FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of a single 50 mg dose, the AUC0- of eltrombopag was 32% to 36% lower in patients with mild to moderate renal impairment, and 60% lower in patients with severe renal impairment compared with healthy volunteers.
Maltese: Wara għoti ta' doża waħda ta' 50 mg, l-AUC0- ta' eltrombopag kienet minn 32% sa 36% anqas f'pazjenti b'indeboliment minn ħafif sa moderat tal-kliewi, u 60% anqas f'pazjenti b'indeboliment qawwi tal-kliewi meta mqabbla ma' voluntiera f'saħħithom.
English: Cytogenetic abnormalities and progression to MDS/AML in patients with SAA
Maltese: Anormalitajiet ċitoġenetiċi u progressjoni tal-MDS/AML f'pazjenti b'SAA
English: The pharmacokinetic parameters of eltrombopag in paediatric patients with ITP are shown in Table 10.
Maltese: Il-parametri farmakokinetiċi ta' eltrombopag f'pazjenti pedjatriċi b'ITP huma mniżżla f'Tabella 10.
English: Your doctor will discuss this with you.
Maltese: Ittabib tiegħek se jiddiskuti dan miegħek.
English: Decrease the daily dose by 25 mg.
Maltese: Naqqas id-doża ta' kuljum bi 25 mg.
English: In controlled studies in thrombocytopenic patients with HCV receiving interferon-based therapy (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag and 6 out of 484 patients (1%) in the placebo group experienced thromboembolic events (TEEs).
Maltese: Fi studji kkontrollati f'pazjenti tromboċitopeniċi b'HCV li kienu qed jirċievu terapija bbażata fuq interferon (n=1,439), 38 minn 955 pazjent (4%) li rċevew kura b'eltrombopag u 6 minn 484 pazjent (1%) fil-grupp tal-plaċebo esperjenzaw avvenimenti tromboemboliċi (TEEs).
English: Concomitant administration of eltrombopag and OATP1B1 (e.g. methotrexate) and BCRP (e.g. topotecan and methotrexate) substrates should be undertaken with caution (see section 5.2).
Maltese: L-għoti ta' eltrombopag flimkien ma' substrati ta' OATP1B1 (eż. methotrexate) u BCRP (eż. topotecan u methotrexate) għandu jsir b'kawtela (ara sezzjoni 5.2).
English: Table 3 Dose adjustments of eltrombopag in patients with severe aplastic anaemia
Maltese: Tabella 3 Aġġustamenti tad-doża ta' eltrombopag f'pazjenti b'anemija aplastika gravi
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu./
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: The plasma eltrombopag concentration-time data collected in 88 patients with ITP in studies TRA100773A and TRA100773B were combined with data from 111 healthy adult subjects in a population PK analysis.
Maltese: Id-dejta dwar il-konċentrazzjoni ta' eltrombopag fil-plasma u l-ħin miġbura minn 88 pazjent b'ITP fl-istudji TRA100773A u TRA100773B tlaqqat flimkien ma' dejta minn 111-il individwu adult f'saħħtu f'analiżi PK ta' popolazzjoni.
English: TRA115450 (PETIT2): The primary endpoint was a sustained response, defined as the proportion of patients receiving eltrombopag, compared to placebo, achieving platelet counts ≥50,000/µl for at least 6 out of 8 weeks (in the absence of rescue therapy), between weeks 5 to 12 during the double-blind randomised period.
Maltese: TRA115450 (PETIT2): Il-punt finali primarju kien rispons sostnut, definit bħala l-proporzjon ta' pazjenti li rċevew eltrombopag, meta mqabbel mal-plaċebo li kisbu għadd tal-plejtlits ta' ≥50,000/μl għal mill-inqas 6 minn 8 ġimgħat (fin-nuqqas ta' terapija ta' salvataġġ), bejn ġimgħat 5 sa 12 matul il-perjodu randomised u double-blind.
English: The most important serious adverse reactions were febrile neutropenia and sepsis/infection.
