natgillin/translations-raw huggingface dataset:
The efficacy and safety of lusutrombopag have not been established when administered before laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Učinkovitost in varnost lusutrombopaga nista bili ugotovljeni za dajanje pred laparotomijo, torakotomijo, operacijo na odprtem srcu, kraniotomijo ali odstranitvijo organov.
INFORMATION IN BRAILLE Mulpleo
PODATKI V BRAILLOVI PISAVI Mulpleo
In the placebo group, 94/107 subjects (87.9%) received the study drug for 7 days.
V skupini s placebom je 94/107 bolnikov (87,9 %) prejemalo raziskovano zdravilo 7 dni.
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 ni bil genotoksičen, ko so ga testirali s testom povratnih mutacij pri bakterijah, testom kromosomskih aberacij na kulturi pljučnih celic kitajskega hrčka ali mikronukleusnim testom in vivo s celicami mišjega kostnega mozga.
Lusutrombopag is not considered to affect the pharmacokinetics of co-administered medicinal products that are substrates of these enzymes or transporters.
Menimo, da lusutrombopag ne vpliva na farmakokinetiko sočasno dajanih zdravil, ki so substrati teh encimov ali prenašalcev.
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 je treba uporabiti, kadar menimo, da je tveganje krvavitve veliko, sodeč po vrednostih kliničnih laboratorijskih preiskav, na primer števila trombocitov, in sistema koagulacija-fibrinoliza, kliničnih simptomih in vrsti invazivnega posega.
Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism.
Preveliko odmerjanje lahko povzroči čezmerno zvečanje števila trombocitov in lahko pozneje izzove zdravstveno stanje, za katerega je verjetno, da bo povzročilo trombozo in trombembolizem.
Mulpleo should be used with contraception (see sub-section Pregnancy and section 5.3).
Zdravilo Mulpleo je treba uporabljati skupaj s kontracepcijo (glejte podpoglavje Nosečnost in poglavje 5.3).
What you need to know before you take Mulpleo
Kaj morate vedeti, preden boste vzeli zdravilo Mulpleo
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 omogočili celotno primerjavo rezultatov študij M0631 in M0634, ki je predstavljena v preglednicah 2 do 5, so ponovno analizirali podatke iz študije M0631 v skladu s primarnim opazovanim dogodkom študije M0634.
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.
Razmerji kopičenja Cmax in AUC sta približno 2 pri večkratnih odmerkih enkrat na dan in zdi se, da se stanje dinamičnega ravnovesja plazemske koncentracije lusutrombopaga doseže po 5. dnevu.
Use in patients with chronic liver disease undergoing invasive procedures
Uporaba pri bolnikih s kronično boleznijo jeter, pri katerih so potrebni invazivni posegi
Therefore, inducers and inhibitors of CYP4A enzymes including CYP4A11 are unlikely to affect the pharmacokinetics of lusutrombopag.
Zato ni verjetno, da bi induktorji in inhibitorji encimov CYP4A, vključno s CYP4A11, vplivali na farmakokinetiko lusutrombopaga.
Lusutrombopag has no known influence on the ability to drive and use machines.
Lusutrombopag nima znanega vpliva na sposobnost vožnje in upravljanja strojev.
Studies in animals have shown lusutrombopag is secreted in the milk of lactating rats (see section 5.3).
Študije na živalih so pokazale, da se lusutrombopag izloča v mleko doječih podgan (glejte poglavje 5.3).
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.
Lusutrombopag deluje na hematopoetične matične celice in na transmembransko domeno človeških TPO receptorjev, izraženih v megakariocitih, tako da spodbuja megakariocite k proliferaciji in diferenciaciji preko podobne poti za prenos signalov za zvečanje izdelave, kot jo uporablja endogeni TPO, kar povzroči trombocitopoezo.
In addition to subjects who received platelet transfusion, subjects who did not receive an invasive procedure regardless of the reason were considered as receiving platelet transfusion.
Poleg bolnikov, ki so prejeli transfuzijo trombocitov, so tudi bolnike, ki ne glede na razlog niso imeli invazivnega posega, šteli, da so prejeli transfuzijo trombocitov.
In addition, although no dose adjustment is required in these subjects, platelet count should be measured at least once approximately 5 days after the first dose and as necessary thereafter.
Čeprav pri teh bolnikih prilagajanje odmerka ni potrebno, je treba število trombocitov določiti vsaj enkrat približno 5 dni po prvem odmerku, pozneje pa po potrebi.
This limited data suggested no abnormal pattern of platelet count rise in this subpopulation.
