FrancophonIA/ELRC3.0 huggingface dataset:
English: Optimal therapy should be guided by resistance testing.
Danish: Optimal behandling bør kontrolleres ved test for resistens.
English: A maximum tolerated dose of telbivudine has not been determined.
Danish: Den maksimalt tolererede dosis for telbivudin er ikke fastsat.
English: Bottle containing the oral solution.
Danish: Flaske, der indeholder den orale opløsning.
English: Do not share personal items that could have blood or body fluids on them, such as toothbrushes or razor blades.
Danish: Vær ikke fælles om personlige ting, som kunne have blod eller legemsvæsker på sig, såsom tandbørster eller barberblade.
English: Clinical studies of telbivudine did not include sufficient numbers of patients  65 years of age to determine whether they respond differently from younger subjects.
Danish: Kliniske studier af telbivudin omfattede ikke et tilstrækkeligt antal patienter ≥65 år til at afgøre, om denne patientgruppe responderer anderledes end yngre personer.
English: ALT normalisation rates (78% vs 70%) continued to be higher by week 104.
Danish: ALAT normaliseringsrater (78 % vs. 70 %) vedblev at være højere i uge 104.
English: Studies in pregnant rabbits showed early delivery and/or abortion secondary to maternal toxicity.
Danish: Studier med drægtige kaniner viste tidlig fødsel og/eller abort sekundært til maternel toksicitet.
English: The mechanism behind these events is not known (see section 4.4).
Danish: Mekanismen bag dette er ikke kendt (se pkt.
English: Haemodialysis (up to 4 hours) reduces systemic telbivudine exposure by approximately 23%.
Danish: Hæmodialyse (op til 4 timer) reducerer systemisk telbivudineksponering med ca. 23 %.
English: Such increased risk cannot be excluded for other interferon alfa (pegylated or standard).
Danish: En sådan øget risiko kan ikke udelukkes for andre interferon-alfa (pegyleret eller standard).
English: Table 2 lists the adverse reactions according to MedDRA system organ class and frequency using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: Tabel 2 lister bivirkningerne i henhold til MedDRA organklassesystem og frekvens ved brug af følgende konvention: Meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not pour it back into the bottle as this could cause contamination.
Danish: Hæld den ikke tilbage i flasken, da dette kan forurene opløsningen.
English: Genotypic mutation pattern and cross-resistance
Danish: Genotypemutationsmønster og krydsresistens
English: The risk of hepatic decompensation - and of a subsequent exacerbation of hepatitis - may be elevated in patients with cirrhosis.
Danish: Risikoen for leverinkompensation - og for en efterfølgende eksacerbation af hepatiten - kan være forhøjet hos patienter med cirrose.
English: Patients with previous exposure to nucleoside/nucleotide analogues
Danish: Patienter med tidligere eksponering for nukleosid/nukleotidanaloger
English: Children and adolescents Sebivo is not recommended for use in children and adolescents.
Danish: Børn og unge Sebivo frarådes til børn og unge.
English: Alternative** dose adjustment with increased dose intervals
Danish: Alternativ** dosisjustering med øgede doseringsintervaller
English: Your doctor or pharmacist needs to know about other medicines because some medicines could affect your kidneys and because Sebivo mainly leaves the body via the kidneys in the urine.
Danish: Det er nødvendigt for lægen eller apoteket at vide, hvilken medicin du tager, fordi nogle former for medicin kan påvirke dine nyrer, og fordi Sebivo hovedsageligt forlader kroppen med urinen via nyrerne.
English: Aspartate aminotransferase increased * This adverse reaction was identified through post-marketing surveillance but not observed in controlled clinical trials.
Danish: Forhøjet aspartataminotransferase * Denne bivirkning er observeret under sikkerhedsovervågning efter produktets markedsførelse, men er ikke observeret i kontrollerede kliniske studier.
English: If a dose is missed, the patient may take the missed dose only up to 4 hours prior to the next scheduled dose.
