FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8 Geometric mean (95% confidence intervals) of steady-state plasma eltrombopag pharmacokinetic parameters in adults with ITP
Croatian: Tablica 8 Geometrijska srednja vrijednost (95%-ni interval pouzdanosti) farmakokinetskih parametara eltrombopaga u stanju dinamičke ravnoteže, za odrasle osobe s ITP-om doza eltrombopaga, jednom dnevno
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag and 6 out of 484 patients (1%) in the placebo group experienced thromboembolic events (TEEs).
Croatian: U kontroliranim ispitivanjima bolesnika s trombocitopenijom i HCV-om koji su primali terapiju temeljenu na interferonu (n=1439), 38 od 955 bolesnika (4%) koji su primali eltrombopag, te 6 od 484 bolesnika (1%) u grupi s placebom imalo je tromboembolijske događaje (TED).
English: Based on estimates from the population pharmacokinetic analysis, Asian ITP patients had approximately 49% higher plasma eltrombopag AUC(0-) values as compared to non-Asian patients who were predominantly Caucasian (see section 4.2).
Croatian: Na temelju procjena iz spomenute analize azijski bolesnici s ITP-om, imali su otprilike 49% više plazmatske vrijednosti AUC(0-) eltrombopaga u odnosu na ne-azijske bolesnike pretežno bijele rase (vidjeti dio 4.2).
English: Immune (primary) thrombocytopenia
Croatian: Imunosna (primarna) trombocitopenija
English: There were no effects of note on red cell mass or reticulocyte counts after dosing for up to 28 weeks in rats, 52 weeks in dogs and 2 years in mice or rats at maximally tolerated doses which were 2 to 4 times human clinical exposure in adult or paediatric ITP patients at 75 mg/day and ≤2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Croatian: Nije bilo značajnijih učinaka na ukupan broj crvenih krvnih stanica ili broj retikulocita nakon primjene lijeka do 28 tjedana u štakora, 52 tjedna u pasa ili 2 godine u miševa ili štakora, u maksimalnim toleriranim dozama koje su bile 2-4 puta više od kliničke izloženosti u odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i ≤2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjerene AUC-om.
English: Common Pyrexia*, chest pain, asthenia *Very common in paediatric ITP Uncommon Feeling hot, vessel puncture site haemorrhage, feeling jittery, inflammation of wound, malaise, sensation of foreign body
Croatian: Opći poremećaji i reakcije na mjestu primjene često pireksija*, bol u prsištu, astenija *Vrlo često kod pedijatrijskog ITP-a manje često osjećaj vrućine, krvarenje na mjestu uboda iglom, osjećaj nervoze, upala rane, malaksalost, osjećaj stranog tijela
English: However blood clots can also form with normal or even low platelet counts.
Croatian: Međutim oni mogu nastati i kad je broj trombocita snižen ili normalan.
English: ≥50,000/µl to ≤100,000/µl
Croatian: 50 000/µl do 100 000/µl
English: Eltrombopag did not affect male fertility in rats at doses up to 40 mg/kg/day, the highest dose tested (3 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Croatian: Eltrombopag nije utjecao na plodnost mužjaka štakora u dozama do 40 mg/kg/dan, najvišoj testiranoj dozi (3 puta veća od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC).
English: Contact a doctor or pharmacist immediately.
Croatian: Vaš liječnik ili ljekarnik.
English: There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels ≤35 g/l or model for end stage liver disease (MELD) score ≥10, when treated with eltrombopag in combination with interferon-based therapy.
Croatian: U trombocitopeničnih bolesnika s HCV-om s uznapredovalom kroničnom bolešću jetre definiranom niskim razinama albumina ≤35 g/l ili indeksom modela završne faze bolesti jetre (MELD) ≥10, pri liječenju eltrombopagom u kombinaciji s terapijom temeljenoj na interferonima postoji povećan rizik od razvoja nuspojava, uključujući i potencijalno letalnu dekompenzaciju jetre i tromboembolijske događaje.
English: >100,000/µl to ≤150,000/µl
Croatian: >100 000/µl do 150 000/µl
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is two 25 mg sachets of Revolade a day.