Ti omejeni podatki niso pokazali nenormalnega vzorca zvečanja števila trombocitov v tej podskupini.
It is unknown whether lusutrombopag or its metabolites are excreted in human milk.
Ni znano, ali se lusutrombopag ali njegovi presnovki izločajo v materino mleko pri ljudeh.
Pregnancy and breast-feeding Do not take Mulpleo if you are pregnant unless your doctor specifically recommends it.
Ne vzemite zdravila Mulpleo, če ste noseči, razen če vam ga zdravnik posebej priporoči.
In Study M0631, 96 subjects received lusutrombopag or placebo once daily: 48 subjects in the lusutrombopag group and 48 subjects in the placebo group.
V študiji M0631 je 96 bolnikov prejemalo lusutrombopag ali placebo enkrat na dan: 48 bolnikov v skupini z lusutrombopagom in 48 bolnikov v skupini s placebom.
In vitro studies revealed that CYP4 enzymes including CYP4A11 and partially CYP3A4 enzyme contributed to ω-oxidation to form 6-hydroxylated lusutrombopag.
Študije in vitro so pokazale, da so encimi CYP4, vključno z encimom CYP4A11 in deloma CYP3A4 prispevali k ω-oksidaciji, tako da je nastal 6-hidroksilirani lusutrombopag.
Mulpleo is supplied in aluminium blisters in a carton containing 7 film-coated tablets.
Zdravilo Mulpleo je na voljo v aluminijastih pretisnih omotih v kartonski škatli, ki vsebuje 7 filmsko obloženih tablet.
Certain people may have a higher risk of blood clots, including people with liver disease, and medicines like Mulpleo could make this problem worse.
Zvečano tveganje za nastanek krvnih strdkov Pri nekaterih ljudeh (sem spadajo ljudje z boleznijo jeter) je tveganje za nastanek krvnih strdkov mogoče večje in zdravila, kot je Mulpleo, lahko ta problem poslabšajo.
In the lusutrombopag group, 73/107 subjects (68.2%) received the study drug for 7 days.
V skupini z lusutrombopagom je 73/107 bolnikov (68,2 %) prejemalo raziskovano zdravilo 7 dni .
In Study M0634, 215 subjects were randomised in the study: 108 in the lusutrombopag 3 mg group and 107 in the placebo group.
V študiji M0634 so randomizirali 215 bolnikov: 108 v skupini z lusutrombopagom 3 mg in 107 v skupini s placebom.
Each box contains 7 film-coated tablets.
Ena škatla vsebuje 7 filmsko obloženih tablet.
Lusutrombopag should only be used in such patients if the expected benefit outweighs the expected risks (see sections 4.2 and 5.2).
Lusutrombopag se sme pri takih bolnikih uporabljati samo, če pričakovana korist odtehta pričakovana tveganja (glejte poglavji 4.4 in 5.2).
The mean (% coefficient of variation) apparent volume of distribution during the terminal phase of lusutrombopag in healthy adult subjects (n = 16) was 39.5 L (23.5%).
navidezni volumen porazdelitve med terminalno fazo lusutrombopaga pri zdravih odraslih preiskovancih (n = 16) je bil 39,5 l (23,5 %).
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 majhen potencial za inhibiranje encimov CYP (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6 in 3A4/5) in za induciranje tako encimov CYP (CYP1A2, 2C9 in 3A4) kot UGT (UGT1A2, 1A6 in 2B7).
Pre- and post-natal development
Pred- in poporodni razvoj
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.
Pri bolnikih s trombozo ali trombembolizmom, z anamnezo tromboze ali trombembolizma, pri tistih brez hepatopetalnega toka krvi v glavnem deblu portalne vene ali bolnikih s prirojeno koagulopatijo se lahko tveganje tromboze ali trombembolizma zveča.
Lusutrombopag was excreted mainly via faecal route in humans (approximately 83% into faeces and 1% into urine).
Lusutrombopag se je pri ljudeh izločal predvsem z blatom (približno 83 % v blatu in 1 % v urinu).
Adverse reaction - Common
Neželeni učinek - pogosti
• Blood clot in the liver (portal vein thrombosis)
• krvni strdek v jetrih (tromboza portalne vene),
OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box.
Pretisni omot iz OPA/aluminijaste folije/PVC prevleke, pakiran v kartonski škatli.
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)
Bolezni kože in podkožja izpuščaj a Kategorije pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
Neither food (including high-fat and high-calorie diet) nor co-administration with calcium has a clinically meaningful effect on the pharmacokinetics of lusutrombopag.
