FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: De entecavir-behandlede patienter havde ved baseline tidligere været behandlet med lamivudin i gennemsnitligt 4,8 år og havde et gennemsnitligt CD4-tal på 494 celler/mm3 (kun 5 patienter havde CD4-tal < 200 celler/mm3).
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
Danish: Genotypevurdering blev udført hos alle patienter med tilgængelige prøver, som havde virologisk svigt til og med uge 96 eller HBV-DNA ≥ 50 IE/ml ved uge 48 eller uge 96 .
English: Lamivudine-refractory HBeAg positive (study 026) ETV 1.0 mg once daily LVD 100 mg once daily n
Danish: Lamivudin-refraktær HBeAg-positiv (studie 026) ETV 1,0 mg én gang dagligt
English: Prothrombin time (≤1 X ULN)b a Roche COBAS Amplicor PCR assay (LLOQ = 300 copies/ml).
Danish: Protrombintid (≤1 X ULN)b a Roche COBAS Amplicor PCR-assay (LLOQ = 300 kopier/ml).
English: Entecavir Accord contains soy polysaccharides
Danish: Entecavir Accord indeholder polysakkarider
English: High baseline Knodell necroinflammatory scores (> 10) were associated with greater histological improvement in nucleoside-naive patients.
Danish: Høje baseline Knodell nekroinflammatoriske scorer (> 10) var forbundet med større histologisk forbedring hos patienter, der ikke tidligere havde været i nukleosidbehandling.
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).
Danish: Det lavere Cmax og AUC ved samtidig fødeindtagelse betragtes ikke som værende klinisk relevant hos patienter, der ikke tidligere har været behandlet med nukleosid, men kan påvirke effekten hos lamivudin-refraktære patienter (se pkt.
English: Contents of the pack and other information What Entecavir Accord contains
Danish: Pakningsstørrelser og yderligere oplysninger Entecavir Accord indeholder:
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.
Danish: For patienter med LVDr-substitutioner ved baseline var andelen af patienter med HBV-DNA <300 kopier/ml 44% for entecavir og 20% for adefovir i uge 24 og 50% for entecavir og 17% for adefovir i uge 48.
English: ALT normalisation (≤ 1 times ULN) occurred in 27% of entecavir-treated and 21% of lamivudine-treated patients at end of dosing.
Danish: Der sås ALAT-normalisering (≤ 1 gange ULN) hos 27% af de entecavir-behandlede og 21% af de lamivudinbehandlede patienter ved behandlingens afslutning.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT (BOTTLE AND BLISTER PRESENTATIONS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE TEKST PÅ YDRE KARTON (BEHOLDER OG BLISTERPAKNINGER)
English: - emerging genotypic ETVrc - genotypic ETVrc with virologic breakthroughd
Danish: - opståen af genotype-ETVrc - genotype-ETVrc med virologisk svigt d
English: Patients with lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance than patients without lamivudine resistance.
Danish: Patienter med lamivudin-resistent HBV har højere risiko for efterfølgende at udvikle entecavir-resistens end patienter, der ikke er lamivudin-refraktære.
English: Lactic acidosis and severe hepatomegaly with steatosis: occurrences of lactic acidosis (in the absence of hypoxaemia), sometimes fatal, usually associated with severe hepatomegaly and hepatic steatosis, have been reported with the use of nucleoside analogues.
Danish: Laktacidose og svær hepatomegali med steatose: Der er indberettet tilfælde af laktacidose (uden hypoksæmi), i nogle tilfælde letal, sædvanligvis forbundet med svær hepatomegali og leversteatose, ved brug af nukleosidanaloger.
English: In cell culture, entecavir selected for an M184I substitution at micromolar concentrations, confirming inhibitory pressure at high entecavir concentrations.
Danish: I cellekulturer valgte entecavir en M184I-substitution i mikromolære koncentrationer, hvilket beviste inhibitorisk aktivitet ved høje entecavir-koncentrationer.
English: Therefore, therapy with entecavir should not be used for HIV/HBV co-infected patients who are not receiving HAART.
Danish: Behandling med entecavir bør derfor ikke anvendes til hiv/HBV-inficerede patienter, som ikke får HAART.
English: Among lamivudine-refractory patients with baseline HBV DNA < 107 log10 copies/ml, 64% (9/14)
Danish: Blandt lamivudin-refraktære patienter med baseline HBV-DNA < 107 log10 kopier/ml opnåede 64%
English: In pregnant rats and rabbits administered entecavir, no effect levels for embryotoxicity and maternal toxicity corresponded to exposures ≥ 21 times those in humans.
