natgillin/translations-raw huggingface dataset:
Platelet count (x109/L)
Število trombocitov (x109/l)
The plasma concentration-time profiles following the oral administration of avatrombopag were characterised by a short lag time (0.5 - 0.75 hours) with peak exposure at 6 - 8 hours post dose.
Absorpcija Po peroralnem dajanju avatrombopaga je bil za profile plazemska koncentracija-čas značilen kratek odzivni čas (0,5 - 0,75 ure) z največjo izpostavljenostjo 6 - 8 ur po odmerku.
Patients were then randomised 2:1 to either avatrombopag or placebo.
Bolniki so bili nato v razmerju 2 : 1 naključno razporejeni v skupini, v katerih so prejemali avatrombopag oz. placebo.
Patients with Child Pugh class C liver disease, should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count.
Bolnike z boleznijo jeter razreda C po Child-Pughovi lestvici je treba na dan posega oceniti glede nepričakovano velikega povečanja števila trombocitov.
Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.25-times the lowest approved dosage) to 80 mg (1.3-times the highest recommended dosage).
Farmakokinetika avatrombopaga je bila po enkratnem odmerku od 10 mg (0,25-kratnik najnižjega odobrenega odmerka) do 80 mg (1,3-kratnik najvišjega odobrenega odmerka) sorazmerna odmerku.
The oxidative metabolism of avatrombopag is mainly mediated by CYP2C9 and CYP3A4.
Biotransformacija Oksidativna presnova avatrombopaga je v glavnem povezana s CYP2C9 in CYP3A4.
Doptelet contains lactose
Zdravilo Doptelet vsebuje laktozo
Responders were defined as patients who did not require a platelet transfusion or any rescue procedure for bleeding after randomisation and up to 7 days following a scheduled procedure.
Odzivni bolniki so bili opredeljeni kot bolniki, pri katerih po randomizaciji in do 7 dni po načrtovanem posegu ni bila potrebna transfuzija trombocitov oz. nikakršen rešilni poseg zaradi krvavitve.
In two-year carcinogenicity studies in mice and rats, neuroendocrine cell (enterochromaffin-like cell, ECL cell) gastric tumours (carcinoids) occurred in the stomach at high doses.
V dvoletnih študijah kancerogenosti so se v želodcu miši in podgan pri velikih odmerkih pojavili nevroendokrini (iz enterokromafinim celicam podobnih celic, celic ECL) tumorji želodca (karcinoidi).
What Doptelet looks like and contents of the pack
Izgled zdravila Doptelet in vsebina pakiranja
In these species, avatrombopag was associated with histopathologic changes in the fundic mucosa of the glandular stomach, characterised by degeneration of the glandular epithelium with a decrease in matured parietal cells.
Pri teh živalskih vrstah je bil avatrombopag povezan s histopatološkimi spremembami fundusne sluznice žleznega dela želodca, za katere je bila značilna degeneracija žleznega epitelija z zmanjšanjem števila zrelih parietalnih celic.
However, these patients should be evaluated on the day of the procedure for an unexpectedly high increase in platelet count (see section 4.2 and 5.2).
Kljub temu pa je te bolnike treba na dan posega oceniti glede nepričakovano velikega povečanja števila trombocitov (glejte poglavji 4.2 in 5.2).
Doptelet is used in adults with chronic liver disease to treat low platelet count (called thrombocytopenia) before having a medical procedure where there is a risk of bleeding.
Zdravilo Doptelet se uporablja pri odraslih s kronično boleznijo jeter za odpravljanje nizkega števila trombocitov (trombocitopenije) pred načrtovanim medicinskim posegom, pri katerem obstaja tveganje za krvavitev.
Doptelet contains an active substance called avatrombopag.
Zdravilo Doptelet vsebuje učinkovino, imenovano avatrombopag.
Avatrombopag inhibits organic anion transporter (OAT) 1 and 3 and breast cancer resistance protein (BCRP) but not organic anion transporter polypeptide (OATP) 1B1 and 1B3, and organic cation transporter (OCT) 2 in vitro.
