FrancophonIA/ELRC3.0 huggingface dataset:
English: P-gp and moderate CYP3A inhibitor
Maltese: P-gp u inibitur moderat ta' CYP3A
English: Musculoskeletal & connective tissue disorders
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: Effect of avatrombopag
Maltese: Effett ta' avatrombopag
English: Table 1 Daily dose recommendation for avatrombopag
Maltese: Tabella 1 Doża rakkomandata ta' kuljum għal avatrombopag
English: 40 mg (Two 20 mg tablets)
Maltese: 40 mg (Żewġ pilloli ta' 20 mg)
English: 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.
Maltese: Avatrombopag ma jinibixxix CYP1A, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1,
English: In Study 2, a total of 204 patients were randomised; 128 patients to the avatrombopag treatment group and 76 patients to the placebo treatment group.
Maltese: Fi Studju 2, total ta' 204 pazjent intgħażlu b'mod każwali; 128 pazjent għall-grupp ta' trattament b'avatrombopag u 76 pazjent għall-grupp ta' trattament bil-plaċebo.
English: • Doptelet is available in 20 mg tablets.
Maltese: • Doptelet huwa disponibbli f'pilloli ta' 20 mg.
English: 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).
Maltese: Wieħed għandu jikkunsidra r-riskju trombotiku miżjud potenzjali meta tagħti Doptelet lil pazjenti b'fatturi ta' riskju magħrufa għal tromboemboliżmu, inkluż kundizzjonijiet protrombotiċi ġenetiċi (Fattur V Leiden, Protrombin 20210A, Defiċjenza ta' antitrombin jew defiċjenza tal-Proteina C jew S).
English: 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.
Maltese: Avatrombopag jinibixxi t-trasportatur tal-anjoni organiku (OAT, organic anion transporter) 1 u 3 u l-proteina tar-reżistenza kontra l-kanċer tas-sider (BCRP, breast cancer resistance protein) iżda mhux il-polypeptide tat-trasportatur tal-anjoni organiku (OATP, organic anion transporter polypeptide) 1B1 u 1B3, u t-trasportatur tal-katjoni organiku (OCT, organic cation transporter)
English: A total of 24.8% of patients were ≥ 65 years of age, 4.6% ≥ 75 years of age, and only 1 (0.2%) ≥ 85 years of age.
Maltese: Total ta' 24.8% tal-pazjenti kellhom età ta' ≥ 65 sena, 4.6% kellhom età ta' ≥ 75 sena, u 1
English: 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).
Maltese: L-esponimenti (AUC) f'dożi li ma wrew l-ebda leżjoni gastrika fost l-ispeċi kienu bejn 3 u 33 darba ogħla mill-esponimenti fi bnedmin fid-doża rakkomandata massima għall-bnedmin (MRHD, maximum recommended human dose).
English: 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.
Maltese: doża waħda ta' 20 mg 14C-avatrombopag lil voluntiera rġiel b'saħħithom, 88% tad-doża ġiet irkuprata fl-ippurgar u 6% fl-awrina.
English: 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.
Maltese: Il-farmakokinetiċi u l-farmakodinamiċi ta' avatrombopag ma ġewx investigati f'pazjenti b'indeboliment tal-kliewi sever (CrCL < 30 mL/min, Cockcroft-Gault), inklużi pazjenti li kienu jeħtieġu emodijaliżi.
English: 60 mg (Three 20 mg tablets)
Maltese: 60 mg (Tliet pilloli ta' 20 mg)
English: Strong CYP3A4/5 or CYP2C9 inducers
Maltese: Inibituri ta' CYP3A4/5 u CYP2C9
English: Placebo (n = 48)
Maltese: (n = 48)
English: A risk to the breast-feeding child cannot be excluded.
Maltese: Ir-riskju gћat-trabi li qed jiġu mreddgħa mhux eskluż.
English: Animal Toxicology and/or Pharmacology
Maltese: Tossikoloġija u/jew Farmakoloġija tal-Annimali
English: High baseline platelet count (≥ 40 to < 50 x 109/L)
Maltese: Għadd għoli tal-plejtlits fil-linja bażi (≥ 40 sa < 50 x 109/L)
English: 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.
Maltese: Avatrombopag ma kienx mutaġeniku f'analiżi tal-mutazzjoni batterjali riversibbli in vitro (AMES) jew klastoġeniku f'analiżi tal-aberrazzjoni tal-kromosoma limfoċita umana in vitro jew f'analiżi tal-mikronukleu tal-mudullun tal-firien in vivo.
English: 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.
