usta za jednokratnu uporabu.
English: Factor V Leiden) or acquired risk factors (e.g. ATIII deficiency, antiphospholipid syndrome), advanced age, patients with prolonged periods of immobilisation, malignancies, contraceptives and hormone replacement therapy, surgery/trauma, obesity and smoking.
Croatian: Oprez je potreban ako se eltrombopag primjenjuje bolesnicima s već poznatim visokim rizikom za nastanak TED uključujući nasljedne (npr. faktor V Leiden) ili stečene čimbenike rizika (npr. nedostatak AT III, antifosfolipidni sindrom), visoku dob, dugotrajnu imobilizaciju, zloćudne bolesti, primjenu oralnih kontraceptiva ili hormonskog nadomjesnog liječenja, operativni zahvat, traumu, pretilost i pušenje.
English: The pharmacokinetics of eltrombopag have been studied after administration of eltrombopag to adult patients with hepatic impairment.
Croatian: Farmakokinetika eltrombopaga proučavana je nakon primjene eltrombopaga odraslim bolesnicima s jetrenim oštećenjem.
English: Tablet coating Hypromellose (E464) Macrogol 400 (E1521) Polysorbate 80 (E433) Titanium dioxide (E171)
Croatian: Ovojnica tablete hipromeloza (E464) makrogol 400 (E1521) polisorbat 80 (E433) titanijev dioksid (E171)
English: • scissors to cut sachet (not supplied)
Croatian: • škare za otvaranje vrećice (nije u kompletu)
English: Mannitol (E421) Sucralose Xanthan gum
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) sukraloza ksantanska guma
English: No dosage adjustment is necessary for HCV patients of East Asian ancestry or patients with mild hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s HCV-om istočnoazijskog podrijetla ili bolesnika s blagim oštećenjem jetre (vidjeti dio 5.2).
English: For patients of Asian ancestry (such as Chinese, Japanese, Taiwanese, Korean or Thai), including those with hepatic impairment, eltrombopag should be initiated at a dose of 25 mg once daily (see section 5.2).
Croatian: U bolesnika azijskog podrijetla (npr. Kinezi, Japanci, Tajvanci, Korejci ili Tajlanđani), uključujući i onih s oštećenjem jetre, liječenje eltrombopagom treba započeti u dozi od 25 mg jednom dnevno (vidjeti dio 5.2).
English: • 25 mg dose - 1 sachet
Croatian: • Doza od 25 mg - 1 vrećica
English: In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) was reported more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
Croatian: U 2 kontrolirana klinička ispitivanja trombocitopeničnih bolesnika s HCV-om, jetrena dekompenzacija (ascites, jetrena encefalopatija, krvarenje iz varikoziteta, spontani bakterijski peritonitis) je češće prijavljena u skupini s eltrombopagom (11%) nego u skupini s placebom (6%).
English: Discontinuation
Croatian: Odlaganje
English: Administration of a single 25 mg dose of eltrombopag as powder for oral suspension with a highcalcium, moderate-fat and moderate-calorie meal reduced plasma eltrombopag mean AUC0-∞ by 75% and mean Cmax by 79%.
Croatian: Primjena jedne doze od 25 mg eltrombopaga u obliku praška za oralnu suspenziju uz obrok s visokim udjelom kalcija, umjerenim udjelom masnoća i umjerenom kalorijskom vrijednošću, smanjila je srednji plazmatski AUC0-∞ eltrombopaga za 75% i srednji Cmax za 79%.
English: If you are taking interferon-based treatments together with Revolade you will be monitored for any signs of bleeding in your stomach or intestine after you stop taking Revolade.
Croatian: Provjera na krvarenje u probavnom sustavu Ako s lijekom Revolade uzimate lijekove koji sadrže interferon, nakon što prestanete uzimati Revolade promatrati će Vas se radi pojave bilo kojeg znaka krvarenja u želucu ili crijevima.
English: The dose of eltrombopag could be adjusted based on individual platelet counts.
Croatian: Doza eltrombopaga mogla se prilagođavati na temelju pojedinačnog broja trombocita.
English: Across the 3 placebo-controlled studies in adults with chronic ITP, 1 patient in the placebo group and 1 patient in the eltrombopag group experienced a Grade 4 liver test abnormality.
Croatian: U preko 3 placebom kontrolirana ispitivanja u odraslih s kroničnim ITP-om, abnormalnost jetrenog testa 4. stupnja doživjeli su 1 bolesnik u placebo skupini i 1 bolesnik u eltrombopag skupini.