Avatrombopag in vitro zavira prenašalca organskih anionov (OAT) 1 in 3 ter protein za odpornost proti raku dojke (BCRP), ne pa tudi polipeptidov prenašalca organskih anionov (OATP) 1B1 in 1B3 ter prenašalca organskih kationov (OCT) 2.
Avatrombopag is an orally active, small molecule thrombopoietin (TPO) receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells resulting in increased production of platelets.
Avatrombopag je peroralno delujoč, malomolekulski agonist trombopoetinskih (TPO) receptorjev, ki spodbuja proliferacijo in diferenciacijo megakariocitov iz predniških celic kostnega mozga, kar povzroči povečano tvorbo trombocitov.
Avatrombopag plasma exposure was comparable in patients with chronic liver disease secondary to viral hepatitis (n = 242), non-alcoholic steatohepatitis (n = 45) and alcoholic liver disease (n = 49) in the pivotal Phase 3 studies, and also comparable to that in healthy subjects (n = 391).
V ključnih študijah 3. faze je bila plazemska izpostavljenost avatrombopagu primerljiva pri bolnikih s kronično boleznijo jeter zaradi virusnega hepatitisa (n = 242), nealkoholnega steatohepatitisa (n = 45) in alkoholne bolezni jeter (n = 49), prav tako pa je bila primerljiva s tisto pri zdravih preiskovancih (n = 391).
No metabolites of avatrombopag were detected in plasma.
V plazmi ni bilo prisotnih presnovkov avatrombopaga.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Nosečnost in dojenje Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
Each carton contains one blister of 10 or 15 film-coated tablets.
Posamezna škatla vsebuje en pretisni omot z 10 ali 15 filmsko obloženimi tabletami.
Doptelet is not expected to affect you being able to drive, cycle or use tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi zdravilo Doptelet vplivalo na vašo sposobnost vožnje, kolesarjenja ali uporabe orodij oz. strojev.
It is unknown whether avatrombopag or its metabolites are excreted in human milk.
Ni znano, ali se avatrombopag/presnovki izločajo v materino mleko.
Elderly No dose adjustment is required for patients aged 65 years and older (see section 5.2).
Starejše osebe Pri bolnikih, starih 65 let in več, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
The safety of avatrombopag was evaluated in two randomised, double-blind, placebo-controlled trials, Study 1 and Study 2, in which 430 patients with chronic liver disease and thrombocytopenia received either avatrombopag (n = 274) or placebo (n = 156), and had 1 post-dose safety assessment.
Varnost avatrombopaga je bila ocenjena v dveh randomiziranih, dvojno slepih, s placebom kontroliranih preskušanjih, imenovanih Študija 1 in Študija 2, v okviru katerih je 430 bolnikov s kronično boleznijo jeter in trombocitopenijo prejemalo bodisi avatrombopag (n = 274) ali placebo (n = 156), po končanem odmerjanju pa je bila pri njih podana 1 ocena varnosti.
Musculoskeletal & connective tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Portal vein thrombosis has been reported at an increased frequency in patients with chronic liver disease who had platelet counts > 200 x 109/L receiving a thrombopoietin receptor agonist (see section 4.8).
O trombozi portalne vene so pogosteje poročali pri bolnikih s kronično boleznijo jeter, ki so imeli število trombocitov > 200 x 109/l in so prejemali agonista trombopoetinskih receptorjev (glejte poglavje 4.8).
Doptelet should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.
Zdravila Doptelet ne smete dajati bolnikom s kronično boleznijo jeter z namenom, da bi normalizirali število trombocitov.
Should overdose occur or be suspected, Doptelet dosing should be stopped and platelet count should be carefully monitored since avatrombopag increases platelet count in a dose-dependent fashion.
Če pride do prevelikega odmerjanja ali ob sumu nanj, je treba odmerjanje zdravila Doptelet prekiniti in skrbno spremljati število trombocitov, saj avatrombopag povečuje število trombocitov v odvisnosti od odmerka.
