natgillin/translations-raw huggingface dataset:
Patient populations were similar between the low and high baseline platelet count cohorts, and consisted of 66% male and 35% female; median age 58 years and 61% White, 34% Asian, and 3% Black.
Populacija bolesnika je bila slična među skupinama s niskom i visokom početnom vrijednošću broja trombocita, a sastojala se od 66% muškaraca i 35% žena, s medijanom dobi 58 godina, te 61% bijelaca, 34% azijata i 3% crnaca.
No dosage adjustment is expected for these patients.
Kod ovih se bolesnika ne očekuju prilagodbe doze.
The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2).
Djelotvornost avatrombopaga je bila slična u raznim podskupinama za objedinjenu populaciju ispitivanja faze 3 (Ispitivanje 1 i Ispitivanje 2).
Effect of avatrombopag
Učinak 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).
Na temelju poznatog metaboličkog profila avatrombopaga i činjenice da se samo 6% doze izlučuje u urinu, smatra se kako je vjerojatnost učinka oštećenja bubrega na farmakokinetiku avatrombopaga vrlo mala (vidjeti dio 4.2 i 4.8).
No dose adjustment is recommended (see section 5.2).
Ne preporučuje se prilagodba doze (vidjeti dio 5.2).
Duration of treatment Due to limited information, avatrombopag should not be taken for more than 5 days.
Zbog ograničenih podataka, avatrombopag se ne smije uzimati duže od 5 dana.
Each film-coated tablet contains 120.8 mg of lactose monohydrate.
Jedna filmom obložena tableta sadrži 120,8 mg laktoza hidrata.
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).
Uzmite u obzir moguće povećanje rizika od tromboze kod primjene Dopteleta u bolesnika s poznatim faktorima rizika za tromboemboliju, uključujući genski uvjetovana protrombotska stanja (faktor V Leiden, protrombin 20210A, deficijencija antitrombina ili deficijencija proteina C ili S).
Therefore, data from these animal studies do not fully model potential adverse effects related to platelet count increases due to avatrombopag in humans.
Stoga podaci iz ovih ispitivanja na životinjama nisu potpuni model mogućih nuspojava povezanih s povećanjem broja trombocita uzrokovanog primjenom avatrombopaga u ljudi.
The gastric carcinoids were considered likely due to prolonged hypergastrinemia observed in toxicity studies.
Smatralo se da su želučani karcinoidi vjerojatno nastali zbog produljene hipergastrinemije uočene u ispitivanjima toksičnosti.
Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Ispitivanja na životinjama su nedostatna za konačan zaključak o reproduktivnoj toksičnosti (vidi dio 5.3).
Avatrombopag has not been studied in patients with severe renal impairment (see section 5.2); however, given the short duration of treatment, no dose adjustment is recommended.
Avatrombopag nije ispitan u bolesnika s teškim oštećenjem bubrega (vidjeti dio 5.2); no s obzirom na kratko trajanje liječenja ne preporučuju se prilagodbe doze.
Contains lactose, see leaflet for further information.
Sadrži laktozu, za više informacija pogledajte uputu o lijeku.
• Your dose will depend on your platelet counts.
• Vaša će doza ovisiti o broju tromobocita.
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.
Bolesnici s odgovorom definirani su kao bolesnici kojima nije trebala transfuzija trombocita niti bilo kakav drugi postupak za terapiju spasa (rescue) zbog krvarenja nakon randomizacije i do 7 dana nakon nekog od zakazanih postupaka.
The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%).
Srednja vrijednost (%CV) klirensa avatrombopaga se procjenjuje na 6,9 l/h (29%).
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).
Avatrombopag je pokazao farmakokinetiku proporcionalnu dozi nakon jedne doze od 10 mg (0,25-struka vrijednost najmanje odobrene doza) do 80 mg (1,3-struka vrijednost najviše preporučene doze).
The proportion of subjects not requiring a platelet transfusion or any rescue procedure for bleeding was generally similar across the various subgroups.
Udio ispitanika kojima nije bila potrebna transfuzija trombocita ili neki drugi postupak za terapiju spasa zbog krvarenja bio je općenito sličan u svim podskupinama.
P-gp inhibitors
Pgp inhibitori
Therefore, avatrombopag is recommended to be administered with food (see section 4.2).