English: Haematologic malignancies
Croatian: Hematološke zloćudne bolesti
English: Five of the 6 patients treated with eltrombopag experienced the TEE at a platelet count >200,000/µl.
Croatian: Pet od 6 bolesnika liječenih eltrombopagom doživjelo je tromboembolijski događaj pri broju trombocita >200 000/µl.
English: Eltrombopag should be initiated at a dose of 50 mg once daily.
Croatian: Liječenje eltrombopagom potrebno je započeti dozom od 50 mg jednom dnevno.
English: Asian paediatric ITP patients had approximately 43% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients.
Croatian: Azijski pedijatrijski bolesnici s ITP-om imali su otprilike 43% više vrijednosti plazmatskog AUC(0-) eltrombopaga u usporedbi s ne-azijskim bolesnicima.
English: When co-administered with eltrombopag, a reduced dose of statins should be considered and careful monitoring for statin adverse reactions should be undertaken (see section 5.2).
Croatian: Ako se statini primjenjuju istodobno s eltrombopagom, treba razmotriti smanjenje doze statina uz praćenje eventualne pojave nuspojava statina (vidjeti dio 5.2).
English: Six of 143 (4%) adult patients with CLD receiving eltrombopag experienced TEEs (all of the portal venous system) and 2 of 145 (1%) patients in the placebo group experienced TEEs (one in the portal venous system and one myocardial infarction).
Croatian: TED je doživjelo šest od 143 (4%) odraslih bolesnika s kroničnom bolešću jetre koji su primali eltrombopag (svi u sustavu vene porte), te 2 od 145 (1%) bolesnika u grupi s placebom (jedan u sustavu vene porte i jedan infarkt miokarda).
English: It is recommended that, if treatment with eltrombopag is discontinued, ITP treatment be restarted according to current treatment guidelines.
Croatian: Preporučuje se da se po prestanku liječenja eltrombopagom nastavi liječenje ITP-a prema važećim smjernicama za liječenje ove bolesti.
English: Cytogenetic abnormalities
Croatian: Citogenetske abnormalnosti
English: Tapering for tri-lineage (white blood cells, red blood cells, and platelets) responders For patients who achieve tri-lineage response, including transfusion independence, lasting at least 8 weeks: the dose of eltrombopag may be reduced by 50%.
Croatian: Kod bolesnika koji postignu odgovor u sve tri loze, uključujući transfuzijsku neovisnost, koji traje najmanje 8 tjedana: doza eltrombopaga može se smanjiti za 50%.
English: In 2 controlled clinical studies in thrombocytopenic patients with HCV, hepatic decompensation (ascites, hepatic encephalopathy, variceal haemorrhage, spontaneous bacterial peritonitis) occurred more frequently in the eltrombopag arm (11%) than in the placebo arm (6%).
Croatian: U 2 kontrolirana klinička ispitivanja trombocitopeničnih bolesnika s HCV-om, dekompenzacija jetre (ascites, hepatička encefalopatija, krvarenje iz varikoziteta, spontani bakterijski peritonitis) pojavila se češće u skupini koja je primala eltrombopag (11%) nego u skupini koja je primala placebo (6%).
English: After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 2 weeks should be observed before increasing the dose.
Croatian: Nakon započinjanja liječenja eltrombopagom u bolesnika s oštećenjem jetre, bolesnika je potrebno pratiti u razdoblju od 2 tjedna prije povećavanja doze.
English: Patients should be closely monitored for signs and symptoms of TEE.
Croatian: Bolesnike treba pažljivo pratiti zbog moguće pojave znakova i simptoma TED.
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije manje često opekline od sunca
English: Also there was no effect on embryofoetal development in rabbits at doses up to 150 mg/kg/day, the highest dose tested (0.3 to 0.5 times the human clinical exposure in ITP patients at 75 mg/day and HCV patients at 100 mg/day, based on AUC).
Croatian: Također nije bilo učinka na embriofetalni razvoj zečeva u dozama do 150 mg/kg/dan, najvišoj testiranoj dozi (0,3 do 0,5 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i bolesnika s HCV-om pri dozi od 100 mg/dan,temeljeno na AUC).
English: Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets
Croatian: Revolade 12,5 mg filmom obložene tablete Revolade 25 mg filmom obložene tablete Revolade 50 mg filmom obložene tablete Revolade 75 mg filmom obložene tablete
English: FBCs including platelet counts and peripheral blood smears should be obtained monthly thereafter.
Croatian: Nakon toga, KKS uključujući broj trombocita, te razmaz periferne krvi treba kontrolirati jednom mjesečno.