Danish: Hvis en dosis glemmes, kan patienten tage den glemte dosis indtil 4 timer før den næste planlagte dosis.
English: Women should not breastfeed if they are taking Sebivo.
Danish: Kvinder må ikke amme, hvis de tager Sebivo.
English: Swallow it whole with some water.
Danish: Synk den hel med lidt vand.
English: Do not store above 30°C.
Danish: Må ikke opbevares ved temperaturer over 30C.
English: Paediatrics and elderly (65 years age and above) Pharmacokinetic studies have not been conducted in paediatric or elderly subjects.
Danish: Pædiatriske patienter og ældre (65 år eller ældre) Der er ikke udført farmakokinetiske studier hos pædiatriske eller ældre personer.
English: Animal studies do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Dyrestudier viser ingen direkte skadelige virkninger i henhold til graviditet, embryoets/fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: N/A = not applicable * Virological breakthrough: “1 log above nadir” definition assessed at week 104
Danish: N/A = Ikke relevant *Virologisk gennembrud: ”1 log over nadir” definition fastsat uge 104
English: Cumulative genotypic resistance rates were also assessed by applying a mathematical model where only patients with undetectable HBV DNA at the beginning of the respective year are considered.
Danish: De kumulative hyppigheder af genotypisk resistens blev også vurderet ved at anvende en matematisk model, hvor kun patienter med ikke målbart HBV-DNA ved starten af det pågældende år blev vurderet.
English: There were no abnormalities in sperm morphology or function, and the testes and ovaries were histologically unremarkable.
Danish: Der var ingen abnormiteter i sædmorfologi eller -funktion, og testikler og ovarier var histologisk almindelige.
English: Take the pack with you and show it to the doctor.
Danish: Tag pakningen med, og vis den til lægen.
English: Telbivudine was not active against HIV in vitro.
Danish: Telbivudin var ikke aktiv mod HIV in vitro.
English: If you have sexual intercourse with a partner who is not immune against hepatitis B, always use condoms and avoid any other exchange of body fluids.
Danish: Hvis du har seksuel kontakt med en partner som ikke er immun mod hepatitis B, skal du altid bruge kondom og undgå enhver anden udveksling af legemsvæske.
English: If any of these applies to you, tell your doctor before you take Sebivo.
Danish: Hvis noget at dette gælder for dig, skal du fortælle din læge det, før du tager Sebivo.
English: If use of the oral solution is not possible, Sebivo film-coated tablets could be used as an alternative and dosing should be adjusted by increasing the time interval between doses, as detailed in Table 1.
Danish: Hvis det ikke er muligt at bruge den orale opløsning, kan Sebivo filmovertrukne tabletter bruges som et alternativ, og doseringen skal justeres ved at øge tidsintervallet mellem doserne, som vist i Tabel 1.
English: - if you are taking any medicines that may cause muscle problems (talk to your doctor or pharmacist if you are unsure).
Danish: - hvis du tager medicin, som kan give muskelproblemer (snak med lægen eller apoteket, hvis der er noget, du er i tvivl om).
English: Telbivudine absorption and exposure were unaffected when a single 600 mg dose was administered with food.
Danish: Telbivudinabsorption og -eksponering blev ikke påvirket, når en enkeltdosis på 600 mg blev indgivet sammen med mad.
English: Changes in Knodell necroinflammatory and Ishak scores were similar for HBeAg-positive and HBeAg-negative patients.
Danish: Ændringer i Knodell nekroinflammatorisk og Ishak score var tilsvarende for HBeAg-positive og HBeAg-negative patienter.
English: It is not known whether telbivudine is excreted in human milk.
Danish: Det vides ikke, om telbivudin udskilles i human mælk.
English: Patients with undetectable HBV DNA at week 24 had better outcomes at 156 and 208 weeks (Table 8).
Danish: Patienter med ikke målbart HBV-DNA ved uge 24 havde bedre resultater ved 156 og 208 uger (Tabel 8).
