natgillin/translations-raw huggingface dataset:
Due to the small sample size and the study design, in particular the lack of treatment arms with pegylated interferon alpha-2a monotherapy and with adefovir monotherapy, it is not possible to draw formal conclusions on the best therapeutic management of HIV co-infected patients with lamivudine-resistant HBV. 
Zaradi majhnega vzorca in načrtovanja študije, predvsem zaradi pomanjkanja krakov zdravljenja, ki bi prejemali monoterapijo s pergiliranim interferonom alfa-2a in monoterapijo z adefovirjem, ni mogoče formalno sklepati o najboljši terapevtski obravnavi bolnikov s HBV odpornim na lamivudin, sočasno okuženih s
Patients with creatinine clearance < 30 ml/min and dialysis patients: 
Bolniki z očistkom kreatinina < 30 ml/min in bolniki na dializi:
Pregelatinised starch Croscarmellose sodium Lactose monohydrate Talc 
Premreženi natrijev karmelozat Laktoza monohidrat Smukec
In the two studies mentioned above, treatment with 10 mg adefovir dipivoxil was associated with significant reductions in serum HBV DNA (3.52 and 3.91 log10 copies/ml, respectively, versus 0.55 and 1.35 log10 copies/ml), increased proportion of patients with normalisation of ALT (48 and 72 % versus 16 and 29 %) or increased proportion of patients with serum HBV DNA below the limits of quantification (< 400 copies/ml Roche Amplicor Monitor PCR assay) (21 and 51 % versus 0 %) when compared with placebo. 
V obeh zgoraj omenjenih študijah je bilo zdravljenje z 10 mg dipivoksiladefovirata v primerjavi s placebom združeno s pomembnim zmanjšanjem serumske HBV DNA (3,52 in 3,91 log10 kopij/ml v primerjavi z 0,55 in 1,35 log10 kopij/ml), z večjim deležem bolnikov z normalizacijo vrednosti ALT (48 in 72% v primerjavi s 16 in 29%) in s povečanim deležem bolnikov s serumsko HBV DNA pod mejo količinske zaznave (< 400 kopij/ml po analizi Roche Amplicor Monitor PCR) (21 in 51% v primerjavi z 0%).
Adefovir is active against hepadnaviruses in vitro, including all common forms of lamivudine-resistant HBV (rtL180M, rtM204I, rtM204V, rtL180M/rtM204V), famciclovir-associated mutations (rtV173L, rtP177L, rtL180M, rtT184S or rtV207I) and hepatitis B immunoglobulin escape mutations (rtT128N and rtW153Q), and in in vivo animal models of hepadnavirus replication. 
Adefovir in vitro deluje proti hepadnavirusom, vključujoč vse običajne oblike na lamivudin odpornih HBV (rtL180M, rtM204I, rtM204V, rtL180M/rtM204V), HBV z mutacijami povezanimi s famciklovirom (rtV173L, rtP177L, rtL180M, rtT184S ali rtV207I) in HBV z hepatitis B
Caution should be exercised when prescribing adefovir dipivoxil to the elderly, keeping in mind the greater frequency of decreased renal or cardiac function in these patients, and the increase in concomitant diseases or concomitant use of other medicinal products in the elderly. 
Pri predpisovanju dipivoksiladefovirata starejšim je potrebna previdnost, saj je treba upoštevati, da je pri teh bolnikih bolj pogosto slabše delovanje ledvic in srca, da imajo več obolenj sočasno oziroma sočasno jemljejo več zdravil.
However, mild to moderate increases in serum creatinine concentrations, hypophosphatemia and a decrease in carnitine concentrations were reported in 3 %, 4 % and 6 % of patients, respectively, on extended treatment. 
Vendar pa so poročali o blagih do zmernih zvišanjih koncentracij serumskega kreatinina pri 3% bolnikov, o hipofosfatemiji pri 4% bolnikov in o znižanju koncentracij karnitina pri 6% bolnikov pri podaljšanem zdravljenju.
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
• Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
In the HBeAg negative study patients on adefovir dipivoxil (0-48 weeks) were re-randomised in a blinded-manner to continue on adefovir dipivoxil or receive placebo for an additional 48 weeks. 
V študiji s HBeAg negativnimi bolniki, ki so jemali dipivoksiladefovirat (0-48 tednov), so bolnike naključno slepo prerazporedili tako, da so nadaljnjih 48 tednov še naprej jemali dipivoksiladefovirat ali pa prejemali placebo.
