FrancophonIA/ELRC3.0 huggingface dataset:
English: The time to onset of HCC or death (whichever occurred first) was comparable in the two treatment groups; on-study cumulative death rates were 23% (23/102) and 33% (29/89) for patients treated with entecavir and adefovir dipivoxil, respectively, and on-study cumulative rates of HCC were 12% (12/102) and 20% (18/89) for entecavir and adefovir dipivoxil, respectively.
Croatian: Vrijeme do nastupa HCC ili smrti (kojegod da se dogodilo prije) bilo je usporedivo u ove dvije liječene skupine; kumulativne stope smrtnosti tijekom ispitivanja bile su 23% (23/102) u bolesnika liječenih entekavirom i 33% (29/89) u bolesnika liječenih adefovir dipivoksilom, a kumulativne stope
English: Calcium carbonate Starch, Pregelatinized Carmellose sodium Soy polysaccharides Citric acid monohydrate Sodium stearyl fumarate
Croatian: Jezgra tablete: kalcijev karbonat škrob, preželatinizirani karmelozanatrij polisaharidi soje hidrat limunske kiseline natrijev stearilfumarat
English: In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Croatian: U malog postotka bolesnika refrakternih na lamivudin, ETVr supstitucije na ostacima rtT184, rtS202 ili rtM250 bile su prisutne od početka.
English: Each 1 mg film-coated tablet contains 52 mg soy polysaccharides.
Croatian: Jedna filmom obložena tableta od 1 mg sadrži 52 mg polisaharida soje.
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.
Croatian: polimeraze, učinkovito se fosforilira do aktivnog trifosfatnog (TP) oblika s unutarstaničnim poluvijekom od 15 sati.
English: Entecavir Accord dosage*
Croatian: Doza lijeka Entekavir Accord*
English: A reduction of the daily dose using entecavir oral solution, as detailed in the table, is recommended.
Croatian: Preporučuje se smanjiti dnevnu dozu pomoću oralne otopine entekavira, kako je prikazano u tablici.
English: c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Croatian: a Roche COBAS Amplicor PCR test (LLOQ = 300 kopija/ml).
English: Mean serum HBV DNA by PCR was 7.83 log10 copies/ml and mean serum ALT was 100 U/l; 54% of patients were HBeAg positive, and 35% of patients had LVDr substitutions at baseline.
Croatian: Srednja vrijednost HBV DNK u serumu mjereno PCR-om bila je 7,83 log10 kopija/ml, srednja vrijednost ALT-a u serumu bila je 100 U/l; 54% bolesnika bilo je HBeAg pozitivno, a 35% bolesnika imalo je LVDr supstitucije na početku ispitivanja.
English: For patients with lamivudine-refractory hepatitis B, see sections 4.4 and 5.1.
Croatian: Za bolesnike s hepatitisom B refrakternim na liječenje lamivudinom, vidjeti dijelove 4.4 i 5.1.
English: The cumulative probability of emerging genotypic entecavir resistance after 1, 2, 3, 4 and 5 years treatment in the lamivudine-refractory studies was 6%, 15%, 36%, 47% and 51%, respectively.
Croatian: Kumulativna vjerojatnost pojave genotipske rezistencije na entekavir u ispitivanjima rezistencije na lamivudin iznosila je 6% nakon 1 godine, 15% nakon 2 godine, 36%
English: Tablet core:
Croatian: Ovojnica tablete:
English: ALT normalizationa HBV DNA < 50 IU/mL
Croatian: Normalizacija ALT-aa HBV DNK < 50 IU/ml a
English: Entecavir Accord 1 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
Croatian: Entekavir Accord 1 mg filmom obložene tablete hipromeloza, titanijev dioksid (E171), makrogol, željezov oksid, crveni (E172)
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Croatian: Genotipska rezistencija na entekavir u svih 5 godina ispitivanja kod bolesti refrakterne na lamivudin 1. godina 2. godina 3. godina a 4. godina a 5. godina a
English: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Croatian: Djeca tjelesne težine od najmanje 32,6 kg mogu uzimati tabletu od 0,5 mg ili može biti dostupna oralna otopina entekavira.
