FrancophonIA/ELRC3.0 huggingface dataset:
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Slovenian: Entecavir Accord 0,5 mg filmsko obložene tablete hipromeloza, titanov dioksid (E171), makrogol, polisorbat 80
English: Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Slovenian: Pojav interakcij med entekavirjem in drugimi zdravili zaradi vpliva na CYP450 je malo verjeten.
English: Entecavir Accord contains soy polysaccharides
Slovenian: Zdravilo Entecavir Accord vsebuje sojine polisaharide
English: In a peri-postnatal study in rats, no adverse effects on offspring were observed.
Slovenian: Pri študiji perinatalnega/postnatalnega razvoja škodljivih vplivov na mladiče niso opazili.
English: e Baseline mean MELD score was 17.1 for ETV and 15.3 for adefovir dipivoxil.
Slovenian: e Izhodiščna srednja vrednost ocene po MELD točkovanju je za ETV znašala 17,1, za adefovirdipivoksil pa 15,3. f Imenovalec so bolniki z nenormalnimi vrednostmi v izhodišču.
English: (ng·h /ml) (CV)
Slovenian: (ng·h /ml)
English: There are no recommendations for entecavir in children less than 2 years of age or weighing less than 10 kg.
Slovenian: Priporočila za uporabo entekavirja pri otrocih, mlajših od 2 let, ali otrocih s telesno maso, manjšo od 10 kg, niso na voljo.
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).
Slovenian: Pri prekinitvi zdravljenja je treba upoštevati naslednje: Pri HBeAg pozitivnih odraslih bolnikih mora zdravljenje trajati še vsaj 12 mesecev po doseženi serokonverziji HBe (izginotje HBeAg in HBV DNA ter pojav protiteles anti-HBe v dveh zaporednih vzorcih seruma, odvzetih z vsaj 3- do 6-mesečnim vmesnim presledkom) ali do serokonverzije HBs, oziroma do izgube učinkovitosti (glejte poglavje 4.4).
English: LVD 100 mg once daily
Slovenian: LVD 100 mg enkrat na dan
English: Baseline ALT levels ≥ 2 times ULN and baseline HBV DNA ≤ 9.0 log10 copies/ml were both associated with higher rates of virologic response (Week 48 HBV DNA < 400 copies/ml) in nucleoside-naive HBeAg-positive patients.
Slovenian: krat ULN in izhodiščne vrednosti HBV DNA ≤ 9,0 log10 kopij/ml povezane z višjim odstotkom virusnega odziva (HBV DNA < 400 kopij/ml v 48. tednu).
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).
Slovenian: Varnost entekavirja pri pediatričnih bolnikih, starih od 2 do < 18 let, temelji na podatkih dveh kliničnih preskušanj, ki še potekata, in sicer enem farmakokinetičnem preskušanju 2. faze (študija 028) in enem preskušanju 3. faze (študija 189) pri bolnikih s kronično okužbo s HBV. Iz teh preskušanj so na voljo podatki o 99-tedenskem (mediana vrednost) trajanju zdravljenja z entekavirjem pri
English: Tell your doctor immediately about any changes in symptoms that you notice after stopping treatment.
Slovenian: Če po prekinitvi zdravljenja opazite kakršne koli spremembe simptomov, o tem nemudoma obvestite svojega zdravnika.
English: CLR (ml/min) (SD)
Slovenian: (CV) CLR (ml/min) (SD)
English: 90 x 1 film-coated tablet
Slovenian: 90 x 1 filmsko obložena tableta
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.
Slovenian: V študijah pri bolnikih, neodzivnih na lamivudin, je bila skupna verjetnost za pojav genotipske odpornosti na entekavir po 1 letu zdravljenja 6%, po 2 letih zdravljenja 15%, po 3 letih zdravljenja 36%, po 4 letih zdravljenja 47% in po 5 letih zdravljenja 51%.
English: Psychiatric disorders: common : insomnia
Slovenian: Psihiatrične motnje: pogosti : nespečnost Bolezni živčevja:
English: High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients.