English: Cases were more often secondary to other serious conditions (e.g. rhabdomyolysis) and/or associated with muscle-related events (e.g. myopathy, myositis).
Danish: Tilfældene var ofte sekundære til andre alvorlige sygdomme (f.eks. rhabdomyolyse) og/eller associeret med muskelrelaterede hændelser (f.eks. myopati, myositis).
English: Initiation of Sebivo treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate.
Danish: Påbegyndelse af Sebivo behandling bør kun overvejes når brugen af alternative antivirale midler med en højere genetisk resistensbarriere ikke er tilgængelig eller egnet.
English: If you forget to take Sebivo - If you forget to take Sebivo, take it as soon as you remember and then take your next dose at its regular time.
Danish: Hvis du har glemt at tage Sebivo - Hvis du glemmer at tage Sebivo, skal du tage det så hurtigt, du kommer i tanker om det, og derefter tage den næste dosis til sædvanlig tid.
English: ALT elevation > 2x baseline and > 10x ULN
Danish: ALAT-stigning >2x udgangsværdi og >10x ULN
English: Clinical and virological efficacy endpoints were evaluated separately in the HBeAg-positive and HBeAg-negative patient populations.
Danish: Kliniske og virologiske effekt-endepunkter blev vurderet separat i de HBeAg-positive og HBeAgnegative patientpopulationer.
English: Inter-subject variability (CV%) for measures of systemic exposures (Cmax, AUC) was typically approximately 30%.
Danish: Interpersonvariabilitet (CV %) mht. parametre for systemisk eksponering (Cmax, AUC) var typisk ca. 30 %.
English: Therefore, hepatic function should be monitored at regular intervals with both clinical and laboratory follow-up for at least 6 months after discontinuation of hepatitis B therapy.
Danish: Leverfunktionen skal derfor monitoreres med regelmæssige intervaller med både klinisk og laboratoriemæssig opfølgning i mindst 6 måneder efter ophør med hepatitis B-behandling.
English: The renal clearance of telbivudine approaches normal glomerular filtration rate, suggesting that filtration is the main mechanism of excretion.
Danish: Den renale clearance af telbivudin nærmer sig normal glomerulær filtrationshastighed, hvilket tyder på, at filtration er den vigtigste udskillelsesmekanisme.
English: Do not chew, split or crush it.
Danish: Lad være med at tygge, dele eller knuse den.
English: Telbivudine is excreted in the milk of rats.
Danish: Telbivudin udskilles i mælken hos rotter.
English: Patients should be advised that treatment with Sebivo has not been shown to reduce the risk of transmission of HBV to others through sexual contact or blood contamination.
Danish: Patienterne skal informeres om, at det ikke er påvist, at Sebivo reducerer risikoen for overførsel af HBV til andre ved seksuel kontakt eller blodkontaminering.
English: Physicians considering concomitant treatment with other agents associated with myopathy should weigh carefully the potential benefits and risks and should monitor patients for any signs or symptoms suggestive of myopathy.
Danish: Læger, der overvejer samtidig behandling med andre midler, der associeres med myopati, skal omhyggeligt afveje potentielle fordele og risici og monitorere patienterne for eventuelle tegn og symptomer, der tyder på myopati.
English: Secondary endpoints included histological response, ALT normalisation, and various measures of antiviral efficacy.
Danish: De sekundære endepunkter omfattede histologisk respons, ALAT-normalisering og forskellige parametre for antiviral effekt.
English: In the 104-week clinical studies, reported adverse reactions were usually classified as mild or moderate in severity.
Danish: De indberettede bivirkninger i de kliniske studier af 104 ugers varighed blev sædvanligvis klassificeret som milde eller moderate i sværhedsgrad.
English: Most CK elevations were asymptomatic and CK values typically decreased by the next visit on continued treatment.
Danish: De fleste CK-forhøjelser var ikke-symptomgivende, og CK-værdierne faldt typisk inden det næste besøg på fortsat behandling.