English: Hepatic impairment: no dose adjustment is required in patients with hepatic impairment.
Croatian: Oštećenje funkcije jetre: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije jetre.
English: b NC=F (noncompleter=failure), meaning treatment discontinuations before the analysis week, including reasons such as death, lack of efficacy, adverse event, noncompliance/loss-to-follow-up, are counted as failures (e.g., HBV DNA ≥ 300 copies/ml) c NC=M (noncompleters=missing) dDefined as decrease or no change from baseline in CTP score.
Croatian: b Nd=Neu (nedovršeno=neuspjeh), liječenje prekinuto prije tjedna analize, uključujući razloge za prekid kao što su smrt, nedostatak djelotvornosti, štetni događaj, nepridržavanje terapije/nije praćen, smatralo se terapijskim neuspjehom (npr.,
English: At study entry, the mean HBV DNA was 8.1 log10 IU/ml and mean ALT was 103 U/l across the study population.
Croatian: U trenutku uključivanja u ispitivanje, u cijeloj je ispitivanoj populaciji srednja vrijednost HBV DNK bila 8,1 log10 IU/ml, a srednja vrijednost ALT-a 103 U/l.
English: 30 x 1 film-coated tablets 90 x 1 film-coated tablets
Croatian: 30 x 1 filmom obložena tableta 90 x 1 filmom obložena tableta
English: This medicinal product contains soy polysaccharides.
Croatian: Ovaj lijek sadrži polisaharide soje.
English: For patients originally assigned to entecavir treatment, the reduction in HBV DNA at 48 weeks was -4.20 log10 copies/ml, ALT normalisation had occurred in 37% of patients with abnormal baseline ALT and none achieved HBeAg seroconversion.
Croatian: Kod bolesnika kojima je prvobitno dodijeljeno liječenje entekavirom, smanjenje HBV DNK u 48. tjednu bilo je -4,20 log10 kopija/ml, normalizacija ALT-a nastupila je u 37% bolesnika s abnormalnom vrijednošću ALT-a na početku ispitivanja i niti jedan bolesnik nije postigao HBeAg serokonverziju.
English: Experience in nucleoside-naive patients with compensated liver disease:
Croatian: Iskustvo u bolesnika prethodno neliječenih analozima nukleozida s kompenziranom bolešću jetre:
English: Soy polysaccharides: This medicinal product contains soy polysaccharides.
Croatian: Polisaharidi soje: Ovaj lijek sadrži polisaharide soje.
English: For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Croatian: Za bolesnike tjelesne težine od 10 do 32,5 kg preporučuje se oralna otopina entekavira.
English: 10.7% e 27% e 41.3% e
Croatian: 10,7% e
English: Bottle pack: 30 film-coated tablets
Croatian: Pakiranje u boci: 30 filmom obloženih tableta
English: LVD 100 mg once daily n
Croatian: LVD 100 mg jednom dnevno n
English: Among entecavir-treated nucleoside-naive patients, ALT elevations had a median time to onset of 2324 weeks, and 86% (24/28) of ALT elevations occurred in HBeAg negative patients.
Croatian: Među bolesnicima liječenima entekavirom prethodno neliječenima analozima nukleozida, povišenja ALT-a nastupila su nakon medijana od 23-24 tjedna, a u 86% (24/28) slučajeva povišenje ALT-a nastupilo je u HBeAg negativnih bolesnika.
English: Therefore, therapy with entecavir should not be used for HIV/HBV co-infected patients who are not receiving HAART.
Croatian: Stoga se terapija entekavirom ne smije primjenjivati u bolesnika istodobno inficiranih HIV-om i HBV-om koji ne primaju HAART.
English: The paediatric resistance assessment is based on data from nucleoside-treatment-naive paediatric patients with HBeAg-positive chronic HBV infection in two ongoing clinical trials (028 and 189).
Croatian: Ocjena rezistencije u pedijatrijskih bolesnika temelji se na podacima prikupljenima u pedijatrijskih bolesnika s HBeAg pozitivnom kroničnom HBV infekcijom prethodno neliječenih analozima nukleozida iz dvaju kliničkih ispitivanja koja su još u tijeku (028 i189).
