FrancophonIA/ELRC3.0 huggingface dataset:
English: This document is a summary of the European public assessment report (EPAR) for Mircera.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Mircera.
English: Why has Mircera been approved?
Maltese: Għaliex ġie approvat Mircera?
English: The epoetin beta is produced by ‘recombinant DNA technology': it is made by a cell that has received a gene, which makes it able to produce epoetin beta.
Maltese: L-epoetin beta jiġi prodott permezz tat-‘teknoloġija rikombinanti tadDNA': huwa jiġi magħmul minn ċellola li tkun irċeviet ġene li jagħmilha kapaċi tipproduċi l-epoetin beta.
English: The first study, in 181 patients on dialysis (a blood clearance technique used in advanced kidney disease), looked at Mircera injected into a vein every two weeks over 24 weeks and compared it with epoetin alfa or beta.
Maltese: L-ewwel wieħed, bis-sehem ta' 181 pazjent li kienu qed jagħmlu dijaliżi (teknika ta' tneħħija tad-demm użata f'pazjenti b'mard tal-kliewi kroniku avvanzat), studja Mircera injettat fil-vina kull ġimagħtejn għal 24 ġimgħa u qabblu ma' epoetin alfa jew beta.
English: Mircera is a solution for injection that contains the active substance methoxy polyethylene glycolepoetin beta.
Maltese: Mircera huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva methoxy polyethylene glycol-epoetin beta.
English: Similar response rates were seen in the patients taking the comparator medicines.
Maltese: Kien hemm rati ta' rispons simili fil-pazjenti li kienu qed jieħdu l-mediċini tat-tqabbil.
English: However, the way it interacts with the receptor is slightly different from natural erythropoietin, which gives it a longer effect.
Maltese: Madankollu, ilmod kif tinteraġixxi mar-reċettur huwa kemmxejn differenti minn eritropojetin naturali, li jagħtih effett itwal.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mircera on 20 July 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Mircera valida fl-Unjoni Ewropea kollha fl-20 ta' Lulju 2007.
English: The second study showed that patients taking Mircera and those taking darbepoetin alfa had similar increases in haemoglobin levels (around 2 g/dl).
Maltese: It-tieni studju wera li l-pazjenti li kienu qed jieħdu Mircera u dawk li kienu qed jieħdu darbepoetin alfa kellhom żidiet simili fil-livelli tal-emoglobina (madwar 2 g/dl).
English: The active substance in Mircera, methoxy polyethylene glycol-epoetin beta, works like natural erythropoietin to stimulate red blood cell production, because it can attach itself to the same receptors as erythropoietin.
Maltese: Is-sustanza attiva f'Mircera, methoxy polyethylene glycol-epoetin beta, taħdem bħal eritropojetin naturali biex tiġi stimulata l-produzzjoni taċ-ċelloli ħomor tad-demm, peress li tista' teħel mal-istess reċetturi bħal eritropojetin.
English: What is Mircera?
Maltese: Kif jintuża Mircera?
English: The second study, in 324 patients not on dialysis, looked at Mircera injected under the skin every two weeks over 28 weeks, comparing it with darbepoetin alfa.
Maltese: It-tieni studju, li fih ħadu sehem 324 pazjent li ma kinux qed jagħmlu d-dijaliżi, studja Mircera injettat taħt il-ġilda kull ġimagħtejn għal 28 ġimgħa, u qabblu ma' darbepoetin alfa.
English: What is the risk associated with Mircera?
Maltese: X'inhu r-riskju assoċjat ma' Mircera?
English: The active substance in Mircera is made up of epoetin beta attached to a chemical called methoxypolyethylene glycol.
Maltese: Is-sustanza attiva f'Mircera hija magħmula minn epoetin beta mwaħħel ma' kimika magħrufa bħala methoxy-polyethylene glycol.
English: Doses should be adjusted according to the patient's response, to obtain haemoglobin levels within the recommended range (between 10 and 12 grams per decilitre).
Maltese: Id-dożi għandhom jiġu aġġustati skont ir-rispons tal-pazjent, li jakkwista livelli ta' emoglobina fir-rakkomandazzjoni varjabbli (bejn 10 u 12-il gramma għal kull deċilitru).
English: Other information about Mircera:
Maltese: Tagħrif ieħor dwar Mircera:
English: Treatment with Mircera must be started under the supervision of a doctor who has experience in the management of patients with kidney disease.
