FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Blood bilirubin increased (hyperbilirubinemia), jaundice Not known Drug-induced liver injury* * Cases of drug-induced liver injury have been reported in patients with ITP and HCV
Croatian: Poremećaji jetre i žuči vrlo često porast transaminaza često porast bilirubina u krvi (hiperbilirubinemija), žutica nepoznato oštećenje jetre uzrokovano lijekom* * Slučajevi oštećenja jetre uzrokovanog lijekom prijavljeni su u bolesnika s ITP-om i HCV-om
English: HMG CoA reductase inhibitors
Croatian: Učinci eltrombopaga na druge lijekove Inhibitori HMG CoA reduktaze
English: • interruption in blood supply to spleen (splenic infarction)
Croatian: • prekid u opskrbi slezene krvlju (infarkt slezene)
English: The co-administration of 200 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 25% and 18%, respectively.
Croatian: Istodobna primjena 200 mg ciklosporina smanjila je Cmax eltrombopaga za 25% i AUCinf eltrombopaga za 18%.
English: Very common
Croatian: Vrlo česte nuspojave
English: Following identification of a stable dose of eltrombopag, full blood count (FBC) with white blood cell count (WBC) differential should be performed monthly.
Croatian: Nakon postizanja stabilne doze eltrombopaga, jednom mjesečno treba provoditi analizu kompletne krvne slike i diferencijalne slike leukocita.
English: The tablets 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: Tablete 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: constipation, swollen stomach, taste disturbances, inflammation of the stomach, piles
Croatian: nadutost trbuha, poremećaji okusa, upala želuca, hemoroidi, nadraženost crijeva
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 (%)
Croatian: Bolesnici sa ≥75% nalaza unutar ciljnog raspona vrijednosti (50 000 do 400 000/l), n (%)
English: Based on model estimate, female HCV patient had approximately 41% higher plasma eltrombopag AUC(0-) as compared to male patients.
Croatian: Temeljem procijenjenog modela, bolesnice s HCV-om imale su približno 41% više vrijednosti AUC(0-) eltrombopaga u plazmi u usporedbi s muškim bolesnicima.
English: Therefore, eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see sections 4.2 and 4.4).
Croatian: Stoga, eltrombopag ne bi smjeli uzimati bolesnici s ITP-om s oštećenjem jetre (≥5 bodova prema Child-Pugh ljestvici) osim ako očekivana dobrobit ne nadmašuje već poznati rizik za trombozu portalne vene (vidjeti dijelove 4.2 i 4.4).
English: Based on estimates from the population pharmacokinetic analysis, Asian patients had approximately 55% higher plasma eltrombopag AUC(0-) values as compared to patients of other races who were predominantly Caucasian (see section 4.2).
Croatian: Temeljem procjena analize populacijske farmakokinetike, bolesnici iz Azije imali su približno 55% veće vrijednosti AUC(0-) eltrombopaga u plazmi u usporedbi s bolesnicima drugih rasa koji su bili većinom bijele rase (vidjeti dio 4.2).
English: Give the medicine to the child. Do this straight away when you have mixed the dose.
Croatian: Napravite to čim ste zamiješali dozu.
English: The clinical status of the patient and the adverse reaction profile of eltrombopag, including dizziness and lack of alertness, should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor and cognitive skills.
Croatian: Kada se razmatra sposobnost bolesnika da izvodi zadatke koji zahtijevaju prosudbu, motoričke i kognitivne sposobnosti treba imati na umu klinički status bolesnika i profil nuspojava eltrombopaga, uključujući omaglicu i smanjenu budnost.
English: • Insert the tip of the syringe into the hole in the lid of the mixing bottle.
Croatian: • Umetnite vršak štrcaljke u rupu u poklopcu bočice za miješanje.
English: Dose adjustments are based upon the platelet count response.
Croatian: Prilagodba doze temelji se na odgovoru prema broju trombocita.
English: • Throw away the used oral dosing syringe.
Croatian: • Bacite iskorištenu dozirnu štrcaljku za usta.
English: ITP is caused by a low blood platelet count (thrombocytopenia).
Croatian: ITP je uzrokovan sniženim brojem trombocita (trombocitopenija).
English: It is recommended to wait for 2 weeks to assess the effects of this and any subsequent dose adjustments.
Croatian: Preporučeno je pričekati 2 tjedna kako bi vidjeli učinke ove i svih narednih prilagodbi doza.
