natgillin/translations-raw huggingface dataset:
Liver transplant recipients: the safety and efficacy of entecavir 1 mg once daily were assessed in a single-arm study in 65 patients who received a liver transplant for complications of chronic HBV infection and had HBV DNA <172 IU/ml (approximately 1000 copies/ml) at the time of transplant. 
Primatelji transplantata jetre: Sigurnost i djelotvornost entekavira u dozi od 1 mg jednom dnevno bile su procijenjene u ispitivanju na jednoj skupini od 65 bolesnika koji su primili transplantat jetre zbog komplikacija kronične infekcije HBV-om i imali HBV DNK <172 IU/ml (približno 1000 kopija/ml) u vrijeme transplantacije.
- emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd 
- pojave genotipske ETVrc - genotipske ETVrc s virološkim probojemd
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. 
U ispitivanjima u bolesnika s kompenziranom bolešću jetre, histološko poboljšanje definiralo se kao smanjenje za ≥ 2 boda na Knodellovom indeksu nekroze i upale u odnosu na početnu vrijednost, bez pogoršanja Knodellovog indeksa fibroze.
There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age). 
Nije bilo vidljive razlike u djelotvornosti entekavira na temelju spola (≈ 25% žena u kliničkim ispitivanjima) ili dobi (≈ 5% bolesnika u dobi od > 65 godina).
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. 
Kako se entekavir najvećim dijelom eliminira bubrezima (vidjeti dio 5.2), istodobna primjena lijekova koji smanjuju funkciju bubrega ili se natječu za aktivnu tubularnu sekreciju može povećati koncentraciju jednog ili drugog lijeka u serumu.
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. 
Rezultati u 48. tjednu randomiziranih, dvostruko slijepih ispitivanja u kojima se uspoređivao entekavir (ETV) s lamivudinom (LVD) u HBeAg pozitivnih (022) i HBeAg negativnih (027) bolesnika prikazani su u sljedećoj tablici.
Patients with advanced liver disease or cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy. 
Bolesnici s uznapredovalom bolešću jetre ili cirozom mogu imati povećani rizik od dekompenzacije jetre nakon egzacerbacije hepatitisa pa se stoga moraju pomno pratiti tijekom terapije.
What you need to know before you take Entecavir Accord Do not take Entecavir Accord if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6). 
Nemojte uzimati Entekavir Accord ako ste alergični (preosjetljivi) na entekavir ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
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. 
ETVr supstitucije (dodatno na LVDr supstitucije rtM204V/I ± rtL180M) opažene su na početku ispitivanja u izolatima dobivenima od 10/187 (5%) bolesnika refrakternih na lamivudin i liječenih entekavirom u kojih se pratila rezistencija, što je pokazalo da se prethodnim liječenjem lamivudinom mogu selektirati ove supstitucije koje dovode do rezistencije i da one mogu postojati u niskoj učestalosti i prije liječenja entekavirom.
Patients with high baseline CTP score were at higher risk of developing serious adverse events (see section 4.4). 
Bolesnici s velikim brojem bodova prema CTP indeksu na početku ispitivanja imali su veći rizik od razvoja ozbiljnih štetnih događaja (vidjeti dio 4.4).
3 years After opening the bottle use within 90 days. 
Rok valjanosti Bočicu upotrijebiti u roku od 90 dana nakon otvaranja.
Dizziness, fatigue and somnolence are common side effects which may impair the ability to drive and use machines. 
Omaglica, umor i somnolencija česte su nuspojave koje mogu narušiti sposobnost upravljanja vozilima i rada sa strojevima.
At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count < 200 cells/mm3). 
Na početku ispitivanja, bolesnici liječeni entekavirom imali su medijan trajanja prethodne terapije lamivudinom od 4,8 godina i medijan broja CD4 od 494 stanica/mm3 (sa samo 5 ispitanika s brojem CD4 < 200 stanica/mm3).
achieved HBV DNA < 300 copies/ml at Week 48. 
