natgillin/translations-raw huggingface dataset:
The dose should be adjusted according to the patient's renal function (see dosage recommendations in renal impairment and section 5.2). 
Odmerek je treba prilagoditi glede na delovanje ledvic (glejte priporočila za odmerjanje pri okvari ledvic in poglavje 5.2).
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. 
V študijah pri bolnikih s kompenzirano boleznijo jeter, je bilo izboljšanje histološke slike definirano kot zmanjšanje stopnje vnetja in nekroze po Knodellu (Knodell necro-inflammatory score) za 2 ali več točk od izhodiščne vrednosti in brez poslabšanja stopnje fibroze po Knodellu (Knodell Fibrosis Score).
Renal impairment: entecavir clearance decreases with decreasing creatinine clearance. 
Okvara ledvic: Z zmanjševanjem kreatininskega očistka se zmanjšuje tudi očistek entekavirja.
Paediatric patients with a body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet with or without food. 
Pediatrični bolniki s telesno maso najmanj 32,6 kg morajo jemati eno 0,5 mg tableto enkrat na dan skupaj s hrano ali brez nje.
Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n 
HBeAg pozitivni (študija 026) ETV 1,0 mg enkrat na dan
Elderly: no dosage adjustment based on age is required. 
Starostniki: Prilagajanje odmerka glede na starost ni potrebno.
Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food. 
Bolniki, ki se še niso zdravili z nukleozidi: Priporočeni odmerek za odrasle je 0,5 mg enkrat na dan, s hrano ali brez nje.
How to store Entecavir Accord Contents of the pack and other information 
Shranjevanje zdravila Entecavir Accord Vsebina pakiranja in dodatne informacije
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. 
Pri testih proti HIV entekavir pri mikromolarnih koncentracijah na celičnih kulturah ni imel antagonističnega vpliva na delovanje teh šestih nukleozidnih in nukleotidnih zaviralcev reverzne transkriptaze (NRTI-jev) ali emtricitabina proti HIV.
No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV. 
Podatki o učinkovitosti entekavirja pri HBeAg negativnih bolnikih s sočasno okužbo z virusom HIV niso na voljo.
Entecavir Accord will not control your HIV infection. 
Zdravilo Entecavir Accord ne more nadzirati okužbe z virusom HIV.
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. 
Entekavir trifosfat s kompeticijo z naravnim substratom deoksigvanozin trifosfatom funkcionalno zavira 3 aktivnosti virusne polimeraze: (1) prileganje ("priming") polimeraze HBV, (2) reverzno transkripcijo negativne verige DNA iz pregenomske informacijske ("messenger") RNA in (3) sintezo pozitivne verige DNA HBV. Ki entekavir trifosfata za HBV DNA polimerazo je 0,0012 μM.
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. 
Zdravilo Entecavir Accord je na voljo v škatlah s 30 x 1 ali 90 x 1 filmsko obloženo tableto (v pretisnih omotih za posamezni odmerek) in v plastenkah s 30 filmsko obloženimi tabletami.
Recombinant viruses encoding adefovir-resistant substitutions at either rtN236T or rtA181V remained fully susceptible to entecavir. 
Rekombinantni virusi s substitucijami, povezanimi z odpornostjo na adefovir, bodisi rtN236T bodisi rtA181V, so ostali popolnoma občutljivi za entekavir.
Breast-feeding: it is unknown whether entecavir is excreted in human milk. 
Dojenje: Ni znano, ali se entekavir izloča v materino mleko.
Patients continued their lamivudine-regimen and were assigned to add either entecavir 1 mg once daily (n = 51) or placebo (n = 17) for 24 weeks followed by an additional 24 weeks where all received entecavir. 
Predpisali so jim še bodisi entekavir v odmerku 1 mg enkrat na dan (n = 51) bodisi placebo (n = 17) za obdobje 24 tednov, nato pa so še dodatnih 24 tednov vsi prejemali entekavir.
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 
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.
Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. 
Bolezenski znaki, kot so siljenje na bruhanje, bruhanje in bolečina v trebuhu lahko kažejo na pojav laktacidoze.
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. 
Za ustrezno odmerjanje pri pediatrični populaciji je na voljo zdravilo Entekavir Accord 0,5 mg filmsko obložene tablete, za odmerke manjše od 0,5 mg pa je lahko na voljo peroralna raztopina.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3). 
Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri visokih odmerkih (glejte poglavje 5.3).
Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm. 
Dimenzije: dolžina 11,00 mm ± 0,20 mm, širina 10,60 mm ± 0,20 mm in debelina 4,20 mm ± 0,30 mm.