Maltese: L-aktar reazzjonijiet avversi serji importanti kienu newtropenija febbrili u spesis/infezzjoni.
English: Uridine diphosphoglucuronyl transferase UGT1A1 and UGT1A3 are responsible for glucuronidation, and bacteria in the lower gastrointestinal tract may be responsible for the cleavage pathway.
Maltese: Uridine diphosphoglucuronyl transferase UGT1A1 u UGT1A3 huma responsabbli għall-glukuronidazzjoni, u batterji fil-parti tan-naħa t'isfel tal-apparat gastrointestinali jistgħu jkunu responsabbli għar-rotta ta' qsim.
English: The most common adverse reactions occurring in at least 10% of patients included nausea, diarrhoea and increased alanine aminotransferase.
Maltese: L-aktar reazzjonijiet avversi komuni li kien hemm f'mill-inqas 10% tal-pazjenti kienu jinkludu nawsja, dijarea u żieda fl-alanine aminotransferase.
English: Thrombocytopenia with HCV infection in adult patients
Maltese: Tromboċitopenja b'infezzjoni HCV f'pazjenti adulti
English: A total of 114 patients with previously treated ITP were randomised 2:1 eltrombopag (n=76) to placebo (n=38).
Maltese: Total ta' 144 pazjent li kienu diġà kkurati għal-ITP qabel kienu randomised 2:1 eltrombopag (n=76) għal plaċebo (n=38).
English: Aluminum blisters (PA/Alu/PVC/Alu) in a carton containing 14 or 28 film-coated tablets and multipacks containing 84 (3 packs of 28) film-coated tablets.
Maltese: Folji tal-aluminju (PA/Alu/PVC/Alu) f'kartuna li fiha 14 jew 28 pillola miksija b'rita u pakketti b'ħafna li fihom 84 (3 pakketti ta' 28) pillola miksija b'rita.
English: In vitro studies also demonstrated that eltrombopag is a breast cancer resistance protein (BCRP) substrate and inhibitor (IC50 value of 2.7 μM (1.2 μg/ml).
Maltese: Studji in vitro wrew ukoll li eltrombopag huwa sottostrat u inibitur tal-proteina ta' reżistenza kontra l-kanċer tas-sider (BCRP) (valur IC50 ta' 2.7 μM (1.2 μg/ml).
English: Revolade 12.5 mg film-coated tablets Revolade 25 mg film-coated tablets Revolade 50 mg film-coated tablets Revolade 75 mg film-coated tablets
Maltese: Revolade 12.5 mg pilloli miksija b'rita Revolade 25 mg pilloli miksijin b'rita Revolade 50 mg pilloli miksija b'rita Revolade 75 mg pilloli miksija b'rita
English: Common Menorrhagia
Maltese: Menorraġja
English: The median time to achieve the target platelet count ≥90,000/µl (ENABLE 1) or ≥100,000/µl (ENABLE 2) was 2 weeks.
Maltese: c L-għadd ta' plejtlits fil-mira kien ta' 90,000/µl għal ENABLE 1 u 100,000/µl għal ENABLE 2.
English: • infection of the urinary system
Maltese: • infezzjoni tas-sistema tal-awrina
English: QTc interval prolongation has been reported in clinical studies of patients with ITP and thrombocytopenic patients with HCV.
Maltese: Titwil tal-intervall tal-QTc kien irrapportat fi studji kliniċi ta' pazjenti b'ITP u f'pazjenti tromboċitopeniċi b'HCV.
English: The influence of hepatic impairment on the pharmacokinetics of eltrombopag following repeat administration was evaluated using a population pharmacokinetic analysis in 28 healthy adults and 714 patients with hepatic impairment (673 patients with HCV and 41 patients with chronic liver disease of other aetiology).
Maltese: L-effett ta' indeboliment tal-fwied fuq il-farmakokinetika ta' eltrombopag wara għoti ripetut kien stmat bl-użu ta' analiżi farmakokinetika tal-popolazzjoni fi 28 adult f'saħħtu u 714-il pazjent b'indeboliment epatiku (673 pazjent b'HCV u 41 pazjent b'mard kroniku tal-fwied ta' etjoloġija oħra).
