natgillin/translations-raw huggingface dataset:
Baseret på urinudskillelsen af uomdannet lægemiddel, vurderes biotilgængeligheden at være mindst 70%.
Based on urinary excretion of unchanged drug, the bioavailability has been estimated to be at least 70%.
I nogle tilfælde er selektion af hiv-varianten M184V blevet observeret, som har implikation på valget af HAART-regimet, som patienten kan få i fremtiden.
In some cases, selection of HIV variant M184V has been observed, which has implications for the selection of HAART regimens that the patient may take in the future.
Entecavir Accord mindsker mængden af virus i kroppen og forbedrer leverens tilstand.
Entecavir Accord reduces the amount of virus in your body, and improves the condition of the liver.
Tag altid den dosis, lægen anbefaler for at være sikker på, at medicinen virker helt som den skal og for at mindske udviklingen af resistens.
Always take the dose recommended by your doctor to ensure that your medicine is fully effective and to reduce the development of resistance to treatment.
Det er vigtigt, at du ikke springer en dosis over.
It is important that you do not miss any doses.
Den kumulative dødelighed i løbet af studiet var 23% (23/102), og dødsårsagerne var generelt lever-relaterede som forventet i denne population.
The on-study cumulative death rate was 23% (23/102), and causes of death were generally liver-related, as expected in this population.
Eksacerbationer efter behandling er sædvanligvis forbundet med stigning i HBV-DNA, og størstedelen synes at være selvbegrænsende.
Post-treatment exacerbations are usually associated with rising HBV DNA, and the majority appears to be self-limited.
Køn: AUC var 14% højere hos kvinder end hos mænd på grund af forskellen i nyrefunktion og vægt.
Gender: AUC was 14% higher in women than in men, due to differences in renal function and weight.
e. Andre særlige populationer
e. Other special populations
hvis du også har en hiv-infektion (humant immundefektvirus), skal du sørge for at fortælle det til din læge.
if you are also infected with HIV (human immunodeficiency virus) be sure to tell your doctor.
Patienter, som opfyldte virologiske, men ikke serologiske eller biokemiske responskriterier, fortsatte blindet behandling.
Patients who met virologic but not serologic or biochemical response criteria continued blinded treatment.
- opståen af genotype-ETVr c
- emerging genotypic ETVr c
CYP450-medierede lægemiddelinteraktioner med entecavir er derfor ikke sandsynlige.
Therefore CYP450 mediated drug interactions are unlikely to occur with entecavir.
Sikkerhed og virkning af entecavir blev også undersøgt i et aktivt kontrolleret klinisk forsøg med 191 HBV
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV
En 4 timers hæmodialyseperiode fjernede ≈ 13% af dosis, og 0,3% blev fjernet ved CAPD.
A 4 hour period of haemodialysis removed ≈ 13% of the dose, and 0.3% was removed by CAPD.
sjældne (forekommer hos mellem 1 og 10 ud af 10.000 patienter): alvorlig allergisk reaktion.
rare (at least 1 in 10,000 patients): severe allergic reaction.
Hvis din leversygdom er meget fremskreden, vil lægen ligeledes vejlede dig i, at du skal tage Entecavir Accord på tom mave.
If your liver disease is very advanced, your doctor will also instruct you to take Entecavir Accord on an empty stomach.
Behandling ud over 48 uger: Fortsat behandling med entecavir, med en gennemsnitlig varighed på 96 uger, har ikke rejst nye sikkerhedsspørgsmål.
Treatment beyond 48 weeks: continued treatment with entecavir for a median duration of 96 weeks did not reveal any new safety signals.
Lægen vil jævnligt kontrollere dig, mens du tager Entecavir Accord.
Your doctor will monitor you regularly while you are receiving Entecavir Accord.
I år 2 blev genotyperesistens over for ETV detekteret hos 2 patienter (1,1% kumulativ sandsynlighed for resistens i år 2).
During Year 2, genotypic resistance to ETV was detected in 2 patients (1.1% cumulative probability of resistance through Year 2).
I tilfælde af overdosis skal patienten monitoreres for tegn på toksicitet og gives understøttende standardbehandling efter behov.