Contents of the pack and other information What Entecavir Accord contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Entecavir Accord
Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP. That expiry date refers to the last day of that month. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake »Uporabno do/EXP«.
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). 
Med in po prekinitvi zdravljenja z entekavirjem so poročali tudi o poslabšanju hepatitisa (glejte poglavje 4.4 in c. Opis nekaterih neželenih učinkov).
After opening the bottle use within 90 days. 
Po odprtju plastenke porabiti v roku 90 dni.
Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus. 
Substitucije, ki so jih opazili pri kliničnih izolatih (rtT184A, C, F, G, I, L, M ali S; rtS202 C, G ali I; in/ali rtM250I, L ali
Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a 
Genotipska odpornost proti entekavirju tekom 5 let v študijah pri bolnikih, neodzivnih na lamivudin 1. leto 2. leto 3. letoa
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. 
Študijsko populacijo je sestavljalo 82 % bolnikov moškega spola, 39 % bolnikov kavkazijskega in 37 % bolnikov azijskega porekla.
There is limited experience of entecavir overdose reported in patients. 
Poročil o primerih prevelikega odmerjanja pri bolnikih je malo.
In a separate study wherein entecavir was administered to pregnant lactating rats at 10 mg/kg, both foetal exposure to entecavir and secretion of entecavir into milk were demonstrated. 
V posebni študiji, v kateri so breje in doječe podgane prejemale entekavir v odmerku do 10 mg/kg, so dokazali tako izpostavljenost plodov entekavirju kot izločanje entekavirja z mlekom.
Assessment of adverse reactions is based on experience from postmarketing surveillance and four clinical studies in which 1,720 patients with chronic hepatitis B infection and compensated liver disease received double-blind treatment with entecavir (n = 862) or lamivudine (n = 858) for up to 107 weeks (see section 5.1). 
Neželeni učinki so bili ocenjeni na podlagi podatkov iz spremljanja zdravila v obdobju trženja in štirih kliničnih študij, v katerih je 1.720 bolnikov s kroničnim hepatitisom B in kompenzirano boleznijo jeter med dvojno slepim zdravljenjem, ki je trajalo do 107 tednov, prejemalo entekavir (n = 862) ali lamivudin (n = 858) (glejte poglavje 5.1).
** on haemodialysis days, administer entecavir after haemodialysis. 
** na dan hemodialize bolniki vzamejo entekavir po hemodializi.
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. 
Za otroke in mladostnike (stare od 2 leti do manj kot 18 let) so na voljo Entecavir Accord 0,5 mg tablete, na voljo pa je lahko tudi peroralna raztopina entekavirja.
Post-Liver transplant: 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. 
Po presaditvi jeter: 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.
Compensated liver disease 
Kompenzirana bolezen jeter
Mechanism of action: entecavir, a guanosine nucleoside analogue with activity against HBV polymerase, is efficiently phosphorylated to the active triphosphate (TP) form, which has an intracellular half-life of 15 hours. 
Mehanizem delovanja: Entekavir je nukleozidni analog gvanozina, ki deluje proti polimerazi HBV in se učinkovito fosforilizira v aktivno trifosfatno (TP) obliko, katere znotrajcelični razpolovni čas je
Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate. 
Jedro tablete: kalcijev karbonat, predgelirani škrob, natrijev karmelozat, sojini polisaharidi, citronska kislina monohidrat, natrijev stearilfumarat.
In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended. 
Pri bolnikih z dekompenzirano boleznijo jeter ali jetrno cirozo zdravljenja ni priporočljivo prekiniti.
Of these 60 patients, 49 received more than 6 months of HBIg therapy. 
Zdravljenje s HBIg je pri 49 od 60 bolnikov trajalo dlje kot 6 mesecev.
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. 
Laktacidoza in huda hepatomegalija s steatozo: 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.
Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use. 
Uporabe entekavirja za zdravljenje okužbe z virusom HIV niso proučevali, zato se ga za zdravljenje okužbe z virusom HIV ne priporoča.
Hepatic impairment: pharmacokinetic parameters in patients with moderate or severe hepatic impairment were similar to those in patients with normal hepatic function. 
Okvara jeter: Pri bolnikih z zmerno ali hudo okvaro jeter so bili farmakokinetični parametri enaki kot pri bolnikih z normalnim delovanjem jeter.
Entecavir Accord must not be used during pregnancy unless specifically directed by your doctor. 
Zdravila Entecavir Accord med nosečnostjo ne smete uporabljati brez izrecnega navodila zdravnika.