English: The concentration of telbivudine that effectively inhibited 50% of viral synthesis (EC50) was approximately 0.2 M.
Danish: Den koncentration af telbivudin, som effektivt hæmmede 50 % af den virale syntese (EC50), var ca. 0,2 M.
English: Maintained ALT normalisation
Danish: Vedligeholdt ALAT normalisering
English: Tell your doctor immediately about any new or unusual symptoms that you notice after stopping treatment.
Danish: Fortæl straks lægen om ethvert nyt eller usædvanligt symptom, som du har bemærket, efter behandlingen er ophørt.
English: Grade 3 or 4 CK elevations newly occurred in 15.9% of patients treated with telbivudine for 208 weeks.
Danish: Grad 3 eller 4 CK-forhøjelser forekom nylig hos 15,9 % af patienterne som blev behandlet med telbivudin i 208 uger.
English: Always put the dosing cup back onto the cap after use and cleaning.
Danish: Sæt altid doseringskoppen tilbage på låget efter brug og rengøring.
English: Remove the dosing cup and open the bottle.
Danish: Fjern doseringskoppen og åbn flasken.
English: Clinical results at week 52
Danish: Kliniske resultater ved uge 52
English: The difference in populations is due to patient discontinuation from the study and missing HBV DNA assessment at week 52.
Danish: Forskellen i populationer er forårsaget af patientfrafald fra studiet og manglende HBV-DNA-undersøgelser ved uge 52.
English: Cellulose microcrystalline Povidone
Danish: Cellulose, mikrokrystallinsk Povidon
English: Patients who failed to achieve virological response following treatment with lamivudine for more than 24 weeks are unlikely to benefit from telbivudine monotherapy.
Danish: Det er usandsynligt, at patienter, der ikke opnåede virologisk respons efter behandling med lamivudin i mere end 24 uger, vil have fordel af telbivudin-monoterapi.
English: If you stop taking Sebivo
Danish: Hvis du holder op med at tage Sebivo
English: EU/1/07/388/001 28 film-coated tablets EU/1/07/388/002 98 film-coated tablets
Danish: EU/1/07/388/001 28 filmovertrukne tabletter EU/1/07/388/002 98 filmovertrukne tabletter
English: The absence of activity of telbivudine against HIV has not been evaluated in clinical trials.
Danish: Fravær af aktivitet af telbivudin mod HIV er ikke blevet undersøgt i kliniske studier.
English: 1 bottle containing 300 ml oral solution [folding box only] 1 cup + 1 oral syringe [folding box only]
Danish: 1 flaske indeholdende 300 ml oral opløsning [kun karton] 1 kop + 1 oral sprøjte [kun karton]
English: The safety and efficacy of Sebivo in the paediatric population have not yet been established.
Danish: Sebivos sikkerhed og virkning hos den pædiatriske population er endnu ikke klarlagt.
English: Table 1 Dosing regimen adjustment of Sebivo in patients with renal impairment
Danish: Tabel 1 Justering af doseringsregime for Sebivo hos patienter med nedsat nyrefunktion
English: In some cases, fatal outcomes were reported when lactic acidosis was secondary to rhabdomyolysis.
Danish: Dødelig udgang blev rapporteret i nogle tilfælde, hvor laktatacidose var sekundært til rhabdomyolyse.
English: It is not known whether the risk of myopathy during treatment with telbivudine is increased with concurrent administration of other medicinal products associated with myopathy (e.g. statins, fibrates, or ciclosporin).
Danish: Det vides ikke, om risikoen for myopati under behandling med telbivudin er forhøjet ved samtidig indgivelse af andre lægemidler, der forbindes med myopati (f.eks. statiner, fibrater eller ciclosporin).
English: 300 ml [bottle label only]
Danish: 300 ml [kun på flaskens etiket]
English: Child-resistant screw cap with a guarantee-ring.
Danish: Børnesikret skruelåg med en sikkerhedsring.
