FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with INTELENCE in one or more subsets of the paediatric population in human immunodeficiency virus infection, as per Paediatric Investigation Plan (PIP) decision in the granted indication (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med INTELENCE i en eller flere undergrupper af den pædiatriske population ved infektion med humant immundefektvirus i henhold til afgørelsen i det Pædiatriske Forsknings- og Udviklingsprogram (PIP) i den godkendte indikation (se pkt.
English: Although etravirine demonstrates in vitro activity against wild type HIV-2 with median EC50 values ranging from 5.7 to 7.2 µM, treatment of HIV-2 infection with etravirine is not recommended in the absence of clinical data.
Danish: 11,5-21,7 nM. Selvom etravirin udviser in vitro-aktivitet mod vild-type hiv-2 med mediane EC50værdier på 5,7-7,2 µM, anbefales det ikke at behandle hiv-2-infektion med etravirin i mangel af kliniske data.
English: It is therefore possible that etravirine may inhibit the metabolism of clopidogrel to its active metabolite by such inhibition of CYP2C19 in vivo.
Danish: Det er derfor muligt, at etravirin kan hæmme metaboliseringen af clopidogrel til dets aktive metabolit gennem tilsvarende CYP2C19-hæmning in vivo.
English: - Stratification: Randomisation was stratified by the intended use of ENF in the BR, previous use of darunavir and screening viral load.
Danish: - Stratificering: Randomiseringen blev stratificeret efter beregnet brug af ENF i baggrundsregimet (BR), tidligere brug af darunavir og virusbelastningen ved screening.
English: HIV infected mothers must not breast-feed, as there is a possibility of infecting the baby with HIV.
Danish: Hiv-smittede kvinder må ikke amme, da der er risiko for, at hiv kan overføres til barnet.
English: Outcomes
Danish: Resultater
English: The breakpoints for reduced efficacy with etravirine (> 2 etravirine-associated mutations at baseline, see clinical results section) applies when etravirine is given in combination with a boosted protease inhibitor.
Danish: Grænseværdierne for nedsat virkning af etravirin (> 2 etravirin-associerede mutationer ved baseline, se afsnittet om kliniske resultater) er gældende, når etravirin gives i kombination med en boostet proteasehæmmer.
English: croscarmellose sodium, magnesium stearate and lactose (as monohydrate).
Danish: croscarmellosenatrium, magnesiumstearat og lactose (som monohydrat).
English: Because 14-OH-clarithromycin has reduced activity against Mycobacterium avium complex (MAC), overall activity against this pathogen may be altered; therefore alternatives to clarithromycin should be considered for the treatment of MAC.
Danish: Eftersom 14-OH-clarithromycin har nedsat aktivitet over for Mycobacterium avium complex (MAC), kan den samlede aktivitet over for denne patogen måske ændres.
English: Co-infection with HBV (hepatitis B virus) or HCV (hepatitis C virus) Caution should be exercised in patients co-infected with hepatitis B or C virus due to the current limited data available.
Danish: Co-infektion med HBV (hepatitis B-virus) eller HCV (hepatitis C-virus) Der bør udvises forsigtighed hos patienter, som er co-inficerede med hepatitis B- eller C-virus på grund af de begrænsede data.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp-lactasemangel eller glucose-galactosemalabsorption bør ikke tage dette lægemiddel.
English: The trial population included PI-naïve, NNRTI-experienced patients with evidence of NNRTI resistance.
Danish: Forsøgspopulationen omfattede PI-naive, NNRTI-erfarne patienter med evidens for NNRTI-resistens.
English: Not studied, but no interaction expected based on the renal elimination pathway of ribavirin.
Danish: Ikke undersøgt, men der forventes ingen interaktion på baggrund af ribavirins elimineringsvej via nyrene.
English: INTELENCE is used in combination with other anti-HIV medicines to treat adults and children 6 years of age and older who are infected by HIV and who have used other anti-HIV medicines before.
Danish: INTELENCE anvendes sammen med andre former for hiv-medicin til behandling af voksne og børn over 6 år med hiv-infektion, som tidligere har fået behandling med andre former for hiv-medicin.
English: The pharmacokinetic properties of etravirine have been evaluated in adult healthy subjects and in adult and paediatric treatment-experienced HIV-1 infected patients.