Maltese: Il-popolazzjonijiet tal-pazjenti kienu simili bejn il-koorti tal-għadd għoli tal-plejtlits fil-linja bażi, u kkonsistew f'66% rġiel u 35% nisa; l-età medjana kienet 58 sena u 61% kienu Bojod, 34% Asjatiċi, u 3% Suwed.
English: Each film-coated tablet contains avatrombopag maleate equivalent to 20 mg of avatrombopag.
Maltese: Kull pillola miksija b'rita fiha avatrombopag maleate ekwivalenti għal 20 mg ta' avatrombopag.
English: Placebo (n = 33)
Maltese: (n = 33)
English: 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.
Maltese: Fil-provi kliniċi ADAPT-1 u ADAPT-2, kien hemm avveniment li rriżulta mit-trattament wieħed ta' trombożi tal-vina portali f'pazjent (n = 1/430) b'mard tal-fwied kroniku u tromboċitopenija li ġie rrappurtat 14-il jum wara li ntemm it-trattament b'Doptelet.
English: The oxidative metabolism of avatrombopag is mainly mediated by CYP2C9 and CYP3A4.
Maltese: Il-metaboliżmu ossidattiv ta' avatrombopag huwa prinċiparjament medjat minn CYP2C9 u CYP3A4.
English: 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.
Maltese: double-blind, u kkontrollati bi plaċebo, Studju 1 u Studju 2, li fihom 430 pazjenti b'mard tal-fwied kroniku u tromboċitopenija rċivew jew avatrombopag (n = 274) jew plaċebo (n = 156), u kellhom valutazzjoni tas-sigurtà wara d-doża waħda.
English: • Start taking Doptelet 10 to 13 days before your planned medical procedure.
Maltese: • Ibda ħu Doptelet bejn 10 u 13-il jum qabel il-proċedura medika ppjanata tiegħek.
English: Doptelet was not studied in patients with prior thromboembolic events.
Maltese: Doptelet ma ġiex studjat f'pazjenti b'passat ta' avvenimenti tromboemboliċi.
English: 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.
Maltese: Il-pazjenti eliġibbli kienu skedati li ssirilhom proċedura (proċeduri b'riskju baxx ta' ħruġ ta' demm, bħal endoskopija u kolonoskopija (60.8%); riskju moderat ta' ħruġ ta' demm, bħal bijopsija tal-fwied u kimoembolizzazzjoni għal HCC (17.2%); jew riskju għoli ta' ħruġ ta' demm, bħal proċeduri tas-snien u ablazzjoni tal-frekwenza tar-radju (22.1%)) bejn 5 u 8 ijiem wara l-aħħar doża tat-trattament.
English: 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).
Maltese: Abbażi tal-profil metaboliku magħruf ta' avatrombopag u l-fatt li 6% tad-doża biss tiġi eliminata fl-awrina, il-probabbiltà tal-effetti ta' indeboliment tal-kliewi fuq il-farmakokinetiċi ta' avatrombopag hi meqjusa li hi baxxa ħafna (ara sezzjonijiet 4.2 u 4.8).
English: The mean plasma elimination half-life (%CV) of avatrombopag is approximately 19 hours (19%).
Maltese: Il-half-life tal-eliminazzjoni fil-plażma medja (%CV) ta' avatrombopag hija madwar 19-il siegħa (19%).
English: Bone pain Myalgia
Maltese: Popolazzjoni pedjatrika
English: In vitro studies suggest that avatrombopag is highly bound to human plasma proteins (> 96%).
Maltese: Studji in vitro jissuġġerixxu li avatrombopag jeħel ħafna mal-proteini tal-plażma tal-bniedem (> 96%).
English: 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.
Maltese: Il-parametri farmakokinetiċi ta' avatrombopag fil-ħalib kienu simili għal dawk fil-plażma bi proporzjon ta' esponiment ta' radjoattività relatata ma' avatrombopag (ħalib għal plażma) ta' 0.94.
English: P-gp inhibitor
Maltese: Inibituri ta' P-gp
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'indeboliment tal-fwied ħafif (Child-Pugh klassi A) sa moderat (Child-Pugh klassi B).
English: Portal vein thrombosis
Maltese: Trombożi fil-vina portali
English: Each blister contains either 10 or 15 tablets.
Maltese: 10 jew 15-il pillola.
English: Moderate CYP2C9 and strong CYP3A inducer
Maltese: Induttur moderat ta' CYP2C9 u qawwi ta' CYP3A
English: Placebo (n = 43)
Maltese: (n = 43)
English: 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).
