FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical experience: the demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Maltese: Esperjenza klinika: it-turija tal-benefiċċju hija bbażata fuq istoloġija, viroloġija, bijokimika u effetti seroloġiċi wara 48 ġimgħa ta' trattament fi provi kliniċi attivi kkontrollati ta' 1,633 adult b'epatite B
English: Entecavir Accord 1 mg film-coated tablets: Pink, triangle shaped, biconvex film-coated tablets debossed with 'J' on one side and '111' on other side.
Maltese: Entecavir Accord 1 mg pilloli miksijin b'rita: Lewn roża, għamla trijangulari, biconvex pilloli miksijin b'rita mmarkati b' “J” fuq naħa u “111” fuq naħa oħra.
English: Amylase levels > 3 times baseline occurred in 2% of patients, lipase levels > 3 times baseline in 18% and platelets < 50,000/mm3 in < 1%.
Maltese: Livelli ta' amylase ta' > 3 darbiet tal-livell fil-linja bażi seħħew fi 2% tal-pazjenti, livelli ta' lipase ta' > 3 darbiet tal-linja bażi fi 18% u plejtlits ta' < 50,000/mm3 f' < 1%.
English: In clinical studies in patients with compensated liver disease, the most common adverse reactions of any severity with at least a possible relation to entecavir were headache (9%), fatigue (6%), dizziness (4%) and nausea (3%).
Maltese: Fi studji kliniċi f'pazjenti li kellhom mard tal-fwied stabbli, l-iktar reazzjonijiet avversi komuni ta' kull gravità, li ta' l-inqas jista' jkollhom il-possibbilità ta' relazzjoni ma' entecavir kienu l-uġigħ ta' ras (9%), għeja (6%), sturdament (4%) u dardir (3%).
English: 3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir).
Maltese: Sa Ġimgħa 240, 3 mill-10 pazjenti esperjenzaw breakthrough viroloġiku (żieda ta' ≥ 1 log10 ‘il fuq min-nadir).
English: 30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
Maltese: 30 x 1 pillola miksija b'rita; 3 folji ta' 10 x 1 pillola miksija b'rita, kull waħda f'folji ta' doża waħda, mtaqqbin ta' Alu/Alu, jew
English: Renal clearance is independent of dose and ranges between 360-471 ml/min suggesting that entecavir undergoes both glomerular filtration and net tubular secretion.
Maltese: Il-clearance tal-kliewi huwa indipendenti mid-doża u jvarja bejn 360-471 ml/min; dan jissuġġerixxi li entecavir jintrema fl-urina kemm minn filtrazzjoni glomerulari kif ukoll minn sekrezzjoni netta tubulari.
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Maltese: Clearance tal-Kreatinina ta' Linja Bażi (ml/min)
English: 90 x 1 film-coated tablet
Maltese: 90 x 1 pillola miksija b'rita
English: Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm.
Maltese: Daqs: Tul 11.00 mm ± 0.20 mm, wisa' 10.
English: Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Maltese: sostituzzjonijiet ETVr f'rtT184, rtS202, jew rtM250 kienet identifikati fi 3 pazjenti kkurati b'entecavir, u 2 minnhom kellhom breakthrough viroloġiku (ara t-tabella).
English: Lamivudine-refractory:
Maltese: Pakkett tal-folji:
English: Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Maltese: Każijiet severi, xi kultant b'riżultati fatali, kienu assoċjati ma' pankreatite, indeboliment tal-fwied/steatożi epatika, indeboliment tal-kliewi u livelli ogħla ta' lactate fis-serum.
English: There is limited experience of entecavir overdose reported in patients.
Maltese: Hemm esperjenza limitata ta' doża eċċessiva ta' entecavir irrapportata f'pazjenti.
English: The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Maltese: Il-ħin għall-bidu ta' HCC jew mewt (skont liema seħħ l-ewwel) kien komparabbli fiż-żewġ gruppi ta' kura; ir-rati kumulattivi ta' mwiet waqt l-istudju kienu 23% (23/102) u 33% (29/89) għal pazjenti kkurati b'entecavir u adefovir dipivoxil, rispettivament, u r-rati kumulattivi waqt l-istudju ta' HCC
English: Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.
Maltese: ETVr tbiddel l-rtT184, rtS202 jew l-rtM250 tnaqqas is-suxxettibilità għal entecavir f'kultura ta' ċelloli.
English: b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥ 300 copies/ml) c NC=M (noncompleters=missing) dDefined as decrease or no change from baseline in CTP score.