Danish: Etravirins farmakokinetiske egenskaber er blevet evalueret hos raske voksne forsøgspersoner og hos voksne og pædiatriske behandlingserfarne hiv-1 inficerede patienter.
English: Etravirine is primarily metabolised and eliminated by the liver.
Danish: Etravirin metaboliseres og elimineres primært af leveren.
English: These pouches should stay in the bottle all the time and are not to be eaten.
Danish: Disse poser må ikke fjernes fra beholderen og må ikke spises.
English: C-etravirine dose, 93.7% and 1.2% of the administered dose of C-etravirine could be retrieved in faeces and urine, respectively.
Danish: C-etravirindosis kunne 93,7 % og 1,2 % af den indgivne C-etravirindosis genfindes i henholdsvis fæces og urin.
English: The type and incidence of adverse reactions in patients > 55 years of age were similar to the ones in younger patients (see sections 4.2 and 5.2).
Danish: Typen og incidensen af bivirkninger hos patienter over 55 år svarede til, hvad der blev observeret hos yngre patienter (se pkt.
English: What you need to know before you take INTELENCE
Danish: Det skal du vide, før du begynder at tage INTELENCE
English: No interaction is expected for either INTELENCE or enfuvirtide when co-administered.
Danish: Der forventes ingen interaktion for hverken INTELENCE eller enfuvirtid, når stofferne indgives samtidig.
English: Following virologic failure of an etravirine-containing regimen it is not recommended to treat patients with efavirenz and/or nevirapine.
Danish: Efter virologisk svigt af et etravirinregime bør patienterne ikke behandles med efavirenz og/eller nevirapin.
English: Sensitivity of the virus to etravirine at screening was required.
Danish: Det var et krav, at virussen udviste følsomhed over for etravirin ved screeningen.
English: ≥ 1 log10 decrease from baseline at week 24, n (%)
Danish: ≥ 1 log10 fald fra baseline i uge 24, n (%)
English: Population pharmacokinetic analysis of etravirine in HIV infected patients indicated no apparent difference in the exposure to etravirine between Caucasian, Hispanic and Black subjects.
Danish: En farmakokinetisk populationsanalyse af hiv-inficerede patienter viser ingen synlig forskel i eksponeringen for etravirin mellem kaukasiske, latinamerikanske og sorte forsøgspersoner.
English: At week 48, 53.5% of all paediatric patients had a confirmed undetectable viral load < 50 HIV-1 RNA copies/ml according to the TLOVR algorithm.
Danish: I uge 48 havde 53,5 % af alle pædiatriske patienter en bekræftet ikke-detekterbar viral load på < 50 hiv-1 RNA kopier/ml i henhold til TLOVR-algoritmen.
English: Unchanged etravirine in faeces is likely to be unabsorbed drug.
Danish: Uforandret etravirin i fæces er sandsynligvis uabsorberet lægemiddel.
English: No human data on the effect of etravirine on fertility are available.
Danish: Der findes ingen data om etravirins virkning på fertiliteten hos mennesker.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for antiarrhythmics when co-administered with INTELENCE.
Danish: Forsigtighed tilrådes, og monitorering af den terapeutiske koncentration anbefales om muligt, når antiarytmika indgives samtidig med INTELENCE.
English: 6 cells/l.
Danish: 6 celler/l.
English: No significant pharmacokinetic differences have been observed between males and females.
Danish: Der er ikke observeret signifikante farmakokinetiske kønsforskelle mellem mænd og kvinder.
English: Caution should be observed in such patients, especially in case of history of a severe cutaneous drug reaction.
Danish: Der bør udvises forsigtighed hos disse patienter, især i tilfælde af tidligere svær kutan lægemiddelreaktion.
English: Concomitant use of PDE-5 inhibitors with INTELENCE may require dose adjustment of the PDE-5 inhibitor to attain the desired clinical effect.
Danish: Ved samtidig brug af PDE5-hæmmere og INTELENCE kan det være nødvendigt at justere dosis af PDE5-hæmmeren for at opnå den ønskede kliniske effekt.