Croatian: Odrasli i djeca (6 do 17 godina) - uobičajena početna doza za ITP su dvije vrećice lijeka Revolade od 25 mg na dan.
English: The longest RBC transfusion-free period for non-responders was 29 days (median).
Croatian: Najduže razdoblje bez transfuzije eritrocita za bolesnike bez odgovora bilo je 29 dana (medijan).
English: Platelet count response between 50,000-400,000/l in the absence of rescue treatment was achieved by significantly more patients in the eltrombopag treated group during the 6 month treatment period, p <0.001.
Croatian: Tijekom 6 mjeseci liječenja, u značajno većeg broja bolesnika koji su primali eltrombopag je postignut odgovor na liječenje s brojem trombocita između 50 000 i 400 000/l, bez dodatnog (rescue) liječenja, p <0,001.
English: In addition, a screw cap (ethylene vinyl acetate / LDPE) with syringeport capability is provided.
Croatian: Uz to, priložen je zatvarač s navojem (etilenvinilacetat / LDPE) u koji se može umetnuti štrcaljka.
English: Revolade 12.5 mg film-coated tablets
Croatian: Revolade 12,5 mg filmom obložene tablete
English: Eltrombopag did not affect female fertility, early embryonic development or embryofoetal development in rats at doses up to 20 mg/kg/day (2 times the human clinical exposure in adult or adolescent (12-17 years old) ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Croatian: Eltrombopag nije utjecao na plodnost ženki, rani embrionalni razvoj ili embriofetalni razvoj štakora u dozama do 20 mg/kg/dan (2 puta veća od kliničke izloženosti odraslih bolesnika ili adolescenata (u dobi od 12 do 17 godina) s ITP-om pri dozi od 75 mg/dan i ekvivalent kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC).
English: Revolade 12.5 mg film-coated tablets eltrombopag
Croatian: Revolade 12,5 mg filmom obložene tablete eltrombopag
English: Revolade 75 mg film-coated tablets EU/1/10/612/007
Croatian: Revolade 75 mg filmom obložene tablete EU/1/10/612/007
English: Liver enzymes measured between Days 2 and 18 after ingestion peaked at a 1.6-fold ULN in AST, a 3.9-fold ULN in ALT, and a 2.4-fold ULN in total bilirubin, The platelet counts were 672,000/µl on Day 18 after ingestion and the maximum platelet count was 929,000/µl.
Croatian: Broj trombocita je 18. dana nakon ingestije iznosio 672 000/µl, a najviši izmjereni broj trombocita je bio 929 000/µl.
English: What Revolade looks like and contents of the pack Revolade 12.5 mg film-coated tablets are round, biconvex, white, debossed with ‘GS MZ1' and ‘12.5' on one side.
Croatian: Revolade 12,5 mg filmom obložene tablete su okrugle, bikonveksne, bijele tablete s utisnutim oznakama „GS MZ1“ i „12,5“ na jednoj strani.
English: Pink, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS FFS' and ‘75' on one side.
Croatian: Ružičasta, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 10,3 mm) s utisnutim oznakama „GS FFS“ i „75“ na jednoj strani.
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 50 mg.
Croatian: Kada broj trombocita bude opet ≤100 000/µl, ponovo započeti liječenje eltrombopagom u dnevnoj dozi smanjenoj za 50 mg.
English: Common Myalgia, muscle spasm, musculoskeletal pain, bone pain, back pain Uncommon Muscular weakness Renal and urinary disorders Common Proteinuria, blood creatinine increased, thrombotic microangiopathy with renal failure Uncommon Renal failure, leukocyturia, lupus nephritis, nocturia, blood urea increased, urine protein/creatinine ratio increased
Croatian: Poremećaji bubrega i mokraćnog sustava često proteinurija, porast kreatinina u krvi, trombotična mikroangiopatija sa zatajenjem bubrega manje često zatajenje bubrega, leukociturija, lupusni nefritis, nokturija, porast ureje u krvi, povišen omjer protein/kreatinin u urinu
English: Thrombocytopenia is likely to reoccur in ITP patients upon discontinuation of treatment with eltrombopag.