Maltese: b NC=F (ma rnexxilux jasal sat-tmiem=nuqqas ta' suċċess), dan ifisser li waqfien mill-kura qabel il-ġimgħa tal-analiżi, inklużi raġunijiet bħal mewt, nuqqas ta' effikaċja, episodju avvers, nuqqas ta' konformità/loss-to-follow-up, huma meqjusin bħala nuqqas ta' suċċess (eż., DNA tal-HBV ≥ 300 kopja/ml)
English: achieved HBV DNA < 300 copies/ml at Week 48.
Maltese: (9/14) kisbu DNA tal-HBV ta' < 300 kopji/ml f'Ġimgħa 48.
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Maltese: Pożittivi għal HBeAg (studju 022): trattament b'entecavir sa 96 ġimgħa (n= 354) irriżulta f'rati ta' titjib kumulattiv ta' 80% għal DNA ta' HBV < 300 kopja/ml skont il-PCR, 87% għal normalizzazzjoni ta' ALT, 31% għal sirokonversjoni ta' HBeAg u 2% għal sirokonversjoni ta' HBsAg (5% għal tnaqqis ta' HBsAg).
English: HIV/HBV co-infected patients receiving concomitant antiretroviral therapy: entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Maltese: Pazjenti ko-infettati bl-HIV/HBV li jkunu qed jingħataw terapija antiretrovirali fl-istess ħin: entecavir ġie studjat fi 68 adult b'infezzjoni fl-istess ħin ta' l-HIV/HBV li kienu qegħdin jingħataw reġim HAART li kien fih lamivudine (ara sezzjoni 5.1).
English: Cmax and Cmin at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
Maltese: Cmas u Cmin f'konċentrazzjoni fissa huma 4.2 u 0.3 ng/ml, rispettivament, għal doża ta' 0.5 mg,
English: HIV/HBV co-infected patients receiving concomitant HAART: study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Maltese: Pazjenti ko-infettati bl-HIV/HBV li jkunu qed jingħataw HAART fl-istess ħin: fl-istudju 038 kien hemm 67 pazjent pożittiv għal HBeAg u pazjent wieħed negattiv għal HBeAg li kienu infettati wkoll bl-HIV.
English: For patients with baseline Ishak fibrosis score ≥ 2, 25/43 (58%)
Maltese: Għal pazjenti b'punteġġ fil-linja bażi tal-fibrożi ta' Ishak ta' ≥ 2, 25/43 (58%) kellhom tnaqqis ta' ≥ 2 punti.
English: Haemodialysis or CAPD**
Maltese: Immaniġġj at b'CAPD (n = 4)
English: Bottle pack: 30 film-coated tablets
Maltese: Pakkett tal-flixkun: 30 pillola miksija b'rita
English: Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Maltese: Kull pillola li fiha entecavir monohydrate ekwivalenti għal 0.5 mg entecavir.
English: NA
Maltese: JIS
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥ 1 point decrease (median decrease from baseline was 1.5 points).
Maltese: L-għaxar (10/10) pazjenti kollha b'fibrożi avvanzata jew ċirrożi fil-linja bażi (punteġġ tal-fibrożi ta' Ishak ta' 4, 5 jew 6) kellhom tnaqqis ta' ≥ 1 punt (it-tnaqqis medjan mil-linja bażi kien ta' 1.5 punti).
English: The ETVr substitutions at residues rtT184, rtS202 and rtM250 alone have only a modest effect on entecavir susceptibility, and have not been observed in the absence of LVDr substitutions in more than 1000 patient samples sequenced.
Maltese: Issostituzzjonijiet ETVr fir-residwi rtT184, rtS202 u rtM250 weħidhom għandhom biss effett modest fuq is-suxxettibilità għal entecavir, u ma ġewx osservati fin-nuqqas ta' sostituzzjonijiet LVDr f'aktar minn 1000 pazjent studjati.
English: At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
Maltese: Fl-24 ġimgħa, it-tnaqqis fil-viral load ta' l-HBV kien ferm ogħla b'entecavir (-3.65 meta mqabbel ma' żjieda ta' 0.11 log10 kopji/ml).
English: Entecavir Accord 1 mg film-coated tablets Bottle packs:
Maltese: Entecavir Accord 1 mg pilloli miksijin b'rita Pakketti tal-flixkun:
English: Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Maltese: Kull pillola fiha entecavir monohydrate ekwivalenti għal 1 mg entecavir.