Danish: Hos drægtige rotter og kaniner, der fik entecavir, svarede nul-effektniveauer for embryotoksicitet og toksicitet hos moderdyret til doser ≥ 21 gange humandosis.
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).
Danish: I toksikologiske studier med gentagne doser til hunde, sås reversibel perivaskulær inflammation i det centrale nervesystem, hvor 0-effekt dosis svarede til 19 og 10 gange den hos mennesker (ved henholdsvis 0,5 og 1 mg).
English: Emerging Genotypic Entecavir Resistance Through Year 5, Nucleoside-Naive Studies
Danish: Opståen af entecavir genotype-resistens til og med År 5 i forsøg med nukleosid-naive patienter
English: Patients treated with Entecavir Accord have reported the following side effects: 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.
Danish: Patienter behandlet med Entecavir Accord har indberettet følgende bivirkninger: almindelige (forekommer hos mellem 1 og 10 ud af 100 patienter): hovedpine, søvnløshed, voldsom træthed, svimmelhed, søvnighed, opkastning, diarré, kvalme, fordøjelsesbesvær og forhøjet indhold af leverenzymer i blodet.
English: The dose should be adjusted according to the patient's renal function (see dosage recommendations in renal impairment and section 5.2).
Danish: Dosis skal justeres i overensstemmelse med patientens nyrefunktion (se doseringsanbefalinger ved nyreinsufficiens samt pkt.
English: b Albumin (≥1 X LLN)
Danish: Albumin (≥1 X LLN)b
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).
Danish: Entecavirs sikkerhed hos pædiatriske patienter fra 2 til < 18 år er baseret på to igangværende kliniske forsøg med forsøgspersoner med kronisk HBV-infektion; et farmakokinetisk fase 2-forsøg (studie 028) og et fase 3-forsøg (studie 189).
English: Entecavir Accord are supplied in cartons containing 30 x 1 or 90 x 1 film-coated tablet (in unit-dose blisters) and in bottles containing 30 film-coated tablets.
Danish: Entecavir Accord fås i pakninger med 30 x 1 eller 90 x 1 filmovertrukket tablet (i enhedsdosisblister) og i beholdere med 30 filmovertrukne tabletter.
English: In juvenile rats administered entecavir from postnatal days 4 to 80, a moderately reduced acoustic startle response was noted during the recovery period (postnatal days 110 to 114) but not during the dosing period at AUC values ≥ 92 times those in humans at the 0.5 mg dose or paediatric equivalent dose.
Danish: Hos unge rotter, der fik entecavir fra dag 4 til 80 postnatalt, blev der observeret et reduceret respons for akustisk forskrækkelse i restitutionsperioden (dag 110 til 114 postnatalt) men ikke i doseringsperioden, ved AUC-værdier ≥ 92 gange AUC hos mennesker ved en dosis på 0,5 mg eller den tilsvarende dosis til børn og unge.
English: The ETVr substitutions at residues rtT184, rtS202 and rtM250 alone have only a modest effect on entecavir susceptibility, and have not been observed in the absence of LVDr substitutions in more than 1000 patient samples sequenced.
Danish: ETVr-substitutioner ved aminosyrerest rtT184, rtS202 og rtM250 alene har kun beskeden effekt på entecavirfølsomheden og er i mere end 1000 sekventerede patientprøver ikke observeret ved fravær af LVDr-substitutioner.
English: Paediatric population: Study 189 is an ongoing study of the efficacy and safety of entecavir among 180 nucleoside-treatment-naïve children and adolescents from 2 to < 18 years of age with HBeAgpositive chronic hepatitis B infection, compensated liver disease, and elevated ALT.
Danish: Pædiatrisk population: Studie 189 er et igangværende studie vedrørende entecavirs virkning og sikkerhed hos 180 nukleosid-naive børn og unge i alderen 2 til < 18 år med HBeAg-positiv kronisk hepatitis B-infektion, kompenseret leversygdom og forhøjet ALAT.
English: In these studies, the safety profiles, including laboratory abnormalities, were comparable for entecavir 0.5 mg daily (679 nucleoside-naive HBeAg positive or negative patients treated for a median of 53 weeks), entecavir 1 mg daily (183 lamivudine-refractory patients treated for a median of 69 weeks), and lamivudine.
Danish: I disse studier var sikkerhedsprofilerne, herunder afvigelser i laboratorieprøver, sammenlignelige for entecavir 0,5 mg dagligt (679 nukleosid-naive HBeAg-positive eller -negative patienter behandlet i gennemsnitligt 53 uger), entecavir 1 mg dagligt (183 lamivudin-refraktære patienter behandlet i gennemsnitligt 69 uger) og lamivudin.
