natgillin/translations-raw huggingface dataset:
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženosti dozama koje su znatno više od maksimalno dopuštenih u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
Lusutrombopag should be used when risk for bleeding is considered to be high according to clinical laboratory test values such as platelet counts and of the coagulation-fibrinolysis system, clinical symptoms and type of invasive procedure.
Lusutrombopag treba primijeniti kad se rizik od krvarenja smatra visokim prema rezultatima kliničkih laboratorijskih testova kao što su broj trombocita i vrijednosti parametara sustava koagulacije i fibrinolize, kliničkim simptomima i vrsti invazivnog postupka.
• pain in the abdomen (tummy), swollen abdomen, blood in your stools.
• bol u trbuhu (abdomenu), otečen trbuh, krv u stolici.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po tableti, tj. sadrži zanemarive količine natrija.
In the placebo group, 94/107 subjects (87.9%) received the study drug for 7 days.
U skupini koja je primala placebo, 94/107 ispitanika (87,9%) primalo je ispitivani lijek 7 dana.
How to take Mulpleo
Kako uzimati Mulpleo
Thus, the data from the toxicology program in these animals do not present potential adverse effects related to exaggerated pharmacology in humans.
Stoga podaci iz programa toksikoloških ispitivanja u ovih životinja ne predstavljaju moguće nuspojave povezane s pojačanim farmakodinamičkim učincima lusutrombopaga u ljudi.
Use in patients with chronic liver disease undergoing invasive procedures
Primjena u bolesnika s kroničnom bolešću jetre u kojih se provode invazivni postupci
The pharmacokinetic parameters in patients with chronic liver disease are shown in Table 6.
Farmakokinetički parametri u bolesnika s kroničnom bolešću jetre prikazani su u tablici 6.
• Blood clot in the liver (portal vein thrombosis)
• krvni ugrušak u jetri (tromboza portalne vene) • osip.
These patients should be clinically monitored when treated with lusutrombopag.
Te je bolesnike potrebno klinički pratiti kod liječenja lusutrombopagom.
Meanwhile, the short thoracolumbar supernumerary ribs were observed at doses without maternal toxicity.
Isto tako, opažena su kratka prekobrojna torakolumbalna rebra uz doze pri kojima nije bilo toksičnosti za majku.
The key secondary endpoints in Studies M0631 and M0634 were
Ključne mjere sekundarnih ishoda u ispitivanjima M0631 i M0634 bile su:
Treatment Group
Terapijska skupina
Lusutrombopag has low potential to inhibit CYP enzymes (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4/5), and to induce both CYP enzymes (CYP1A2, 2C9, and 3A4) and UGT enzymes (UGT1A2, 1A6, and 2B7).
Lusutrombopag ima niski potencijal za inhibiciju enzima CYP-a (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 i 3A4/5) te za indukciju enzima CYP-a (CYP1A2, 2C9 i 3A4) i enzima UGT-a (UGT1A2, 1A6 i 2B7).
Do not breast-feed during treatment with Mulpleo, as it is not known if the medicine passes into milk.
Nemojte dojiti za vrijeme liječenja lijekom Mulpleo jer nije poznato prelazi li ovaj lijek u majčino mlijeko.
Neither food (including high-fat and high-calorie diet) nor co-administration with calcium has a clinically meaningful effect on the pharmacokinetics of lusutrombopag.
Ni hrana (uključujući visokokaloričnu prehranu s velikim udjelom masti) ni istodobna primjena s kalcijem nisu imali klinički značajan učinak na farmakokinetiku lusutrombopaga.
In rats, results indicated that lusutrombopag and its metabolites transfer to fetus via placenta.
U štakora su rezultati pokazali da lusutrombopag i njegovi metaboliti prolaze preko posteljice u fetus.
Warnings and precautions Talk to your doctor: - if you are at risk of blood clots in your veins or arteries, or if you previously have had blood clots - if you have severe liver disease - if your spleen has been removed - if you are having interferon treatment.