English: HIV variants containing the M184V substitution showed loss of susceptibility to entecavir (see section 4.4).
Maltese: Varjanti ta' l-HIV li kien fihom is-sostituzzjoni ta' M184V tilfu s-suxxettibilità għal entecavir (ara sezzjoni 4.4).
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Maltese: Il-livelli ta' ALT u HBV DNA fis-serum għandhom jiġu segwiti b'mod regolari wara li titwaqqaf il-kura (ara sezzjoni 4.4).
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Maltese: Tnaqqis fil-viral load (log10 kopji/ml)c
English: For children and adolescents (from 2 to less than 18 years of age), Entecavir Accord 0.5 mg tablets are available or an entecavir oral solution may be available.
Maltese: Għal tfal u adolexxenti (minn sentejn sa inqas minn 18-il sena), huma disponibbli pilloli ta' 0.5 mg ta' Entecavir Accord jew tista' tkun disponibbli soluzzjoni orali ta' entecavir.
English: Hepatic impairment: pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function.
Maltese: Indeboliment tal-fwied: il-parametri farmakokinetiċi f'pazjenti b'indeboliment moderat jew gravi talfwied kienu simili għal ta' dawk f'pazjenti b'funzjoni normali.
English: The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Maltese: Il-farmakokinetika ta' entecavir wara doża waħda ta' 1 mg f'pazjenti mingħajr infezzjoni kronika ta' l-epatite B jidhru fit tabella:
English: Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food.
Maltese: Pazjenti nucleoside-naive: id-doża rrakkomandata fl-adulti hija ta' 0.5 mg darba kuljum, ma' l-ikel jew mhux ma' l-ikel.
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
Maltese: a pazjenti b'istoloġija ta' linja bażi li tista' tiġi evalwata (Knodell Necroinflammatory Score ta' linja bażi ≥ 2) b punt aħħari primarju.
English: Antiviral activity: entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Maltese: Attività antivirali: entecavir impedixxa s-sintesi ta' DNA ta' HBV (tnaqqis ta' 50%, EC50)
English: Hepatic function should be monitored at repeated intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Maltese: Il-funzjoni epatika trid tiġi mmonitorjata f'intervalli ripetuti b'follow up kemm kliniku kif ukoll mil-laboratorju għal mill-inqas 6 xhur wara t-twaqqif tat-terapija għal epatite B.
English: Entecavir Accord are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Maltese: Entecavir Accord jiġu f'kaxex tal-kartun li fihom 30 x 1 or 90 x 1 pillola miksija b'rita (f'folji ta' doża waħda) u fi fliexken li fihom 30 pillola miksija b'rita.
English: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Maltese: Tfal li jiżnu tal-inqas 32.6 kg jistgħu jieħdu pillola ta' 0.5 mg jew tista' tkun disponibbli soluzzjoni orali ta' entecavir.
English: The entecavir dosage was 0.5 mg daily in the pivotal studies (mean exposure 85 weeks) and 1 mg daily in the rollover study (mean exposure 177 weeks), and 51 patients in the rollover study initially also received lamivudine (median duration 29 weeks).
Maltese: Id-dożaġġ ta' entecavir kien ta' 0.5 mg kuljum fl-istudji importanti ħafna (medja tal-espożizzjoni ta' 85 ġimgħa) u 1 mg kuljum fl-istudju rollover (medja talespożizzjoni ta' 177 ġimgħa), u 51 pazjent fl-istudju rollover inizjalment ukoll irċivew lamivudine (medjan ta' tul ta' żmien ta' 29 ġimgħa).
English: copies/ml by PCR at Week 24 had a lower rate of resistance than those who did not (5-year cumulative probability 17.6% [n= 50] versus 60.5% [n= 135], respectively).
Maltese: [n=50] kontra 60.5% [n=135], rispettivament).
English: At the time of the long-term biopsy, all patients had HBV DNA < 300 copies/ml and 49/57 (86%) had serum ALT ≤ 1 times ULN.
Maltese: Fil-ħin tal-bijopsija għal żmien fit-tul, il-pazjenti kellhom DNA tal-HBV ta' < 300 kopji/ml u 49/57 (86%) kellhom ALT tas-serum ta' ≤ darba ULN.
English: ETVr substitutions (in addition to LVDr substitutions rtM204V/I ± rtL180M) were observed at baseline in isolates from 10/187 (5%) lamivudine-refractory patients treated with entecavir and monitored for resistance, indicating that prior lamivudine treatment can select these resistance substitutions and that they can exist at a low frequency before entecavir treatment.