Croatian: Nakon prekida liječenja eltrombopagom u bolesnika s ITP-om najvjerojatnije će se ponovo javiti trombocitopenija.
English: Thrombocytopenia following discontinuation of treatment
Croatian: Trombocitopenija nakon prekida liječenja
English: If you are taking interferon-based treatments together with Revolade to treat low platelet count due to hepatitis C, some liver problems can get worse.
Croatian: Neki problemi s jetrom se mogu pogoršati ako uzimate terapiju temeljenu na interferonu zajedno s lijekom Revolade za liječenje sniženog broja trombocita kao posljedicu hepatitisa C.
English: Pooled data
Croatian: Zbirni podaci
English: Common Rash, alopecia, hyperhidrosis, pruritus generalised, petechiae Uncommon Urticaria, dermatosis, cold sweat, erythema, melanosis,
Croatian: Poremećaji kože i potkožnog tkiva često osip, alopecija, hiperhidroza, generalizirani svrbež, petehije manje često urtikarija, dermatoze, hladan znoj, eritem, melanoza, poremećaji pigmentacije, diskoloracija kože, ljuštenje kože
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg tablet of Revolade a day.
Croatian: Djeca (1 do 5 godina) - uobičajena početna doza za ITP je jedna tableta lijeka Revolade od 25 mg na dan.
English: 30 single-use oral dosing syringes
Croatian: 30 dozirnih štrcaljki za usta za jednokratnu uporabu
English: White, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS NX3' and ‘25' on one side.
Croatian: Bijela, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 10,3 mm) s utisnutim oznakama „GS NX3“ i „25“ na jednoj strani.
English: Common Rash, dry skin, eczema, rash pruritic, erythema, hyperhidrosis, pruritus generalised, alopecia Uncommon Skin lesion, skin discolouration, skin hyperpigmentation, night sweats
Croatian: Poremećaji kože i potkožnog tkiva vrlo često svrbež često osip, suha koža, ekcem, pruritički osip, eritem, hiperhidroza, generalizirani svrbež, alopecija manje često oštećenje kože, diskoloracija kože, hiperpigmentacija kože, noćno znojenje
English: Chronic hepatitis C (HCV) associated thrombocytopenia
Croatian: Trombocitopenija povezana s kroničnim hepatitisom C (HCV)
English: Revolade 50 mg film-coated tablets are round, biconvex, brown, debossed with ‘GS UFU' and ‘50' on one side.
Croatian: Revolade 50 mg filmom obložene tablete su okrugle, bikonveksne, smeđe tablete s utisnutim oznakama „GS UFU“ i „50“ na jednoj strani.
English: In the phase II refractory SAA clinical study with eltrombopag at a dose of 150 mg/day (with ethnic or age related modifications as indicated) (ELT116826), the incidence of new cytogenetic abnormalities was observed in 22.6% of adult patients [7/31 (where 3 of them had changes in chromosome 7)].
Croatian: U kliničkom ispitivanju faze II refraktorne teške aplastične anemije s eltrombopagom pri dozi od 150 mg/dan (s etničkim ili s dobi povezanim modifikacijama doze po potrebi) (ELT116826), incidencija novih citogenetskih abnormalnosti bila je uočena u 22,6% odraslih bolesnika [7/31 (gdje su 3 od njih imala promjene na kromosomu 7)]. Svih 7 bolesnika imalo je normalnu citogenetiku na početku.
English: Common Anaemia, eosinophilia, leukocytosis, thrombocytopenia, haemoglobin decreased, white blood cell count decreased Uncommon Anisocytosis, haemolytic anaemia, myelocytosis, band neutrophil count increased, myelocyte present, platelet count increased, haemoglobin increased
Croatian: Poremećaji krvi i limfnog sustava često anemija, eozinofilija, leukocitoza, trombocitopenija, sniženje hemoglobina, smanjenje broja leukocita manje često anizocitoza, hemolitička anemija, mijelocitoza, povišenje broja nesegmentiranih neutrofila, pojava mijelocita, porast broja trombocita, povišenje hemoglobina
English: There are limited data on the use of eltrombopag in HCV and SAA patients aged over 75 years.
