FrancophonIA/ELRC3.0 huggingface dataset:
English: • 3 or more primary PI mutations at screening
Danish: • Tre eller flere primære proteasehæmmermutationer ved screening
English: If you have been told by your doctor that you have an intolerance to some sugars (lactose), contact your doctor before taking this medicine.
Danish: Hvis lægen har fortalt dig, at du ikke kan tåle visse sukkerarter (lactose), skal du spørge lægen, før du tager denne medicin.
English: This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Danish: Dette er til dels forbundet med forbedret helbredstilstand og livsstil, og for lipidernes vedkommende sommetider med selve hiv-medicinen.
English: ANTIBIOTICS Azithromycin
Danish: ANTIBIOTIKA Azithromycin
English: CORTICOSTEROIDS Dexamethasone (systemic)
Danish: KORTIKOSTEROIDER Dexamethason (systemisk)
English: Effects on drug levels Least Squares Mean Ratio (90% CI; 1.00 = No effect)
Danish: Virkninger på lægemiddelniveau Middelværdi i mindste kvadraters metode (90 % CI; 1,00 = ingen virkning)
English: Exposure to etravirine was lower (35-50%) in HIV-1 infected patients than in healthy subjects.
Danish: Eksponeringen for etravirin var lavere (35-50 %) hos de hiv-1 inficerede patienter end hos de raske forsøgspersoner.
English: Boosted protease inhibitors, like darunavir/ritonavir, show a higher barrier to resistance compared to other classes of antiretrovirals.
Danish: Boostede proteasehæmmere, såsom darunavir/ritonavir, udviser en højere resistensbarriere sammenlignet med andre klasser af antiretrovirale lægemidler.
English: - In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Danish: - Ud over de opportunistiske infektioner kan autoimmune lidelser (skyldes, at immunsystemet angriber sundt kropsvæv) også opstå, efter du er begyndt at tage medicin til behandling af din hiv-infektion.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af, en vigtig milepæl
English: A limited number of females were included in the studies.
Danish: Antallet af kvinder i forsøgene er begrænset.
English: No unchanged drug was detected in urine so the impact of renal impairment on etravirine elimination is expected to be minimal.
Danish: Der blev ikke påvist uforandret lægemiddel i urinen, så indvirkningen af nedsat nyrefunktion på elimineringen af etravirin forventes at være minimal.
English: TMC125-C227 was an exploratory, randomised, active-controlled open-label trial, which investigated the efficacy and safety of etravirine in a treatment regimen, which is not approved under the current indication.
Danish: TMC125-C227 var et eksplorativt, randomiseret, aktivt kontrolleret åbent forsøg, som havde til formål at undersøge effekten og sikkerheden af etravirin i et behandlingsregime, som ikke er godkendt under den aktuelle indikation.
English: The most common adverse reaction leading to discontinuation was rash.
Danish: Den mest almindelige bivirkning, som førte til ophør, var udslæt.
English: The frequency of this is unknown (see section 4.4).
Danish: Frekvensen herfor er ikke kendt (se pkt.
English: No interaction study has been performed.
Danish: Der er ikke udført nogen interaktionsforsøg.
English: Etravirine is approximately 99.9% bound to plasma proteins, primarily to albumin (99.6%) and α1-acid glycoprotein (97.66%-99.02%) in vitro.
Danish: Etravirin er ca. 99,9 % bundet til plasmaproteiner, primært til albumin (99,6 %) og α1-syreglykoprotein (97,66-99,02 %) in vitro.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2. i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Then take the next dose as usual.
Danish: Herefter skal du blot fortsætte med den sædvanlige dosis.
English: The distribution of etravirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Danish: Fordelingen af etravirin i andre kompartmenter end plasma (f.eks. cerebrospinalvæske, genitalsekreter) er ikke evalueret hos mennesker.
English: The population pharmacokinetic estimates for etravirine AUC12h and C0h are summarised in the table below.
Danish: De populationsfarmakokinetiske estimater for etravirins AUC12h og C0h fremgår af tabellen nedenfor.
English: Conclusions regarding the relevance of particular mutations or mutational patterns are subject to change with additional data, and it is recommended to always consult current interpretation systems for analysing resistance test results.