Maltese: Sostituzzjonijiet ETVr (flimkien mas-sostituzzjonijiet LVDr rtM204V/I ± rtL180M) ġew osservati fillinja bażika f'iżolati minn 10/187 (5%) pazjenti rifrattorji għal lamivudine ttrattati b'entecavir u mmonitorjati għar-reżistenza, li juri li t-trattament preċedenti b'lamivudine jista' jagħżel dawn issostituzzjonijiet tar-reżistenza u li dawn jistgħu jeżistu bi frekwenza baxxa qabel it-trattament b'entecavir.
English: High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients.
Maltese: Linji bażi għoljin ta' Knodell necro-nflammatory scores (> 10) ġew assoċjati ma' titjib ikbar fl-istoloġija f'pazjenti li huma nucleoside naïve.
English: EXP Bottle pack:
Maltese: Qalba tal-pillola:
English: Breast-feeding should be discontinued during treatment with Entecavir Accord.
Maltese: It-treddigħ għandu jitwaqqaf waqt it trattament b' Entecavir Accord.
English: Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Maltese: Pazjenti refrattarji għal lamivudine (jiġifieri b'evidenza ta' viremja waqt li jkunu fuq lamivudine jew fil-preżenza ta' tibdil ġenetiku għar-reżistenza għal lamivudine [LVDr]) (ara sezzjonijiet 4.4 u 5.1): id doża rakkomandata fl-adulti hija ta' 1 mg darba kuljum, li trid tittieħed fuq stonku vojt (iktar min sagħtejn qabel u iktar minn sagħtejn wara l-ikel) (ara sezzjoni 5.2).
English: Soy polysaccharides: This medicinal product contains soy polysaccharides.
Maltese: Polysaccharides tas-sojja: dan il-prodott mediċinali fih polysaccharides tas-sojja.
English: Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg.
Maltese: L-espożizzjoni għal entecavir fost individwi li jirċievu dożi darba kuljum ta' entecavir 0.015 mg/kg sa doża massima ta' 0.5 mg kienet simili għall-espożizzjoni miksuba f'pazjenti adulti li jirċievu dożi darba kuljum ta' 0.5 mg.
English: - genotypic ETVr c with virologic breakthrough d a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
Maltese: Snin 4 u 5 u ta' terapija kkombinata ta' entecavir-lamivudine (segwita minn terapija fit-tul b'entecavir) għal medjan ta' 20 ġimgħa għal 130 minn 149 pazjenti f'Sena 3 u għal ġimgħa waħda għal 1 minn 121 pazjent f'Sena 4 fi studju rollover.
English: Blister packs: EU/1/17/1211/005 EU/1/17/1211/006
Maltese: EU/1/17/1211/005 EU/1/17/1211/006
English: In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Maltese: F'perċentwal żgħir ta' pazjenti refrattarji għal lamivudine, sostituzzjonijiet ETVr f'residwi rtT184, rtS202 jew rtM250 kienu preżenti fil-linja bażi.
English: In these studies, the safety profiles, including laboratory abnormalities, were comparable for entecavir 0.5 mg daily (679 nucleoside-naive HBeAg positive or negative patients treated for a median of 53 weeks), entecavir 1 mg daily (183 lamivudine-refractory patients treated for a median of 69 weeks), and lamivudine.
Maltese: F'dawn l-istudji, il-profili tas-sigurtà li jinkludu anormalitajiet tal-laboratorju kienu komparabbli għal 0.5 mg ta' entecavir kuljum (679 pazjent nucleoside-naive ta' HBeAg pożittiv jew negattiv, ittrattati għal medjan ta' 53 ġimgħa), 1 mg ta' entecavir kuljum (183 pazjent refrattorju b'lamivudine ittrattati għal medjan ta' 69 ġimgħa) u lamivudine.
English: Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Maltese: Pazjenti infettati bil-virus ta' l-immunodefiċjenza umana (HIV)/HBV li ma jkunux jingħataw kura antiretrovirali fl-istess ħin: entecavir ma ġiex evalwat f'pazjenti infettati bl-HIV/HBV li ma kinux qegħdin jieħdu kura effettiva fl-istess ħin kontra l-HIV.
English: Apart from lamivudine, adefovir dipivoxil and tenofovir disoproxil fumarate, the effects of coadministration of entecavir with medicinal products that are excreted renally or affect renal function have not been evaluated.