English: Tenofovir disoproxil 245 mg once daily tenofovir
Danish: Tenofovirdisoproxil 245 mg en gang dagligt tenofovir
English: ANTI-INFECTIVES Antiretrovirals NRTIs
Danish: ANTIINFEKTIVA Antiretrovirale midler NRTI-midler
English: These individual mutations occurred in the presence of other NNRTI RAMs.
Danish: Disse individuelle mutationer opstod ved tilstedeværelse af andre NNRTIresistensassocierede mutationer.
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Danish: Behandlingens varighed, samtidig brug af kortikosteroider, alkoholforbrug, svært nedsat immunforsvar (immunsuppression) og højere body mass indeks er nogle af de mange risikofaktorer for udvikling af denne sygdom.
English: Interactions between etravirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not done as “ND”, confidence interval as “CI”).
Danish: Interaktioner mellem etravirin og samtidigt indgivne lægemidler angives i tabel 1 (forhøjelse angives med "↑", reduktion angives med "↓", ingen ændring angives med "↔", ikke undersøgt angives med "ND", konfidensinterval angives med "CI").
English: As a precaution it is recommended that concomitant use of etravirine and clopidogrel should be discouraged.
Danish: Som forsigtighedsregel anbefales det at undgå samtidig brug af etravirin og clopidogrel.
English: In vitro experiments with human liver microsomes (HLMs) indicate that etravirine primarily undergoes oxidative metabolism by the hepatic cytochrome CYP450 (CYP3A) system and, to a lesser extent, by the CYP2C family, followed by glucuronidation.
Danish: In vitro-forsøg med humane levermikrosomer indikerer, at etravirin primært gennemgår oxidativ metabolisme via det hepatiske CYP-system (CYP3A) og i mindre grad via CYP2C-familien, efterfulgt af glukuronidering.
English: Furthermore, it is important that you carefully read the package leaflets that are provided with these medicines.
Danish: Det er også vigtigt, at du læser indlægssedlen for de andre typer medicin grundigt.
English: The most frequent (incidence ≥ 10%) adverse reactions of all intensities reported for etravirine were rash, diarrhoea, nausea and headache.
Danish: De hyppigste (incidens ≥ 10 %) bivirkninger uanset sværhedsgrad, der er rapporteret for etravirin, var udslæt, diaré, kvalme og hovedpine.
English: Etravirine efficacy in relation to NNRTI resistance at baseline has mainly been analysed with etravirine given in combination with darunavir/ritonavir (DUET-1 and DUET-2).
Danish: Effekten af etravirin i relation til NNRTI-resistens ved baseline er hovedsageligt blevet analyseret ved etravirin i kombination med darunavir/ritonavir (DUET-1 og DUET-2).
English: The combination of INTELENCE and atorvastatin can be given without any dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response.
Danish: INTELENCE og atorvastatin kan gives i kombination uden dosisjustering, men det kan være nødvendigt at justere atorvastatindosis på basis af det kliniske respons.
English: HEPATITIS C VIRUS (HCV) DIRECT-ACTING ANTIVIRALS Ribavirin
Danish: ANTIVIRALE MIDLER MED DIREKTE VIRKNING PÅ HEPATITIS C-VIRUS (HCV) Ribavirin
English: In a postmarketing retrospective cohort study aiming at substantiating the long-term safety profile of etravirine in HIV-1-infected children and adolescents receiving etravirine with other HIV-1 antiretrovirals (N = 182), Stevens-Johnson Syndrome was reported at a higher incidence (1%) than has been reported in adult clinical trials (<0.1%).
Danish: I et retrospektivt kohortestudie efter markedsføringen, hvis formål var at dokumentere den langsigtede sikkerhedsprofil for etravirin hos hiv 1-inficerede børn og unge, der fik etravirin sammen med andre hiv 1-antiretrovirale lægemidler (N = 182), blev der rapporteret Stevens-Johnsons syndrom med højere incidens (1 %) end i kliniske forsøg med voksne (< 0,1 %).
English: Cmin, ng/mL Cmax, ng/mL AUC12h, h*ng /mL
Danish: Cmin, ng/ml Cmax, ng/ml AUC12t, t*ng/ml n = 9 for AUC12t
English: Etravirine is primarily metabolised and eliminated by the liver and highly bound to plasma proteins.
Danish: Etravirin metaboliseres og elimineres primært via leveren og er stærkt bundet til plasmaproteiner.
