natgillin/translations-raw huggingface dataset:
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).
Udio ispitanika kojima nije bila potrebna ni transfuzija trombocita prije primarnog invazivnog postupka, ni hitna terapija zbog krvarenja od trenutka randomizacije do 7 dana nakon primarnog invazivnog postupka, bio je statistički značajno veći u skupini liječenoj lusutrombopagom nego u skupini koja je primala placebo i po pojedinačnom ispitivanju i u analizi objedinjenih podataka
Common side effects (may affect up to 1 in 10 people)
(mogu se pojaviti u najviše 1 na 10 osoba) • glavobolja
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 nije bio kancerogen u mužjaka i ženki miševa pri dozama do 20 mg/kg na dan (doza s izloženošću najmanje 45 puta višom od kliničke izloženosti u odraslih osoba na temelju AUC-a) ni u mužjaka štakora pri dozama do 20 mg/kg na dan i ženki štakora pri dozi od 2 mg/kg na dan (doze s izloženošću 49 odnosno 30 puta višom od kliničke izloženosti odraslih osoba na temelju AUC-a).
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.
U štakora je lusutrombopag imao štetne učinke na intrauterini rast i skeletnu morfologiju fetusa u obliku: supresije intrauterinog rasta fetusa (mala tjelesna težina fetusa i smanjenje broja osificiranih sternebri) pri dozi od 80 mg/kg na dan, visoke incidencije kratkih prekobrojnih vratnih rebara pri dozi od 40 mg/kg na dan ili višoj, i visoke incidencije kratkih prekobrojnih torakolumbalnih rebara pri dozi od 4 mg/kg na dan ili višoj.
In the human mass balance study using [14C]-lusutrombopag, unchanged lusutrombopag (97% of radioactivity in plasma) was the major circulating component, and the metabolites, such as deshexyl, β-oxidated carboxylic acid, taurine conjugate of β-oxidated carboxylic acid, and acyl glucuronide, were detected with less than 2.6% of radioactivity in plasma.
(97% radioaktivnosti u plazmi) bio je glavna komponenta u cirkulaciji, a otkriveni metaboliti poput desheksila, β-oksidirane karboksilne kiseline, taurinskog konjugata β-oksidirane karboksilne kiseline i acilglukuronida činili su manje od 2,6% radioaktivnosti u plazmi.
Therefore, inducers and inhibitors of CYP4A enzymes including CYP4A11 are unlikely to affect the pharmacokinetics of lusutrombopag.
Stoga nije vjerojatno da će induktori i inhibitori enzima CYP4A uključujući CYP4A11
The changes were also noted in F1 pups on postnatal day (PND) 4 at 12.5 mg/kg/day or more in the preand postnatal development study; however, F1 mature animals showed no full and short thoracolumbar supernumerary rib.
4. postnatalnog dana pri dozi od 12,5 mg/kg na dan ili višoj u ispitivanju prenatalnog i postnatalnog razvoja; međutim, u odraslih životinja generacije F1 nije bilo punog i kratkog prekobrojnog torakolumbalnog rebra.
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”.
Svjetlocrvene, okrugle, filmom obložene tablete promjera 7,0 mm, s utisnutim zaštitnim znakom tvrtke Shionogi iznad identifikacijske oznake „551“ na jednoj strani te utisnutom oznakom jačine „3“ na drugoj strani.
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.
Analiza populacijske farmakokinetike na temelju koncentracija lusutrombopaga u plazmi u kliničkim ispitivanjima lusutrombopaga nije pokazala klinički značajan učinak dobi, spola ili etničke pripadnosti na farmakokinetiku lusutrombopaga.
There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Podaci o primjeni lusutrombopaga u bolesnika prethodno izloženih lusutrombopagu su ograničeni.
Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis.
U bolesnika s kroničnom bolešću jetre postoji rizik od tromboze portalne vene i tromboze mezenteričke vene.
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 filmom obložene tablete svjetlocrvene su, okrugle, filmom obložene tablete promjera 7,0 mm, s utisnutim zaštitnim znakom tvrtke Shionogi iznad identifikacijske oznake „551” na jednoj strani te utisnutom jačinom „3“na drugoj strani.