English: virus (HBV) through sexual contact or body fluids (including blood contamination).
Croatian: uzimanje lijeka Entekavir Accord neće spriječiti prijenos infekcije virusom hepatitisa B (HBV) na druge osobe putem spolnog kontakta ili tjelesnih tekućina (uključujući kontaminiranu krv).
English: If you have any concerns consult your doctor.
Croatian: Ako ste zbog toga zabrinuti, potražite savjet liječnika.
English: For patients with LVDr substitutions at baseline, the percentage of patients with HBV DNA <300 copies/ml was 44% for entecavir and 20% for adefovir at week 24 and 50% for entecavir and 17% for adefovir at week 48.
Croatian: Među bolesnicima s LVDr supstitucijama na početku ispitivanja, postotak bolesnika s HBV DNK <300 kopija/ml bio je 44% bolesnika liječenih entekavirom i 20% liječenih adefovirom u 24. tjednu te 50% liječenih entekavirom i 17% liječenih adefovirom u 48. tjednu.
English: Entecavir exposure among nucleoside naïve subjects receiving once daily doses of entecavir 0.015 mg/kg up to a maximum dose of 0.5 mg was similar to the exposure achieved in adults receiving once daily doses of 0.5 mg.
Croatian: Izloženost entekaviru u ispitanika koji nisu bili liječeni analozima nukleozida, a primali su doze entekavira od 0,015 mg/kg do najviše 0,5 mg jednom dnevno bila je slična izloženosti koja se postiže u odraslih koji primaju doze od 0,5 mg jednom dnevno.
English: 30 x 1 film-coated tablet; 3 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters, or
Croatian: • 30 × 1 filmom obloženu tabletu; 3 blistera s 10 × 1 filmom obloženom tabletom, svaka u Al/Al perforiranim blisterima s jediničnim dozama, ili
English: Breast-feeding should be discontinued during treatment with Entecavir Accord.
Croatian: Dojenje treba prekinuti tijekom liječenja lijekom Entekavir
English: In HBeAg positive adult patients, treatment should be administered at least until 12 months after achieving HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection on two consecutive serum samples at least 3-6 months apart) or until HBs seroconversion or there is loss of efficacy (see section 4.4).
Croatian: Prekid liječenja mora se razmotriti u sljedećim slučajevima: Kod HBeAg pozitivnih odraslih bolesnika, liječenje se mora primjenjivati barem do 12 mjeseci nakon postizanja HBe serokonverzije (nestanak HBeAg i nestanak HBV DNK s prisutnim antiHBe na dva uzastopna mjerenja u uzorcima seruma u razmaku od najmanje 3-6 mjeseci) ili do HBs serokonverzije ili postoji gubitak djelotvornosti (vidjeti dio 4.4).
English: Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Croatian: Smanjenje HIV RNK prijavljeno je u bolesnika s istodobnom infekcijom HIV-om i HBV-om koji su primali monoterapiju entekavirom bez HAART-a.
English: Cmax and Cmin at steady-state are 4.2 and 0.3 ng/ml, respectively, for a dose of 0.5 mg, and 8.2 and 0.5 ng/ml, respectively, for 1 mg.
Croatian: Cmax u stanju dinamičke ravnoteže je 4,2, a Cmin 0,3 ng/ml za dozu od 0,5 mg odnosno 8,2 i 0,5 ng/ml za dozu od 1 mg.
English: These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
Croatian: Ova su ispitivanja pružila iskustvo liječenja entekavirom tijekom medijana od 99 tjedana u 195
English: Experience in lamivudine-refractory patients with compensated liver disease: In a randomised, double-blind study in HBeAg positive lamivudine-refractory patients (026), with 85% of patients presenting LVDr mutations at baseline, patients receiving lamivudine at study entry either switched to entecavir 1 mg once daily, with neither a washout nor an overlap period (n = 141), or continued on lamivudine 100 mg once daily (n = 145).
