FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Pri teh bolnikih je vrednost Cmax znašala 6,31 ng/ml, vrednost AUC (0-24) 18,33 ng h/ml, vrednost Cmin pa 0,28 ng/ml.
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.
Slovenian: HBeAg pozitivni (študija 026): pri zdravljenju z entekavirjem do 96 tednov (n = 141) so bili kumulativni odstotki odziva naslednji: 30% za HBV DNA < 300 kopij/ml (s PCR) in 85% za normalizacijo vrednosti ALT ter 17% za serokonverzijo HBeAg.
English: Entecavir
Slovenian: Odmerjanje
English: In studies with lamivudine-refractory patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 11% of lamivudine treated patients.
Slovenian: študijah pri bolnikih, neodzivnih na lamivudin, so se vrednosti ALT med zdravljenjem povečale za > 10 krat od ULN in > 2 krat od izhodiščnih vrednosti pri 2% bolnikov, ki so se zdravili z entekavirjem in 11% bolnikov, ki so se zdravili z lamivudinom.
English: Dizziness, fatigue and somnolence are common side effects which may impair the ability to drive and use machines.
Slovenian: Sposobnost vožnje in upravljanja strojev lahko zmanjšajo omotica, utrujenost in somnolenca, ki so pogosti neželeni učinki.
English: Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Slovenian: 4.6 Plodnost, nosečnost in dojenje Ženske v rodni dobi: Ženske v rodni dobi morajo uporabljati učinkovito kontracepcijo, saj možna tveganja za razvoj ploda niso znana.
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.
Slovenian: Immunodeficiency Virus) in HBV, ki sočasno ne prejemajo protiretrovirusnega zdravljenja: Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se sočasno niso zdravili z učinkovito obliko zdravljenja okužbe z virusom HIV, uporabe entekavirja niso ovrednotili.
English: HBeAg negative (study 027): treatment with entecavir up to 96 weeks (n = 325) resulted in cumulative response rates of 94% for HBV DNA < 300 copies/ml by PCR and 89% for ALT normalisation versus 77% for HBV DNA < 300 copies/ml by PCR and 84% for ALT normalisation for lamivudine-treated patients (n = 313).
Slovenian: HBeAg negativni (študija 027): pri zdravljenju z entekavirjem do 96 tednov (n = 325) so bili kumulativni odstotki odziva naslednji: 94% za HBV DNA < 300 kopij/ml (s PCR) in 89% za normalizacijo vrednosti ALT, pri zdravljenju z lamivudinom (n = 313) pa 77% za HBV DNA < 300 kopij/ml (s PCR) in 84% za normalizacijo vrednosti ALT.
English: Laboratory test abnormalities: In clinical studies with nucleoside-naive patients, 5% had ALT elevations > 3 times baseline, and < 1% had ALT elevations > 2 times baseline together with total bilirubin > 2 times upper limit of normal (ULN) and > 2 times baseline.
Slovenian: Odstopanja od normalnih vrednosti laboratorijskih preiskav: V kliničnih študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so bile pri 5% bolnikov vrednosti ALT > 3 krat večje od izhodiščnih vrednosti, pri < 1% bolnikov pa so bile vrednosti ALT > 2 krat večje od izhodiščnih vrednosti in sočasno povečane tudi vrednosti skupnega bilirubina, ki so bile > 2 krat večje od zgornje meje normalne vrednosti (ULN - Upper Limit of Normal”) in > 2 krat večje od izhodiščnih vrednosti.
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, might be indicative of lactic acidosis development.
Slovenian: Pojav laktacidoze lahko nakazujejo benigni prebavni simptomi, kot so navzea, bruhanje in abdominalna bolečina.
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Slovenian: Izboljšanje stopnje fibroze po Ishak-u
English: Entecavir Accord 0.5 mg film-coated tablets Entecavir Accord 1 mg film-coated tablets
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete Entecavir Accord 1 mg filmsko obložene tablete
English: Blister packs: EU/1/17/1211/002 EU/1/17/1211/003
Slovenian: Pakiranje v pretisnih omotih: EU/1/17/1211/002 EU/1/17/1211/003
English: Nervous system disorders: common : headache, dizziness, somnolence Gastrointestinal disorders: common : vomiting, diarrhoea, nausea, dyspepsia Hepatobiliary disorders: common : increased transaminases Skin and subcutaneous tissue disorders: uncommon : rash, alopecia General disorders and administration site conditions: common : fatigue
Slovenian: pogosti : glavobol, omotica, somnolenca Bolezni prebavil: pogosti : bruhanje, driska, navzea, dispepsija
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.