Slovenian: Visoke izhodiščne vrednosti stopnje vnetja in nekroze po Knodellu (> 10) so bile pri bolnikih, ki se še niso zdravili z nukleozidi, povezane z večjim izboljšanjem histološke slike.
English: If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach.
Slovenian: Da jemljite zdravilo Entecavir Accord na prazen želodec, vam bo zdravnik naročil tudi v primeru, ko je bolezen jeter že močno napredovala.
English: Also, lamivudine-refractory patients who achieved HBV DNA < 104 log10
Slovenian: Pri bolnikih, neodzivnih na lamivudin, ki so v 24. tednu po metodi PCR imeli vrednost HBV DNA <104 log10
English: 1 mg once daily
Slovenian: 1 mg enkrat na dan
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.
Slovenian: Vrednosti Cmax in Cmin v stanju dinamičnega ravnovesja so naslednje: pri 0,5 mg odmerku 4,2 ng/ml in 0,3 ng/ml, pri 1 mg odmerku pa 8,2 ng/ml in 0,5 ng/ml.
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammaliancell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Slovenian: Pri Amesovem testu mutagenosti na mikrobih, testu genskih mutacij v celicah sesalcev in testu celične transformacije embrionalnih celic sirijskega hrčka niso odkrili znakov genotoksičnosti.
English: In rabbits, embryo-foetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at high exposures.
Slovenian: Pri kuncih so pri visoki izpostavljenosti zasledili škodljive vplive na zarodke/plodove (resorpcije), zmanjšano osifikacijo (hioid) in večjo pojavnost 13-tega rebra.
English: Each 0.5 mg film-coated tablet contains 26 mg soy polysaccharides.
Slovenian: Ena 0,5 mg filmsko obložena tableta vsebuje 26 mg sojinih polisaharidov.
English: Absorption: entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.51.5 hours.
Slovenian: Največje koncentracije v plazmi so dosežene v 0,51,5 ure.
English: Tell your doctor if you are pregnant or planning to become pregnant.
Slovenian: Če ste noseči ali nameravate zanositi, to povejte svojemu zdravniku.
English: Nucleoside Naive HBeAg Positive (study 022)
Slovenian: Bolniki, ki se še niso zdravili z nukleozidi HBeAg pozitivni (študija 022)
English: Soy polysaccharides: This medicinal product contains soy polysaccharides.
Slovenian: Sojini polisaharidi: Zdravilo vsebuje sojine polisaharide.
English: For lamivudine (n = 355), cumulative response rates were 39% for HBV DNA < 300 copies/ml by PCR, 79% for ALT normalisation, 26% for HBeAg seroconversion, and 2% for HBsAg seroconversion (3% for HBsAg loss).
Slovenian: Pri zdravljenju z lamivudinom (n = 355) so bili kumulativni odstotki odziva naslednji: 39% za HBV DNA < 300 kopij/ml (s PCR), 79% za normalizacijo vrednosti ALT, 26% za serokonverzijo HBeAg in 2% za serokonverzijo HBsAg (3% za izginotje HBsAg).
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Slovenian: Po prekinitvi zdravljenja je treba redno nadzirati vrednosti ALT in HBV DNA v serumu (glejte poglavje 4.4).
English: Incorporation of additional ETVr amino acid changes rtT184, rtS202 or rtM250 decreases entecavir susceptibility in cell culture.
Slovenian: Vgraditev dodatnih aminokislin s substitucijami rtT184, rtS202 ali rtM250, ki so povezane z odpornostjo proti entekavirju (ETVr), zmanjša občutljivost za entekavir na celičnih kulturah.
English: infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected withHBV and HIV.
Slovenian: izvedenem pri 191 bolnikih, ki so bili okuženi z virusom HBV in so imeli dekompenzirano bolezen jeter, ter v kliničnem preskušanju pri 68 bolnikih, ki so bili sočasno okuženi z virusom HBV in virusom HIV.