English: Liver transplant recipients: renal function should be carefully evaluated before and during entecavir therapy in liver transplant recipients receiving cyclosporine or tacrolimus (see section 5.2).
Danish: Levertransplanterede patienter: Nyrefunktionen skal vurderes omhyggelig inden og under behandling med entecavir til levertransplanterede patienter, der får ciclosporin eller tacrolimus (se pkt.
English: Entecavir Accord is also indicated for the treatment of chronic HBV infection in nucleoside naive paediatric patients from 2 to < 18 years of age with compensated liver disease who have evidence of active viral replication and persistently elevated serum ALT levels, or histological evidence of moderate to severe inflammation and/or fibrosis.
Danish: Entecavir Accord er også indiceret til behandling af kronisk HBV-infektion hos nukleosid-naive pædiatriske patienter fra 2 til < 18 år med kompenseret leversygdom, som har tegn på aktiv virusreplikation og vedvarende forhøjet serum-ALAT eller histologisk påvist moderat til svær inflammation og/eller fibrose.
English: No data are available on the efficacy of entecavir in HBeAg-negative patients co-infected with HIV.
Danish: Der foreligger ingen data vedrørende effekten af entecavir hos HBeAgnegative patienter med samtidig hiv-infektion.
English: Dimension: Length 8.70 mm ± 0.20 mm, width 8.40 mm ± 0.20 mm and thickness 3.40 mm ± 0.30 mm.
Danish: Størrelse: Længde 8,70 mm ± 0,20 mm, bredde 8,40 mm ± 0,20 mm og tykkelse 3,40 mm ± 0,30 mm.
English: Entecavir is not a substrate, an inducer or an inhibitor of cytochrome P450 (CYP450) enzymes (see section 5.2).
Danish: Entecavir er ikke et substrat af og virker ikke inducerende eller hæmmende på cytokrom P450enzymer (CYP450) (se pkt.
English: achieved HBV DNA < 300 copies/ml at Week 48.
Danish: (9/14) HBV-DNA <300 kopier/ml i Uge 48.
English: Children weighing at least 32.6 kg may take the 0.5 mg tablet or an entecavir oral solution may be available.
Danish: Børn, der vejer mindst 32,6 kg kan tage 0,5 mg tabletten eller der kan fås en oral entecaviropløsning.
English: Dizziness, fatigue and somnolence are common side effects which may impair the ability to drive and use machines.
Danish: Svimmelhed, træthed og søvnighed er hyppige bivirkninger, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: Dimension: Length 11.00 mm ± 0.20 mm, width 10.60 mm ± 0.20 mm and thickness 4.20 mm ± 0.30 mm.
Danish: Størrelse: Længde 11,00 mm ± 0,20 mm, bredde 10,60 mm ± 0,20 mm og tykkelse 4,20 mm ± 0,30 mm.
English: (96%) had histological improvement as previously defined (see above), and 50/57 (88%) had a ≥ 1point decrease in Ishak fibrosis score.
Danish: Af disse patienter opnåede 55/57 (96%) histologisk forbedring som tidligere defineret (se ovenstående), og 50/57 (88%) opnåede ≥ 1 point fald i Ishak fibrose-score.
English: Recombinant viruses encoding adefovir-resistant substitutions at either rtN236T or rtA181V remained fully susceptible to entecavir.
Danish: Rekombinante vira, kodende for adefovir-resistente substitutioner ved rtN236T eller rtA181V, forblev fuldt følsomme over for entecavir.
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).
Danish: Dosis af entecavir var 0,5 mg dagligt i de pivotale forsøg (gennemsnitlig eksponering 85 uger) og 1 mg dagligt i rollover-forsøget (gennemsnitlig eksponering 177 uger), og 51 patienter i rollover-forsøget fik initialt også lamivudin (gennemsnitlig varighed 29 uger).
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.
Danish: Pædiatrisk population: Entecavirs farmakokinetik ved steady state blev undersøgt (studie 028) hos 24 nukleosid-naive forsøgspersoner og 19 lamivudin-erfarne HBeAG-positive pædiatriske forsøgspersoner i alderen 2 til < 18 år med kompenseret leversygdom.
English: 3 years After opening the bottle use within 90 days.
Danish: 3 år Efter åbning af beholder skal indholdet anvendes inden for 90 dage.