Maltese: Għandha tingħata d-doża l-aktar baxxa li tipprovdi kontroll xieraq tas-sintomi.
English: Erythropoietin is produced by the kidneys.
Maltese: Eritropojetin huwa prodott mill-kliewi.
English: In the studies of patients who had already been receiving medicines to stimulate red blood cell production, patients who changed to Mircera maintained their haemoglobin levels as effectively as the patients who remained on their existing medicines.
Maltese: Fl-istudji ta' pazjenti li kienu diġà qed jieħdu mediċini li jistimulaw il-produzzjoni ta' ċelloli tad-demm ħomor, il-pazjenti li bdew jieħdu Mircera minflok il-mediċina l-oħra effettivament żammew il-livelli talemoglobina daqs il-pazjenti li baqgħu jieħdu l-mediċini ta' qabel.
English: As a result, Mircera can be given less often than natural erythropoietin.
Maltese: B'riżultat ta' dan, Mircera jista' jingħata inqas spiss minn eritropojetin naturali.
English: The CHMP concluded that Mircera corrected and maintained haemoglobin levels in patients with chronic kidney disease and that its effects are comparable with those of other epoetins.
Maltese: Il-livelli tal-emoglobina għandhom jiġu sorveljati kull ġimgħatejn sakemm ikunu stabbli, u wara perjodikament.
English: Mircera is used to treat anaemia (low red blood cell counts) that is causing symptoms in adults with chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly).
Maltese: Mircera jintuża għall-kura tal-anemija (għadd baxx ta' ċelloli ħomor tad-demm) li tikkawża sintomi f'adulti b'mard kroniku tal-kliewi (tnaqqis progressiv għall-perjodu fit-tul fl-abbiltà tal-kliewi li jibqgħu jaħdmu sew).
English: Repeated toxicity
Maltese: Tossiċità ripetuta
English: Kingsfordweg 151, 1043GR Amsterdam The Netherlands
Maltese: Kingsfordweg 151, 1043GR Amsterdam In-Netherlands
English: INFORMATION IN BRAILLE Mulpleo
Maltese: INFORMAZZJONI BIL-BRAILLE Mulpleo
English: The Netherlands
Maltese: IN-NETHERLANDS
English: Age, gender and race
Maltese: Età, sess tal-persuna u razza
English: Platelet Count (*10^4/uL)
Maltese: Għadd tal-Plejtlits (*10^4/uL)
English: It may harm them,
Maltese: Proporzjon ta' individwi [a] (numru ta' individwi)
English: Total - n - Median (days) - (Q1, Q3) - P value [a]
Maltese: Total - n - Medjan (jiem) - (Q1, Q3)
English: Thrombotic/thromboembolic complications
Maltese: Komplikazzjonijiet trombotiċi/ tromboemboliċi
English: 8465RX
Maltese: 8465RX in-Netherlands
English: [b] Cochran-Mantel-Haenszel test with baseline platelet count as stratum.
Maltese: [b] Test ta' Cochran-Mantel-Haenszel bl-għadd tal-plejtlits fil-linja bażi bħala stratum.
English: - 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)
Maltese: - Qalba tal-pillola: mannitol, microcrystalline cellulose, magnesium oxide, sodium lauryl sulfate, hydroxypropylcellulose, carmellose calcium u magnesium stearate - Kisi b'rita: hypromellose, titanium dioxide, triethyl citrate, talc u red-ferric oxide (E172)
English: Invasive procedure was performed between Days 9 and 14.
Maltese: Il-proċedura medika invażiva twettqet bejn Jiem 9 u 14.
English: AUC0-τ (ng·hr/mL)
Maltese: AUC0-τ (ng·siegħa/mL)
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU- DATA LI TINQARA MILL-BNIEDEM PC:
English: Patients with body weight <45 Kg
Maltese: <45 kg.
English: - Use reliable methods of contraception while you are taking Mulpleo.
Maltese: - Uża metodi affidabbli ta' kontraċezzjoni waqt li tkun qed tieħu Mulpleo.
English: 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).
Maltese: Lusutrombopag għandu potenzjal baxx biex jinibixxi enzimi ta' CYP (CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, u 3A4/5), u biex jinduċi kemm enzimi ta' CYP (CYP1A2, 2C9, u 3A4) u kif ukoll enzimi ta' UGT (UGT1A2, 1A6, u 2B7).