Doptelet has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Doptelet nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
There is no specific antidote for overdose with avatrombopag.
Posebnega protisredstva za prevelik odmerek avatrombopaga ni.
In 4-week or longer repeated-dose toxicity studies, treatment-related gastric lesions were observed in mice, rats, and cynomolgus monkeys.
V okviru štiri- ali večtedenskih študij toksičnosti s ponavljajočimi se odmerki so pri miših, podganah in opicah vrste Cynomolgus ugotovili želodčne lezije, povezane z zdravljenjem.
There are no or limited amount of data from the use of avatrombopag in pregnant women.
Podatkov o uporabi avatrombopaga pri nosečnicah ni oziroma so omejeni.
Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag.
Ena filmsko obložena tableta vsebuje avatrombopag maleat v količini, ki ustreza 20 mg avatrombopaga.
Table 1 Daily dose recommendation for avatrombopag
Preglednica 1 Priporočeni dnevni odmerek avatrombopaga
• blood clot in the portal vein (blood vessel that carries blood to the liver from the intestines)
• krvni strdek v portalni veni (krvna žila, ki dovaja kri iz prebavil v jetra), ki lahko povzroči bolečine ali zatekanje v zgornjem delu trebuha
Human studies demonstrated that the renal route is not a major pathway for either unchanged avatrombopag or its metabolite's elimination.
Ok vara ledvic Študije pri ljudeh so pokazale, da glavna pot izločanja nespremenjenega avatrombopaga ali njegovega presnovka ni skozi ledvice.
The most important treatment-emergent adverse reaction associated with avatrombopag was portal vein thrombosis.
Najpomembnejši neželeni učinek, ki se je pojavil med zdravljenjem in ki je bil povezan z avatrombopagom, je tromboza portalne vene.
Thrombotic/thromboembolic events
Trombotični/tromboembolični dogodek
How to take Doptelet
Kako jemati zdravilo Doptelet
Hypergastrinemia-related gastric carcinoids in rodents are generally considered to be of low risk or relevance to humans.
Na splošno velja, da so karcinoidi želodca, povezani s hipergastrinemijo pri glodalcih, za ljudi manj nevarni in manjšega pomena.
P-gp inhibitor
Zaviralec P-gp
Patients in the low baseline platelet count cohort received 60 mg avatrombopag or matching placebo once daily for 5 days, and patients in the high baseline platelet count cohort received 40 mg avatrombopag or matching placebo once daily for 5 days.
60 mg avatrombopaga ali enakovreden odmerek placeba, bolniki v kohorti z velikim številom trombocitov ob izhodišču pa so 5 dni enkrat na dan prejemali 40 mg avatrombopaga ali enakovreden odmerek placeba.
Avatrombopag is not renally excreted, therefore no dose adjustment is required in patients with mild or moderate renal impairment.
Ok vara ledvic Avatrombopag se ne izloča skozi ledvice, zato pri bolnikih z blago ali zmerno okvaro ledvic prilagoditev odmerka ni potrebna.
The predominant route of avatrombopag excretion is via faeces.
Poglavitna pot izločanja avatrombopaga je preko blata.
Concomitant use of avatrombopag with strong CYP3A4/5 or CYP2C9 inhibitors increases avatrombopag exposure.
Sočasna uporaba avatrombopaga in močnih zaviralcev CYP3A4/5 ali CYP2C9 poveča izpostavljenost avatrombopagu.
It belongs to a group of medicines called thrombopoietin receptor agonists.
imenovanih agonisti trombopoetinskih receptorjev.
Doptelet is not recommended during pregnancy and in women of childbearing potential not using contraception.
Uporaba zdravila Doptelet ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcijske zaščite.
However, administration of avatrombopag with both a high- and low-fat meal reduced inter-subject and intra-subject pharmacokinetic variability of avatrombopag by approximately 50%.