(9/14) je postiglo HBV DNK < 300 kopija/ml u 48. tjednu.
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). 
Procjena nuspojava temelji se na iskustvu iz razdoblja praćenja lijeka nakon stavljanja u promet i četiri klinička ispitivanja u kojima je 1720 bolesnika s kroničnom infekcijom hepatitisom B i kompenziranom bolešću jetre primalo dvostruko slijepo liječenje entekavirom (n = 862) ili lamivudinom (n = 858) u trajanju do 107 tjedana (vidjeti dio 5.1).
Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis. 
Simptomi poput mučnine, povraćanja i bolova u želucu mogu biti znakovi razvoja laktacidoze.
Pre-existing lamivudine-resistant HBV is associated with an increased risk for subsequent entecavir resistance regardless of the degree of liver disease; in patients with decompensated liver disease, virologic breakthrough may be associated with serious clinical complications of the underlying liver disease. 
HBV koji je već otprije rezistentan na lamivudin povezan je s povećanim rizikom od posljedične rezistencije na entekavir bez obzira na stupanj bolesti jetre; u bolesnika s dekompenziranom bolešću jetre, virološki proboj može biti povezan s ozbiljnim kliničkim komplikacijama podležeće bolesti jetre.
Results at 48 weeks are presented in the table. 
Rezultati u 48. tjednu prikazani su u sljedećoj tablici.
In rabbits, embryo-foetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at high exposures. 
U kunića je opažena embriofetalna toksičnost (resorpcije), smanjena osifikacija (hioid) i povećana incidencija 13. rebra kod visokih izloženosti.
Adverse reactions considered at least possibly related to treatment with entecavir are listed by body system organ class. 
Nuspojave za koje se smatralo da postoji barem mogućnost da su povezane s liječenjem entekavirom navedene su prema klasifikaciji organskih sustava.
Altered renal function contributed to the increase in entecavir exposure in these patients (see section 4.4). 
Poremećena funkcija bubrega pridonijela je povećanju izloženosti entekaviru u ovih bolesnika (vidjeti dio 4.4).
Available toxicological data in animals have shown excretion of entecavir in milk (for details see section 5.3). 
Dostupni toksikološki podaci iz ispitivanja na životinjama pokazali su da se entekavir izlučuje u mlijeko (za detalje vidjeti dio 5.3).
These substitutions were observed only in the presence of LVDr substitutions (rtM204V and rtL180M). 
Te supstitucije bile su opažene samo u prisutnosti LVDr supstitucija (rtM204V i rtL180M).
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. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci, blisteru ili kutiji iza oznake „Rok valjanosti“ ili „EXP“.
High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients. 
Visoki početni Knodellov indeks nekroze i upale (> 10) bio je povezan s većim histološkim poboljšanjem kod bolesnika prethodno neliječenih analozima nukleozida.
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. 
Bolesnici su nastavili svoj režim lamivudinom i uz njega dodali ili entekavir u dozi od 1 mg jednom dnevno (n = 51) ili placebo (n = 17), koje su uzimali tijekom 24 tjedna, nakon čega su tijekom dodatna 24
Entecavir Accord can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease). 
Entekavir Accord se može primjenjivati u osoba koje imaju oštećenu jetru, ali ona još ispravno radi (kompenzirana bolest jetre) i u osoba koje imaju oštećenu jetru i ona ne radi ispravno (dekompenzirana bolest jetre).
e Baseline mean MELD score was 17.1 for ETV and 15.3 for adefovir dipivoxil. 
e Srednja vrijednost broja MELD bodova na početku ispitivanja bila je 17,1 za ETV i 15,3 za adefovir dipivoksil.
Entecavir was superior to adefovir dipivoxil on the primary efficacy endpoint of mean change from baseline in serum HBV DNA by PCR at week 24. 
Entekavir se pokazao superiornim adefovir dipivoksilu na primarnoj mjeri ishoda djelotvornosti za srednju vrijednost promjene u odnosu na početnu vrijednost serumske HBV DNK mjerene PCR-om u 24. tjednu.
