FrancophonIA/ELRC3.0 huggingface dataset:
English: A trend towards higher rates of HBeAg loss (35% vs 29%) and seroconversion (30% vs 25%) was also observed for telbivudine.
Danish: Der var også en tendens mod højere hyppighed af HBeAg tab (35 % vs 29 %) og serokonvertering (30 % vs 25 %) for telbivudin.
English: On average, 4-5 weeks elapsed prior to the occurrence of an exacerbation in patients treated with telbivudine.
Danish: I gennemsnit gik der 4-5 uger, før der forekom en eksacerbation hos de patienter, der fik behandling med telbivudin.
English: Sebivo has not been investigated in co-infected hepatitis B patients (e.g. patients co-infected with human immunodeficiency virus [HIV], hepatitis C virus [HCV] or hepatitis D virus [HDV]).
Danish: Sebivo er ikke blevet undersøgt hos co-inficerede hepatitis B-patienter (f.eks. patienter, der er coinficerede med humant immundefektvirus [HIV], hepatitis C-virus [HCV] eller hepatitis D-virus [HDV]).
English: Always close the bottle with the cap after use.
Danish: Luk altid flasken med låget efter brug.
English: Telbivudine is eliminated primarily by urinary excretion of unchanged substance.
Danish: Telbivudin elimineres primært ved urinudskillelse af uomdannet stof.
English: Telbivudine therapy should be discontinued if myopathy is diagnosed.
Danish: Telbivudinbehandling skal seponeres, hvis der diagnosticeres myopati.
English: Conversions at position 80, 180 and polymorphic positions 91, 229 were always detected in sequences that harboured the M204I mutation that confers genotypic resistance.
Danish: Omdannelse ved position 80, 180 og polymorf position 91, 229 blev altid påvist i sekvenser, som havde M204I-mutation, der bekræfter genotyperesistens.
English: Oral syringe for measuring out doses that cannot be precisely measured using the cup.
Danish: Oral sprøjte til at udmåle dosis, der ikke kan udmåles præcist med doseringskoppen.
English: In rabbits doses of telbivudine providing exposure levels of 37 times those observed in humans at the therapeutic dose (600 mg) were associated with an increased incidence of abortion and early delivery.
Danish: I kaniner blev doser af telbivudin, der fremkaldte eksponeringsniveauer på 37 gange dem, der blev set hos mennesker på den terapeutiske dosis (600 mg), sat i forbindelse med en øget incidens af abort og tidlig fødsel.
English: PVC/aluminium blisters
Danish: PVC/PVDC-blister
English: Myopathy, defined as persistent unexplained muscle aches and/or muscle weakness regardless of the degree of increases in creatine kinase (CK) levels, should be considered in any patient with diffuse unexplained myalgias, muscle tenderness, muscle weakness or myositis (defined as myopathy with histological evidence of muscle damage).
Danish: Myopati, defineret som persisterende uklarlagte muskelsmerter og/eller nedsat muskelkraft, skal uanset graden af stigninger i kreatinkinaseniveauer (CK) overvejes hos enhver patient med diffuse uforklarede myalgier, muskelømhed, nedsat muskelkraft eller myositis (defineret som myopati med histologisk evidens af muskelskade).
English: Your doctor will monitor you regularly while you are receiving Sebivo.
Danish: Din læge vil undersøge dig jævnligt, mens du får Sebivo.
English: Note: If the amount poured into the cup exceeds the required dose, discard the excess in the sink.
Danish: Note: Hvis du hælder mere op i koppen end du skal bruge, skal du smide den overflødige opløsning i vasken.
English: Baseline factors associated with development of genotypic drug resistance included: lamivudine treatment, higher baseline HBV DNA, lower baseline serum ALT, and increased body weight/BMI.
Danish: Baseline faktorer, som var forbundet med udvikling af genotypisk lægemiddelresistens, inkluderede: lamivudinbehandling, højere baseline HBV-DNA, lavere baseline serum ALAT, og øget kropsvægt/BMI.
English: Sebivo belongs to a group of medicines called antiviral medicines, which are used to treat infections caused by viruses.