Maltese: L-esponiment għal avatrombopag fil-plażma kien kumparabbli f'pazjenti b'mard tal-fwied kroniku sekondarju għal epatite virali (n = 242), statoepatite mhux alkoħolika (n = 45) u mard tal-fwied alkoħoliku (n = 49) fl-istudji pivitali ta' Fażi 3, u kien kumparabbli wkoll għal dak f'individwi b'saħħithom (n = 391).
English: Moderate CYP3A and CYP2C9 inhibitor
Maltese: Inibitur moderat ta' CYP3A u CYP2C9
English: There is limited information on the use of avatrombopag in patients with severe (Child-Pugh class C, MELD score > 24) hepatic impairment.
Maltese: Hemm informazzjoni limitata dwar l-użu ta' avatrombopag f'pazjenti b'indeboliment tal-fwied sever (Child-Pugh klassi C, punteġġ MELD > 24).
English: The mean (%CV) of the clearance of avatrombopag is estimated to be 6.9 L/hr (29%).
Maltese: Il-medja (%CV) tat-tneħħija ta' avatrombopag hija stmata li hi 6.9 L/siegħa (29%).
English: In 4-week or longer repeated-dose toxicity studies, treatment-related gastric lesions were observed in mice, rats, and cynomolgus monkeys.
Maltese: Fi studji tat-tossiċità ta' dożi ripetuti ta' 4 ġimgħat jew iżjed, leżjonijiet gastriċi relatati mat-trattament kienu osservati fil-ġrieden, firien, u xadini cynomolgus.
English: Low baseline platelet count cohort (< 40 x 109/L)
Maltese: Il-koort tal-għadd baxx tal-plejtlits fil-linja bażi (< 40 x 109/L)
English: Placebo (n = 34)
Maltese: (n = 34)
English: How to take Doptelet
Maltese: X'fih Doptelet
English: There is limited information on the use of avatrombopag in patients previously exposed to avatrombopag.
Maltese: Hemm informazzjoni limitata dwar l-użu ta' avatrombopag f'pazjenti li fil-passat kienu esposti għal avatrombopag.
English: Table 2: Efficacy results by baseline platelet count cohort and treatment group - Study 1 and Study 2
Maltese: Tabella 2: Riżultati tal-effikaċja skont il-koort tal-għadd tal-plejtlits fil-linja bażi u l-grupp tat-trattament - Studju 1 u Studju 2
English: Pale yellow, round biconvex film-coated 7.6 mm tablet debossed with “AVA” on one side and “20” on the other.
Maltese: Pillola miksija b'rita safra ċar, tonda u bbuzzata fuq iż-żewġ naħat ta' 7.6 mm imnaqqxa b'“AVA” fuq naħa waħda u “20” fuq in-naħa l-oħra.
English: Population pharmacokinetic analysis of avatrombopag plasma concentrations from clinical studies with healthy subjects and patients with thrombocytopenia due to chronic liver disease, that included 11% (84/787) of the study population ≥ 65 years of age, suggested that avatrombopag exposures are not affected by age (see section 4.2).
Maltese: Analiżi farmakokinetika tal-popolazzjoni tal-konċentrazzjonijiet ta' avatrombopag fil-plażma minn studji kliniċi b'individwi b'saħħithom u pazjenti bi tromboċitopenija minħabba mard tal-fwied kroniku, li inkludew 11% (84/787) tal-popolazzjoni tal-istudju li kellhom età ta' ≥ 65 sena, issuġġerit li l-esponimenti għal avatrombopag ma kinux affettwati mill-età (ara sezzjoni 4.2).
English: 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.
Maltese: Il-profili taż-żmien mal-konċentrazzjoni fil-plażma wara l-għoti orali ta' avatrombopag kienu kkaratterizzati b'dewmien qasir (0.5 - 0.75 sigħat) bl-ogħla esponiment 6 - 8 sigħat wara d-doża.
English: 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).
Maltese: Madanakollu, kien hemm tnaqqis sinifikanti (b'madwar 50%) fil-varjabbiltà ta' avatrombopag AUC u Cmax bejn u fl-individwi meta mogħti mal-ikel (ara sezzjonijiet 4.2 u 4.5).
English: Avatrombopag 40 mg (n = 58) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec a Two-sided 95% confidence interval based on normal approximation.
Maltese: Medja (SD) x 109/L Medjan x 109/L Valur-pc a 95% intervall ta' kunfidenza minn żewġ naħat ibbażat fuq approssimazzjoni normali.