English: Entecavir Accord 0.5 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, polysorbate 80
Danish: Entecavir Accord 0,5 mg filmovertrukne tabletter Hypromellose, titandioxid (E171), macrogol, og polysorbat 80.
English: HIV/HBV co-infected patients receiving concomitant HAART: study 038 included 67 HBeAg positive and 1 HBeAg negative patients co-infected with HIV.
Danish: hiv/HBV-inficerede patienter, som samtidig får HAART-behandling: Studie 038 inkluderede 67 HBeAg-positive patienter og 1 HBeAg-negativ patient med samtidig hiv-infektion.
English: infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected withHBV and HIV.
Danish: inficerede patienter med inkompenseret leversygdom og i et klinisk forsøg med 68 patienter, der varco-inficerede med HBV og hiv.
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.
Danish: Hvis du tidligere har fået medicin, der indeholder lamivudin, skal du dog være opmærksom på følgende: Hvis du er skiftet til Entecavir Accord, fordi behandlingen med lamivudin ikke virkede, skal du tage Entecavir Accord på tom mave, én gang dagligt.
English: In rats, maternal toxicity, embryofoetal toxicity (resorptions), lower foetal body weights, tail and vertebral malformations, reduced ossification (vertebrae, sternebrae, and phalanges), and extra lumbar vertebrae and ribs were observed at high exposures.
Danish: Der er hos rotter observeret toksicitet hos moderdyret, embryo-føtal toksicitet (resorptioner), lavere føtal kropsvægt, hale- og vertebrale misdannelser, reduceret ossifikation (vertebra, sternebra og falanger) samt ekstra vertebrae lumbalis og ribben ved store doser.
English: The active substance is entecavir.
Danish: Aktivt stof: entecavir.
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.
Danish: Såvel baseline ALAT-niveauer ≥ 2 gange ULN som baseline HBV-DNA ≤ 9,0 log10 kopier/ml var forbundet med højere forekomst af virologisk respons (Uge 48 HBV-DNA < 400 kopier/ml) hos nukleosid-naive, HBeAg-positive patienter.
English: 3 of the 10 patients experienced virologic breakthrough (≥ 1 log10 increase above nadir).
Danish: Til og med Uge 240 oplevede 3 ud af de 10 patienter virologisk svigt (≥ 1 log10 stigning over nadir).
English: If you get any side effects, talk to your doctor or pharmacist or.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Entecavir Accord 1 mg film-coated tablets Hypromellose, titanium dioxide (E171), macrogol, iron oxide red (E172)
Danish: Entecavir Accord 1 mg filmovertrukne tabletter Hypromellose, titandioxid (E171), macrogol, og rød jernoxid (E172)
English: These substitutions were observed only in the presence of LVDr substitutions (rtM204V and rtL180M).
Danish: Disse substitutioner sås kun ved tilstedeværelsen af LVDr-substitutioner (rtM204V og rtL180M).
English: *p value vs lamivudine < 0.05 a patients with evaluable baseline histology (baseline Knodell Necroinflammatory Score ≥ 2) b a primary endpoint c Roche Cobas Amplicor PCR assay (LLOQ = 300 copies/ml)
Danish: *p-værdi vs. lamivudin < 0,05 a patienter med evaluérbar histologi ved baseline (baseline Knodell-nekroinflammatorisk score ≥ 2) b et primært endepunkt c Roche Cobas Amplicor PCR-assay (LLOQ = 300 kopier/ml)
English: In rabbits, embryo-foetal toxicity (resorptions), reduced ossification (hyoid), and an increased incidence of 13th rib were observed at high exposures.
Danish: Der er hos kaniner observeret embryo-føtal toksicitet (resorptioner), reduceret ossifikation (hyoid) samt øget forekomst af 13. ribben ved store doser.
English: Experience in patients with decompensated liver disease: the safety profile of entecavir in patients with decompensated liver disease was assessed in a randomized open-label comparative study in which patients received treatment with entecavir 1 mg/day (n = 102) or adefovir dipivoxil 10 mg/day (n = 89) (study 048).
Danish: Erfaring med patienter med inkompenseret leversygdom: Entecavirs sikkerhedsprofil hos patienter med inkompenseret leversygdom er blevet undersøgt i et randomiseret, åbent, sammenlignende studie, hvor patienter blev behandlet med entecavir 1 mg/dag (n=102) eller adefovirdipivoxil 10 mg/dag (n=89) (studie 048).
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).
Danish: Vurdering af resistens hos børn og unge er baseret på data fra nukleosid-naive pædiatriske patienter med HBeAg-positiv kronisk HBV-infektion i to igangværende kliniske forsøg (028 og 189).