Danish: Sebivo hører til en gruppe medicin, som bruges til behandling af infektioner, der skyldes virus (kaldet antiviral medicin).
English: No definitive conclusion could be drawn regarding the effects of telbivudine on the pharmacokinetics of pegylated interferon due to high interindividual variability of pegylated interferon alfa-2a concentrations.
Danish: Der kunne ikke drages nogen definitiv konklusion vedrørende telbivudins virkninger på det pegylerede interferons farmakokinetik på grund af høj interindividuel koncentrationsvariabilitet for pegyleret interferon alfa-2a.
English: Periodic monitoring of hepatic function is recommended during treatment (see section 4.4).
Danish: Det anbefales at monitorere leverfunktionen periodisk under behandlingen (se pkt.
English: During the treatment with Sebivo: - Sebivo can cause persistent unexplained muscle weakness or muscle pain (myopathy).
Danish: Under behandling med Sebivo: - Sebivo kan forårsage vedvarende uforklarlig muskelsvaghed eller muskelsmerte (myopati).
English: If peripheral neuropathy is suspected, treatment with telbivudine should be reconsidered (see section 4.8).
Danish: Hvis der er mistanke om perifer neuropati, bør behandling med telbivudin genovervejes (se pkt.
English: Transient reductions in HIV-1 RNA have been reported in a small number of patients after administration of telbivudine in the absence of antiretroviral therapy.
Danish: Der er blevet rapporteret om forbigående reduktioner i HIV-1 RNA hos et lille antal patienter efter administration af telbivudin ved fravær af antiretrovirale behandling.
English: If this applies to you, do not take Sebivo.
Danish: Hvis dette gælder for dig, må du ikke tage Sebivo.
English: Preparing a 6 ml dose of medicine using the oral syringe
Danish: Forberedelse af en 6 ml dosis af medicinen ved brug af den orale sprøjte
English: In this case your doctor will want to monitor you more closely.
Danish: I så fald vil lægen gerne føre særlig tæt kontrol med din tilstand.
English: Your doctor may order laboratory tests to check your kidneys are working properly before and during treatment.
Danish: Din læge vil muligvis bestille laboratorietests for at kontrollere din nyrefunktion før og under behandlingen.
English: Sebivo is used to treat adults with chronic hepatitis B. Starting treatment with Sebivo should only be considered when it is not possible or appropriate to use an alternative medicine to which the hepatitis B virus is less likely to develop resistance.
Danish: Sebivo bruges til behandling af voksne med kronisk hepatitis B. Behandling med Sebivo skal kun overvejes, hvis det ikke er muligt eller hensigtsmæssigt at bruge et andet lægemiddel, for hvilket det er mindre sandsynligt, at hepatitis B-virus vil udvikle resistens over for.
English: Literature shows that exposure to telbivudine in the second and/or third trimester of pregnancy has been shown to reduce the risk of HBV transmission from mother to infant if telbivudine is given in addition to Hepatitis B immune globulin and Hepatitis B vaccine.
Danish: Litteratur viser, at eksponering for telbivudin i graviditetens andet og/eller tredje trimester er vist at reducere risicien for overførsel af HBV fra moder til nyfødt, hvis telbivudin gives sammen med hepatitis B immunglobulin og hepatitis B-vaccine.
English: When secondary to other conditions, some cases were also associated with pancreatitis, liver failure/hepatic steatosis and renal failure.
Danish: Hvis sekundær til andre sygdomme, var nogle tilfælde også associeret med pankreatitis, leversvigt/hepatisk steatose og nyresvigt.
English: C-telbivudine in humans.
Danish: C-telbivudin til mennesker.
English: Hepatitis B is caused by infection with the hepatitis B virus, which multiplies in the liver and causes liver damage.
Danish: Hepatitis B forårsages af infektion med hepatitis B-virus, som mangedobles i leveren og forårsager leverskade.
English: Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo since your hepatitis B infection may get worse or become very serious after stopping treatment.
Danish: Din læge vil holde øje med dit helbred og tage regelmæssige blodprøver for at tjekke din lever, efter du er holdt op med Sebivo-behandlingen, da din hepatitis B-infektion kan blive værre eller blive meget alvorlig efter behandlingen er ophørt.
