FrancophonIA/ELRC3.0 huggingface dataset:
English: In 3 controlled and 2 uncontrolled clinical studies among adult ITP patients receiving eltrombopag (n=446), 17 patients experienced a total of 19 TEEs, which included (in descending order of occurrence) deep vein thrombosis (n=6), pulmonary embolism (n=6), acute myocardial infarction (n=2), cerebral infarction (n=2), embolism (n=1) (see section 4.4).
Maltese: Fi 3 studji kliniċi kkontrollati u 2 studji mhux ikkontrollati fost pazjenti adulti b'ITP li kienu qed jirċievu eltrombopag (n=446), 17-il pazjent kellhom total ta' 19-il TTE, li kienu jinkludu (b'dawk li seħħew l-aktar imsemmijin l-ewwel) trombożi fil-vini tal-fond (n=6), emboliżmu fil-pulmuni (n=6), infart mijokardijaku akut(n=2), infart ċerebrali (n=2), emboliżmu (n=1) (ara sezzjoni 4.4).
English: In studies utilising human liver microsomes, eltrombopag (up to 100 M) showed no in vitro inhibition of the CYP450 enzymes 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, and 4A9/11 and was an inhibitor of CYP2C8 and CYP2C9 as measured using paclitaxel and diclofenac as the probe substrates.
Maltese: Fi studji li wżaw mikrosomi tal-fwied uman, eltrombopag (sa 100 M) ma wera l-ebda impediment tal-enzimi 1A2, 2A6, 2C19, 2D6, 2E1, 3A4/5, u 4A9/11 ta' CYP450 in vitro u kien impeditur ta' CYP2C8 u CYP2C9 kif tkejjel bl-użu ta' paclitaxel u diclofenac bħala s-substrati ta' stħarriġ.
English: • high temperature
Maltese: • temperatura għolja
English: 1 to 5 years (n=38)
Maltese: sena sa 5 snin (n=38)
English: The safety of Revolade was assessed using the pooled double-blind, placebo-controlled studies TRA100773A and B, TRA102537 (RAISE) and TRA113765, in which 403 patients were exposed to Revolade and 179 to placebo, in addition to data from the completed open-label studies TRA108057, TRA105325 (EXTEND) and TRA112940.
Maltese: Is-sigurtà ta' Revolade ġiet ivvalutata permezz ta' studji double-blind, ikkontrollati bi plaċebo, miġbura TRA100773A u B, TRA102537 (RAISE) u TRA113765, li fihom 403 pazjenti kienu esposti għal Revolade u 179 għal plaċebo, minbarra d-data mill-istudji kompluti b'tikketta miftuħa TRA108057, TRA105325 (EXTEND) u TRA112940.
English: Table 2 Dose adjustments of eltrombopag in HCV patients during antiviral therapy
Maltese: Tabella 2 Aġġustamenti tad-doża ta' eltrombopag f'pazjenti b'HCV matul terapija antivirali
English: HMG CoA reductase inhibitors
Maltese: Impedituri ta' HMG CoA reductase
English: Uncommon Tachycardia, acute myocardial infarction, cardiovascular disorder, cyanosis, sinus tachycardia, electrocardiogram QT prolonged
Maltese: Takikardija, infart mijokardijaku akut, disturb kardjovaskulari, ċjanożi, takikardija tas-sinus, QT tal-elettrokardjogramm imtawwal
English: Overall, eltrombopag was administered to 277 ITP patients for at least 6 months and 202 patients for at least 1 year.
Maltese: Globalment, eltrombopag ingħata lil 277 pazjent b'ITP għal mill-anqas 6 xhur u lil 202 pazjenti għal mill-anqas sena.
English: For ITP
Maltese: Għal ITP
English: In the controlled clinical studies in chronic ITP with eltrombopag, increases in serum ALT, AST and bilirubin were observed (see section 4.4).
Maltese: Fl-istudji kliniċi kkontrollati f'ITP kronika b'eltrombopag, kienu osservati żidiet fl-ALT, AST u bilirubin fis-serum (ara sezzjoni 4.4).
