FrancophonIA/ELRC3.0 huggingface dataset:
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
Maltese: Il-popolazzjoni tal-istudju kienu 82% irġiel, 39% Kawkasi, u 37% Asjatiċi, b'età medja ta'
English: Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Maltese: LHBV DNA medju fis-serum skont PCR kien 7.83 log10 kopji/ml u l-ALT medju tas-serum kien 100
English: Adverse reactions considered at least possibly related to treatment with entecavir are listed by body system organ class.
Maltese: Reazzjonijiet avversi meqjusin li ta' l-inqas jistgħu jkunu relatati ma' entecavir huma elenkati skont is sistema ta' klassifika ta' l-organi.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Maltese: Bidliet testikolari (deġenerazzjoni tubulari seminiferuża) kienu evidenti fi studji tossikoloġiċi b'doża ripetuta f'annimali li jgerrmu u klieb b'dozi ≥ 26 darba dawk fl-umani.
English: Clinical resistance in Adults: patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Maltese: (nucleoside-naive) jew 1.0 mg (lamivudine-rifrattorji) u b'kejl tal-PCR HBV DNA waqt it-terapija f'Ġimgħa 24 jew wara ġew immonitorjati għar-reżistenza.
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Maltese: a pazjenti b'istoloġija ta' linja bażi li tista' tiġi evalwata (Knodell Necroinflammatory Score ta' linja bażi ≥ 2) b punt aħħari primarju c Roche Cobas Amplicor PCR assay (LLOQ = 300 kopja/ml) Esperjenza f'pazjenti li huma refrattarji għal lamivudine b'mard tal-fwied stabbli:
English: Renal impairment: entecavir clearance decreases with decreasing creatinine clearance.
Maltese: Indeboliment tal-kliewi: il-clearance ta' entecavir skont il-clearance tal-kreatinina.
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Maltese: Għal adulti, id-doża rakkomandata hija jew 0.5 mg jew 1 mg darba kuljum li tittieħed oralment (millħalq).
English: Lactic acidosis and severe hepatomegaly with steatosis: occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Maltese: Aċidożi lattika u epatomegalija severa bi steatożi: okkorrenzi ta' aċidożi lattika (mingħajr hypoxaemia), xi kultant fatali, li s-soltu huma assoċjati ma' epatomegalija gravi u ma' stenożi epatika, ġew irrapportati bl-użu ta' nucleoside analogues.
English: Nervous system disorders: common : headache, dizziness, somnolence Gastrointestinal disorders: common : vomiting, diarrhoea, nausea, dyspepsia Hepatobiliary disorders: common : increased transaminases Skin and subcutaneous tissue disorders: uncommon : rash, alopecia General disorders and administration site conditions: common : fatigue
Maltese: komuni (għallinqas pazjent 1 minn kull 100): uġigħ ta' ras, insomnja (diffikultà biex wieħed jorqod), għeja (għeja kbira), sturdament, ngħas (ħedla), rimettar, dijarea, dardir, dispepsja (indiġestjoni), u livelli ogħla ta' enzimi tal-fwied fid-demm. mhux komuni (tal-anqas 1 f'kull 1,000 pazjent): raxx, telf ta' xagħar.
English: HBV DNA < 50 IU/mLa HBeAg seroconversion a
Maltese: IU/mL u serokonverżjoni a
English: In clinical studies with lamivudine-refractory patients, 4% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Maltese: Fi studji kliniċi b'pazjenti refrattorji b'lamivudin, 4% kellhom livelli ogħla ta' ALT > 3 darbiet tallinja bażi u < 1% kellhom livelli ogħla ta' ALT ta' > darbtejn il-linja bażi b'bilirubina totali ta'
English: In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during posttreatment follow-up.
Maltese: Fi studji f'pazjenti refrattarji għal lamivudine, b'numru limitat ta' pazjenti li kienu qegħdin jiġu osservati, 11% tal-pazjenti ttrattati b'entecavir u ebda pazjenti ttrattat b'lamivudine ma żviluppaw żjidiet fl-ALT waqt follow-up li sar wara t trattament.
English: Week 96 Week 48
Maltese: Ġimgħa 96 Ġimgħa 48
English: In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.
Maltese: F'assaġġi antivirali ta' l-HIV, entecavir f'konċentrazzjonijiet mikromolari ma kienx antagonistiku għall-attività kontra l-HIV f'kultura ta' ċelloli ta' dawn is-sitt
English: These 14 patients had a lower rate of genotypic entecavir resistance (cumulative probability 18.8% through 5 years of follow-up) than the overall study population (see table).
