FrancophonIA/ELRC3.0 huggingface dataset:
English: Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥50 IU/ml at Week 48 or Week 96.
Slovenian: Genotipska vrednotenja so bila izvedena pri vseh bolnikih z razpoložljivimi vzorci, pri katerih je do 96. tedna prišlo do povečanja virusnega bremena (»virologic breakthrough«), ali so imeli v 48. tednu ali 96. tednu vrednost HBV DNA ≥ 50 i.e./ml.
English: Through Week 240, 3 of the 10 patients experienced virologic breakthrough (≥1 log10 increase above nadir).
Slovenian: V obdobju 240 tednov se je pri 3 od 10 bolnikov pojavilo povečanje virusnega bremena (≥ 1 log10 povečanje nad najnižjo vrednostjo).
English: Resistance and specific precaution for lamivudine-refractory patients
Slovenian: Odpornost in posebna previdnost pri bolnikih, neodzivnih na lamivudin
English: * for doses <0.5 mg entecavir oral solution is recommended ** on haemodialysis days, administer entecavir after haemodialysis.
Slovenian: * za odmerke < 0,5 mg priporočamo uporabo peroralne raztopine entekavirja ** na dan hemodialize bolniki vzamejo entekavir po hemodializi.
English: Also, lamivudine-refractory patients who achieved HBV DNA <104 log10 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).
Slovenian: Pri bolnikih, neodzivnih na lamivudin, ki so v 24. tednu po metodi PCR imeli vrednost HBV DNA < 104 log10 kopij/ml je bil delež odpornosti nižji kot pri bolnikih, pri katerih ta vrednost ni bila dosežena (5-letna skupna verjetnost 17,6 % [n = 50] v primerjavi s 60,5 % [n = 135].
English: Entecavir Mylan is only available as 0.5 and 1 mg film-coated tablets.
Slovenian: Zdravilo Entekavir Mylan je na voljo samo v obliki 0,5 in 1 mg filmsko obloženih tablet.
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58
Slovenian: b Vključuje bolnike z vsaj eno določitvijo HBV DNA s PCR, v 24. tednu zdravljenja ali kasneje do 58. tedna (1. leto),
English: Entecavir exposure in HBV-infected liver transplant recipients on a stable dose of cyclosporine A or tacrolimus (n = 9) was ≈ 2 times the exposure in healthy subjects with normal renal function.
Slovenian: Pri bolnikih, okuženih s HBV, s presajenimi jetri, ki so prejemali stabilne odmerke ciklosporina A ali takrolimusa (n = 9), je bila izpostavljenost entekavirju ≈ 2-krat večja od izpostavljenosti pri zdravih osebah z normalnim delovanjem ledvic.
English: Stable or improved CTP scoreb,d MELD score
Slovenian: Stabilna ali izboljšana ocena po lestvici
English: Children and adolescents Entecavir Mylan should not be used for children below 2 years of age or weighing less than 10 kg.
Slovenian: Zdravila Entekavir Mylan se ne sme uporabljati pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg.
English: There are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Slovenian: Podatki o učinkovitosti entekavirja pri bolnikih s sočasno okužbo z virusom hepatitisa C ali D niso na voljo.
English: Creatinine clearance (ml/min)
Slovenian: Kreatininski očistek (ml/min)
English: Entecavir Mylan must not be used during pregnancy unless specifically directed by your doctor.
Slovenian: Zdravila Entekavir Mylan med nosečnostjo ne smete uporabljati brez izrecnega navodila zdravnika.
English: Cumulative probability of: - emerging genotypic ETVr c - genotypic ETVr c with virologic breakthrough d
Slovenian: Skupna verjetnost za: - pojav genotipske ETVr c - genotipsko ETVr c s povečanjem virusnega bremena d
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.
Slovenian: Delovanje jeter je treba v rednih časovnih presledkih nadzirati tako klinično kot laboratorijsko še najmanj 6 mesecev po prekinitvi zdravljenja hepatitisa B. Zdravljenje hepatitisa B bo morda treba ponovno uvesti.
English: Entecavir Mylan can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Slovenian: Zdravilo Entekavir Mylan se lahko uporablja pri otrocih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter).