English: No testicular changes were evident in a 1-year study in monkeys.
Slovenian: Pri 1-letnih študijah na opicah sprememb na modih niso zasledili.
English: There are limited data on patients co-infected with HIV who have low CD4 cell counts (< 200 cells/mm3).
Slovenian: Podatki pri bolnikih s sočasno okužbo z virusom HIV z nizkim številom CD4 celic
English: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Slovenian: Otroci s telesno maso vsaj 32,6 kg lahko jemljejo 0,5 mg tablete, na voljo pa je lahko tudi peroralna raztopina entekavirja.
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.
Slovenian: V prisotnosti mutacij LVDr je treba razmisliti o kombiniranem zdravljenju 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 (glejte poglavje 4.4).
English: Exacerbations after discontinuation of treatment: acute exacerbations of hepatitis have been reported in patients who have discontinued anti-hepatitis B virus therapy, including therapy with entecavir (see section 4.4).
Slovenian: Poslabšanja po prekinitvi zdravljenja: Po prekinitvi protivirusnega zdravljenja hepatitisa B, tudi zdravljenja z entekavirjem, so poročali o pojavu akutnih poslabšanj hepatitisa (glejte poglavje 4.4).
English: Film-coated tablet 30 film-coated tablets
Slovenian: filmsko obložena tableta 30 filmsko obloženih tablet
English: Patients with decompensated liver disease: 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.
Slovenian: Bolniki z dekompenzirano boleznijo jeter: v študiji 048 je 191 HBeAg pozitivnih ali negativnih bolnikov s kronično okužbo z virusom HBV in z znaki dekompenzacije jeter, opredeljene z oceno 7 ali večjo po CTP lestvici, prejemalo entekavir v odmerku 1 mg enkrat na dan ali adefovirdipivoksil v odmerku 10 mg enkrat na dan. Bolniki se zaradi okužbe z virusom HBV predhodno še niso ali pa so se zdravili (vendar pa ne z entekavirjem, adefovirdipivoksilom ali tenofovirdizoproksil fumaratom).
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors
Slovenian: Farmakoterapevtska skupina: zdravila za sistemsko zdravljenje virusnih infekcij, nukleozidni in nukleotidni zaviralci reverzne transkriptaze, oznaka ATC: J05AF10
English: Severe Managed with Haemodialysis
Slovenian: Močno zmanjšan Zdravljenje s hemodializo
English: With respect to the decision to initiate treatment in paediatric patients, see sections 4.2, 4.4, and 5.1.
Slovenian: Za odločanje glede uvedbe zdravljenja pri pediatričnih bolnikih glejte poglavja 4.2, 4.4 in 5.1.
English: When your treatment with Entecavir Accord is stopped, your doctor will continue to monitor you and take blood tests for several months.
Slovenian: Po prekinitvi zdravljenja z zdravilom Entecavir Accord boste še naprej pod zdravniškim nadzorom.
English: Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Slovenian: Poslabšanja po zdravljenju so običajno povezana z naraščanjem HBV DNA in domnevno večinoma sama izzvenijo, vendar pa so poročali tudi o hudih poslabšanjih, vključno s smrtnimi primeri.
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Slovenian: Izboljšanje histološke slike po prejšnji definiciji (glejte zgoraj) je bilo ugotovljeno pri 55/57 bolnikov (96%), zmanjšanje indeksa fibroze po Ishak-u za ≥ 1-točko pa pri 50/57 bolnikov
English: So, it is important to take appropriate precautions to prevent others from becoming infected with HBV. A vaccine is available to protect those at risk from becoming infected with HBV.
Slovenian: Za zaščito oseb, pri katerih obstaja tveganje za okužbo s HBV, je na voljo cepivo.
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).
Slovenian: Ocena odpornosti pri pediatrični populaciji temelji na podatkih iz dveh še potekajočih kliničnih preskušanj (028 in 189) pri pediatričnih bolnikih s HBeAg pozitivno kronično okužbo s HBV, ki se predhodno še niso zdravili z nukleozidi.