Lusutrombopag is a substrate of P-gp and BCRP, but is not a substrate of OATP1B1, OATP1B3 or OCT1.
Lusutrombopag je supstrat P-gp-a i BCRP-a, ali nije supstrat OATP1B1, OATP1B3 ili OCT1.
Among the 48 subjects in the placebo group, 46 were treated for 7 days and 2 were treated for 4 days.
Od 48 ispitanika u skupini koja je primala placebo, njih 46 primalo je placebo 7 dana, a 2 ispitanika 4 dana.
Mulpleo 3 mg film-coated tablets lusutrombopag
Mulpleo 3 mg filmom obložene tablete lusutrombopag
Thromboembolic and thrombotic complications are known to occur with thrombopoetin (TPO) receptor agonists based upon mechanism of action associated with increases in platelets.
Poznato je da se kod primjene agonista trombopoetinskih (TPO) receptora događaju tromboembolijske i trombotičke komplikacije putem mehanizma djelovanja povezanog s povećanjem broja trombocita.
In Study M0634, 3 subjects with Child-Pugh class C liver disease were erroneously enrolled (all in the lusutrombopag group).
Tri su ispitanika s bolešću jetre stupnja C prema Child-Pugh klasifikaciji bila pogrešno uključena u ispitivanje M0634 (svi u skupinu liječenu lusutrombopagom).
The pharmacokinetics of lusutrombopag was similar in both healthy subjects and the chronic liver disease population.
Farmakokinetika lusutrombopaga u populacije s kroničnom bolešću jetre bila je slična onoj u zdravih ispitanika.
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.
Tromboza portalne vene zabilježena je u randomiziranim, dvostruko slijepim, placebom kontroliranim kliničkim ispitivanjima faze 3 u kojima se lusutrombopag primjenjivao do 7 dana u dozi od 3 mg jedanput dnevno (1,2%, 2/171 bolesnika); incidencija je bila usporediva s onom u skupini koja je primala placebo (1,2%, 2/170 bolesnika); zabilježen je samo jedan slučaj srčane ventrikularne tromboze (0,6%, 1/171) u skupini liječenoj lusutrombopagom.
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).
PT-a i APTT-a (štakori), povećanu aktivnost ALT-a i AST-a u plazmi (štakori i psi), adrenalnu toksičnost (štakori i psi), lezije kože i predželuca (štakori) i bubrežnu toksičnost (štakori).
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 Profil broja trombocita tijekom vremena u ispitivanjima faze 3 u trombocitopeničnih bolesnika s kroničnom bolešću jetre (ispitanici liječeni lusutrombopagom bez transfuzije trombocita i ispitanici koji su primali placebo s transfuzijom trombocita) Faza 3 ispitivanja M0631
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 nije utjecao na plodnost mužjaka ili ženki štakora pri dozama s izloženošću do 176 odnosno 252 puta višom od kliničke izloženosti odraslih osoba na temelju AUC-a u muškaraca i žena (vidjeti dio 5.3).
NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Shionogi
There is limited information on the use of lusutrombopag in patients with severe (Child-Pugh class C) hepatic impairment (see section 5.1).
Ograničene su informacije o primjeni lusutrombopaga u bolesnika s teškim (Child-Pugh stadij C) oštećenjem funkcije jetre (vidjeti dio 5.1).
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.
Mjera primarnog ishoda u ispitivanju M0634 bila je udio ispitanika kojima nije bila potrebna transfuzija trombocita (tj. postignut broj trombocita bio je > 50 000/µl) prije primarnog invazivnog postupka, a hitna terapija zbog krvarenja nije im bila potrebna od trenutka randomizacije do 7 dana nakon primarnog invazivnog postupka.
A subject was considered a nonresponder if the subject met the responder criterion only after platelet transfusion.
Ispitanikom u kojeg nije bilo terapijskog odgovora smatrao se ispitanik koji je zadovoljio kriterij za terapijski odgovor tek nakon transfuzije trombocita.
➤ Get medical help immediately if you notice any of these.
➤Ako opazite bilo koji od ovih znakova, odmah potražite liječničku pomoć.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 3 mg of lusutrombopag.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga.