- ako je kod Vas prisutan rizik od nastanka krvnih ugrušaka u venama ili arterijama ili ako ste prije imali krvne ugruške - ako imate tešku bolest jetre - ako Vam je uklonjena slezena
Interferon preparations have been known to reduce platelet counts, therefore, this should be considered when co-administering lusutrombopag with interferon preparations.
Poznato je da pripravci interferona smanjuju broj trombocita pa je to potrebno uzeti u obzir kad se lusutrombopag primjenjuje istodobno s pripravcima interferona.
Due to limited information available, the safety and efficacy of Mulpleo in patients with severe hepatic impairment (Child-Pugh class C) have not been established (see sections 4.4 and 5.1).
Zbog ograničenosti dostupnih informacija, sigurnost i djelotvornost lijeka Mulpleo u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) nisu ustanovljene (vidjeti dijelove 4.4 i 5.1).
Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Mulpleo sadrži djelatnu tvar lusutrombopag, koja pripada skupini lijekova pod nazivom agonisti trombopoetinskih receptora.
Pregnancy and breast-feeding Do not take Mulpleo if you are pregnant unless your doctor specifically recommends it.
Nemojte uzimati Mulpleo ako ste trudni, osim ako Vam je to liječnik posebno preporučio.
This limited data suggested no abnormal pattern of platelet count rise in this subpopulation.
Ovi ograničeni podaci nisu ukazali na poremećeni obrazac povećanja broja trombocita u ove podpopulacije.
Lusutrombopag was not genotoxic when tested in a bacterial reverse mutation test, a chromosomal aberration test with cultured Chinese hamster lung cells, or an in vivo micronucleus test with mouse bone marrow cells.
Lusutrombopag nije bio genotoksičan kad je testiran testom bakterijske reverzne mutacije, testom kromosomske aberacije na uzgojenim stanicama pluća kineskog hrčka ili in vivo mikronukleusnim testom na stanicama koštane srži miša.
- The other ingredients are: - Tablet core: mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropylcellulose, carmellose calcium and magnesium stearate - Film coating: hypromellose, titanium dioxide, triethyl citrate, talc and red-ferric oxide (E172)
- Drugi sastojci su: - Jezgra tablete: manitol, mikrokristalična celuloza, magnezijev oksid, natrijev laurilsulfat, hidroksipropilceluloza, karmelozakalcij i magnezijev stearat - Film-ovojnica: hipromeloza, titanijev dioksid, trietilcitrat, talk i crveni željezov oksid (E172)
Geometric mean (%CV) other than for Tmax, which is median (range).
n = 9 Geometrijska sredina (% koeficijenta varijacije) za sve osim Tmax, za koji je prikazan medijan (raspon).
The procedure should be performed from day 9 after the start of lusutrombopag treatment.
Invazivni postupak provodi se od 9. dana po uvođenju liječenja lusutrombopagom.
In vitro studies revealed that CYP4 enzymes including CYP4A11 and partially CYP3A4 enzyme contributed to ω-oxidation to form 6-hydroxylated lusutrombopag.
In vitro ispitivanja pokazala su da su ω-oksidaciji pridonijeli enzimi CYP4 uključujući CYP4A11 i djelomično enzim CYP3A4, pri čemu je nastao 6-hidroksilirani lusutrombopag.
Studies in animals have shown lusutrombopag is secreted in the milk of lactating rats (see section 5.3).
Ispitivanja na životinjama pokazala su da se lusutrombopag izlučuje u mlijeko ženki štakora tijekom laktacije (vidjeti dio 5.3).
The European Medicines Agency has waived the obligation to submit the results of studies with Mulpleo in all subsets of the paediatric population for thrombocytopenia secondary to liver disease (see section 4.2 for information on paediatric use).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Mulpleo u svim podskupinama pedijatrijske populacije za trombocitopeniju kao posljedicu bolesti jetre (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
The p value and confidence interval were calculated using the Wald method.
Vrijednost p i rasponi pouzdanosti izračunani su pomoću Waldove metode.
In Study M0631, 96 subjects received lusutrombopag or placebo once daily: 48 subjects in the lusutrombopag group and 48 subjects in the placebo group.