Danish: Konklusionerne vedrørende relevansen af bestemte mutationer eller mutationsmønstre kan ændres, når der fremkommer yderligere oplysninger, og det anbefales altid at konsultere de aktuelle fortolkningssystemer med henblik på analyse af testresultater for resistens.
English: - Do not use warm (40°C and above) or carbonated beverages when taking INTELENCE tablet(s).
Danish: - Brug ikke varme drikke (40°C eller varmere) eller drikke med kulsyre, når du tager INTELENCE tablet/tabletter.
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandlingen bør iværksættes af en læge med erfaring i behandling af hiv-infektion.
English: The week 48 results from the pooled analysis of DUET-1 and DUET-2 demonstrated that the etravirine arm was superior to the placebo arm irrespective of whether ENF was used de novo (p = 0.0199) or not (p < 0.0001).
Danish: Resultaterne fra uge 48 af den poolede analyse af DUET-1 og DUET2 viser, at etravirin-gruppen var placebogruppen overlegen, uanset om ENF blev brugt de novo (p = 0,0199) eller ej (p < 0,0001).
English: The pharmacokinetics in other races have not been sufficiently evaluated.
Danish: De farmakokinetiske egenskaber er ikke evalueret tilstrækkeligt hos andre racer.
English: H2-RECEPTOR ANTAGONISTS Ranitidine
Danish: H2-RECEPTORANTAGONISTER Ranitidin
English: No studies on the effects of INTELENCE on the ability to drive or operate machines have been performed.
Danish: Der er ikke udført studier af virkningen af INTELENCE på evnen til at føre motorkøretøj eller betjene maskiner.
English: The differences were less pronounced for unbound etravirine exposure.
Danish: Forskellene var mindre udtalte for eksponering for ubundet etravirin.
English: Pharmacotherapeutic group: Antivirals for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG04.
Danish: Farmakoterapeutisk klassifikation: Antivirale midler til systemisk brug, non-nukleosid revers transkriptasehæmmere, ATC-kode: J05AG04.
English: INTELENCE has minor influence on the ability to drive and use machines.
Danish: INTELENCE påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Time to onset is usually around 3-6 weeks and the outcome in most cases is favourable upon discontinuation and after initiation of corticosteroid therapy.
Danish: Dette forekommer sædvanligvis efter 3-6 uger, og udfaldet er i de fleste tilfælde favorabelt efter seponering og efter påbegyndelse af kortikosteriodbehandling.
English: In addition, etravirine demonstrates a fold change (FC) in EC50 ≤ 3 against 60% of 6,171 NNRTI-resistant clinical isolates.
Danish: Endvidere udviser etravirin en fold-ændring (FC) i EC50-værdier ≤ 3 mod 60 % af 6.171 NNRTI-resistente kliniske isolater.
English: C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
Danish: C-etravirin viste, at < 1,2 % af den indgivne etravirindosis udskilles med urinen.
English: Study was conducted with tenofovir disoproxil fumarate 300 mg once daily Note: In drug-drug interaction studies, different formulations and/or doses of etravirine were used which led to similar exposures and, therefore, interactions relevant for one formulation are relevant for the other.
Danish: Studiet blev udført med tenofovirdisoproxilfumarat 300 mg en gang dagligt Bemærk: I lægemiddelinteraktionsforsøg blev der anvendt forskellige formuleringer og/eller doser af etravirin, som førte til nogenlunde ens eksponeringer, og interaktioner, som er relevante for den ene formulering, er derfor også relevante for den anden.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Danish: Relevante eksempler er retinitis forårsaget af cytomegalovirus, generaliserede og/eller fokale mykobakterielle infektioner og Pneumocystis jiroveci-pneumoni.
English: BENZODIAZEPINES Diazepam
Danish: BENZODIAZEPINER Diazepam
English: 0.5 mg single dose digoxin
Danish: 0,5 mg enkeltdosis digoxin
English: Adverse reactions reported in patients treated with etravirine are summarised in Table 2.
Danish: Bivirkninger, som blev rapporteret hos patienter i behandling med etravirin, opsummeres i tabel 2.
English: There is no specific antidote for overdose with etravirine.
Danish: Der findes ingen specifik antidot mod overdosering af etravirin.
English: Since etravirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Danish: Eftersom etravirin er stærkt proteinbundet, er det usandsynligt, at dialyse kan medføre signifikant eliminering af det aktive stof.