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide black (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Croatian: Ovojnica tablete Hipromeloza (E464) željezov oksid crveni (E172) željezov oksid crni (E172) makrogol 400 (E1521) titanijev dioksid (E171)
English: At non-tolerated doses in pre-weaning juvenile rats dosed from Days 4-32 (approximately equating to a 2-year-old human at the end of the dosing period), ocular opacities were observed (histology not performed) at 9 times the maximum human clinical exposure in paediatric ITP patients at 75 mg/day, based on AUC.
Croatian: U juvenilnih štakora prije odbijanja od sise, koji su primali doze od 4.-32. dana (što otprilike odgovara 2-godišnjem djetetu na kraju razdoblja primjene doze), pri dozama koje se ne podnose dobro bila su uočena zamućenja oka (histologija nije obavljena) pri izloženosti koja je 9 puta veća od maksimalne kliničke izloženosti u pedijatrijskih bolesnika s ITP-om pri 75 mg/dan, mjerene AUC-om.
English: • toothache
Croatian: • zubobolja
English: If after 2 weeks of eltrombopag therapy at 100 mg the required platelet level to initiate antiviral therapy is not achieved, eltrombopag should be discontinued.
Croatian: Liječenje eltrombopagom treba prekinuti ako se nakon 2 tjedna primjene lijeka u dozi od 100 mg ne postigne broj trombocita potreban za započinjanje antivirusnog liječenja.
English: Three patients had cytogenetic abnormalities at baseline.
Croatian: Troje bolesnika imalo je citogenetske abnormalnosti na početku.
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Croatian: Ovojnica tablete Hipromeloza (E464) željezov oksid crveni (E172) željezov oksid žuti (E172) makrogol 400 (E1521) titanijev dioksid (E171)
English: Treatment-related cataracts were detected in rodents and were dose and time-dependent.
Croatian: U glodavaca je zabilježena pojava katarakte vezane uz liječenje eltrombopagom, a koja je bila ovisna o dozi i duljini primjene.
English: ATC code: B02BX 05.
Croatian: Farmakoterapijska skupina: Antihemoragici, ostali sistemski hemostatici, ATK oznaka: B02BX 05.
English: In ITP and SAA patients a lower starting dose of eltrombopag should be used.
Croatian: U bolesnika s ITP-om i teškom aplastičnom anemijom potrebno je koristiti niže početne doze eltrombopaga.
English: • Start with the plunger pushed all the way into the syringe.
Croatian: • Započnite s klipom gurnutim do kraja u štrcaljku.
English: Your doctor will carry out tests to check that you do not have this blood condition before you start Revolade.
Croatian: Prije početka liječenja lijekom Revolade, Vaš će liječnik provesti testiranje kako bi provjerio da nemate ovu krvnu bolest.
English: In vitro studies with eltrombopag suggest a potential phototoxicity risk; however, in rodents there was no evidence of cutaneous phototoxicity (10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 5 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) or ocular phototoxicity (4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Croatian: In vitro ispitivanja s eltrombopagom sugeriraju potencijalni rizik od fototoksičnosti, međutim, u glodavaca nije bilo dokaza kožne fototoksičnosti (10 ili 7 puta veća od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 5 puta kliničke izloženosti bolesnika s HCVom pri dozi od 100 mg/dan, temeljeno na AUC) ili fototoksičnosti za oči (4 puta veća od kliničke izloženosti odraslih ili pedijatrijskih 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).
English: 50,000/µl to 150,000/µl
Croatian: 50 000/µl do 150 000/µl
English: Revolade 25 mg powder for oral suspension eltrombopag
Croatian: Revolade 25 mg prašak za oralnu suspenziju eltrombopag
English: Revolade 75 mg film-coated tablets are round, biconvex, pink, debossed with ‘GS FFS' and ‘75' on one side.
Croatian: Revolade 75 mg filmom obložene tablete su okrugle, bikonveksne, ružičaste tablete s utisnutim oznakama „GS FFS“ i „75“ na jednoj strani.
English: Common Dry eye, vision blurred, eye pain, visual acuity reduced Uncommon Lenticular opacities, astigmatism, cataract cortical, lacrimation increased, retinal haemorrhage, retinal pigment epitheliopathy, visual impairment, visual acuity tests abnormal, blepharitis, keratoconjunctivitis sicca
Croatian: Poremećaji oka često suhoća očiju, zamagljen vid, bol oka, smanjenje vidne oštrine manje često opaciteti leće, astigmatizam, kortikalna katarakta, pojačano suzenje, krvarenje u retini, retinalna pigmentna epiteliopatija, poremećaji vida, abnormalni testovi vidne oštrine, blefaritis, suhi keratokonjunktivitis
English: Heat-sealed foil laminate sachets.