Vendar pa se je pri dajanju avatrombopaga tako skupaj z obrokom z veliko vsebnostjo maščob kot tudi obrokom z malo vsebnostjo maščob interindividualna in intraindividualna farmakokinetična variabilnost avatrombopaga zmanjšala za približno 50%.
Open label, randomised, cross-over replicate design clinical trials were conducted in healthy subjects to assess the effects of high-fat and low-fat food on the bioavailability and pharmacokinetic variability of avatrombopag.
Pri zdravih preiskovancih so bile za oceno učinkov hrane z veliko vsebnostjo maščob in hrane z majhno vsebnostjo maščob na biološko razpoložljivost in farmakokinetično variabilnost avatrombopaga opravljena odprta, randomizirana, navzkrižna klinična preskušanja na podlagi ponovitvenega načrta.
You should be scheduled to undergo your procedure 5 to 8 days after the last dose of Doptelet.
Na kirurški poseg morate biti naročeni od 5 do 8 dni po zadnjem prejetem odmerku zdravila Doptelet.
Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
Avatrombopag ni kompetitiven s TPO pri vezavi na receptor TPO, skupaj s TPO pa ima aditivni učinek na tvorbo trombocitov.
Avatrombopag was not mutagenic in an in vitro bacterial reverse mutation (AMES) assay or clastogenic in an in vitro human lymphocyte chromosomal aberrations assay or in an in vivo rat bone marrow micronucleus assay.
Avatrombopag se ni izkazal za mutagenega pri preizkusu reverznih mutacij pri bakterijah (AMES) in vitro oz. za klastogenega pri preizkusu kromosomskih aberacij v človeških limfocitih in vitro ali preizkusu mikrojeder v podganjem kostnem mozgu in vivo.
Dova Pharmaceuticals Ireland, Limited 6th Floor, 2 Grand Canal Square Dublin 2
Imetnik dovoljenja za promet z zdravilom Dova Pharmaceuticals Ireland, Limited 6th Floor, 2 Grand Canal Square Dublin 2
A measured increase in platelet counts was observed in both avatrombopag treatment groups over time beginning on Day 4 post-dose, which peaked on Day 10-13 and then returned to near baseline values by Day 35 (Figure 1); mean platelet count remained greater than or equal to 50 x 109/L on Day 17 (Visit 5).
Pri obeh skupinah bolnikov, zdravljenih z avatrombopagom, se je izmerjeno število trombocitov postopno povečevalo z začetkom na 4. dan po odmerjanju in bilo največje od 10.-13. dneva, nato pa se je do 35. dneva (slika 1) zmanjšalo skoraj na izhodiščne vrednosti; na 17. dan (5. obisk) je povprečno število trombocitov ostalo večje ali enako 50 x 109/l.
Consider the potential increased thrombotic risk when administering Doptelet to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).
Pri dajanju zdravila Doptelet bolnikom z znanimi dejavniki tveganja za tromboembolijo, vključno z genetskimi protrombotičnimi stanji (faktor V Leiden, protrombin 20210A, pomanjkanje antitrombina ali pomanjkanje proteina C oz. S), upoštevajte možno povečano tveganje za trombozo.
The increase in avatrombopag exposure is not expected to have a clinically important effect on platelet counts due to the 5-day treatment duration, and no dose adjustment is recommended.
Zaradi 5-dnevnega trajanja zdravljenja ni pričakovati, da bi večja izpostavljenost avatrombopagu imela klinično pomemben učinek na število trombocitov, zato prilagoditev odmerka ni potrebna.
If any of the above applies to you, or you are not sure, talk to your doctor or pharmacist before taking Doptelet.
Če za vas velja kar koli od zgoraj navedenega ali pa ste negotovi, se pred jemanjem zdravila Doptelet posvetujte z zdravnikom ali farmacevtom.
Eligible patients were scheduled to undergo their procedure (low bleeding risk procedures, such as endoscopy and colonoscopy (60.8%); moderate bleeding risk, such as liver biopsy and chemoembolization for HCC (17.2%); or high bleeding risk, such as dental procedures and radiofrequency ablation (22.1%)) 5 to 8 days after their last dose of treatment.
