natgillin/translations-raw huggingface dataset:
TRA100773B: The primary efficacy endpoint was the proportion of responders, defined as ITP patients who had an increase in platelet counts to 50,000/l at Day 43 from a baseline of <30,000/l; patients who withdrew prematurely due to a platelet count 200,000/l were considered responders, those that discontinued for any other reason were considered non-responders irrespective of platelet count.
TRA100773B: Primarna mjera ishoda djelotvornosti bila je udio bolesnika koji su odgovorili na liječenje (tzv. „respondera“), osoba s ITP-om u kojih je do 43. dana ispitivanja s početne vrijednosti od <30 000/l, došlo do porasta broja trombocita na 50 000/l; bolesnici koji su prijevremeno prekinuli ispitivanje zbog porasta broja trombocita 200 000/l su također smatrani „responderima“, a oni koji su prekinuli sudjelovanje u ispitivanju iz bilo kojeg drugog razloga smatrani su „non-responderima“, bez obzira na broj trombocita.
If new cytogenetic abnormalities are detected, it must be evaluated whether continuation of eltrombopag is appropriate.
Ako se uoče nove citogenetske abnormalnosti, mora se ocijeniti je li nastavak liječenja eltrombopagom primjeren.
Ocular changes
Promjene na očima
EU/1/10/612/013 (30 sachets of powder for oral suspension)
EU/1/10/612/013 (30 vrećica praška za oralnu suspenziju)
Revolade 50 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).
Revolade 50 mg filmom obložene tablete također sadrže i željezov oksid crveni (E172) i željezov oksid žuti (E172).
Preliminary results from a supportive study (Study ELT116826), an ongoing non-randomised, phase II, single-arm, open-label study in refractory SAA patients, showed consistent results.
Preliminarni rezultati iz potpornog ne-randomiziranog otvorenog ispitivanja faze II s jednom skupinom (ispitivanje ELT116826) u refrakternih bolesnika s teškom aplastičnom anemijom koje je trenutno u tijeku, pokazali su konzistentne rezultate.
You will be monitored for any signs or symptoms of side effects and given appropriate treatment immediately.
Pratit će se pojava eventualnih znakova ili simptoma nuspojava te ćete u slučaju njihove pojave odmah dobiti odgovarajuće liječenje.
In eltrombopag clinical studies in ITP thromboembolic events were observed at low and normal platelet counts.
U kliničkim ispitivanjima eltrombopaga u bolesnika s ITP-om, tromboembolijski događaji (TED) su primijećeni i pri niskom i normalnom broju trombocita.
Thrombocytopenia with HCV infection in adult patients
Trombocitopenija s HCV infekcijom u odraslih bolesnika
Eltrombopag dose adjustment is permitted during the course of the treatment based on the patient's platelet count (see section 4.2).
Prilagođavanje doze eltrombopaga dopušteno je tijekom liječenja temeljem broja trombocita svakog pojedinog bolesnika (vidjeti dio 4.2).
Thrombotic/thromboembolic events (TEEs)
Trombotični/tromboembolijski događaji (TED)
Patients with impaired renal function should use eltrombopag with caution and close monitoring, for example by testing serum creatinine and/or performing urine analysis (see section 5.2).
Bolesnici s oštećenom bubrežnom funkcijom moraju uzimati eltrombopag s oprezom i biti detaljno praćeni, npr. kontrolom serumskog kreatinina i/ili analizom urina (vidjeti dio 5.2).
ITP study population
Ispitivana populacija s ITP-om
Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).
Revolade je indiciran u odraslih bolesnika sa stečenom teškom aplastičnom anemijom koji su ili refrakterni na prethodnu imunosupresivnu terapiju ili jako pretretirani i neprikladni za transplantaciju hematopoetskih matičnih stanica (vidjeti dio 5.1).
Serum discolouration and interference with total bilirubin and creatinine testing have been reported in patients taking Revolade.
U bolesnika koji uzimaju Revolade zabilježeni su diskoloracija seruma i interferencija s testovima za ukupni bilirubin i kreatinin.
• yellowing of the skin or the whites of the eyes (jaundice)
• žutilo kože ili bjeloočnica (žutica)
Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.4 and 5.1).