English: Treatment Group
Maltese: Grupp tat-Trattament
English: Mulpleo contains sodium
Maltese: Mulpleo fih ftit sodium.
English: Study M0631
Maltese: Studju M0631
English: P-gp and BCRP inhibitors
Maltese: Inibituri ta' P-gp u BCRP
English: Study M0634
Maltese: Studju M0634
English: What Mulpleo contains - The active substance is lusutrombopag.
Maltese: X'fih Mulpleo - Is-sustanza attiva hi lusutrombopag.
English: 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)
Maltese: Kategorija tal-frekwenza: komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000), u rari ħafna (<1/10,000).
English: 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).
Maltese: L-aktar reazzjonijiet avversi komuni kienu wġigħ ta' ras (4.7%, 8/171 pazjent fil-grupp ta' lusutrombopag; 3.5%, 6/170 pazjent fil-grupp tal-plaċebo), dardir (2.3%, 4/171 pazjent fil-grupp ta' lusutrombopag; 4.1%, 7/170 pazjent fil-grupp tal-plaċebo), trombożi fil-vina portali (1.2%, 2/171 pazjent fil-grupp ta' lusutrombopag; 1.2%, 2/170 pazjent fil-grupp tal-plaċebo) u raxx (1.2%, 2/171 pazjent fil-grupp ta' lusutrombopag; 0%, 0/170 pazjent fil-grupp tal-plaċebo).
English: Geometric mean of t1/2 (% coefficient of variation), was 38.3 hours (18.7%) after multiple oral dose of 3 mg lusutrombopag.
Maltese: Il-medja ġeometrika ta' t1/2 (% koeffiċjent tal-varjazzjoni), kienet ta' 38.3 sigħat (18.7%) wara doża orali multipla ta' 3 mg ta' lusutrombopag.
English: Lusutrombopag has also low potential to inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K, and BSEP.
Maltese: BCRP, OATP1B1, OATP1B3, OCT1, OCT2, OAT1, OAT3, MATE1, MATE2-K, u BSEP.
English: Human plasma protein binding ratio is ≥ 99.9%.
Maltese: Il-proporzjon tat-twaħħil tal-proteina tal-plażma tal-bniedem hu ta' ≥ 99.9%.
English: CL/F (L/hr)
Maltese: CL/F
English: Tabulated list of adverse reactions
Maltese: Tabella 1 Reazzjonijiet avversi
English: Table 6 Pharmacokinetic parameters of lusutrombopag after 3 mg dose once daily in thrombocytopenic patients with chronic liver disease (Study M0634)
Maltese: Tabella 6 Parametri farmakokinetiċi ta' lusutrombopag wara doża ta' 3 mg darba kuljum f'pazjenti bi tromboċitopenija u b'mard kroniku tal-fwied (Studju M0634)
English: All 3 received 7 days of treatment with lusutrombopag.
Maltese: Kollha rċevew 7 ijiem ta' trattament b'lusutrombopag.
English: In the lusutrombopag group, 73/107 subjects (68.2%) received the study drug for 7 days.
Maltese: Fil-grupp ta' lusutrombopag, 73/107 individwu (68.2%) irċevew il-mediċina tal-istudju għal 7 ijiem.
English: In Study M0631, 96 subjects received lusutrombopag or placebo once daily: 48 subjects in the lusutrombopag group and 48 subjects in the placebo group.
Maltese: Fi Studju M0631, 96 individwu rċevew lusutrombopag jew plaċebo darba kuljum: 48 individwu fil grupp ta' lusutrombopag u 48 individwu fil-grupp tal-plaċebo.
English: 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%).
Maltese: Il-medja (% koeffiċjent tal-varjazzjoni) tal-volum apparenti ta' distribuzzjoni matul il-fażi terminali ta' lusutrombopag f'individwi adulti b'saħħithom (n = 16) kienet ta' 39.5 L (23.5%).
English: Lusutrombopag showed no teratogenicity in rats and rabbits at up to 80 mg/kg/day and 1000 mg/kg/day respectively.
Maltese: Lusutrombopag ma wera ebda teratoġeniċità fil-firien u l-fniek f'dożi li jaslu sa 80 mg/kg/jum u 1000 mg/kg/jum, rispettivament.