If overdose occurs, the patient must be monitored for evidence of toxicity and given standard supportive treatment as necessary.
Der er ingen data vedrørende effekt af entecavir på overførsel af HBV fra mor til nyfødt.
There are no data on the effect of entecavir on transmission of HBV from mother to newborn infant.
MELD-score Gennemsnitlig ændring fra baselinec,e
MELD score Mean change from baselinec,e
Det er dog ikke muligt at bestemme præcise nul-effektniveauer.
However, the no effect levels could not be precisely established.
Ikke alle pakningsstørrelser og beholdertyper er nødvendigvis markedsført.
Not all pack sizes and container types may be marketed.
Entecavir Accord vil ikke kontrollere din hiv-infektion.
Entecavir Accord will not control your HIV infection.
Der bør derfor interveneres på relevant vis for at forhindre neonatal erhvervelse af HBV.
Therefore, appropriate interventions should be used to prevent neonatal acquisition of HBV.
Periodisk monitorering af leverfunktion anbefales under behandling.
Periodic monitoring of hepatic function is recommended during treatment.
Opståen af entecavirresistens i lamivudinrefraktære studier til og med Uge 240 opsummeres i tabellen.
Emerging entecavir resistance in lamivudine-refractory studies through Week 240 is summarized in the table.
Den kumulative forekomst af carcinoma hepatocellulare (HCC) i løbet af studiet var 12% (12/102).
The on-study cumulative rate of hepatocellular carcinoma (HCC) was 12% (12/102).
Der kan fås en oral opløsning til patienter med en kropsvægt under 32,6 kg.
An oral solution may be available for patients with body weight less than 32.6 kg.
Børn og unge (fra 2-18 år) kan tage Entecavir Accord med eller uden mad.
Children and adolescents (from 2 to less than 18 years of age) can take Entecavir Accord with or without food.
Alvorlige bivirkninger var generelt lever-relaterede med en kumulativ forekomst i studiet på 69%.
Serious adverse events were generally liver-related, with an on-study cumulative frequency of 69%.
Hæmodialyse eller CAPD**
Haemodialysis or CAPD**
Ikke anvendte lægemidler samt affald heraf bør destrueres i henhold til lokale retningslinjer.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Hver æske indeholder én beholder.
Each carton contains one bottle.
Efter justering for forskelle i kreatinin-clearance og kropsvægt var der ingen forskel i optagelse hos kvindelige og mandlige patienter.
After adjusting for differences in creatinine clearance and body weight there was no difference in exposure between male and female subjects.
Der sås ingen testikelforandringer i et 1-årigt studie med aber.
No testicular changes were evident in a 1-year study in monkeys.
Nukleosid-naive patienter
Nucleoside naïve patients
(HBV) gennem seksuel kontakt eller kropsvæsker (fx blod).
virus (HBV) through sexual contact or body fluids (including blood contamination).
e ETVr der forekommer i et givent år, virologisk svigt i det specificerede år.
e ETVr occurring in any year; virologic breakthrough in specified year.
AUC var 29% højere hos ældre end hos yngre patienter, primært på grund af forskelle i nyrefunktion og vægt.
AUC was 29% higher in elderly than in young subjects, mainly due to differences in renal function and weight.
Lægen vil give dig besked om, hvorvidt du skal afslutte behandingen, og hvornår du skal afslutte behandlingen.
Your doctor will tell you if and when you should stop the treatment.
Hvis du har glemt at tage Entecavir Accord
If you forget to take Entecavir Accord
Beslutningen om at behandle pædiatriske patienter bør være baseret på en omhyggelig vurdering af den enkelte patients behov og i henhold til gældende retningelinjer for pædiatrisk behandling, herunder histologiske oplysninger ved baseline.
The decision to treat paediatric patients should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information.
I henhold til gældende retningslinjer for pædiatrisk behandling bør seponering af behandlingen overvejes i følgende tilfælde:
In accordance with current paediatric practice guidelines, treatment discontinuation may be considered as follows:
Generelt: Patienterne skal informeres om, at det ikke er påvist, at behandling med entecavir mindsker risikoen for overførsel af HBV, og at der derfor fortsat skal tages relevante forholdsregler.
