FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or pharmacist before taking Entecavir Accord if you have ever had problems with your kidneys, tell your doctor.
Danish: Kontakt lægen eller apoteket, før du tager Entecavir Accord hvis du tidligere har haft problemer med nyrerne, skal du fortælle din læge det.
English: Of these 60 patients, 49 received more than 6 months of HBIg therapy.
Danish: Af disse 60 patienter fik de 49 HBIg-behandling i mere end 6 måneder.
English: What you need to know before you take Entecavir Accord Do not take Entecavir Accord if you are allergic (hypersensitive) to entecavir or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du begynder at tage Entecavir Accord Tag ikke Entecavir Accord hvis du er overfølsom (allergisk) over for entecavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: A risk to the infants cannot be excluded.
Danish: Det kan ikke udelukkes, at der er en risiko for spædbørn.
English: It is important that women of childbearing age receiving treatment with Entecavir Accord use an effective method of contraception to avoid becoming pregnant.
Danish: Det er vigtigt, at frugtbare kvinder, som er i behandling med Entecavir Accord, anvender effektiv svangerskabsforebyggelse for at forhindre graviditet.
English: Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
Danish: Demografien ved baseline og HBV-sygdomskarakteristika var sammenlignelige mellem de 2 behandlingsarme og på tværs af aldersgrupper.
English: In a peri-postnatal study in rats, no adverse effects on offspring were observed.
Danish: I et peri-postnatalt studie med rotter sås ingen bivirkninger hos afkommet.
English: Infection by the hepatitis B virus can lead to damage to the liver.
Danish: Infektion med hepatitis-B virus kan medføre leverskader.
English: If you miss a dose of Entecavir Accord, take it as soon as possible, and then take your next scheduled dose at its regular time.
Danish: Hvis du glemmer at tage en dosis af Entecavir Accord, skal du tage den så hurtigt som muligt, og herefter tage næste dosis til sædvanlig tid.
English: For patients who are not able to swallow tablets or for whom a dose reduction is recommended, other entecavir-containing products with more suitable formulations may be available.
Danish: For patienter, der ikke kan synke tabletter eller for hvem en dosisreduktion anbefales, fås andre entecavirholdige produkter med mere egnede formuleringer.
English: Duration of therapy for paediatric patients
Danish: Behandlingsvarighed hos pædiatriske patienter
English: In HIV antiviral assays, entecavir at micromolar concentrations was not antagonistic to the anti-HIV activity in cell culture of these six NRTIs or emtricitabine.
Danish: I antivirale hiv-assays var entecavir i mikromolære koncentrationer ikke antagonistisk over for anti-hiv-aktivitet i cellekulturer af disse 6 NRTI'er eller emtricitabin.
English: Entecavir Accord should not be used during pregnancy unless clearly necessary.
Danish: Entecavir Accord bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: * for doses < 0.5 mg entecavir oral solution is recommended.
Danish: * ved doser < 0,5 mg entecavir anbefales oral opløsning.
English: To differentiate between elevations in aminotransferases due to response to treatment and increases potentially related to lactic acidosis, physicians should ensure that changes in ALT are associated with improvements in other laboratory markers of chronic hepatitis B.
Danish: For at differentiere mellem stigninger i aminotransferaser på grund af respons på behandling og stigninger, der kan være forbundet med laktacidose, bør lægen sikre sig, at stigningerne i ALAT er forbundet med forbedringer i andre laboratoriemarkører for kronisk hepatitis B.
English: Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
Danish: Efter administration af 14C-entecavir sås ingen oxidative eller acetylerede metabolitter og der sås mindre mængder af fase II-metabolitterne, glucuronid- og sulfatkonjugater.
English: Since some paediatric patients may require long-term or even lifetime management of chronic active hepatitis B, consideration should be given to the impact of entecavir on future treatment options.
Danish: Eftersom nogle pædiatriske patienter kan have behov for længevarende eller endog livsvarig behandling af kronisk aktiv hepatitis-B, bør entecavirs påvirkning af fremtidige behandlingsmuligheder tages i betragtning.
English: All (10/10) patients with advanced fibrosis or cirrhosis at baseline (Ishak fibrosis score of 4, 5 or 6) had a ≥ 1 point decrease (median decrease from baseline was 1.5 points).
Danish: Alle (10/10) patienter med fremskreden fibrose eller cirrose ved baseline (Ishak fibrose-score på 4, 5 eller 6) havde ≥ 1 point fald (gennemsnitligt fald fra baseline var 1,5 point).
English: Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Danish: Tom mave betyder mindst 2 timer efter et måltid og mindst 2 timer før det næste måltid.
