FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Pri bolnikih z napredovalo boleznijo jeter ali jetrno cirozo je tveganje za jetrno dekompenzacijo po poslabšanju hepatitisa lahko večje, zato jih je treba med zdravljenjem skrbno nadzirati.
English: 3 years After opening the bottle use within 90 days.
Slovenian: 3 leta Po odprtju plastenke porabiti v roku 90 dni.
English: Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM.
Slovenian: Entekavir trifosfat je šibek zaviralec celičnih DNA polimeraz α, β in δ z vrednostmi Ki od 18 do 40 μM.
English: Available toxicological data in animals have shown excretion of entecavir in milk (for details see section 5.3).
Slovenian: Razpoložljivi toksikološki podatki pri živalih kažejo na izločanje entekavirja v mleko (za podrobnosti glejte poglavje 5.3).
English: Entecavir Accord is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Slovenian: To je pomembno, ker se zdravilo Entecavir Accord iz telesa izloča skozi ledvice in vam bo zdravnik morda moral odmerek ali odmerno shemo prilagoditi.
English: Also contains soy polysaccharides.
Slovenian: Vsebuje tudi sojine polisaharide.
English: What Entecavir Accord is and what it is used for What you need to know before you take Entecavir Accord How to take Entecavir Accord Possible side effects
Slovenian: Kaj je zdravilo Entecavir Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Entecavir Accord Kako jemati zdravilo Entecavir Accord
English: Response criteria were HBV virological suppression (HBV DNA < 0.7 MEq/ml by bDNA) and loss of HBeAg (in HBeAg positive patients) or ALT < 1.25 times ULN (in HBeAg negative patients).
Slovenian: Kriteriji odziva so bili zavrtje virusa HBV (HBV DNA < 0,7 MEq/ml z metodo bDNA) in izginotje HBeAg (pri HBeAg pozitivnih bolnikih) ali vrednosti ALT < 1,25 krat ULN (pri HBeAg negativnih bolnikih).
English: Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF United Kingdom
Slovenian: Accord Healthcare Limited Sage House, 319 Pinner road North Harrow, Middlesex HA1 4HF Velika Britanija
English: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF United Kingdom
Slovenian: Accord Healthcare Limited Sage House, 319 Pinner Road North Harrow, Middlesex, HA1 4HF Velika Britanija
English: discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
Slovenian: vprašajte svojega zdravnika ali vaša jetra delujejo normalno, in če ne, kako lahko nenormalno delovanje jeter vpliva na zdravljenje z zdravilom Entecavir Accord.
English: Each carton contains either:
Slovenian: Ena škatla vsebuje:
English: However, if you have had a previous treatment with a medicine containing the active substance lamivudine you should consider the following.
Slovenian: Če ste se predhodno zdravili z zdravilno učinkovino lamivudin, morate upoštevati naslednje.
English: Elderly: the effect of age on the pharmacokinetics of entecavir was evaluated comparing elderly subjects in the age range 65-83 years (mean age females 69 years, males 74 years) with young subjects in the age range 20-40 years (mean age females 29 years, males 25 years).
Slovenian: Starostniki: Vpliv starosti na farmakokinetiko entekavirja je bil ovrednoten s primerjavo farmakokinetike pri starostnikih, starih od 65 do 83 let (srednja starost: ženske 69 let, moški 74 let) in mlajših osebah, starih od 20 do 40 let (srednja starost: ženske 29 let, moški 25 let).
English: Entecavir was clastogenic to human lymphocyte cultures at concentrations substantially higher than those achieved clinically.
Slovenian: Na kulturah človeških limfocitov je entekavir deloval klastogeno, in sicer pri koncentracijah, ki so bile znatno večje od koncentracij, doseženih pri klinični uporabi.
English: 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: 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: In some cases, selection of HIV variant M184V has been observed, which has implications for the selection of HAART regimens that the patient may take in the future.
Slovenian: M184V virusa HIV, kar lahko vpliva na izbor režima HAART za prihodnje zdravljenje.
English: All 61 patients had HBsAg loss post-transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).
Slovenian: 61 bolnikov je bilo po presaditvi HBsAg negativnih, 2 bolnika sta kasneje sicer postala HBsAg pozitivna, vendar pa so vrednosti HBV DNA pri njiju kljub temu ostale nedokazljive (< 6 i.e./ml).
English: Entecavir Accord should not be used for children below 2 years of age or weighing less than 10 kg.
Slovenian: Zdravila Entecavir Accord se ne sme uporabljati pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg.
English: Severe Managed with CAPD
Slovenian: Močno zmanjšan Zdravljenje s CAPD
English: 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.
Slovenian: Pri bolnikih s kompenzirano boleznijo jeter povišanje vrednosti serumske ALT običajno ne spremlja povišanje serumskih koncentracij bilirubina ali jetrna dekompenzacija.
English: Other medicines and Entecavir Accord
Slovenian: Druga zdravila in zdravilo Entecavir Accord
English: The recommended dose for adult patients with decompensated liver disease is 1 mg once daily, which must be taken on an empty stomach (more than 2 hours before and more than 2 hours after a meal) (see section 5.2).