Stoga se preporučuje uzimanje avatrombopaga s hranom (vidi dio 4.2).
Doptelet contains lactose
Doptelet sadrži laktozu
The pharmacokinetic parameters of avatrombopag in milk were similar to those in plasma with an exposure ratio of avatrombopag-related radioactivity (milk to plasma) of 0.94.
Farmakokinetički parametri avatrombopaga u mlijeku bili su slični onima u plazmi uz omjer izlaganja radioaktivnosti povezanoj s avatrombopagom (mlijeko prema plazmi) od 0,94.
Avatrombopag does not stimulate platelet production in mice, rats, monkeys, or dogs because of the unique TPO receptor specificity.
Avatrombopag ne potiče proizvodnju trombocita u miševa, štakora, majmuna ni pasa zbog specifičnosti jedinstvenog TPO receptora.
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.
Iako će profil koristi i rizika za postupke koji nisu bili posebno uključeni u klinička ispitivanja vjerojatno biti usporediv, djelotvornost i sigurnost avatrombopaga nisu utvrđene u većim kirurškim zahvatima poput laparotomije, torakotomije, otvorene operacije srca, kraniotomije ili uklanjanja organa.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Učinci su u nekliničkim ispitivanjima uočeni samo pri izloženosti koja se smatra dovoljno većom u odnosu na maksimalnu izloženost u ljudi, ukazujući na malu relevantnost za kliničku primjenu.
Of the 88% of drug-related material in the faeces, 77% was identified as parent (34%) and the 4-hydroxy metabolite (44%).
Od 88% u stolici izlučene tvari lijeka, 77% su činili nepromijenjeni lijek (34%) i 4-hidroksi-metabolit (44%).
How to take Doptelet
Kako uzimati Doptelet
The effect of avatrombopag on human fertility has not been established.
Učinak avatrombopaga na plodnost u ljudi nije ustanovljen.
Doptelet is not expected to affect you being able to drive, cycle or use tools or machines.
Ne očekuje se da će Doptelet utjecati na Vašu sposobnost vožnje automobila ili bicikla, odnosno korištenja strojeva ili alata.
Avatrombopag does not inhibit CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A, does not induce CYP1A, CYP2B6, CYP2C, and CYP3A, and weakly induces CYP2C8 and CYP2C9 in vitro.
Avatrombopag ne inhibira CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ili CYP3A, ne inducira CYP1A, CYP2B6, CYP2C i CYP3A i slabo inducira CYP2C8 i CYP2C9 in vitro.
Thrombotic/thromboembolic events
Trombotski/tromboembolijski događaji
If you forget to take Doptelet
Ako ste zaboravili uzeti Doptelet
Doptelet was not studied in patients with prior thromboembolic events.
Doptelet nije ispitivan u bolesnika s prethodnim tromboembolijskim događajima.
You should be scheduled to undergo your procedure 5 to 8 days after the last dose of Doptelet.
Planiranom postupku trebate se podvrgnuti 5. do 8. dan nakon zadnje doze Dopteleta.
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.
Prikladni bolesnici trebali su biti podvrgnuti invazivnom postupku (postupci s niskim rizikom od krvarenja, poput endoskopije i kolonoskopije (60,8%), umjerenim rizikom od krvarenja, poput biopsije jetre ili kemoembolizacije za HCC (17,2%), ili postupci s visokim rizikom od krvarenja, poput stomatoloških postupaka i radiofrekvencijske ablacije (22,1%) od 5 do 8 dana nakon zadnje doze lijeka.
Avatrombopag is a substrate for P-glycoprotein (P-gp) mediated transport (see Table 3).
Avatrombopag je supstrat za transport posredovan p-glikoproteinom (Pgp) (vidjeti Tablicu 3).
The severity of gastric lesions was dependent on the dose and duration of avatrombopag administration and showed a clear trend towards reversibility during the recovery period.
Težina želučanih lezija ovisila je o dozi i trajanju primjene avatrombopaga te je pokazala jasan trend prema reverzibilnosti tijekom razdoblja oporavka.
Patients' MELD scores ranged from < 10 (37.5%), 10 to 14 (46.3%) and from > 14 to < 24 (16.2%), and included patients with CTP Class A (56.4%), Class B (38.1%), and Class C (5.6%).