Maltese: Dawn l-14-il pazjent kellhom rata iktar baxxa ta' reżistenza għal entecavir ġenotipiku (probabbiltà kumulattiva ta' 18.8% sa 5 snin ta' followup) milli fil-popolazzjoni totali tal-istudju (ara t-tabella).
English: In rabbits, embryo-foetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at high exposures.
Maltese: Fil-fniek, tossiċità embrijo-fetali (assorbiment mill-ġdid), ossifikazzjoni imnaqqsa (hyoid), u inċidenza ikbar tat-13-il kustilja ġew osservati b'dożi qawwija.
English: At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count < 200 cells/mm3).
Maltese: ta' 494 ċelloli/mm3 (b'5 pazjenti biss li kellhom ammont ta' CD4 < 200 ċellola/mm3).
English: ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Maltese: Innormalizzazzjoni ta' l-ALT (≤ 1 x ULN) instabet f'27% tal-pazjenti ttrattati b'entecavir u f'21% talpazjenti ttrattati b'lamivudine fl-aħħar tad-dożi.
English: Experience in lamivudine-refractory patients with compensated liver disease: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
Maltese: (026), b'85% tal-pazjenti jippreżentaw mutazzjonijiet ta' LVDr fil-linja bażi, pazjenti li rċevew lamivudine malli daħlu fl-istudju jew qalbu għal 1 mg ta' entecavir darba kuljum, mingħajr washout u mingħajr perijodu ta' overlap (n= 141), jew komplew b'100 mg ta' lamivudine darba kuljum (n= 145).
English: Also contains soy polysaccharides.
Maltese: TA' EĊĊIPJENTI Fih ukoll polysaccharides ta' sojja.
English: Lamivudine-refractory or decompensated liver disease
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected withHBV and HIV.
Maltese: b'mard tal-fwied mhux stabbli u fi prova klinika ta' 68 pazjent ko-infettati b'HBV u b'HIV.
English: Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
Maltese: Anormalitajiet fit-testijiet tal-laboratorju: fi studji kliniċi b'pazjenti li qatt ma kienu kkurati fil-passat b'nukleoside, 5% kellhom livelli għoljin ta' ALT ta' > 3 darbiet tal-linja bażi, u < 1% kellhom livelli ta' ALT għoli ta' > darbtejn tal-linja bażi flimkien ma' bilirubina totali ta' > darbtejn tal-limitu ta' fuq tan-normal (ULN) u ta' > darbtejn tal-linja bażi. Livelli ta' albumina ta' < 2.5 g/dl seħħew f'< 1 % tal pazjenti, livelli ta' amylase ta' > 3 darbiet tal-linja bażi fi 2% , livelli ta' lipase ta' > 3 darbiet tal-linja bażi fi 11% u plejtlits ta' < 50,000/mm3 f'< 1%.
English: Entecavir Accord 1 mg film-coated tablets Hypromellose
Maltese: Entecavir Accord 1 mg pilloli miksijin b'rita Hypromellose
English: ETV 0.5 mg once daily
Maltese: ETV 0.5 mg darba kuljum
English: polymerase is 0.0012 μM.
Maltese: 0.010-0.059 µM).
English: Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Maltese: Ir-riżultati wara 48 ġimgħa ta' studji magħmulin b'mod każwali, double blind li jqabblu entecavir (ETV) ma' lamivudine (LVD) f'pazjenti pożittivi għal HBeAg (022) u f'pazjenti negattivi għal
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Maltese: Fl-aħħar tad-dożi, fost pazjenti li komplew it-trattament b'entecavir għal aktar minn 52 ġimgħa (medja ta' 96 ġimgħa), 81% mill-243 pazjent ttrattat b'entecavir u 39% mill-164 pazjent ttrattat b'lamivudine kellhom DNA ta' HBV < 300 kopja/ml skont il-PCR waqt li normalizzazzjoni fl-ALT (≤ 1 x ULN) seħħet f'79% tal-pazjenti ttrattati b'entecavir u f'68% tal-pazjenti ttrattati b'lamivudine.
English: Response criteria were HBV virological suppression (HBV DNA < 0.7 MEq/ml by bDNA) and loss of HBeAg (in HBeAg positive patients) or ALT < 1.25 times ULN (in HBeAg negative patients).