English: When prescribing INTELENCE to females, prescribers should be aware that the incidence of rash was higher in females (see section 4.8).
Danish: Ved ordination af INTELENCE til kvinder bør den ordinerende læge være opmærksom på, at incidencen af udslæt var højere hos kvindelige forsøgspersoner (se pkt.
English: ANTICONVULSANTS Carbamazepine Phenobarbital Phenytoin
Danish: ANTIEPILEPTIKA Carbamazepin Phenobarbital Phenytoin
English: Immunologic parameters
Danish: Immunologiske parametre
English: 0.035 mg once daily
Danish: 0,035 mg en gang dagligt
English: In mice, the key target organs identified were the liver and the coagulation system.
Danish: Hos mus var de identificerede primære målorganer leveren og koagulationssystemet.
English: Etravirine is a weak inducer of CYP3A4.
Danish: Etravirin er en svag inducer af CYP3A4.
English: The evidence of efficacy of etravirine is based on 48-week data from 2 Phase III trials DUET-1 and DUET-2.
Danish: Evidensen for effekten af etravirin er baseret på 48 ugers-data fra de to fase III-forsøg, DUET-1 og DUET-2.
English: Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Danish: Symptomerne på osteonekrose er ømme, smertende og stive led (især i hofte, knæ og skulder) samt bevægelsesbesvær.
English: Weight and increased blood lipids and glucose
Danish: Vægt og forhøjede lipider og glucose i blodet
English: These trials were identical in design and similar efficacy for etravirine was seen in each trial.
Danish: Disse forsøg har identisk design, og virkningen af etravirin var sammenlignelig i de to forsøg.
English: Itraconazole Ketoconazole Posaconazole
Danish: Itraconazol Ketoconazol Posaconazol
English: Etravirine is an NNRTI of human immunodeficiency virus type 1 (HIV-1).
Danish: Etravirin er en non-nukleosid revers transkriptasehæmmer (NNRTI) af humant immundefektvirus type 1 (hiv-1).
English: INTELENCE contains the active substance etravirine.
Danish: INTELENCE indeholder det aktive stof etravirin.
English: Severe cutaneous and hypersensitivity reactions
Danish: Svære kutane reaktioner og overfølsomhedsreaktioner
English: The presence of K103N alone, which was the most prevalent NNRTI mutation in DUET-1 and DUET-2 at baseline, was not identified as a mutation associated with resistance to etravirine.
Danish: K103N som eneste mutation var den mest prævalente NNRTI-mutation i DUET-1 og DUET-2 ved baseline og blev ikke identificeret som en etravirin-resistensassocieret mutation.
English: Reused/not used ENF
Danish: Brugte igen/brugte ikke ENF
English: If a rash occurs, it usually appears soon after anti-HIV treatment with INTELENCE is started and often disappears within 1 to 2 weeks, even with continued use of the medicine.
Danish: Hvis der opstår udslæt, sker det normalt hurtigt efter påbegyndelse af hiv-behandlingen med INTELENCE, og udslættet forsvinder normalt efter 1-2 ugers fortsat behandling.
English: No dose adjustment for INTELENCE is necessary.
Danish: Ingen dosisjustering er nødvendig for INTELENCE.
English: Close monitoring of antimalarial response is warranted when co-administering INTELENCE and artemether/lumefantrine as a significant decrease in exposure of artemether and its active metabolite, dihydroartemisinin, may result in decreased antimalarial efficacy.
Danish: Tæt monitorering af malaria behandlings respons er berettiget ved samtidig administration af INTELENCE og artemether/lumefantrin da et observeret fald i eksponeringen af artemether og/eller dets aktive metabolit, dihydroartemisinin, kan resultere i atantimalariaeffekten falder.
English: - Virologic response was defined as achieving a confirmed undetectable viral load (< 50 HIV-1 RNA copies/ml).
Danish: - Virologisk respons blev defineret som opnåelse af bekræftet udetekterbar virusmængde (< 50 hiv-1 RNA kopier/ml).
English: INTELENCE should optimally be combined with other antiretrovirals that exhibit activity against the patient's virus (see section 5.1).
Danish: For at virke optimalt bør INTELENCE kombineres med andre antiretrovirale lægemidler, som er aktive mod patientens virus (se pkt.