English: Compared to healthy volunteers, patients with mild hepatic impairment had approximately 111% (95% CI: 45% to 283%) higher plasma eltrombopag AUC(0-) values and patients with moderate hepatic impairment had approximately 183% (95% CI: 90% to 459%) higher plasma eltrombopag AUC(0-) values.
Maltese: Meta mqabbla ma' voluntiera b'saħħithom, pazjenti b'indeboliment epatiku ħafif kellhom valuri tal-AUC(0-) ta' eltrombopag fil-plasma ta' madwar 111% (95% CI: 45% għal 283%) ogħla u pazjenti b'indeboliment epatiku moderat kellhom valuri tal-AUC(0-) ta' eltrombopag fil-plasma madwar 183% (95% CI: 90% għal 459%) ogħla.
English: The co-administration of 600 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 39% and 24%, respectively.
Maltese: L-għoti fl-istess ħin ta' 600 mg ciclosporin naqqas is-Cmax u l-AUCinf ta' eltrombopag b'39% u 24%, rispettivament.
English: (haemorrhoids), irritation of the gut
Maltese: (emorrojdi), irritazzjoni tal-musrana
English: The plasma elimination half-life of eltrombopag is approximately 21-32 hours.
Maltese: Il-half-life ta' eliminazzjoni millplażma hija ta' madwar 21-32 siegħa.
English: AUC(0-) (µg.hr/ml)
Maltese: AUC(0-) (µg.siegħa/ml)
English: Symptoms needing attention: see a doctor
Maltese: Sintomi li jeħtieġu attenzjoni: ara tabib
English: Abnormal serum liver tests should be evaluated with repeat testing within 3 to 5 days.
Maltese: Riżultati ta' testijiet tas-serum tal-fwied mhux normali għandhom jiġu evalwati b'ripetizzjoni tat-test fi żmien 3 sa 5 ijiem.
English: The adverse reactions in the adult ITP studies (N=763), paediatric ITP studies (N=171), the HCV studies (N=1,520), the SAA studies (N=43) and post-marketing reports are listed below by MedDRA system organ class and by frequency.
Maltese: Ir-reazzjonijiet avversi fl-istudji dwar ITP fl-adulti (N=763), fl-istudji dwar ITP fit-tfal (N=171), flistudji fuq HCV (N=1,520), fl-istudji fuq SAA (N=43) u minn rapporti wara t-tqegħid tal-prodott fissuq huma elenkati skont is-sistema ta' klassi ta' organi ta' MedDRA u skont il-frekwenza.
English: • chills
Maltese: • gass
English: The other ingredients are: mannitol, sucralose and xanthan gum.
Maltese: Is-sustanzi l-oħra huma: mannitol, sucralose u xanthan gum.
English: Increase daily dose by 50 mg to a maximum of 150 mg/day.
Maltese: Żid id-doża ta' kuljum b'50 mg sa massimu ta' 150 mg/kuljum.
English: In the in vitro mouse lymphoma assay, eltrombopag was marginally positive (<3-fold increase in mutation frequency).
Maltese: Fl-analiżi tal-limfoma tal-ġurdien in vitro, eltrombopag kien posittiv b'mod insinifikanti (żieda ta' <3 darbiet aktar fil-frekwenza ta' mutazzjoni).
English: At baseline, 71% of patients in the eltrombopag group and 69% in the placebo group reported any bleeding (WHO Grades 1-4).
Maltese: Fil-linja bażi, 71% tal-pazjenti fil-grupp ta' eltrombopag u 69% fil-grupp tal-plaċebo rrappurtaw xi fsada (WHO Gradi 1-4).
English: ≤ 35g/l > 35g/l MELD score f a Eltrombopag given in combination with peginterferon alfa-2a (180 μg once weekly for 48 weeks for genotypes 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1200 mg daily in 2 divided doses orally) b Eltrombopag given in combination with peginterferon alfa-2b (1.5 μg/kg once weekly for 48 weeks for genotype 1/4/6; 24 weeks for genotype 2/3) plus ribavirin (800 to 1400 mg orally in 2 divided doses) c Target platelet count was 90,000/µl for ENABLE 1 and 100,000/µl for ENABLE 2.