Slovenian: Pri bolnikih s substitucijami LVDr v izhodišču je bila vrednost HBV DNA < 300 kopij/ml v 24. tednu dosežena pri 44% bolnikov, ki so se zdravili z entekavirjem, in 20% bolnikov, ki so se zdravili z adefovirjem.
English: Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Slovenian: Rasa: Analiza populacijske farmakokinetike ne kaže, da bi rasa pomembneje vplivala na farmakokinetiko entekavirja, vendar pa lahko o tem sklepamo le pri osebah kavkaškega in azijskega porekla, saj je bilo število oseb drugačnega porekla premajhno.
English: Your doctor will monitor you regularly while you are receiving Entecavir Accord.
Slovenian: Med zdravljenjem z zdravilom Entecavir Accord boste pod rednim zdravniškim nadzorom.
English: Entecavir Accord 1 mg tablets entecavir
Slovenian: Entecavir Accord 1 mg tablete entekavir
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%.
Slovenian: Pri 2% bolnikov so bile vrednosti amilaze > 3 krat večje od izhodiščnih vrednosti, pri 18% bolnikov vrednosti lipaze > 3 krat večje od izhodiščnih vrednosti in pri < 1% bolnikov število trombocitov < 50.000/mm3.
English: There is a doseproportionate increase in Cmax and AUC values following multiple doses ranging from 0.1-1 mg. Steady-state is achieved between 6-10 days after once daily dosing with ≈ 2 times accumulation.
Slovenian: Stanje dinamičnega ravnovesja je doseženo v 6-ih do 10-ih dneh po začetku odmerjanja enkrat na dan s ≈ 2-kratno akumulacijo.
English: HIV/HBV co-infected patients not receiving concomitant HAART: entecavir has not been evaluated in HIV/HBV co-infected patients not concurrently receiving effective HIV treatment.
Slovenian: Bolniki s sočasno okužbo s HIV/HBV, ki se sočasno ne zdravijo po režimu HAART: Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se sočasno niso zdravili z učinkovito obliko zdravljenja okužbe z virusom HIV, uporabe entekavirja niso ovrednotili.
English: Clinical resistance in Adults: patients in clinical trials initially treated with entecavir 0.5 mg (nucleoside-naive) or 1.0 mg (lamivudine-refractory) and with an on-therapy PCR HBV DNA measurement at or after Week 24 were monitored for resistance.
Slovenian: Klinična odpornost pri odraslih: V kliničnih preskušanjih so spremljali odpornost pri bolnikih, ki so se v začetku zdravili z entekavirjem 0,5 mg (bolniki, ki se še niso zdravili z nukleozidi) ali 1 mg
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.
Slovenian: Po prilagoditvi glede na razlike kreatininskega očistka in telesne mase so bile pri starostnikih vrednosti AUC za 12,5% večje od vrednosti pri mlajših osebah.
English: Entecavir Accord 0.5 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir .
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete Ena tableta vsebuje 0,5 mg entekavirja v obliki entekavir monohidrata.
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.
Slovenian: V študijah pri bolnikih, neodzivnih na lamivudin, so po prekinitvi zdravljenja spremljali le manjše število bolnikov.
English: Patients with decompensated liver disease: a higher rate of serious hepatic adverse events (regardless of causality) has been observed in patients with decompensated liver disease, in particular in those with Child-Turcotte-Pugh (CTP) class C disease, compared with rates in patients with compensated liver function.
Slovenian: Bolniki z dekompenzirano boleznijo jeter: V primerjavi z bolniki s kompenziranim delovanjem jeter so pri bolnikih z dekompenzirano boleznijo jeter opazili večji odstotek resnih jetrnih neželenih dogodkov
English: HBeAg positive (study 022): treatment with entecavir for up to 96 weeks (n = 354) resulted in cumulative response rates of 80% for HBV DNA < 300 copies/ml by PCR, 87% for ALT normalisation, 31% for HBeAg seroconversion and 2% for HBsAg seroconversion (5% for HBsAg loss).
Slovenian: HBeAg pozitivni (študija 022): pri zdravljenju z entekavirjem do 96 tednov (n = 354) so bili kumulativni odstotki odziva naslednji: 80% za HBV DNA < 300 kopij/ml (s PCR), 87% za normalizacijo vrednosti ALT, 31% za serokonverzijo HBeAg in 2% za serokonverzijo HBsAg (5% za izginotje HBsAg).