English: Revolade 25 mg powder for oral suspension:
Maltese: Revolade 25 mg trab għal suspensjoni orali:
English: Revolade 50 mg film-coated tablets also contain iron oxide red (E172) and iron oxide yellow (E172).
Maltese: Revolade 50 mg pilloli miksija b'rita fihom ukoll iron oxide red (E172) u iron oxide yellow (E172).
English: Human liver microsome studies identified CYP1A2 and CYP2C8 as the enzymes responsible for eltrombopag oxidation.
Maltese: Studji ta' mikrosomi tal-fwied uman identifikaw CYP1A2 u CYP2C8 bħala l-enzimi responsabbli għall-ossidazzjoni ta' eltrombopag.
English: The median baseline platelet count was 59,500/µl in both treatment groups: 0.8%, 28% and 72% of the patients recruited had platelet counts <20,000/µl, <50.000/µl and ≥50,000/µl respectively.
Maltese: L-għadd medjan tal-plejtlits fil-linja bażi kien ta' 59,500/μl fiż-żewġ gruppi ta' kura: 0.8%, 28% u 72% tal-pazjenti li ħadu sehem kellhom għadd tal-plejtlits <20,000/µl, <50.
English: % patients achieving virologic response
Maltese: % ta' pazjenti li kisbu rispons viroloġiku
English: Liver problems
Maltese: Disturbi vaskulari
English: No clinically significant interactions are expected when eltrombopag and CYP450 substrates are co-administered (see section 5.2).
Maltese: L-ebda interazzjonijiet li huma sinifikanti b'mod kliniku ma huma mistennija meta eltrombopag u substrati ta' CYP450 jingħataw flimkien (ara sezzjoni 5.2).
English: In the clinical studies there was one report of overdose where the patient ingested 5000 mg of eltrombopag.
Maltese: Fl-istudji kliniċi kien hemm rapport wieħed ta' doża eċċessiva fejn il-pazjent bela' 5000 mg ta' eltrombopag.
English: The profile of adverse reactions was comparable to that seen in adults with some additional adverse reactions, marked ♦ in the table below.
Maltese: Il-profil ta' reazzjonijiet avversi kien komparabbli ma' dak osservat f'adulti bi ftit reazzjonijiet avversi addizzjonali, murija b'♦ fit-tabella li ġejja.
English: Retinal haemorrhages, mostly Grade 1 or 2, have been reported in HCV patients receiving interferon, ribavirin and eltrombopag (2% of the eltrombopag group and 2% of the placebo group.
Maltese: Emorraġiji fir-retina, laktar tal-Grad 1 jew 2, kienu rrappurtati f'pazjenti b'HCV li kienu qed jirċievu interferon, ribavirin u eltrombopag (2% tal-grupp ta' eltrombopag u 2% tal-grupp tal-plaċebo.
English: In vitro studies demonstrated that eltrombopag is not a substrate for the organic anion transporter polypeptide, OATP1B1, but is an inhibitor of this transporter (IC50 value of 2.7 μM (1.2 μg/ml).
Maltese: Studji in vitro urew li eltrombopag mhuwiex sottostrat għall-polipeptide organiku tat-trasportatur anjoniku, OATP1B1, iżda huwa inibitur ta' dan it-trasportatur (valur IC50 ta' 2.7 μM (1.2 μg/ml).
English: b p-value a a Logistic regression model adjusted for randomisation stratification variables b 21 out of 63 (33%) patients treated with eltrombopag who were taking an ITP medicinal product at baseline permanently discontinued all baseline ITP medicinal products.
Maltese: Valur-p a a Mudell ta' rigressjoni loġistika aġġustat għal varjabbli ta' stratifikazzjoni u randomisation b 21 minn 63 (33%) pazjent kkurat b'eltrombopag li kienu qed jieħdu prodott mediċinali għal ITP fil-linja bażi waqqfu b'mod permanenti l-prodotti mediċinali kollha tal-linja bażi għal ITP.