Long-term treatment with adefovir dipivoxil may increase the risk of renal impairment. 
Dolgotrajno zdravljenje z dipivoksiladefoviratom lahko poveča tveganje za motnje v delovanju ledvic.
In patients who develop renal insufficiency and have advanced liver disease or cirrhosis, dosing interval adjustment of adefovir or switch to an alternative therapy for hepatitis B infection should be considered. 
Pri bolnikih, ki razvijejo ledvično insuficienco in imajo napredovalo bolezen jeter ali cirozo, je treba razmisliti o prilagajanju intervalov med odmerki adefovirja ali menjavi k alternativni terapiji za hepatitis B. Prenehanje zdravljenja kroničnega hepatitisa B pri teh bolnikih ni priporočljivo.
Following oral administration of a single dose of 10 mg adefovir dipivoxil to chronic hepatitis B patients, the median (range) peak serum concentration (Cmax) was achieved after 1.75 h (0.58-4.0 h). 
Po peroralno vzetem enkratnem odmerku 10 mg dipivoksiladefovirata bolnikov s kroničnim hepatitisom B je bila mediana (območje) vrednost najvišje serumske koncentracije (Cmax) dosežena po 1,75 h (0,58-4,0 h).
Clinical resistance: Lamivudine-refractory patients and patients harbouring HBV with evidence of resistance to lamivudine (mutations at rtL180M, rtA181T and/or rtM204I/V) should not be treated with adefovir dipivoxil monotherapy in order to reduce the risk of resistance to adefovir. 
Klinična odpornost: Bolnikov, ki se ne odzivajo na zdravljenje z lamivudinom in bolnikov, ki so nosilci HBV z dokazano odpornostjo na lamivudin (mutacija na rtL180M, rtA181T in/ali rtM204I/V), se ne sme zdraviti z monoterapijo dipivoksiladefovirata, zato da bi zmanjšali tveganje za odpornost na adefovir.
Hepatic impairment: No dose adjustment is required in patients with hepatic impairment (see section 5.2). 
Motnje v delovanju jeter: Za bolnike z motnjami v delovanju jeter prilagajanje odmerkov ni potrebno (glejte poglavje 5.2).
In these patients, including patients with decompensated liver disease, treatment cessation is not recommended and these patients should be monitored closely during therapy. 
Pri teh bolnikih, vključno z bolniki z dekompenzirano boleznijo jeter, prenehanje zdravljenja ni priporočljivo.
In patients with compensated liver disease, the most frequently reported adverse reactions during 48 weeks of adefovir dipivoxil therapy were asthenia (13 %), headache (9 %), abdominal pain (9 %) and nausea (5 %). 
Neželeni učinki, o katerih so najpogosteje poročali pri bolnikih s kompenzirano boleznijo jeter med 48-tedenskim jemanjem dipivoksiladefovirata, so bili astenija (13%), glavobol (9%), abdominalna bolečina (9%) in navzea (5%).
There are limited data on the use of adefovir dipivoxil in pregnant women. 
Podatkov o uporabi dipivoksiladefovirata pri nosečnicah je malo.
In patients with decompensated liver disease, the most frequently reported adverse reactions during up to 203 weeks of adefovir dipivoxil therapy were increased creatinine (7 %) and asthenia (5 %). 
Neželena učinka, o katerih so najpogosteje poročali pri bolnikih z dekompenzirano boleznijo jeter v do 203 tednih zdravljenja z dipivoksiladefoviratom, sta bila povečana koncentracija kreatinina (7%) in astenija (5%).
In the pre-liver transplantation cohort, 25 of 33 (76 %) patients achieved undetectable HBV DNA levels and 84 % of patients had ALT normalisation at 96 weeks. 
V skupini bolnikov pred transplantacijo jeter je 25 od 33 bolnikov (76%) doseglo nezaznavne koncentracije HBV DNA in 84% bolnikov je imelo normalizacijo vrednosti za ALT v 96. tednu.
Administration of adefovir dipivoxil in these patients should only be considered if the potential benefits outweigh the potential risks. 
Možnost uporabe dipivoksiladefovirata pri teh bolnikih se lahko pretehta samo, če morebitne koristi odtehtajo morebitna tveganja.
• The active substance in Hepsera is adefovir dipivoxil. 
• Učinkovina v zdravilu Hepsera je dipivoksiladefovirat.
Hepsera contains lactose monohydrate. 
