FrancophonIA/ELRC3.0 huggingface dataset:
English: common: headache, dizziness, somnolence
Croatian: često: glavobolja, omaglica, somnolencija
English: If your doctor instructs you to take Entecavir Mylan on an empty stomach, empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Croatian: Ako Vam liječnik da uputu da uzimate Entekavir Mylan na prazan želudac, to znači da ga morate uzeti najmanje 2 sata nakon obroka i najmanje 2 sata prije sljedećeg obroka.
English: You should not take Entecavir Mylan to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Croatian: Ne smijete uzimati Entekavir Mylan za liječenje infekcije hepatitisom B ako u isto vrijeme ne uzimate lijekove protiv HIV-a, jer to može smanjiti učinkovitost budućeg liječenja protiv HIV-a.
English: Entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Croatian: Entekavir nije supstrat, inhibitor niti induktor enzimskog sustava CYP450.
English: Mutations in the HBV polymerase that encode lamivudine-resistance substitutions may lead to the subsequent emergence of secondary substitutions, including those associated with entecavir associated resistance (ETVr).
Croatian: Mutacije HBV polimeraze koje kodiraju supstitucije zaslužne za rezistenciju na lamivudin mogu dovesti do posljedičnog nastanka sekundarnih supstitucija, uključujući onih povezanih s rezistencijom na entekavir (ETVr).
English: taking Entecavir Mylan will not stop you from infecting other people with hepatitis B virus (HBV) through sexual contact or body fluids (including blood contamination).
Croatian: • uzimanje lijeka Entekavir Mylan neće spriječiti prijenos infekcije virusom hepatitisa B (HBV) na druge osobe putem spolnog kontakta ili tjelesnih tekućina (uključujući kontaminiranu krv).
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors.
Croatian: Farmakoterapijska skupina: antivirusni lijekovi za sustavnu primjenu, nukleozidni i nukleotidni inhibitori reverzne transkriptaze.
English: whether you have kidney problems.
Croatian: • tome imate li tegobe s bubrezima.
English: Of these patients, 55/57 (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥1-point decrease in Ishak fibrosis score.
Croatian: Od ovih 57 bolesnika, 55 (96%) je imalo histološko poboljšanje kako je prethodno definirano (vidjeti gore), a 50 (88%) je imalo smanjenje fibroze za ≤ 1 boda prema Ishakovom indeksu fibroze.
English: Entecavir Mylan should not be used during pregnancy unless clearly necessary.
Croatian: Entekavir Mylan se ne smije primjenjivati tijekom trudnoće, osim ako to stvarno nije neophodno.
English: There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg.
Croatian: Nema preporuka za doziranje entekavira u djece mlađe od 2 godine ili tjelesne težine manje od 10 kg.
English: Common (at least 1 in 100 patients): headache, insomnia (inability to sleep), fatigue (extreme tiredness), dizziness, somnolence (sleepiness), vomiting, diarrhoea, nausea, dyspepsia (indigestion), and increased blood levels of liver enzymes.
Croatian: Često (u najmanje 1 na 100 bolesnika): glavobolja, nesanica (nemogućnost spavanja), iscrpljenost (izraziti umor), omaglica, izrazita pospanost (pospanost), povraćanje, proljev, mučnina, dispepsija (probavne smetnje) i povišena razina jetrenih enzima u krvi.
English: This finding was not observed in repeat-dose studies in other species, including monkeys administered entecavir daily for 1 year at exposures ≥100 times those in humans.
Croatian: Ovaj se nalaz nije opazio u ispitivanjima toksičnosti ponovljenih doza u drugih vrsta, uključujući majmune kojima se entekavir primjenjivao svakodnevno tijekom 1 godine uz izloženosti koje su bile ≤ 100 puta veće od onih u ljudi.
English: The population pharmacokinetic analysis covering patients in the age range 16-75 years did not identify age as significantly influencing entecavir pharmacokinetics.
Croatian: Analiza populacijske farmakokinetike u bolesnika u dobi od 16 do 75 godina nije pokazala da je dob značajno utjecala na farmakokinetiku entekavira.