English: Comparison with placebo [b]: Difference of proportion (95% CI)
Maltese: Differenza fil-proporzjon (95% CI) valur p
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Lusutrombopag has no phototoxic potential in the skin phototoxicity study in hairless mice at doses up to 500 mg/kg (96.3 µg/mL) (613 times the human clinical exposures in adults based on Cmax [0.157 µg/mL]).
Maltese: Lusutrombopag m'għandu l-ebda potenzjal fototossiku fl-istudju dwar il-fototossiċità fil-ġilda fi ġrieden mingħajr xagħar b'dożi li jaslu sa 500 mg/kg (96.3 µg/mL) (613 darba tal-esponimenti kliniċi tal-bniedem fl-adulti abbażi ta' Cmax [0.157 µg/mL]).
English: The mean (range) maximum platelet count in subjects without platelet transfusion in the lusutrombopag group in Studies M0631 and M0634 was 90,200 (59,000 to 145,000)/µL and 86,900 (25,000 to 219,000)/µL, respectively; and the median (range) time to reach the maximum platelet count was 14.0 (6 to 28) days and 12.0 (5 to 35) days, respectively, and platelet count is expected to decrease thereafter.
Maltese: Il-medja (firxa) tal-għadd tal-plejtlits massimu f'individwi mingħajr trasfużjonijiet tal-plejtlits fil grupp ta' lusutrombopag fi Studji M0631 u M0634 kienet ta' 90,200 (59,000 sa 145,000/µL u 86,900 (25,000 sa 219,000)/µL, rispettivament, u l-ħin medjan (firxa) biex jintlaħaq l-għadd tal-plejtlits massimu kien 14.
English: In vitro studies revealed that CYP4 enzymes including CYP4A11 and partially CYP3A4 enzyme contributed to ω-oxidation to form 6-hydroxylated lusutrombopag.
Maltese: Studji in vitro żvelaw li enzimi ta' CYP4 inkluż CYP4A11 u parzjalment enzima ta' CYP3A4 kkontribwew għal biex l-ossidazzjoni ω tifforma 6-hydroxylated lusutrombopag.
English: Table 4 Proportion of responders Study M0631
Maltese: Tabella 4 Proporzjon ta' dawk li wrew rispons Studju M0631
English: P value
Maltese: valur P [a]
English: Lusutrombopag is rarely excreted into urine (approximately 1%).
Maltese: Lusutrombopag rari jitneħħa fl-awrina (bejn wieħed u ieħor 1%).
English: How to store Mulpleo
Maltese: Tiħux Mulpleo:
English: [a] A responder was defined as a subject who achieved a platelet count of ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline.
Maltese: [a] Individwu li juri rispons kien definit bħala individwu li laħaq għadd tal-plejtlits ta' ≥ 50,000/μL b'żieda ta' ≥ 20,000/μL mil-linja bażi.
English: Duration of the increase in platelet count to ≥ 50,000/μL
Maltese: It-tul taż-żieda fl-għadd tal-plejtlits għal ≥ 50,000/μL
English: 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.
Maltese: Fl-ippurgar, ilkomponenti ta' radjuattività kienu lusutrombopag mhux mibdul (16% tar-radjuattività mogħtija) u metaboliti relatati ma' ossidazzjoni-β (35% tar-radjuattività mogħtija), li jissuġġerixxu li lusutrombopag ikun metabolizzat l-ewwel permezz ta' ossidazzjoni-ω, u sussegwentement metabolizzat permezz tal-ossidazzjoni-β tal-katina tal-ġenb O-hexyl.
English: BN
Maltese: Kg
English: 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.
Maltese: Indeboliment epatiku ħafif u moderat (ħafif, Child-Pugh klassi A; moderat, Child-Pugh klassi B) huwa mistenni li jkollu effett żgħir fuq il-farmakokinetika ta' lusutrombopag.
English: Of the remaining subjects in the lusutrombopag group, 15, 8, and 11 subjects received study drug for 4, 5, and 6 days, respectively.
Maltese: lusutrombopag, 15, 8, u 11-il individwu rċevew il-mediċina tal-istudju għal 4, 5, u 6 ijiem, rispettivament.
English: LUSU = lusutrombopag; Q1 = 25th percentile; Q3 = 75th percentile [a] P-value was calculated by the van Elteren test with platelet transfusion status as stratum.