English: At poorly tolerated doses in rats and dogs (>10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and>4 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC), decreased reticulocyte counts and regenerative bone marrow erythroid hyperplasia (rats only) were observed in short-term studies.
Croatian: U slabo podnošljivim dozama u štakora i pasa (>10 ili 7 puta kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i >4 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjereno AUC-om) zabilježeni su smanjen broj retikulocita i regenerativna eritroidna hiperplazija koštane srži (samo u štakora) tijekom kratkoročnih studija.
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo) (see section 4.4).
Croatian: Tromboza portalne vene bio je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na < 1% za placebo) (vidjeti dio 4.4).
English: Chronic hepatitis C associated thrombocytopenia studies
Croatian: Ispitivanja kroničnog hepatitisa C povezanog s trombocitopenijom
English: • increase in bilirubin (a substance produced by the liver)
Croatian: • povišeni bilirubin (tvar koju proizvodi jetra)
English: It is not known whether eltrombopag increases the risk of cytogenetic abnormalities in patients with SAA.
Croatian: Nije poznato povećava li eltrombopag rizik od citogenetskih abnormalnosti u bolesnika s teškom aplastičnom anemijom.
English: Common Sleep disorder, depression Uncommon Apathy, mood altered, tearfulness
Croatian: Psihijatrijski poremećaji često poremećaji spavanja, depresija manje često apatija, promjene raspoloženja, plačljivost
English: • joint pain, back pain, bone pain, pain in the hands or feet, muscle spasms
Croatian: • bol u zglobovima, leđima, kostima, rukama ili nogama, grčevi u mišićima
English: • swelling, pain, heat, redness, or tenderness in one leg
Croatian: • oticanja, boli, vrućine, crvenila ili osjetljivosti jedne noge
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus <1% for placebo).
Croatian: Tromboza portalne vene bila je najčešći TED u obje terapijske skupine (2% u bolesnika koji su primali eltrombopag u odnosu na <1% za placebo).
English: The following side effects have been reported to be associated with treatment with Revolade in patients with severe aplastic anaemia (SAA):
Croatian: Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u bolesnika s teškom aplastičnom anemijom:
English: 5.2 Pharmacokinetic properties
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika
English: Eltrombopag should be initiated at a dose of 25 mg once daily.
Croatian: Liječenje eltrombopagom treba započeti dozom od 25 mg jednom dnevno.
English: Caution is required when administering eltrombopag to patients with hepatic disease.
Croatian: Potreban je oprez kod primjene eltrombopaga u bolesnika s bolešću jetre.
English: The most common adverse reactions in paediatric ITP patients 1 year and older (≥3% and greater than placebo) were upper respiratory tract infection, nasopharyngitis, cough, pyrexia, abdominal pain, oropharyngeal pain, toothache and rhinorrhoea.
Croatian: Najčešće nuspojave u pedijatrijskih bolesnika s ITP-om u dobi od 1 i više godina (≥ 3% i više od placeba) bile su infekcija gornjeg dijela dišnog sustava, nazofaringitis, kašalj, pireksija, bol u abdomenu, orofaringealna bol, zubobolja i rinoreja.
English: How to store Revolade
Croatian: Kako čuvati Revolade
English: The most common adverse reactions occurring in at least 10% of patients included headache, anaemia, decreased appetite, cough, nausea, diarrhoea, hyperbilirubinaemia, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza-like illness, asthenia, chills and oedema.
Croatian: Najčešće nuspojave koje su se pojavile u najmanje 10% bolesnika uključivale su glavobolju, anemiju, smanjeni apetit, kašalj, mučninu, proljev, hiperbilirubinemiju, alopeciju, svrbež, mialgiju, pireksiju, umor, bolest sličnu gripi, asteniju, zimicu i edeme.
English: The reoccurrence of thrombocytopenia is possible upon discontinuation of treatment (see section 4.4).
Croatian: Moguća je pojava trombocitopenije nakon prestanka liječenja (vidjeti dio 4.4).
English: The long-term safety of eltrombopag should be considered prior to starting therapy.
Croatian: Prije uvođenja terapije treba razmotriti dogotrajnu sigurnost eltrombopaga.
English: The most common adverse reactions occurring in at least 10% of patients included headache, dizziness, cough, oropharyngeal pain, nausea, diarrhoea, abdominal pain, transaminases increased, arthralgia, pain in extremity, fatigue and pyrexia.
Croatian: Najčešće nuspojave koje su se pojavile u najmanje 10% bolesnika uključivale su glavobolju, omaglicu, kašalj, orofaringealnu bol, mučninu, proljev, bol u abdomenu, porast transaminaza, artralgiju, bol u ekstremitetima, umor, i pireksiju.