English: Do not use this medicine if the pack is damaged or shows signs of tampering.
Danish: Brug ikke dette lægemiddel, hvis pakningen er beskadiget eller viser tegn på, at nogen har forsøgt at åbne den.
English: Do not take Sebivo if you are using pegylated or standard interferon alfa (see “Do not take Sebivo”), because the combination of these medicines may increase your risk of developing peripheral neuropathy (numbness, tingling, and/or burning sensations in the arms and/or legs).
Danish: Tag ikke Sebivo, hvis du får pegyleret eller standard interferon alfa (se "Tag ikke Sebivo"), da kombination af disse lægemidler kan øge risikoen for at udvikle perifer neuropati (følelsesløshed, snurren og/eller brændende følelse i arme og/eller ben).
English: Most grade 3 or 4 CK elevations were asymptomatic and transient.
Danish: De fleste grad 3 eller 4 CK-forhøjelser var ikke-symptomgivende og forbigående.
English: The adverse effects on fertility were greater in a separate study in juvenile animals when both sexes received telbivudine (see section 5.3).
Danish: Bivirkninger på fertilitet var større i et separat studie i unge dyr, når begge køn fik telbivudin (se pkt.
English: Pharmacotherapeutic group: Antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors, ATC code: J05AF11
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, hæmmere af nukleosid- og nukleotid-revers-transkriptase, ATC-kode: J05AF11
English: The in vitro antiviral activity of telbivudine was assessed in the HBV-expressing human hepatoma cell line 2.2.15.
Danish: Den antivirale aktivitet af telbivudin in vitro blev vurderet i den HBV-eksprimerende humane hepatoma-cellelinje 2.2.15.
English: Even if you take Sebivo, you may still infect others with hepatitis B virus (HBV) through sexual contact or exposure to contaminated blood or other body fluids.
Danish: Selvom du tager Sebivo, kan du stadig smitte andre med hepatitis B-virus (HBV) gennem seksuel kontakt, eller ved at udsætte dem for forurenet blod eller andre legemsvæsker.
English: Regardless of baseline characteristics, the majority of patients taking Sebivo showed histological, virological, biochemical, and serological responses to treatment.
Danish: Uanset udgangskarakteristika viste hovedparten af de patienter, der tog Sebivo, histologisk, virologisk, biokemisk og serologisk respons på behandlingen.
English: There is currently no clinical data to properly assess the benefit and risk of switching to telbivudine for lamivudine-treated patients who achieve complete viral suppression on lamivudine.
Danish: På nuværende tidspunkt foreligger der ikke tilstrækkelige kliniske data til at vurdere fordele og ulemper ved at skifte til telbivudin for lamivudin-behandlede patienter, som opnåede komplet virologisk suppression med lamivudin.
English: This may increase the chance of you getting unwanted side effects.
Danish: Det kan øge risikoen for, at du får bivirkninger.
English: Sebivo is to be taken orally, with or without food.
Danish: Sebivo tages oralt med eller uden mad.
English: If you cannot measure the prescribed amount precisely using the dosing cup alone, you should use the oral syringe.
Danish: Hvis du ikke kan afmåle den doserede mængde præcist ved at bruge doseringskoppen alene, kan du bruge den orale sprøjte.
English: 84.2% (48/57) of patients.
Danish: 98,2 % (56/57) af patienterne.
English: Sebivo has minor influence on the ability to drive and use machines.
Danish: Sebivo kan i mindre grad påvirke evnen til at føre motorkøretøj og bruge maskiner.
English: There are no adequate efficacy and safety data in patients with decompensated cirrhosis.
Danish: Der er ikke tilstrækkelige effekt- eller sikkerhedsdata for patienter med dekompenseret cirrose.
English: The antiviral activity of telbivudine is specific to the hepatitis B virus and related hepadnaviruses.
Danish: Telbivudins antivirale aktivitet er specifik for hepatitis B-virus og relaterede hepadnavira.
English: Clear, colourless to pale yellow solution.