Croatian: Vrećice od toplinski zavarene laminirane folije.
English: >150,000/µl to 250,000/µl
Croatian: >150 000/µl do 250 000/µl
English: White, round, biconvex film-coated tablet (approximately 7.9 mm in diameter) debossed with ‘GS MZ1' and ‘12.5' on one side.
Croatian: Bijela, okrugla, bikonveksna filmom obložena tableta (promjera otprilike 7,9 mm) s utisnutim oznakama „GS MZ1“ i „12,5“ na jednoj strani.
English: The product contact material is the polyethylene heat seal layer.
Croatian: Materijal u kontaktu s lijekom je toplinski zavaren sloj polietilena niske gustoće.
English: • feeling sick (nausea)
Croatian: • osjećaj vrtnje (vrtoglavica)
English: It is important to tell a doctor if you develop these symptoms.
Croatian: Ako razvijete ove simptome, važno je da obavijestite liječnika o tome.
English: • blisters in the mouth
Croatian: Za primjenu kroz usta
English: Common Hypokalaemia, decreased appetite, blood uric acid increased Uncommon Anorexia, gout, hypocalcaemia
Croatian: Poremećaji metabolizma i prehrane često hipokalijemija, smanjeni apetit, povišena razina mokraćne kiseline u krvi manje često anoreksija, giht, hipokalcijemija,
English: • 1 reusable mixing bottle with lid and cap (supplied in the kit)
Croatian: • 1 bočica za miješanje za višekratnu uporabu s poklopcem i zatvaračem (nalazi se u kompletu)
English: A very high blood platelet count may increase the risk of blood clotting.
Croatian: Povišeni broj trombocita može povisiti rizik za nastanak krvnih ugrušaka.
English: • Pull cap off the lid of the mixing bottle
Croatian: • Maknite zatvarač s poklopca s bočice za miješanje
English: Tests to check your bone marrow
Croatian: Testovi za provjeru koštane srži
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom
Croatian: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG12 0DJ, Ujedinjeno Kraljevstvo Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ujedinjeno Kraljevstvo
English: Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis.
Croatian: Eltrombopag ne treba primjenjivati kod bolesnika s ITP-om i oštećenjem jetre (≥5 bodova po Child-Pugh ljestvici), osim ako očekivana dobrobit ne nadmašuje već poznati rizik za nastanak tromboze portalne vene.
English: Female paediatric ITP patients had approximately 25% higher plasma eltrombopag AUC(0-) values as compared to male patients.
Croatian: Ženski pedijatrijski bolesnici s ITP-om imali su otprilike 25% više vrijednosti plazmatskog AUC(0-) eltrombopaga u odnosu na muške bolesnike.
English: At ≥6 times the human clinical exposure in adult ITP patients at 75 mg/day and 3 times the human clinical exposure in adult HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 6 weeks and rats after 28 weeks of dosing.
Croatian: Pri ≥6 puta većoj izloženosti od kliničke izloženosti odraslih bolesnika s ITPom pri dozi od 75 mg/dan i 3 puta većoj kliničkoj izloženosti od odraslih bolesnika s HCV-om pri dozi od 100 mg/dan, mjerenoj AUC-om, katarakta je zamijećena u miševa nakon 6 tjedana i štakora nakon 28 tjedana primjene lijeka.
English: The exposure at the lowest dose was 1.2 or 0.8 times the human clinical exposure based on AUC in adult or paediatric ITP patients at 75 mg/day and 0.6 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC.
Croatian: Temeljeno na AUC, izloženost pri najnižim dozama bila je 1,2 ili 0,8 puta veća od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 0,6 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan.
English: The longest platelet transfusion-free period for responders was 287 days (median).
Croatian: Najduže razdoblje bez transfuzije trombocita za bolesnike s odgovorom bilo je 287 dana (medijan).
English: revolade 25 mg sachets
Croatian: revolade 25 mg vrećice
English: Screw the lid onto the mixing bottle.
Croatian: Navijte poklopac na bočicu za miješanje.
English: Syringe tip
Croatian: Česte nuspojave
English: It is necessary to wait for at least 2 weeks to see the effect of any dose adjustment on the patient's platelet response prior to considering another dose adjustment.
Croatian: Da biste kod bolesnika vidjeli odgovor trombocita na bilo koje prilagodbe doze, potrebno je pričekati barem 2 tjedna prije nego se odlučite na novu prilagodbu doze lijeka.