Revolade je indiciran za liječenje trombocitopenije u odraslih bolesnika s kroničnom infekcijom virusom hepatitisa C (HCV) u kojih je stupanj trombocitopenije glavni čimbenik koji sprječava započinjanje ili ograničava mogućnost održavanja optimalnog liječenja interferonom (vidjeti dijelove 4.4 i 5.1).
Phototoxicity
Fototoksičnost
When eltrombopag is given in combination with antivirals reference should be made to the full summary of product characteristics of the respective coadministered medicinal products for comprehensive details of relevant safety information or contraindications.
Pri primjeni eltrombopaga u kombinaciji s antiviroticima, za detalje o važnim sigurnosnim informacijama ili kontraindikacijama potrebno je vidjeti cjelovite Sažetke opisa svojstava pojedinih lijekova koji se istodobno primjenjuju.
Therefore, caution should be used when co-administration of eltrombopag with lopinavir/ritonavir takes place.
Stoga je potreban oprez prilikom istodobne primjene eltrombopaga i lopinavira/ritonavira.
g.h/ml a, g/ml Cmax
N AUC(0-) a, g.h/ml a, g/ml Cmax
Empty the water into the mixing bottle.
12. Ispraznite vodu u bočicu za miješanje.
Paediatric population aged 1 to 5 years The recommended starting dose of eltrombopag is 25 mg once daily.
Pedijatrijska populacija u dobi od 1 do 5 godina Preporučena početna doza eltrombopaga je 25 mg jednom dnevno.
In both studies, patients with a platelet count of <75,000/µl were enrolled and stratified by platelet count (<50,000/µl and ≥50,000/µl to <75,000/µl), screening HCV RNA (<800,000 IU/ml and ≥800,000 IU/ml), and HCV genotype (genotype 2/3, and genotype 1/4/6).
U oba ispitivanja su bolesnici s brojem trombocita <75 000/µl uključeni i stratificirani prema broju trombocita (<50 000/µl i ≥50 000/µl do <75 000/µl), HCV RNA pri probiru (<800 000 IU/ml i ≥800 000 IU/ml) te HCV genotipu (genotip 2/3, i genotip 1/4/6).
Platelet counts should be monitored weekly during antiviral therapy until a stable platelet count is achieved, normally around 50,000-75,000/µl.
Broj trombocita tijekom antivirusnog liječenja potrebno je pratiti svakoga tjedna, sve do postizanja stabilnog broja trombocita, obično oko 50 000-75 000/µl.
The influence of gender on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 111 healthy adults (14 females) and 88 patients with ITP (57 females).
Utjecaj spola na farmakokinetiku eltrombopaga procjenjivan je koristeći podatke iz populacijske analize farmakokinetike 111 zdravih odraslih osoba (14 žena) i 88 bolesnika s ITP-om (57 žena).
The adverse reactions in the adult ITP studies (N=763), paediatric ITP studies (N=171), the HCV studies (N=1,520), the SAA studies (N=43) and post-marketing reports are listed below by MedDRA system organ class and by frequency.
Nuspojave iz ispitivanja odraslih s ITP-om (N=763), pedijatrijskih ispitanika s ITP-om (N=171), ispitivanja HCV-a (N=1520), ispitivanja teške aplastične anemije (N=43) te izvješća nakon stavljanja lijeka u promet navedene su niže prema MedDRA klasifikaciji organskih sustava i učestalosti.
rash, itching, skin lesion
(petehije), osip, svrbež, kožne lezije
Patients were randomised 2:1 and received Revolade (n=63) or placebo (n=29) for up to 13 weeks in the randomised period of the study.
Bolesnici su bili randomizirani u omjeru 2:1 i primali su Revolade (n=63) ili placebo (n=29) do 13 tjedana u randomiziranom razdoblju ispitivanja.
Following administration of a single 50 mg dose, the AUC0- of eltrombopag was 32% to 36% lower in patients with mild to moderate renal impairment, and 60% lower in patients with severe renal impairment compared with healthy volunteers.
Nakon jednokratne primjene doze od 50 mg, AUC0- eltrombopaga je bila 32% do 36% niža u bolesnika s blagim do umjerenim oštećenjem bubrega, i 60% niža u bolesnika s teškim oštećenjem bubrega, u odnosu na zdrave dobrovoljce.
When to take it
Kada uzeti lijek
The efficacy and safety of eltrombopag have not been established in patients with both moderate to severe renal impairment and hepatic impairment.