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 i teška hepatomegalija sa steatozom: S primjenom analoga nukleozida prijavljene su pojave laktacidoze (u odsutnosti hipoksemije), ponekad sa smrtnim ishodom i obično povezane s teškom hepatomegalijom i jetrenom steatozom.
Each carton contains either: 
Jedna kutija sadrži:
Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n 
Refrakterni na lamivudin HBeAg pozitivni (ispitivanje 026) ETV 1,0 mg jednom dnevno
Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n 
Poboljšanje Ishakovog indeksa fibroze Pogoršanje Ishakovog indeksa fibroze n
Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food. 
Bolesnici prethodno neliječeni analozima nukleozida: Preporučena doza za odrasle je 0,5 mg jednom dnevno s hranom ili bez nje.
Paediatric population: A lower rate of virologic response (HBV DNA < 50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥ 8.0 log10 IU/ml (see section 5.1). 
Pedijatrijska populacija: Primijećena je niža stopa virološkog odgovora (HBV DNK < 50 IU/ml) u pedijatrijskih bolesnika čija je početna vrijednost HBV DNK bila ≥ 8,0 log10 IU/ml (vidjeti dio 5.1).
Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance. 
Bolesnici s HBV-om rezistentnim na lamivudin imaju viši rizik od razvoja posljedične rezistencije na entekavir nego bolesnici bez rezistencije na lamivudin.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT 
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU TEKST NALJEPNICE NA BOCI
HIV variants containing the M184V substitution showed loss of susceptibility to entecavir (see section 4.4). 
Pokazalo se da varijante HIV-a, koje sadrže M184V supstituciju, gube osjetljivost na entekavir (vidjeti dio 4.4).
Baseline HBV DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48. 
HBV DNK ≥ 8 log10 IU/ml aNd=Neu (nedovršeno=neuspjeh) *Bolesnici randomizirani za primanje placeba koji nisu postigli HBe- serokonverziju do 48. tjedna prešli su na otvoreno liječenje entekavirom tijekom druge godine ispitivanja; stoga su podaci o randomiziranoj usporedbi dostupni samo do 48. tjedna.
3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir). 
Do 240. tjedna, u 3 od tih 10 bolesnika nastupio je virološki proboj (≥ 1 log10 povećanje iznad najniže točke).
The safety of entecavir in paediatric patients from 2 to < 18 years of age is based on two ongoing clinical trials in subjects with chronic HBV infection; one Phase 2 pharmacokinetic trial (study 028) and one Phase 3 trial (study 189). 
Pedijatrijska populacija Sigurnost entekavira u pedijatrijskih bolesnika u dobi od 2 do < 18 godina temelji se na dvama kliničkim ispitivanjima u ispitanika s kroničnom HBV infekcijom koja su još u tijeku; jednom farmakokinetičkom ispitivanju faze 2 (ispitivanje 028) i jednom ispitivanju faze 3 (ispitivanje 189).
With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1. 
Kod odluke o započinjanju liječenja pedijatrijskih bolesnika, vidjeti dijelove 4.2, 4.4, i 5.1.
Fertility: toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3). 
Plodnost: Toksikološka ispitivanja na životinjama kojima se primjenjivao entekavir nisu pokazala da dolazi do oštećenja plodnosti (vidjeti dio 5.3).
Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and thickness 3.40 mm ± 0.30 mm. 
Dimenzije: dužina 8,70 mm ± 0,20 mm, širina 8,40 mm ± 0,20 mm i debljina 3,40 mm ± 0,30 mm.
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 djecu i adolescente (od 2 do manje od 18 godina) dostupne su Entekavir Accord 0,5 mg tablete ili može biti dostupna oralna otopina entekavira.
Renal clearance is independent of dose and ranges between 360-471 ml/min suggesting that entecavir undergoes both glomerular filtration and net tubular secretion. 
Bubrežni klirens ne ovisi o dozi i kreće se u rasponu između 360-471 ml/min, što pokazuje da entekavir prolazi glomerularnu filtraciju i neto tubularnu sekreciju.