Niti hrana (vključno z dieto z veliko maščob in veliko kalorij) niti sočasno dajanje s kalcijem nimata klinično pomembnega vpliva na farmakokinetiko lusutrombopaga.
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.
Spremembe so v študiji pred- in poporodnega razvoja opazili tudi pri F1 mladičih na poporodni dan (postnatal day - PND) 4 pri 12,5 mg/kg/dan ali več; vendar F1 zrele živali niso imele popolnega ali kratkega torakolumbalnega nadštevilnega rebra.
Lusutrombopag is not recommended during pregnancy and in women of child-bearing potential not using contraception.
Lusutrombopaga ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Do not chew, break, or crush the tablet.
Tablete ne žvečite, razdelite ali zdrobite.
Mulpleo should not be administered to breast-feeding women as it was excreted in mammary milk in animals.
Zdravilo Mulpleo se ne sme dajati doječim materam, ker se je pri živalih izločalo v materino mleko.
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).
Ker je na voljo malo podatkov, varnost in učinkovitost zdravila Mulpleo pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu) nista bili dokazani (glejte poglavji 4.4 in 5.1).
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.
Veliki odmerki (10 mg/kg/dan) in dolgoročno zdravljenje (8 tednov) z lusutrombopagom prinašajo možno tveganje fibroze v kostnem mozgu preko človeškega receptorja za TPO na podlagi rezultatov študije na miših TPOR-Ki/Shi s himerno človeško transmembransko domeno receptorja za TPO,
Geometric mean of t1/2 (% coefficient of variation), was 38.3 hours (18.7%) after multiple oral dose of 3 mg lusutrombopag.
Geometrična sredina t1/2 (odstotni koeficient variacije) po večkratnih peroralnih 3-miligramskih odmerkih lusutrombopaga je bila 38,3 ure (18,7 %).
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.
Opozorila in previdnostni ukrepi Posvetujte se z zdravnikom: - če pri vas obstaja tveganje za nastanek krvnih strdkov v vaših venah ali arterijah, ali če ste kdaj prej že imeli krvne strdke;
Table 5 Duration of the increase in platelet count to ≥ 50,000/µL
Preglednica 5 Trajanje zvečanja števila trombocitov na ≥ 50.000/µl
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.
V študiji masnega ravnovesja pri človeku, v kateri so uporabili [14C]-lusutrombopag, je bil nespremenjeni lusutrombopag (97 % radioaktivnosti v plazmi) poglavitna sestavina v krvi, presnovki, na primer desheksil, β-oksidirano karboksilno kislino, konjugat tavrina z β-oksidirano karboksilno kislino in acil-glukuronid, pa so predstavljali manj kot 2,6 % radioaktivnosti v plazmi.
- 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)
- Druge sestavine zdravila so: - sredica tablete: manitol, mikrokristalna celuloza, magnezijev oksid, natrijev lavrilsulfat, hidroksipropilceluloza, kalcijev karmelozat in magnezijev stearat; - filmska obloga: hipromeloza, titanov dioksid, trietilcitrat, smukec in rdeči železov oksid (E172).
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).
Najpogostejši neželeni učinki so bili glavobol (4,7 %, 8/171 bolnikov v skupini z lusutrombopagom; 3,5 %, 6/170 bolnikov v skupini s placebom), navzea (2,3 %, 4/171 bolnikov v skupini z lusutrombopagom; 4,1 %, 7/170 bolnikov v skupini s placebom), tromboza portalne vene (1,2 %, 2/171 bolnikov v skupini z lusutrombopagom; 1,2 %, 2/170 bolnikov v skupini s placebom) in izpuščaj (1,2 %, 2/171 bolnikov v skupini z lusutrombopagom; 0 %, 0/170 bolnikov v skupini s placebom).
The pharmacokinetic parameters in patients with chronic liver disease are shown in Table 6.
Farmakokinetične parametre pri bolnikih s kronično boleznijo jeter kaže preglednica 6.
There is no specific antidote for lusutrombopag overdose.
Za preveliko odmerjanje lusutrombopaga ni specifičnega antidota.
- Use reliable methods of contraception while you are taking Mulpleo.
- Tačas ko jemljete zdravilo Mulpleo, uporabljajte zanesljive kontracepcijske metode.
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 v farmakokinetiki enkratnega odmerka 0,75 mg lusutrombopaga so bile razmeroma majhne tako pri bolnikih z blago okvaro jeter kot pri bolnikih z zmerno okvaro jeter v primerjavi s kontrolno skupino zdravih oseb s primerljivimi demografskimi podatki.
Common side effects (may affect up to 1 in 10 people)
(lahko se pojavijo pri največ 1 od 10 bolnikov)
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.