MELD rezultati u bolesnika su se kretali od < 10 (37,5%), od 10 do 14 (46,3%) i od > 14 do < 24 (16,2%) te uključivali bolesnike s CTP (Child-Turcotte-Pugh) A (56,4%), B (38,1%), i C (5,6%).
Patients with chronic liver disease are known to be at increased risk for thromboembolic events.
U bolesnika s kroničnom bolešću jetre poznat je povećan rizik od tromboembolijskih događaja.
Patients were then randomised 2:1 to either avatrombopag or placebo.
Bolesnici su zatim bili randomizirani u omjeru 2:1 na avatrombopag ili na placebo.
Each carton contains one blister of 10 or 15 film-coated tablets.
Svaka kutija sadrži jedan blister s 10 ili 15 filmom obloženih tableta.
The primary toxicity of avatrombopag in pivotal repeated-dose studies was in the stomach at high doses with adequate safety margins when compared to the exposure at the maximum recommended human dose; these effects were reversible even in the chronic toxicity studies.
Primarna toksičnost avatrombopaga u pivotalnim ispitivanjima ponavljanog doziranja bila je želučana toksičnost pri visokim dozama uz odgovarajuće sigurnosne margine u usporedbi s izloženošću maksimalnoj preporučenoj dozi za ljude; ovi su učinci bili reverzibilni čak i u ispitivanjima kronične toksičnosti.
Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
Preosjetljivost na avatrombopag ili neku od pomoćnih tvari navedenih u dijelu 6.1.
The recommended daily dose of avatrombopag is based on the patient's platelet count (see Table 1).
Preporučena dnevna doza avatrombopaga temelji se na broju trombocita u bolesnika (vidjeti Tablicu 1).
Following administration of a single 20 mg 14C-avatrombopag dose to healthy male volunteers, 88% of the dose was recovered in faeces and 6% in urine.
14C avatrombopaga od 20 mg u zdravih muških dobrovoljaca, 88% doze se izlučilo u stolici, a 6% u urinu.
Human studies demonstrated that the renal route is not a major pathway for either unchanged avatrombopag or its metabolite's elimination.
Ispitivanja u ljudi su pokazala kako izlučivanje putem bubrega nije glavni put eliminacije nepromijenjenog avatrombopaga ni njegova metabolita.
In 4-week or longer repeated-dose toxicity studies, treatment-related gastric lesions were observed in mice, rats, and cynomolgus monkeys.
U ispitivanjima toksičnosti ponovljenih doza tijekom 4 tjedna ili dulje, želučane lezije povezane s liječenjem su uočene u miševa, štakora i makaki majmuna.
However, there was a significant reduction (by approximately 50%) in the between- and within-subject variability of avatrombopag AUC and Cmax when administered with food (see sections 4.2 and 4.5).
No došlo je do značajnog smanjenja (za oko 50%) interindividualno i intraindividualno u varijabilnosti AUC-a i Cmax avatrombopaga kad se uzima zajedno s hranom (vidjeti dio 4.2 i 4.5).
The oxidative metabolism of avatrombopag is mainly mediated by CYP2C9 and CYP3A4.
Oksidativni metabolizam avatrombopaga se uglavnom posreduje preko CYP2C9 i CYP3A4.
It is unknown whether avatrombopag or its metabolites are excreted in human milk.
Nije poznato izlučuje li se avatrombopag ili njegovi metaboliti u majčino mlijeko.
In animal studies, avatrombopag had no effect on male and female fertility or early embryogenesis in rats (see section 5.3).
U ispitivanjima na životinjama avatrombopag nije imao učinka na plodnost u muškaraca i žena, kao ni na ranu embriogenezu u štakora (vidi dio 5.3).
Pharmacokinetics and pharmacodynamics of avatrombopag have not been investigated in patients with severe renal impairment (CrCL < 30 mL/min, Cockcroft-Gault) including patients requiring haemodialysis.
Farmakokinetika i farmakodinamika avatrombopaga nije ispitana u bolesnika s teškim oštećenjem bubrega (CrCL < 30 ml/min, CockcroftGault), uključujući bolesnike kojima je potrebna hemodijaliza.