Maltese: f a Eltrombopag mogħti f'kombinazzjoni ma' peginterferon alfa-2a (180 μg darba fil-ġimgħa għal 48 ġimgħa għall-ġenotipi 1/4/6; 24 ġimgħa għall-ġenotip 2/3) flimkien ma' ribavirin (800 għal 1200 mg kuljum f'2 dożi diviżi oralment) b Eltrombopag mogħti f'kombinazzjoni ma' peginterferon alfa-2b (1.5 μg/kg darba fil-ġimgħa għal 48 ġimgħa għall-ġenotip 1/4/6; 24 ġimgħa għall-ġenotip 2/3) flimkien ma' ribavirin (800 għal 1400 mg orali f'2 dożi diviżi)
English: Other medicines and Revolade
Maltese: Mediċini oħra u Revolade
English: Table 8 Geometric mean (95% confidence intervals) of steady-state plasma eltrombopag pharmacokinetic parameters in adults with ITP
Maltese: Tabella 8 Medja ġeometrika (95% confidence intervals) tal-parametri farmakokinetiċi ta' eltrombopag fil-plasma fl-istat fiss f'adulti b'ITP
English: The influence of gender on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 111 healthy adults (14 females) and 88 patients with ITP (57 females).
Maltese: L-influwenza tas-sess fuq il-farmakokinetika ta' eltrombopag ġiet evalwata permezz ta' analiżi ta' farmakokinetika ta' popolazzjoni f'111-il adult f'saħħtu (14-il mara) u 88 pazjent b'ITP (57 mara).
English: For hepatitis C
Maltese: Għall-epatite Ċ
English: Key secondary endpoints Patients with a Day 43 bleeding assessment, n Bleeding (WHO Grades 1-4) n (%)
Maltese: Miri sekondarji importanti Pazjenti bi stima tal-fsada fil-Jum 43, n Fsada (Gradi 1-4 tal-WHO) n (%)
English: RAISE: 197 ITP patients were randomised 2:1, eltrombopag (n=135) to placebo (n=62), and randomisation was stratified based upon splenectomy status, use of ITP medicinal products at baseline and baseline platelet count.
Maltese: RAISE: 197 pazjent b'ITP kienu randomised 2:1, eltrombopag (n=135) għal placebo (n=62), u rrandomisation kienet stratifikata fuq il-bażi ta' jekk il-milsa tneħħietx jew le, tal-użu ta' prodotti mediċinali għal ITP fil-linja bażi u tal-għadd tal-plejtlits fil-linja bażi.
English: Eltrombopag was studied in a single-arm, single-centre open-label study in 43 patients with severe aplastic anaemia with refractory thrombocytopenia following at least one prior immunosuppressive therapy (IST) and who had a platelet count ≤30,000/µl.
Maltese: Eltrombopag ġie studjajt fi grupp wieħed ta' pazjenti waqt studju open-label single-centre fost 43 pazjent b'anemija aplastika gravi bi tromboċitopenija rikorrenti wara li ngħataw mill-inqas terapija immunosuppressiva waħda (IST) u bl-għadd ta' plejtlits tagħhom ta' ≤30,000/µl.
English: For ENABLE 1, 682 patients were randomised to the antiviral treatment phase; however 2 patients then withdrew consent prior to receiving antiviral therapy d p-value <0.05 for eltrombopag versus placebo e 64% patients participating in ENABLE 1 and ENABLE 2 were genotype 1 f Post-hoc analyses
Maltese: Għal ENABLE 1, 682 pazjent kienu randomizzati għall-fażi ta' kura antivirali; madanakollu 2 pazjenti mbagħad irtiraw il-kunsens qabel ma rċevew terapija antivirali d Valur-p <0.05 għal eltrombopag kontra plaċebo e 64% tal-pazjenti li pparteċipaw f'ENABLE 1 u ENABLE 2 kienu tal-ġenotip 1 f Analiżi post-hoc
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide black (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Maltese: Iron oxide red (E172) Iron oxide black (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
English: Overall, a significantly greater proportion of eltrombopag patients (62%) compared with placebo patients (32%) met the primary endpoint (Odds Ratio: 4.3 [95% CI: 1.4, 13.3] p=0.011).