Slovenian: Priporočeni odmerek za odrasle je 1 mg enkrat na dan. Bolniki morajo priporočeni odmerek jemati na prazen želodec (več kot 2 uri pred in več kot 2 uri po obroku) (glejte poglavje 5.2).
English: Pharmacokinetics in paediatric patients with renal or hepatic impairment have not been studied.
Slovenian: Farmakokinetike pri pediatričnih bolnikih z okvaro ledvic ali jeter niso preučevali.
English: 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.
Slovenian: Celostna analiza kliničnih študij 2. in 3. faze: V celostni analizi podatkov o odpornosti proti entekavirju iz 17 kliničnih študij 2. in 3. faze, izvedeni po prihodu zdravila na trg, je bila pri 5 od 1.461 oseb med zdravljenjem z entekavirjem odkrita z odpornostjo proti entekavirju povezana substitucija rtA181C.
English: If you have any concerns consult your doctor.
Slovenian: Če imate glede tega kakršne koli skrbi, se posvetujte s svojim zdravnikom.
English: These substitutions were observed only in the presence of LVDr substitutions (rtM204V and rtL180M).
Slovenian: Te substitucije so opazili le ob prisotnosti substitucij LVDr (rtM204V in rtL180M).
English: High-density polyethylene (HDPE) bottle contians a silica gel cainster with child resistant polypropylene closure containing 30 film-coated tablets.
Slovenian: Plastenke iz polietilena visoke gostote (HDPE) vsebuje vsebnik iz silikagela z za otroke varno polipropilensko zaporko, ki vsebujejo 30 filmsko obloženih tablet.
English: For both compensated and decompensated liver disease, this indication is based on clinical trial data in nucleoside naive patients with HBeAg positive and HBeAg negative HBV infection.
Slovenian: Pri obeh, kompenzirani in dekompenzirani bolezni jeter, indikacija temelji na podatkih kliničnega preskušanja pri HBeAg pozitivnih in HBeAg negativnih bolnikih, okuženih s HBV, ki se še niso zdravili z nukleozidi.
English: ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Slovenian: ≥ 1 log10 povečanje nad najnižjo vrednostjo HBV DNA, določene s PCR, potrjeno z zaporednimi meritvami ali ob koncu časovnega okvira.
English: c. Description of selected adverse reactions
Slovenian: c. Opis nekaterih neželenih učinkov
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
Slovenian: Varnost in učinkovitost entekavirja so vrednotili tudi v aktivno nadzorovanem kliničnem preskušanju,
English: 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.
Slovenian: Substitucije ETVr (poleg LVDr substitucij rtM204V/I ± rtL180M) so na začetku zdravljenja opazili tudi pri 10 od 187 (5%) izolatih bolnikov, neodzivnih na lamivudin, ki so se zdravili z entekavirjem in pri katerih so spremljali odpornost, kar kaže na to, da lahko predhodno zdravljenje vpliva na vrsto substitucije pri odpornosti ter da le-te, sicer redko, lahko obstajajo že pred zdravljenjem z entekavirjem.
English: whether you have kidney problems.
Slovenian: morebitnih težav z ledvicami.
English: 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: For patients who are not able to swallow tablets or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
Slovenian: Za bolnike, ki ne porejo pogoltniti tablet ali za katere je priporočen zmanjšan odmerek, so morda na voljo druga zdravila, ki vsebujejo entekavir in so v primerneši farmacevtski obliki/jakoti.
English: Fertility: toxicology studies in animals administered entecavir have shown no evidence of impaired fertility (see section 5.3).
Slovenian: Plodnost: Toksikološke študije pri živalih, ki so prejemale entekavir, ne kažejo vpliva na plodnost (glejte poglavje 5.3).
English: Patients with high baseline CTP score were at higher risk of developing serious adverse events (see section 4.4).
Slovenian: Pri bolnikih z visoko izhodiščno oceno po CTP lestvici je bilo tveganje za pojav resnih neželenih učinkov večje (glejte poglavje 4.4).
English: Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and thickness 3.40 mm ± 0.30 mm.
Slovenian: Dimenzije: dolžina 8,70 mm ± 0,20 mm, širina 8,40 mm ± 0,20 mm in debelina 3,40 mm ± 0,30 mm.
English: As an alternative, in case the oral solution is not available, the dose can be adjusted by increasing the dosage interval, also shown in the table.
Slovenian: Če peroralne raztopine ni na voljo, se odmerek alternativno lahko prilagodi tudi s podaljšanjem odmernega intervala, kot je tudi prikazano v preglednici.
English: In cell culture, entecavir selected for an M184I substitution at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations.
Slovenian: Na celičnih kulturah je entekavir pri mikromolarnih koncentracijah povzročil selekcijo substitucije M184I, kar potrjuje tendenco zaviralnega delovanja pri visokih koncentracijah entekavirja.
English: Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
Slovenian: HBV bolezni so bile v izhodišču med obema skupinama zdravljenja in starostnimi skupinami primerljive.
English: The dose should be adjusted according to the patient's renal function (see dosage recommendations in renal impairment and section 5.2).