Table 3: Drug interactions: Changes in pharmacokinetics of avatrombopag in the presence of co-administered drug
Tablica 3: Interakcije s lijekovima: Promjene u farmakokinetici avatrombopaga u prisutnosti drugog, istodobno primijenjenog lijeka
Geometric mean ratio [90% CI] of avatrombopag PK with/without co administered drug (No Effect = 1.00)
Omjer geometrijskih srednjih vrijednosti [90% CI] PK-a avatrombopaga s/bez istodobno primijenjenog lijeka (bez učinka = 1,00)
b Cochran-Mantel-Haenszel Test. c Wilcoxon Rank Sum Test.
b Cochran-Mantel-Haenszelov test.
In a multiple-dose pharmacokinetic study in healthy volunteers, steady state was reached by day 5 of dosing.
U farmakokinetičkom ispitivanju višekratnog doziranja u zdravih dobrovoljaca, stanje dinamičke ravnoteže postignuto do 5. dana doziranja.
Doptelet is not recommended in pregnancy and in women who are able to have children and are not using contraception.
Doptelet se ne preporučuje tijekom trudnoće ili u žena koje mogu zanijeti, a ne koriste kontracepciju.
You may be at higher risk of blood clots as you get older or if: - you have had to stay in bed for a long time - you have cancer - you are taking the contraceptive birth control pill or hormone replacement therapy - you have recently had surgery or been injured
Rizik od krvnih ugrušaka može rasti kako starite ili ako: ste morali dugo boraviti u krevetu imate rak uzimate kontracepcijsku pilulu ili nadomjesnu hormonsku terapiju ste nedavno operirani ili se ozlijedili ste izrazito prekomjerne tjelesne težine pušite imate uznapredovalu kroničnu bolest jetre.
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.
U dvogodišnjim ispitivanjima kancerogeničnosti u miševa i štakora pojavili su se želučani tumori neuroendokrinih stanica (stanice nalik na enterokromafine, ECL stanice) (karcinoidi) u trbuhu pri visokim dozama.
Macrogol 3350 (E1521) Titanium dioxide (E171) Iron oxide yellow (E172)
Makrogol 3350 (E1521) Titanijev dioksid (E171) Željezov oksid, žuti (E172)
Concomitant use of avatrombopag with P-gp inhibitors resulted in alterations in exposure that were not clinically significant.
Istodobna primjena avatrombopaga s Pgp inhibitorima dovela je do promjena u izloženosti koje nisu bili klinički značajne.
The exposures (AUC) at doses that showed no gastric lesions across the species were 3- to 33-fold higher than the exposures in humans at the maximum recommended human dose (MRHD).
Izloženosti (AUC) pri dozama koje nisu pokazale želučane lezije u raznih vrsta bile su od 3 do 33 puta veće od izloženosti u ljudi pri maksimalnoj preporučenoj dozi za ljude
Doptelet 20 mg film-coated tablets are pale yellow, round, rounded on the upper and lower side, marked with “AVA” imprinted on one side and “20” on the other.
Doptelet 20 mg filmom obložene tablete su svijetlo žute, okrugle tablete zaobljene na gornjoj i donjoj strani, s utisnutom oznakom „AVA” na jednoj strani i „20” na drugoj.
60 mg (Three 20 mg tablets)
60 mg (tri tablete od 20 mg)
Platelet count (x109/L)
Broj trombocita (x109/L)
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).
Izloženost avatrombopagu u plazmi je bila usporediva u bolesnika s kroničnom bolešću jetre uzrokovanom virusnim hepatitisom (n = 242), nealkoholnim steatohepatitisom (n = 45) i alkoholnom bolešću jetre (n = 49) u pivotalnim ispitivanjima faze 3, ali također usporediva i s onom u zdravih ispitanika (n = 391).
Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i svakom blisteru.
Avatrombopag was present in milk of lactating rats after oral administration of radioactive labeled avatrombopag.
Avatrombopag je bio prisutan u mlijeku štakora nakon peroralne primjene radioaktivno označenog avatrombopaga.
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.
Ne očekuje se kako će povećanje izloženosti avatrombopagu imati klinički značajan učinak na broj trombocita jer liječenje traje pet dana, pa se ne preporučuje prilagodba doze.