The dose should be adjusted according to the patient's renal function (see dosage recommendations in renal impairment and section 5.2). 
Dozu treba prilagoditi sukladno funkciji bubrega bolesnika (vidjeti preporuke za doziranje kod oštećenja funkcije bubrega i dio 5.2).
Patients were either HBV-treatment-naïve or pretreated (excluding pretreatment with entecavir, adefovir dipivoxil, or tenofovir disoproxil fumarate). 
Bolesnici prethodno ili nisu ili jesu bili liječeni zbog HBV-a (isključujući prethodno liječenje entekavirom, adefovir dipivoksilom ili tenofovir disoproksil fumaratom).
- genotypic ETVrc with virologic breakthrough d 
- genotipskom ETVrc s virološkim probojem d
Lamivudine-refractory: 
Refrakternost na lamivudin:
ULN=upper limit of normal, LLN=lower limit of normal. 
*p<0,05 GGN=gornja granica normale, DGN=donja granica normale.
Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4). 
Iskustvo u bolesnika istodobno inficiranih HIV-om: Profil sigurnosti entekavira u ograničenog broja bolesnika s istodobnom infekcijom HIV-om i HBV-om koji su primali HAART režim koji sadrži lamivudin (visoko aktivnu antiretrovirusnu terapiju), bio je sličan profilu sigurnosti entekavira u bolesnika inficiranih samo HBV-om (vidjeti dio 4.4).
Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose. 
Eliminacija: Entekavir se uglavnom eliminira bubrezima, a u mokraći se može naći oko 75% doze u obliku neizmijenjenog lijeka pri stanju dinamičke ravnoteže.
HIV/HBV co-infected patients receiving concomitant HAART: study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV. 
Bolesnici istodobno inficirani HIV-om i HBV-om koji su istodobno primali HAART: Ispitivanje 038 uključilo je 67 HBeAg pozitivnih i 1 HBeAg negativnog bolesnika istodobno inficiranih HIV-om.
Entecavir Accord should not be used for children below 2 years of age or weighing less than 10 kg. 
Entekavir Accord se ne smije primjenjivati u djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg. 
Nema preporuka za doziranje entekavirau djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14) 
Od bolesnika s bolešću refrakternom na lamivudin i početnom HBV DNK < 107 log10 kopija/ml, 64%
Lamivudine-refractory or decompensated liver disease 
Refrakterna na lamivudin ili dekompenzirana bolest jetre
Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm. 
Dimenzije: dužina 11,00 mm ± 0,20 mm, širina 10,60 mm ± 0,20 mm i debljina 4,20 mm ± 0,30 mm.
Exacerbations after discontinuation of treatment: acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4). 
Egzacerbacije nakon prekida liječenja: akutne egzacerbacije hepatitisa prijavljene su u bolesnika koji su prekinuli terapiju protiv virusa hepatitisa B, uključujući terapiju entekavirom (vidjeti dio 4.4).
In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation. 
U bolesnika s kompenziranom bolešću jetre, ova povišenja ALT-a u serumu općenito nisu popraćena povišenjem koncentracija bilirubina u serumu ili dekompenzacijom jetre.
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. 
U vrijeme biopsije jetre, svi su bolesnici imali HBV DNK < 300 kopija/ml, a 49/57 (86%) imalo je serumsku ALT ≤ 1 puta iznad GGN.
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. 
Bolesnici koji se liječe lijekom Entekavir Accord prijavili su sljedeće nuspojave: često (u najmanje 1 na 100 bolesnika): glavobolja, nesanica (nemogućnost spavanja), iscrpljenost (izraziti umor), omaglica, izrazita pospanost (pospanost), povraćanje, proljev, mučnina, dispepsija
- 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. 