English: This substitution was detected only in the presence of lamivudine resistance-associated substitutions rtL180M plus rtM204V.
Danish: Denne substitution blev kun fundet ved tilstedeværelsen af lamivudin-resistensassocierede substitutioner rtL180M plus rtM204V.
English: Breast-feeding: it is unknown whether entecavir is excreted in human milk.
Danish: Amning: Det vides ikke, om entecavir udskilles i modermælk.
English: Liver biopsy results: 57 patients from the pivotal nucleoside-naive studies 022 (HBeAg positive) and 027 (HBeAg negative) who enrolled in a long-term rollover study were evaluated for long-term liver histology outcomes.
Danish: Resultater fra leverbiopsi: 57 patienter fra pivotale nukleosid-naive studier 022 (HBeAg-positive) og 027 (HBeAg-negative), som deltog i et længerevarende rollover-forsøg, blev undersøgt for længerevarende påvirkning af leverhistologi.
English: Entecavir Accord must not be used during pregnancy unless specifically directed by your doctor.
Danish: Entecavir Accord må ikke anvendes under graviditet undtagen, hvis lægen har ordineret det til dig.
English: EXP After opening the bottle use within 90 days.
Danish: EXP Efter åbning af beholder skal indholdet anvendes inden for 90 dage.
English: Pharmacokinetics in paediatric patients with renal or hepatic impairment have not been studied.
Danish: Farmakokinetikken hos pædiatriske patienter med nedsat nyre- eller leverfunktion er ikke undersøgt.
English: ** on haemodialysis days, administer entecavir after haemodialysis.
Danish: **på hæmodialysedage administreres entecavir efter hæmodialysen.
English: Renal impairment: dosage adjustment is recommended for patients with renal impairment (see section 4.2).
Danish: Nyreinsufficiens: Justering af dosis anbefales til patienter med nyreinsufficiens (se pkt.
English: Severe cases, sometimes with fatal outcome, were associated with pancreatitis, liver failure/hepatic steatosis, renal failure and higher levels of serum lactate.
Danish: Svære tilfælde, i visse tilfælde med dødelig udgang, har været forbundet med pankreatitis, leversvigt/leversteatosis, nyresvigt og forhøjede niveauer af serum-lactat.
English: Reductions in HIV RNA have been reported in HIV/HBV co-infected patients receiving entecavir monotherapy without HAART.
Danish: Reduktioner i hiv-RNA er blevet rapporteret hos hiv/HBV-inficerede patienter, der modtog entecavir-monoterapi uden HAART.
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.
Danish: Blandt andet medregnes årsager som død, manglende virkning, bivirkning, noncompliance/manglende opfølgning som svigt (f.eks. HBV-DNA ≥ 300 kopier/ml) c NC=M (noncompleters=svigt) dDefineres som nedgang eller ingen ændring fra baseline i CTP-tal.
English: taking Entecavir Accord will not stop you from infecting other people with hepatitis B
Danish: selvom du tager Entecavir Accord, kan du stadig smitte andre med hepatitis-B virus
English: If it is almost time for your next dose, do not take the missed dose.
Danish: Hvis det næsten er tid til næste dosis, skal du ikke tage den glemte dosis, men vente og tage næste dosis til sædvanlig tid.
English: Calcium carbonate Starch, Pregelatinized Carmellose sodium Soy polysaccharides Citric acid monohydrate Sodium stearyl fumarate
Danish: Calciumcarbonat Stivelse, prægelatiniseret Carmellosenatrium Sojapolysakkarider Citronsyremonohydrat Natriumstearylfumarat
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE LABEL TEXT
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TEKST PÅ BEHOLDERENS ETIKET
English: In patients with a suboptimal virological response after 24 weeks of treatment with entecavir, a modification of treatment should be considered (see sections 4.5 and 5.1).
Danish: Hos patienter med suboptimal virologisk repons efter 24 ugers behandling med entecavir bør justering af behandlingen overvejes (se pkt.
English: The pharmacokinetics of entecavir following a single 1 mg dose in patients (without chronic hepatitis B infection) are shown in the table below:
Danish: Tabellen viser entecavirs farmakokinetik efter enkelt 1 mg dosis (til patienter uden kronisk hepatitis B-infektion):
English: Among entecavir-treated patients on-treatment exacerbations had a median time of onset of 4-5 weeks.
Danish: Blandt entecavir-behandlede patienter var den gennemsnitlige tid til ALAT-stigninger under behandling 4 - 5 uger.