natgillin/translations-raw huggingface dataset:
Microcrystalline cellulose Magnesium oxide Sodium lauryl sulfate Hydroxypropylcellulose Carmellose calcium Magnesium stearate 
Sredica tablete manitol mikrokristalna celuloza magnezijev oksid natrijev lavrilsulfat hidroksipropilceluloza kalcijev karmelozat magnezijev stearat
Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists. 
Zdravilo Mulpleo vsebuje učinkovino lusutrombopag, ki pripada skupini zdravil, ki se imenujejo agonisti receptorja za trombopoetin.
Lusutrombopag 3 mg 
Zdravljena skupina lusutrombopag 3 mg placebo
NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi 
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Shionogi
- If you do become pregnant during treatment with Mulpleo, tell your doctor immediately. 
- Če vseeno zanosite med zdravljenjem z zdravilom Mulpleo, to nemudoma povejte zdravniku.
In the phase 2b study one patient had portal vein thrombosis reported as a treatment-emergent adverse event (TEAE) in the lusutrombopag 2 mg and 4 mg groups. 
V študiji faze 2b je imel en bolnik trombozo portalne vene, o kateri so poročali kot o neželenem učinku, ki se je pojavil med zdravljenjem (treatment-emergent adverse event - TEAE) v skupinah z lusutrombopagom v odmerku 2 mg in 4 mg.
Table 6 Pharmacokinetic parameters of lusutrombopag after 3 mg dose once daily in thrombocytopenic patients with chronic liver disease (Study M0634) 
Preglednica 6 Farmakokinetični parametri lusutrombopaga po 3-miligramskem odmerku enkrat na dan pri trombocitopeničnih bolnikih s kronično boleznijo jeter (študija M0634)
P value [a] Proportion of subjects who required no platelet transfusion during the study (i.e., from Day 1 through Day 35). 
Vrednost p [a] Delež bolnikov, ki niso potrebovali transfuzije trombocitov med študijo (tj. od 1. do vključno 35. dne).
Mild and moderate hepatic impairment (mild, Child-Pugh class A; moderate, Child-Pugh class B) is expected to have little effect on the pharmacokinetics of lusutrombopag. 
Pričakujemo, da bo blaga in zmerna okvara jeter (blaga, razred A po Child-Pughu; zmerna, razred B po Child-Pughu) le malo vplivala na farmakokinetiko lusutrombopaga.
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. 
V blatu so bile sestavine radioaktivnosti nespremenjeni lusutrombopag (16 % dane radioaktivnosti) in presnovki, povezani z β-oksidacijo (35 % dane radioaktivnosti), kar kaže, da se lusutrombopag presnavlja najprej z ω-oksidacijo, nato pa z β-oksidacijo O-heksilne stranske verige.
Lusutrombopag is an orally active TPO receptor agonist. 
Mehanizem delovanja Lusutrombopag je peroralno aktiven agonist receptorjev za TPO.
On Day 5 to Day 7, the platelet count was measured before administration of study drug. 
Od 5. do 7. dne so pred dajanjem raziskovanega zdravila izmerili število trombocitov.
Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures (see section 5.1). 
Zdravilo Mulpleo je indicirano za zdravljenje hude trombocitopenije pri odraslih bolnikih s kronično boleznijo jeter, pri katerih so potrebni invazivni posegi (glejte poglavje 5.1).
Thromboembolic and thrombotic complications are known to occur with thrombopoetin (TPO) receptor agonists based upon mechanism of action associated with increases in platelets. 
Znano je, da se trombembolični in trombotični zapleti pojavljajo pri agonistih receptorja za trombopoetin (TPO) na podlagi mehanizma delovanja, ki je povezan z zvečanjem števila trombocitov.
One subject in the lusutrombopag group withdrew from the study prior to administration of study drug. 
En bolnik v skupini z lusutrombopagom je prekinil sodelovanje v študiji pred dajanjem raziskovanega zdravila.
What Mulpleo looks like and contents of the pack 
Izgled zdravila Mulpleo in vsebina pakiranja
There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag. 
Podatkov o uporabi lusutrombopaga pri bolnikih, ki so bili predhodno izpostavljeni lusutrombopagu, je malo.
Other medicines and Mulpleo Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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). 