English: Experience in nucleoside-naive patients with compensated liver disease:
Slovenian: Izkušnje pri bolnikih s kompenzirano boleznijo jeter, neodzivnih na lamivudin:
English: Lamivudine-refractory or decompensated liver disease
Slovenian: Bolniki, neodzivni na lamivudin, ali bolniki z dekompenzirano boleznijo jeter
English: Through Week 240 in nucleoside-naive studies, genotypic evidence of ETVr substitutions at rtT184, rtS202, or rtM250 was identified in 3 patients treated with entecavir, 2 of whom experienced virologic breakthrough (see table).
Slovenian: Po 240 tednih zdravljenja v študijah pri bolnikih, ki se še niso zdravili z nukleozidi, so genotipske dokaze za ETVr substitucije na rtT184, rtS202 ali rtM250 odkrili pri 3 bolnikih, ki so se zdravili z entekavirjem.
English: ETV 0.5 mg once daily
Slovenian: ETV 0,5 mg enkrat na dan
English: There are no data on the effect of entecavir on transmission of HBV from mother to newborn infant.
Slovenian: Podatkov o vplivu entekavirja na prenos HBV z matere na novorojenca ni, zato je za preprečitev neonatalne okužbe s HBV treba izvesti ustrezne ukrepe.
English: Bilirubin (≤1 X ULN)b
Slovenian: ALT (≤ 1 x ULN)b albumina (≥ 1 x LLN)b bilirubina (≤ 1 x ULN)b protrombinskega časa
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
Slovenian: 30 x 1 filmsko obloženo tableto v 3 perforiranih pretisnih omotih za posamezne odmerke (Alu/Alu), ali
English: Entecavir Accord is only available as 0.5 and 1 mg film-coated tablets.
Slovenian: Zdravilo Entecavir Accord je na voljo le v obliki 0,5 mg in 1 mg filmsko obloženih tablet.
English: At baseline, patients had a mean CTP score of 8.59 and 26% of patients were CTP class C. The mean baseline Model for End Stage Liver Disease (MELD) score was 16.23.
Slovenian: izhodišču je srednja vrednost ocene po CTP lestvici znašala 8,59, 26% bolnikov pa je po tej isti lestvici spadalo v skupino C. Srednja vrednost ocene po MELD (“Model for End Stage Liver
English: Results at 48 weeks of randomised, double blind studies comparing entecavir (ETV) to lamivudine (LVD) in HBeAg positive (022) and HBeAg negative (027) patients are presented in the table.
Slovenian: Izkušnje pri bolnikih s kompenzirano boleznijo jeter, ki se še niso zdravili z nukleozidi: Rezultati 48-tedenskih, randomiziranih, dvojno slepih študij, ki so primerjale entekavir (ETV) z lamivudinom (LVD) pri HBeAg pozitivnih (022) in HBeAg negativnih (027) bolnikih, so predstavljeni v preglednici.
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.
Slovenian: Pri teh bolnikih je vrednost Cmax znašala 14,48 ng/ml, vrednost AUC (0-24) 38,58 ng h/ml, vrednost Cmin pa 0,47 ng/ml.
English: 30 x 1 film-coated tablets 90 x 1 film-coated tablets
Slovenian: Pakiranje v pretisnem omotu: 30 x 1 filmsko obložena tableta 90 x 1 filmsko obložena tableta
English: Lamivudine-resistant strains harboring rtL180M plus rtM204V in combination with amino acid substitution rtA181C conferred 16- to 122-fold reductions in entecavir phenotypic susceptibility.
Slovenian: Pri proti lamivudinu odpornih sevih s prisotnostjo rtL180M in rtM204V v kombinaciji z aminokislinsko substitucijo rtA181C je bila fenotipska občutljivost za entekavir manjša za
English: This medicinal product contains soy polysaccharides.
Slovenian: Zdravilo vsebuje sojine polisaharide.
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Slovenian: (≤ 1 krat ULN)b a Roche COBAS Amplicor PCR test (LLOQ = 300 kopij/ml).