English: Blister (polyamide and polyvinyl chloride-laminated aluminium film with push-through aluminium and polyethylene terephthalate foil) containing either 10 or 15 film-coated tablets.
Maltese: Folja (rita tal-aluminium laminat b'polyamide u polyvinyl chloride b'foil ta' push-through aluminium u polyethylene terephthalate) li fiha jew 10 jew 15-il pillola miksija b'rita.
English: 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).
Maltese: (0.25 darbiet tad-dożaġġ approvat l-aktar baxx) sa 80 mg (1.3 darbiet tal-ogħla dożaġġ rakkomandat).
English: What you need to know before you take Doptelet 3.
Maltese: X'għandek tkun taf qabel ma tieħu Doptelet 3.
English: The patient should undergo their procedure 5 to 8 days after the last dose of avatrombopag.
Maltese: Il-pazjent għandha ssirlu l-proċedura bejn 5 u 8 ijiem wara l-aħħar doża ta' avatrombopag.
English: 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.
Maltese: 22 darba, jew fil-firien nisa f'esponimenti 114-il darba, ogħla mill-AUC osservat f'pazjenti fid-doża rakkomandata ta' 60 mg darba kuljum.
English: 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.
Maltese: Avatrombopag huwa agonist tar-riċettur oralment attiv tat-trombopoietin (TPO) b'molekula żgħira li jistimula l-proliferazzjoni u d-differenzjazzjoni ta' megakarjoċiti minn ċelluli proġenituri tal-mudullun li jirriżulta f'żieda fil-produzzjoni tal-plejtlits.
English: Due to limited information available, the safety and efficacy of avatrombopag in patients with severe hepatic impairment (Child-Pugh class C, MELD score > 24) have not been established (see section 4.4).
Maltese: Minħabba l-informazzjoni limitata li hemm disponibbli, is-sigurtà u l-effikaċja ta' avatrombopag f'pazjenti b'indeboliment tal-fwied sever (Child-Pugh klassi C, punteġġ MELD > 24) ma ġewx stabbiliti (ara sezzjoni 4.4).
English: 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.
Maltese: Avatrombopag ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi sever (ara sezzjoni 5.2); madanakollu, minħabba t-tul qasir tat-trattament,
English: No clinically important difference in avatrombopag exposures were observed between patients with Child-Turcotte-Pugh Scores (Range = 5 to 12) or MELD scores (Range = 4 to 23) and healthy subjects.
Maltese: L-ebda differenza klinikament importanti f'esponimenti għal avatrombopag ma kienet osservata bejn pazjenti b'Punteġġi ta' Child-Turcotte-Pugh (Medda = 5 sa 12) jew punteġġi ta' MELD (Medda = 4 sa 23) u individwi b'saħħithom.
English: In the low baseline platelet count cohort, the mean baseline platelet count for the avatrombopag-treated group was 31.1 x 109/L and for placebo-treated patients was 30.7 x 109/L.
Maltese: Fil-koort tal-għadd baxx tal-plejtlits fil-linja bażi, l-għadd medju tal-plejtlits fil-linja bażi għall-grupp ittrattat b'avatrombopag kien 31.1 x 109/L u għall-pazjenti ttrattati bi plaċebo kien 30.7 x 109/L.
English: P-gp inhibitors
Maltese: Valur-pb
English: In Study 1, a total of 231 patients were randomised; 149 patients to the avatrombopag group and 82 patients to the placebo group.
Maltese: Fi Studju 1, total ta' 231 pazjent intgħażlu b'mod każwali; 149 pazjent għall-grupp ta' avatrombopag u
English: Concomitant use of avatrombopag with strong CYP3A4/5 or CYP2C9 inhibitors increases avatrombopag exposure.
Maltese: L-użu fl-istess ħin ta' avatrombopag ma' inibituri qawwija ta' CYP3A4/5 jew CYP2C9 iżid l-esponiment għal avatrombopag.
English: Patients with severe hepatic impairment should be supported in line with clinical practice by close monitoring for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.
Maltese: Pazjenti b'indeboliment sever tal-fwied għandhom jingħataw appoġġ skont il-prattika klinika permezz ta' monitoraġġ mill-qrib għal sinjali bikrija ta' aggravar jew bidu ġdid ta' enċefalopatija tal-fwied, axxite, u tendenza trombotika jew ta' ħruġ ta' demm, permezz ta' monitoraġġ ta' testijiet tal-funzjoni tal-fwied, testijiet użati għall-valutazzjoni tal-istat tat-tagħqid tad-demm u permezz ta' immaġni ta'
English: Hypersensitivity to avatrombopag or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għal avatrombopag jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: The efficacy of avatrombopag was similar across various subgroups for the pooled Phase 3 study population (Study 1 and Study 2).
