FrancophonIA/ELRC3.0 huggingface dataset:
English: This study is a phase III, randomised, double-blind study of telbivudine 600 mg once daily compared to lamivudine 100 mg once daily for a treatment period of 104 weeks in 332 nucleosidenaïve chronic hepatitis B HBeAg-positive and HBeAg-negative Chinese patients.
Danish: Dette studie er et fase-III, randomiseret, dobbeltblindet studie af telbivudin 600 mg givet én gang daglig sammenlignet med lamivudin 100 mg givet én gang daglig i en behandlingsperiode på 104 uger i 332 nukleosid-naive kroniske hepatitis B HBeAg-positive og HBeAg-negative kinesiske patienter.
English: Outcome results at week 104, based on level of HBV DNA at week 24, for either HBeAg-positive or HBeAg-negative patients are presented in Table 7.
Danish: Resultater i uge 104 baseret på HBV-DNA niveau i uge 24 for henholdsvis HBeAg-positive og HBeAg-negative patienter er vist i Tabel 7.
English: Push the plunger slowly and carefully until the solution reaches the 6 ml mark.
Danish: Skub langsomt og forsigtigt til stemplet, indtil opløsningen når 6 ml mærket.
English: Missing week 52 biopsy
Danish: Manglende biopsi i uge 52 12 %
English: These patients should be closely monitored for clinical, biochemical and virological parameters associated with hepatitis B during treatment and after treatment is discontinued.
Danish: Under og efter behandling skal disse patienter monitoreres tæt for kliniske, biokemiske og virologiske parametre, der associeres med hepatitis B.
English: Outcome for key efficacy end points at 104 weeks based on week 24 results Therapeutic response n/N (%)
Danish: HBV-DNA uge 24 Resultat af vigtigste endepunkter uge 104 baseret på resultat i uge 24 Terapeutisk respons n/N (%)
English: Renal function (creatinine clearance in ml/min)
Danish: Nyrefunktion (kreatininclearance i ml/min)
English: Following oral administration of a 600 mg single dose of telbivudine to healthy subjects (n = 42), the peak plasma concentration (Cmax) of telbivudine was 3.2  1.1 g/ml (mean  SD) and occurred at median 3.0 hours post dose.
Danish: Efter oral administration af en enkeltdosis på 600 mg telbivudin til raske forsøgspersoner (n=42) var den maksimale plasmakoncentration (Cmax) af telbivudin 3,21,1 g/ml (middel  SD).
English: Maintained undetectable HBV DNA (< 300 copies/ml)
Danish: Vedligeholdt ikke målbart HBV-DNA (<300 kopier/ml)
English: Close the bottle firmly.
Danish: Luk flasken til.
English: In vitro, telbivudine was not active against the HBV strains containing rtM204V/rtL180M or rtM204I mutations (see section 5.1).
Danish: In vitro var telbivudin ikke aktivt mod HBV-stammer indeholdende rtM204V/rtL180M eller rtM204I mutationer (se pkt.
English: The incidence of post-treatment alanine aminotransferase (ALT) flares in the two treatment arms are further described in Table 4 below.
Danish: Hyppigheden af ALAT-stigning efter behandlingsophør i de to behandlingsgrupper er yderligere beskrevet i tabel 4 herunder.
English: Severe (< 30) (n = 6) 200 mg
Danish: Svær (<30) (n=6) 200 mg
English: Patients who achieve HBV DNA levels < 3 log10 copies/ml by week 24 had optimal responses to treatment; conversely patients with HBV DNA levels > 4 log10 copies/ml at 24 weeks had less favourable outcomes at week 52.
Danish: Patienter, der opnåede HBV-DNA-niveauer <3 log10 kopier/ml inden uge 24, havde optimalt respons på behandlingen; omvendt havde patienter med HBV-DNA-niveauer >4 log10 kopier/ml ved uge 24 mindre favorable resultater ved uge 52.
English: Following dose interval adjustment for creatinine clearance, no additional dose modification is necessary during routine haemodialysis (see section 4.2).
Danish: kreatininclearance er yderligere dosismodifikation ikke nødvendig under rutinemæssig hæmodialyse (se pkt.
English: Patients should be advised to report promptly any persistent unexplained muscle aches, pain, tenderness or weakness.
Danish: Patienterne skal tilrådes straks at indberette uafklarede vedvarende muskelsmerter, muskelsmerter af kortere varighed, muskelømhed eller nedsat muskelkraft.
English: There are no clinical data on the effects of telbivudine on male or female fertility.