Maltese: Barra lamivudine, adefovir dipivoxil u tenofovir disoproxil fumarate, l-effetti ta' l-għoti ta' entecavir ma' prodotti mediċinali oħra li joħorġu mill-kliewi jew ma' xi prodotti li jaffettwaw il-funzjoni renali ma ġewx evalwati.
English: Entecavir was clastogenic to human lymphocyte cultures at concentrations substantially higher than those achieved clinically.
Maltese: Entecavir kien klastoġeniku għal kulturi tal-limfoċiti umani f'konċentrazzjonijiet sostanzjalment ogħla minn dawk li ntlaħqu klinikalment.
English: 30 x 1 film-coated tablet
Maltese: 30 x 1 pillola miksija b'rita
English: HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.
Maltese: Pożittivi għal HBeAg (studju 026): trattament b'entecavir sa 96 ġimgħa (n= 141) irriżulta f'rati ta' titjib kumulattiv ta' 30% għal DNA ta' HBV < 300 kopja/ml skont il-PCR, 85% għal normalizzazzjoni ta' l-ALT u 17% għal sirokonversjoni ta' l-HBeAg.
English: virus (HBV) through sexual contact or body fluids (including blood contamination).
Maltese: permezz ta' kuntatt sesswali jew fluwidi tal-ġisem (inkluż kontaminazzjoni bid-demm).
English: Absorption: entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.51.5 hours.
Maltese: Assorbiment: entecavir jiġi assorbit malajr, bl-ogħla konċentrazzjonijiet fil-plażma jseħħu bejn 0.5-1.5 sigħat.
English: Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Maltese: mard stabbli tal-fwied u b'evidenza ta' replikazzjoni virali attiva, b'livelli kostantament għoljin ta' alanine aminotransferase (ALT) fis-serum u b'evidenza istoloġika ta' infjammazzjoni attiva u/jew fibrożi.
English: Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Maltese: Entecavir Accord 0.5 mg pilloli miksijin b'rita Entecavir Accord 1 mg pilloli miksijin b'rita
English: The entecavir-TP Ki for HBV DNA
Maltese: Linja Bażi HBV
English: Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Maltese: Wara li tinbeda t-terapija antivirali, l-ALT fis serum f'xi pazjenti jista' jiżdied, filwaqt li l-livelli ta' DNA ta' HBV fis-serum jonqsu (ara sezzjoni 4.8).
English: Mild
Maltese: Lott
English: Entecavir Accord 0.5 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir .
Maltese: Entecavir Accord 0.5 mg pilloli miksijin b'rita Kull pillola fiha entecavir monohydrate ekwivalenti għal 0.5 mg entecavir.
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)
Maltese: a Proporzjon ma setax jiġi osservat (< 300 kopja/ml)b c -4.48*
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
Maltese: entecavir ġew evalwati wkoll fi prova klinika kkontrollata b'mod attiv ta' 191 pazjent infettati b'HBV
English: Two-year carcinogenicity studies: in male mice, increases in the incidences of lung tumours were observed at exposures ≥ 4 and ≥ 2 times that in humans at 0.5 mg and 1 mg respectively.
Maltese: Studji ta' sentejn fuq il-karċinoġeniċità: fi ġrieden irġiel, ġew osservati żjidiet fl-inċidenza ta' tumuri tal-pulmun b'dożi ta' ≥ 4 u ≥ darbtejn dawk fl-umani b'doża ta' 0.5 mg u 1 mg rispettivament.
English: In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
Maltese: F'assaġġi ta' kombinazzjoni ta' HBV f'kultura ta' ċelloli, abacavir, didanosine, lamivudine, stavudine,
English: In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
Maltese: Fi studji f'pazjenti li huma nucleoside naïve, 6% tal-pazjenti ttrattati b'entecavir u 10% tal-pazjenti ttrattati b'lamivudine urew żjidiet fl-ALT (> 10 darbiet l-ULN u > darbtejn ir-referenza [il-minimu tal-linja bażi jew l-aħħar kejl fl-aħħar tad-dożi]) waqt follow-up ta' wara t-trattament.
English: Resistance in cell culture: relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Maltese: Reżistenza f'kultura ta' ċelloli: fir-rigward ta' HBV wild-type, virusijiet LVDr li fihom sostituzzjonijiet ta' rtM204V u rtL180M fir-reverse transcriptase juru suxxettibilità ta' 8 darbiet inqas għal entecavir.