Djelotvornost i sigurnost eltrombopaga nije ustanovljena za bolesnike s umjerenim do teškim oštećenjem bubrega i jetre.
The most important serious adverse reactions were hepatotoxicity and thrombotic/thromboembolic events.
Najvažnije ozbiljne nuspojave bile su hepatotoksičnost i trombotični/tromboembolijski događaji.
Overall, total bilirubin ≥1.5 x ULN was reported in 76% and 50% of the eltrombopag and placebo groups, respectively.
Sveukupno, ukupni bilirubin ≥1,5 x GGN dogodio se u 76% slučajeva u eltrombopag grupi i 50% u placebo grupi.
Human liver microsome studies identified UGT1A1 and UGT1A3 as the enzymes responsible for eltrombopag glucuronidation.
Ispitivanja na humanim mikrosomima jetre identificirala su UGT1A1 i UGT1A3 kao enzime odgovorne za glukuronidaciju eltrombopaga.
Pack size of 30 sachets.
Pakiranje od 30 vrećica.
Platelet counts should be closely monitored.
Potrebno je pažljivo pratiti broj trombocita.
Use lowest dose of eltrombopag to maintain platelet counts.
Primijeniti najnižu dozu eltrombopaga za održavanje broja trombocita.
Patient platelet count should continue to be monitored and the standard criteria for further dose modification followed.
Broj trombocita u bolesnika i dalje treba redovito pratiti i slijediti uobičajene preporuke o daljnjim prilagođavanjima doze.
Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc (see sections 4.2 and 4.5).
Eltrombopag tvori kelate s polivalentnim kationima poput željeza, kalcija, magnezija, aluminija, selena i cinka (vidjeti dijelove 4.2 i 4.5).
If you are of Asian origin (Chinese, Japanese, Taiwanese, Thai or Korean) you may need to start at a lower dose of 25 mg.
Ako ste porijeklom iz Azije (Kinez, Japanac, Tajvanac, Tajlanđanin ili Korejac), možda ćete trebati nižu početnu dozu od 25 mg.
The lowest dose of eltrombopag needed to achieve the targets should be used.
Treba primjenjivati najnižu dozu eltrombopaga koja je dovoljna za postizanje ciljeva.
The dose of eltrombopag should be adjusted in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy.
Dozu eltrombopaga treba povećavati ako je potrebno, za 25 mg svaka 2 tjedna kako bi se postigla ciljna vrijednost broja trombocita potrebna za započinjanje antivirusnog liječenja.
In the single-arm, open-label study in SAA, three (7%) patients were diagnosed with MDS following treatment with eltrombopag, in the two ongoing studies (ELT116826 and ELT116643), 1/28 (4%) and 1/62 (2%) patient has been diagnosed with MDS or AML in each study.
U otvorenom ispitivanju teške aplastične anemije s jednom skupinom, u troje (7%) bolesnika dijagnosticiran je MDS nakon liječenja eltrombopagom, u dva ispitivanja koja su u tijeku (ELT116826 i ELT116643), u 1/28 (4%) i 1/62 (2%) bolesnika dijagnosticiran je MDS ili AML u svakom od ispitivanja.
The dose regimen of concomitant ITP medicinal products should be modified, as medically appropriate, to avoid excessive increases in platelet counts during therapy with eltrombopag.
Shodno tome treba prilagoditi dozu ostalih lijekova za liječenje ITP-a kako bi se izbjegao prekomjerni porast broja trombocita tijekom terapije eltrombopagom.
The influence of Asian ethnicity (such as Japanese, Chinese, Taiwanese and Korean) on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 111 healthy adults (31 Asians) and 88 patients with ITP (18 Asians).
Utjecaj etničke (azijske) pripadnosti (poput Japanaca, Kineza, Tajvanaca i Korejaca) na farmakokinetiku eltrombopaga procjenjivan je koristeći podatke iz populacijske analize farmakokinetike 111 zdravih odraslih osoba (31 iz Azije) i 88 bolesnika s ITP-om (18 osoba iz Azije).
Eltrombopag should be terminated if antiviral therapy is discontinued for hepatic decompensation.
Eltrombopag treba prestati davati ako se prekine liječenje antivirusnim lijekovima zbog dekompenzacije jetre.