En bolnik je imel trombozo mezenterične vene, o kateri so poročali kot o TEAE, v skupini s 4 mg lusutrombopaga; dva bolnika sta imela trombozo mezenterične vene, o kateri so poročali kot o TEAE, v skupini s placebom (glejte poglavje 4.4).
Driving and using machines Mulpleo has no known effects on your ability to drive or to use machines. 
Zdravilo Mulpleo nima znanih učinkov na vašo sposobnost upravljanja vozil ali uporabe strojev.
A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity. 
Zaviranje intrauterine rasti ploda in vratna rebra so se pojavili pri odmerkih (40 mg/kg/dan ali več), ki so bili toksični za mater,
Lusutrombopag showed no teratogenicity in rats and rabbits at up to 80 mg/kg/day and 1000 mg/kg/day respectively. 
Lusutrombopag ni bil teratogen za podgane oziroma kunce v odmerkih do 80 mg/kg/dan oziroma 1000 mg/kg/dan.
You can also report side effects directly via the national reporting system listed in Appendix V. 
O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v
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] Delež bolnikov, ki niso potrebovali transfuzije trombocitov pred primarnim invazivnim posegom in nikakršnega rešilnega zdravljenja (vključno s transfuzijo trombocitov) za krvavitev od randomizacije do vključno 7. dne po primarnem invazivnem posegu.
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. 
V študiji pred- in poporodnega razvoja pri podganah pri odmerkih do 40 mg/kg/dan so bili neželeni učinki lusutrombopaga na poporodni razvoj pri 40 mg/kg/dan naslednji: podaljšanje obdobja brejosti pri samicah, zmanjšana sposobnost preživetja pred odstavitvijo, zapoznela poporodna rast, na primer zapoznela negativna geotaksija ali zapoznelo odpiranje vek, manjša telesna masa mladičev, zmanjšan indeks plodnosti samic, nagnjenost k zmanjšanemu številu rumenih telesc ali ugnezditev in nagnjenost k pogostejši izgubi zarodka pred ugnezditvijo in abnormalni klinični znaki, na primer izraziti obročasti kolobarji na repu po odstavitvi.
In rats, results indicated that lusutrombopag and its metabolites transfer to fetus via placenta. 
Pri podganah so rezultati pokazali, da lusutrombopag in njegovi presnovki prehajajo v plod skozi posteljico.
• swelling, pain, heat, redness, or tenderness in your leg 
• otekanje, bolečina, zvišana temperatura, rdečina ali občutljivost v vaši nogi;
This medicinal product may pose a risk to the environment (see section 5.3). 
6.6 Posebni varnostni ukrepi za odstranjevanje To zdravilo lahko predstavlja tveganje za okolje (glejte poglavje 5.3).
Day 
Dni
In Study M0634, 3 subjects with Child-Pugh class C liver disease were erroneously enrolled (all in the lusutrombopag group). 
V študijo M0634 so pomotoma vključili 3 bolnike z boleznijo jeter razreda C po Child-Pughovi lestvici (vse v skupino z lusutrombopagom).
A subject was considered a nonresponder if the subject met the responder criterion only after platelet transfusion. 
Bolnik je veljal za bolnika, ki se ni odzval na zdravljenje, če je izpolnil merilo za bolnika, ki se je odzval na zdravljenje, šele po transfuziji trombocitov.
The principal toxicity findings associated with lusutrombopag administration included prolongation of PT and APTT (rats), increased activities of plasma ALT and AST (rats and dogs), adrenal toxicity (rats and dogs), skin and forestomach lesions (rats) and renal toxicity (rats). 
Toksičnost ponavljajočih se odmerkov Poglavitne ugotovitve glede toksičnosti, povezane z dajanjem lusutrombopaga, so vključevale podaljšanje PT in APTT (podgane), zvečano aktivnost plazemske ALT in AST (podgane in psi), toksičnost za nadledvične žleze (podgane in psi), lezije kože in predželodca (podgane) in toksičnost za ledvice (podgane).
Study M0631 
Študija M0631
There are no or limited amount of data from the use of lusutrombopag in pregnant women. 
Podatkov o uporabi lusutrombopaga pri nosečnicah ni oziroma so omejeni.
How to take Mulpleo 
Kako jemati zdravilo Mulpleo
➤ Check with your doctor if this applies to you before you take Mulpleo 
➤ Posvetujte se z zdravnikom, če to velja za vas, preden vzamete zdravilo Mulpleo.
A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of age, gender or race on the pharmacokinetics of lusutrombopag. 