Slovenian: Odmerek je treba prilagoditi glede na delovanje ledvic (glejte priporočila za odmerjanje pri okvari ledvic in poglavje 5.2).
English: In studies in patients with compensated liver disease, histological improvement was defined as a ≥ 2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
Slovenian: 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).
English: Renal impairment: entecavir clearance decreases with decreasing creatinine clearance.
Slovenian: Okvara ledvic: Z zmanjševanjem kreatininskega očistka se zmanjšuje tudi očistek entekavirja.
English: 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.
Slovenian: 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.
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Slovenian: HBeAg pozitivni (študija 026) ETV 1,0 mg enkrat na dan
English: Elderly: no dosage adjustment based on age is required.
Slovenian: Starostniki: Prilagajanje odmerka glede na starost ni potrebno.
English: Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food.
Slovenian: Bolniki, ki se še niso zdravili z nukleozidi: Priporočeni odmerek za odrasle je 0,5 mg enkrat na dan, s hrano ali brez nje.
English: How to store Entecavir Accord Contents of the pack and other information
Slovenian: Shranjevanje zdravila Entecavir Accord Vsebina pakiranja in dodatne informacije
English: 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.
Slovenian: 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.
English: No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV.
Slovenian: Podatki o učinkovitosti entekavirja pri HBeAg negativnih bolnikih s sočasno okužbo z virusom HIV niso na voljo.
English: Entecavir Accord will not control your HIV infection.
Slovenian: Zdravilo Entecavir Accord ne more nadzirati okužbe z virusom HIV.
English: By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Recombinant viruses encoding adefovir-resistant substitutions at either rtN236T or rtA181V remained fully susceptible to entecavir.
Slovenian: Rekombinantni virusi s substitucijami, povezanimi z odpornostjo na adefovir, bodisi rtN236T bodisi rtA181V, so ostali popolnoma občutljivi za entekavir.
English: Breast-feeding: it is unknown whether entecavir is excreted in human milk.
Slovenian: Dojenje: Ni znano, ali se entekavir izloča v materino mleko.
English: 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.
Slovenian: 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.
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
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: Symptoms such as nausea, vomiting and stomach pain might indicate the development of lactic acidosis.
Slovenian: Bolezenski znaki, kot so siljenje na bruhanje, bruhanje in bolečina v trebuhu lahko kažejo na pojav laktacidoze.
English: 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.
Slovenian: 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.
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Slovenian: Študije na živalih so pokazale vpliv na sposobnost razmnoževanja pri visokih odmerkih (glejte poglavje 5.3).
English: Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm.
Slovenian: Dimenzije: dolžina 11,00 mm ± 0,20 mm, širina 10,60 mm ± 0,20 mm in debelina 4,20 mm ± 0,30 mm.
English: Contents of the pack and other information What Entecavir Accord contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Entecavir Accord
English: 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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na plastenki, pretisnem omotu ali škatli poleg oznake »Uporabno do/EXP«.
English: 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).
Slovenian: Med in po prekinitvi zdravljenja z entekavirjem so poročali tudi o poslabšanju hepatitisa (glejte poglavje 4.4 in c. Opis nekaterih neželenih učinkov).
English: After opening the bottle use within 90 days.
Slovenian: Po odprtju plastenke porabiti v roku 90 dni.
English: 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.
Slovenian: 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
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Slovenian: Genotipska odpornost proti entekavirju tekom 5 let v študijah pri bolnikih, neodzivnih na lamivudin 1. leto 2. leto 3. letoa
English: 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.
Slovenian: Študijsko populacijo je sestavljalo 82 % bolnikov moškega spola, 39 % bolnikov kavkazijskega in 37 % bolnikov azijskega porekla.
English: There is limited experience of entecavir overdose reported in patients.
Slovenian: Poročil o primerih prevelikega odmerjanja pri bolnikih je malo.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: ** on haemodialysis days, administer entecavir after haemodialysis.
Slovenian: ** na dan hemodialize bolniki vzamejo entekavir po hemodializi.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Compensated liver disease
Slovenian: Kompenzirana bolezen jeter
English: 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.
Slovenian: 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
English: Tablet core: Calcium carbonate, starch, pregelatinized, carmellose sodium, soy polysaccharides, citric acid monohydrate, sodium stearyl fumarate.
Slovenian: Jedro tablete: kalcijev karbonat, predgelirani škrob, natrijev karmelozat, sojini polisaharidi, citronska kislina monohidrat, natrijev stearilfumarat.
English: In patients with decompensated liver disease or cirrhosis, treatment cessation is not recommended.
Slovenian: Pri bolnikih z dekompenzirano boleznijo jeter ali jetrno cirozo zdravljenja ni priporočljivo prekiniti.
English: Of these 60 patients, 49 received more than 6 months of HBIg therapy.
Slovenian: Zdravljenje s HBIg je pri 49 od 60 bolnikov trajalo dlje kot 6 mesecev.
English: 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.
Slovenian: 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.
English: Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.
Slovenian: Uporabe entekavirja za zdravljenje okužbe z virusom HIV niso proučevali, zato se ga za zdravljenje okužbe z virusom HIV ne priporoča.