FrancophonIA/ELRC3.0 huggingface dataset:
English: 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: 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: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 0.5 mg tablets entecavir
Maltese: TAL-PRODOTT MEDIĊINALI Entecavir Mylan 0.5 mg pilloli entecavir ISEM
English: See leaflet for further information 4.
Maltese: Sorsi oħra ta' informazzjoni
English: Cumulative probability of: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Maltese: Pazjenti f'sena speċifika b': - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikud
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 mill-inqas 32.6 kg jistgħu jieħdu lpillola ta' 0.5 mg jew tista' tkun disponibble soluzzjoni orali ta' entecavir.
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: 0.15 mg once daily* OR 0.5 mg every 72 hours
Maltese: 0.15 mg darba kuljum* JEW 0.5 mg kull 72 siegħa
English: Майлан ЕООД Teл.
Maltese: • Żomm dan il-fuljett.
English: Relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Maltese: Fir-rigward ta' HBV wild-type, virusijiet LVDr li fihom sostituzzjonijiet ta' rtM204V u rtL180M firreverse transcriptase juru suxxettibilità ta' 8 darbiet inqas għal entecavir.
English: Of the 61 patients who were evaluable for efficacy (received entecavir for at least 1 month), 60 also received hepatitis B immune globulin (HBIg) as part of the post-transplant prophylaxis regimen.
Maltese: Mill-61 pazjent li kienu evalwabbli għall-effikaċja (irċevew entecavir għal tal-anqas 1 xahar), 60 irċevew ukoll epatite B immuni globulina (HBIg) bħala parti mill-kors tal-profilassi ta' wara t-trapjant.
English: Entecavir Mylan will not control your HIV infection.
Maltese: Entecavir Mylan ma jikkontrollax l-infezzjoni tal-HIV tiegħek.
English: 0.1 mg once daily* OR 0.5 mg every 72 hours
Maltese: 0.1 mg darba kuljum* JEW 0.5 mg kull 72 siegħa
English: Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%.
Maltese: B'mod ġenerali, avvenimenti avversi serji kienu relatati mal-fwied, bi frekwenza kumulattiva ta' waqt l-istudju ta' 69%.
English: 0.5 mg once daily
Maltese: 0.5 mg darba kuljum
English: Lactic acidosis and severe hepatomegaly with steatosis
Maltese: Aċidożi lattika u epatomegalija severa bi steatożi:
English: By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Maltese: (1) priming ta' polymerase ta' HBV, (2) traskrizzjoni bil-maqlub ta' listrand negattiv tad-DNA mill-messaġġier pregenomiku RNA, u (3) sintesi ta' l- istrand pożittiv tadDNA tal-HBV.
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Maltese: Refrattarji għal lamivudine Pożittivi għal HBeAg (studju 026) ETV 1.0 mg darba kuljum
English: Severe (n = 6)
Maltese: Sever (n = 6)
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: The paediatric resistance assessment is based on data from nucleoside-treatment-naive paediatric patients with HBeAg-positive chronic HBV infection in two ongoing clinical trials (028 and 189).
Maltese: L-evalwazzjoni ta' reżistenza pedjatrika hi bbażata fuq dejta minn pazjenti pedjatriċi nucleoside-naive għat-trattament b'infezzjoni kronika bl-HBV u pożittivi għal HBeAg, f'żewġ provi kliniċi li għadhom għaddejjin (028 u 189).
English: Relative to the adverse reactions noted in section Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Maltese: Lista f'għamla ta' tabella ta' reazzjonijiet avversi, ġiet osservata reazzjoni avversa addizzjonali waħda [tnaqqis tal-bikarbonat fiddemm (2%)] f'pazjenti kkurati b'entecavir sa ġimgħa 48.
English: Emergence of HIV resistance has been observed when entecavir was used to treat chronic hepatitis B infection in patients with HIV infection not receiving highly active antiretroviral therapy (HAART) (see section 5.1).
Maltese: Ġie osservat li tfaċċat reżistenza ta' l-HIV meta entecavir intuża għall-kura ta' infezzjoni kronika ta' l-epatite B f'pazjenti b'infezzjoni ta' l-HIV li ma kinux qegħdin jingħataw kura antiretrovirali effettiva ħafna (HAART) (ara sezzjoni 5.1).
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): iddoża 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: The potential risk for humans is unknown.
Maltese: Mhux magħruf ir-riskju potenzjali fuq in- nisa.
English: 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: Fi studju b'mod każwali, double blind f'pazjenti pożittivi għal HBeAg u refrattorji għal lamivudine (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: Renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Maltese: 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: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (<300 copies/ml by PCR)c
Maltese: HBV DNA li ma jistax jiġi osservat (<300 kopja/mL skont PCR)c
English: 43.6% e a Results reflect use of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 13 weeks for 48 of 80 patients in Year 3, a median of 38 weeks for 10 of 52 patients in Year 4, and for 16 weeks for 1 of 33 patients in Year 5 in a rollover study.