English: Entecavir Mylan tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Croatian: Entekavir Mylan tablete primjenjuju se i za liječenje kronične (dugotrajne) HBV infekcije u djece i adolescenata u dobi od 2 godine do manje od 18 godina.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥26 times those in humans.
Croatian: Promjene na testisima (degeneracija sjemenih kanalića) bile su očite u ispitivanjima toksičnosti ponovljenih doza u glodavaca i pasa pri izloženostima koja su bile ≤ 26 puta veće od onih u ljudi.
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAgnegative disease at the time of transplant.
Croatian: U ispitnoj populaciji bilo je 82% muškaraca, 39% bijelaca i 37% azijata, prosječne dobi od 49 godina; 89% bolesnika imalo je HBeAg-negativnu bolest u vrijeme transplantacije.
English: Do not use this medicine after the expiry date which is stated on the bottle, blister or carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci, blisteru ili kutiji iza „Rok valjanosti“.
English: Through Week 240, 3 of the 10 patients experienced virologic breakthrough (≥1 log10 increase above nadir).
Croatian: Do 240. tjedna, u 3 od tih 10 bolesnika nastupio je virološki proboj (≤ 1 log10 povećanje iznad najniže točke).
English: 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.
Croatian: U 72. tjednu nakon transplantacije, niti jedan od 55 promatranih slučajeva nije prijavio virološki povrat HBV-a [definiran kao HBV DNK ≤50 IU/ml (približno 300 kopija/ml)] i nije bilo prijavljenog virološkog povrata u vrijeme cenzuriranja podataka za preostalih 6 bolesnika.
English: The population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Croatian: Analiza populacijske farmakokinetike nije utvrdila da rasa značajno utječe na farmakokinetiku entekavira.
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (<200 cells/mm3).
Croatian: Postoje samo ograničeni podaci o bolesnicima istodobno inficiranima HIV-om koji imaju nizak broj CD4 stanica (< 200 stanica/mm3).
English: Entecavir Mylan can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Croatian: Entekavir Mylan se može primijeniti u djece čija je jetra oštećena, ali još uvijek ispravno radi (kompenzirana bolest jetre).
English: What Entecavir Mylan is and what it is used for
Croatian: Što je Entekavir Mylan i za što se koristi
English: 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).
Croatian: Niže Cmax i AUC kad se entekavir uzima s hranom ne smatraju se klinički značajnim u bolesnika prethodno neliječenih analozima nukleozida, ali mogle bi utjecati na djelotvornost u bolesnika refrakternih na lamivudin (vidjeti dio 4.2).
English: • compensated liver disease and evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Croatian: • kompenziranom bolešću jetre i dokazanom aktivnom replikacijom virusa, konstantno povišenim razinama alanin aminotransferaze (ALT) u serumu i histološki dokazanom aktivnom upalom i/ili fibrozom.
English: An analysis of the inhibitory activity of entecavir against a panel of laboratory and clinical HIV-1 isolates using a variety of cells and assay conditions yielded EC50 values ranging from 0.026 to >10 µM; the lower EC50 values were observed when decreased levels of virus were used in the assay.
Croatian: Analiza inhibicijske aktivnosti entekavira protiv panela laboratorijskih i kliničkih izolata HIV-1 u raznim vrstama stanica i raznim uvjetima testiranja pokazala je da se vrijednosti EC50 kreću od 0,026 do > 10 µM; niže vrijednosti EC50 bile su opažene kad su se u testu koristile manje razine virusa.
English: Patients were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Croatian: Bolesnici su randomizirani (2:1) da primaju slijepo liječenje entekavirom u dozi od 0,015 mg/kg do najviše 0,5 mg/dan (N = 120) ili placebo (N = 60).
English: Entecavir inhibited HBV DNA synthesis (50% reduction, EC50) at a concentration of 0.004 µM in human HepG2 cells transfected with wild-type HBV.