Maltese: Q3 = il-75 perċentil [a] Il-valur-P kien ikkalkulat permezz tat-test ta' van Elteren bl-istat tat-trasfużjoni tal-plejtlits bħala stratum.
English: In Study M0634, 215 subjects were randomised in the study: 108 in the lusutrombopag 3 mg group and 107 in the placebo group.
Maltese: Fi Studju M0634, 215-il individwu ntgħażlu b'mod każwali fl-istudju: 108 fil-grupp ta' lusutrombopag 3 mg u 107 fil-grupp tal-plaċebo.
English: In Study M0634, 3 subjects with Child-Pugh class C liver disease were erroneously enrolled (all in the lusutrombopag group).
Maltese: Fi Studju M0634, 3 individwi b'marda tal-fwied Child-Pugh Klassi C ġew irreġistrati bi żball (kollha fil-grupp ta' lusutrombopag).
English: Pharmacotherapeutic group: Antihemorrhagics, other systemic hemostatics, ATC code: B02BX07
Maltese: Antiemorraġiċi, emostatiċi sistemiċi oħra, Kodiċi ATC:
English: Lusutrombopag was not carcinogenic to mice at doses up to 20 mg/kg/day in males and females (a dose at least 45 times the human clinical exposures in adults based on AUC), or rats at doses up to 20 mg/kg/day in males and 2 mg/kg/day in females (a dose 49 and 30 times, respectively, the human clinical exposures in adults based on AUC).
Maltese: Lusutrombopag ma kienx karċinoġeniku għal ġrieden b'dożi li jaslu sa 20 mg/kg/jum fl-irġiel u finnisa (doża mill-inqas 45 darba aktar l-esponimenti kliniċi tal-bniedem fl-adulti abbażi tal-AUC), jew għal ġrieden b'dożi li jaslu sa 20 mg/kg/jum fl-irġiel u 2 mg/kg/jum fin-nisa (doża 49 u 30 darba aktar, rispettivament, l-esponimenti kliniċi tal-bniedem fl-adulti abbażi tal-AUC).
English: The key secondary endpoints in Studies M0631 and M0634 were
Maltese: Il-punti aħħarin sekondarji ewlenin fi Studji M0631 u M0634 kienu
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1348
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1348
English: Portal vein thrombosis has been reported in Phase 3 randomised, double-blind, placebo-controlled clinical studies with 3 mg of lusutrombopag once daily for up to 7 days (1.2%, 2/171 patients); the incidence was comparable to that of the placebo group (1.2%, 2/170 patients); one case of cardiac ventricular thrombosis was reported (0.6%, 1/171) in the lusutrombopag group only.
Maltese: Ġiet irrappurtata trombożi fil-vina portali fi studji kliniċi ta' Fażi 3, fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo bi 3 mg ta' lusutrombopag darba kuljum għal sa 7 ijiem (1.2%, 2/171 pazjent); l-inċidenza kienet simili għall-grupp tal-plaċebo (1.2%, 2/170 pazjent) każ wieħed ta' trombożi ventikulari kardijaka ġie rrappurtat (0.6%, 1/171) fil-grupp ta' lusutrombopag biss.
English: Light red, 7.0 mm round film-coated tablets debossed with the Shionogi trademark above the identifier code “551” on one side and debossed on the other side with the strength “3”.
Maltese: Pilloli miksija b'rita tondi, ta' lewn aħmar ċar, ta' 7.0 mm, imnaqqxa bit-trademark ta' Shionogi fuq ilkodiċi tal-identifikatur “551” fuq naħa waħda, u mnaqqxa bil-qawwa “3” fuq in-naħa l-oħra.
English: Adverse reaction - Common
Maltese: Reazzjoni avversa - Komuni
English: Lusutrombopag is a substrate of P-gp and BCRP, but not a substrate of OATP1B1, OATP1B3, and OCT1.
Maltese: Lusutrombopag huwa substrat ta' P-gp u BCRP, iżda mhux substrat ta' OATP1B1, OATP1B3, u OCT1.
English: Paediatric population No pharmacokinetic data have been obtained in children.
Maltese: Ma nkisbet ebda data farmakokinetika għat-tfal.
English: OPA/Aluminium foil/PVC film blister with push through aluminium lidding foil, packed in a cardboard box.