Two doses should not be taken at one time to make up for a missed dose.
Ne smije se uzeti dvostruka doza kako bi se nadoknadila propuštena.
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.
Otvorena, randomizirana, ukrižena ispitivanja replikativnog dizajna provedena su u zdravih ispitanika kako bi se procijenio učinak hrane s visokim udjelom masnoća i hrane s niskim udjelom masnoća na bioraspoloživost te farmakokinetičku varijabilnost avatrombopaga.
Avatrombopag is not a substrate for OATP1B1, OATP1B3, OCT2, OAT1, and OAT3.
Avatrombopag nije supstrat za OATP1B1, OATP1B3, OCT2, OAT1 i OAT3.
40 mg (Two 20 mg tablets)
40 mg (dvije tablete od 20 mg)
Avatrombopag is not renally excreted, therefore no dose adjustment is required in patients with mild or moderate renal impairment.
Avatrombopag se ne izlučuje putem bubrega, pa nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem bubrega.
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 supstrat za transport posredovan p-glikoproteinom (Pgp), iako se ne očekuju klinički značajne razlike u povećanju broja trombocita kada se avatrombopag primjenjuje zajedno sa snažnim inhibitorom Pgp-a.
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.
Profili koncentracija-vrijeme u plazmi su za peroralno primjenjen avatrombopag okarakterizirani kratkom odgodom (0,5 - 0,75 sati) i vrhuncem izloženosti 6 - 8 sati nakon doze.
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).
Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Doptelet u svim podskupinama pedijatrijske populacije s trombocitopenijom kao posljedicom bolesti jetre (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
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 nije utjecao na plodnost ni rani embrionalni razvoj u mužjaka štakora pri 22-strukim vrijednostima izloženosti niti u ženki štakora pri 114-strukim vrijednostima izloženosti (AUC) postignute u bolesnika pri preporučenoj dozi od 60 mg jednom dnevno.
Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.
Doptelet je indiciran za liječenje teške trombocitopenije u odraslih bolesnika s kroničnom bolešću jetre koji će biti podvrgnuti invazivnom postupku.
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.
Ako dođe do predoziranja ili sumnje na predoziranje, uzimanje Dopteleta treba prekinuti, a broj trombocita treba pažljivo pratiti, jer je povećanje broja trombocita ovisno o dozi avatrombopaga.
Keep this medicine out of the sight and reach of children.
Kako čuvati Doptelet Lijek čuvajte izvan pogleda i dohvata djece.
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.
U bolesnika s bolešću jetre stupnja Child Pugh C treba na dan postupka provjeriti prisutnost neočekivano visokog porasta broja trombocita.
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.
U kliničkim ispitivanjima ADAPT-1 i ADAPT-2 je došlo do pojave 1 događaja tromboze portalne vene u jednog bolesnika (n = 1/430) s kroničnom bolešću jetre i trombocitopenijom, koji je prijavljen 14 dana nakon završetka liječenja Dopteletom.
Avatrombopag does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production.
Avatrombopag se ne natječe s TPO-om u vezivanju na receptor TPO-a i ima aditivan učinak djelovanju TPO-a na proizvodnju trombocita.
Administration with either type of food did not have any clinically important effects on rate (Cmax) or extent (AUC) of avatrombopag exposure.
Uzimanje s bilo kojom vrstom hrane nije imalo nikakav klinički značajan učinak na stopu (Cmax) ili opseg (AUC)
No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Nije potrebna prilagodba doze u bolesnika s blagim (Child-Pugh A) do umjerenim (Child-Pugh B)
The predominant route of avatrombopag excretion is via faeces.
Dominantan put izlučivanja avatrombopaga je putem stolice.
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 aktivan agonist receptora trombopoetina (TPO), male molekularne mase, koji potiče proliferaciju i diferencijaciju megakariocita iz progenitorskih stanica koštane srži i koji uzrokuje povećanu proizvodnju trombocita.
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.
Sigurnost avatrombopaga je procijenjena u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja, Ispitivanju 1 i Ispitivanju 2, u kojima je 430 bolesnika s kroničnom bolešću jetre i trombocitopenijom uzimalo ili avatrombopag (n = 274) ili placebo (n = 156) te imalo 1 sigurnosnu procjenu nakon uzimanja.