English: A similar platelet response was maintained throughout the study, with 52% and 16% of patients responding at the end of the 6-month treatment period.
Croatian: Sličan je odgovor (prema broju trombocita) održan tijekom cijelog ispitivanja, odnosno 52% bolesnika koji su primali eltrombopag, i 16% bolesnika koji su primali placebo odgovorilo je na liječenje na kraju šestomjesečnog perioda.
English: Common Blood bilirubin increased, weight decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, international normalised ratio increased, activated partial thromboplastin time prolonged, blood glucose increased, blood albumin decreased Uncommon Electrocardiogram QT prolonged Grouped term with preferred terms oliguria, renal failure and renal impairment
Croatian: Pretrage često povećana razina bilirubina u krvi, smanjenje tjelesne težine, sniženi broj leukocita, sniženi hemoglobin, snižen broj neutrofila, povećan INR, produženo aktivirano parcijalno tromboplastinsko vrijeme, povišena koncentracija glukoze u krvi, sniženi albumin u krvi manje često produljenje QT intervala u elektrokardiogramu Grupni pojam s preporučenim pojmovima oligurija, zatajenje bubrega i oštećenje bubrega
English: • Push the cap firmly back on to the lid of the mixing bottle.
Croatian: • Gurnite zatvarač čvrsto natrag na poklopac bočice za miješanje.
English: Hepatotoxixity
Croatian: Hepatotoksičnost
English: Revolade 25 mg powder for oral suspension:
Croatian: Revolade 25 mg prašak za oralnu suspenziju:
English: In addition, the benefits of treatment in terms of the proportion achieving sustained virological response (SVR) compared with placebo were modest in these patients (especially for those with baseline albumin ≤35g/l) compared with the group overall.
Croatian: U nastavku, koristi od liječenja prema udjelu postignutog održanog virološkog odgovora (SVR) 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 (vidjeti dio 5.1).
English: • Put the tip of the syringe all the way into the water
Croatian: • Gurnite vršak štrcaljke do kraja u vodu.
English: • Slowly push the plunger all the way into the syringe.
Croatian: • Polako gurnite klip do kraja u štrcaljku.
English: Within two weeks of stopping Revolade, your blood platelet count will usually drop back down to what it was before starting Revolade.
Croatian: Krvarenje ili modrice nakon prestanka liječenja Unutar dva tjedna od prestanka uzimanja lijeka Revolade, broj trombocita će obično pasti na razinu od prije početka uzimanja lijeka Revolade.
English: At 4 times the human clinical exposure in ITP patients at 75 mg/day and 2 times the human exposure in HCV patients at 100 mg/day, based on AUC, cataracts were observed in mice after 13 weeks and in rats after 39 weeks of dosing.
Croatian: Pri 4 puta većoj izloženosti od kliničke izloženosti bolesnika s ITP-om pri dozi od 75 mg/dan dan i 2 puta većoj kliničkoj izloženosti od bolesnika s HCV-om pri dozi od 100 mg/dan, mjerenoj AUC-om, katarakta je zabilježena u miševa nakon 13 tjedana i u štakora nakon 39 tjedana primjene lijeka.
English: Eltrombopag should not be used in ITP patients with hepatic impairment (Child-Pugh score ≥5) unless the expected benefit outweighs the identified risk of portal venous thrombosis (see section 4.4).
Croatian: Eltrombopag ne smiju uzimati bolesnici s ITP-om s oštećenjem jetre (≥5 bodova po Child-Pugh ljestvici) osim ako očekivana dobrobit ne nadmašuje već poznati rizik za trombozu portalne vene (vidjeti dio 4.4).
English: Endosteal hyperostosis was observed in a 28-week toxicity study in rats at a non-tolerated dose of 60 mg/kg/day (6 times or 4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Croatian: Endostealna hiperostoza je zamijećena u 28-tjednom ispitivanju toksičnosti na štakorima, pri netolerirajućim dozama od 60 mg/kg/dan (doza 6 ili 4 puta veća od kliničke izloženosti odraslih ili pedijatrijskih 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).
English: Eltrombopag dose may need to be increased based on these platelet counts.
Croatian: Možda će biti potrebno povećanje doze eltrombopaga temeljem broja trombocita.
English: Eltrombopag was not mutagenic or clastogenic in a bacterial mutation assay or in two in vivo assays in rats (micronucleus and unscheduled DNA synthesis, 10 times or 8 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 7 times the human clinical exposure in HCV patients at 100 mg/day, based on Cmax).