Zdravilo Hepsera vsebuje laktozo monohidrat.
In a second open-label, one-arm study, 10 mg adefovir dipivoxil and pegylated interferon alpha-2a were added to ongoing lamivudine therapy in 18 HIV/HBV co-infected patients with lamivudine-resistant HBV. 
V drugi odprti študiji z enim krakom so 10 mg dipivoksiladefovirata in pegiliranega interferona alfa-2a dodali potekajočemu zdravljenju z lamivudinom pri 18 bolnikih, sočasno okuženih z virusoma HIV/HBV, z na lamivudin odpornim HBV.
Adefovir induced chromosomal aberrations in the in vitro human peripheral blood lymphocyte assay without metabolic activation. 
Adefovir je povzročil kromosomske aberacije pri in vitro preizkusu limfocitov periferne krvi človeka brez presnovne aktivacije.
The efficacy and safety of a daily dose of 0.25 mg/kg to 10 mg adefovir dipivoxil in children (aged from 2 to < 18 years) were examined in a double-blind, randomised, placebo-controlled study in 173 paediatric patients (115 on adefovir dipivoxil, 58 on placebo) who had HBeAg positive chronic hepatitis B, serum ALT levels ≥ 1.5 x upper limit of normal (ULN) and compensated liver disease. 
Učinkovitost in varnost dnevnega odmerka 0,25 mg/kg do 10 mg dipivoksiladefovirata pri otrocih (starih od 2 do < 18 let) so raziskali v dvojno slepi, randomizirani, s placebom kontrolirani študiji na 173 pediatričnih bolnikih (115 jih je prejemalo dipivoksiladefovirat, 58 pa placebo), ki so imeli HBeAg pozitivni kronični hepatitis B, serumske vrednosti ALT ≥ 1,5 krat zgornja referenčna vrednost (ULN) in kompenzirano bolezen jeter.
Co-administration of 10 mg adefovir dipivoxil with other medicinal products that are eliminated by tubular secretion or alter tubular function may increase serum concentrations of either adefovir or the co-administered medicinal product (see section 4.4). 
Sočasno jemanje 10 mg dipivoksiladefovirata z drugimi zdravili, ki se izločajo preko tubularne sekrecije ali spremenijo tubularno funkcijo, lahko povzroči zvišanje serumske koncentracije adefovirja oziroma sočasno vzetega zdravila (glejte poglavje 4.4).
Renal impairment: The mean (± SD) pharmacokinetic parameters of adefovir following administration of a single dose of 10 mg adefovir dipivoxil to patients with varying degrees of renal impairment are described in the table below: 
Motnje v delovanju ledvic: Povprečni (± SD) farmakokinetični parametri za adefovir, po vzetju enkratnega odmerka 10 mg dipivoksiladefovirata pri bolnikih z različnimi stopnjami motenj v delovanju ledvic, so opisani v spodnji tabeli: Skupine glede na ledvično funkcijo
Hepsera is supplied in high-density polyethylene (HDPE) bottles with a child-resistant closure. 
Zdravilo Hepsera se nahaja v plastenki iz zgoščenega polietilena (HDPE, High Density Polyethylene) z za otroke varno zaporko.
However, the proportions of subjects who achieved HBeAg seroconversion at week 48 were similar (11 %) between the placebo arm and the adefovir dipivoxil 10 mg arm in adolescent patients. 
Vendar pa je bil pri mladostnikih delež bolnikov, pri katerih je prišlo do HBeAg serokonverzije v 48. tednu, podoben (11%) v skupini, ki je prejemala placebo in skupini, ki je prejemala 10 mg dipivoksiladefovirata.
Co-administration of 10 mg adefovir dipivoxil with medicinal products in these patients may lead to an increase in serum concentrations of either adefovir or a co-administered medicinal product. 
Sočasno jemanje 10 mg dipivoksiladefovirata s temi zdravili lahko pri bolnikih privede do povišanja serumskih koncentracij bodisi adefovirja, bodisi sočasno vzetega zdravila.
In vitro binding of adefovir to human plasma or human serum proteins is ≤ 4 %, over the adefovir concentration range of 0.1 to 25 μg/ml. 
In vitro je bila vezava adefovirja v koncentracijskem območju od 0,1 do 25 μg/ml na človeške plazemske ali serumske proteine ≤ 4%.
No differences in the median fibrosis score were seen between groups using the Knodell fibrosis score. 