U ispitivanju M0631, lusutrombopag ili placebo jedanput na dan primalo je 96 ispitanika: 48 ispitanika u skupini liječenoj lusutrombopagom i 48 ispitanika u skupini koja je primala placebo.
Mulpleo is for oral use.
Mulpleo namijenjen je za peroralnu primjenu.
Lusutrombopag is not considered to affect the pharmacokinetics of co-administered medicinal products that are substrates of these enzymes or transporters.
Smatra se da lusutrombopag ne utječe na farmakokinetiku istodobno primijenjenih lijekova koji su supstrati ovih enzima ili prijenosnika.
In order to allow an overall comparison of the results across Studies M0631 and M0634, as presented in Table 2 to Table 5, data from study M0631 was reanalysed according to the primary endpoint for study M0634.
Da bi se mogla provesti ukupna usporedba rezultata ispitivanja M0631 i M0634, prikazanih u tablicama 2 do 5, podaci iz ispitivanja M0631 ponovno su analizirani prema mjeri primarnog ishoda u ispitivanju M0634.
Each box contains 7 film-coated tablets.
Jedna kutija sadrži 7 filmom obloženih tableta.
Table 6 Pharmacokinetic parameters of lusutrombopag after 3 mg dose once daily in thrombocytopenic patients with chronic liver disease (Study M0634)
Tablica 6 Farmakokinetički parametri lusutrombopaga nakon doze od 3 mg jedanput na dan u trombocitopeničnih bolesnika s kroničnom bolešću jetre (ispitivanje M0634)
In Study M0634, 215 subjects were randomised in the study: 108 in the lusutrombopag 3 mg group and 107 in the placebo group.
U ispitivanju M0634 bilo je randomizirano 215 ispitanika: 108 u skupinu liječenu lusutrombopagom u dozi od 3 mg i 107 u skupinu koja je primala placebo.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Ispitivanja na životinjama su nedostatna za konačan zaključak o reproduktivnoj toksičnosti. (vidjeti dio 5.3).
In faeces, the components of radioactivity were unchanged lusutrombopag (16% of administered radioactivity) and β-oxidation related metabolites (35% of administered radioactivity), suggesting that lusutrombopag is metabolised by ω-oxidation first, and subsequently metabolised by β-oxidation of O-hexyl side chain.
Komponente radioaktivnosti u stolici činili su nepromijenjeni lusutrombopag (16% primijenjene radioaktivnosti) i metaboliti povezani s β-oksidacijom (35% primijenjene radioaktivnosti), što ukazuje na to da se lusutrombopag prvo metabolizira ω-oksidacijom, nakon čega se β-oksidacijom metabolizira O-heksilni postranični lanac.
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures (see section 5.1).
Mulpleo indiciran je za liječenje teške trombocitopenije u odraslih bolesnika s kroničnom bolešću jetre koji se podvrgavaju invazivnim postupcima (vidjeti dio 5.1).
Phase 3 Study M0634
Faza 3 ispitivanja M0634
Microcrystalline cellulose Magnesium oxide Sodium lauryl sulfate Hydroxypropylcellulose Carmellose calcium Magnesium stearate
Jezgra tablete manitol mikrokristalična celuloza magnezijev oksid natrijev laurilsulfat hidroksipropilceluloza karmelozakalcij magnezijev stearat
Table 1 Adverse reactions System Organ Class
Tablica 1 Nuspojave Klasifikacija organskih sustava
Portal vein thrombosis Skin and subcutaneous tissue disorders Rash a Category of frequency: very common (≥1/10), common (≥1/100 to <1/10) , uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) , and very rare (<1/10,000)
Poremećaji kože i potkožnog tkiva osip a Kategorija učestalosti: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100),
In the lusutrombopag group, 73/107 subjects (68.2%) received the study drug for 7 days.
U skupini liječenoj lusutrombopagom, 73/107 ispitanika (68,2%) primalo je ispitivani lijek 7 dana.
Lusutrombopag was excreted mainly via faecal route in humans (approximately 83% into faeces and 1% into urine).
Lusutrombopag se u ljudi uglavnom izlučio stolicom (približno 83% u stolici i 1% u mokraći).