English: Dose adjustments for these HMG Co-A reductase inhibitors may be necessary.
Danish: Det kan være nødvendigt at justere dosis af disse HMGCoA-reduktasehæmmere.
English: rd trimester of pregnancy mean values of these parameters were comparable.
Danish: I andet og tredje trimester af graviditeten var middelværdierne for disse parametre sammenlignelige.
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy.
Danish: Der er rapporteret tilfælde af osteonekrose, især hos patienter med generelt anerkendte risikofaktorer, fremskredet hiv-sygdom eller langvarig eksponering for antiretroviral kombinationsterapi.
English: Close monitoring for virologic response and for rifabutin related adverse reactions is recommended.
Danish: Det anbefales, at der monitoreres omhyggeligt for virologisk respons og for rifabutinrelaterede bivirkninger.
English: No interaction between pravastatin and etravirine is expected.
Danish: Der forventes ingen interaktion mellem pravastatin og etravirin.
English: INTELENCE tablets contain lactose.
Danish: INTELENCE-tabletterne indeholder lactose.
English: After administration of a radiolabeled
Danish: Efter indgift af en radioaktivt mærket
English: Use in children and adolescents 6 years of age and older and weighing at least 16 kg The doctor will work out the right dose based on the weight of the child.
Danish: Brug til børn og unge i alderen 6 år og ældre, som vejer mindst 16 kg Lægen fastsætter den rette dosis ud fra barnets vægt.
English: Please contact your doctor immediately if you experience these symptoms.
Danish: Kontakt straks lægen, hvis du oplever disse symptomer.
English: IMMUNOSUPPRESSANTS Cyclosporin
Danish: IMMUNSUPPRESSIVA Ciclosporin
English: Given the increased etravirine exposure during pregnancy, caution should be applied for those pregnant patients that require concomitant medicinal products or have comorbidities that may further increase etravirine exposure.
Danish: På grund af den øgede eksponering for etravirin under graviditet skal der udvises forsigtighed ved behandling af gravide patienter, som kræver samtidig behandling med lægemidler eller har komorbiditeter, der kan medføre en øget eksponering for etravirin.
English: INTELENCE should be used in combination with a boosted PI. Rifampicin is contraindicated in combination with boosted PIs.
Danish: INTELENCE bør anvendes i kombination med en boosted PI. Rifampicin er kontraindiceret i kombination med boostede proteasehæmmere.
English: Placental transfer has been seen in pregnant rats, but it is not known whether placental transfer of etravirine also occurs in pregnant women.
Danish: Der er set overførsel via placenta hos drægtige rotter, men det vides ikke, om etravirin passerer placenta hos gravide kvinder.
English: After oral administration with food, the maximum plasma concentration of etravirine is generally achieved within 4 hours.
Danish: Efter peroral indgift sammen med mad opnås den maksimale plasmakoncentration af etravirin normalt inden for 4 timer.
English: Note: The median protein binding adjusted EC50 for MT4 cells infected with HIV-1/IIIB in vitro = 4 ng/ml.
Danish: Bemærk: Median EC50 justeret for proteinbinding for MT4-celler inficeret med hiv-1/-IIIB in vitro = 4 ng/ml.
English: Unchanged etravirine was not detected in urine.
Danish: Uforandret etravirin blev ikke påvist i urin.
English: This breakpoint might be lower in antiretroviral combination therapy not including a boosted protease inhibitor.
Danish: Dette grænseværdi er muligvis lavere ved antiretroviral kombinationsterapi, som ikke inkluderer en boostet proteasehæmmer.
English: Data from the DUET studies suggest that baseline fold change (FC) in EC50 to etravirine was a predictive factor of virologic outcome, with gradually decreasing responses observed above FC 3 and FC 13.
Danish: Data fra DUET-forsøgene tyder på, at fold-ændringen (FC) i EC50 over for etravirin ved baseline var en prædiktiv faktor for virologisk resultat med gradvist reduceret respons observeret over FC 3 og FC 13.
English: FC subgroups are based on the select patient populations in DUET-1 and DUET-2 and are not meant to represent definitive clinical susceptibility breakpoints for etravirine.
Danish: FC-undergrupperne er baseret på de udvalgte patientpopulationer i DUET-1 og DUET-2 og er ikke beregnet til at repræsentere definitive kliniske grænseværdier for følsomhed over for etravirin.