Croatian: U randomiziranom, dvostruko slijepom ispitivanju u HBeAg pozitivnih bolesnika refrakternih na lamivudin (026), od kojih je 85% bolesnika na početku imalo LVDr mutacije, bolesnici koji su primali lamivudin pri ulasku u ispitivanje prebačeni su na entekavir u dozi od 1 mg jednom dnevno, bez razdoblja ispiranja i razdoblja preklapanja (n = 141), ili su nastavili uzimati lamivudin u dozi od
English: With respect to patients with lamivudine-refractory hepatitis B, see sections 4.2, 4.4 and 5.1.
Croatian: Za bolesnike s hepatitisom B refrakternim na liječenje lamivudinom, vidjeti dijelove 4.2, 4.4 i 5.1.
English: Creatinine clearance (ml/min)
Croatian: Klirens kreatinina (ml/min)
English: Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Croatian: Jedna filmom obložena tableta od 0,5 mg sadrži 26 mg polisaharida soje.
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Croatian: Entekavir Accord 0,5 mg filmom obložene tablete hipromeloza, titanijev dioksid (E171), makrogol, polisorbat 80
English: 90 x 1 film-coated tablet
Croatian: 90 x 1 filmom obložena tabelta
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).
Croatian: Također su prijavljene egzacerbacije hepatitisa tijekom i nakon prekida terapije entekavirom (vidjeti dio 4.4 i c.
English: In studies in nucleoside-naive patients, 6% of entecavir-treated patients and 10% of lamivudine-treated patients experienced ALT elevations (> 10 times ULN and > 2 times reference [minimum of baseline or last end-of-dosing measurement]) during post-treatment follow-up.
Croatian: U ispitivanjima u bolesnika prethodno neliječenih analozima nukleozida, 6% bolesnika liječenih entekavirom i 10% bolesnika liječenih lamivudinim imalo je povišenja ALT-a (> 10 puta iznad GGN i > 2 puta iznad referentne vrijednosti [minimalno od početne vrijednosti ili posljednjeg mjerenja na kraju doziranja]) tijekom praćenja nakon prestanka liječenja.
English: Immune system disorders: rare
Croatian: Poremećaji probavnog sustava: često
English: You should not take Entecavir Accord 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: ako u isto vrijeme ne uzimate lijekove protiv HIV-a, jer to može smanjiti učinkovitost budućeg liječenja protiv HIV-a.
English: Decompensated liver disease
Croatian: Dekompenzirana bolest jetre
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point 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
English: Relative to the adverse reactions noted in section b. Tabulated list of adverse reactions, one additional adverse reaction [decrease in blood bicarbonate (2%)] was observed in entecavir-treated patients through week 48.
Croatian: Tablični prikaz nuspojava, opažena je jedna dodatna nuspojava [sniženje bikarbonata u krvi (2%)] u bolesnika liječenih entekavirom do 48. tjedna.
English: Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Croatian: Entekavir Accord se može primijeniti u djece čija je jetra oštećena, ali još uvijek ispravno radi (kompenzirana bolest jetre) Infekcija virusom hepatitisa B može dovesti do oštećenja jetre.
English: HBV DNA < 50 IU/mL and HBeAg seroconversion a
Croatian: HBV DNK < 50 IU/ml i HBeAg serokonverzija a
English: It is not known whether entecavir, the active ingredient in Entecavir Accord, is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se entekavir, djelatna tvar u lijeku Entekavir Accord, u majčino mlijeko.
English: For patients who met protocol-defined response criteria, response was sustained throughout the 24week post-treatment follow-up in 75% (83/111) of entecavir responders vs 73% (68/93) for lamivudine responders in study 022 and 46% (131/286) of entecavir responders vs 31% (79/253) for lamivudine responders in study 027.
Croatian: bolesnika s odgovorom na entekavir naspram 73% (68/93) bolesnika s odgovorom na lamivudin u ispitivanju 022 te 46% (131/286) bolesnika s odgovorom na entekavir naspram 31% (79/253)
English: Among entecavir-treated patients on-treatment exacerbations had a median time of onset of 4-5 weeks.
Croatian: Među bolesnicima koji se liječe entekavirom, egzacerbacije su nastupile s medijanom od 4-5 tjedana.