Maltese: B'mod ġenerali, proporzjon akbar b'mod sinifikanti ta' pazjenti fuq eltrombopag (62%) meta mqabbel ma' pazjenti fuq plaċebo (32%) kisbu l-punt finali primarju (Proporzjon ta' Odds: 4.3 [CI ta' 95%: 1.4, 13.3] p=0.011).
English: AUC(0-) and Cmax based on population PK post-hoc estimates
Maltese: AUC(0-) u Cmax ibbażat fuq stimi post-hoc tal-PK tal-popolazzjoni
English: Tablet coating Hypromellose (E464) Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
Maltese: Iron oxide red (E172) Iron oxide yellow (E172) Macrogol 400 (E1521) Titanium dioxide (E171)
English: Patients were randomised 2:1 and received Revolade (n=44) or placebo (n=21), for up to 7 weeks.
Maltese: Il-pazjenti kienu randomizzati 2:1 u ngħataw Revolade (n=44) jew plaċebo (n=21), sa 7 ġimgħat.
English: In clinical studies with eltrombopag in SAA, 4% of patients (5/133) were diagnosed with MDS.
Maltese: Waqt studji kliniċi b'eltrombopag f'pazjenti b'SAA, 4% tal-pazjenti (5/133) instab li kellhom MDS.
English: The influence of Asian ethnicity (such as Chinese, Japanese, Taiwanese, Korean, and Thai) on the pharmacokinetics of eltrombopag was evaluated using a population pharmacokinetic analysis in 635 patients with HCV (145 Asians and 69 South Asians).
Maltese: L-influwenza ta' etniċità Asjatika (bħal Ċiniżi, Ġappuniżi, mit-Tajwan, Koreani, u Tajlandiżi) fuq ilfarmakokinetika ta' eltrombopag kienet ivvalutata bl-użu ta' analiżi tal-farmakokinetika talpopolazzjoni f'635 pazjent b'HCV (145 Asjatiku u 69 Asjatiku tan-Nofsinhar).
English: Revolade 25 mg powder for oral suspension eltrombopag
Maltese: Revolade 25 mg trab għal suspensjoni orali eltrombopag
English: • some medicines to treat HIV infection, such as lopinavir and/or ritonavir
Maltese: • xi mediċini għall-kura tal-infezzjoni tal-HIV, bħal lopinavir u/jew ritonavir
English: The most important serious adverse reactions identified were hepatotoxicity and thrombotic/thromboembolic events.
Maltese: L-aktar reazzjonijiet avversi gravi importanti kienu epatotossiċità u episodji ta' trombolitiċi/tromboemboliċi.
English: Severe aplastic anaemia
Maltese: Anemija aplastika gravi
English: A study in 40 healthy volunteers showed that the co-administration of a single 100 mg dose of eltrombopag with repeat dose lopinavir/ritonavir 400/100 mg twice daily resulted in a reduction in eltrombopag plasma AUCinf by 17% (90% CI: 6.6%, 26.6%).
Maltese: Studju f'40 voluntier b'saħħtu wera li l-għoti flimkien ta' doża waħda ta' 100 mg ta' eltrombopag ma' dożi ripetuti ta' lopinavir/ritonavir 400/100 mg darbtejn kuljum wassal għal tnaqqis ta' 17% (90% CI: 6.6%, 26.
English: Eltrombopag chelates with polyvalent cations such as iron, calcium, magnesium, aluminium, selenium and zinc (see sections 4.2 and 4.5).
Maltese: Eltrombopag jikkela ma' katjoni polivalenti bħal ħadid, kalċju, manjeżju, aluminju, selenju u żingu (ara sezzjonijiet 4.2 u 4.5).
English: Key primary endpoints
Maltese: Miri primarji importanti
English: There is an increased risk for adverse events, including hepatic decompensation and thromboembolic events, in thrombocytopenic patients with advanced chronic liver disease treated with eltrombopag, either in preparation for invasive procedure or in HCV patients undergoing antiviral therapy (see sections 4.4 and 4.8).