English: Human liver microsome studies identified UGT1A1 and UGT1A3 as the enzymes responsible for eltrombopag glucuronidation.
Maltese: Studji ta' mikrosomi tal-fwied uman identifikaw UGT1A1 u UGT1A3 bħala l-enzimi responsabbli għall-glukuronidazzjoni ta' eltrombopag.
English: Revolade 12.5 mg film-coated tablets EU/1/10/612/010
Maltese: Revolade 12.5 mg pilloli miksija b'rita EU/1/10/612/010
English: The sachets are co-packaged in a kit with a 40 ml HDPE mixing bottle, and 30 single-use 20 ml oral dosing syringes (polypropylene/silicon rubber) with 1 ml graduations.
Maltese: Il-qratas huma fl-istess pakkett ma' flixkun li tħallat fih HDPE ta' 40 ml, u 30 siringa għal doża orali ta' 20 ml li tintuża darba (lastiku tal-polypropylene/tas-silicon) bi gradwazzjonijiet ta' 1 ml.
English: • muscle pain, muscle spasm, muscle weakness
Maltese: • uġigħ fil-muskoli, spażmi fil-muskoli, dgħufija fil-muskoli
English: The predominant route of eltrombopag excretion is via faeces (59%) with 31% of the dose found in the urine as metabolites.
Maltese: Ir-rotta predominanti tat-tneħħija ta' eltrombopag hija permezz tal-ippurgar (59%) b'31% tad-doża misjuba fl-awrina bħala metaboliti.
English: All 7 patients had normal cytogenetics at baseline.
Maltese: Is-7 pazjenti kollha kellhom ċitoġenetika normali fil-linja bażi.
English: Table 10 Geometric mean (95% CI) steady-state plasma eltrombopag pharmacokinetic parameters in paediatric patients with ITP (50 mg once daily dosing regimen)
Maltese: Tabella 10 Medja ġeometrika (CI ta' 95%) tal-parametri farmakokinetiċi ta' eltrombopag filplażma fi stat fiss f'pazjenti pedjatriċi b'ITP (kors ta' dożaġġ ta' 50 mg darba kuljum)
English: Safety and efficacy have not been established in combination with direct-acting antiviral agents approved for treatment of chronic hepatitis C infection.
Maltese: Is-sigurtà u l-effikaċja ma ġewx stabbiliti f'kombinazzjoni ma' sustanzi antivirali b'azzjoni diretta approvati għall-kura ta' infezzjoni kronika tal-epatite Ċ.
English: In vitro studies with eltrombopag suggest a potential phototoxicity risk; however, in rodents there was no evidence of cutaneous phototoxicity (10 or 7 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 5 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC) or ocular phototoxicity (4 times the human clinical exposure in adult or paediatric ITP patients at 75 mg/day and 3 times the human clinical exposure in HCV patients at 100 mg/day, based on AUC).
Maltese: Studji in vitro b'eltrombopag jissuġġerixxu li jista' jkun hemm riskju ta' fototossiċità; madankollu, fl-annimali gerriema ma kien hemm l-ebda evidenza ta' fototossiċità fil-ġilda (10 jew 7 darbiet aktar mill-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u 5 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum, ibbażat fuq l-AUC) jew fototossiċita fl-għajnejn (4 drabi l-esponiment kliniku uman f'pazjenti adulti jew pedjatriċi b'ITP f'75 mg/kuljum u 3 darbiet ogħla mill-esponiment kliniku uman f'pazjenti b'HCV f'100 mg/kuljum ibbażat fuq l-AUC).
English: Common Syncope
Maltese: Sinkope
English: • Revolade is used to treat a bleeding disorder called immune (primary) thrombocytopenia (ITP) in patients aged 1 year and above who have already taken other medicines (corticosteroids or immunoglobulins), which have not worked.
Maltese: • Revolade jintuża għall-kura ta' disturb fil-fsada msejjaħ tromboċitopenja immuni (primarja) (ITP) f'pazjenti ta' età minn sena 'l fuq li diġà ħadu mediċini oħra (kortikosterojdi jew immunoglobulini) li ma ħadmux.