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).
Croatian: Također, bolesnici s bolešću refrakternom na lamivudin u kojih se postigla vrijednost HBV DNK < 104 log10 kopija/ml mjerena PCR-om u 24. tjednu imali su nižu stopu rezistencije od onih koji nisu postigli tu vrijednost (5-godišnja kumulativna vjerojatnost od 17,6% [n= 50] naspram 60,5% [n= 135]).
English: HBeAg positive (study 026): treatment with entecavir for up to 96 weeks (n = 141) resulted in cumulative response rates of 30% for HBV DNA < 300 copies/ml by PCR, 85% for ALT normalisation and 17% for HBeAg seroconversion.
Croatian: HBeAg pozitivni (ispitivanje 026): liječenje entekavirom u trajanju do 96 tjedana (n = 141) rezultiralo je kumulativnim stopama odgovora od 30% za HBV DNK < 300 kopija/ml mjereno PCR-om, 85% za normalizaciju ALT-a i 17% za HBeAg serokonverziju.
English: Bilirubin (≤1 X ULN)b
Croatian: ALT (≤1 x GGN)b Albumin (≥1 x DGN)b Bilirubin (≤1 x GGN)b
English: You should not breast-feed during treatment with Entecavir Accord.
Croatian: Ne smijete dojiti tijekom liječenja lijekom Entekavir Accord.
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Croatian: POSEBNO UPOZORENJE O ČUVANJU IZVAN POGLEDA
English: Film-coated tablet 30 film-coated tablets
Croatian: Filmom obložena tableta 30 filmom obloženih tableta
English: 1 mg once daily
Croatian: 1 mg jednom dnevno
English: Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Croatian: Oštećenje funkcije bubrega: Preporučuje se prilagoditi dozu kod bolesnika s oštećenjem funkcije bubrega (vidjeti dio 4.2).
English: 90 x 1 film-coated tablet; 9 blister cards of 10 x 1 film-coated tablet each in Alu/Alu perforated unit dose blisters.
Croatian: • 90 × 1 filmom obloženu tabletu; 9 blistera s 10 × 1 filmom obloženom tabletom, svaka u Al/Al perforiranim blisterima s jediničnim dozama
English: The Cmax, AUC(0-24), and Cmin for these subjects was 14.48 ng/ml, 38.58 ng∙h/ml, and 0.47 ng/ml, respectively.
Croatian: U tih je ispitanika Cmax iznosio 14,48 ng/ml, AUC(0-24) 38,58 ng∙h/ml, a Cmin 0,47 ng/ml.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Croatian: 4.2 Doziranje i način primjene Liječenje mora započeti liječnik s iskustvom u liječenju kronične infekcije hepatitisom B.
English: f Denominator is patients with abnormal values at baseline.
Croatian: U nazivniku su bolesnici s abnormalnim vrijednostima na početku ispitivanja.
English: LVD 100 mg once daily
Croatian: LVD 100 mg jednom dnevno
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.
Croatian: Ova se indikacija temelji, kako za kompenziranu, tako i za dekompenziranu bolest jetre, na podacima iz kliničkog ispitivanja u bolesnika s HBeAg pozitivnom i HBeAg negativnom HBV infekcijom prethodno nisu bili liječeni analozima nukleozida.
English: Entecavir
Croatian: Doziranje
English: Amylase levels > 3 times baseline occurred in 2% of patients, lipase levels > 3 times baseline in 18% and platelets < 50,000/mm3 in < 1%.
Croatian: Razine amilaze > 3 puta iznad početne vrijednosti javile su se u 2% bolesnika, razine lipaze > 3 puta iznad početne vrijednosti u 18% i trombociti < 50 000/mm3 u < 1% bolesnika.
English: Among entecavir-treated patients, on-treatment ALT elevations had a median time to onset of 4-5 weeks, generally resolved with continued treatment, and, in a majority of cases, were associated with a ≥ 2 log10/ml reduction in viral load that preceded or coincided with the ALT elevation.