S populacijsko farmakokinetično analizo z uporabo plazemskih koncentracij lusutrombopaga iz kliničnih študij z lusutrombopagom niso ugotovili klinično pomembnega vpliva starosti, spola ali rase na farmakokinetiko lusutrombopaga.
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. 
Med 48 bolniki v skupini z lusutrombopagom je 40 bolnikov prejemalo lusutrombopag 7 dni, 4 bolniki 6 dni, 1 bolnik 5 dni in 3 bolniki 4 dni.
4.5 Interaction with other medicinal products and other forms of interaction 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Inhibitorji P-gp in BCRP
Mulpleo is for oral use. 
Zdravilo Mulpleo je namenjeno za peroralno uporabo.
Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis. 
Pri bolnikih s kronično boleznijo jeter obstaja tveganje tromboze portalne vene in tromboze mezenterične vene.
Each film-coated tablet contains 3 mg lusutrombopag. 
Ena filmsko obložena tableta vsebuje 3 mg lusutrombopaga.
Mulpleo should not be taken for more than 7 days. 
Trajanje zdravljenja Zdravilo Mulpleo se sme jemati največ 7 dni.
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. 
Razmerje AUC glede na zdravo kontrolno skupino s primerljivimi demografskimi podatki je bilo 1,05 pri preiskovancih z blago okvaro jeter in 1,20 pri preiskovancih z zmerno okvaro jeter.
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. 
Tako Cmax kot AUC lusutrombopaga se pri bolnikih s kronično boleznijo jeter zvečujeta sorazmerno z odmerkom, v razponu večkratnih peroralnih odmerkov 0,25 do 4 mg enkrat na dan.
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. 
kot je pač potrebno, skrbno spremljamo glede zgodnjih znakov poslabšanja ali novega pojava hepatične encefalopatije, ascitesa in nagnjenosti k trombozam ali krvavitvam s spremljanjem testov delovanja jeter, testov, ki se uporabljajo za ocenjevanje stanja strjevanja krvi in s slikanjem portalnega žilja.
Mulpleo 3 mg film-coated tablets are light red, 7 mm, round, film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed with the strength “3” on the other side. 
Mulpleo 3 mg filmsko obložene tablete so svetlordeče, 7 mm velike, okrogle filmsko obložene tablete z vtisnjeno blagovno znamko družbe Shionogi nad identifikacijsko šifro “551” na eni strani in z vtisnjeno jakostjo “3” na drugi strani.
What Mulpleo contains - The active substance is lusutrombopag. 
Kaj vsebuje zdravilo Mulpleo - Učinkovina je lusutrombopag.
Among the 48 subjects in the placebo group, 46 were treated for 7 days and 2 were treated for 4 days. 
Med 48 bolniki v skupini s placebom jih je 46 prejemalo placebo 7 dni, 2 bolnika pa 4 dni.
Lusutrombopag was not carcinogenic to mice at doses up to 20 mg/kg/day in males and females (a dose at least 45 times the human clinical exposures in adults based on AUC), or rats at doses up to 20 mg/kg/day in males and 2 mg/kg/day in females (a dose 49 and 30 times, respectively, the human clinical exposures in adults based on AUC). 
Lusutrombopag ni bil kancerogen za miši v odmerkih do 20 mg/kg/dan pri samcih in samicah (odmerek, vsaj 45-krat večji od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC) ali za podgane v odmerkih do 20 mg/kg/dan pri samcih in 2 mg/kg/dan pri samicah (odmerek, 49-krat oziroma 30-krat večji od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi AUC).
Light red, 7.0 mm round film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed on the other side with the strength “3”. 
Svetlordeče, 7,0 mm velike, okrogle filmsko obložene tablete z vtisnjeno blagovno znamko družbe Shionogi nad identifikacijsko šifro “551” na eni strani in z vtisnjeno jakostjo “3” na drugi strani.
Two Phase 3, randomised, double-blind, placebo-controlled studies were conducted to evaluate lusutrombopag versus placebo in thrombocytopenic (platelet count < 50,000/µL) subjects with chronic liver disease (Child-Pugh class A and B), undergoing elective invasive procedures (excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection) in Japan (M0631 (L-PLUS 1)) and multiple countries (M0634 (L-PLUS 2)). 