Danish: telbivudins virkninger på mandlig eller kvindelig fertilitet.
English: Rare post-marketing cases of lactic acidosis have been reported with telbivudine.
Danish: Sjældne tilfælde af laktatacidose er blevet rapporteret efter markedsføring af telbivudine.
English: Studies NV-02B-007 (GLOBE) and CLDT600A2303 - cumulative genotypic resistance rates The original analysis for cumulative genotypic resistance at week 104 and 208 was based on the ITT population and included all patients who continued treatment until 4 years, regardless of HBV DNA levels.
Danish: Studierne NV-02B-007 (GLOBE) og CLDT600A2303 - kumulative hyppigheder af genotypisk resistens De orginale analyser for kumulative hyppigheder af genotypisk resistens ved uge 104 og 208 var baseret på ITT populationen og inkluderede alle patienter, som fortsatte behandling op til 4 år uanset HBV-DNA-nivauer.
English: Remove the dosing cup.
Danish: Fjern doseringskoppen.
English: Sebivo oral solution contains approximately 47 mg of sodium per 600 mg dose (30 ml).
Danish: Sebivo oral opløsning indeholder ca. 47 mg natrium per 600 mg dosis (30 ml).
English: - The other ingredients are: benzoic acid, sodium saccharin, passion fruit flavouring, sodium hydroxide, citrc acid anhydrous, water.
Danish: Øvrige indholdsstoffer: benzoesyre, saccharinnatrium, passionsfrugtsmagstof, natriumhydroxid, vandfri citronsyre, vand.
English: At week 24, 203 HBeAg-positive (44%) and 177 HBeAg-negative (80%) telbivudine-treated subjects achieved undetectable HBV DNA levels.
Danish: I uge 24 havde 203 HBeAg-positive (44 %) og 177 HBeAg-negative (80 %) telbivudinbehandlede patienter opnået ikke målbare HBV-DNA-niveauer.
English: When considering patients with viral breakthrough by 104 weeks in NV-02B-007 (GLOBE), the rate of resistance was lower in patients with HBV DNA < 300 copies/ml at week 24 than in patients with HBV DNA ≥ 300 copies/ml at week 24.
Danish: Hos patienter med viralt gennembrud efter 104 uger i NV-02B-007 (GLOBE) var resistens-raten lavere i patienter med HBV-DNA <300 kopier/ml i uge 24, end i patienter med HBV-DNA ≥300 kopier/ml i uge 24.
English: Stopping treatment with Sebivo may result in a worsening of your hepatitis B infection i.e. progression of the disease and abnormal test results (increase of viral load, ALT increase).
Danish: Din hepatitis B-infektion, kan blive forværret, hvis du stopper behandlingen med Sebivo, f.eks. kan sygdommen udvikle sig og der kan komme unormale prøve resultater (stigning i virus mængde, ALAT stigning).
English: Table 5 Virological, biochemical and serological endpoints at week 52 in NV-02B-007 (GLOBE) study
Danish: Tabel 5 Virologiske, biokemiske og serologiske endepunkter i uge 52 i NV-02B-007 (GLOBE)-studiet
English: Table 7 Key efficacy endpoints at week 104 by serum HBV DNA levels at week 24, telbivudine-treated patients in NV-02B-007 (GLOBE) study
Danish: Tabel 7 Vigtigste effekt endepunkter i uge 104 baseret på serum HBV-DNA niveau uge 24, telbivudinbehandlede patienter i NV-02B-007 (GLOBE)-studiet
English: Remove the water from the dosing cup, wipe it with a clean tissue and place it back on top of the cap.
Danish: Hæld vandet fra doseringskoppen, tør den med et rent stykke køkkenrulle og sæt koppen tilbage på låget.
English: Results of these studies indicate that no dosage adjustment is necessary for patients with hepatic impairment (see section 4.2).
Danish: Resultaterne fra disse undersøgelser tyder på, at det ikke er nødvendigt at reducere dosis hos patienter med nedsat leverfunktion (se pkt.
English: Immediately swallow the solution direct from the syringe.
Danish: Drik straks opløsningen direkte fra sprøjten.
English: What Sebivo contains - The active substance is telbivudine.
Danish: Sebivo indeholder - Aktivt stof: telbivudin.
English: ALT normalisation assessed only in patients with ALT > ULN at baseline.
Danish: ALAT-normalisering kun vurderet hos patienter med ALAT >ULN ved studiestart.