English: Result for the main efficacy endpoints at Week 48 and Week 96 are presented below.
Danish: Resultaterne for de vigtigste endepunkter ved uge 48 og uge 96 er vist herunder.
English: Entecavir Accord belongs to a class of medicines that can cause lactic acidosis (excess of lactic acid in your blood) and enlargement of the liver.
Danish: Entecavir Accord tilhører en gruppe medicin, der kan forårsage lactacidose (ophobning af mælkesyre i blodet) og forstørret lever.
English: Method of administration Entecavir Accord should be taken orally.
Danish: Entecavir Accord skal tages oralt.
English: Given the exposure margin, this finding is considered of unlikely clinical significance.
Danish: På grund af eksponeringmarginen anses det for usandsyndligt, at disse fund har klinisk betydning.
English: These 14 patients had a lower rate of genotypic entecavir resistance (cumulative probability 18.8% through 5 years of follow-up) than the overall study population (see table).
Danish: Disse 14 patienter havde en lavere forekomst af genotype entecavir-resistens (kumulativ sandsynlighed på 18,8% i 5 års opfølgningsperiode) end den samlede forsøgspopulation (se tabel).
English: No evidence of genotoxicity was observed in an Ames microbial mutagenicity assay, a mammaliancell gene mutation assay, and a transformation assay with Syrian hamster embryo cells.
Danish: Der sås ingen tegn på genotoksicitet i Ames mikrobielle mutagenicitetsassay, en genmutations-assay med pattedyrsceller og en transformations-assay med embryoceller fra syrisk hamster.
English: Responses for patients with baseline Knodell Fibrosis Scores of 4 (cirrhosis) were comparable to overall responses on all efficacy outcome measures (all patients had compensated liver disease).
Danish: Respons hos patienter med en Knodell fibrose-score på 4 (cirrose) ved baseline var sammenlignelig med det overordnede respons på alle effektmæssige resultatmål (alle patienter havde kompenseret leversygdom).
English: Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Danish: Entecavir Accord kan anvendes til børn, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom).
English: Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Danish: Histologisk forbedringb Forbedring i Ishak fibrose-score Forværring i Ishak fibrose-score n
English: The study population was 82% male, 39% Caucasian, and 37% Asian, with a mean age of 49 years; 89% of patients had HBeAg-negative disease at the time of transplant.
Danish: Studiepopulationen bestod af 82% mænd, 39% var kaukasere og 37% asiatere, og gennemsnitsalderen var 49 år; 89% af patienterne havde HBeAgnegativ sygdom på transplantationstidspunktet.
English: HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Danish: HAART-regimet indeholdt ikke emtricitabin eller tenofovirdisoproxilfumerat.
English: The benefits of long-term virologic suppression with continued therapy must be weighed against the risk of prolonged treatment, including the emergence of resistant hepatitis B virus.
Danish: Fordelene ved længerevarende virologisk suppression skal afvejes mod risikoen ved langvarig behandling, herunder udvikling af resistent hepatitis B-virus.
English: Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
Danish: Race: Den populations-farmakokinetiske analyse viste ikke, at race i signifikant grad påvirkede entecavirs farmakokinetik.
English: Healthy subjects who received up to 20 mg/day for up to 14 days, and single doses up to 40 mg had no unexpected adverse reactions.
Danish: Raske frivillige, som har fået op til 20 mg/dag i op til 14 dage og enkeltdoser på op til 40 mg, har ikke oplevet uventede bivirkninger.
English: Absorption: entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.51.5 hours.
Danish: Absorption: Entecavir absorberes hurtigt, og maksimal plasmakoncentration nås efter 0,5 - 1,5 time.
English: discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
Danish: tal med lægen om din lever fungerer ordentligt, og hvis ikke, find ud af, hvordan det kan påvirke din behandling med Entecavir Accord.
English: No pharmacokinetic interactions between entecavir and lamivudine, adefovir or tenofovir were observed.
Danish: Der er ikke observeret farmakokinetiske interaktioner mellem entecavir og lamivudin, adefovir eller tenofovir.
English: There is a doseproportionate increase in Cmax and AUC values following multiple doses ranging from 0.1-1 mg. Steady-state is achieved between 6-10 days after once daily dosing with ≈ 2 times accumulation.
Danish: Der er en dosisproportional stigning i Cmax og AUC-værdier efter gentagne doser på 0,1 - 1 mg. Steady-state opnås 6 - 10 dage efter én gang daglig dosering med ≈ 2 gange akkumulering.