The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
Trajanje povećanja broja trombocita na ≥ 50 000/µl u ispitivanjima M0631 i M0634 i objedinjenoj skupini (ispitivanja M0631 i M0634) liječenoj lusutrombopagom bilo je značajno dulje nego ono uz placebo (tablica 5).
No dosage adjustment is necessary in patients with renal impairment (see section 5.2).
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
On Day 5 to Day 7, the platelet count was measured before administration of study drug.
Broj trombocita izmjeren je između 5. i 7. dana prije primjene ispitivanog lijeka.
On the basis of the results, the no observed adverse effect level (NOAEL) was estimated to be near 4 mg/kg/day in the embryo-foetal development study in rats (23 times the human clinical exposures in adults based on AUC).
Na temelju ovih rezultata, razina pri kojoj nisu opaženi štetni učinci (engl. no observed adverse effect level, NOAEL) u ispitivanju embriofetalnog razvoja u štakora procijenjena je na oko 4 mg/kg na dan (izloženost 23 puta viša od kliničke izloženosti odraslih osoba na temelju
P value [a] Proportion of subjects who required no platelet transfusion during the study (i.e., from Day 1 through Day 35).
P vrijednost [a] Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja (tj. od 1. do 35. dana).
Marketing Authorisation Holder Shionogi B.V.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Shionogi B.V.
Of the remaining subjects in the placebo group, 5, 4, and 4 subjects received study drug for 4, 5, and 6 days, respectively.
Od preostalih ispitanika u skupini koja je primala placebo, 5 ispitanika primalo je ispitivani lijek 4 dana, 4 ispitanika tijekom 5, a 4 tijekom 6 dana.
Table 3 Proportion of Subjects who required no platelet transfusion during the study (Day 1 through Day 35)
Tablica 3 Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja (od 1. do 35. dana)
Duration of the increase in platelet count to ≥ 50,000/μL
Trajanje povećanja broja trombocita na ≥ 50 000/μl
Kingsfordweg 151, 1043GR Amsterdam The Netherlands
1043GR Amsterdam
In patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy the risk for thrombosis or thromboembolism may increase.
Rizik od tromboze i tromboembolije može biti povećan u bolesnika s trombozom ili tromboembolijom, s anamnezom tromboze ili tromboembolije, bez hepatopetalnog protoka kroz glavno stablo portalne vene ili u bolesnika s kongenitalnom koagulopatijom.
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.
Analiza populacijske farmakokinetike na temelju koncentracije lusutrombopaga u plazmi u kliničkim ispitivanjima lusutrombopaga nije pokazala kinički značajan učinak funkcije bubrega na farmakokinetiku lusutrombopaga.
Mulpleo contains sodium
Mulpleo sadrži natrij
Of the remaining subjects in the lusutrombopag group, 15, 8, and 11 subjects received study drug for 4, 5, and 6 days, respectively.
Od preostalih ispitanika u skupini liječenoj lusutrombopagom, 15 ispitanika primalo je ispitivani lijek 4 dana, 8 ispitanika tijekom 5, a 11 tijekom 6 dana.
No effects on foetal viability embryo-foetal development were noted in rabbits at doses up to 1000 mg/kg/day (161 times the human clinical exposures in adults based on AUC).
Nisu opaženi nikakvi učinci na vijabilnost fetusa ili embriofetalni razvoj kunića pri dozama do 1000 mg/kg na dan (izloženost 161 puta viša od kliničke izloženosti odraslih osoba na temelju AUC-a).
Adverse reaction - Common
Nuspojava - često
Lusutrombopag did not affect male and female fertility and early embryo development in rats at doses up to 100 mg/kg/day (176 and 252 times respectively, the human clinical exposures in adults based on AUC).
Lusutrombopag nije utjecao na plodnost mužjaka i ženki i rani embrionalni razvoj štakora pri dozama do 100 mg/kg na dan (izloženost 176 odnosno 252 puta viša od kliničke izloženosti odraslih osoba na temelju AUC-a).
Study M0631
Ispitivanje M0631 Ispitivanje M0634
Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use.