English: Simultaneously press down (2a) and turn the child resistant cap (2b) to the left to open the bottle.
Danish: Tryk på samme tid ned (2a) og drej det børnesikrede låg (2b) mod venstre for at åbne flasken.
English: Caucasian ethnicity was associated with lower treatment response to both antiviral agents used in the NV-02B-007 (GLOBE) study; however the Caucasian patient population was very limited (n = 98).
Danish: Kaukasisk etnicitet var forbundet med lavere behandlingsrespons for begge antivirale midler anvendt i NV-02B-007 (GLOBE)-studiet; den kaukasiske patientpopulation var dog meget begrænset (n=98).
English: After a median off-treatment follow-up period of 120 weeks, the majority of HBeAg-positive telbivudine treated-patients showed sustained HBeAg loss (83.3%; 25/30), and sustained HBeAg seroconversion (79.2%; 19/24).
Danish: Efter en gennemsnitlig opfølgningsperiode på 120 uger uden behandling, viste størstedelen af HBeAg-positive telbivudinbehandlede patienter vedvarende HBeAg tab (83,3 %; 25/30), og vedvarende HBeAg serokonvertering (79,2 %; 19/24).
English: The no observed adverse effect level (NOAEL) for effects on fertility or mating parameters amounted to 250 mg/kg/day, which provided exposure levels 2.5 to 2.8 times higher than those achieved in humans with normal renal function at the therapeutic dose.
Danish: NOAEL (no observed adverse effect level) for virkninger på fertilitet eller parringparametre var 250 mg/kg/dag, hvilket gav eksponeringsniveauer på 2,5 til 2,8 gange højere end de niveauer, der blev opnået hos mennesker med normal nyrefunktion ved den terapeutiske dosis.
English: A clinical trial investigating the combination of telbivudine, 600 mg daily, with pegylated interferon alfa-2a, 180 micrograms once weekly by subcutaneous administration, indicates that this combination is associated with an increased risk of developing peripheral neuropathy.
Danish: Et klinisk studie, der undersøger kombinationen af telbivudin 600 mg daglig og pegyleret interferon alfa-2a, 180 mikrogram én gang ugentlig ved subkutan administration indikerer, at kombinationen er forbundet med en øget risiko for at udvikle perifer neuropati.
English: Telbivudine is not recommended to be used with lamivudine because in a phase II study, the treatment response observed with combination therapy of telbivudine and lamivudine was lower than with telbivudine alone.
Danish: Telbivudin bør ikke bruges sammen med lamivudin, da det behandlingsrespons, der blev observeret for kombinationsterapi med telbivudin og lamivudin i et fase II-studie, var lavere end med telbivudin alene.
English: Take the pack of tablets with you and show it to your doctor.
Danish: Tag tabletpakningen med, og vis den til lægen.
English: Table 9 Pharmacokinetic parameters (mean  SD) of telbivudine in subjects with various degrees of renal function
Danish: Tabel 9 Farmakokinetiske parametre (middel  SD) for telbivudin hos forsøgspersoner med forskellige grader af nyrefunktion
English: HBeAg-negative patients: The mean age of patients was 43 years, 79% were male, 65% were Asian, 23% were Caucasian, and 11% had previously received alfa-interferon therapy.
Danish: HBeAg-negative patienter: Patienternes gennemsnitsalder var 43 år, 79 % var mænd, 65 % var asiater, 23 % var kaukasere og 11 % havde tidligere fået behandling med alfa-interferon.
English: - However, if it is within 4 hours before your next dose, skip the dose you missed and take the next one at the usual time.
Danish: - Hvis det er indenfor 4 timer inden næste dosis, skal du springe den glemte dosis over og tage den næste dosis til sædvanlig tid.
English: Exacerbations of hepatitis have also been reported in patients who have terminated treatment of hepatitis B. Post-treatment ALT flares are normally associated with increases in serum HBV DNA levels, and the majority of such cases have proven to be self-limiting.
Danish: Hepatitiseksacerbationer er også beskrevet hos patienter, som har afsluttet behandling af hepatitis B. Forhøjede ALAT-niveauer efter afsluttet behandling er normalt forbundet med forhøjelser i serumHBV-DNA-niveau, og hovedparten af disse tilfælde har vist sig at være selvbegrænsende.