Croatian: Eltrombopag nije pokazao mutageno ili klastogeno svojstvo u probi bakterijskih mutacija ili u dvije in vivo probe na štakorima (DNA sinteza u jezgricama i nepredviđena DNA sinteza pri izloženosti 10 ili 8 puta većoj od kliničke izloženosti odraslih ili pedijatrijskih bolesnika s ITP-om pri dozi od 75 mg/dan i 7 puta kliničke izloženosti bolesnika s HCV-om pri dozi od 100 mg/dan, temeljeno na Cmax).
English: Patients with low albumin levels (≤35 g/l) or MELD ≥10 had a 2-fold greater risk of TEEs than those with higher albumin levels; those aged ≥60 years had a 2-fold greater risk of TEEs compared to younger patients.
Croatian: Bolesnici koji su imali niske razine albumina (≤35 g/l) ili MELD indeks ≥10 imali su 2 puta veći rizik od TED nego oni s visokim razinama albumina; oni stariji od ≥60 godina imali su dva puta veći rizik od TED u odnosu na mlađe bolesnike.
English: See also ‘Bleeding or bruising after you stop treatment' in section 4.
Croatian: Pogledajte također „Krvarenje ili modrice nakon prestanka liječenja“ u dijelu 4. U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: Platelet counts should be monitored every week prior to starting antiviral therapy.
Croatian: Prije početka antivirusnog liječenja potrebno je pratiti broj trombocita svaki tjedan.
English: Revolade 25 mg film-coated tablets are round, biconvex, white, debossed with ‘GS NX3' and ‘25' on one side.
Croatian: Revolade 25 mg filmom obložene tablete su okrugle, bikonveksne, bijele tablete s utisnutim oznakama „GS NX3“ i „25“ na jednoj strani.
English: Adults - the usual starting dose for hepatitis C is one 25 mg tablet of Revolade a day.
Croatian: Odrasli - uobičajena početna doza za hepatitis C je jedna tableta lijeka Revolade od 25 mg na dan.
English: In controlled studies in thrombocytopenic patients with HCV (n=1439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs.
Croatian: U kontroliranim ispitivanjima trombocitopeničnih bolesnika s HCV-om (n=1439), 38 od 955 bolesnika (4%) liječenih eltrombopagom doživjelo je TED, dok je u placebo skupini TED imalo 6 od 484 bolesnika (1%).
English: The longest platelet transfusion-free period for non-responders was 27 days (median).
Croatian: Najduže razdoblje bez transfuzije trombocita za bolesnike bez odgovora bilo je 27 dana (medijan).
English: The longest RBC transfusion-free period for responders was 266 days (median).
Croatian: Najduže razdoblje bez transfuzije eritrocita za bolesnike s odgovorom bilo je 266 dana (medijan).
English: Revolade 12.5 mg film-coated tablets EU/1/10/612/010
Croatian: Revolade 12,5 mg filmom obložene tablete EU/1/10/612/010
English: • Insert the syringe tip into the hole in the bottle lid. 9.
Croatian: • Umetnite vršak štrcaljke u rupu na poklopcu bočice.
English: For patients taking 25 mg once daily, the dose should be increased to 50 mg daily before increasing the dose amount by 50 mg. A dose of 150 mg daily must not be exceeded.
Croatian: Bolesnicima koji uzimaju 25 mg jednom dnevno, potrebno je povećati dozu na 50 mg dnevno prije povećavanja doze za 50 mg.
English: Eltrombopag was not carcinogenic in mice at doses up to 75 mg/kg/day or in rats at doses up to 40 mg/kg/day (exposures up to 4 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: Eltrombopag nije bio karcinogen za miševe u dozama do 75 mg/kg/dan ili u štakora pri dozama do 40 mg/kg/dan (izloženost veća do 4 ili 2 puta 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, mjereno AUC).
English: Adults and children (6 to 17 years) - the usual starting dose for ITP is one 50 mg tablet of Revolade a day.
Croatian: Odrasli i djeca (6 do 17 godina) - uobičajena početna doza za ITP je jedna tableta lijeka Revolade od 50 mg na dan.
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon therapy (n=1,439), progression of pre-existing baseline cataract(s) or incident cataracts was reported in 8% of the eltrombopag group and 5% of the placebo group.
Croatian: U kontroliranim ispitivanjima bolesnika s trombocitopenijom i HCV-om koji su primali terapiju interferonom (n=1439) progresija već postojeće (ishodišno prisutne) katarakte ili pojava katarakte zabilježena je u 8% bolesnika u skupini koja je primala eltrombopag, te 5% u skupini koja je primala placebo.