Maltese: Il-kriterji kienu tnaqqis tal-virus HBV (DNA ta' HBV < 0.7 MEq/ml minn bDNA) u tnaqqis fl-HBeAg (f'pazjenti pożittivi għall-HBeAg) jew ALT
English: Duration of therapy for paediatric patients
Maltese: Perjodu tat-terapija għal pazjenti pedjatriċi
English: HBsAg lossb Normalization of:
Maltese: Is-sustanzi l-oħra huma:
English: Entecavir Accord 0.5 mg film-coated tablets Bottle packs:
Maltese: Entecavir Accord 0.5 mg pilloli miksijin b'rita Pakketti tal-flixkun:
English: For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Maltese: 10 darbiet dawk fl-umani (f'0.5 u 1 mg rispettivament).
English: Bottle pack:
Maltese: Pakketti tal-folji:
English: decompensated liver disease (see section 4.4)
Maltese: Prodott, sezzjoni 4.2).
English: How to store Entecavir Accord
Maltese: X'fih Entecavir Accord
English: Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
Maltese: EU/1/17/1211/002 EU/1/17/1211/003
English: Nucleoside Naive HBeAg Positive (study 022)
Maltese: Rifrattorji għal Lamivudine Pożittivi għal HBeAg (studju 026)
English: Entecavir was superior to adefovir dipivoxil on the primary efficacy endpoint of mean change from baseline in serum HBV DNA by PCR at week 24.
Maltese: Entecavir kien superjuri għal adefovir dipivoxil fil-punt primarju tat-tmiem taleffikaċja tal-bidla medja mil-linja bażi fid-DNA tal-HBV fis-serum skont PCR f'ġimgħa 24.
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Maltese: Hemm ftit tagħrif fuq pazjenti li huma infettati wkoll bl-HIV li għandhom ammont baxx ta' ċelloli CD4 (< 200 ċelloli/mm3).
English: Exacerbations of hepatitis during and after discontinuation of entecavir therapy have also been reported (see section 4.4 and c. Description of selected adverse reactions).
Maltese: Aggravamenti tal-epatite waqt u wara it-twaqqif tat-terapija b'entecavir ġew irrappurtati wkoll (ara sezzjonijiet 4.4 u ċ. Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: All 61 patients had HBsAg loss post-transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).
Maltese: Il-61 pazjenti kollha ma kellhomx HBsAg wara t-trapjant, u 2 minn dawn tal-aħħar saru HBsAg pożittivi minkejja l-fatt li żammew HBV DNA (<6 IU/ml) li ma dehritx.
English: The potential risk for humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali fuq innisa.
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Maltese: Trattament b'nucleoside analogues irid jitwaqqaf meta jkun hemm livelli ta' aminotransferase li jkunu qed jogħlew b'rata mgħaġġla, epatomegalija progressiva jew aċidożi metabolika/lattika ta' etjoloġija mhux magħrufa.
English: In juvenile rats administered entecavir from postnatal days 4 to 80, a moderately reduced acoustic startle response was noted during the recovery period (postnatal days 110 to 114) but not during the dosing period at AUC values ≥ 92 times those in humans at the 0.5 mg dose or paediatric equivalent dose.
Maltese: Fil-firien ta' età żgħira mogħtija entecavir minn 4 ijiem sa 80 jum wara t-twelid, ġie osservat rispons moderatament imnaqqas għal ħasda akustika matul il-perjodu ta' rkupru (110-114-il jum wara t-twelid) iżda mhux matul il-perjodu ta'
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose
Maltese: Entecavir Accord 0.5 mg pilloli miksijin b'rita Hypromellose
English: 3 years After opening the bottle use within 90 days.
Maltese: Wara li tiftaħ il-flixkun użat fi żmien 90 jum.
English: Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Maltese: Fir-rigward tar-reazzjonijiet avversi li hemm referenza għalihom fis-sezzjoni b. Lista f'għamla ta' tabella ta' reazzjonijiet avversi, ġiet osservata reazzjoni avversa addizzjonali waħda [tnaqqis tal-bikarbonat fid-demm (2%)] f'pazjenti kkurati b'entecavir sa ġimgħa 48.
English: For patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Maltese: Għal pazjenti b'epatite B rifrattorji għal lamivudine, ara sezzjonijiet 4.4 u 5
English: 1 mg once daily
Maltese: 1 mg darba kuljum
English: An oral solution may be available for patients with body weight less than 32.6 kg.
Maltese: Tista' tkun disponibbli soluzzjoni orali għal pazjenti b'piż tal-ġisem inqas minn 32.6 kg.