Maltese: L-effikaċja ta' avatrombopag kienet simili fost il-bosta subgruppi għall-popolazzjoni ta' studju ta' Fażi 3 miġbura (Studju 1 u Studju 2).
English: Avatrombopag was present in the milk of lactating rats, see section 5.3.
Maltese: L-ebda aġġustament fid-doża mhu rakkomandat (ara sezzjoni 5.2).
English: The efficacy and safety of avatrombopag for the treatment of adult patients with chronic liver disease and a platelet count ˂ 50 x 109/L who were scheduled to undergo a procedure were studied in 2 identically-designed multicenter, randomised, double-blind, placebo-controlled Phase 3 studies (Study 1 and Study 2).
Maltese: L-effikaċja u s-sigurtà ta' avatrombopag għat-trattament ta' pazjenti adulti b'mard tal-fwied kroniku u għadd tal-plejtlits < 50 x 109/L li kienu skedati li ssirilhom proċedura ġew studjati f'2 studji mfassla b'mod identiku, b'aktar minn ċentru wieħed, fejn il-pazjenti ntgħażlu b'mod każwali, double-blind u kkontrollati bi plaċebo ta' Fażi 3 (Studju 1 u Studju 2).
English: No metabolites of avatrombopag were detected in plasma.
Maltese: L-ebda metaboliti ta' avatrombopag ma kienu identifikati fil-plażma.
English: Do not use this medicine after the expiry date which is stated on the carton and on each blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq kull folja wara ‘EXP'.
English: You should be scheduled to undergo your procedure 5 to 8 days after the last dose of Doptelet.
Maltese: Għandek tiġi skedat li ssirlek il-proċedura bejn 5 u 8 ijiem wara l-aħħar doża ta' Doptelet.
English: 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
Maltese: L-għadd medju tal-plejtlits (+/- żball standard) skont il-jiem mill-bidu tad-dożaġġ skont il-koort tal-għadd tal-plejtlits fil-linja bażi u l-grupp ta' trattament - Studju 1
English: 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).
Maltese: L-analiżi farmakokinetika tal-popolazzjoni ta' avatrombopag f'individwi b'saħħithom u individwi bi tromboċitopenija minħabba mard tal-fwied kroniku indikat esponimenti simili bejn individwi b'saħħithom u individwi b'indeboliment tal-kliewi ħafif u moderat (CrCL ≥ 30 mL/min,
English: 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.
Maltese: Analiżi farmakokinetika tal-popolazzjoni tal-konċentrazzjonijiet ta' avatrombopag fil-plażma minn studji kliniċi b'individwi b'saħħithom u pazjenti bi tromboċitopenija minħabba mard tal-fwied kroniku indikat li l-esponimenti għal avatrombopag kienu simili fost ir-razez differenti studjati.
English: Patients with chronic liver disease are known to be at increased risk for thromboembolic events.
Maltese: Pazjenti b'mard tal-fwied kroniku huma magħrufa li għandhom riskju miżjud ta' avvenimenti tromboemboliċi.
English: 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.
Maltese: Il-volum apparenti tad-distribuzzjoni ta' avatrombopag f'pazjenti bi tromboċitopenija u mard tal-fwied kroniku abbażi ta' analiżi farmakokinetika tal-popolazzjoni huwa madwar 180 L, li tissuġġerixxi li avatrombopag jiġi distribwit b'mod estensiv.
English: This adverse reaction was assessed as non-serious.
Maltese: Din ir-reazzjoni avversa kienet ivvalutata bħala mhux serja.
English: Avatrombopag 60 mg (n = 70) Proportion of subjects not requiring a platelet transfusion or rescue procedure for bleeding Responders 95% CIa P-valueb Proportion of subjects who achieved a platelet count ≥ 50 × 109/L on procedure day Responders 95% CIa P-valueb Change in platelet count from baseline to procedure day Mean (SD) x 109/L Median x 109/L P-valuec
Maltese: Il-pazjenti fil-koort tal-għadd baxx tal-plejtlits fil-linja bażi rċivew 60 mg avatrombopag jew plaċebo li jaqbel darba kuljum għal 5 ijiem, u l-pazjenti fil-koort tal-għadd għoli tal-plejtlits fil-linja bażi rċivew 40 mg avatrombopag jew plaċebo li jaqbel darba kuljum għal 5 ijiem.