The influence of age on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 28 healthy subjects, 673 patients with HCV, and 41 patients with chronic liver disease of other aetiology ranging from 19 to 74 years old.
Utjecaj dobi na farmakokinetiku eltrombopaga procijenjen je koristeći analizu populacijske farmakokinetike na 28 zdravih ispitanika, 673 bolesnika s HCV-om i 41 bolesnik s kroničnom bolešću jetre druge etiologije u rasponu od 19 do 74 godina starosti.
No dose adjustment is necessary in patients with renal impairment.
Nije potrebna prilagodba doze za bolesnike s bubrežnim oštećenjem.
Adults and paediatric population aged 6 to 17 years The recommended starting dose of eltrombopag is 50 mg once daily.
Odrasli i pedijatrijska populacija u dobi od 6 do 17 godina Preporučena početna doza eltrombopaga je 50 mg jednom dnevno.
Overall, a significantly greater proportion of eltrombopag patients (40%) compared with placebo patients (3%) achieved the primary endpoint (Odds Ratio: 18.0 [95% CI: 2.3, 140.9] p <0.001) which was similar across the three age cohorts (Table 6).
Ukupno je značajno veći udio bolesnika na eltrombopagu (40%) u usporedbi s onima na placebu (3%) postigao mjeru primarnog ishoda (omjer izgleda: 18,0 [95% CI: 2,3; 140,9] p <0,001), što je bilo slično u sve tri dobne kohorte (tablica 6).
In a placebo-controlled study (n=288, Safety population), following 2 weeks' treatment in preparation for invasive procedures, 6 of 143 (4%) adult patients with chronic liver disease receiving eltrombopag experienced 7 TEEs of the portal venous system and 2 of 145 (1%) patients in the placebo group experienced 3 TEEs.
U placebom kontroliranoj studiji (n=288, sigurnosna skupina), nakon 2 tjedna liječenja u okviru priprema za invazivne zahvate, 6 od 143 (4%) odraslih bolesnika s kroničnom jetrenom bolešću koji su primali eltrombopag, doživjelo je 7 tromboembolijskih događaja u sustavu portalne vene dok su 2 od 145 (1%) bolesnika u placebo grupi doživjela 3 tromboembolijska događaja.
A decrease in eltrombopag exposure was observed with co-administration of 200 mg and 600 mg ciclosporin (a BCRP inhibitor).
Smanjenje izloženosti eltrombopagu uočeno je kod istodobne primjene s ciklosporinom (BCRP inhibitor) u dozi od 200 mg i 600 mg.
• eye problems, including cloudy lens in the eye (cataract), dry eye, small yellow deposits in the retina, yellowing of the whites of the eye
• problemi s očima, uključujući zamućenje očne leće (katarakta), suhoću očiju, male žute nakupine na mrežnici, žutilo bjeloočnica
The median baseline platelet count was 59,500/µl in both treatment groups: 0.8%, 28% and 72% of the patients recruited had platelet counts <20,000/µl, <50.000/µl and ≥50,000/µl respectively.
Medijan početnog broja trombocita bio je 59 500/µl u obje terapijske skupine: 0,8% uključenih bolesnika imalo je broj trombocita <20 000/µl, 28% <50 000/µl, a 72% ≥50 000/µl.
If immature or dysplastic cells are observed, peripheral blood smears should be examined for new or worsening morphological abnormalities (e.g. teardrop and nucleated red blood cells, immature white blood cells) or cytopenia(s).
Ako se primijete nezrele ili displastične stanice, potrebno je prekontrolirati periferni razmaz krvi radi eventualne pojave novih ili pogoršanja postojećih morfoloških abnormalnosti (npr. pojava eritrocita s jezgrom ili u obliku suze, nezrelih leukocita) ili citopenije.
Patients were diagnosed with chronic ITP for at least 1 year and were refractory or relapsed to at least one prior ITP therapy or unable to continue other ITP treatments for a medical reason and had platelet count <30,000/µl.
Bolesnicima je dijagnosticiran kronični ITP najmanje 1 godinu i bili su refraktorni ili imali relaps na najmanje jednoj prethodnoj terapiji za ITP ili nisu mogli nastaviti druge terapije za ITP iz medicinskog razloga te su imali broj trombocita <30 000/µl.