English: Take Entecavir Accord as long as your doctor has told you.
Danish: Tag Entecavir Accord lige så længe som lægen har foreskrevet.
English: At 24 weeks the reduction in HBV viral load was significantly greater with entecavir (-3.65 vs an increase of 0.11 log10 copies/ml).
Danish: Ved 24 uger var fald i HBV viral load signifikant større med entecavir (-3,65 vs. en stigning på 0,11 log10 kopier/ml).
English: Patients with high baseline CTP score were at higher risk of developing serious adverse events (see section 4.4).
Danish: Patienter med højt CTP-tal ved baseline havde større risiko for at få alvorlige bivirkninger (se pkt 4.4).
English: d. Paediatric Population
Danish: d. Pædiatrisk population
English: There is limited experience of entecavir overdose reported in patients.
Danish: Der er begrænset erfaring med tilfælde af overdosering af entecavir hos patienter.
English: Patients continued their lamivudine-regimen and were assigned to add either entecavir 1 mg once daily (n = 51) or placebo (n = 17) for 24 weeks followed by an additional 24 weeks where all received entecavir.
Danish: Patienterne fortsatte deres lamivudin-regime og blev allokeret til tillæg af entecavir 1 mg én gang dagligt (n = 51) eller placebo (n = 17) i 24 uger efterfulgt af yderligere 24 uger, hvor alle fik entecavir.
English: After reaching peak levels, entecavir plasma concentrations decreased in a biexponential manner with a terminal elimination half-life of ≈ 128-149 hours.
Danish: Efter maksimalt niveau er nået, falder plasmakoncentrationen af entecavir bi-eksponentielt med en halveringstid på ≈ 128 - 149 timer.
English: In studies in patients with compensated liver disease, histological improvement was defined as a ≥ 2point decrease in Knodell necro-inflammatory score from baseline with no worsening of the Knodell fibrosis score.
Danish: I forsøg med patienter med kompenseret leversygdom defineredes histologisk forbedring som et ≥ 2-point fald i Knodell nekro-inflammatorisk score fra baseline uden forværring i Knodell fibrosescoren.
English: Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.
Danish: Entecavir er ikke blevet undersøgt til behandling af hiv-infektion og frarådes til dette brug.
English: By competing with the natural substrate deoxyguanosine TP, entecavir-TP functionally inhibits the 3 activities of the viral polymerase: (1) priming of the HBV polymerase, (2) reverse transcription of the negative strand DNA from the pregenomic messenger RNA, and (3) synthesis of the positive strand HBV DNA.
Danish: Ved at konkurrere med det naturlige substrat deoxyguanosin-TP, hæmmer entecavir-TP funktionelt de 3 aktiviteter af den virale polymerase: (1) priming af HBV-polymerase, (2) reverstranskription af den negative streng DNA fra det prægenome messenger-RNA og (3) syntese af den positive streng HBV-DNA.
English: Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food.
Danish: Nukleosid-naive patienter: Den anbefalede dosis til voksne er 0,5 mg én gang dagligt, med eller uden mad.
English: For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
Danish: Til voksne er den anbefalede dosis 0,5 mg eller 1 mg én gang dagligt oralt (igennem munden).
English: Entecavir Accord can be used in people whose liver is damaged but still functions properly (compensated liver disease) and in people whose liver is damaged and does not function properly (decompensated liver disease).
Danish: Entecavir Accord kan anvendes til mennesker, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom) og til mennesker, hvis lever er skadet og ikke fungerer ordentligt (inkompenseret leversygdom).
English: Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Danish: Kvinder i fertil alder: Da de potentielle risici for fostret ikke kendes, bør kvinder i den fertile alder bruge effektiv kontraception.
English: Altered renal function contributed to the increase in entecavir exposure in these patients (see section 4.4).
Danish: Ændret nyrefunktion bidrog til stigningen i eksponeringen af entecavir hos disse patienter (se pkt.
English: Also contains soy polysaccharides.
Danish: Indeholder også polysakkarider.
English: In patients with compensated liver disease, these increases in serum ALT are generally not accompanied by an increase in serum bilirubin concentrations or hepatic decompensation.
Danish: Hos patienter med kompenseret leversygdom ledsages disse stigninger i serum-ALAT generelt ikke af stigninger i serum-bilirubin eller hepatisk inkompensation.
English: Biotransformation: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
Danish: Biotransformation: Entecavir er ikke et substrat af og virker ikke inducerende eller hæmmende på CYP450-enzymsystemet.