English: Paediatric population: A lower rate of virologic response (HBV DNA < 50 IU/ml) was observed in paediatric patients with baseline HBV DNA ≥ 8.0 log10 IU/ml (see section 5.1).
Slovenian: ≥ 8,0 log10 i.e./ml, so opazili manjši delež virološkega odziva (HBV DNA < 50 i.e./ml) (glejte poglavje 5.1).
English: 30 x 1 film-coated tablet
Slovenian: 30 x 1 filmsko obložena tableta
English: Albumin levels < 2.5 g/dl occurred in < 1% of patients, amylase levels > 3 times baseline in 2%, lipase levels > 3 times baseline in 11% and platelets < 50,000/mm3 in < 1%.
Slovenian: Pri < 1% bolnikov so bile koncentracije albumina < 2,5 g/dl, pri 2% bolnikov vrednosti amilaze > 3 krat večje od izhodiščnih vrednosti, pri 11% bolnikov vrednosti lipaze > 3 krat večje od izhodiščnih vrednosti in pri < 1% bolnikov število trombocitov < 50.000/mm3.
English: virus (HBV) through sexual contact or body fluids (including blood contamination).
Slovenian: jemanje zdravila Entecavir Accord ne bo preprečilo prenosa okužbe z virusom hepatitisa B (HBV) na druge pri spolnih stikih ali s telesnimi izločki (vključno s krvjo).
English: Patients treated and monitored for resistance b
Slovenian: Bolniki, ki so bili zdravljeni in pri katerih so spremljali razvoj odpornostib
English: 0.5 mg once daily
Slovenian: 0,5 mg enkrat na dan
English: ALT normalizationa HBV DNA < 50 IU/mL
Slovenian: HBV DNA < 50 i.e./mla
English: It has not been demonstrated that Entecavir Accord is safe to use during pregnancy.
Slovenian: Varnost uporabe zdravila Entecavir Accord med nosečnostjo ni dokazana.
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance.
Slovenian: obstaja večje tveganje za nadaljnji razvoj odpornosti na entekavir kot pri bolnikih brez odpornosti na lamivudin.
English: Testicular changes (seminiferous tubular degeneration) were evident in repeat-dose toxicology studies in rodents and dogs at exposures ≥ 26 times those in humans.
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih so pri glodavcih in psih pri izpostavljenosti, ki je bila ≥ 26
English: For the 77 patients who continued entecavir treatment beyond 52 weeks (median 96 weeks), 40% of patients had HBV DNA < 300 copies/ml by PCR and 81% had ALT normalisation (≤ 1 times ULN) at end of dosing.
Slovenian: Pri zdravljenju z entekavirjem, ki je trajalo dlje kot 52 tednov (v povprečju 96 tednov), je ob koncu zdravljenja 40% od 77 bolnikov imelo HBV DNA < 300 kopij/ml (s PCR) in 81% normalne vrednosti ALT (≤ 1 krat ULN).
English: Patients had stable controlled HIV (HIV RNA < 400 copies/ml) with recurrence of HBV viraemia on a lamivudine-containing HAART regimen.
Slovenian: Bolniki so imeli stabilno nadzorovano breme HIV (HIV RNA < 400 kopij/ml)
English: Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies
Slovenian: Pojav genotipske odpornosti proti entekavirju tekom 5 let v študijah pri bolnikih, ki se še niso zdravili z nukleozidi
English: : anaphylactoid reaction
Slovenian: : anafilaktoidna reakcija
English: Treatment with nucleoside analogues should be discontinued when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur.
Slovenian: V primeru nenadnega povišanja vrednosti aminotransferaz, pojava progresivne hepatomegalije ali metabolične acidoze/laktacidoze neznane etiologije je treba zdravljenje z nukleozidnimi analogi prekiniti.
English: At baseline entecavir-treated patients had a median duration of prior lamivudine therapy of 4.8 years and median CD4 count of 494 cells/mm3 (with only 5 subjects having CD4 count < 200 cells/mm3).