English: Plasma eltrombopag concentration-time data collected in 590 patients with HCV enrolled in phase III studies TPL103922/ENABLE 1 and TPL108390/ENABLE 2 were combined with data from patients with HCV enrolled in the phase II study TPL102357 and healthy adult subjects in a population PK analysis.
Maltese: Dejta dwar il-konċentrazzjoni-ħin ta' eltrombopag fil-plasma miġbura minn 590 pazjent b'HCV li ħadu sehem fl-istudji tal-fażi III TPL103922/ENABLE 1 u TPL108390/ENABLE 2 kienet ikkombinata ma' dejta minn pazjenti b'HCV li ħadu sehem fl-istudju tal-fażi II TPL102357 u individwi b'saħħithom f'analiżi tal-farmakokinetika tal-popolazzjoni.
English: AUC (0-) and Cmax based on population PK post-hoc estimates at the highest dose in the data for each patient.
Maltese: AUC (0-) u Cmax ibbażati fuq stimi post-hoc tal-farmakokinetika tal-popolazzjoni fl-ogħla doża fiddejta għall-kull pazjent.
English: The effects of race and sex on plasma eltrombopag CL/F estimates were consistent between paediatric and adult patients.
Maltese: L-effetti tar-razza u tas-sess fuq l-istimi ta' CL/F ta' eltrombopag mill-plażma kienu konsistenti bejn pazjenti pedjatriċi u adulti.
English: For SAA
Maltese: Għal SAA
English: Eltrombopag should be discontinued if ALT levels increase (3 times the upper limit of normal [x ULN] in patients with normal liver function, or ≥3 x baseline or >5 x ULN, whichever is the lower, in patients with pre-treatment elevations in transaminases) and are:
Maltese: Eltrombopag għandu jitwaqqaf jekk il-livelli talALT jiżdiedu ( 3 darbiet il-limitu superjuri tan-normal [x ULN] f'pazjenti b'funzjoni normali talfwied, jew ≥3 x fil-linja bażi jew >5 x ULN, skont liema minnhom hu l-aktar baxx, f'pazjenti b'żidiet għolja fit-transaminażi qabel il-kura) u jkunu:
English: • Pull back on the plunger to the 20 ml mark on the syringe.
Maltese: • Iġbed il-planġer lura sal-marka ta' 20 ml fuq is-siringa.
English: TPO is the main cytokine involved in regulation of megakaryopoiesis and platelet production, and is the endogenous ligand for the TPO-R. Eltrombopag interacts with the transmembrane domain of the human TPO-R and initiates signalling cascades similar but not identical to that of endogenous thrombopoietin (TPO), inducing proliferation and differentiation from bone marrow progenitor cells.
Maltese: TPO huwa ċ-ċitokin prinċipali involut fir-regulazzjoni tal-megakarjopojesi u l-produzzjoni talplejtlits, u huwa l-ligand endoġeniku għal TPO-R. Eltrombopag ikollu interazzjoni mal-unità transmembranika ta' TPO-R uman u jibda sensiela ta' sinjali jixbhu iżda mhux identiċi għal dawk ta' trombopoietin (TPO) endoġeniku, filwaqt li jinduċi proliferazzjoni u divrenzjar ta' megakarjoċiti miċ-ċelluli proġenitur tal-mudullun tal-għadam.
English: Revolade 75 mg film-coated tablets are round, biconvex, pink, debossed with ‘GS FFS' and ‘75' on one side.
Maltese: Il-pilloli miksijin b'rita Revolade 75 mg huma tondi, konvessi fuq iż-żewġ naħat, roża u mnaqqxin b'‘GS FFS' u ‘75' fuq naħa waħda.
English: In HCV clinical studies, a higher incidence of gastrointestinal bleeding, including serious and fatal cases, was reported following discontinuation of peginterferon, ribavirin, and eltrombopag.