Opravili so dve randomizirani, dvojno slepi, s placebom kontrolirani študiji 3. faze za oceno lusutrombopaga proti placebu pri trombocitopeničnih (število trombocitov < 50.000/µl) bolnikih s kronično boleznijo jeter (razred A in B po Child-Pughu), ki so jim naredili elektivne invazivne posege (razen laparotomije, torakotomije, kraniotomije, operacije na odprtem srcu, resekcije organov ali delne resekcije organov) na Japonskem (M0631 (L-PLUS 1)) in v več drugih državah (M0634 (L-PLUS 2)).
A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of renal function on the pharmacokinetics of lusutrombopag. 
S populacijsko farmakokinetično analizo z uporabo plazemskih koncentracij lusutrombopaga iz kliničnih študij z lusutrombopagom niso ugotovili klinično pomembnega vpliva funkcije ledvic na farmakokinetiko lusutrombopaga.
Therefore, a potential interaction with either P-gp or BCRP inhibitors cannot be excluded, but no dose adjustment is necessary at the recommended clinical dosage of 3 mg in adults. 
P-gp bodisi BCRP, vendar pri priporočenem kliničnem odmerku 3 mg pri odraslih prilagajanje odmerka ni potrebno.
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]). 
Fototoksičnost Lusutrombopag v študiji fototoksičnosti za kožo pri golih miših ni imel fototoksičnega potenciala v odmerkih do 500 mg/kg (96,3 µg/ml) (613-krat večja izpostavljenost od kliničnih izpostavljenosti pri odraslih ljudeh na podlagi Cmax [0,157 µg/ml])
Study M0634 
Študija M0634
➤ Talk to your doctor before taking Mulpleo, if any of these applies. 
➤ Posvetujte se z zdravnikom, preden vzamete zdravilo Mulpleo, če velja kaj od naštetega.
A double dose should not be taken to make up for a missed dose. 
Ni dovoljeno vzeti dvojnega odmerka, da bi nadomestili pozabljeno tableto.
• pain in the abdomen (tummy), swollen abdomen, blood in your stools. 
• bolečina v trebuhu, otekel trebuh, kri v blatu.
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). 
Zdravljenje z lusutrombopagom smemo uvesti pri bolnikih s hudo okvaro jeter le, če pričakovana korist odtehta pričakovana tveganja (glejte poglavji 4.4
Lusutrombopag has also low potential to inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K, and BSEP. 
Lusutrombopag ima tudi majhen potencial za inhibicijo P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K in BSEP.
Randomisation was stratified by platelet count at screening/baseline and primary invasive procedure. 
Randomizacija je bila stratificirana po številu trombocitov ob presejanju /v izhodišču in primarnem invazivnem posegu.
No dosage adjustment is necessary in patients 65 years of age or older (see section 5.2). 
Pri bolnikih, starih 65 let ali več, prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
In rats, there were adverse effects of lusutrombopag on foetal intrauterine growth and skeletal morphology as follows: a suppression of foetal intrauterine growth (low foetal body weight and a decrease in the number of ossified sternebrae) at 80 mg/kg/day, and an high incidence of short cervical supernumerary ribs at 40 mg/kg/day or more, and an high incidence of short thoracolumbar supernumerary rib at 4 mg/kg/day or more. 
Pri podganah je lusutrombopag neugodno vplival na intrauterino rast ploda in morfologijo skeleta takole: zaviranje intrauterine rasti ploda (majhna telesna masa ploda in zmanjšanje števila okostenelih segmentov prsnice) pri 80 mg/kg/dan, velika pogostnost kratkih vratnih nadštevilnih reber pri 40 mg/kg/dan ali več in velika pogostnost kratkega torakolumbalnega nadštevilnega rebra pri 4 mg/kg/dan ali več.
Portal vein thrombosis has been reported in Phase 3 randomised, double-blind, placebo-controlled clinical studies with 3 mg of lusutrombopag once daily for up to 7 days (1.2%, 2/171 patients); the incidence was comparable to that of the placebo group (1.2%, 2/170 patients); one case of cardiac ventricular thrombosis was reported (0.6%, 1/171) in the lusutrombopag group only. 
O trombozi portalne vene so poročali v randomiziranih, dvojno slepih, s placebo kontroliranih kliničnih študijah 3. faze s 3 mg lusutrombopaga enkrat na dan do 7 dni (1,2 %, 2/171 bolnikov); pogostnost je bila primerljiva s tisto v skupini s placebom (1,2 %, 2/170 bolnikov); o enem primeru tromboze srčnega prekata so poročali (0,6 %, 1/171) samo v skupini s lusutrombopagom.