Maltese: Hemm żieda fir-riskju għal avvenimenti avversi, inkluż dikumpensazzjoni epatika u avvenimenti tromboemboliċi, f'pazjenti tromboċitopeniċi b'HCV li jkunu qed jieħdu terapija antivirali u avvenimenti tromboemboliċi f'pazjenti tromboċitopeniċi b'mard kroniku avvanzat tal-fwied li jkunu qed jirċievu kura b'eltrombopag, jew bi tħejjija għal proċedura invażiva jew f'pazjenti HCV li jkunu qegħdin jagħmlu terapija antivirali (ara sezzjonijiet 4.4 u 4.8).
English: The haematological response rate was 40% (17/43 patients; 95 % CI 25, 56), the majority were unilineage responses (13/17, 76%) whilst there were 3 bilineage and 1 trilineage responses at week 12.
Maltese: Ir-rata ta' rispons ematoloġiku kienet ta' 40% (17/43 pazjent; 95% CI 25, 56), il-biċċa l-kbira kien rispons unlineari (13/17, 76%) filwaqt li kien hemm 3 bilineali u 1 trilineali fit-12-il ġimgħa.
English: In the single-arm, open-label study in SAA, three (7%) patients were diagnosed with MDS following treatment with eltrombopag, in the two ongoing studies (ELT116826 and ELT116643), 1/28 (4%) and 1/62 (2%) patient has been diagnosed with MDS or AML in each study.
Maltese: MDS wara t-trattament b'eltrombopag, fiż-żewġ studji għaddejjin preżentament (ELT116826 u ELT116643), 1/28 (4%) u 1/62 (2%) tal-pazjenti nstab li kellhom MDS jew AML f'kull studju.
English: Plasma eltrombopag AUC(0-) and Cmax estimates for ITP patients are presented (Table 8).
Maltese: L-istimi tal-AUC(0-) u tas-Cmax għal eltrombopag fil-plażma għall-pazjenti b'ITP huma ppreżentati (Tabella 8).
English: Additional adverse reactions observed in paediatric studies (aged 1to 17 years).
Maltese: Reazzjonijiet avversi addizzjonali osservati fi studji pedjatriċi (li għandhom bejn sena u 17il sena).
English: At baseline the median platelet count was 20,000/µl, haemoglobin was 8.4 g/dl, ANC was 0.58 x 10
Maltese: Fil-linja bażi l-għadd medju tal-plejtlits kien ta' 20,000/µl, l-emoglobina ta' 8.4 g/dl, l-ANC ta' 0.58 x 10
English: The influence of gender on eltrombopag pharmacokinetics was evaluated using population pharmacokinetics analysis in 635 patients with HCV (260 females).
Maltese: L-influwenza tas-sess fuq il-farmakokinetika ta' eltrombopag ġiet evalwata permezz ta' analiżi talfarmakokinetika tal-popolazzjoni f'635 pazjent b'HCV (260 mara).
English: The co-administration of 200 mg ciclosporin decreased the Cmax and the AUCinf of eltrombopag by 25% and 18%, respectively.
Maltese: L-għoti fl-istess ħin ta' 200 mg ta' ciclosporin naqqas is-Cmax u lAUCinf ta' eltrombopag b'25% u 18%, rispettivament.
English: • increased levels of bilirubin (a substance produced by the liver)
Maltese: • żieda fil-livelli ta' bilirubin (sustanza prodotta mill-fwied)
English: Immune thrombocytopenia in adult and paediatric patients
Maltese: Tromboċitopenja immuni f'pazjenti adulti u pedjatriċi
English: In 2 controlled clinical studies in patients with HCV, ALT or AST 3 x ULN was reported in 34% and 38% of the eltrombopag and placebo groups, respectively.
Maltese: F'żewġ studji kliniċi kkontrollati f'pazjenti b'HCV, kienu rrappurtati ALT jew AST 3 x ULN f'34% u 38% tal-gruppi ta' eltrombopag u plaċebo, rispettivament.
English: Sustained response was seen in 50% of the initial responders during 20 out of 24 weeks in the PETIT 2 study and 15 out of 24 weeks in the PETIT Study.
Maltese: Rispons sostnut kien osservat f'50% tal-individwi b'rispons inizjali waqt 20 minn 24 ġimgħa flistudju PETIT 2 u waqt 15 minn 24 ġimgħa fl-istudju PETIT.
English: Eltrombopag is primarily metabolised through cleavage, oxidation and conjugation with glucuronic acid, glutathione, or cysteine.