Maltese: Fi studji kliniċi f'HCV, kienet irrapportata inċidenza ogħla ta' fsada gastrointestinali, li tinkludi każijiet serji u fatali, wara l-waqfien ta' peginterferon, ribavirin, u eltrombopag.
English: All patients initiated treatment with eltrombopag 50 mg. From Day 29 to the end of treatment, 15 to 28% of eltrombopag treated patients were maintained on ≤25 mg and 29 to 53% received 75 mg.
Maltese: Mill-Jum 29 sa tmiem il-kura, bejn 15 u 28% tal-pazjenti kkurati b'eltrombopag inżammu fuq ≤25 mg u bejn 29 u 53% rċivew 75 mg.
English: Portal vein thrombosis was the most common TEE in both treatment groups (2% in patients treated with eltrombopag versus < 1% for placebo) (see section 4.4).
Maltese: Trombożi tal-vina portali kienet l-aktar TEE komuni fiż-żewġ gruppi ta' kura (2% f'pazjenti li rċevew kura b'eltrombopag kontra < 1% għall-plaċebo) (ara sezzjoni 4.4).
English: A greater proportion of patients on eltrombopag did not require any antiviral dose reduction as compared to placebo (45% vs. 27%).
Maltese: Proporzjon akbar ta' pazjenti fuq eltrombopag ma kienu jeħtieġu l-ebda tnaqqis fid-doża antivirali meta mqabbla ma' plaċebo (45% kontra 27%).
English: Common Ear pain, vertigo
Maltese: Uġigħ fil-widnejn, vertiġini
English: Revolade is indicated for the treatment of patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).
Maltese: Revolade hu indikat għat-trattament ta' pazjenti ta' età minn sena 'l fuq bi tromboċitopenja immuni primarja (ITP) li damet 6 xhur jew aktar mid-dijanjosi u li ma rrispondewx għal kura oħra (eż. kortikosterojdi, immunoglobulini) (ara sezzjonijiet 4.2 u 5.1).
English: ♦, upper respiratory tract infection
Maltese: ♦, infezzjoni fl-apparat respiratorju ta' fuq
English: There is an increased risk for adverse reactions, including potentially fatal hepatic decompensation and thromboembolic events, in thrombocytopenic HCV patients with advanced chronic liver disease, as defined by low albumin levels ≤35 g/l or model for end stage liver disease (MELD) score ≥10, when treated with eltrombopag in combination with interferon-based therapy.
Maltese: Hemm żieda fir-riskju għal reazzjonijiet avversi, li jinkludu dikumpensazzjoni epatika potenzjalment fatali u avvenimenti tromboemboliċi, f'pazjenti tromboċitopeniċi b'HCV b'mard kroniku avvanzat tal-fwied, kif definiti b'livelli baxxi ta' albumina ≤35 g/l jew punteġġ fuq il-Mudell għal Mard talFwied tal-Fażi tat-Tmiem (MELD) ≥10, meta jirċievu kura b'eltrombopag f'kombinazzjoni ma' terapija bbażata fuq interferon.
English: Overall SVR
Maltese: SVR globali d
English: Reported thrombotic/thromboembolic complications included both venous and arterial events.
Maltese: Kumplikazzjonijiet trombotiċi/tromboemboliċi rrappurtati kienu jinkludu kemm avvenimenti fil-vini u arterjali.
English: Preliminary results from a supportive study (Study ELT116826), an ongoing non-randomised, phase II, single-arm, open-label study in refractory SAA patients, showed consistent results.
Maltese: Riżultati preliminari minn studju ta' sapport (Studju ELT116826), studju open-label kontinwu mhux randomizzat, f'fażi
English: Revolade 12.5 mg film-coated tablets eltrombopag
Maltese: Revolade 12.5 mg pilloli miksija b'rita eltrombopag
English: Taking Revolade may make it easier for you to complete a full course of antiviral medicine (peginterferon and ribavirin).
Maltese: Li tieħu Revolade jista' jagħmilha aktar faċli għalik biex tlesti kors sħiħ ta' mediċini antivirali (peginterferon u ribavirin).