Slovenian: CD4 je bila 494 celic/mm3 (le pri 5-ih osebah je bilo število celic CD4 < 200 celic/mm3).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT
Slovenian: PODATKI NA PRIMARNI OVOJNINI BESEDILO NA NALEPKI PLASTENKE
English: What Entecavir Accord is and what it is used for Entecavir Accord tablets are anti-viral medicines, used to treat chronic (long term) hepatitis B
Slovenian: Entecavir Accord tablete so protivirusno zdravilo, ki ga uporabljamo za zdravljenje kronične
English: In repeat-dose toxicology studies in dogs, reversible perivascular inflammation was observed in the central nervous system, for which no-effect doses corresponded to exposures 19 and 10 times those in humans (at 0.5 and 1 mg respectively).
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih so pri psih opazili reverzibilno perivaskularno vnetje v centralnem živčevju, pri čemer so odmerki brez učinka ustrezali izpostavljenosti, ki je bila 19
English: For 26 entecavir-treated and 28 lamivudine-treated patients who continued treatment beyond 52 weeks (median 96 weeks), 96% of entecavir-treated and 64% of lamivudine-treated patients had HBV DNA < 300 copies/ml by PCR at end of dosing.
Slovenian: Pri zdravljenju, ki je trajalo dlje kot 52 tednov (v povprečju 96 tednov), je 96% od 26 z entekavirjem zdravljenih bolnikov in 64% od 28 z lamivudinom zdravljenih bolnikov ob koncu zdravljenja imelo HBV DNA < 300 kopij/ml (s PCR).
English: After reaching peak levels, entecavir plasma concentrations decreased in a biexponential manner with a terminal elimination half-life of ≈ 128-149 hours.
Slovenian: Končna razpolovna doba izločanja je ≈ 128 - 149 ur.
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.
Slovenian: 90 x 1 filmsko obloženo tableto v 9 perforiranih pretisnih omotih za posamezne odmerke (Alu/Alu).
English: Bottle pack: 30 film-coated tablets
Slovenian: Pakiranje v plastenki: 30 filmsko obloženih tablet
English: Entecavir was superior to adefovir dipivoxil on the primary efficacy endpoint of mean change from baseline in serum HBV DNA by PCR at week 24.
Slovenian: Pri primarnem opazovanem dogodku učinkovitosti, to je srednji spremembi vrednosti HBV DNA (s PCR) v serumu v
English: If you were switched over to Entecavir Accord because the treatment with lamivudine was not successful, you should take Entecavir Accord on an empty stomach once daily.
Slovenian: V primeru zamenjave zdravljenja, če vam je zdravnik zdravilo Entecavir Accord predpisal zato, ker je bilo predhodno zdravljenje z zdravilom z zdravilno učinkovino lamivudin neuspešno, morate zdravilo
English: Viral load reduction (log10 copies/ml)c HBV DNA undetectable (< 300 copies/ml by PCR)c
Slovenian: Nedokazljivost HBV DNA (< 300 kopij/ml s PCR)c
English: Entecavir Accord 1 mg film-coated tablets Each tablet contains entecavir monohydrate equivalent to 1 mg entecavir.
Slovenian: Entecavir Accord 1 mg filmsko obložene tablete Ena tableta vsebuje 1 mg entekavirja v obliki entekavir monohidrata.
English: Emergence of HIV resistance has been observed when entecavir was used to treat chronic hepatitis B infection in patients with HIV infection not receiving highly active antiretroviral therapy (HAART) (see section 5.1).
Slovenian: Active Antiretroviral Therapy), so pri zdravljenju kronične okužbe z virusom hepatitisa B z entekavirjem poročali o pojavu odpornosti virusa HIV (glejte poglavje 5.1).
English: Blister packs: EU/1/17/1211/005 EU/1/17/1211/006
Slovenian: Pakiranje v pretisnih omotih: EU/1/17/1211/005 EU/1/17/1211/006
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B.