English: This medicinal product contains soy polysaccharides.
Maltese: Dan il-prodott mediċinali fih polysaccharides tas-sojja.
English: All 57 patients remained positive for HBsAg.
Maltese: Is-57 pazjenti kollha baqgħu pożittivi għal HBsAg.
English: Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Maltese: Taħrix akut ta' l-epatite ġie rrappurtat ukoll f'pazjenti li waqqfu t-terapija għal epatite B (ara sezzjoni 4.2).
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.
Maltese: Fir-rigward tad-deċiżjoni li tinbeda kura f'pazjenti pedjatriċi, ara sezzjonijiet 4.2, 4.4, u 5
English: Method of administration Entecavir Accord should be taken orally.
Maltese: Entecavir Accord.
English: For appropriate dosing in the paediatric population, Entecavir Accord 0.5 mg film-coated tablets are available and for dosages below 0.5 mg an oral solution may be available.
Maltese: Għal dożaġġ xieraq fil-popolazzjoni pedjatrika, hemm disponibbli Entecavir Accord 0.5 mg pilloli miksijin b'rita u għal dożaġġi inqas minn 0.5 mg tista' tkun disponibbli soluzzjoni orali.
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Maltese: Minn dawn il-pazjenti, 55/57 (96%) kellhom titjib istoloġiku kif definit qabel (ara hawn fuq), u 50/57 (88%) kellhom tnaqqis ta' ≥ 1 punt fil-punteġġ tal-fibrożi ta'
English: At baseline, patients had a mean CTP score of 8.59 and 26% of patients were CTP class C. The mean baseline Model for End Stage Liver Disease (MELD) score was 16.23.
Maltese: Fil-linja bażi, il-pazjenti kellhom punteġġ CTP medju ta' 8.59 u 26% tal-pazjenti kellhom CTP klassi Ċ.
English: Warning and precautions
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.The population pharmacokinetic analysis covering patients in the age range 1675 years did not identify age as significantly influencing entecavir pharmacokinetics.
Maltese: L-analiżi farmakokinetika tal-popolazzjoni li kopriet pazjenti ta' età bejn 16-75 sena ma wrietx li l-età għandha effett b'mod sinifikanti fuq il-farmakokinetika ta' entecavir.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Maltese: It-terapija trid tinbeda minn tabib b'esperjenza fil-maniġment ta' infezzjoni kronika ta' l-epatite B.
English: Package leaflet: Information for the user Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets entecavir
Maltese: Reżistenza klinika fl-Adulti: il-pazjenti fil-provi kliniċi inizjalment ittrattati b'entecavir 0.5 mg
English: ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Maltese: d Żieda ta' ≥ 1 log10 fuq l-inqas ammont fid-DNA tal-HBV minn PCR, ikkonfermat b'kejl sussegwenti jew fittmiem tal- windowed time point.
English: Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Maltese: Riċevituri ta' trapjant tal-fwied: il-funzjoni tal-kliewi trid tiġi evalwata b'attenzjoni kbira qabel u waqt it-terapija b'entecavir f'riċevituri ta' trapjant tal-fwied li jkunu qed jirċievu cyclosporine jew tacrolimus (ara sezzjoni 5.2).
English: Accord Healthcare Limited, UK
Maltese: Pharmadox Healthcare Ltd.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Maltese: Reżistenza Ġenotipika għal Entecavir Sa Sena 5, Studji dwar Pazjenti Refrattarji għal Lamivudine
English: HIV/HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Maltese: Pazjenti ko-infettati bl-HIV/HBV li ma jkunux qed jingħataw HAART fl-istess ħin: entecavir ma ġiex evalwat f'pazjenti infettati fl-istess ħin bl-HIV/HBV li ma kinux qegħdin jirċievu fl-istess ħin kura effettiva kontra l-HIV.
English: Baseline HBV DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
Maltese: * Pazjenti randomizzati għall-plaċebo li ma kellhomx serokonverżjoni HBe- sa Ġimgħa 48 qalbu għal entecavir b'tikketta mikxufa għat-tieni sena tal-istudju; għalhekk id-data ta' paragun randomizzata hija disponibbli biss f'Ġimgħa 48.
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Maltese: Il-benefiċċji ta' suppressjoni viroloġika fit-tul b'terapija kontinwata għandhom jitqabblu mar-riskju ta' kura mtawwla, inkluż it-tfaċċar ta' virus reżistenti tal-epatite B.
English: In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM).