Pri uporabi Knodellove fibrozne lestvice niso med skupinama opazili nobenih razlik v mediani fibrozne lestvice.
Clinical resistance in patients receiving adefovir dipivoxil as monotherapy and in combination with lamivudine: In several clinical studies (HBeAg positive, HBeAg negative, pre- and post-liver transplantation with lamivudine-resistant HBV and lamivudine-resistant HBV co-infected with HIV patients), genotypic analyses were conducted on HBV isolates from 379 of a total of 629 patients, treated with adefovir dipivoxil for 48 weeks. 
Klinična odpornost pri bolnikih, ki prejemajo dipivoksiladefovirat kot monoterapijo in v kombinaciji z lamivudinom: V več kliničnih študijah (HBeAg pozitivni, HBeAg negativni bolniki, bolniki pred in po transplantaciji jeter z na lamivudin odpornim HBV in bolniki z na lamivudin odpornim HBV, sočasno okuženi s HIV) so bile izpeljane genotipske analize na izolatih HBV pri 379 bolnikih od skupno 629 bolnikov, ki so bili 48 tednov zdravljeni z dipivoksiladefoviratom.
Adefovir dipivoxil 
Dipivoksiladefovirat
As a result, the frequency category of proximal renal tubulopathy and Fanconi syndrome is revised from unknown to uncommon in section 4.8 of Hepsera SmPC and in the corresponding section of the package leaflet. 
Zato je kategorija pogostnosti proksimalne ledvične tubulopatije in Fanconijevega sindroma v poglavju 4.8 povzetka glavnih značilnosti zdravila Hepsera in ustreznega navodila za uporabo popravljena iz “neznana” v “občasni”.
How to store Hepsera 
Kako jemati zdravilo Hepsera
Treatment with adefovir dipivoxil resulted in improvement in the liver fibrosis from baseline to 96 weeks therapy when analysed using the Ishak score (median change: Δ= -1). 
Zdravljenje z dipivoksiladefoviratom je pripeljalo do izboljšanja jetrne fibroze od začetne vrednosti v 96. tednu, merjeno z Ishakovo lestvico (mediana spremembe: Δ= -1).
• an open-label study in which pre- (n=226) and post-liver transplantation patients (n=241) with lamivudine-resistant HBV were treated with 10 mg adefovir dipivoxil once daily, for up to 203 weeks (median 51 and 99 weeks, respectively). 
• odprti študiji, v kateri so bili bolniki z na lamivudin odpornim HBV pred (n=226) in po transplantaciji jeter (n=241) zdravljeni z 10 mg dipivoksiladefovirata, ki so ga prejemali enkrat na dan do 203 tedne (mediana 51 oz. 99 tednov).
Treatment with adefovir dipivoxil may result in renal impairment. 
Zdravljenje z dipivoksiladefoviratom lahko privede do motenj v delovanju ledvic.
• Do not breast-feed while taking Hepsera. 
• Med jemanjem zdravila Hepsera ne dojite.
What Hepsera is and what it is used for What Hepsera is 
Kaj je zdravilo Hepsera in za kaj ga uporabljamo
Assessment of adverse reactions is based on experience from post-marketing surveillance and from three pivotal clinical studies in patients with chronic hepatitis B: 
b. Povzetek neželenih učinkov, prikazan v preglednici Ocenjevanje neželenih učinkov temelji na izkušnjah po pridobitvi dovoljenja za promet in trženju zdravila in na treh osrednjih kliničnih študijah pri bolnikih s kroničnim hepatitisom B:
Adefovir dipivoxil is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Dipivoksiladefovirata ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
Common: 
Pogosto:
In order to reduce the risk of resistance in patients receiving adefovir dipivoxil monotherapy, a modification of treatment should be considered if serum HBV DNA remains above 1,000 copies/ml at or beyond 1 year of treatment. 
Da bi zmanjšali tveganje odpornosti pri bolnikih na monoterapiji z dipivoksiladefoviratom, je treba razmisliti o spremembi zdravljenja, če vrednost serumske HBV DNA po enem letu ostane večja od
Clinical resistance in monotherapy studies in nucleoside naïve patients: In patients receiving adefovir dipivoxil monotherapy (HBeAg negative study) the cumulative probability of developing adefovir-associated resistance mutations was 0 %, 3 %, 11 %, 18 % and 29 % at 48, 96, 144, 192 and 240 weeks respectively. 