Maltese: 41.3% e 43.6% e a Ir-riżultati jirriflettu l-użu ta' terapija kombinata b'entecavir-lamivudine (segwita minn terapija fit-tul b'entecavir) għal medjan ta' 13-il ġimgħa għal 48 minn 80 pazjent f'Sena 3, medjan ta' 38 ġimgħa għal 10 minn 52 pazjent f'Sena 4, u għal 16-il ġimgħa għal 1 minn 33 pazjent f'Sena 5 fi studju rollover.
English: Cumulative probability of: - emerging genotypic ETVr c - 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: Probabbiltà kumuluttaiva ta': - ETVrc ġenotipika ġdida - ETVrc ġenotipika bi breakthrough viroloġikud a Ir-riżultati jirriflettu l-użu ta' doża ta' 1 mg ta' entecavir għal 147 minn 149 pazjent f'Sena 3 u fil-pazjenti kollha fi Snin
English: HIV/HBV co-infected patients receiving concomitant antiretroviral therapy
Maltese: Pazjenti ko-infettati bl-HIV/HBV li jkunu qed jingħataw terapija antiretrovirali fl-istess ħin:
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: ALT normalisation (≤1 times ULN)
Maltese: Normalizzazzjoni tal-ALT (≥1 drabi talULN)
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: Għal 26 pazjent li ġew ittrattati b'entecavir u 28 pazjent li ġew ittrattati għal iktar minn 52 ġimgħa (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: 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 tallaboratorju 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: 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 post-treatment 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: 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 HBeAg (027) jidhru fit-tabella.
English: Entecavir Mylan contains lactose
Maltese: Kif jidher Entecavir Mylan u l-kontenut tal-pakkett
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 il-polymerase ta' γ jew is-sintesi tadDNA fil-mitochondrion f'ċelloli HepG2 (Ki >160 µM).
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets
Maltese: Entecavir Mylan 0.5 mg pilloli miksija b'rita Entecavir Mylan 1 mg pilloli miksija b'rita
English: NAME OF THE MEDICINAL PRODUCT Entecavir Mylan 1 mg tablets entecavir
Maltese: TAL-PRODOTT MEDIĊINALI Entecavir Mylan 1 mg pilloli entecavir ISEM
English: Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy
Maltese: Pazjenti infettati bil-virus ta' l-immunodefiċjenza umana (HIV)/HBV li ma jkunux jingħataw kura antiretrovirali fl-istess ħin:
English: Proportion undetectable (<300 copies/ml)b Mean change from baseline (log10 copies/ml)c
Maltese: Tnaqqis tal-ammont virali (log10 kopja/mL)c
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: Lamivudine-refractory
Maltese: rari: reazzjoni anafilattojdi
English: Laboratory test abnormalities
Maltese: Informazzjoni għall-utent
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: Hepatobiliary disorders:
Maltese: Disturbi psikjatriċi:
English: Entecavir dosage* Nucleoside naïve patients
Maltese: Nucleoside Naive
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 issistema ta' klassifika ta' l-organi.
English: 0.5 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Maltese: 0.5 mg: il-pilloli miksija b'rita (pilloli) huma bojod, miksija b'rita, tondi, bikonvessi, bit-tarf imżerżaq, imnaqqxa b'“M” fuq naħa waħda tal-pillola u “EA” fuq in-naħa l-oħra.
English: Ishak fibrosis score improvement Ishak fibrosis score worsening n
Maltese: Deterjorament fil-punteġġ tal-fibrożi Ishak n
English: Entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Maltese: 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: Mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Maltese: Mutazzjonijiet fl-HBV polymerase li jirriżultaw f'sostituzzjonijiet li jsarrfu f'reżistenza għal lamivudine jistgħu iwasslu għall-feġġa sussegwenti ta' sostituzzjonijiet sekondarji, inklużi dawk assoċjati ma' reżistenza assoċjata ma' entecavir (ETVr).
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 tal-HBV kien ferm ogħla b'entecavir (-3.65 meta mqabbel ma' żjieda ta' 0.11 log10 kopji/mL).
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
Maltese: Fillinja bażi, pazjenti ttrattati b'entecavir kellhom terapija preċedenti b'lamivudine għal medja ta' 4.8 snin u ammont medju ta' CD4 ta' 494 ċelloli/mm3 (b'5 pazjenti biss li kellhom ammont ta' CD4 <200
English: Entecavir clearance decreases with decreasing creatinine clearance.
Maltese: Il-clearance ta' entecavir skont il-clearance tal-kreatinina.