General: patients should be advised that therapy with entecavir has not been proven to reduce the risk of transmission of HBV and therefore appropriate precautions should still be taken.
Resultaterne for udvalgte endepunkter fra studiets uge 24 og 48 er vist i tabellen.
Results for selected study endpoints at weeks 24 and 48 are shown in the table.
Patienter, som ikke havde virologisk respons, blev tilbudt anden behandling.
Patients who did not have a virologic response were offered alternative treatment.
Kontakt lægen eller apoteket, før du tager Entecavir Accord hvis du tidligere har haft problemer med nyrerne, skal du fortælle din læge det.
Talk to your doctor or pharmacist before taking Entecavir Accord if you have ever had problems with your kidneys, tell your doctor.
Af disse 60 patienter fik de 49 HBIg-behandling i mere end 6 måneder.
Of these 60 patients, 49 received more than 6 months of HBIg therapy.
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).
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).
Det kan ikke udelukkes, at der er en risiko for spædbørn.
A risk to the infants cannot be excluded.
Det er vigtigt, at frugtbare kvinder, som er i behandling med Entecavir Accord, anvender effektiv svangerskabsforebyggelse for at forhindre graviditet.
It is important that women of childbearing age receiving treatment with Entecavir Accord use an effective method of contraception to avoid becoming pregnant.
Demografien ved baseline og HBV-sygdomskarakteristika var sammenlignelige mellem de 2 behandlingsarme og på tværs af aldersgrupper.
Baseline demographics and HBV disease characteristics were comparable between the 2 treatment arms and across age cohorts.
I et peri-postnatalt studie med rotter sås ingen bivirkninger hos afkommet.
In a peri-postnatal study in rats, no adverse effects on offspring were observed.
Infektion med hepatitis-B virus kan medføre leverskader.
Infection by the hepatitis B virus can lead to damage to the liver.
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.
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.
For patienter, der ikke kan synke tabletter eller for hvem en dosisreduktion anbefales, fås andre entecavirholdige produkter med mere egnede formuleringer.
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.
Behandlingsvarighed hos pædiatriske patienter
Duration of therapy for paediatric patients
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.
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.
Entecavir Accord bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
Entecavir Accord should not be used during pregnancy unless clearly necessary.
* ved doser < 0,5 mg entecavir anbefales oral opløsning.
* for doses < 0.5 mg entecavir oral solution is recommended.
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.
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.
Efter administration af 14C-entecavir sås ingen oxidative eller acetylerede metabolitter og der sås mindre mængder af fase II-metabolitterne, glucuronid- og sulfatkonjugater.
Following administration of 14C-entecavir, no oxidative or acetylated metabolites and minor amounts of the phase II metabolites, glucuronide and sulfate conjugates, were observed.
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.
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.
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).
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).
Tom mave betyder mindst 2 timer efter et måltid og mindst 2 timer før det næste måltid.
Empty stomach means at least 2 hours after a meal and at least 2 hours before your next meal.
Resultaterne for de vigtigste endepunkter ved uge 48 og uge 96 er vist herunder.
Result for the main efficacy endpoints at Week 48 and Week 96 are presented below.
Entecavir Accord tilhører en gruppe medicin, der kan forårsage lactacidose (ophobning af mælkesyre i blodet) og forstørret lever.
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.
Entecavir Accord skal tages oralt.
Method of administration Entecavir Accord should be taken orally.
På grund af eksponeringmarginen anses det for usandsyndligt, at disse fund har klinisk betydning.
Given the exposure margin, this finding is considered of unlikely clinical significance.
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).
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).
Der sås ingen tegn på genotoksicitet i Ames mikrobielle mutagenicitetsassay, en genmutations-assay med pattedyrsceller og en transformations-assay med embryoceller fra syrisk hamster.
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.
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).
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).
Entecavir Accord kan anvendes til børn, hvis lever er skadet, men stadig fungerer ordentligt (kompenseret leversygdom).
Entecavir Accord can be used in children whose liver is damaged but still functions properly (compensated liver disease).