Maltese: Eltrombopag huwa primarjament immetabolizzat permezz ta' qsim, ossidazzjoni u konjugazzjoni ma' glucuronic acid, glutathione, jew cysteine.
English: Results of a drug-drug pharmacokinetic (PK) interaction study show that co-administration of repeat doses of boceprevir 800 mg every 8 hours or telaprevir 750 mg every 8 hours with a single dose of eltrombopag 200 mg did not alter plasma eltrombopag exposure to a clinically significant extent.
Maltese: Riżultati ta' studju ta' interazzjoni farmakokinetika (PK) bejn mediċina u oħra juru li l-għoti flimkien ta' dożi ripetuti ta' boceprevir 800 mg kull 8 sigħat jew telaprevir 750 mg kull 8 sigħat ma' doża unika ta' eltrombopag 200 mg ma biddilx l-espożizzjoni ta' eltrombopag fil-plasma b'mod klinikament sinifikanti.
English: CYP1A2 and CYP2C8 inhibitors and inducers
Maltese: Inibituri u indutturi ta' CYP1A2 u CYP2C8
English: Key secondary endpoints
Maltese: Miri sekondarji importanti
English: In both studies, patients with a platelet count of <75,000/µl were enrolled and stratified by platelet count (<50,000/µl and ≥50,000/µl to <75,000/µl), screening HCV RNA (<800,000 IU/ml and ≥800,000 IU/ml), and HCV genotype (genotype 2/3, and genotype 1/4/6).
Maltese: Fiż-żewġ studji, ħadu sehem pazjenti b'għadd ta' plejtlits ta' <75,000/μl u kienu stratifikati skont l-għadd tal-plejtlits (<50,000/µl u ≥50,000/µl sa <75,000/µl), skrinjar għal HCV RNA (<800,000 IU/ml u ≥800,000
English: In the single-arm phase II monotherapy refractory SAA study, concurrent ALT or AST >3 x ULN with total (indirect) bilirubin >1.5 x ULN were reported in 5% of patients.
Maltese: II u b'fergħa waħda, kienu rrappurtati ALT jew AST >3 x ULN fl-istess ħin b'bilirubin totali (indirett) ta' >1.5 x ULN f'5% tal-pazjenti.
English: • disturbances of heart rhythm (QT prolongation)
Maltese: • disturbi fir-ritmu tal-qalb (titwil tal-QT)
English: Discontinuation
Maltese: Epistassis
English: After mixing, Revolade oral suspension should be administered immediately, but may be stored for no more than 30 minutes at room temperature.
Maltese: Wara li jitħallat, Revolade suspensjoni orali għandu jingħata immedjatament, iżda jista' jinħażen għal mhux aktar minn 30 minuta f'temperatura tal-kamra.
English: Patients received study medication for up to 8 years (in EXTEND).
Maltese: Il-pazjenti ngħataw medikazzjoni ta' studju sa 8 snin (f'EXTEND).
English: Six of 143 (4%) adult patients with CLD receiving eltrombopag experienced TEEs (all of the portal venous system) and 2 of 145 (1%) patients in the placebo group experienced TEEs (one in the portal venous system and one myocardial infarction).
Maltese: Sitta minn 143 (4%) pazjent adult b'CLD li kienu qed jirċievu eltrombopag kellhom TEEs (kollha kienu fissistema tal-vini portali) u 2 minn 145 (1%) pazjent fil-grupp ta' plaċebo kellhom TEEs (wieħed fissistema tal-vini portali u wieħed kien infart mijokardijaku).
English: (haemolytic anaemia)
Maltese: Anemija emolitika
English: Number of cumulative weeks with platelet counts 50,000-400,000/µl, Mean (SD) Patients with ≥75% of assessments in the target range (50,000 to 400,000/l), n (%)
Maltese: Pazjenti b' ≥75% tal-istimi fil-medda tal-mira (50,000 sa 400,000/l), n (%)
English: In a relative bioavailability study in adults, the eltrombopag powder for oral suspension delivered 22% higher plasma AUC(0-) than the film-coated tablet formulation.