English: There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy (see sections 4.4 and 4.8).
Croatian: U trombocitopeničnih bolesnika s uznapredovalom kroničnom bolešću jetre koji su na liječenju eltrombopagom, bilo tijekom priprema za invazivne zahvate ili u bolesnika s HCV-om na antivirusnom liječenju, postoji povišen rizik od štetnih događaja, uključujući dekompenzaciju jetre i tromboembolijske događaje (vidjeti dijelove 4.4 i 4.8).
English: Based on estimates from the population pharmacokinetic analysis, female ITP patients had approximately 23% higher plasma eltrombopag AUC(0-) as compared to male patients, without adjustment for body weight differences.
Croatian: Na temelju procjena iz spomenute analize, žene s ITP-om imale su otprilike 23% više plazmatske vrijednosti AUC(0-) eltrombopaga u odnosu na muškarce, a bez prilagođavanja obzirom na tjelesnu težinu.
English: Increase daily dose by 25 mg to a maximum of 100 mg/day.
Croatian: Povećati dnevnu dozu za 25 mg do maksimalno 100 mg/dan.
English: †, dysuria
Croatian: †, dizurija
English: Other liver problems (bile not flowing properly) are uncommon and may affect up to 1 in 100 people.
Croatian: Ostale jetrene tegobe (otežan protok žuči) su manje česte nuspojave koje se mogu javiti u do 1 na 100 osoba.
English: The suspension should be taken at least two hours before or four hours after any products such as antacids, dairy products (or other calcium containing food products), or mineral supplements containing polyvalent cations (e.g. iron, calcium, magnesium, aluminium, selenium and zinc) (see sections 4.5 and 5.2).
Croatian: Suspenziju treba uzeti barem dva sata prije ili četiri sata nakon bilo kojeg pripravka kao što su antacidi, mliječni proizvodi (ili druge vrste hrane koje sadrže kalcij), nadomjesni preparati minerala koji sadrže polivalentne katione (npr. željezo, kalcij, magnezij, aluminij, selen i cink) (vidjeti dijelove 4.5 i 5.2).
English: Signs of bone marrow changes may show up as abnormal results in your blood tests.
Croatian: Znakovi promjena na koštanoj srži mogu se očitovati kao poremećeni rezultati krvnih pretraga.
English: However, at a maternally toxic dose of 60 mg/kg/day (6 times the human clinical exposure in ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) in rats, eltrombopag treatment was associated with embryo lethality (increased preand post-implantation loss), reduced foetal body weight and gravid uterine weight in the female fertility study and a low incidence of cervical ribs and reduced foetal body weight in the embryofoetal development study.
Croatian: Međutim pri dozama toksičnim za ženku štakora od 60 mg/kg/dan (6 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i 3 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan temeljeno na AUC), primjena eltrombopaga je bila povezana s letalitetom embrija (povišeni pre- i post-implantacijski gubitak), smanjenjem fetalne tjelesne težine i težine gravidnog uterusa u studiji plodnosti ženki te niskom incidencijom cervikalnih rebara i smanjenjem fetalne tjelesne težine u studijama embriofetalnog razvoja.
English: A total of 114 patients with previously treated ITP were randomised 2:1 eltrombopag (n=76) to placebo (n=38).
Croatian: Ukupno 114 bolesnika s prethodno liječenim ITP-om randomizirano je u omjeru 2:1, u skupinu koja je dobivala eltrombopag (n=76) i skupinu koja je dobivala placebo (n=38).
English: After initiating the dose of eltrombopag in patients with hepatic impairment an interval of 3 weeks should be observed before increasing the dose.
Croatian: Nakon uvođenja svake nove doze u bolesnika s oštećenjem jetre, bolesnika je potrebno pratiti u razdoblju od 3 tjedna prije povećavanja doze.
English: Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets eltrombopag
Croatian: Revolade 12,5 mg filmom obložene tablete Revolade 25 mg filmom obložene tablete Revolade 50 mg filmom obložene tablete Revolade 75 mg filmom obložene tablete eltrombopag
English: Common Iron overload, decreased appetite, hypoglycaemia, increased appetite
Croatian: Poremećaji metabolizma i prehrane često preopterećenje željezom, smanjeni apetit, hipoglikemija, povećani apetit
English: • 1 single-use oral dosing syringe (supplied in the kit)
Croatian: • 1 dozirna štrcaljka za usta za jednokratnu uporabu (nalazi se u kompletu)