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-dożaġġ, fost pazjenti li komplew it-trattament b'entecavir għal aktar minn 52 ġimgħa (medjan ta' 96 ġimgħa), 81% mill-243 pazjent ittrattati b'entecavir u 39% mill-164 pazjent ittrattati 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: 0.5 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EA” on the other side.
Maltese: 0.5 mg: pillola miksija b'rita, bajda, tonda, bikonvessa, bit-tarf imżerżaq, imnaqqxa b'“M” fuq naħa waħda tal-pillola u “EA” fuq in-naħa l-oħra.
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: L-HBV DNA medju fis-serum skont PCR kien 7.83 log10 kopji/mL u l-ALT medju tas-serum kien 100
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.
Maltese: Wara aġġustament għaddifferenzi fil-clearance tal-kreatinina u l-piż tal-ġisem, is-suġġetti anzjani kellhom AUC 12.5% ogħla minn suġġetti żgħar.
English: f Denominator is patients with abnormal values at baseline.
Maltese: f Denominatur huwa pazjenti b'valuri anormali fil-linja bażi.
English: 1 mg: white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Maltese: 1 mg: pillola miksija b'rita, bajda, tonda, bikonvessa, bit-tarf imżerżaq, imnaqqxa b'“M” fuq naħa waħda tal-pillola u “EB” fuq in-naħa l-oħra.
English: 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: Il-farmakokinetika ta' entecavir fl-istat fiss ġiet evalwata (studju 028) f'24 individwu pedjatriku u 19-il individwu pedjatriku b'esperjenza ta' lamivudine u pożittivi għal HBeAg, li kellhom minn sentejn sa <18-il sena b'mard tal-fwied kumpensat.
English: 1 mg: the film-coated tablets (tablets) are white, film-coated, round, biconvex, beveled edge tablet debossed with “M” on one side and “EB” on the other side.
Maltese: 1 mg: il-pilloli miksija b'rita (pilloli) huma bojod, miksija b'rita, tondi, bikonvessi, bit-tarf imżerżaq, imnaqqxa b'“M” fuq naħa waħda tal-pillola u “EB” fuq in-naħa l-oħra.
English: * for doses <0.5 mg entecavir oral solution is recommended ** on haemodialysis days, administer entecavir after haemodialysis.
Maltese: * għal dożi ta' <0.5 mg ta' entecavir, soluzzjoni orali hija rrakkomandata.
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: 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: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatmentnaïve children and adolescents from 2 to <18 years of age with HBeAg positive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Maltese: Studju 189 huwa studju kontinwu fuq l-effikaċja u s-sigurtà ta' entecavir fost 180 tfal u adolexxenti li qatt ma ħadu l-kura qabel b'nucleoside minn sentejn sa <18-il sena b'infezzjoni tal-epatite B kronika pożittiva għal HBeAg, mard tal-fwied kumpensat, u ALT għoli.
English: Co-infection with hepatitis C or D
Maltese: Infezzjoni fl-istess ħin bl-epatite Ċ jew D:
English: ALT normalisation (≤1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Maltese: In normalizzazzjoni 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: 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
Maltese: 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 tallinja bażi.
English: Entecavir Mylan is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to <18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Maltese: Entecavir Mylan huwa indikat ukoll għall-kura ta' infezzjoni HBV kronika f'pazjenti pedjatriċi li qatt ma ħadu nucleoside qabel, li għandhom minn sentejn sa <18-il sena b'mard tal-fwied kumpensat, li għandhom evidenza ta' replikazzjoni virali attiva u livelli ALT fis-serum għoljin, jew evidenza istoloġika ta' infjammazzjoni u/jew fibrożi moderata sa severa.
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' > darbtejn tal-ULN u ta' > darbtejn tal-livell tal-linja bażi.
English: Resistance and specific precaution for lamivudine-refractory patients
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: In studies in patients with compensated liver disease, histological improvement was defined as a ≥2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
Maltese: Fl-istudji f'pazjenti b'mard tal-fwied stabbli, it-titjib istoloġiku ġie definit bħala tnaqqis ta' ≤ 2 punti f'Knodell necro-inflammatory score mil-linja bażi mingħajr ma' l-Knodell fibrosis score imur għallagħar.
English: Baseline Creatinine Clearance (ml/min) Unimpaired
Maltese: Tneħħija tal-krejatinina (ml/min)
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Post-Liver transplant
Maltese: TAL-PRODOTT MEDIĊINALI
English: e ETVr occurring in any year; virologic breakthrough in specified year.
Maltese: e ETVr li jseħħ fi kwalunkwe sena; breakthrough viroloġiku f'sena speċifika.
English: How to store Entecavir Mylan
Maltese: X'fih Entecavir Mylan