English: Adefovir Dipivoxil 10 mg once daily
Slovenian: 1 mg enkrat na dan adefovirdipivoksil 10 mg enkrat na dan
English: Baseline HBV DNA < 8 log10 IU/ml Baseline HBV DNA ≥ 8 log10 IU/ml aNC=F (noncompleter=failure) * Patients randomized to placebo who did not have HBe- seroconversion by Week 48 rolled over to open-label entecavir for the second year of the study; therefore randomized comparison data are available only through Week 48.
Slovenian: * Bolniki, randomizirani na placebo, ki niso dosegli serokonverzije Hbe do 48. tedna, so v drugem letu študije prešli na odprto zdravljenje z entekavirjem, zato so randomizirani primerjalni podatki na voljo le do 48. tedna.
English: If you get any side effects, talk to your doctor or pharmacist.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom ali s farmacevtom.
English: Paediatric population: the steady-state pharmacokinetics of entecavir were evaluated (study 028) in 24 nucleoside naïve and 19 lamivudine-experienced HBeAg-positive paediatric subjects from 2 to < 18 years of age with compensated liver disease.
Slovenian: (študija 028) pri 24 z nukleozidi predhodno še nezdravljenimi in 19 z lamivudinom predhodno zdravljenimi HBeAg pozitivnimi pediatričnimi bolniki, starih od 2 do < 18 let, s kompenzirano boleznijo jeter.
English: Entecavir Accord is indicated for the treatment of chronic hepatitis B virus (HBV) infection (see section 5.1) in adults with: 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.
Slovenian: s kompenzirano boleznijo jeter in dokazano aktivno replikacijo virusa, persistentno povečanimi vrednostmi serumske alanin-aminotransferaze (ALT) in histološko dokazanim aktivnim vnetjem in/ali fibrozo.
English: Entecavir Accord 0.5 mg tablets entecavir
Slovenian: Entecavir Accord 0,5 mg tablete entekavir
English: MELD score Mean change from baselinec,e
Slovenian: Ocena po MELD točkovanju Povprečna sprememba od izhodiščac,e -2,0
English: Some patients must take Entecavir Accord on an empty stomach (see Entecavir Accord with food and drink in Section 2).
Slovenian: Nakateri bolniki morajo jemati zdravilo Entecavir Accord na prazen želodec (glejte Zdravilo
English: Therefore, in patients with both decompensated liver disease and lamivudine-resistant HBV, 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.
Slovenian: Pri bolnikih s potrjeno okužbo z virusom HBV, odpornim na lamivudin, je treba razmisliti o uvedbi kombiniranega zdravljenja z entekavirjem in drugim protivirusnim zdravilom (ki si ne deli navzkrižne odpornosti ne z lamivudinom ne z entekavirjem) in takšnemu zdravljenju dati prednost pred monoterapijo z entekavirjem.
English: - genotypic ETVr c with virologic breakthrough d a Results reflect use of a 1-mg dose of entecavir for 147 of 149 patients in Year 3 and all patients in Years 4 and 5 and of combination entecavir-lamivudine therapy (followed by long-term entecavir therapy) for a median of 20 weeks for 130 of 149 patients in Year 3 and for 1 week for 1 of 121 patients in Year 4 in a rollover study.
Slovenian: 5. letu ter kombinirano zdravljenje z entekavirjem in lamivudinom (čemur je sledilo dolgotrajno zdravljenje z entekavirjem) z mediano 20 tednov pri 130 od 149 bolnikov v 3. letu ter 1 tedna pri 1 od 121 bolnikov v 4 letu v nadaljnji študiji.
English: How to store Entecavir Accord
Slovenian: Shranjevanje zdravila Entecavir Accord
English: had a ≥ 2-point decrease.
Slovenian: Zasledili pa so manjše količine presnovkov II.
English: Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
Slovenian: Po dajanju 14C-entekavirja niso zasledili oksidiranih ali acetiliranih presnovkov.
English: Entecavir Accord dosage*
Slovenian: Odmerjanje* zdravila Entecavir Accord
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14)
Slovenian: Pri bolnikih, neodzivnih na lamivudin, z izhodiščno vrednostjo HBV DNA <107 log10 kopij/ml je bila v 48. tednu pri 64% (9/14) dosežena vrednost HBV DNA <300 kopij/ml.
English: Experience in patients co-infected with HIV: the safety profile of entecavir in a limited number of HIV/HBV co-infected patients on lamivudine-containing HAART (highly active antiretroviral therapy) regimens was similar to the safety profile in monoinfected HBV patients (see section 4.4).