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation to detect any late virological relapse.
Danish: Serum ALAT og HBV-DNA-niveauer bør overvåges regelmæssigt efter afslutning af behandlingen for at bestemme ethvert virologisk tilbagefald.
English: Since telbivudine is eliminated primarily by renal excretion, co-administration of Sebivo with substances that affect renal function (such as aminoglycosides, loop diuretics, platinum compounds, vancomycin, amphotericin B) may affect plasma concentrations of telbivudine and/or the coadministered substance.
Danish: Da telbivudin primært elimineres vha. renal udskillelse, kan samtidig administration af Sebivo og stoffer, som påvirker nyrefunktionen (så som aminoglykosider, loop-diuretika, platinpræparater, vancomycin, amphotericin B), påvirke plasmakoncentrationerne af telbivudin og/eller det samtidigt administrerede stof.
English: In addition, telbivudine does not alter the pharmacokinetics of lamivudine, adefovir dipivoxil, tenofovir disoproxil fumarate or ciclosporin.
Danish: Endvidere ændrer telbivudin ikke farmakokinetikken hos lamivudin, adefovir dipivoxil, tenofovir disoproxil fumarat eller ciclosporin.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle label.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og etiketten.
English: - if you are infected with HIV, hepatitis C or D, or are being treated with any antiviral medicines.
Danish: - hvis du er inficeret med HIV, hepatitis C eller D eller hvis du er blevet behandlet med medicin til behandling af infektioner, der skyldes virus (antiviral medicin).
English: After reaching peak concentration, plasma disposition of telbivudine declined in a bi-exponential manner with a terminal elimination half-life (t1/2) of 41.8 ± 11.8 hours.
Danish: Efter at have nået maksimal koncentration aftog eliminationen af telbivudin fra plasma bieksponentielt med en terminal eliminationshalveringstid (t1/2) på 41,8±11,8 timer.
English: Sebivo is indicated for the treatment of chronic hepatitis B in adult patients with compensated liver disease and evidence of viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis.
Danish: Sebivo er indiceret til behandling af kronisk hepatitis B hos voksne patienter med kompenseret leversygdom og bevis for virusreplikation, vedvarende forhøjede niveauer af serumalaninaminotransferase (ALAT) og histologiske tegn på aktiv inflammation og/eller fibrose.
English: It can be taken with or without food.
Danish: Opløsningen kan tages med eller uden mad.
English: One isolated rtM204V mutation and two rtM204I/V/M mutations were reported in telbivudine-treated patients experiencing viral breakthrough up to week 208.
Danish: Én isoleret rtM204V-mutation og to rtM204I/V/M-mutationer blev rapporteret hos patienter i behandling med telbivudin, som oplevede viralt gennembrud op til uge 208.
English: Cumulative HBeAg seroconversion rates in patients with undetectable HBV DNA at week 24 (%)
Danish: Kumulativ HBeAg serokonvertering rater hos patienter med ikke målbart HBV-DNA ved uge 24 (%)
English: Telbivudine-5'-triphosphate inhibits HBV DNA polymerase (reverse transcriptase) by competing with the natural substrate, thymidine 5'-triphosphate.
Danish: Telbivudin-5'-trifosfat hæmmer HBV-DNA-polymerase (revers transkriptase) ved at konkurrere med det naturlige substrat, tymidin 5'-trifosfat.
English: The incidence of on treatment alanine aminotransferase (ALT) flares in the two treatment arms according to AASLD (American Association for the Study of Liver Diseases) definition (ALT elevation > 2x baseline and > 10x ULN) are further described in Table 3 below.
Danish: Hyppigheden af forhøjede ALAT-stigning under behandling i de to behandlingsgrupper ifølge AASLD (American Association for the Study of Liver Diseases) definition (ALAT-stigning >2x udgangsværdi og >10x ULN) er yderligere beskrevet i Tabel 3 herunder.
English: Telbivudine monotherapy is not an option for patients with established lamivudine-resistant hepatitis B virus infection.