Administration of study drug was stopped if the platelet count was ≥ 50,000/µL together with an increase of ≥ 20,000/µL from baseline. 
Raziskovano zdravilo so prenehali dajati, če je bilo število trombocitov ≥ 50.000/µl, skupaj z zvečanjem za ≥ 20.000/µl od izhodišča.
→ If you are already breast-feeding, talk to your doctor immediately. 
→ Če že dojite, se takoj pogovorite z zdravnikom.
Figure 1 Time course profiles of platelet count in the Phase 3 studies in thrombocytopenic patients with chronic liver disease (lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion) Phase 3 Study M0631 
Slika 1 Profili časovnega poteka števila trombocitov v študijah 3. faze pri trombocitopeničnih bolnikih s kronično boleznijo jeter (bolniki, zdravljeni z lusutrombopagom brez transfuzije trombocitov in bolniki, ki so prejemali placebo in transfuzijo trombocitov) Študija 3. faze M0631
Mulpleo 3 mg film-coated tablets lusutrombopag 
Mulpleo 3 mg filmsko obložene tablete lusutrombopag
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. 
Primarni opazovani dogodek v študiji M0631 je bil delež bolnikov, ki pred primarnim invazivnim posegom niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl).
Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio. 
Bolnike so randomizirali v razmerju 1:1 bodisi na 3 mg lusutrombopaga ali placebo.
Marketing Authorisation Holder Shionogi B.V. 
Imetnik dovoljenja za promet z zdravilom Shionogi B.V.
The primary endpoint in Study M0634 was the proportion of subjects who required no platelet transfusion (i.e. achieved platelet count >50,000/µL) before the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure. 
Primarni opazovani dogodek v študiji M0634 je bil delež bolnikov, ki niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl) pred primarnim invazivnim posegom in nikakršnega rešilnega zdravljenja za krvavitev od randomizacije do vključno 7. dne po primarnem invazivnem posegu.
The proportion of subjects who required no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure was statistically significantly greater in the lusutrombopag group compared with placebo group for the individual study and pooled analyses (Table 2). 
Delež bolnikov, ki niso potrebovali transfuzije trombocitov (tj., ki so dosegli število trombocitov >50.000/µl) pred primarnim invazivnim posegom in nikakršnega rešilnega zdravljenja za krvavitev od randomizacije do vključno 7. dne po primarnem invazivnem posegu, je bil statistično značilno večji v skupini z lusutrombopagom kot v skupini s placebom tako v posamični študiji kot v združenih analizah (preglednica 2).
Table 4 Proportion of responders Study M0631 
Preglednica 4 Delež bolnikov, ki so se odzvali na zdravljenje Študija M0631
Phase 3 Study M0634 
Študija 3. faze M0634
Lusutrombopag did not affect male or female fertility in rats at doses up to 176 and 252 times the human clinical exposures in adults based on AUC in males and females, respectively (see section 5.3). 
Lusutrombopag ni vplival na plodnost pri samcih oziroma samicah podgan v odmerkih, ki povzročajo izpostavljenost, 176-krat oziroma 252-krat večjo od klinične izpostavljenosti odraslega človeka na podlagi AUC pri moških oziroma ženskah (glejte poglavje 5.3).
Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1. 
Lusutrombopag je substrat P-gp in BCRP, ni pa substrat OATP1B1, OATP1B3 in OCT1.
There is limited information on the use of lusutrombopag in patients with severe (Child-Pugh class C) hepatic impairment (see section 5.1). 
O uporabi lusutrombopaga pri bolnikih s hudo (razred C po Child-Pughu) okvaro jeter je na voljo malo podatkov (glejte poglavje 5.1).
[a] A responder was defined as a subject who achieved a platelet count of ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline. 
Vrednost P [a] Bolnik, ki se je odzval na zdravljenje, je bil opredeljen kot bolnik, ki je dosegel število trombocitov ≥ 50.000/μl, z zvečanjem za ≥ 20.000/μl od izhodišča.
Red ferric oxide (E172) 
Filmska obloga hipromeloza titanov dioksid trietilcitrat smukec rdeči železov oksid (E172)
NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets 
IME ZDRAVILA Mulpleo 3 mg filmsko obložene tablete