Maltese: Folja b'rita tal-OPA/Fojl tal-aluminju, PVC b'push through aluminium lidding foil, ippakkjata f'kaxxa tal-kartun.
English: Ratios of AUC relative to the healthy matched control group were 1.05 in subjects with mild hepatic impairment and 1.20 in subjects with moderate hepatic impairment.
Maltese: Il-proporzjonijiet ta' AUC relattivi għal grupp ta' kontroll ta' individwi b'saħħithom li ġie pparagunat kienu ta' 1.05 f'individwi b'indeboliment epatiku ħafif u 1.20 f'individwi b'indeboliment epatiku moderat.
English: Therefore, inducers and inhibitors of CYP4A enzymes including CYP4A11 are unlikely to affect the pharmacokinetics of lusutrombopag.
Maltese: Għalhekk indutturi u inibituri ta' enzimi ta' CYP4A inkluż CYP4A11 aktarx mhux se jaffettwaw il-farmakokinetika ta' lusutrombopag.
English: Mulpleo 3 mg film-coated tablets lusutrombopag
Maltese: Mulpleo 3 mg pilloli miksija b'rita lusutrombopag
English: Drug interactions via inhibition and induction of any CYP4A enzymes have not been reported in clinical use.
Maltese: Interazzjonijiet tal-mediċina permezz tal-inibizzjoni u induzzjoni ta' kwalunkwe enzimi ta' CYP4A ma ġewx irrappurtati fl-użu kliniku.
English: Lusutrombopag did not affect male and female fertility and early embryo development in rats at doses up to 100 mg/kg/day (176 and 252 times respectively, the human clinical exposures in adults based on AUC).
Maltese: Lusutrombopag ma' affettwax il-fertilità fl-irġiel u fin-nisa, u l-iżvilupp bikri tal-embrijun fil-firien b'dożi li jaslu sa 100 mg/kg/jum (176 u 252 aktar rispettivament, l-esponimenti kliniċi tal-bniedem fl adulti abbażi tal-AUC).
English: Among the 48 subjects in the lusutrombopag group, 40 subjects received lusutrombopag for 7 days, 4 subjects for 6 days, 1 subject for 5 days, and 3 subjects for 4 days.
Maltese: Fost it-48 individwu fil-grupp ta' lusutrombopag, 40 individwu rċevew lusutrombopag għal 7 ijiem, 4 individwi għal 6 ijiem,
English: Geometric mean (%CV) other than for Tmax, which is median (range).
Maltese: Medja ġeometrika (%CV, coefficient of variation) apparti dik għal Tmax, li hija medjana (firxa).
English: ES
Maltese: JIS
English: Lusutrombopag was excreted mainly via faecal route in humans (approximately 83% into faeces and 1% into urine).
Maltese: Lusutrombopag kien imneħħi prinċipalment mir-rotta tal-ippurgar fil-bnedmin (madwar 83% flippurgar u 1% fl-awrina).
English: The procedure should be performed from day 9 after the start of lusutrombopag treatment.
Maltese: Il-proċedura għandha tkun imwettqa minn jum 9 wara li jinbeda t-trattament b'lusutrombopag.
English: 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.
Maltese: Trattament b'doża għolja (10 mg/kg/jum) u fit-tul (8 ġimgħat) ta' lusutrombopag jippreżenta riskju potenzjali ta' fibrożi fil-mudullun permezz ta' riċettur TPO uman abbażi tar-riżultati tal-istudju fuq ġrieden TPOR-Ki/Shi b'riċettur TPO uman fid-dominju transmembrane kimeriku knocked-in mar riċettur TPO tal-ġrieden.
English: A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of age, gender or race on the pharmacokinetics of lusutrombopag.
Maltese: Analiżi farmakokinetika tal-popolazzjoni bl-użu ta' konċentrazzjonijiet fil-plażma ta' lusutrombopag mill-istudji kliniċi b'lusutrombopag ma identifikawx effett klinikament sinifikanti ta' età, sess, jew razza fuq il-farmakokinetika ta' lusutrombopag.
English: Of the remaining subjects in the placebo group, 5, 4, and 4 subjects received study drug for 4, 5, and 6 days, respectively.
Maltese: Mill-individwi li kien jifdal fil-grupp tal-plaċebo, 5, 4, u 4 individwi rċevew il-mediċina tal istudju għal 4, 5, u 6 ijiem, rispettivament.