Slovenian: in HBV, ki so se med protiretrovirusnem zdravljenju po režimu HAART zdravili tudi z lamivudinom, je bil varnostni profil entekavirja podoben kot pri bolnikih, okuženih le s HBV (glejte poglavje 4.4).
English: 0.05 mg once daily* OR 0.5 mg every 5-7 days
Slovenian: 0,5 mg vsakih 5-7 dni
English: There was no apparent difference in efficacy for entecavir based on gender (≈ 25% women in the clinical trials) or age (≈ 5% of patients > 65 years of age).
Slovenian: Glede na spol (≈ 25% žensk v kliničnih preskušanjih) ali starost (≈ 5% bolnikov, starejših od 65 let) se učinkovitost entekavirja očitneje ne razlikuje.
English: ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Slovenian: Ob koncu zdravljenja je 27% z entekavirjem zdravljenih in 21% z lamivudinom zdravljenih bolnikov imelo normalne vrednosti ALT (≤ 1 krat ULN).
English: Exacerbations during treatment: in studies with nucleoside naive patients, on treatment ALT elevations > 10 times ULN and > 2 times baseline occurred in 2% of entecavir treated patients vs 4% of lamivudine treated patients.
Slovenian: Poslabšanja med zdravljenjem: V študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so se vrednosti ALT med zdravljenjem povečale za > 10 krat od ULN in > 2 krat od izhodiščnih vrednosti pri 2% bolnikov, ki so se zdravili z entekavirjem in 4% bolnikov, ki so se zdravili z lamivudinom.
English: In a small percentage of lamivudine-refractory patients, ETVr substitutions at residues rtT184, rtS202 or rtM250 were present at baseline.
Slovenian: Pri majhnem odstotku bolnikov, neodzivnih na lamivudin, so bile ETVr substitucije na ostankih rtT184,
English: Some people get very serious hepatitis symptoms when they stop taking Entecavir Accord.
Slovenian: Pri nekaterih bolnikih se po prekinitvi zdravljenja z zdravilom Entecavir Accord lahko pojavijo zelo resni bolezenski znaki hepatitisa.
English: The entecavir dosage was 0.5 mg daily in the pivotal studies (mean exposure 85 weeks) and 1 mg daily in the rollover study (mean exposure 177 weeks), and 51 patients in the rollover study initially also received lamivudine (median duration 29 weeks).
Slovenian: V ključnih študijah so bolniki prejemali entekavir v odmerku 0,5 mg na dan (srednji čas izpostavljenosti 85 tednov), v obnovljeni študiji pa 1 mg na dan (srednji čas izpostavljenosti
English: Entecavir Accord tablets are also used to treat chronic (long term) HBV infection in children and adolescents aged 2 years to less than 18 years.
Slovenian: Entecavir Accord tablete uporabljamo tudi za zdravljenje kronične (dolgotrajne) okužbe s HBV
English: Therefore, therapy with entecavir should not be used for HIV/HBV co-infected patients who are not receiving HAART.
Slovenian: Pri bolnikih s sočasno okužbo z virusoma HIV in HBV, ki se ne zdravijo po režimu HAART, se entekavir torej ne sme uporabljati.
English: At end of dosing, among patients who continued treatment beyond 52 weeks (median of 96 weeks), 81% of 243 entecavir-treated and 39% of 164 lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR while ALT normalisation (≤ 1 times ULN) occurred in 79% of entecavirtreated and 68% of lamivudine-treated patients.
Slovenian: 81% od 243 z entekavirjem zdravljenih bolnikov in 39% od 164 z lamivudinom zdravljenih bolnikov imelo HBV DNA < 300 kopij/ml (s PCR), normalne vrednosti ALT (≤ 1 krat ULN) pa 79% z entekavirjem zdravljenih in 68% z lamivudinom zdravljenih bolnikov.
English: Two-year carcinogenicity studies: in male mice, increases in the incidences of lung tumours were observed at exposures ≥ 4 and ≥ 2 times that in humans at 0.5 mg and 1 mg respectively.
Slovenian: Dvoletne študije kancerogenosti: pri mišjih samcih so opazili večjo pojavnost pljučnih tumorjev pri izpostavljenosti ≥ 4-krat od izpostavljenosti človeka pri odmerku 0,5 mg in ≥ 2-kratni izpostavljenosti človeka pri odmerku 1 mg. Pred pojavom tumorja so zasledili proliferacijo pnevmocitov, česar pa pri podganah, psih ali opicah niso opazili, kar kaže, da je ključni dogodek pri razvoju pljučnega tumorja, ki so ga opazili pri miših, lahko vrstno specifičen.