Klinična odpornost v študijah monoterapije pri bolnikih, ki še niso bili zdravljeni z nukleozidi: Pri bolnikih, ki so prejemali dipivoksiladefovirat kot monoterapijo (študija s HBeAg negativnimi bolniki), je bila kumulativna verjetnost razvoja mutacij za rezistenco, povezanih z adefovirjem 0% v 48. tednu, 3% v 96. tednu, 11% v 144. tednu, 18% v 192. tednu in 29% v 240. tednu.
It is recommended that creatinine clearance is calculated in all patients prior to initiating therapy with adefovir dipivoxil and that renal function (creatinine clearance and serum phosphate) be monitored every four weeks during the first year and then every three months thereafter. 
Pred začetkom zdravljenja z dipivoksiladefoviratom se priporoča določiti očistek kreatinina pri vseh bolnikih in spremljanje ledvične funkcije (očistek kreatinina in koncentracija fosfata v serumu) vsake
• If you are allergic to adefovir, adefovir dipivoxil or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na adefovir, dipivoksiladefovirat ali katero koli sestavino tega zdravila
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Ireland 
Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill Co. Cork Irska
Each tablet contains 10 mg adefovir dipivoxil. 
Vsaka tableta vsebuje 10 mg dipivoksiladefovirata.
Clinical resistance in studies where adefovir dipivoxil was added to ongoing lamivudine in patients with lamivudine-resistance: In an open-label study of pre- and post-liver transplantation patients with clinical evidence of lamivudine-resistant HBV, no adefovir-associated resistance mutations were observed at week 48. 
Klinična odpornost v študijah, v katerih je bil dipivoksiladefovirat dodan k tekočemu zdravljenju z lamivudinom pri bolnikih z rezistenco proti lamivudinu: V odprti študiji pri bolnikih pred in po transplantaciji jeter s kliničnimi dokazi za obstoj na lamivudin odpornega HBV v 48. tednu niso bile opažene mutacije za rezistenco, povezane z adefovirjem.
After 96, 144, 192 and 240 weeks of treatment with adefovir dipivoxil, resistance surveillance was performed for 293, 221, 116 and 64 patients, respectively. 
Po 96 tednih zdravljenja z dipivoksiladefoviratom je bila opravljena kontrola odpornosti pri 293 bolnikih, po 144 tednih pri 221 bolnikih, po 192 tednih pri 116 bolnikih in po 240 tednih pri 64 bolnikih.
Based on a PRAC request, the MAH has reconsidered the frequency categories of Fanconi syndrome and proximal renal tubulopathy in the SmPC for Hepsera. 
Glede na zahtevo Odbora PRAC je imetnik dovoljenja za promet z zdravilom v povzetku glavnih značilnosti zdravila Hepsera znova preučil kategorije pogostnosti Fanconijevega sindroma in proksimalne ledvične tubulopatije.
Blinded, ranked assessments of both necroinflammatory activity and fibrosis at baseline and week 48, demonstrated that patients treated with 10 mg adefovir dipivoxil had improved necro-inflammatory and fibrosis scores relative to placebotreated patients. 
Slepa, razvrščena ocena tako nekroinflamatorne aktivnosti kot fibroze na začetku in v 48. tednu je pokazala, da so imeli bolniki zdravljeni z 10 mg dipivoksiladefovirata boljše nekroinflamatorne in fibrozne rezultate glede na bolnike, ki so prejemali placebo.
Adefovir dipivoxil is not recommended in patients with creatinine clearance of < 30 ml/min or in patients on dialysis (see section 4.2 and 4.4). 
Pri bolnikih z očistkom kreatinina < 30 ml/min ali pri bolnikih na dializi uporaba dipivoksiladefovirata ni priporočena (glejte poglavji 4.2 in 4.4).
In the pre-liver transplantation and post-liver transplantation cohorts 77 of 109 (71 %) patients and 64 of 159 (40 %) patients, respectively, achieved undetectable HBV DNA levels at week 48 (< 1,000 copies/ml Roche Amplicor Monitor PCR assay). 
V skupini bolnikov pred transplantacijo jeter je 77 od 109 bolnikov (71%) doseglo nezaznavne koncentracije HBV DNA v 48. tednu, v skupini bolnikov po transplantaciji jeter pa 64 od 159 bolnikov (40%) (< 1.000 kopij/ml po analizi Roche Amplicor Monitor PCR).
High baseline ALT levels (≥ 2 x ULN) and Knodell Histology Activity Index (HAI) scores (≥ 10) and low HBV DNA (< 7.6 log10 copies/ml) were associated with greater histological improvement. 