Pri primernih bolnikih je bil načrtovan ustrezen kirurški poseg (posegi z majhnim tveganjem za krvavitev, kot sta endoskopija in kolonoskopija (60,8%); posegi z zmernim tveganjem za krvavitev, kot sta biopsija jeter in kemoembolizacija pri hepatocelularnem karcinomu (HCC) (17,2%);
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
4.1 Terapevtske indikacije Zdravilo Doptelet je indicirano za zdravljenje hude trombocitopenije pri odraslih bolnikih s kronično boleznijo jeter, pri katerih je načrtovan invazivni poseg.
Tablet core: lactose monohydrate (see section 2 “Doptelet contains lactose”); microcrystalline cellulose [E460(i)]; crospovidone type B [E1202]; silica, colloidal anhydrous [E551]; magnesium stearate [E470b].
Jedro tablete: laktoza monohidrat (glejte poglavje 2 »Zdravilo Doptelet vsebuje laktozo«); mikrokristalna celuloza [E460(i)]; krospovidon tipa B [E1202]; brezvoden koloidni silicijev dioksid [E551]; magnezijev stearat [E470b].
Avatrombopag did not affect fertility or early embryonic development in male rats at exposures 22-times, or in female rats at exposures 114-times, the AUC observed in patients at the recommended dose of 60 mg once daily.
Avatrombopag ni vplival na plodnost ali zgodnji embrionalni razvoj pri samcih podgan ob izpostavljenosti 22-kratnika oz. pri samicah podgan ob izpostavljenosti 114-kratnika vrednosti AUC
10 film-coated tablets 15 film-coated tablets
15 filmsko obloženih tablet
Co-administration of avatrombopag with either a high-fat or low-fat meal did not result in clinically important changes in rate or extent of absorption of avatrombopag.
Sočasno dajanje avatrombopaga z obrokom z veliko vsebnostjo maščob oz. obrokom z majhno vsebnostjo maščob ni pokazalo klinično pomembnih sprememb hitrosti ali obsega absorpcije avatrombopaga.
Based on the known metabolic profile of avatrombopag and the fact that only 6% of the dose is excreted in urine, the likelihood of effects of renal impairment on pharmacokinetics of avatrombopag is considered to be very low (see sections 4.2 and 4.8).
odmerka izloča v urin, se šteje, da je verjetnost učinkov okvare ledvic na farmakokinetiko avatrombopaga zelo majhna (glejte poglavji 4.2 in 4.8).
The population pharmacokinetic analysis of avatrombopag in healthy subjects and subjects with thrombocytopenia due to chronic liver disease indicated similar exposures between healthy subjects and subjects with mild and moderate renal impairment (CrCL ≥ 30 mL/min, Cockcroft-Gault).
Populacijska farmakokinetična analiza avatrombopaga pri zdravih preiskovancih in preiskovancih s trombocitopenijo zaradi kronične bolezni jeter je pokazala podobno izpostavljenost pri zdravih preiskovancih in preiskovancih z blago do zmerno okvaro ledvic (CrCL ≥ 30 ml/min, Cockcroft-Gault).
Doptelet was not studied in patients with prior thromboembolic events.
Zdravila Doptelet pri bolnikih s tromboemboličnimi dogodki v anamnezi niso proučevali.
While the benefit-risk profile for procedures that were not specifically included in the clinical studies is likely to be comparable, the efficacy and safety of avatrombopag have not been established in major surgeries like laparotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.
Sicer je pri posegih, ki niso bili posebej vključeni v klinične študije, razmerje med tveganji in koristmi najverjetneje podobno, vendar pa učinkovitost in varnost avatrombopaga pri večjih kirurških posegih, npr. laparotomiji, torakotomiji,
Table 2: Efficacy results by baseline platelet count cohort and treatment group - Study 1 and Study 2
Preglednica 2: Rezultati o učinkovitosti glede na kohorto bolnikov z majhnim/velikim številom trombocitov ob izhodišču in skupino zdravljenja - Študija 1 in Študija 2
In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-emergent event of portal vein thrombosis in a patient (n = 1/430) with chronic liver disease and thrombocytopenia which was reported 14 days after treatment with Doptelet ended.