English: rare: anaphylactoid reaction
Slovenian: redki: anafilaktoidna reakcija
English: Entecavir has been studied in 68 adults with HIV/HBV co-infection receiving a lamivudine-containing HAART regimen (see section 5.1).
Slovenian: Uporabo entekavirja so proučevali pri 68 odraslih bolnikih s sočasno okužbo z virusoma HIV/HBV, ki so se zdravili po režimu HAART, ki je vključeval lamivudin (glejte poglavje 5.1).
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance.
Slovenian: Pri bolnikih s HBV, odpornim na lamivudin, obstaja večje tveganje za nadaljnji razvoj odpornosti na entekavir kot pri bolnikih brez odpornosti na lamivudin.
English: Experience in patients co-infected with HIV
Slovenian: Izkušnje pri bolnikih s sočasno okužbo s HIV:
English: At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population.
Slovenian: Ob vstopu v študijo je povprečna vrednost HBV DNA za celotno študijsko populacijo znašala 8,1 log10 i.e./ml povprečna vrednost ALT pa 103 i.e./l.
English: No data are available on the efficacy of entecavir in HBeAgnegative patients co-infected with HIV.
Slovenian: Podatki o učinkovitosti entekavirja pri HBeAg negativnih bolnikih s sočasno okužbo z virusom HIV niso na voljo.
English: Placebo*
Slovenian: entekavir placebo*
English: Common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Slovenian: Pri bolnikih, ki so se zdravili z entekavirjem, so poročali o naslednjih neželenih učinkih: Pogosti (pri več kot 1 od 100 bolnikov): glavobol, insomnija (nespečnost), utrujenost (močna oslabelost), omotica, somnolenca (otopelost), bruhanje, driska, siljenje na bruhanje, dispepsija (prebavne motnje) in povečane vrednosti jetrnih encimov v krvi.
English: The adverse reactions observed in paediatric subjects who received treatment with entecavir were consistent with those observed in clinical trials of entecavir in adults (see Summary of the safety profile and section 5.1).
Slovenian: Pri pediatričnih bolnikih, ki so se zdravili z entekavirjem, so bili neželeni učinki skladni z neželenimi učinki, opaženimi v kliničnih preskušanjih entekavirja pri odraslih (glejte Povzetek varnostnega profila in poglavje 5.1).
English: HBV DNA <50 IU/mL and HBeAg seroconversiona HBV DNA <50 IU/mLa HBeAg seroconversiona ALT normalisationa HBV DNA <50 IU/mLa
Slovenian: HBV DNA <50 i.e./ml in serokonverzija HBeAga HBV DNA < 50 i.e./mla
English: 117 Allée des Parcs 69800 Saint Priest
Slovenian: 69800 Saint Priest
English: Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase
Slovenian: Po dajanju 14C-entekavirja niso zasledili oksidiranih ali acetiliranih presnovkov.
English: For patients with baseline Ishak fibrosis score ≥2, 25/43 (58%) had a ≥2-point decrease.
Slovenian: Pri bolnikih z izhodiščnim indeksom fibroze po Ishak-u ≥ 2 so zmanjšanje indeksa fibroze za ≥ 2 točki ugotovili pri 25/43 bolnikov (58 %).
English: There was no apparent difference in the safety profile of entecavir with respect to gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients >65 years of age).
Slovenian: Varnostni profil entekavirja se glede na spol (≈ 25 % žensk v kliničnih preskušanjih) ali starost (≈ 5 % bolnikov, starejših od 65 let) očitneje ne razlikuje.
English: common: vomiting, diarrhoea, nausea, dyspepsia
Slovenian: pogosti: bruhanje, driska, navzea, dispepsija
English: Toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Slovenian: Toksikološke študije pri živalih, ki so prejemale entekavir, ne kažejo vpliva na plodnost (glejte poglavje 5.3).
English: The safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudinecontaining HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Slovenian: Pri omejenem številu bolnikov s sočasno okužbo s HIV in HBV, ki so se med protiretrovirusnem zdravljenju po režimu HAART ("highly active antiretroviral therapy") zdravili tudi z lamivudinom, je bil varnostni profil entekavirja podoben kot pri bolnikih, okuženih le s HBV (glejte poglavje 4.4).