Croatian: Entekavir je inhibirao sintezu HBV DNK (50%-tno smanjenje, EC50) pri koncentraciji od 0,004 µM u ljudskim HepG2 stanicama transficiranima divljim tipom HBV-a.
English: 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.
Croatian: 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.
English: Genotypic evaluations were performed for all patients with available samples who had virologic breakthrough through Week 96 or HBV DNA ≥50 IU/ml at Week 48 or Week 96.
Croatian: Genotipske procjene provedene su za sve bolesnike s dostupnim uzorcima koji su doživjeli virološki proboj do 96. tjedna ili koji su imali HBV DNK ≤ 50 IU/ml u 48. tjednu ili 96. tjednu.
English: Uncommon (at least 1 in 1,000 patients): rash, hair loss.
Croatian: Manje često (u najmanje 1 na 1000 bolesnika): osip, ispadanje kose.
English: This is important because Entecavir Mylan is eliminated from your body through the kidneys and your dose or dosing schedule may need to be adjusted.
Croatian: Entekavir Mylan uklanja iz tijela putem bubrega i možda će Vam trebati prilagoditi dozu ili raspored doziranja.
English: Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Croatian: Odgovori bolesnika koji su na početku imali 4 boda prema Knodellovom indeksu fibroze (ciroza) mogli su se usporediti s ukupnim odgovorima u svim mjerama ishoda djelotvornosti (svi su bolesnici imali kompenziranu bolest jetre).
English: Paediatric patients with body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet with or without food.
Croatian: Pedijatrijskim bolesnicima tjelesne težine od najmanje 32,6 kg treba primijeniti dnevnu dozu od jedne tablete od 0,5 mg, s hranom ili bez nje.
English: The demonstration of benefit is based on histological, virological, biochemical, and serological responses after 48 weeks of treatment in active-controlled clinical trials of 1,633 adults with chronic hepatitis B infection, evidence of viral replication and compensated liver disease.
Croatian: Korist od liječenja pokazala se na temelju histoloških, viroloških, biokemijskih i seroloških odgovora nakon 48 tjedana liječenja u aktivno kontroliranim kliničkim ispitivanjima 1633 odrasla bolesnika s infekcijom kroničnim hepatitisom B, dokazom umnažanja virusa i kompenziranom bolešću jetre.
English: Results for the main efficacy endpoints at Week 48 and Week 96 are presented in the table below.
Croatian: Rezultati za glavne mjere ishoda za djelotvornost u 48. tjednu i 96. tjednu prikazane su u sljedećoj tablici.
English: Therefore, entecavir should not be used in this setting due to the potential for development of HIV resistance (see section 4.4).
Croatian: Stoga se u takvim situacijama entekavir ne smije primjenjivati, zbog mogućeg razvoja rezistencije HIV-a (vidjeti dio 4.4).
English: Exacerbations after discontinuation of treatment
Croatian: Egzacerbacije nakon prekida liječenja
English: 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.
Croatian: Entekavir, nukleozidni analog gvanozina koji je aktivan protiv HBV polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Croatian: Liječenje mora započeti liječnik s iskustvom u liječenju kronične infekcije hepatitisom B.
English: If you take more Entecavir Mylan than you should Contact your doctor at once.
Croatian: Ako uzmete više lijeka Entekavir Mylan nego što ste trebali Odmah se javite liječniku.
English: Tablet coating: titanium dioxide (E171), hypromellose, macrogol 400, polysorbate 80.
Croatian: Ovojnica tablete: titanijev dioksid (E171), hipromeloza, makrogol 400, polisorbat 80.
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥1 point decrease (median decrease from baseline was 1.5 points).
Croatian: Svi (10/10) bolesnici s uznapredovalom fibrozom ili cirozom na početku ispitivanja (stupanj fibroze 4, 5 ili 6 prema Ishakovom indeksu) imali su smanjenje za ≤ 1 boda (medijan smanjenja u odnosu na početnu vrijednost bio je 1,5 boda).
English: Your dose will depend on: whether you have been treated for HBV infection before, and what medicine you received.