Večje histološko izboljšanje je bilo povezano z visokimi začetnimi vrednostmi ALT (≥ 2 krat zgornja referenčna vrednost - ULN), z visokimi vrednostmi Knodellovega indeksa histološke aktivnosti (HAI, Histology Activity Index) (≥ 10) in z nizkim HBV DNA (< 7,6 log10 kopij/ml).
Rash, pruritus Musculoskeletal and connective tissue disorders: 
Bolezni mišično-skeletnega sistema in vezivnega tkiva:
Based on post-marketing data, long-term treatment with adefovir dipivoxil may lead to progressive alteration of renal function resulting in renal impairment (see section 4.4). 
Na podlagi podatkov iz obdobja trženja zdravila lahko dolgotrajno zdravljenje z dipivoksiladefovirata povzroči progresivne spremembe ledvične funkcije, kar lahko privede do motenj v delovanju ledvic
Nervous system disorders: Common: 
Bolezni živčevja: Pogosto:
No human data on the effect of adefovir dipivoxil on fertility are available. 
Ni podatkov o učinkih dipivoksiladefovirata na plodnost za ljudi.
The role of adefovir and add-on lamivudine+adefovir in HBV therapy strategy should be regularly discussed in the light of emerging data. 
V smislu novih podatkov je treba redno ovrednotiti vlogo adefovirja in dodatnega dajanja lamivudina+adefovirja pri strategiji zdravljenja HBV.
Hepsera 10 mg tablets Adefovir dipivoxil 
Hepsera 10 mg tablete dipivoksiladefovirat
Hepsera can affect the way your kidneys work. 
Zdravilo Hepsera lahko vpliva na delovanje ledvic.
In the study in HBeAg positive patients, HBeAg seroconversion (12 %) and HBeAg loss (24 %) was observed significantly more frequently in patients receiving 10 mg adefovir dipivoxil than in patients receiving placebo (6 % and 11 %, respectively) after 48 weeks of treatment. 
V študiji pri HBeAg pozitivnih bolnikih, ki so prejemali 10 mg dipivoksiladefovirata napram placebu je bila značilno bolj pogosto opažena HBeAg serokonverzija (12% napram 6%) in izguba HBeAg (24% napram 11%) po 48 tednih zdravljenja.
Adefovir dipivoxil is a dipivaloyloxymethyl ester prodrug of the active substance adefovir, an acyclic nucleotide analogue which is actively transported into cells where it is converted by host enzymes to adefovir diphosphate. 
Dipivoksiladefovirat je predzdravilo, dipivaloiloksimetilni ester zdravilne učinkovine adefovir, acikličen analog nukleotidu, ki se aktivno prenaša v celice, kjer ga encimi gostitelja pretvorijo v adefovir difosfat.
Experience in patients with compensated liver disease and lamivudine-resistant HBV: In a double-blind comparative study in chronic hepatitis B patients with lamivudine-resistant HBV (n=58), there was no median reduction in HBV DNA from baseline after 48 weeks of treatment with lamivudine. 
Izkušnje pri bolnikih s kompenzirano boleznijo jeter in z na lamivudin odpornim HBV: V dvojno slepi primerjalni študiji bolnikov s kroničnim hepatitisom B z na lamivudin odpornim HBV (n=58) ni prišlo do znižanja koncentracij (mediana) HBV DNA od začetne vrednosti po 48 tednih zdravljenja z lamivudinom.
Osteomalacia (manifested as bone pain and infrequently contributing to fractures) and myopathy, both associated with proximal renal tubulopathy Renal and urinary disorders: Very common: 
osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom) in miopatija, obe povezani s proksimalno ledvično tubulopatijo
Hepsera [outer packaging only] 
[samo na zunanji ovojnini]
Patients with a confirmed increase in creatinine of ≥ 0.3 mg/dl by week 48 were at a statistically significant higher risk of a subsequent confirmed increase in creatinine of ≥ 0.5 mg/dl. Hypophosphatemia and a decrease in carnitine concentrations were reported each in 3 % of patients on extended treatment. 
Bolniki s potrjenim povečanjem kreatinina za ≥ 0,3 mg/dl do 48. tedna so bili izpostavljeni statistično pomembnemu večjemu tveganju za pozneje potrjeno povečanje kreatinina za ≥ 0,5 mg/dl.
• Stomach pain 
• bolečina v trebuhu