Croatian: Podaci o uporabi eltrombopaga u bolesnika s HCV-om i bolesnika s teškom aplastičnom anemijom starijih od 75 godina su ograničeni.
English: 25 mg powder for oral suspension
Croatian: 25 mg prašak za oralnu suspenziju
English: Adults - the usual starting dose for hepatitis C is one 25 mg sachet of Revolade a day.
Croatian: Odrasli - uobičajena početna doza za hepatitis C je jedna vrećica lijeka Revolade od 25 mg na dan.
English: Revolade 75 mg film-coated tablets
Croatian: Revolade 75 mg filmom obložene tablete
English: Symptoms include: - black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people) - blood in your stools - vomiting blood or something that looks like coffee grounds
Croatian: Simptomi uključuju: - crne katranaste stolice (promjena boje stolice je manje česta nuspojava koja se može javiti u do
English: Genotype 1/4/6
Croatian: Genotip 1/4/6e Razina albumina f
English: There were no bone changes observed in mice or rats after lifetime exposure (2 years) at 4 times or 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 2 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Croatian: Nisu nađene promjene na kostima miševa i štakora nakon izloženosti tijekom cijelog života (2 godine) pri 4 ili 2 puta većoj od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 2 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na AUC.
English: • abdominal (stomach) pain, enlarged abdomen, blood in your stools
Croatian: • bol u trbuhu, povećanje opsega trbuha, krv u stolici
English: Each film-coated tablet contains eltrombopag olamine equivalent to 12.5 mg eltrombopag.
Croatian: Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 12,5 mg eltrombopaga.
English: Fertility was not affected in male or female rats at exposures that were comparable to those in humans.
Croatian: Pri razinama izloženosti lijeku koja je usporediva s onima kod ljudi nije utvrđen utjecaj na plodnost bilo kod ženki ili mužjaka štakora.
English: Revolade 25 mg powder for oral suspension
Croatian: Revolade 25 mg prašak za oralnu suspenziju
English: • fast or irregular heartbeat (palpitations), shortness of breath
Croatian: • brzi ili nepravilni otkucaji srca (palpitacije), nedostatak zraka produktivni kašalj, curenje nosa, gripa, herpes, grlobolja i nelagoda pri gutanju
English: Revolade 75 mg film-coated tablets eltrombopag
Croatian: Revolade 75 mg filmom obložene tablete eltrombopag
English: Brown, round, biconvex film-coated tablet (approximately 10.3 mm in diameter) debossed with ‘GS UFU' and ‘50' on one side.
Croatian: Smeđa, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 10,3 mm) s utisnutim oznakama „GS UFU“ i „50“ na jednoj strani.
English: 50 mg film-coated tablets Each film-coated tablet contains eltrombopag olamine equivalent to 50 mg eltrombopag.
Croatian: 50 mg filmom obložene tablete Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 50 mg eltrombopaga.
English: If your doctor considers that the benefits of taking Revolade outweigh the risks, you will be closely monitored during treatment.
Croatian: Tijekom liječenja bit ćete pažljivo praćeni ako Vaš liječnik smatra da očekivana korist nadmašuje rizike primjene lijeka Revolade.
English: • muscle pain, muscle weakness
Croatian: • bolovi u mišićima
English: Revolade 50 mg film-coated tablets EU/1/10/612/004
Croatian: Revolade 50 mg filmom obložene tablete EU/1/10/612/004
English: In patients with low albumin levels (≤35 g/l) or MELD score ≥10 at baseline, there was a 3-fold greater risk of hepatic decompensation and an increase in the risk of a fatal adverse event compared to those with less advanced liver disease.
Croatian: U bolesnika s niskim početnim vrijednostima albumina (≤35 g/l) ili MELD indeksom ≥10, zamijećen je 3 puta veći rizik od jetrene dekompenzacije i povećanje rizika od letalnih štetnih događaja u usporedbi s bolesnicima s manje uznapredovalom jetrenom bolešću.