Histologisk forbedringb Forbedring i Ishak fibrose-score Forværring i Ishak fibrose-score n
Histological improvementb Ishak fibrosis score improvement Ishak fibrosis score worsening n
Studiepopulationen bestod af 82% mænd, 39% var kaukasere og 37% asiatere, og gennemsnitsalderen var 49 år; 89% af patienterne havde HBeAgnegativ sygdom på transplantationstidspunktet.
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.
HAART-regimet indeholdt ikke emtricitabin eller tenofovirdisoproxilfumerat.
HAART regimens did not include emtricitabine or tenofovir disoproxil fumarate.
Fordelene ved længerevarende virologisk suppression skal afvejes mod risikoen ved langvarig behandling, herunder udvikling af resistent hepatitis B-virus.
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.
Race: Den populations-farmakokinetiske analyse viste ikke, at race i signifikant grad påvirkede entecavirs farmakokinetik.
Race: the population pharmacokinetic analysis did not identify race as significantly influencing entecavir pharmacokinetics.
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.
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.
Absorption: Entecavir absorberes hurtigt, og maksimal plasmakoncentration nås efter 0,5 - 1,5 time.
Absorption: entecavir is rapidly absorbed with peak plasma concentrations occurring between 0.51.5 hours.
tal med lægen om din lever fungerer ordentligt, og hvis ikke, find ud af, hvordan det kan påvirke din behandling med Entecavir Accord.
discuss with your doctor whether your liver functions properly and, if not, what the possible effects on your Entecavir Accord treatment may be.
Der er ikke observeret farmakokinetiske interaktioner mellem entecavir og lamivudin, adefovir eller tenofovir.
No pharmacokinetic interactions between entecavir and lamivudine, adefovir or tenofovir were observed.
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.
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.
Tag Entecavir Accord lige så længe som lægen har foreskrevet.
Take Entecavir Accord as long as your doctor has told you.
Ved 24 uger var fald i HBV viral load signifikant større med entecavir (-3,65 vs. en stigning på 0,11 log10 kopier/ml).
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).
Patienter med højt CTP-tal ved baseline havde større risiko for at få alvorlige bivirkninger (se pkt 4.4).
Patients with high baseline CTP score were at higher risk of developing serious adverse events (see section 4.4).
d. Pædiatrisk population
d. Paediatric Population
Der er begrænset erfaring med tilfælde af overdosering af entecavir hos patienter.
There is limited experience of entecavir overdose reported in patients.
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.
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.
Efter maksimalt niveau er nået, falder plasmakoncentrationen af entecavir bi-eksponentielt med en halveringstid på ≈ 128 - 149 timer.
After reaching peak levels, entecavir plasma concentrations decreased in a biexponential manner with a terminal elimination half-life of ≈ 128-149 hours.
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.
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.
Entecavir er ikke blevet undersøgt til behandling af hiv-infektion og frarådes til dette brug.
Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.
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.
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.
Nukleosid-naive patienter: Den anbefalede dosis til voksne er 0,5 mg én gang dagligt, med eller uden mad.
Nucleoside naïve patients: the recommended dose in adults is 0.5 mg once daily, with or without food.
Til voksne er den anbefalede dosis 0,5 mg eller 1 mg én gang dagligt oralt (igennem munden).
For adults the recommended dose is either 0.5 mg or 1 mg once daily orally (by mouth).
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).
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).
Kvinder i fertil alder: Da de potentielle risici for fostret ikke kendes, bør kvinder i den fertile alder bruge effektiv kontraception.
Women of childbearing potential: given that the potential risks to the developing foetus are unknown, women of childbearing potential should use effective contraception.
Ændret nyrefunktion bidrog til stigningen i eksponeringen af entecavir hos disse patienter (se pkt.
Altered renal function contributed to the increase in entecavir exposure in these patients (see section 4.4).
Indeholder også polysakkarider.
Also contains soy polysaccharides.
Hos patienter med kompenseret leversygdom ledsages disse stigninger i serum-ALAT generelt ikke af stigninger i serum-bilirubin eller hepatisk inkompensation.
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.
Biotransformation: Entecavir er ikke et substrat af og virker ikke inducerende eller hæmmende på CYP450-enzymsystemet.
Biotransformation: entecavir is not a substrate, inhibitor or inducer of the CYP450 enzyme system.
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.
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.
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.
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.