The film-coated tablet is to be taken once daily with liquid, swallowed whole and should not be chewed, divided, or crushed.
Tableta se mora progutati cijela i ne smije se žvakati, lomiti ni drobiti.
Lusutrombopag therapy should only be initiated in patients with severe hepatic impairment if the expected benefit outweighs the expected risks (see sections 4.4 and 5.2).
Terapija lusutrombopagom smije se započeti u bolesnika s teškim oštećenjem funkcije jetre samo ako je očekivana korist veća od očekivanih rizika (vidjeti dijelove 4.4 i 5.2).
There are no or limited amount of data from the use of lusutrombopag in pregnant women.
Nema podataka ili su podaci o primjeni lusutrombopaga u trudnica ograničeni.
A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity.
Do supresije intrauterinog rasta fetusa i nastanka vratnih rebara dolazilo je uz doze (40 mg/kg na dan ili više) pri kojima se pokazala toksičnost za majku.
Table 5 Duration of the increase in platelet count to ≥ 50,000/µL
Tablica 5 Trajanje povećanja broja trombocita na ≥ 50 000/µl
It is unknown whether lusutrombopag or its metabolites are excreted in human milk.
Nije poznato izlučuju li se lusutrombopag ili njegovi metaboliti u majčino mlijeko.
The efficacy and safety of lusutrombopag have not been established when administered in patients with a history of splenectomy.
Djelotvornost i sigurnost lusutrombopaga nisu ustanovljene kad se primjenjivao splenektomiranim bolesnicima.
Due to the unstable nature of these patients, they should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
Zbog nestabilnosti njihova stanja, tim je bolesnicima potrebna potpora u skladu s kliničkom praksom koja se sastoji od pažljivog praćenja bolesnika zbog moguće pojave ranih znakova pogoršanja ili nastupa hepatičke encefalopatije, ascitesa i sklonosti trombozi ili krvarenju, što se provodi putem testova jetrene funkcije, koagulacijskih pretraga i, po potrebi, slikovnih pretraga portalnih krvnih žila.
Lusutrombopag showed no teratogenicity in rats and rabbits at up to 80 mg/kg/day and 1000 mg/kg/day respectively.
Lusutrombopag se nije pokazao teratogenim u štakora i kunića pri dozama do 80 mg/kg na dan odnosno 1000 mg/kg na dan.
The accumulation ratios of the Cmax and the AUC are approximately 2 at once-daily multiple doses and the steady-state of the plasma concentration of lusutrombopag appear to be achieved after Day 5.
Omjeri akumulacije za Cmax i AUC iznose približno 2 kod primjene višekratnih doza uz doziranje jedanput na dan i čini se da se dinamička ravnoteža koncentracije lusutrombopaga u plazmi postiže nakon 5. dana.
Lusutrombopag is an orally active TPO receptor agonist.
Lusutrombopag je peroralno djelatan agonist receptora TPO.
LUSU = lusutrombopag [a] Proportion of subjects who required no platelet transfusion prior to the primary invasive procedure and no rescue therapy (including platelet transfusion) for bleeding from randomisation through 7 days after the primary invasive procedure.
LUSU = lusutrombopag [a] Udio ispitanika kojima nije bila potrebna ni transfuzija trombocita prije primarnog invazivnog postupka ni hitna terapija (uključujući i transfuziju trombocita) zbog krvarenja od trenutka randomizacije do 7 dana nakon primarnog invazivnog postupka.
Both Cmax and AUC for lusutrombopag increase dose-proportionally over dose range of multiple oral dose of 0.25 to 4 mg once daily in patients with chronic liver disease.
I Cmax i AUC lusutrombopaga povećavaju se proporcionalno dozi u rasponu doza od 0,25 do 4 mg jedanput na dan nakon višekratne peroralne primjene u bolesnika s kroničnom bolešću jetre.
One patient had mesenteric vein thrombosis reported as a TEAE in the lusutrombopag 4 mg group; two patients had mesenteric vein thrombosis reported as a TEAE in the placebo group (see section 4.4).