Take Revolade
Uzeti Revolade
Co-administration of a single dose of eltrombopag 200 mg with telaprevir 750 mg every 8 hours did not alter plasma telaprevir exposure.
Istodobna primjena jedne doze eltrombopaga od 200 mg s telaprevirom u dozi od 750 mg svakih 8 sati nije promijenila izloženost telapreviru u plazmi.
Plasma eltrombopag concentration-time data collected in 590 patients with HCV enrolled in phase III studies TPL103922/ENABLE 1 and TPL108390/ENABLE 2 were combined with data from patients with HCV enrolled in the phase II study TPL102357 and healthy adult patients in a population PK analysis.
Podaci o koncentraciji eltrombopaga u plazmi tijekom vremena za 590 bolesnika s HCV-om uključenih u fazu III ispitivanja TPL103922/ENABLE 1 i TPL108390/ENABLE 2 bile su združene s podacima bolesnika s HCV-om uključenih u fazu II ispitivanja TPL102357 i zdravih odraslih ispitanika u populaciji za PK analizu.
≤ 35g/l > 35g/l MELD score f a Eltrombopag given in combination with peginterferon alfa-2a (180 μg once weekly for 48 weeks for genotypes 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1200 mg daily in 2 divided doses orally) b Eltrombopag given in combination with peginterferon alfa-2b (1.5 μg/kg once weekly for 48 weeks for genotype 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1400 mg orally in 2 divided doses) c Target platelet count was 90,000/µl for ENABLE 1 and 100,000/µl for ENABLE 2.
≤35 g/l >35 g/l MELD indeks f a Eltrombopag dan u kombinaciji s peginterferonom alfa-2a (180 μg jednom tjedno tijekom 48 tjedana za genotip 1/4/6; 24 tjedna za genotip 2/3) uz ribavirin (800 do 1200 mg dnevno u 2 odvojene peroralne doze) b Eltrombopag dan u kombinaciji s peginterferonom alfa-2b (1,5 μg/kg jednom tjedno tijekom 48 tjedana za genotip 1/4/6; 24 tjedna za genotip 2/3) uz ribavirin (800 do 1400 mg peroralno u 2 odvojene doze) c Ciljni broj trombocita bio je 90 000/µl u ENABLE 1 i 100 000/µl u ENABLE 2.
Increase daily dose by 25 mg to a maximum of 75 mg/day*.
Povećati dnevnu dozu za 25 mg do maksimalno 75 mg/dan*.
Following the administration of a single 50 mg dose, the AUC0- of eltrombopag was 41% higher in patients with mild hepatic impairment and 80% to 93% higher in patients with moderate to severe hepatic impairment compared with healthy volunteers.
Nakon jednokratne primjene doze od 50 mg, AUC0- eltrombopaga je bila 41% viša u bolesnika s blagim oštećenjem jetre, i 80% do 93% viša u bolesnika s umjerenim do teškim oštećenjem jetre, u odnosu na zdrave dobrovoljce.
The following side effects have been reported to be associated with treatment with Revolade in combination with peginterferon and ribavirin in patients with HCV:
Za sljedeće nuspojave zabilježeno je da su povezane s liječenjem lijekom Revolade u kombinaciji s peginterferonom i ribavirinom u bolesnika s hepatitisom C:
Common Blood alkaline phosphatase increased Uncommon Blood albumin increased, protein total increased, blood albumin decreased, pH urine increased
Pretrage često porast alkalne fosfataze u krvi manje često porast albumina u krvi, povišenje ukupnih proteina, sniženje albumina u krvi, porast pH mokraće
CYP1A2 and CYP2C8 inhibitors and inducers
Inhibitori i induktori CYP1A2 i CYP2C8
On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose reductions should be avoided.
Nakon započinjanja antivirusnog liječenja broj trombocita može pasti tako da treba izbjegavati neposredno smanjivanje doze eltrombopaga.
Table 1 Dose adjustments of eltrombopag in ITP patients
Tablica 1 Prilagodba doze eltrombopaga u bolesnika s ITP-om
All events were resolved without sequelae following treatment.
Svi navedeni događaji prošli su bez posljedica i bez potrebe za daljnjim liječenjem.
On initiation of antiviral therapy the platelet count may fall, so immediate eltrombopag dose adjustments should be avoided (see Table 2).