English: Baseline ALT levels > 2x ULN and baseline HBV DNA < 9 log10 copies/ml were associated with higher rates of HBeAg seroconversion in HBeAg-positive patients.
Danish: Udgangsniveauer for ALAT >2x ULN og udgangsværdier for HBV-DNA <9 log10 kopier/ml var ledsaget af en større grad af HBeAg serokonvertering blandt HBeAg-positive-patienter.
English: Withdraw all the solution from the cup into the syringe.
Danish: Træk al opløsningen fra koppen op i sprøjten.
English: Virological breakthrough* n/N (%)
Danish: Virologisk gennembrud* n/N (%)
English: CLDT600A2303 - Off-treatment durability of HBeAg responses Study CLDT600A2303 included HBeAg-positive patients from studies NV-02B-007 (GLOBE) or NV-02B-015 for off-treatment follow up.
Danish: CLDT600A2303 - Varighed af HBeAg responser uden behandling CLDT600A2303-studiet inkluderede HBeAg-positive patienter fra studierne NV-02B-007 (GLOBE) eller NV-02B-015 til opfølgning uden behandling.
English: In HBeAg-positive patients, telbivudine was superior to lamivudine in therapeutic response (75.3% vs 67.0% responders; p = 0.0047).
Danish: Blandt HBeAg-positive patienter var telbivudin bedre end lamivudin mht. terapeutisk respons (75,3 % vs. 67,0 % respondenter; p=0,0047).
English: Baseline to week 24 Week 24 to end of study
Danish: Uge 24 til slutningen af studiet
English: Slowly and carefully pour the solution from the bottle into the dosing cup until it reaches the prescribed amount.
Danish: Hæld langsomt og forsigtigt opløsningen fra flasken over i doseringskoppen indtil den når den ordinerede mængde.
English: Holding the cup at eye level, carefully and slowly pour the solution from the bottle into the cup until it comes to about halfway between the 5 ml and 10 ml marks.
Danish: Hold koppen i øjenniveau, mens du forsigtigt og langsomt hælder opløsningen fra flasken over i doseringskoppen, indtil opløsningen når halvvejs mellem målestregen for 5 ml og målestregen for 10 ml.
English: Assessment of adverse reactions is mainly based on two studies, NV-02B-007 (GLOBE) and NV-02B015, in which 1,699 patients with chronic hepatitis B received double-blind treatment with telbivudine 600 mg/day (n = 847) or lamivudine (n = 852) for 104 weeks.
Danish: Vurderingen af bivirkninger er hovedsageligt baseret på to studier, NV-02B-007 (GLOBE) og NV02B-015, hvor 1.699 patienter med kronisk hepatitis B fik behandling med telbivudin 600 mg/dag (n=847) eller lamivudin (n=852) i 104 uger.
English: At week 48 among HBeAg-positive and HBeAg-negative patients, 5% (23/458) and 2% (5/222), respectively, had virological rebound with detectable HBV resistance mutations.
Danish: I uge 48 havde henholdsvis 5 % (23/458) og 2 % (5/222) af de HBeAg-positive og HBeAg-negative patienter virologiske tilbagefald med målbare HBV resistensmutationer.
English: Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment (see “If you stop taking Sebivo” in section 3 of this leaflet).
Danish: Fortæl det straks til din læge, hvis du oplever nye eller usædvanlige symptomer, efter du er stoppet med behandlingen (se 'Hvis du holder op med at tage Sebivo' i pkt.
English: In cell-based assays, lamivudine-resistant HBV strains containing either the rtM204I mutation or the rtL180M/rtM204V double mutation had ≥ 1,000-fold reduced susceptibility to telbivudine.
Danish: Ved cellebaserede analyser havde lamivudinresistente HBV-stammer med enten rtM204I-mutationen eller rtL180M/rtM204Vdobbeltmutationen ≥1.000 gange mindre følsomhed for telbivudin.
English: Study NV-02B-007 (GLOBE)
Danish: NV-02B-007 (GLOBE)-studiet
English: ESRD/ Haemodialysis (n = 6) 200 mg
Danish: ESRD/ Hæmodialyse (n=6) 200 mg
English: Patients with ≥ one dose of study drug with evaluable baseline liver biopsies and baseline Knodell Histological Activity Index (HAI) score > 3.
Danish: Patienter med >én dosis testmedicin med vurderbare leverbiopsier ved studiestart og Knodells histologiske aktivitetsindeks (HAI)-score >3 ved studiestart.