English: Mannitol (E421) Sucralose Xanthan gum
Maltese: 6.1 Lista ta' eċċipjenti Mannitol (E421) Sucralose
English: A QTc study in healthy volunteers dosed 150 mg eltrombopag per day did not show a clinically significant effect on cardiac repolarisation.
Maltese: Studju tal-QTc f'voluntiera b'saħħithom li kienu qed jirċievu doża ta' 150 mg eltrombopag kuljum ma weriex effett klinikament sinifikanti fuq ir-ripolarizzazzjoni kardijaka.
English: • painful swollen joints caused by uric acid (gout)
Maltese: • ġogi minfuħin u juġgħu kkawżati minn uric acid (gotta)
English: ANNEX II
Maltese: Tabella 6
English: • increased levels of uric acid
Maltese: • żieda fil-livelli ta' uric acid
English: Common Cataract, retinal exudates, dry eye, ocular icterus, retinal haemorrhage
Maltese: Katarretti, effużjonijiet retinali, għajnejn xotti, ikterus okulari, emorraġija fir-retina
English: Revolade 75 mg film-coated tablets EU/1/10/612/007
Maltese: Revolade 75 mg pilloli miksija b'rita EU/1/10/612/007
English: Multipack containing 84 (3 packs of 28) film-coated tablets
Maltese: Pakkett b'ħafna li fih 84 (3 pakketti ta' 28) pillola miksija b'rita
English: Thirty-one percent of patients had been treated with prior HCV therapies, primarily pegylated interferon plus ribavirin.
Maltese: Wieħed u tletin fil-mija tal-pazjenti kienu rċevew kura b'terapiji preċedenti ta' HCV, primarjament pegylated interferon flimkien ma' ribavirin.
English: • Discard the used oral syringe.
Maltese: • Armi s-siringa orali użata.
English: The improvement in the proportion of patients who achieved SVR was consistent across all subgroups in the randomisation strata (baseline platelet counts (<50,000 vs. >50,000), viral load (<800,000 IU/ml vs. ≥800,000 IU/ml) and genotype (2/3 vs. 1/4/6)).
Maltese: It-titjib fil-proporzjon ta' pazjenti li kisbu SVR kien konsistenti fis-sottogruppi kollha fl-istrata ta' randomizzazzjoni (għadd tal-plejtlits fil-linja bażi (<50,000 kontra >50,000), tagħbija virali (<800,000 IU/ml kontra ≥ 800,000
English: The influence of age on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 28 healthy subjects, 673 patients with HCV, and 41 patients with chronic liver disease of other aetiology ranging from 19 to 74 years old.
Maltese: L-influwenza tal-età fuq il-farmakokinetika ta' eltrombopag ġiet evalwata permezz ta' analiżi talfarmakokinetika tal-popolazzjoni f'28 individwu b'saħħtu, 673 pazjent b'HCV, u 41 pazjent b'mard kroniku tal-fwied ta' etjoloġija oħra b'firxa ta' età minn 19 sa 74 sena.
English: The safety and efficacy of eltrombopag has not been established in children and adolescents (<18 years) with chronic HCV related thrombocytopenia or SAA.
Maltese: Is-sigurtà u l-effikaċja ta' eltrombopag fit-tfal u adolexxenti (<18-il sena) bi tromboċitopenija jew SAA relatati ma' HCV kronika ma ġewx determinati s'issa.
English: In controlled studies in thrombocytopenic patients with HCV (n=1,439), 38 out of 955 patients (4%) treated with eltrombopag experienced a TEE and 6 out of 484 patients (1%) in the placebo group experienced TEEs.
Maltese: Fi studji kkontrollati f'pazjenti tromboċitopeniċi b'HCV (n=1,439), 38 minn 955 pazjent (4%) li rċevew kura b'eltrombopag esperjenzaw TEE u 6 minn 484 pazjent (1%) fil-grupp tal-plaċebo esperjenzaw TEEs.
English: <50,000/µl following at least 2 weeks of therapy
Maltese: <50,000/µl wara mill-inqas ġimagħtejn ta' terapija