English: The efficacy and safety of eltrombopag for the treatment of thrombocytopenia in patients with HCV infection were evaluated in two randomised, double-blind, placebo-controlled studies.
Croatian: U dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja procjenjivana je djelotvornost i sigurnost primjene eltrombopaga u liječenju trombocitopenije u bolesnika s HCV infekcijom.
English: Revolade 50 mg film-coated tablets
Croatian: Revolade 50 mg filmom obložene tablete
English: In the phase II refractory SAA clinical study with eltrombopag with a starting dose of 50 mg/day (escalated every 2 weeks to a maximum of 150 mg/day) (ELT112523), the incidence of new cytogenetic abnormalities was observed in 17.1% of adult patients [7/41 (where 4 of them had changes in chromosome 7)].
Croatian: U kliničkom ispitivanju faze II refraktorne teške aplastične anemije s eltrombopagom s početnom dozom od 50 mg/dan (koja je povećavana svaka 2 tjedna do najviše 150 mg/dan) (ELT112523), incidencija novih citogenetskih abnormalnosti bila je uočena u 17,1% odraslih bolesnika [7/41 (pri čemu je 4 od njih imalo promjene u kromosomu 7)]. Medijan vremena provedenog u ispitivanju do citogenetske abnormalnosti bio je 2,9 mjeseci.
English: Excessive platelet count responses or important liver test abnormalities also necessitate discontinuation.
Croatian: Prekid liječenja nužan je i kod odgovora s pretjeranim porastom broja trombocita ili kod značajnih abnormalnosti testova jetrene funkcije.
English: Cataracts have not been observed in adult dogs after 52 weeks of dosing at 2 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and equivalent to the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Croatian: Katarakte nisu nađene u odraslih pasa nakon 52 tjedna primjene lijeka pri 2 puta većoj izloženosti od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i ekvivalentom kliničkoj izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, mjerena AUC-om.
English: Revolade 50 mg film-coated tablets eltrombopag
Croatian: Revolade 50 mg filmom obložene tablete eltrombopag
English: Consideration should be given to performing a bone marrow aspirate and biopsy over the course of the disease and treatment, particularly in patients over 60 years of age, those with systemic symptoms, or abnormal signs such as increased peripheral blast cells.
Croatian: Kod bolesnika starijih od 60 godina, sa sustavnim simptomima ili abnormalnim znakovima kao što su povećanje broja perifernih blasta, tijekom bolesti i liječenja trebalo bi razmotriti punkciju koštane srži i biopsiju.
English: Revolade 25 mg film-coated tablets
Croatian: Revolade 25 mg filmom obložene tablete
English: Revolade 25 mg film-coated tablets EU/1/10/612/001
Croatian: Revolade 25 mg filmom obložene tablete EU/1/10/612/001
English: Renal impairment
Croatian: Jetrene tegobe
English: Each sachet contains eltrombopag olamine equivalent to 25 mg of eltrombopag.
Croatian: Jedna vrećica sadrži eltrombopagolamin u količini koja odgovara 25 mg eltrombopaga.
English: Revolade 25 mg film-coated tablets eltrombopag
Croatian: Revolade 25 mg filmom obložene tablete eltrombopag
English: Wait 2 weeks to assess the effects of this and any subsequent dose adjustments.
Croatian: Pričekati 2 tjedna za procjenu učinka ove ili naknadnih prilagodbi doze.
English: EU/1/10/612/010 (14 film-coated tablets)
Croatian: EU/1/10/612/010 (14 filmom obloženih tableta)
English: Close monitoring is required when administering to patients with hepatic impairment (see section 4.2).
Croatian: Potrebno je pomno pratiti bolesnike s oštećenjem jetre kod kojih se primjenjuje eltrombopag (vidjeti dio 4.2).