English: No adjustment to the recommended dose of Sebivo is necessary in patients with hepatic impairment (see section 5.2).
Danish: Justering af den anbefalede dosis Sebivo er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
English: Holding the cup at eye level, carefully and slowly pour the prescribed amount of solution from the bottle into the dosing cup until the solution reaches the top of the appropriate graduation.
Danish: Hold koppen i øjenniveau, mens du forsigtigt og langsomt hælder den ordinerede mængde opløsning fra flasken over i doseringskoppen, indtil opløsningen når toppen af den korrekte målestreg.
English: Maintained undetectable HBV DNA (< 300 copies/ml) with undetectable HBV DNA at week 24
Danish: Vedligeholdt ikke målbart HBV-DNA (<300 kopier/ml) med ikke målbart HBV-DNA ved uge 24
English: Limited clinical data (less than 300 pregnancy outcomes) after exposure to telbivudine during the first trimester of pregnancy indicate no malformative toxicity and a large amount of data (more than 1000 pregnancy outcomes) after exposure during the second and third trimesters indicate no foetal/neonatal toxicity.
Danish: Data fra anvendelse af telbivudin hos et stort antal gravide kvinder (mere end 1000 graviditeter) i andet og tredje trimester indikerer ingen føtal/neonatal toksicitet.
English: End-stage renal disease patients For patients with ESRD, Sebivo should be administered after haemodialysis (see section 5.2).
Danish: End stage renal disease-patienter Til patienter med ESRD skal Sebivo indgives efter hæmodialyse (se pkt.
English: No data are available to support a specific dose recommendation for patients over the age of 65 years (see section 4.4).
Danish: Ældre (over 65 år) Der foreligger ingen data, der støtter en specifik dosisanbefaling til patienter over 65 år (se pkt.
English: Knodell necroinflammatory score ≤ 3 (no or minimal necroinflammation) was observed in 98.2% (56/57) of patients.
Danish: Ishak fibrosescore ≤1 (ingen eller minimal fibrose) blev observeret hos 84,2 % (48/57) af patienterne.
English: Treatment with Sebivo reduces the amount of hepatitis B virus in the body by blocking its growth, resulting in less liver damage and improved liver function.
Danish: Behandling med Sebivo reducerer mængden af hepatitis B-virus i kroppen ved at blokere for væksten.
English: Steady state was achieved after 5 to 7 days of once-daily administration with an approximate 1.5-fold accumulation in systemic exposure, suggesting an effective accumulation half-life of approximately 15 hours.
Danish: Telbivudins farmakokinetik er dosisproportional gennem området 25 til 1.800 mg. Steady-state blev opnået efter 5-7 dage efter administration 1 gang dagligt med en omtrentlig 1,5 gange stor akkumulation ved systemisk eksponering, hvilket tyder på en effektiv akkumulationshalveringstid på ca. 15 timer.
English: There were no significant changes in telbivudine pharmacokinetics in hepatically impaired subjects compared to unimpaired subjects.
Danish: Telbivudins farmakokinetik var ikke signifikant ændret for forsøgspersoner med nedsat leverfunktion sammenlignet med personer uden nedsat leverfunktion.
English: In HBeAg-positive patients with HBV DNA < 300 copies/ml at week 24, resistance was 1% (3/203) at 48 weeks and 9% (18/203) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 8% (20/247) at 48 weeks and 39% (97/247) at week 104.
Danish: I HBeAg-positive patienter med HBV-DNA <300 kopier/ml i uge 24, var resitensen1 % (3/203) ved 48 uger og 9 % (18/203) i uge 104, mens hos patienter med HBV-DNA ≥300 kopier/ml var resistensen 8 % (20/247) ved 48 uger og 39 % (97/247) i uge 104.
English: Table 6 Histological improvement and change in Ishak Fibrosis Score at week 52 in NV-02B007 (GLOBE) study
Danish: Tabel 6 Histologisk bedring og ændring ved Ishaks fibrosescore i uge 52 i NV-02B-007 (GLOBE)-studiet
English: In HBeAg-negative patients with HBV DNA < 300 copies/ml at week 24, resistance was 0% (0/177) at 48 weeks and 5% (9/177) at week 104, whilst in patients with HBV DNA ≥ 300 copies/ml resistance was 11% (5/44) at 48 weeks and 34% (15/44) at week 104.
Danish: Hos HBeAgnegative patienter med HBV-DNA <300 kopier/ml i uge 24, var resistensen 0 % (0/177) ved 48 uger og 5 % (9/177) i uge 104, mens hos patienter med HBV-DNA ≥300 kopier/ml var resistensen 11 % (5/44) ved 48 uger og 34 % (15/44) i uge 104.