English: Substitutions observed in clinical isolates (rtT184A, C, F, G, I, L, M or S; rtS202 C, G or I; and/or rtM250I, L or V) further decreased entecavir susceptibility 16- to 741-fold relative to wild-type virus.
Danish: Substitutioner observeret i kliniske isolater (rtT184A, C, F, G, I, L, M eller S; rtS202 C, G eller I; og/eller rtM250I, L eller V) reducerede yderligere entecavirfølsomheden 16 til 741 gange i forhold til vild-type virus.
English: Of the 61 patients who were evaluable for efficacy (received entecavir for at least 1 month), 60 also received hepatitis B immune globulin (HBIg) as part of the post-transplant prophylaxis regimen.
Danish: Af de 61 patienter, som var evaluerbare for virkning (fik entecavir i mindst 1 måned), fik de 60 også hepatitis B-immunglobulin (HBIg) som en del af den forebyggende behandling efter transplantationen.
English: In the clinical trials entecavir treatment was discontinued if patients achieved a prespecified response.
Danish: I de kliniske forsøg blev behandling med entecavir seponeret, hvis patienterne oplevede et præspecificeret respons.
English: Immune system disorders: rare
Danish: Immunsystemet: sjælden
English: d ≥ 1 log10 increase above nadir in HBV DNA by PCR, confirmed with successive measurements or at the end of the windowed time point.
Danish: d ≥ 1 log10 stigning over nadir i HBV-DNA ved PCR, bekræftet ved på hinanden følgende målinger eller ved afslutningen af tidsvinduet.
English: The observed drug accumulation index is ≈ 2 times with once daily dosing, suggesting an effective accumulation half-life of about 24 hours.
Danish: Det observerede lægemiddelakkumuleringsindeks er ≈ 2 timer ved dosering én gang dagligt, hvilket tyder på en effektiv akkumuleringshalveringstid på ca. 24 timer.
English: All 61 patients had HBsAg loss post-transplantation, and 2 of these later became HBsAg positive despite maintaining undetectable HBV DNA (<6 IU/ml).
Danish: Alle 61 patienter var HBsAg-negative efter transplantationen, og 2 af patienterne blev senere HBsAg-positive på trods af ikke-detekterbart HBV-DNA (<6 IE/ml).
English: Entecavir was clastogenic to human lymphocyte cultures at concentrations substantially higher than those achieved clinically.
Danish: Entecavir var clastogent over for humane lymfocytkulturer ved koncentrationer, der var betragteligt større end de kliniske.
English: You should not take Entecavir Accord to treat your hepatitis B infection unless you are taking medicines for HIV at the same time, as the effectiveness of future HIV treatment may be reduced.
Danish: Du bør ikke tage Entecavir Accord for at behandle din hepatitis-B-infektion, medmindre du samtidig også tager medicin mod hiv, idet virkningen af fremtidig hivbehandling kan blive nedsat.
English: Therapy should be initiated by a physician experienced in the management of chronic hepatitis B infection.
Danish: Behandlingen skal initieres af en læge med erfaring i behandling af kronisk hepatitis B-infektion.
English: do not stop taking Entecavir Accord without your doctor's advice since your hepatitis may worsen after stopping treatment.
Danish: du skal ikke holde op med at tage Entecavir Accord uden at have talt med din læge om det først, da din hepatitis kan forværres, efter at behandlingen stoppes.
English: The frequency and nature of adverse events in this study were consistent with those expected in patients who have received a liver transplant and the known safety profile of entecavir.
Danish: Hyppigheden og typen af bivirkninger i dette studie var sammenlignelige med de bivirkninger, der forventes hos patienter, som har gennemgået en levertransplantation, og i overensstemmelse med entecavirs kendte sikkerhedsprofil.
English: Entecavir-TP is a weak inhibitor of cellular DNA polymerases α, β, and δ with Ki values of 18 to 40 µM.
Danish: Entecavir-TP er en svag hæmmer af cellulær DNA-polymerase α, β og δ med Ki værdier på 18 - 40 µM.
English: Genotypic Entecavir Resistance Through Year 5, Lamivudine-Refractory Studies Year 1 Year 2 Year 3a
Danish: Opståen af entecavir genotype-resistens til og med År 5, lamivudin-refraktære forsøg År 1 År 2 År 3a
English: For patients weighing from 10 kg to 32.5 kg, an entecavir oral solution is recommended.
Danish: Patienter, der vejer fra 10 kg til 32,5 kg, anbefales oral entecaviropløsning.
English: Entecavir was superior to adefovir dipivoxil on the primary efficacy endpoint of mean change from baseline in serum HBV DNA by PCR at week 24.