How to take Entecavir Accord Not all patients need to take the same dose of Entecavir Accord. 
Kako jemati zdravilo Entecavir Accord Odmerek zdravila Entecavir Accord ni enak pri vseh bolnikih.
Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048). 
Izkušnje pri bolnikih z dekompenzirano boleznijo jeter: pri bolnikih z dekompenzirano boleznijo jeter je bil profil varnosti entekavirja ovrednoten z randomizirano, odprto, primerjalno študijo, v kateri so bolniki prejemali entekavir v odmerku 1 mg/dan (n = 102) ali adefovirdipivoksil v odmerku 10 mg/dan (n = 89) (študija 048).
b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58 (Year 1), after week 58 through week 102 (Year 2), after week 102 through week 156 (Year 3), after week 156 through week 204 (Year 4), or after week 204 through week 252 (Year 5). 
Vključuje bolnike z vsaj eno določitvijo HBV DNA s PCR, v 24. tednu zdravljenja ali kasneje do 58. tedna (1. leto), med 58. tednom in 102. tednom (2. leto), med 102. tednom in 156. tednom (3. leto), med 156. tednom in 204. tednom (4. leto) ali med 204. tednom in 252. tednom (5. leto).
Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate. 
Hujši primeri, ki so se včasih končali smrtno, so bili povezani s pankreatitisom, z odpovedjo jeter/jetrno steatozo, odpovedjo ledvic in s povišanimi vrednostmi serumskega laktata.
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. 
Substitucije na ostankih rtT184, rtS202 in rtM250, ki so povezane z odpornostjo proti entekavirju (ETVr), imajo le zmeren učinek na občutljivost za entekavir in jih v odsotnosti substitucij, ki so povezane z odpornostjo na lamivudin (LVDr), v več kot 1000 vzorcih bolnikov, vzetih v določenih zaporedjih, niso opazili.
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. 
Razen za lamivudin, adefovirdipivoksil in tenofovirdizoproksil fumarat učinki sočasnega zdravljenja z entekavirjem in zdravili, ki se izločajo preko ledvic ali vplivajo na delovanje ledvic, niso bili ovrednoteni.
Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section 
V takšnih okoliščinah se entekavirja zaradi možnega razvoja odpornosti virusa HIV torej ne sme uporabljati
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC (-CI), ODGOVOREN (-NI) ZA SPROŠČANJE SERIJ
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. 
Delovanje jeter je treba v rednih časovnih presledkih nadzirati tako klinično kot laboratorijsko še vsaj 6 mesecev po prekinitvi zdravljenja hepatitisa B. Zdravljenje hepatitisa B bo morda treba ponovno uvesti.
Gender/age: 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). 
Spol/starost: Varnostni profil entekavirja se glede na spol (≈ 25% žensk v kliničnih preskušanjih) ali starost (≈ 5% bolnikov, starejših od 65 let) očitneje ne razlikuje.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS) 
PODATKI NA ZUNANJI OVOJNINI BESEDILO NA ŠKATLI (PLASTENKE IN PRETISNI OMOTI)
e. Other special populations 
e. Druge posebne skupine bolnikov
At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population. 
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 e./l.
HIV/HBV co-infected patients receiving concomitant HAART: study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV. 
Bolniki s sočasno okužbo s HIV/HBV, ki se sočasno zdravijo po režimu HAART: V študijo 038 je bilo vključenih 67 HBeAg pozitivnih bolnikov in 1 HBeAg negativen bolnik.
Creatinine clearance (ml/min) 
Izhodiščni kreatininski očistek (ml/min)
Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease). 
Zdravilo Entecavir Accord se lahko uporablja pri otrocih z okvaro jeter, ki še delujejo normalno (kompenzirana bolezen jeter).
A reduction of the daily dose using entecavir oral solution, as detailed in the table, is recommended. 
Pri zmanjšanju dnevnega odmerka priporočamo uporabo peroralne raztopine entekavirja, kot je prikazano v preglednici.
Calcium carbonate Starch, Pregelatinized Carmellose sodium Soy polysaccharides Citric acid monohydrate Sodium stearyl fumarate 
Jedro tablete: kalcijev karbonat predgelirani škrob natrijev karmelozat sojini polisaharidi citronska kislina monohidrat natrijev stearilfumarat
In reproductive toxicology studies in which animals were administered entecavir for up to 4 weeks, no evidence of impaired fertility was seen in male or female rats at high exposures. 
Pri študijah vplivov na sposobnost razmnoževanja, v katerih so živali prejemale entekavir do 4 tedne, pri visoki izpostavljenosti samcev in samic podgan vplivov na plodnost niso zasledili.