Danish: Telbivudin-monoterapi er ikke en løsning for patienter med påvist lamivudinresistent hepatitis B-virus-infektion.
English: Clinical resistance
Danish: Klinisk resistens
English: In reproductive toxicology studies in adult animals, fertility was slightly reduced when both male and female rats received telbivudine.
Danish: I toksikologiske reproduktionsstudier i voksne dyr var fertiliteten let nedsat, når både han- og hunrotter fik telbivudin.
English: Cumulative HBeAg seroconversion rates (%)
Danish: Kumulativ HBeAg serokonvertering rater (%)
English: The most common adverse reactions were grade 3 or 4 blood creatine kinase elevations (6.8%), fatigue (4.4%), headache (3.0%) and nausea (2.6%).
Danish: De mest almindelige bivirkninger var grad 3 eller 4 forhøjelser af kreatininkinase i blodet (6,8 %), træthed (4,4 %), hovedpine (3,0 %) og kvalme (2,6 %).
English: White to slightly yellowish, oval film-coated tablet, imprinted with “LDT” on one side.
Danish: Hvid til svagt gullig, oval filmovertrukket tablet, præget med ”LDT” på den ene side.
English: Lactic acidosis is a rare but serious side effect which can occasionally be fatal.
Danish: Store mængder mælkesyre i blodet (mælkesyreacidose) er en sjælden, men alvorlig bivirkning, som undertiden kan være dødbringende.
English: Incorporation of telbivudine-5'-triphosphate into viral DNA causes DNA chain termination, resulting in inhibition of HBV replication.
Danish: Inkorporering af telbivudin-5'-trifosfat i viralt DNA medfører DNA-kæde-terminering, hvilket resulterer i hæmning af HBV-replikation.
English: However the ovarian and uterine parameters of those females mating successfully were unaffected.
Danish: Ovarie- og livmoderparametrene for de hunner, der ynglede med succes, var dog upåvirkede.
English: HBeAg-negative (n = 446)
Danish: HBeAg-negativ (n=446)
English: Gender There are no significant gender-related differences in telbivudine pharmacokinetics.
Danish: Køn Der er ingen signifikante kønsrelaterede forskelle i telbivudins farmakokinetik.
English: Preparing a dose of medicine using the dosing cup
Danish: Forberedelse af en dosis af medicinen ved brug af doseringskoppen
English: Fertility was reduced in pairs given ≥ 1000 mg/kg/day as shown by decreases in fertility and mating indices, and reduced conception rate.
Danish: Der sås nedsat fertilitet hos par, der fik ≥1.000 mg/kg/dag vist ved nedsættelse i fertilitets- og parringsindeks og nedsat konceptionshyppighed.
English: * The population without viral resistance at entry into study CLDT600A2303 consisted of 502 patients (293 HBeAg-positive and 209 HBeAg-negative).
Danish: *Populationen uden viral resistens ved påbegyndelse i CLDT600A2303-studiet bestod af 502 patienter (293 HBeAg-positive og 209 HBeAg-negative).
English: Cumulative resistance rates at year 4 were 22.3% for HBeAg-positive patients and 16.0% for HBeAgnegative patients in this analysis.
Danish: De kumulative hyppigheder ved 4. år var 22,3 % for HBeAg-positive patienter og 16,0 % for HBeAg-negative patienter i denne analyse.
English: These patients had completed ≥ 52 weeks of telbivudine treatment, and had exhibited HBeAg loss for ≥ 24 weeks with HBV DNA < 5 log10 copies/ml at the last on-treatment visit.
Danish: Disse patienter havde fuldført ≥52 uger med telbivudinbehandling, og havde udvist HBeAg tab i ≥24 uger med HBV-DNA <5 log10 kopier/ml ved det sidste besøg med behandling.
English: ≥ 3 log10 copies/ml
Danish: ≥3 log10 kopier/ml
English: Response parameter
Danish: Responsparameter
English: Sebivo contains sodium
Danish: Sebivo indeholder natrium
English: HBeAg-positive patients: The mean age of patients was 32 years, 74% were male, 82% were Asian, 12% were Caucasian, and 6% had previously received alfa-interferon therapy.