Jedan je bolesnik imao trombozu mezenteričke vene zabilježenu kao TEAE u skupini liječenoj lusutrombopagom u dozi od 4 mg; dva su bolesnika imala trombozu mezenteričke vene zabilježenu kao TEAE u skupini koja je primala placebo (vidjeti dio 4.4).
The most common adverse reactions were headache (4.7%, 8/171 patients in the lusutrombopag group; 3.5%, 6/170 patients in the placebo group), nausea (2.3%, 4/171 patients in the lusutrombopag group; 4.1%, 7/170 patients in the placebo group), portal vein thrombosis (1.2%, 2/171 patients in the lusutrombopag group; 1.2%, 2/170 patients in the placebo group) and rash (1.2%, 2/171 patients in the lusutrombopag group; 0%, 0/170 patients in the placebo group).
3,5%, 6/170 bolesnika u skupini koja je primala placebo), mučnina (2,3%, 4/171 bolesnika u skupini liječenoj lusutrombopagom; 4,1%, 7/170 bolesnika u skupini koja je primala placebo), tromboza portalne vene (1,2%, 2/171 bolesnika u skupini liječenoj lusutrombopagom; 1,2%, 2/170 bolesnika u skupini koja je primala placebo) i osip (1,2%, 2/171 bolesnika u skupini liječenoj lusutrombopagom; 0%, 0/170 bolesnika u skupini koja je primala placebo).
No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim (Child-Pugh stadij A) do umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
Randomisation was stratified by platelet count at screening/baseline and primary invasive procedure.
Randomizacija je bila stratificirana prema broju trombocita na probiru/početku ispitivanja i primarnom invazivnom postupku.
Ratios of AUC relative to the healthy matched control group were 1.05 in subjects with mild hepatic impairment and 1.20 in subjects with moderate hepatic impairment.
Omjeri AUC-a u odnosu na zdravu podudarnu kontrolnu skupinu bili su 1,05 u ispitanika s blagim oštećenjem funkcije jetre i 1,20 u ispitanika s umjerenim oštećenjem funkcije jetre.
Keep this medicine out of the sight and reach of children.
Kako čuvati Mulpleo Lijek čuvajte izvan pogleda i dohvata djece.
Lusutrombopag has also low potential to inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K, and BSEP.
Lusutrombopag također ima niski potencijal za inhibiciju P-gp-a, BCRP-a, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K i BSEP-a.
Platelet Count (*10^4/uL)
Broj trombocita (*10^4/µl)
Mulpleo should not be administered to breast-feeding women as it was excreted in mammary milk in animals.
Mulpleo ne smije se primjenjivati u dojilja jer se u sisavaca izlučivao u mlijeko.
In the pre- and postnatal development study in rats at doses up to 40 mg/kg/day, there were adverse effects of lusutrombopag on postnatal development at 40 mg/kg/day as follow: prolongation of gestation period in dams, low viability before weaning, delayed postnatal growth such as delayed negative geotaxis or delayed eyelid opening, low pup body weight, low female fertility index, a tendency to low number of corpora lutea or implantations, and a tendency to increased preimplantation loss rate and an abnormal clinical sign such as prominent annular rings on tail after weaning.
U ispitivanju utjecaja lusutrombopaga u dozama do 40 mg/kg na dan na prenatalni i postnatalni razvoj štakora, štetni učinci lusutrombopaga u dozi od 40 mg/kg na dan na postnatalni razvoj bili su sljedeći: produljenje razdoblja gestacije u majki, mala sposobnost preživljavanja prije prestanka sisanja, zaostajanje u postnatalnom rastu poput kasnije negativne geotaksije ili kasnijeg otvaranja očiju, mala tjelesna težina mladunčadi, nizak indeks plodnosti u ženki, tendiranje malom broj žutih tijela ili implantacija te povećanoj stopi predimplantacijskih gubitaka i abnormalni klinički znakovi kao što su izraženi anularni prsteni na repu nakon prestanka sisanja.