English: Entecavir Accord 1 mg film-coated tablets entecavir
Slovenian: Entecavir Accord 1 mg filmsko obložene tablete entekavir
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.
Slovenian: Vzroki za predčasno prekinitev zdravljenja so lahko smrt, pomanjkanje učinkovitosti, neželeni učinki, nesodelovanje bolnika, onemogočeno spremljanje bolnika ipd. c NC=M (bolnik, pri katerem študija ni bila dokončana=manjkajoči podatek).
English: *p<0.05
Slovenian: *p vrednost v primerjavi z lamivudinom < 0,05
English: Exacerbations of hepatitis: spontaneous exacerbations in chronic hepatitis B are relatively common and are characterised by transient increases in serum ALT. After initiating antiviral therapy, serum ALT may increase in some patients as serum HBV DNA levels decline (see section 4.8).
Slovenian: Pri nekaterih bolnikih se po uvedbi protivirusnega zdravljenja vrednosti serumske ALT lahko povišajo, medtem ko se vrednosti serumske HBV DNA zmanjšajo (glejte poglavje 4.8).
English: 0.3 mg once daily* OR 0.5 mg every 48 hours
Slovenian: 0,5 mg vsakih 48 ur
English: For patients with baseline Ishak fibrosis score ≥ 2, 25/43 (58%)
Slovenian: ≥ 2-točki ugotovili pri 25/43 bolnikov (58%).
English: Entecavir Accord 1 mg film-coated tablets Bottle packs:
Slovenian: Entecavir Accord 1 mg filmsko obložene tablete Pakiranje v plastenkah:
English: Entecavir Accord 0.5 mg film-coated tablets
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete
English: Entecavir Accord 0.5 mg film-coated tablets Bottle packs:
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete Pakiranje v plastenkah:
English: Patients should be monitored closely for adverse reactions when entecavir is coadministered with such medicinal products.
Slovenian: Bolnike, ki se sočasno zdravijo z entekavirjem in omenjenimi zdravili, je treba skrbno nadzirati glede pojava neželenih učinkov.
English: Entecavir Accord 0.5 mg film-coated tablets: White to off white, triangle shaped, biconvex filmcoated tablets debossed with ‘J' on one side and ‘110' on other side.
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete: bele do umazano bele barve, bikonveksne in trikotne oblike.
English: Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Slovenian: V stanju dinamičnega ravnovesja se približno 75% odmerka izloči v nespremenjeni obliki.
English: Pre-existing lamivudine-resistant HBV is associated with an increased risk for subsequent entecavir resistance regardless of the degree of liver disease; in patients with decompensated liver disease, virologic breakthrough may be associated with serious clinical complications of the underlying liver disease.
Slovenian: Že obstoječa odpornost virusa HBV proti lamivudinu je povezana z večjim tveganjem za kasnejši razvoj odpornosti proti entekavirju, ne glede na stopnjo bolezni jeter.
English: These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
Slovenian: 195 HBeAg pozitivnih bolnikih, ki se predhodno še niso zdravili z nukleozidi.
English: Mild
Slovenian: Normalen
English: Proportion undetectable (<300 copies/ml)b 49%* Mean change from baseline (log10 copies/ml)
Slovenian: Delež nedokazljivih (<300 kopij/ml)b
English: An oral solution may be available for patients with body weight less than 32.6 kg.
Slovenian: Pri bolnikih s telesno maso, manjšo od 32,6 kg, je treba uporabljati peroralno raztopino.
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.
Slovenian: študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so se med spremljanjem po zdravljenju vrednosti ALT povečale (za > 10 krat od ULN in > 2 krat od referenčne vrednosti [najmanjše ob izhodišču ali zadnje, izmerjene ob prekinitvi zdravljenja]) pri 6% bolnikov, ki so se zdravili z entekavirjem in 10% bolnikov, ki so se zdravili z lamivudinom.
English: Each tablet contains entecavir monohydrate equivalent to 0.5 mg entecavir.
Slovenian: Ena tableta vsebuje 0,5 mg entekavirja v obliki entekavir monohidrata.
English: Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Slovenian: Ena tableta vsebuje 1 mg entekavirja v obliki entekavir monohidrata.
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.
Slovenian: Pri bolnikih, ki so se zdravili z entekavirjem, je bil kumulativni delež smrtnih izidov med študijo 23-odstoten (23/102), pri bolnikih, ki so se zdravili z adefovirdipivoksilom pa 33-odstoten (29/89).
English: Method of administration Entecavir Accord should be taken orally.
Slovenian: Zdravilo Entecavir Accord mora bolnik jemati peroralno.