English: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Slovenian: Otroci s telesno maso vsaj 32,6 kg lahko jemljejo 0,5 mg tableto ali je zanje morda na voljo peroralna razpotina entekavirja.
English: Relative to wild-type HBV, LVDr viruses containing rtM204V and rtL180M substitutions within the reverse transcriptase exhibit 8-fold decreased susceptibility to entecavir.
Slovenian: V primerjavi z divjim tipom HBV so LVDr virusi z rtM204V in rtL180M substitucijami v reverzni transkriptazi 8-krat manj občutljivi za entekavir.
English: Exacerbations during treatment
Slovenian: Poslabšanja med zdravljenjem
English: • In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Slovenian: • Pri HBeAg pozitivnih odraslih bolnikih mora zdravljenje trajati še vsaj 12 mesecev po doseženi serokonverziji HBe (izginotje HBeAg in HBV DNA ter pojav protiteles anti-HBe v dveh zaporednih vzorcih seruma, odvzetih z vsaj 3- do 6-mesečnim vmesnim presledkom) ali do serokonverzije HBs, oziroma do izgube učinkovitosti (glejte poglavje 4.4).
English: For children and adolescents (from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg Filmcoated Tablets are available or an oral solution may be available.
Slovenian: Za otroke in mladostnike (stare od 2 leti do manj kot 18 let) je na voljo zdravilo Entekavir Mylan 0,5 mg filmsko obložene tablete ali peroralna raztopina.
English: Proportion undetectable (<300 copies/ml)b Mean change from baseline (log10 copies/ml)c
Slovenian: Delež nedokazljivih (< 300 kopij/ml)b Povprečna sprememba od izhodišča (log10 kopij/ml)c
English: 30 x 1 film-coated tablets
Slovenian: 30 x 1 filmsko obložena tableta
English: Administration of 0.5 mg entecavir with a standard high-fat meal (945 kcal, 54.6 g fat) or a light meal (379 kcal, 8.2 g fat) resulted in a minimal delay in absorption (1-1.5 hour fed vs. 0.75 hour fasted), a decrease in Cmax of 44-46%, and a decrease in AUC of 18-20%.
Slovenian: Pri dajanju entekavirja v odmerku 0,5 mg skupaj s standardnim obrokom z visoko vsebnostjo maščob (945 kcal; 54,6 g maščob) ali z lahkim obrokom (379 kcal, 8,2 g maščob) se je absorpcija minimalno zakasnila (1-1,5 ure po hranjenju v primerjavi z 0,75 ure na tešče).
English: An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to >10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
Slovenian: Analize zaviralnega delovanja entekavirja proti vrsti laboratorijskih in kliničnih izolatov virusa HIV-1 so pri različnih celičnih in testnih pogojih pokazale, da se vrednosti EC50 gibljejo v razponu od 0,026 do > 10 µM.
English: What you need to know before you take Entecavir Mylan
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Entekavir Mylan
English: whether you have kidney problems.
Slovenian: • morebitnih težav z ledvicami.
English: * p value vs lamivudine <0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint.
Slovenian: *p vrednost v primerjavi z lamivudinom < 0,05 a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2) b primarni opazovani dogodek.
English: High density polyethylene (HDPE) bottle with child-resistant polypropylene closure containing 30 or 90 film-coated tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) z za otroke varno polipropilensko zaporko, ki vsebujejo 30 ali 90 filmsko obloženih tablet.
English: Year 1 Year 2 Year 3a Year 4 a Year 5a
Slovenian: 1. leto 2. leto 3. letoa
English: In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Slovenian: Pri majhnem odstotku bolnikov, neodzivnih na lamivudin, so bile ETVr substitucije na ostankih rtT184, rtS202 ali rtM250 prisotne že ob začetku zdravljenja.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included 18.
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
English: In rats, maternal toxicity, embryo-foetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
Slovenian: Pri podganah so pri visoki izpostavljenosti zasledili tako škodljive vplive na mater kot na zarodke/plodove (resorpcije), nižjo telesno maso plodov, malformacije repa in vretenc, zmanjšano osifikacijo (vretenca, prsnica in falange) ter pojav dodatnih ledvenih vretenc in reber.