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. 
Rezultati odražajo kombinirano zdravljenje z entekavirjem in lamivudinom (čemur je sledilo dolgotrajno zdravljenje z entekavirjem) z mediano 13 tednov pri 48 od 80 bolnikov v 3. letu, mediano 38 tednov pri 10 od 52 bolnikov v 4. letu ter mediano 16 tednov pri 1 od 33 bolnikov v 5. letu v nadaljnji študiji.
All dosing will be taken once daily orally (by mouth). 
Bolnik mora predpisani odmerek jemati peroralno (skozi usta) enkrat na dan.
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. 
V 72. tednu po presaditvi pri nobenem od 55 opazovanih primerov niso zasledili virološke ponovitve HBV [opredeljena z vrednostjo HBV DNA ≥ 50 i.e./ml (približno 300 kopij/ml)]
Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2). 
Okvara ledvic: Pri bolnikih z okvaro ledvic priporočamo prilagoditev odmerka (glejte poglavje 4.2).
For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended. 
Pri bolnikih s telesno maso od 10 kg do 32,5 kg je priporočena uporaba peroralne raztopine entekavirja.
c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml) 
c Roche Cobas Amplicor PCR test (LLOQ = 300 kopij/ml)
Entecavir Accord 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. 
Zdravilo Entecavir Accord je indicirano tudi za zdravljenje kronične okužbe s HBV pri z nukleozidi predhodno še nezdravljenih pediatričnih bolnikih, starih od 2 do < 18 let, ki imajo kompenzirano bolezen jeter in znake aktivne replikacije virusa ter persistentno povečane vrednosti serumske ALT ali histološke znake zmernega do hudega vnetja in/ali fibroze.
The lower Cmax and AUC when taken with food is not considered to be of clinical relevance in nucleoside-naive patients but could affect efficacy in lamivudine-refractory patients (see section 4.2). 
Menimo, da pri bolnikih, ki se še niso zdravili z nukleozidi, zmanjšanje vrednosti Cmax in AUC zaradi jemanja skupaj s hrano nima kliničnega pomena, pri bolnikih, neodzivnih na lamivudin, pa lahko vpliva na učinkovitost (glejte poglavje 4.2).
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. 
Odpornost na celičnih kulturah: V primerjavi z divjim tipom HBV so LVDr virusi z rtM204V in rtL180M substitucijami v reverzni transkriptazi 8-krat manj občutljivi za entekavir.
This substitution was detected only in the presence of lamivudine resistance-associated substitutions rtL180M plus rtM204V. 
To substitucijo so odkrili le ob prisotnosti z odpornostjo proti lamivudinu povezanih substitucij rtL180M in rtM204V.
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). 
Bolniki s sočasno okužbo z virusoma HIV in HBV, ki sočasno prejemajo protiretrovirusno zdravljenje: 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).
It is not known whether entecavir, the active ingredient in Entecavir Accord, is excreted in human breast milk. 
Ni znano, če se entekavir (zdravilna učinkovina zdravila Entecavir Accord) izloča v materino mleko.
Increased incidences of other tumours including brain gliomas in male and female rats, liver carcinomas in male mice, benign vascular tumours in female mice, and liver adenomas and carcinomas in female rats were seen only at high lifetime exposures. 
Le pri visokih doživljenjskih izpostavljenostih so zasledili večjo pojavnost drugih tumorjev, vključno z možganskimi gliomi pri samcih in samicah podgan, jetrnih karcinomov pri mišjih samcih, benignih žilnih tumorjev pri mišjih samicah in jetrnih adenomov in karcinomov pri samicah podgan.
You should not breast-feed during treatment with Entecavir Accord. 
Med zdravljenjem z zdravilom Entecavir Accord ne smete dojiti.
Duration of therapy 
Trajanje zdravljenja
Acute exacerbation of hepatitis has also been reported in patients who have discontinued hepatitis B therapy (see section 4.2). 
O akutnem poslabšanju hepatitisa so poročali tudi po prekinitvi zdravljenja hepatitisa B (glejte poglavje 4.2).
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%. 
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).
Patients treated with Entecavir Accord have reported the following side effects: 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. 
Pri bolnikih, ki so se zdravili z zdravilom Entecavir Accord, so poročali o naslednjih neželenih učinkih: pogosti (pri več kot 1 od 100 bolnikov): glavobol, insomnija (nespečnost), utrujenost (močna oslabelost), omotica, somnolenca (zaspanost), bruhanje, driska, siljenje na bruhanje, dispepsija