Maltese: Barra minn hekk, doża qawwija ta' entecavir ma kellha l-ebda effett negattiv fuq ilpolymerase ta' γ jew is-sintesi tad-DNA fil-mitochondrion f'ċelloli HepG2 (Ki > 160 µM).
English: Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Maltese: Razza: l-analiżi farmakokinetika tal-popolazzjoni ma wrietx li r-razza għandha effett b'mod sinifikanti fuq il-farmakokinetika ta' entecavir.
English: In the presence of LVDr mutations, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy (see section 4.4.
Maltese: Fil-preżenza ta' mutazzjonijiet ta' LVDr, l-użu kkombinat ta' entecavir flimkien mat-tieni mediċina antivirali (li ma tikkonvidix reżistenza inkroċjata la ma' lamivudine jew entecavir) għandha tkun kkunsidrata bi preferenza għal monoterapija b'entecavir (ara sezzjoni 4.4).
English: Patients with decompensated liver disease: in study 048, 191 patients with HBeAg positive or negative chronic HBV infection and evidence of hepatic decompensation, defined as a CTP score of 7 or higher, received entecavir 1 mg once daily or adefovir dipivoxil 10 mg once daily.
Maltese: Pazjenti b'mard tal-fwied mhux stabbli: fi studju 048, 191 pazjent b'infezzjoni HBV kronika pożittiva jew negattiva tal-HBeAg u b'evidenza ta' distabbilizzazzjoni epatika, definita bħala punteġġ CTP ta' 7
English: At Week 72 post-transplant, none of 55 observed cases had virologic recurrence of HBV [defined as HBV DNA ≥50 IU/ml (approximately 300 copies/ml)], and there was no reported virologic recurrence at time of censoring for the remaining 6 patients.
Maltese: Fil-Ġimgħa 72 ta' wara t-trapjant, l ebda wieħed mill-55 każ osservat ma kellu rikorrenza viroloġika tal-HBV [definita bħala HBA DNA ≥50
English: Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
Maltese: f'24 individwu pedjatriku pożittiv għal HBeAg li qatt ma ħadu nucleoside qabel u 19 li esperjenzaw lamivudine minn sentejn sa <18-il sena b'mard tal-fwied kumpensat.
English: For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR at end of dosing.
Maltese: (medja ta' 96 ġimgħa), 96% ta' dawk il-pazjenti ittrattati b'entecavir u 64% ta' dawk il-pazjenti ttrattati b'lamivudine kellhom DNA ta' HBV < 300 kopja/ml skont il-PCR fl-aħħar tad-dożi.
English: High-density polyethylene (HDPE) bottle contians a silica gel cainster with child resistant polypropylene closure containing 30 film-coated tablets.
Maltese: Studju tal-mikronukleju u studju tat-tiswija tad-DNA fil-firien kienu negattivi ukoll.
English: - emerging genotypic ETVr c
Maltese: - ETVrc ġenotipika ġdida
English: HBV DNA < 50 IU/mL and HBeAg seroconversion a
Maltese: Entecavir Accord ma' ikel u xorb
English: (See section 4.3).
Maltese: (ara sezzjoni 4.4).
English: Difference (95 % CI)
Maltese: (95 % CI)
English: EU/1/07/437/003 EU/1/07/437/004
Maltese: EU/1/07/437/004
English: Immunosuppressants
Maltese: Immunosoppressanti
English: Date of first authorisation: 11 January 2008 Date of latest renewal: 11 January 2013
Maltese: Data tal-aħħar tiġdid: 11 ta' Jannar 2013
English: 12 - 17 years old 115mg, 80mg, 80mg
Maltese: 115mg, 80mg, 80mg
English: Aprepitant is a selective high-affinity antagonist at human substance P neurokinin 1 (NK1) receptors.
Maltese: Aprepitant huwa antagonista ta' affinità qawwija selettiv f'riċetturi P neurokinin 1 (NK1) tas-sustanza umana.
English: Acute phase§§
Maltese: Il-fażi akuta§§
English: 3-day IV/IV/IV dose
Maltese: Doża IV/IV/IV ta'
English: P-Value
Maltese: Valur p
English: What IVEMEND contains - The active substance is fosaprepitant.
Maltese: X'fih IVEMEND - Is-sustanza attiva hi fosaprepitant.
English: Data are lacking regarding effects on CYP2C8 and CYP2C19.
Maltese: M'hemmx dejta biżżejjed dwar l-effetti ta' CYP2C8 u CYP2C19.