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)
Slovenian: *p vrednost v primerjavi z lamivudinom < 0,05 a bolniki z ovrednoteno histološko sliko v izhodišču (stopnja vnetja in nekroze po Knodell-u v izhodišču ≥ 2) b primarni opazovani dogodek c Roche Cobas Amplicor PCR test (LLOQ = 300 kopij/ml)
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.
Slovenian: V izhodišču je srednja vrednost ocene po CTP lestvici znašala 8,59, 26 % bolnikov pa je po tej isti lestvici spadalo v skupino C. Srednja vrednost ocene po MELD (“Model for End Stage Liver Disease”) točkovanju je v izhodišču znašala 16,23.
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.
Slovenian: Bolniki, ki so bili zdravljeni in pri katerih so spremljali razvoj odpornosti b Bolniki v določenem letu: - s pojavom genotipske ETVr c - z genotipsko ETVr c s povečanjem virusnega bremena d Skupna verjetnost za: - pojav genotipske ETVr c - genotipsko ETVr c s povečanjem virusnega bremena d a Rezultati odražajo zdravljenje z 1 mg entekavirja pri 147 od 149 bolnikov v 3. letu in pri vseh bolnikih v 4. in 5. letu ter kombinirano zdravljenje z entekavirjem in lamivudinom (čemur je sledilo dolgotrajno zdravljenje z entekavirjem) z mediano 20 tednov pri 130 od 149 bolnikov v 3. letu ter 1 tedna pri 1 od 121 bolnikov v 4. letu v nadaljnji študiji.
English: High baseline Knodell necroinflammatory scores (>10) were associated with greater histological improvement in nucleoside-naive patients.
Slovenian: Visoke izhodiščne vrednosti stopnje vnetja in nekroze po Knodell-u (> 10) so bile pri bolnikih, ki se še niso zdravili z nukleozidi, povezane z večjim izboljšanjem histološke slike.
English: 4.5 Interaction with other medicinal products and other forms of interaction Since entecavir is predominantly eliminated by the kidney (see section 5.2), coadministration with medicinal products that reduce renal function or compete for active tubular secretion may increase serum concentrations of either medicinal product.
Slovenian: Ker se entekavir v glavnem izloča preko ledvic (glejte poglavje 5.2), se pri sočasni uporabi katerega koli zdravila, ki zmanjšuje delovanje ledvic ali je kompetitor za aktivno tubulno sekrecijo, lahko povečajo serumske koncentracije obeh zdravil.
English: Dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Slovenian: Pri bolnikih z okvaro ledvic priporočamo prilagoditev odmerka (glejte poglavje 4.2).
English: • In HBeAg positive paediatric patients, treatment should be administered for at least 12 months after achieving undetectable HBV DNA and HBeAg seroconversion (HBeAg loss and anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy.
Slovenian: • Pri HBeAg pozitivnih pediatričnih bolnikih mora zdravljenje trajati vsaj 12 mesecev po dosegu nemerljive vrednosti HBV DNA in serokonverzije HBeAg (izginotje HBeAg in pojav anti-HBe protiteles v dveh zaporednih vzorcih seruma, odvzetih z vsaj 3- do 6-mesečnim vmesnim presledkom) ali do serokonverzije HBs oziroma izgube učinkovitosti.
English: Each film-coated tablet contains 62.5 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 62,5 mg laktoze monohidrata.
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.
Slovenian: Farmakokinetiko entekavirja v stanju dinamičnega ravnovesja so vrednotili (študija 028) pri 24 z nukleozidi predhodno še nezdravljenimi in 19 z lamivudinom predhodno zdravljenimi HBeAg pozitivnimi pediatričnimi bolniki, starimi od 2 do < 18 let, s kompenzirano boleznijo jeter.
English: Laboratory test abnormalities
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav
English: II metabolites, glucuronide and sulfate conjugates, were observed.
Slovenian: faze, in sicer glukuroniranih in sulfatiranih konjugatov.
English: OPA/Aluminium/PVC-Aluminium perforated unit-dose foil blister packs containing 30 x 1 or 90 x 1 film-coated tablets.
Slovenian: Perforirani pretisni omoti iz OPA/aluminijaste/PVC-aluminijaste folije za posamezni odmerek, ki vsebujejo 30 x 1 ali 90 x 1 filmsko obloženo tableto.
English: In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥21 times those in humans.