Croatian: • tome jeste li se prije liječili zbog HBV-infekcije i koje ste lijekove primali.
English: Resistance and specific precaution for lamivudine-refractory patients
Croatian: Rezistencija i posebne mjere opreza kod bolesnika refrakternih na lamivudin
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammalian cell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Croatian: Nije bilo dokaza genotoksičnosti u Amesovom testu mikrobne mutagenosti, testu genske mutacije na stanicama sisavaca te transformacijskom testu na stanicama embrija sirijskog hrčka.
English: 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).
Croatian: Učinak dobi na farmakokinetiku entekavira procijenio se usporedbom starijih ispitanika u dobi od 65 do 83 godine (prosječna dob žena: 69 godina, muškaraca: 74 godine) s mlađim ispitanicima u dobi od 20 do 40 godina (prosječna dob žena: 29 godina, muškaraca: 25 godina).
English: - emerging genotypic ETVr c
Croatian: - pojavom genotipske ETVr c
English: achieved HBV DNA <300 copies/ml at Week 48.
Croatian: (9/14) je postiglo HBV DNK < 300 kopija/ml u 48. tjednu.
English: Entecavir Mylan must not be used during pregnancy unless specifically directed by your doctor.
Croatian: Entekavir Mylan ne smijete uzimati tijekom trudnoće osim ako to nije izričita uputa liječnika.
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Croatian: Razine ALT-a i HBV DNK u serumu treba redovito pratiti nakon prekida liječenja (vidjeti dio 4.4.).
English: Tablet core: microcrystalline cellulose, crospovidone, lactose monohydrate (see section 2, “Entacavir Mylan contains lactose”), magnesium stearate
Croatian: Jezgra tablete: mikrokristalična celuloza, krospovidon, laktoza hidrat, (vidjeti dio 2, „Entekavir Mylan sadrži laktozu”), magnezijev stearat
English: common: vomiting, diarrhoea, nausea, dyspepsia
Croatian: često: povraćanje, proljev, mučnina, dispepsija
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.
Croatian: 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 tjedna svi primali entekavir.
English: In study 048, 191 patients with HBeAg positive or negative chronic HBV infection and evidence of hepatic decompensation, defined as a CTP score of 7 or higher, received entecavir 1 mg once daily or adefovir dipivoxil 10 mg once daily.
Croatian: U ispitivanju 048, 191 bolesnik s HBeAg pozitivnom ili negativnom kroničnom HBV infekcijom i dokazanom dekompenzacijom jetre, koja se definirala kao CTP indeks 7 ili viši, primao je entekavir u dozi od 1 mg jednom dnevno ili adefovir dipivoksil u dozi od 10 mg jednom dnevno.
English: In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥21 times those in humans.
Croatian: U trudnih ženki štakora i kunića kojima se primjenjivao entekavir, razine bez embriotoksičnih i za majku toksičnih učinaka odgovarale su izloženostima koje su bile ≤ 21 puta veće od onih u ljudi.
English: - genotypic ETVr with virologic breakthrough d
Croatian: - genotipskom ETVr s virološkim probojem d
English: Entecavir Mylan 0.5 mg film-coated tablets Entecavir Mylan 1 mg film-coated tablets are supplied in blisters packs containing 30 tablets, perforated blister packs containing 30 x 1 or 90 x 1 tablets, and in bottles containing 30 or 90 tablets.
Croatian: Entekavir Mylan 0,5 mg filmom obložene tablete Entekavir Mylan 1 mg filmom obložene tablete isporučuju se u blisterima koji sadrže 30 tableta, perforiranim blisterima koji sadrže 30 x 1 ili 90 x 1 tableta, i u bočicama koje sadrže 30 ili 90 tableta.
English: What Entecavir Mylan looks like and contents of the pack
Croatian: Kako Entekavir Mylan izgleda i sadržaj pakiranja
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.
Croatian: 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.
English: common: insomnia
Croatian: često: nesanica
English: For children and adolescents (from 2 to less than 18 years of age), Entecavir Mylan 0.5 mg Filmcoated Tablets are available or an oral solution may be available.