U kliničkoj primjeni nisu zabilježene interakcije lijekova putem inhibicije i indukcije bilo kojeg enzima
Use in patients with a history of splenectomy
Primjena u splenektomiranih bolesnika
Caution should be exercised with respect to thromboembolic events after invasive procedures as well as post-treatment regardless of platelet counts.
Bez obzira na broj trombocita, potreban je oprez zbog mogućih tromboembolijskih događaja nakon invazivnih postupaka, kao i nakon liječenja.
Each film-coated tablet contains 3 mg lusutrombopag.
Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga.
The time course of platelet counts in lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion in Studies M0631 and M0634 is presented in Figure 1.
Promjene broja trombocita tijekom vremena u ispitanika liječenih lusutrombopagom bez transfuzije trombocita i ispitanika koji su primali placebo s transfuzijom trombocita u ispitivanjima M0631 i M0634 prikazane su na slici 1.
Red ferric oxide (E172)
Film-ovojnica hipromeloza titanijev dioksid trietilcitrat talk crveni željezov oksid (E172)
Repeated toxicity
Ponavljanje liječenja
Proportion of subjects [a] 75.5% 12.5% 64.8% 29.0% 68.2% 23.9% (number of subjects)
59 000 do 145 000)/µl odnosno 86 900 (od 25 000 do 219 000)/µl.
Lusutrombopag acts on the haematopoietic stem cells and on the transmembrane domain of human TPO receptors expressed in megakaryocytes, to stimulate the megakaryocyte to proliferate and differentiate via the similar signal transduction pathway for up-regulating production used by endogenous TPO, thus leading to thrombocytopoiesis.
čime potiče megakariocite na proliferaciju i diferencijaciju putem signalnog transdukcijskog puta za povećanje njihovog stvaranja sličnog onome kakvim se koristi endogeni TPO te tako dovodi do trombocitopoeze.
NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets
NAZIV LIJEKA Mulpleo 3 mg filmom obložene tablete
High dose (10 mg/kg/day) and long-term treatment (8 weeks) of lusutrombopag has a potential risk of fibrosis in the bone marrow via human TPO receptor based on the results of study in TPOR-Ki/Shi mice with chimeric human transmembrane domain TPO receptor knocked-in to the mouse TPO receptor.
Na temelju rezultata ispitivanja u miševa tipa TPOR-Ki/Shi s kimeričnom ljudskom transmembranskom domenom TPO-receptora ubačenom (engl. knocked-in) u mišji TPO receptor, kod visoke doze (10 mg/kg na dan) i dugotrajnog liječenja (8 tjedana) lusutrombopagom postoji potencijalni rizik od fibroze koštane srži posredovane ljudskim TPO receptorom.
There is limited information on the use of lusutrombopag in patients with body weight <45 Kg. Platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Potrebno je odrediti broj trombocita barem jedanput približno 5 dana nakon prve doze, a poslije po potrebi.
Table 2 Proportion of subjects who required no platelet transfusion and no rescue therapy Study M0631
Tablica 2 Udio ispitanika kojima nije bila potrebna ni transfuzija trombocita ni hitna terapija
The ranges of observed Cmax and AUC0-τ overlapped among the patients with Child-Pugh class A, B, and C. Cmax and AUC0-τ of all patients with Child-Pugh class C did not exceed the maximum values from Child-Pugh class A and class B. Due to the limited information available, lusutrombopag should not be used in Child-Pugh class C patients unless the expected benefit outweighs the expected risks.
U svih bolesnika s Child-Pugh stadijem C vrijednosti Cmax i AUC0-τ nisu premašile maksimalne vrijednosti kod Child-Pugh stadija A i stadija B.
The mean (range) maximum platelet count in subjects without platelet transfusion in the lusutrombopag group in Studies M0631 and M0634 was 90,200 (59,000 to 145,000)/µL and 86,900 (25,000 to 219,000)/µL, respectively; and the median (range) time to reach the maximum platelet count was 14.0 (6 to 28) days and 12.0 (5 to 35) days, respectively, and platelet count is expected to decrease thereafter.