Slovenian: Pri podganah in kunčicah, ki so med brejostjo prejemale entekavir, izpostavljenost ≥ 21-krat večja od izpostavljenosti pri človeku, ni bila povezana s škodljivimi vplivi na zarodke ali mater.
English: Hepatic impairment: no dose adjustment is required in patients with hepatic impairment.
Slovenian: Okvara jeter: pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
English: Each film-coated tablet contains 125 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 125 mg laktoze monohidrata.
English: If you forget to take Entecavir Mylan
Slovenian: Če ste pozabili vzeti zdravilo Entekavir Mylan
English: • In HBeAg negative paediatric patients, treatment should be administered until HBs seroconversion or there is evidence of loss of efficacy.
Slovenian: • Pri HBeAg negativnih pediatričnih bolnikih mora zdravljenje trajati do serokonverzije HBs ali do pojava znakov izgube učinkovitosti.
English: Of these patients, 55/57 (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥1-point decrease in Ishak fibrosis score.
Slovenian: Izboljšanje histološke slike po prejšnji definiciji (glejte zgoraj) je bilo ugotovljeno pri 55/57 bolnikov (96 %), zmanjšanje indeksa fibroze po Ishak-u za ≥ 1 točko pa pri 50/57 bolnikov (88 %).
English: You should not breast-feed during treatment with Entecavir Mylan.
Slovenian: Med zdravljenjem z zdravilom Entekavir Mylan ne smete dojiti.
English: • In HBeAg negative adult patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy.
Slovenian: • Pri HBeAg negativnih odraslih bolnikih mora zdravljenje trajati vsaj do serokonverzije HBs ali do pojava znakov izgube učinkovitosti.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥26 times those in humans.
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih so pri glodavcih in psih pri izpostavljenosti, ki je bila ≥ 26krat večja od izpostavljenosti človeka, opazili spremembe na modih (degeneracija semenskih cevk).
English: It is not known whether entecavir, the active ingredient in Entecavir Mylan, is excreted in human breast milk.
Slovenian: Ni znano, če se entekavir (zdravilna učinkovina zdravila Entekavir Mylan) izloča v materino mleko.
English: Entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Slovenian: Pri transfekciji humanih HepG2 celic z divjim tipom HBV entekavir zavira sintezo HBV DNA (50 % zmanjšanje, EC50) pri koncentraciji 0,004 µM.
English: Your dose will depend on: whether you have been treated for HBV infection before, and what medicine you received.
Slovenian: • morebitnega predhodnega zdravljenja okužbe s HBV in zdravila, s katerim ste se zdravili.
English: 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.
Slovenian: Pri uporabi nukleozidnih analogov so poročali o pojavih laktacidoze (brez hipoksemije), ki se je včasih končala smrtno in je bila običajno povezana s hudo hepatomegalijo in jetrno steatozo.
English: a NC=F (noncompleter = failure) * Patients randomised to placebo who did not have HBe serconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomised comparison data are available only through Week 48.
Slovenian: Izhodiščna vrednost HBV DNA < 8 log10 i.e./ml Izhodiščna vrednost HBV DNA ≥ 8 log10 i.e./ml a NC = F (bolnik, pri katerem študija ni bila dokončana = neuspešno zdravljenje) * Bolniki, randomizirani na placebo, ki niso dosegli serokonverzije Hbe do 48 tedna, so v drugem letu študije prešli na odprto zdravljenje z entekavirjem, zato so randomizirani primerjalni podatki na voljo le do 48. tedna.
English: For patients who met protocol-defined response criteria, response was sustained throughout the 24-week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
Slovenian: Pri bolnikih, ki so dosegli po protokolu definirane kriterije odziva, se je med 24-tedenskim spremljanjem po zdravljenju v študiji 022 odziv ohranil pri 75 % (83/111) bolnikov, ki so se odzvali na entekavir in 73 % (68/93) bolnikov, ki so se odzvali na lamivudin.
English: Among entecavir-treated patients ontreatment exacerbations had a median time of onset of 4-5 weeks.
Slovenian: Pri bolnikih, ki so se zdravili z entekavirjem, so se poslabšanja med zdravljenjem pojavila v povprečju po 4 - 5 tednih zdravljenja.