Danish: HBeAg-positive patienter: Patienternes gennemsnitsalder var 32 år, 74 % var mænd, 82 % var asiater, 12 % var kaukasere og 6 % havde tidligere fået behandling med alfa-interferon.
English: In patients with compensated liver disease, this elevation of serum ALT is generally not accompanied by elevated levels of serum bilirubin or by other signs of hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom ledsages denne forhøjelse af serum-ALAT i reglen ikke af forhøjede niveauer af serumbilirubin eller af andre tegn på leverinkompensation.
English: Muscular effects
Danish: Muskelvirkninger
English: No evidence of impaired fertility was seen in other studies when either male or female rats were treated at doses up to 2000 mg/kg/day and mated with untreated rats (systemic exposure levels approximately 6-14 times higher than those achieved in humans).
Danish: Der er ikke set tegn på nedsat fertilitet i andre studier, når enten han- eller hunrotter blev behandlet med doser på op til 2.000 mg/kg/dag og parret med ubehandlede rotter (systemiske eksponeringsniveauer ca. 6-14 gange højere end dem, der er opnået i mennesker).
English: Benign digestive symptoms, such as nausea, vomiting and abdominal pain, may be indicative of lactic acidosis development.
Danish: Benigne symptomer fra fordøjelseskanalen, såsom kvalme, opkastning og mavesmerter, kan være tegn på udvikling af laktatacidose.
English: Following initiation of antiviral treatment, serum ALT may rise in some patients while serum levels of HBV DNA fall (see section 4.8).
Danish: Efter påbegyndelse af antiviral behandling kan serum-ALAT stige hos nogle patienter, mens serum HBV-DNA falder (se pkt.
English: FOLDING BOX AND BOTTLE LABEL
Danish: KARTON OG FLASKEETIKET
English: HBV DNA levels should be monitored at 24 weeks of treatment to assure complete viral suppression (HBV DNA less than 300 copies/ml).
Danish: HBV-DNA-niveauer bør monitoreres i uge 24 under behandlingen for at sikre komplet virologisk suppression (HBV-DNA mindre end 300 kopier/ml).
English: 200 mg (10 ml) once daily 600 mg once every 72 hours
Danish: 200 mg (10 ml) 1 gang dagligt 600 mg 1 gang hver 72. time
English: Daily dose adjustment
Danish: Daglig dosisjustering
English: The long-term safety population consisted of 655 patients including 518 from NV-02B-007 (GLOBE) and 137 from NV02B-015.
Danish: Langtidssikkerhedspopulationen bestod af 655 patienter herunder 518 fra NV-02B-007 (GLOBE) og 137 fra NV-02B-015.
English: Telbivudine is a synthetic thymidine nucleoside analogue with activity against HBV DNA polymerase.
Danish: Telbivudin er en syntetisk tymidinnukleosidanalog med aktivitet rettet mod HBV-DNA-polymerase.
English: Clinical experience
Danish: Klinisk erfaring
English: Your doctor will monitor your health and do regular blood tests to check your liver after you stop treatment with Sebivo.
Danish: Din læge vil holde nøje øje med dit helbred og tage regelmæssige blodprøver for at tjekke din lever, efter du er holdt op med Sebivo-behandlingen.
English: Pack sizes: 28 or 98 film-coated tablets
Danish: Pakningsstørrelser: 28 eller 98 filmovertrukne tabletter
English: Treatment with telbivudine should be discontinued when metabolic/lactic acidosis of unknown aetiology occurs.
Danish: Behandling med telbivudin skal seponeres, hvis der forekommer metabolisk acidose/laktatacidose af ukendt ætiologi.
English: Telbivudine is not a substrate, inhibitor or inducer of the cytochrome P450 (CYP450) enzyme system.
Danish: Telbivudin er ikke et substrat, en hæmmer eller inducer af det cytokrome P450 (CYP450)enzymsystem.
English: Moreover, the benefit of the combination of telbivudine with interferon alfa (pegylated or standard) is not currently established.
Danish: Derudover er fordelene ved kombination af telbivudin med interferon alfa (pegyleret eller standard) ikke fastslået på nuværende tidspunkt.