English: Common Vomiting, ascites, abdominal pain, abdominal pain upper, dyspepsia, dry mouth, constipation, abdominal distension, toothache, stomatitis, gastrooesophagal reflux disease, haemorrhoids, abdominal discomfort, varices oesophageal Uncomon Oesophageal varices haemorrhage, gastritis, aphthous stomatitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja vrlo često kašalj često dispneja, orofaringealna bol, dispneja pri naporu, produktivni kašalj Poremećaji probavnog sustava vrlo često mučnina, proljev često povraćanje, ascites, bol u abdomenu, bol u gornjem abdomenu, dispepsija, suha usta, konstipacija, distenzija abdomena, zubobolja, stomatitis, gastroezofagealna refluksna bolest, hemoroidi, nelagoda u abdomenu, varikoziteti jednjaka manje često krvarenje varikoziteta jednjaka, gastritis, aftozni stomatitis
English: Wait 2 weeks to assess the effects of this and any subsequent dose adjustments
Croatian: Pričekati 2 tjedna za procjenu učinka ove ili sljedećih prilagodbi doza
English: • changes in the enzymes that control blood clotting
Croatian: • snižena razina proteina u krvi povećana razina bilirubina u krvi (tvari koju proizvodi jetra) promjene enzima koji kontroliraju zgrušavanje krvi
English: Common Petechiae, rash, pruritus, urticaria, skin lesion, rash macular Not known Skin discolouration, skin hyperpigmentation
Croatian: Poremećaji kože i potkožnog tkiva često petehije, osip, pruritus, urtikarija, kožne lezije, makularni osip nepoznato diskoloracija kože, hiperpigmentacija kože
English: Pharmacokinetics
Croatian: FARMACEUTSKI
English: Children (1 to 5 years) - the usual starting dose for ITP is one 25 mg sachet of Revolade a day.
Croatian: Djeca (1 do 5 godina) - uobičajena početna doza za ITP je jedna vrećica lijeka Revolade od 25 mg na dan.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta često vrtoglavica
English: EU/1/10/612/011 (28 film-coated tablets)
Croatian: EU/1/10/612/011 (28 filmom obloženih tableta)
English: • black tarry stools (discoloured bowel movements are a uncommon side effect that may affect up to 1 in 100 people)
Croatian: • crne katranaste stolice (promjena boje stolice je manje česta nuspojava koja se može javiti u do
English: Common Hyperbilirubinaemia, jaundice, drug-induced liver injury Uncommon Portal vein thrombosis, hepatic failure
Croatian: Poremećaji jetre i žuči često hiperbilirubinemija, žutica, oštećenje jetre uzrokovano lijekom manje često tromboza portalne vene, zatajenje jetre
English: Once the platelet count is ≤100,000/µl, reinitiate therapy at a daily dose reduced by 25 mg*.
Croatian: Kada broj trombocita bude opet ≤100 000/µl, ponovo započnite liječenje eltrombopagom u dnevnoj dozi smanjenoj za 25 mg*.
English: Common Pharyngitis, influenza, oral herpes, pneumonia, sinusitis, tonsillitis,
Croatian: ♦, infekcija gornjeg dijela dišnog sustava često faringitis, influenca, herpes u ustima, pneumonija, sinusitis, tonzilitis, infekcije dišnih puteva, gingivitis manje često kožne infekcije
English: Each film-coated tablet contains eltrombopag olamine equivalent to 25 mg eltrombopag.
Croatian: Jedna filmom obložena tableta sadrži eltrombopagolamin u količini koja odgovara 25 mg eltrombopaga.
English: EU/1/10/612/012 84 film-coated tablets (3 packs of 28)
Croatian: EU/1/10/612/012 84 filmom obloženih tableta (3 pakiranja po 28)
English: Adults - the usual starting dose for SAA is one 50 mg tablet of Revolade a day.
Croatian: Odrasli - uobičajena početna doza za tešku aplastičnu anemiju je jedna tableta lijeka Revolade od 50 mg na dan.
English: You will have blood tests to check your liver function before you start taking Revolade and at intervals while you are taking it. You may need to stop taking Revolade if the amount of these substances increases too much, or if you get other signs of liver damage.
Croatian: Možda ćete morati prekinuti liječenje lijekom Revolade ako jetreni enzimi previše porastu ili razvijete druge znakove jetrenog oštećenja.