Nakon započinjanja antivirusnog liječenja broj trombocita može pasti tako da treba izbjegavati neposredno prilagođavanje doze eltrombopaga (vidjeti tablicu 2).
TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand for the TPO-R. Eltrombopag interacts with the transmembrane domain of the human TPO-R and initiates signalling cascades similar but not identical to that of endogenous thrombopoietin (TPO), inducing proliferation and differentiation from bone marrow progenitor cells.
Eltrombopag reagira s transmembranskom domenom humanog TPO-R i započinje signalnu kaskadu sličnu, iako ne i identičnu, djelovanju endogenog trombopoetina, potičući proliferaciju i diferencijaciju iz progenitorskih stanica koštane srži.
Higher risk of blood clots
Povišeni rizik od stvaranja krvnih ugrušaka
In the 3 controlled clinical ITP studies, transient decreases in platelet counts to levels lower than baseline were observed following discontinuation of treatment in 8% and 8% of the eltrombopag and placebo groups, respectively (see section 4.4).
U 3 kontrolirana klinička ispitivanja ITP-a, nakon prekida liječenja zabilježen je prolazni pad broja trombocita na vrijednosti niže od ishodišnih u 8% bolesnika na eltrombopagu i 8% ispitanika na placebu (vidjeti dio 4.4).
If platelet counts drop to <30,000/µl, haemoglobin drops to <9 g/dl or absolute neutrophil count (ANC) to <0.5 x 10
Ako broj trombocita padne na <30 000/µl, hemoglobin padne na <9 g/dl ili apsolutni broj neutrofila (ABN) na <0,5 x 10
The median baseline platelet count was 19,000/l prior to eltrombopag administration.
Medijan početnog broja trombocita iznosio je 19 000/l prije primjene eltrombopaga.
The most important serious adverse reactions identified were hepatotoxicity and thrombotic/thromboembolic events.
Najvažnije uočene ozbiljne nuspojave bile su hepatotoksičnost i trombotični/tromboembolijski događaji.
Powder for oral suspension
Prašak za oralnu suspenziju.
In two placebo-controlled studies in paediatric patients (aged 1 to 17 years) with chronic ITP, ALT 3 x ULN was reported in 4.7% and 0% of the eltrombopag and placebo groups, respectively.
U dva placebo kontrolirana ispitivanja u pedijatrijskih bolesnika (u dobi od 1 do 17 godina) s kroničnim ITP-om, povišenje ALT-a 3 x GGN bilo je prijavljeno u 4,7% slučajeva u eltrombopag skupini i 0% slučajeva u placebo skupini.
• swelling, pain or tenderness in one leg
• oticanje, bol ili osjetljivost u jednoj nozi
During the randomised period of the study, patients were randomised by three age cohort strata (2:1) to eltrombopag (n=45) or placebo (n=22).
Tijekom randomiziranog razdoblja ispitivanja bolesnici su bili randomizirani prema tri stratuma dobnih kohorti (2:1) na eltrombopag (n=45) ili placebo (n=22).
Table 2 Dose adjustments of eltrombopag in HCV patients during antiviral therapy
Tablica 2 Prilagodba doze eltrombopaga u bolesnika s HCV-om tijekom antivirusnog liječenja Broj trombocita
1 reusable mixing bottle with lid and cap (notethe mixing bottle may become stained)
1 bočicu za miješanje za višekratnu uporabu s poklopcem i zatvaračem (napomena - bočica za miješanje može potamniti)
• 75 mg dose - 3 sachets
• Doza od 75 mg - 3 vrećice
Cytogenetic abnormalities and progression to MDS/AML in patients with SAA
Citogenetske abnormalnosti i progresija u MDS/AML u bolesnika s teškom aplastičnom anemijom
Administration of a single 50 mg dose of eltrombopag in tablet form with a standard high-calorie, high-fat breakfast that included dairy products reduced plasma eltrombopag mean AUC0-∞ by 59% and mean Cmax by 65%.
Primjena jedne doze od 50 mg eltrombopaga u obliku tablete sa standardnim visoko kaloričnim doručkom s visokim udjelom masnoća koji je uključivao mliječne proizvode smanjila je srednji plazmatski AUC0-∞ eltrombopaga za 59% te srednji Cmax za 65%.
Decrease the daily dose by 25 mg.
Smanjiti dnevnu dozu za 25 mg.