V okviru kliničnih preskušanj ADAPT-1 in ADAPT-2 so 14 dni po končanem zdravljenju z zdravilom Doptelet poročali o enem dogodku tromboze portalne vene, nastalem zaradi zdravljenja, in sicer pri bolniku (n = 1/430) s kronično boleznijo jeter in trombocitopenijo.
Doptelet is not recommended in pregnancy and in women who are able to have children and are not using contraception.
Zdravila Doptelet ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Avatrombopag is a substrate for p-glycoprotein (P-gp) mediated transport, although no clinically important differences in platelet count elevations are expected when avatrombopag is co-administered with a strong P-gp inhibitor.
Avatrombopag je substrat za prenos s p-glikoproteinom (P-gp), čeprav pri sočasnem dajanju avatrombopaga in močnega zaviralca P-gp ni pričakovati klinično pomembnih razlik v povečanju števila trombocitov.
If you have any questions on the use of this medicine, ask your doctor or pharmacist.
Če imate dodatna kakršna koli vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali farmacevtom.
High baseline platelet count (≥ 40 to < 50 x 109/L)
Veliko število trombocitov ob izhodišču (≥ 40 do < 50 x 109/l)
Film coating: poly(vinyl alcohol) [E1203]; talc [E553b]; macrogol 3350 [E1521]; titanium dioxide [E171]; iron oxide yellow [E172].
Filmska obloga: polivinilalkohol [E1203]; smukec [E553b]; makrogol 3350 [E1521]; titanijev dioksid [E171]; železov oksid [E172].
Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity.
Avatrombopag zaradi edinstvene specifičnosti za receptorje TPO ne spodbuja tvorbe trombocitov pri miših, podganah, opicah ali psih.
The apparent volume of distribution of avatrombopag in patients with thrombocytopenia and chronic liver disease based on population pharmacokinetic analysis is approximately 180 L, suggesting that avatrombopag is extensively distributed.
Glede na populacijsko farmakokinetično analizo pri bolnikih s trombocitopenijo in kronično boleznijo jeter znaša navidezni volumen porazdelitve avatrombopaga približno 180 l, kar kaže na obsežno porazdelitev avatrombopaga.
The usual recommended dose is either 40 mg (2 tablets) or
Običajen priporočeni odmerek je bodisi 40 mg (2 tableti) ali 60 mg (3 tablete) na dan 5 dni zapored.
Mean platelet count (+/- standard error) by days from start of dosing by baseline platelet count cohort and treatment group - pooled Study 1 and Study 2
Slika 1:Povprečno število trombocitov (+/- standardna napaka) po dnevih od začetka odmerjanja glede na kohorto bolnikov z majhnim/velikim številom trombocitov ob izhodišču in skupino zdravljenja - zbrani podatki iz Študije 1 in Študije 2
There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.
O uporabi avatrombopaga pri bolnikih, ki so se predhodno zdravili z avatrombopagom, je malo podatkov.
The European Medicines Agency has waived the obligation to submit the results of studies with Doptelet in all subsets of the paediatric population in thrombocytopenia secondary to liver disease (see section 4.2 for information on paediatric use).
Doptelet za vse podskupine pediatrične populacije pri zdravljenju trombocitopenije, ki je posledica bolezni jeter (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Population pharmacokinetic analysis of avatrombopag plasma concentrations from the clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease indicated that avatrombopag exposures were similar across the different races studied.
Populacijska farmakokinetična analiza plazemskih koncentracij avatrombopaga iz kliničnih študij pri zdravih preiskovancih in bolnikih s trombocitopenijo zaradi kronične bolezni jeter je pokazala podobno izpostavljenost avatrombopagu v vseh proučevanih rasnih skupinah.