Croatian: Među bolesnicima liječenima entekavirom, povišenja ALT-a tijekom liječenja nastupila su nakon medijana od 4-5 tjedana i općenito se povukla s nastavkom liječenja, a u većini su slučajeva bila povezana sa smanjenjem virusnog opterećenja od
English: In studies in lamivudine-refractory patients, with only limited numbers of patients being followed up, 11% of entecavir-treated patients and no lamivudine-treated patients developed ALT elevations during posttreatment follow-up.
Croatian: U ispitivanjima u bolesnika s hepatitisom refrakternim na lamivudin, kad se pratio samo ograničen broj bolesnika, povišenja ALT-a tijekom praćenja nakon liječenja nastupila su u 11% bolesnika liječenih entekavirom i niti u jednog bolesnika liječenog lamivudinom.
English: Human immunodeficiency virus (HIV)/HBV co-infected patients not receiving concomitant antiretroviral therapy: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Croatian: Bolesnici istodobno inficirani virusom humane imunodeficijencije (HIV) i HBV-om koji istodobno ne primaju antiretrovirusnu terapiju: Entekavir se nije ispitivao u bolesnika istodobno inficiranih HIVom i HVB-om koji nisu istodobno primali učinkovito liječenje protiv HIV-a.
English: Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies
Croatian: Pojava genotipske rezistencije na entekavir do kraja 5. godine ispitivanja u bolesnika prethodno neliječenih analozima nukleozida
English: Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets.
Croatian: Entekavir Accord dostupan je samo u obliku filmom obloženih tableta od 0,5 i 1 mg.
English: The Cmax, AUC(024), and Cmin for these subjects was 6.31 ng/ml, 18.33 ng h/ml, and 0.28 ng/ml, respectively.
Croatian: U tih je ispitanika Cmax iznosio 6,31 ng/ml, AUC(0-24) 18,33 ng∙h/ml, a Cmin 0,28 ng/ml.
English: In the presence of LVDr mutations, combination use of entecavir plus a second antiviral agent (which does not share cross-resistance with either lamivudine or entecavir) should be considered in preference to entecavir monotherapy (see section 4.4.
Croatian: Ako su prisutne LVDr mutacije, treba razmotriti i dati prednost kombiniranoj uporabi entekavira s drugim antivirusnim lijekom (koji ne dijeli križnu rezistenciju bilo s lamivudinom bilo s entekavirom) naspram monoterapije entekavirom (vidjeti dio 4.4.).
English: Laboratory test abnormalities: through week 48 among entecavir-treated patients with decompensated liver disease, none had ALT elevations both > 10 times ULN and > 2 times baseline, and 1% of patients had ALT elevations > 2 times baseline together with total bilirubin > 2 times ULN and > 2 times baseline.
Croatian: Abnormalnosti laboratorijskih nalaza: Do 48. tjedna niti jedan od bolesnika liječenih entekavirom s dekompenziranom bolešću jetre nije imao povišenja ALT > 10 puta iznad GGN i > 2 puta iznad početne vrijednosti, a 1% bolesnika imao je povišenja ALT > 2 puta iznad početne vrijednosti s ukupnim bilirubinom > 2 puta iznad GGN i > 2 puta iznad početne vrijednosti.
English: After adjusting for differences in creatinine clearance and body weight, elderly subjects had a 12.5% higher AUC than young subjects.The population pharmacokinetic analysis covering patients in the age range 1675 years did not identify age as significantly influencing entecavir pharmacokinetics.
Croatian: Nakon prilagodbe za razlike u klirensu kreatinina i tjelesnoj težini, stariji ispitanici imali su 12,5% višu AUC od mladih ispitanika.
English: ETV 1 mg once daily
Croatian: ETV 1 mg jednom dnevno
English: 0.5 mg once daily
Croatian: 0,5 mg jednom dnevno
English: This substitution was detected only in the presence of lamivudine resistance-associated substitutions rtL180M plus rtM204V.
Croatian: Ta je supstitucija bila opažena samo u prisutnosti supstitucija rtL180M plus rtM204V povezanih s rezistencijom na lamivudin.
English: Entecavir Accord contains soy polysaccharides
Croatian: Entekavir Accord sadrži polisaharide soje.