Croatian: Za djecu i adolescente (od 2 do manje od 18 godina), dostupne su Entekavir Mylan 0,5 mg filmom obložene tablete ili može biti dostupna oralna otopina.
English: The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV-infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Croatian: Sigurnost i djelotvornost entekavira provjerile su se i u aktivno kontroliranom kliničkom ispitivanju na 191 bolesniku inficiranom HBV-om s dekompenziranom bolešću jetre i u kliničkom ispitivanju sa 68 bolesnika istodobno inficiranih HBV-om i HIV-om.
English: do not stop taking Entecavir Mylan without your doctor's advice since your hepatitis may worsen after stopping treatment.
Croatian: • nemojte prestati uzimati Entekavir Mylan ako Vam to nije savjetovao liječnik, budući da Vam se hepatitis može pogoršati nakon prestanka liječenja.
English: Exacerbations of hepatitis
Croatian: Egzacerbacije hepatitisa
English: d ≥1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Croatian: d Povećanje od ≤ 1 log10 iznad najniže točke HBV DNK mjerene PCR-om, što je bilo potvrđeno uzastopnim mjerenjima ili na kraju specificirane vremenske točke.
English: 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).
Croatian: 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).
English: Lamivudine-refractory patients (i.e. with evidence of viraemia while on lamivudine or the presence of lamivudine resistance [LVDr] mutations) (see sections 4.4 and 5.1): the recommended dose in adults 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).
Croatian: Bolesnici s bolešću refrakternom na liječenje lamivudinom (tj. s dokazanom viremijom za vrijeme liječenja lamivudinom ili prisutnim mutacijama za rezistenciju na lamivudin [LVDr]) (vidjeti dijelove 4.4 i 5.1): preporučena doza za odrasle je 1 mg jednom dnevno, a mora se uzeti na prazan želudac (više od 2 sata prije i više od 2 sata poslije obroka) (vidjeti dio 5.2).
English: What you need to know before you take Entecavir Mylan
Croatian: Što morate znati prije nego počnete uzimati Entekavir Mylan
English: Entecavir Mylan 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).
Croatian: Entekavir Mylan 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).
English: High baseline Knodell necroinflammatory scores (>10) were associated with greater histological improvement in nucleoside-naive patients.
Croatian: Visoki početni Knodellov indeks nekroze i upale (> 10) bio je povezan s većim histološkim poboljšanjem kod bolesnika prethodno neliječenih analozima nukleozida.
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).
Croatian: Kriteriji za odgovor bili su virološka supresija HBV (HBV DNK < 0,7 MEq/ml prema bDNK) i nestanak HBeAg (u HBeAg pozitivnih bolesnika) ili ALT < 1,25 puta iznad GGN (u HBeAg negativnih bolesnika).
English: b Includes patients with at least one on-therapy HBV DNA measurement by PCR at or after week 24 through week 58
Croatian: b Uključuje bolesnike s najmanje jednim mjerenjem HBV DNK pomoću PCR-a tijekom terapije u 24. tjednu ili kasnije do
English: Entecavir Mylan is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with:
Croatian: Entekavir Mylan je indiciran za liječenje kronične infekcije virusom hepatitisa B (HBV) (vidjeti dio 5.1) u odraslih s:
English: There are no data on the efficacy of entecavir in patients co-infected with hepatitis C or D virus.
Croatian: Nema podataka o djelotvornosti entekavira u bolesnika koji su istodobno inficirani virusom hepatitisa C ili D.
English: f Denominator is patients with abnormal values at baseline.
Croatian: f U nazivniku su bolesnici s abnormalnim vrijednostima na početku ispitivanja.
English: Dizziness, tiredness (fatigue) and sleepiness (somnolence) are common side effects which may impair your ability to drive and use machines.
Croatian: Omaglica, umor (iscrpljenost) i pospanost (izrazita pospanost) česte su nuspojave koje mogu narušiti Vašu sposobnost upravljanja vozilima i rada na strojevima.