English: Out of the 680 telbivudine-treated patients initially included in the pivotal study NV-02B-007 (GLOBE), 517 (76%) enrolled into study CLDT600A2303 for continued telbivudine treatment for up to 208 weeks.
Danish: Ud af de 680 telbivudinpatienter, som oprindeligt blev inkluderet i det pivotale studie NV-02B-007 (GLOBE), indgik 517 (76 %) i CLDT600A2303-studiet med fortsat telbivudinbehandling i op til 208 uger.
English: Push the plunger carefully and slowly to remove the air until a droplet of solution appears.
Danish: For at fjerne luften, skub forsigtigt og langsomt til stemplet, indtil en dråbe opløsning kommer til syne.
English: Sebivo 20 mg/ml oral solution is supplied as 300 ml of a clear, colourless to pale yellow solution in an brown glass bottle with a child-resistant white polypropylene closure, including a polyethylene sealing disc and a guarantee ring.
Danish: Opløsningen er en klar, farveløs til svagt gul opløsning i en brun glasflaske med et hvidt børnesikret låg af propylen, inklusiv en forseglingsskive af polyethylen og en sikkerhedsring.
English: to 1.4 (SD 0.9) with a mean change of -6.3 (SD 2.8).
Danish: (SD 1,0) med en gennemsnitlig ændring på -1,3 (SD 1,3).
English: Diarrhoea, blood lipase increased, nausea, abdominal pain
Danish: Diarré, forhøjet s-lipase, kvalme, mavesmerter
English: • The mean Ishak score of 2.2 (SD 1.1) at baseline improved (p < 0.0001) to 0.9 (SD 1.0) with a mean change of -1.3 (SD 1.3).
Danish: • Den gennemsnitlige Ishak score på 2,2 (SD 1,1) ved baseline blev forbedret (p<0,0001) til 0,9
English: If you have taken too much Sebivo, or if someone else accidentally takes your oral solution, go to your doctor or hospital for advice straight away.
Danish: Hvis du har taget for meget Sebivo oral opløsning Hvis du har taget for meget Sebivo oral opløsning, eller hvis andre ved et uheld har taget din orale opløsning, skal du straks tage til lægen eller på hospitalet for at blive vejledt.
English: 30 ml oral solution contain 600 mg telbivudine.
Danish: 30 ml oral opløsning indeholder 600 mg telbivudin.
English: For patients with detectable HBV DNA after 24 weeks of therapy, treatment modification should be considered.
Danish: Ændring af behandling bør overvejes til patienter med målbart HBV-DNA efter 24 ugers behandling.
English: HBeAg seroconversion n/N (%)
Danish: HBeAg serokonvertering n/N (%)
English: What Sebivo looks like and contents of the pack Sebivo film-coated tablets are white to slightly yellowish, oval, film-coated tablets with “LDT” imprinted on one side.
Danish: Sebivo filmovertrukne tabletter er hvide til svagt gule, ovale filmovertrukne tabletter præget med ”LDT” på den ene side.
English: UNIQUE IDENTIFIER - 2D BARCODE [folding box only]
Danish: 17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE [kun karton]
English: Among HBeAg-negative patients, differences in therapeutic response (78% vs 66%) and key secondary endpoints (mean log10 HBV DNA reduction: -5.00 vs -4.17, and HBV DNA undetectability: 82% vs 57%; p < 0.0001) were higher for telbivudine up to week 104.
Danish: Blandt HBeAg-negative patienter var forskellen i terapeutisk respons (78 % vs. 66 %) og i vigtigste sekundære endepunkter (middel log10 HBV-DNA reduktion: -5,00 vs. -4,17, og ikke målbart HBVDNA: 82 % vs. 57 %: p<0,0001) høj for telbivudin op til uge 104.
English: Lamivudine n/N (%)
Danish: Lamivudin n/N (%)
English: Ask your doctor or pharmacist if you are not sure what to do.
Danish: Spørg din læge eller på apoteket, hvis der er noget, du er i tvivl om.
English: A reduction of the daily dose using Sebivo oral solution, as detailed in Table 1 below, is recommended.
Danish: Som vist i Tabel 1 herunder, anbefales en reduktion i den daglige dosis ved hjælp af Sebivo oral opløsning.