Danish: Entecavir var superior til adefovirdipivoxil mht. det primære endepunktgennemsnitlig ændring fra baseline i serum-HBV-DNA ved PCR i uge 24.
English: If treatment is discontinued without regard to treatment response, the rate of post-treatment ALT flares could be higher.
Danish: Hvis behandling seponeres uafhængigt af behandlingsrespons, kan forekomst af ALAT-stigninger efter seponering være højere.
English: Paediatric patients with a body weight of at least 32.6 kg, should be administered a daily dose of one 0.5 mg tablet with or without food.
Danish: Pædiatriske patienter med en kropsvægt på mindst 32,6 kg skal have en daglig dosis på en 0,5 mg tablet med eller uden mad.
English: Pharmacotherapeutic group: antivirals for systemic use, nucleoside and nucleotide reverse transcriptase inhibitors
Danish: Farmakoterapeutisk klassifikation: antivirale midler til systemisk brug, nukleosid og nukleotid revers transkriptase-hæmmere
English: Serum ALT and HBV DNA levels should be followed regularly after treatment discontinuation (see section 4.4).
Danish: SerumALAT og HBV-DNA-niveauer bør følges regelmæssigt efter seponering af behandlingen (se pkt.
English: In addition, high exposures of entecavir had no relevant adverse effects on γ polymerase or mitochondrial DNA synthesis in HepG2 cells (Ki > 160 µM).
Danish: Dertil kommer, at høj eksponering af entecavir ikke havde relevante bivirkninger på γ-polymerase eller mitochondriel DNA-syntese i HepG2-celler (Ki > 160 µM).
English: It has not been demonstrated that Entecavir Accord is safe to use during pregnancy.
Danish: Det vides ikke, om det er sikkert at bruge Entecavir Accord under graviditet.
English: Entecavir Accord should not be used for children below 2 years of age or weighing less than 10 kg.
Danish: Entecavir Accord bør ikke anvendes til børn under 2 år eller børn, der vejer under 10 kg.
English: These trials provide experience in 195 HBeAg-positive nucleosidetreatment-naïve subjects treated with entecavir for a median duration of 99 weeks.
Danish: Disse forsøg tilvejebringer erfaring fra 195 nukleosid-naive, HBeAgpositive forsøgspersoner, som behandles med entecavir i gennemsnitlig 99 uger.
English: In a separate study wherein entecavir was administered to pregnant lactating rats at 10 mg/kg, both foetal exposure to entecavir and secretion of entecavir into milk were demonstrated.
Danish: I et separat studie, hvor entecavir blev administreret til drægtige, diegivende rotter med 10 mg/kg, påvistes både føtal optagelse af entecavir og udskillelse af entecavir i mælken.
English: Caution should be exercised when prescribing nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease.
Danish: Der bør udvises forsigtighed, når nukleosidanaloger ordineres til patienter (særligt overvægtige kvinder) med hepatomegali, hepatitis eller andre kendte risikofaktorer for leversygdom.
English: In HBV combination assays in cell culture, abacavir, didanosine, lamivudine, stavudine, tenofovir or zidovudine were not antagonistic to the anti-HBV activity of entecavir over a wide range of concentrations.
Danish: I HBV-kombinationsassays i cellekulturer var abacavir, didanosin, lamivudin, stavudin, tenofovir og zidovudin ikke antagonistiske over for entecavirs anti-HBV-aktivitet inden for et større koncentrationsspænd.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS/ALU-ALU BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERKORT/ALU-ALU BLISTERSTRIPS
English: Breast-feeding should be discontinued during treatment with Entecavir Accord.
Danish: Amning bør afbrydes under behandling med Entecavir Accord.
English: e Baseline mean MELD score was 17.1 for ETV and 15.3 for adefovir dipivoxil.
Danish: e Gennemsnitlig MELD-score ved baseline var 17,1 for ETV og 15,3 for adefovirdipivoxil.
English: Elimination: entecavir is predominantly eliminated by the kidney with urinary recovery of unchanged drug at steady-state of about 75% of the dose.
Danish: Eliminering: Entecavir elimineres primært via nyrerne, hvor omkring 75% af dosis ved steady-state kan genfindes som uomdannet lægemiddel i urinen.
English: Subjects were randomized (2:1) to receive blinded treatment with entecavir 0.015 mg/kg up to 0.5 mg/day (N = 120) or placebo (N = 60).
Danish: Forsøgspersonerne blev randomiseret (2:1) til blindet behandling med entecavir 0,015 mg/kg op til 0,5 mg/dag (N = 120) eller placebo (N = 60).