Medijan (raspon) vremena do postizanja maksimalnog broja trombocita bio je 14,0 (od 6 do 28) dana te 12,0 (od 5 do 35) dana, a nakon toga se očekivalo smanjenje broja trombocita.
Platelet count should be measured prior to the procedure.
Prije postupka mora se odrediti broj trombocita.
➤ Check with your doctor if this applies to you before you take Mulpleo
➤ Prije nego što uzmete lijek Mulpleo provjerite sa svojim liječnikom vrijedi li ovo za Vas.
Proportion of subjects who required no platelet transfusion during the study (Day 1 through Day 35) The proportion of subjects who required no platelet transfusion during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 3).
Udio ispitanika kojima nije bila potrebna transfuzija trombocita tijekom ispitivanja bio je značajno veći i u skupinama liječenima lusutrombopagom u pojedinačnim ispitivanjima i u objedinjenoj skupini (ispitivanja M0631 i M0634) liječenoj lusutrombopagom u usporedbi s placebom (tablica 3).
Environmental risk assessment studies have shown that lusutrombopag has the potential to be very persistent, very bioaccumulative and toxic to the environment.
Procjena rizika za okoliš (ERA) Ispitivanja procjene rizika za okoliš pokazala su da lusutrombopag može biti vrlo postojan,
Subjects were randomised to either of 3 mg of lusutrombopag or placebo in a 1:1 ratio.
Ispitanici su bili randomizirani u omjeru 1:1 u skupinu koja je primala lusutrombopag u dozi od 3 mg i skupinu koja je primala placebo.
if the platelet count reaches ≥50,000/µL as a result of a 20,000/µL increase from baseline.
≥ 50 000/μl uz povećanje za ≥ 20 000/μl od početne vrijednosti.
EU/1/18/1348
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1348
≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Udio ispitanika s terapijskim odgovorom Udio ispitanika koji su tijekom ispitivanja zadovoljili kriterij za terapijski odgovor (definiran kao povećanje broja trombocita na ≥ 50 000/μl uz povećanje za ≥ 20 000/μl od početne vrijednosti) bio je značajno veći i u skupinama liječenima lusutrombopagom u pojedinačnim ispitivanjima i u objedinjenoj (ispitivanja M0631 i M0634) skupini liječenoj lusutrombopagom u usporedbi s placebom (tablica 4).
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.
U skupinama liječenima lusutrombopagom u dozi od 2 mg i 4 mg u ispitivanju faze 2b, jedan je bolesnik imao trombozu portalne vene zabilježenu kao štetan događaj nastao tijekom liječenja (engl. treatment-emergent adverse event, TEAE).
How to store Mulpleo
Moguće nuspojave Kako čuvati Mulpleo
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.
Child-Pugh stadij B) utjecati na farmakokinetiku lusutrombopaga.
Platelet count should be carefully monitored in patients with a history of splenectomy treated with lusutrombopag.
U splenektomiranih bolesnika koji se liječe lusutrombopagom potrebno je pažljivo pratiti broj trombocita.
There were no effects on pregnancy, parturition, lactation in F0 dams and postnatal development in F1 pups at doses up to 12.5 mg/kg/day (89 times the human clinical exposures in adults based on AUC).
Nije bilo utjecaja na graviditet, parturiciju ili laktaciju u majki generacije F0 i postnatalni razvoj mladunčadi generacije F1 pri dozama do
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)).
< 50 000/µl) s kroničnom bolešću jetre (Child-Pugh stadij A i B) u kojih su se provodili elektivni invazivni postupci (isključujući laparatomiju, torakotomiju, kraniotomiju, otvorenu operaciju srca,
NAME OF THE MEDICINAL PRODUCT Mulpleo 3 mg film-coated tablets lusutrombopag
Uputa o lijeku: Informacije za bolesnika Mulpleo 3 mg filmom obložene tablete lusutrombopag
Proportion of responders The proportion of subjects who met the responder criterion (defined as platelet count increase to
P vrijednost [a] Ispitanik s terapijskim odgovorom definiran je kao ispitanik u kojeg je broj trombocita postigao vrijednost
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 3 mg lusutrombopag
Jedna filmom obložena tableta sadrži 3 mg lusutrombopaga
Film-coating
Česte nuspojave