Danish: Klar, farveløs til svagt gul opløsning.
English: The tablet should not be chewed, split or crushed.
Danish: Tabletten må ikke tygges, deles eller knuses.
English: Sebivo film-coated tablets are supplied in packs of 28 or 98 tablets.
Danish: Sebivo filmovertrukne tabletter er tilgængelige i pakninger med 28 eller 98 tabletter.
English: Talk to your doctor before taking Sebivo: - if you have or have had any kidney problems.
Danish: Kontakt lægen, før du tager Sebivo: - hvis du har eller har haft nyreproblemer.
English: Approximately 42% of the dose is recovered in the urine over 7 days following a single 600 mg oral dose of telbivudine.
Danish: Ca. 42 % af dosis genfindes i urinen over 7 dage efter en oral enkeltdosis på 600 mg telbivudin.
English: Do not take Sebivo - if you are allergic to telbivudine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Sebivo - hvis du er allergisk over for telbivudin eller et af de øvrige indholdsstoffer i denne medicin
English: The telbivudine area under the plasma concentration-time curve (AUC0-∞) was 28.0  8.5 gh/ml (mean  SD).
Danish: Telbivudinarealet under plasmakoncentration/tid-kurven (AUC0-∞) var 28,08,5 gt/ml (middel  SD).
English: 120 mg (6 ml) once daily 600 mg once every 96 hours * End stage renal disease ** In case use of the oral solution is not possible
Danish: 120 mg (6 ml) 1 gang dagligt 600 mg 1 gang hver 96. time * End stage renal disease (nyresygdom i slutstadiet) ** Hvis anvendelse af oral opløsning ikke er muligt.
English: On-treatment response at week 24 has been shown to be predictive of longer-term response (see Table 7 in section 5.1).
Danish: Respons i uge 24 under behandling er vist at kunne forudsige længere behandlingsrespons (se Tabel 7 i pkt.
English: Selected virological, biochemical and serological outcome measures are shown in Table 5 and histological response in Table 6.
Danish: Udvalgte virologiske, biokemiske og serologiske resultatparametre er vist i tabel 5 og histologisk respons i tabel 6.
English: Severe acute exacerbations of chronic hepatitis B are relatively frequent, and are characterised by transient elevation of serum ALT.
Danish: Svære akutte eksacerbationer af kronisk hepatitis B er relativt hyppige og karakteriseres ved forbigående forhøjelse af serum-ALAT.
English: Therapy must be initiated by a physician experienced in the management of chronic hepatitis B infection.
Danish: Behandlingen skal indledes af en læge med erfaring i behandling af kronisk hepatitis B-infektion.
English: Blood creatine phosphokinase increased, blood alanine aminotransferase increased, blood amylase increased
Danish: Forhøjet kreatinkinase i blodet, forhøjet alaninaminotransferase i blodet, forhøjet amylase i blodet
English: For both HBeAg-positive and HBeAg-negative patients, week 24 HBV DNA results were a predictor of long-term favourable outcomes.
Danish: For både HBeAg-positive og HBeAg-negative patienter var HBV-DNA resultaterne i uge 24 en prædiktor for et farvorabelt langtidsresultat.
English: In the juvenile toxicology study, rats were treated from day 14 to day 70 post-partum and were mated with rats receiving the same treatment (no sibling mating).
Danish: I den juvenile toksikologiundersøgelse blev unge rotter behandlet fra dag 14 til dag 70 post partum og parret med rotter, der fik den samme behandling (ingen søskendeparringer).
English: Swallow the entire contents of the dosing cup immediately.
Danish: Synk hele indholdet fra doseringskoppen med det samme.
English: Out of these 517 patients 159 patients (HBeAg-positive=135, HBeAg-negative=24) had detectable HBV DNA.
Danish: Ud af disse 517 patienter havde 159 patienter (HBeAgpositive=135, HBeAg-negative=24) målbart HBV-DNA.
English: Overall
Danish: Generelt