- genotipske ETVr c s virološkim probojem d a Rezultati primjene doze entekavira od 1 mg za 147 od 149 bolesnika u 3. godini i sve bolesnike u 4. i 5. godini i kombinirane terapije entekavirom i lamivudinom (nakon čega je uslijedila dugotrajna terapija entekavirom) tijekom medijana od 20 tjedana za 130 od 149 bolesnika u 3. godini i 1 tjedan za 1 od 121 bolesnika u 4. godini u rotacijskom ispitivanju.
polymerase is 0.0012 μM. 
Ki entekavira-TP za HBV DNK polimerazu je 0,0012 μM.
Given the exposure margin, this finding is considered of unlikely clinical significance. 
smatra se da ovaj nalaz vjerojatno nema kliničkog značaja.
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). 
Iskustvo u bolesnika s dekompenziranom bolešću jetre: Profil sigurnosti entekavira u bolesnika s dekompenziranom bolešću jetre procijenio se u randomiziranom usporednom ispitivanju otvorenog tipa u kojem su bolesnici liječeni entekavirom u dozi od 1 mg/dan (n = 102) ili adefovir dipivoksilom u dozi od 10 mg/dan (n = 89) (ispitivanje 048).
Integrated Analysis of Phase 2 and 3 Clinical Studies: In a post-approval integrated analysis of entecavir resistance data from 17 Phase 2 and 3 clinical studies, an emergent entecavir resistanceassociated substitution rtA181C was detected in 5 out of 1461 subjects during treatment with entecavir. 
Analiza objedinjenih podataka iz kliničkih ispitivanja faze 2 i 3: U analizi objedinjenih podataka o rezisteniciji na entekavir iz 17 kliničkih ispitivanja faze 2 i 3, koja je provedena nakon stavljanja lijeka u promet, u 5 od 1461 ispitanika je tijekom liječenja entekavirom utvrđena pojava supstitucije rtA181C povezane s rezistencijom na entekavir.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3). 
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost entekavira pri visokim dozama (vidjeti dio 5.3).
Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2). 
Primatelji transplantata jetre: Kod primatelja transplantata jetre koji primaju ciklosporin ili takrolimus treba pažljivo procijeniti funkciju bubrega prije i tijekom terapije entekavirom (vidjeti dio 5.2).
It has not been demonstrated that Entecavir Accord is safe to use during pregnancy. 
Nije se dokazala sigurnost lijeka Entekavir Accord tijekom trudnoće.
Compensated liver disease 
Kompenzirana bolest jetre
Clinical resistance in Adults: patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance. 
Klinička rezistencija u odraslih: bolesnici u kliničkim ispitivanjima koji su se na početku liječili entekavirom u dozi od 0,5 mg (prethodno neliječeni analozima nukleozida) ili 1,0 mg (refrakterni na lamivudin) i u kojih se HBV DNK tijekom terapije mjerio pomoću PCR-a u 24. tjednu ili nakon toga, praćeni su zbog rezistencije.
Recombinant viruses encoding adefovir-resistant substitutions at either rtN236T or rtA181V remained fully susceptible to entecavir. 
Rekombinantni virusi sa supstitucijama koje kodiraju rezistenciju prema adefoviru na rtN236T ili na rtA181V ostali su potpuno osjetljivi na entekavir.
Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section 
Stoga se u takvim situacijama entekavir ne smije primjenjivati, zbog mogućeg razvoja rezistencije HIV-a (vidjeti dio 4.4).
In HBeAg negative adult patients, treatment should be administered at least until HBs seroconversion or there is evidence of loss of efficacy. 
Kod HBeAg negativnih odraslih bolesnika, liječenje se mora primjenjivati barem do HBs serokonverzije ili dokazanog gubitka djelotvornosti.
No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV. 
Nema dostupnih podataka o djelotvornosti entekavira kod HBeAg-negativnih bolesnika istodobno inficiranih HIV-om.
Renal impairment: the clearance of entecavir decreases with decreasing creatinine clearance (see section 5.2). 
Oštećenje funkcije bubrega: Klirens entekavira smanjuje se sa smanjenjem klirensa kreatinina (vidjeti dio 5.2).