Maltese: Fi studju dwar il-bijodisponibilità relattiva fl-adulti, eltrombopag trab għal suspensjoni orali ta' AUC(0-) fil-plażma ogħla b'22% mill-formulazzjoni tal-pillola miksija b'rita.
English: Cohort 3 (1 to 5 years)
Maltese: Koorti 3 (sena sa 5 snin)
English: Based on model estimate, elderly (≥65 years) patients had approximately 41% higher plasma eltrombopag AUC(0-) as compared to younger patients (see section 4.2).
Maltese: Fuq bażi ta' stimi minn mudelli, pazjenti anzjani (≥65 sena) kellhom AUC(0-) ta' eltrombopag fil-plasma madwar 41% ogħla meta mqabbla ma' pazjenti iżgħar fl-età (ara sezzjoni 4.2).
English: Uncommon Thrombotic microangiopathy with acute renal failure
Maltese: Mikroangijopatija trombotika b'insuffiċjenza akuta tal-kliewi disurja
English: Common Dizziness, disturbance in attention, dysgeusia, hepatic encephalopathy, lethargy, memory impairment, paraesthesia
Maltese: Sturdament, disturb fl-attenzjoni, disgewżja, enċefalopatija epatika, letarġija, indeboliment tal-memorja, parasteżija
English: • Use a reliable method of contraception while you're taking Revolade, to prevent pregnancy
Maltese: • Uża metodu ta' kontraċezzjoni li tista' toqgħod fuqu waqt li tkun qed tieħu Revolade, biex tilqa' kontra tqala.
English: Uncommon Hypersensitivity
Maltese: Sensittività eċċessiva
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 eltrombopag
Maltese: Revolade 12.5 mg pilloli miksija b'rita Revolade 25 mg pilloli miksijin b'rita Revolade 50 mg pilloli miksijin b'rita Revolade 75 mg pilloli miksijin b'rita eltrombopag
English: In two placebo-controlled studies in paediatric patients (aged 1 to 17 years) with chronic ITP, ALT 3 x ULN was reported in 4.7% and 0% of the eltrombopag and placebo groups, respectively.
Maltese: F'żewġ studji kkontrollati bi plaċebo f'pazjenti pedjatriċi (li għandhom bejn sena u 17-il sena) b'ITP kronika, ġie rrappurtat ALT 3 x ULN f'4.7% u 0% tal-gruppi ta' eltrombopag u plaċebo, rispettivament.
English: Nine of these patients achieved a multi-lineage response, 4 of the 9 remain on treatment and 5 tapered off treatment with eltrombopag and maintained the response (median follow up: 20.6 months, range: 5.7 to 22.5 months).
Maltese: Disgħa minn dawn il-pazjenti kisbu rispons multilineari, 4 mid-9 baqgħu bit-trattament u 5 waqfu mit-trattament b'eltrombopag gradwalment filwaqt li żammew ir-rispons (medja tal-follow up: 20.6 xhur, medda: 5.7 sa 22.5 xhur).
English: In vitro studies suggest that CYP1A2 and CYP2C8 are responsible for oxidative metabolism of eltrombopag.
Maltese: Studji in vitro jissuġġerixxu li CYP1A2 u CYP2C8 huma responsabbli għal metaboliżmu ossidattiv ta' eltrombopag.
English: Patients were permitted to reduce or discontinue baseline ITP therapy only during the open-label phase of the study and 53% (8/15) of patients were able to reduce (n=1) or discontinue (n=7) baseline ITP therapy, mainly corticosteroids, without needing rescue therapy.
Maltese: Il-pazjenti tħallew inaqqsu jew iwaqqfu t-terapija ta' ITP fil-linja bażi biss matul il-fażi open-label tal-istudju u 53% (8/15) tal-pazjenti kienu kapaċi jnaqqsu (n=1) jew iwaqqfu (n=7) it-terapija ta' ITP fil-linja bażi, fil-biċċa l-kbira kortikosterojdi, mingħajr il-bżonn ta' terapija ta' salvataġġ.
English: The majority of patients were HCV genotype 1 (64%) and had bridging fibrosis/cirrhosis.
Maltese: Il-maġġoranza tal-pazjenti kienu tal-ġenotip HCV 1 (64%) u kellhom fibrożi/ċirrożi li tgħaqqad.