English: The combination of INTELENCE with a boosted PI and rifabutin should be used with caution due to the risk of decrease in etravirine exposure and the risk of increase in rifabutin and 25-O-desacetyl-rifabutin exposures.
Danish: Kombinationen af INTELENCE sammen med en boostet PI og rifabutin bør anvendes med forsigtighed på grund af risikoen for reduktion af etravirineksponering og risikoen for øget eksponering for rifabutin og 25-O-desacetylrifabutin.
English: INTELENCE is not a cure for HIV infection.
Danish: INTELENCE kan ikke kurere hiv-infektionen.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Contact your doctor if you are uncertain about what to do if you miss a dose or vomit.
Danish: Tal med lægen, hvis du er i tvivl om, hvad du skal gøre, hvis du glemmer at tage en dosis eller kaster op.
English: In the dog, changes were observed in the liver and gall bladder at exposures approximately 8-fold higher than human exposure observed at the recommended dose (200 mg twice daily).
Danish: Hos hunde blev der observeret ændringer i lever og galdeblære ved eksponeringer, som var ca. 8 gange højere end den eksponering, som observeres hos mennesker ved den anbefalede dosis (200 mg 2 gange dagligt).
English: In the TMC125-C227 study, etravirine (N = 59) was administered with 2 investigator-selected NRTIs (i.e. without a ritonavir-boosted PI) and compared to an investigator-selected combination of a PI with 2 NRTIs (N = 57).
Danish: I TMC125-C227-forsøget blev etravirin (N = 59) indgivet sammen med to investigatorvalgte NRTI-midler (dvs. uden en ritonavir-boostet PI) og sammenlignet med en investigatorvalgt kombination af én PI med to NRTI-midler (N = 57).
English: Etravirine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site.
Danish: Etravirin binder direkte til revers transkriptase (RT) og blokerer de RNA- og DNA-afhængige DNA-polymeraseaktiviteter ved at forstyrre enzymets katalytiske center.
English: Patients with coexisting conditions
Danish: Patienter med andre samtidige tilstande
English: An intravenous formulation of etravirine is unavailable, thus, the absolute bioavailability of etravirine is unknown.
Danish: Etravirin er ikke tilgængelig i en intravenøs formulering, hvorfor den absolutte biotilgængelighed ikke kendes.
English: Haemorrhagic cardiomyopathy was only observed in male mice and was considered to be secondary to severe coagulopathy mediated via the vitamin K pathway.
Danish: Hæmoragisk kardiomyopati blev kun observeret hos mus af hankøn og blev betragtet som sekundær til svær koagulopati medieret via vitamin K-processen.
English: The recommended dose for maraviroc when combined with INTELENCE and a PI is 150 mg twice daily, except for fosamprenavir/ritonavir which is not recommended with maraviroc.
Danish: Den anbefalede dosis af maraviroc i kombination med INTELENCE og en proteasehæmmer er 150 mg 2 gange daglig bortset fra fosamprenavir/ritonavir, som frarådes sammen med maraviroc.
English: An increase in the incidences of hepatocellular adenomas and carcinomas were observed in female mice.
Danish: Der blev observeret en stigning i tilfælde af hepatocellulære adenomer og carcinomer i hunmus.
English: If you belong to this age group, please discuss the use of INTELENCE with your doctor.
Danish: Hvis du tilhører denne aldersgruppe, skal du tale med lægen om, hvorvidt du kan tage INTELENCE.
English: Based on the biliary elimination pathway of azithromycin, no drug interactions are expected between azithromycin and INTELENCE.
Danish: Eftersom azithromycin udskilles via galdevejene, forventes ingen lægemiddelinteraktioner mellem azithromycin og INTELENCE.
English: In the Phase III studies, the rates of discontinuation due to any adverse reaction were 7.2% in patients receiving etravirine.
Danish: I fase III-studierne forekom behandlingsophør på grund af bivirkninger hos 7,2 % af de patienter, som fik etravirin.
English: In clinical trials, the frequency, type and severity of adverse reactions in paediatric patients were comparable to those observed in adults.
Danish: I kliniske forsøg svarede bivirkningernes hyppighed, art og sværhedsgrad hos pædiatriske patienter til niveauerne observeret hos voksne.