English: Histological response Improvement No improvement Ishak Fibrosis Score Improvement No change
Danish: Ingen bedring Ishaks fibrosescore Bedring
English: Table 8 Efficacy analysis in pooled data from NV-02B-007 (GLOBE), NV-02B-015 and CLDT600A2303 studies
Danish: Tabel 8 Effektanalyser i samlede data fra NV-02B-007 (GLOBE), NV-02B-015 og CLDT600A2303 studierne
English: The safety and effectiveness of these dosing adjustment guidelines have not been clinically evaluated.
Danish: Sikkerhed og effekt af disse retningslinjer for doseringsjustering er ikke vurderet klinisk, hvorfor tæt klinisk monitorering hos disse patienter anbefales.
English: Of those HBeAg-positive subjects, 95% achieved non-detectable HBV DNA, 39% achieved HBeAg seroconversion, 90% achieved ALT normalisation at week 52 and 0.5% exhibited resistance at week 48.
Danish: Af disse HBeAg-positive personer havde 95 % stadig ikkedetekterbart HBV-DNA, 39 % havde opnået HBeAg-serokonvertering og 90 % havde opnået ALATnormalisering i uge 52.
English: How long to take Sebivo
Danish: Så længe skal du tage Sebivo
English: The recommended dose of Sebivo is 30 ml of oral solution (600 mg telbivudine) once a day.
Danish: Den anbefalede dosis Sebivo er 30 ml oral opløsning (600 mg telbivudin) 1 gang daglig.
English: Histological response defined as a ≥ 2 point decrease in Knodell Necroinflammatory Score from baseline with no worsening of the Knodell Fibrosis Score.
Danish: Histologisk respons defineret som et >2 points fald i Knodells nekroinflammatoriske score ift.
English: After 104 weeks of telbivudine therapy, 78% of patients (530/680) from study NV-02B-007 (GLOBE) and 82% (137/167) of patients from study NV-02B-015 enrolled into the extension study CLDT600A2303 (see section 5.1) to continue treatment for up to 208 weeks.
Danish: Efter 104 ugers behandling med telbivudin indgik 78 % af patienterne (530/680) fra NV-02B-007 (GLOBE)-studiet og 82 % (137/167) af patienterne fra NV-02B-015-studiet i CLDT600A2303forlængelsesstudiet med fortsat behandling op til 208 uger (se pkt.
English: There is no information on intentional overdose of telbivudine, but one subject was given an unintentional overdose which was asymptomatic.
Danish: Én forsøgsperson fik dog en utilsigtet overdosis, som ikke var symptomgivende.
English: Telbivudine n/N (%)
Danish: Telbivudin n/N (%)
English: No evidence of a direct toxic effect of telbivudine was seen in standard tests of reproduction toxicology.
Danish: Standardtest af reproduktionstoksikologi viste ingen evidens for en direkte toksisk virkning af telbivudin.
English: Similarly of those HBeAg-negative subjects, 96% achieved non-detectable HBV DNA, 79% achieved ALT normalisation at week 52 and 0% exhibited resistance at week 48.
Danish: Ligeledes havde 96 % af de HBeAg-negative personer fortsat ikke-detekterbart HBV-DNA og 79 % havde opnået ALAT-normalisering i uge 52.
English: Tell your doctor if you are breast- feeding.
Danish: Giv din læge besked, hvis du ammer.
English: colloidal anhydrous; magnesium stearate; hypromellose; titanium dioxide (E171); talc;
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose; povidon; natriumstivelsesglucolat, vandfri silika kolloid, magnesiumstearat, hypromellose, titandioxid (E171); talcum; macrogol.
English: How to take Sebivo
Danish: Sådan skal du tage Sebivo
English: Among HBeAg-positive patients, therapeutic response (63% vs 48%; p < 0.0001) and key secondary endpoints (mean log10 HBV DNA reduction: -5.74 vs -4.42; p < 0.0001, HBV DNA undetectability: 56% vs 39%; p < 0.0001 and ALT normalisation of 70% vs 62%) demonstrated a widening difference at week 104 between telbivudine and lamivudine, respectively.
Danish: Blandt HBeAg-positive patienter var der i uge 104 tiltagende forskel i terapeutisk respons (63 % vs 48 %; p<0,0001) og vigtigste sekundære endepunkter (middel log10 HBV-DNA reduktion; -5,74 vs4,42: p<0,0001, ikke målbart HBV-DNA: 56 % vs 39 %: p<0,0001 og ALAT normalisering på 70 % vs 62 %) mellem henholdsvis telbuvidin og lamivudin.