In the clinical drug-drug interaction study, co-administration of cyclosporine, a P-gp and BCRP dual inhibitor, increased the Cmax and AUCinf values of lusutrombopag by approximately 20% compared with lusutrombopag administration alone.
istodobnom primjenom ciklosporina, koji je dvostruki inhibitor i P-gp-a i BCRP-a, povećale su se vrijednosti Cmax i AUCinf lusutrombopaga za približno 20% u usporedbi s onima kad se lusutrombopag primjenjivao sam.
Lusutrombopag does not stimulate platelet production in the species used for toxicological testing because of unique human TPO receptor specificity.
Lusutrombopag ne potiče stvaranje trombocita u vrsta koje se koriste u toksikološkim testiranjima zato što ljudski TPO receptor ima jedinstvene značajke.
The primary endpoint in Study M0631 was the proportion of subjects who required no platelet transfusion (i.e. achieved platelet count >50,000/µL) before the primary invasive procedure.
Mjera primarnog ishoda u ispitivanju M0631 bila je udio ispitanika kojima nije bila potrebna transfuzija trombocita (tj. postignut broj trombocita bio je > 50 000/µl) prije primarnog invazivnog postupka.
Among the 48 subjects in the lusutrombopag group, 40 subjects received lusutrombopag for 7 days, 4 subjects for 6 days, 1 subject for 5 days, and 3 subjects for 4 days.
Od 48 ispitanika u skupini liječenoj lusutrombopagom, 40 ispitanika primalo je lusutrombopag 7 dana, 4 ispitanika 6 dana, 1 ispitanik 5 dana, a 3 ispitanika 4 dana.
→ If you are already breast-feeding, talk to your doctor immediately.
→Ako već dojite, odmah se obratite liječniku.
Driving and using machines Mulpleo has no known effects on your ability to drive or to use machines.
Mulpleo nema poznatih učinaka na sposobnost upravljanja vozilima i rada strojevima.
Lusutrombopag has no phototoxic potential in the skin phototoxicity study in hairless mice at doses up to 500 mg/kg (96.3 µg/mL) (613 times the human clinical exposures in adults based on Cmax [0.157 µg/mL]).
Lusutrombopag nije pokazao fototoksični potencijal u ispitivanju kožne fototoksičnosti u bezdlakih miševa u dozama do 500 mg/kg (96,3 µg/ml) (izloženost 613 puta viša od kliničke izloženosti odraslih osoba na temelju Cmax [0,157 µg/ml]).
Adverse reactions with 3 mg of lusutrombopag once daily for up to 7 days in randomised, doubleblind, placebo-controlled trials in thrombocytopenic patients with chronic liver disease undergoing an invasive procedure (M0626, M0631 and M0634; N=171) are listed in Table 1 by MedDRA System Organ Class.
Nuspojave lusutrombopaga primjenjivanog do 7 dana u dozi od 3 mg jedanput na dan u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima u trombocitopeničnih bolesnika s kroničnom bolešću jetre koji su se podvrgavali invazivnom postupku (M0626, M0631 i M0634; N=171) navedene su u tablici 1 prema MedDRA-inoj klasifikaciji organskih sustava.
One subject in the lusutrombopag group withdrew from the study prior to administration of study drug.
Jedan ispitanik u skupini liječenoj lusutrombopagom povukao se iz ispitivanja prije primjene ispitivanog lijeka.
The differences in pharmacokinetics of a single 0.75 mg dose of lusutrombopag were relatively small in both subjects with mild hepatic impairment and subjects with moderate hepatic impairment, compared with the healthy matched control group.
Razlike u farmakokinetici jedne doze lusutrombopaga od 0,75 mg u ispitanika s blagim oštećenjem funkcije jetre i ispitanika s umjerenim oštećenjem funkcije jetre bile su relativno male u usporedbi sa zdravom podudarnom kontrolnom skupinom.
Administration of study drug was stopped if the platelet count was ≥ 50,000/µL together with an increase of ≥ 20,000/µL from baseline.
Primjena ispitivanog lijeka bila je zaustavljena ako je broj trombocita bio ≥ 50 000/µl zajedno s povećanjem za ≥ 20 000/µl od početne vrijednosti.