English: The systemic exposure (AUC) to etravirine was decreased by about 50% when etravirine was administered under fasting conditions, as compared to administration following a meal.
Danish: Den systemiske eksponering (AUC) for etravirin blev reduceret med ca. 50 %, når etravirin blev indgivet i fastende tilstand sammenlignet med indgift efter et måltid.
English: The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines.
Danish: Virkningen af INTELENCE eller af anden medicin kan blive påvirket, hvis du tager INTELENCE sammen med nedenstående medicin.
English: It is not recommended to combine etravirine with tipranavir/ritonavir, due to a marked pharmacokinetic interaction (76% decrease of etravirine AUC) that could significantly impair the virologic response to etravirine.
Danish: Det frarådes at kombinere etravirin med tipranavir/ritonavir på grund af en udtalt farmakokinetisk interaktion (76 % reduktion i etravirins AUC), som i væsentligt omfang kan nedsætte det virologiske respons på etravirin.
English: Increased unbound exposure could be expected.
Danish: Der kan muligvis forventes øget ubunden eksponering.
English: The rash is usually mild to moderate.
Danish: Udslættet er normalt let til moderat.
English: Paediatric population (less than 6 years of age)
Danish: Pædiatrisk population (i alderen under 6 år)
English: Etravirine N = 101
Danish: Etravirin N = 101
English: Based on these trial results, etravirine is not recommended for use in combination with N(t)RTIs only in patients who have experienced virological failure on an NNRTI- and N(t)RTI-containing regimen.
Danish: På baggrund af disse forsøgsresultater bør etravirin ikke bruges i kombination alene med N(t)RTImidler til patienter, som har oplevet virologisk svigt med et NNRTI- og N(t)RTI-regime.
English: Possible side effects').
Danish: 4 Bivirkninger).
English: There are no data with regard to symptomatic overdose with etravirine, but it is possible that the most frequent adverse reactions of etravirine, i.e. rash, diarrhoea, nausea, and headache would be the most common symptoms noted.
Danish: Der foreligger ingen oplysninger om symptomatisk overdosering med etravirin, men det er muligt, at de hyppigste bivirkninger med etravirinl, dvs. udslæt, diarré, kvalme og hovedpine, i så fald ville være de mest almindelige symptomer.
English: - Tell your doctor immediately if you notice any symptoms of infections.
Danish: - Fortæl det straks til lægen, hvis du mærker symptomer på infektion.
English: A potential increased risk of liver enzymes increase cannot be excluded.
Danish: En øget risiko for forhøjelse af leverenzymer kan ikke udelukkes.
English: In vitro and in vivo studies with etravirine revealed no evidence of a mutagenic potential.
Danish: In vitro- og in vivo-forsøg med etravirin har ikke vist evidens for mutagent potentiale.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/.
English: Etravirine is also a weak inhibitor of P-glycoprotein.
Danish: Etravirin er også en svag hæmmer af P-glykoprotein.
English: It is therefore important to contact your doctor immediately if you develop a rash.
Danish: Det er derfor vigtigt, at du straks kontakter lægen, hvis du får udslæt.
English: Marketing Authorisation Holder Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Danish: Indehaver af markedsføringstilladelsen Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgien
English: Typically, such reactions have been observed within the first weeks or months of initiation of CART.
Danish: Sådanne reaktioner er typisk blevet observeret inden for de første uger eller måneder efter initiering af antiretroviral kombinationsbehandling.
English: There was no gender difference in severity or treatment discontinuation due to rash.
Danish: Der var ingen kønsmæssig forskel i sværhedsgrad eller behandlingsophør som følge af udslæt.
English: Effects on unbound exposure could be expected (has not been studied) and therefore caution is advised in patients with moderate hepatic impairment.
Danish: Der kan forventes virkninger på ubunden eksponering (er ikke undersøgt), hvorfor forsigtighed tilrådes hos patienter med moderat nedsat leverfunktion.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og beholderen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Danish: INTELENCE hører til en gruppe lægemidler mod hiv-infektion, der kaldes non-nukleoside reverse transkriptasehæmmere (NNRTI).
English: The proportion of paediatric patients with < 400 HIV-1 RNA copies/ml was 63.4%.
Danish: Andelen af pædiatriske patienter med < 400 hiv-1 RNA kopies/ml var 63,4 %.