English: The incidence of rash was higher in women compared to men in the etravirine arm in the DUET trials (rash ≥ grade 2 was reported in 9/60 [15.0%] women versus 51/539 [9.5%] men; discontinuations due to rash were reported in 3/60 [5.0%] women versus 10/539 [1.9%] men) (see section 4.4).
Danish: Incidensen af udslæt var højere hos kvinder i forhold til mænd i etravirin-gruppen i DUET-forsøgene (udslæt ≥ grad 2 blev rapporteret hos 9/60 [15,0 %] kvinder kontra 51/539 [9,5 %] mænd, og behandlingsophør, på grund af udslæt, blev rapporteret hos 3/60 [5,0 %] kvinder kontra 10/539 [1,9 %] mænd) (se pkt.
English: - Treatment: Etravirine vs. placebo, in addition to a background regimen (BR) including darunavir/ritonavir (DRV/rtv), investigator-selected N(t)RTIs and optional enfuvirtide (ENF).
Danish: - Behandling: etravirin over for placebo ud over et baggrundsregime (BR) bestående af darunavir/ritonavir (DRV/rtv), investigatorvalgte N(t)RTI-midler og valgfri enfuvirtid (ENF).
English: Combination not recommended.
Danish: Kombination frarådes.
English: Delay in stopping INTELENCE treatment after the onset of severe rash may result in a life-threatening reaction.
Danish: Hvis seponering af behandlingen med INTELENCE udsættes efter indtrædelse af alvorligt udslæt, kan dette medføre en livstruende reaktion.
English: Study TMC114HIV3015 evaluated etravirine 200 mg twice daily in combination with other antiretroviral medicinal products in 15 pregnant women during the second and third trimesters of pregnancy and postpartum.
Danish: Studiet TMC114HIV3015 evaluerede 200 mg etravirin to gange dagligt i kombination med andre antiretrovirale lægemidler hos 15 gravide kvinder i andet og tredje trimester af graviditeten og post partum.
English: Summary of efficacy results
Danish: Oversigt over effektresultater
English: ANTIFUNGALS Fluconazole 200 mg once in the morning fluconazole
Danish: ANTIMYKOTIKA Fluconazol 200 mg en gang om morgenen fluconazol
English: Patients should be informed to seek medical advice if severe rash or hypersensitivity reactions occur.
Danish: Patienter bør informeres om at søge læge, hvis de får alvorligt udslæt eller alvorlige overfølsomhedsreaktioner.
English: Lactose intolerance and lactase deficiency
Danish: Lactoseintolerans og lactasemangel
English: INTELENCE should be used with caution in these patients (see also sections 4.4 and 5.2).
Danish: INTELENCE bør anvendes med forsigtighed til disse patienter (se også pkt.
English: Cardiac disorders common myocardial infarction uncommon atrial fibrillation, angina pectoris
Danish: Hjerte almindelig myokardieinfarkt ikke almindelig atrieflimmer, angina pectoris
English: The clinical data are limited and an increased risk of cutaneous reactions in patients with a history of NNRTI-associated cutaneous reactions cannot be excluded.
Danish: De kliniske data er begrænsede, og en øget risiko for kutane reaktioner hos patienter med tidligere NNRTI-associerede kutane reaktioner kan ikke udelukkes.
English: As a general rule, it is recommended that mothers infected by HIV do not breastfeed their babies under any circumstances in order to avoid transmission of HIV.
Danish: For at undgå hiv-transmission anbefales det som hovedregel ikke, at mødre inficeret med hiv under nogen omstændigheder ammer deres børn.
English: Recommended dose of etravirine for paediatric patients 6 years to less than 18 years of age Body weight
Danish: Anbefalet dosis etravirin til pædiatriske patienter i alderen 6 år til yngre end 18 år Kropsvægt
English: In women receiving etravirine 200 mg twice daily, higher mean values for Cmax, AUC12h and Cmin were observed during pregnancy compared to postpartum.
Danish: Hos kvinder, der fik 200 mg etravirin to gange dagligt, blev der observeret højere middelværdier for Cmax, AUC12t og Cmin under graviditeten i forhold til post partum.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS Sildenafil 50 mg single dose
Danish: FOSFODIESTERASE-5-HÆMMERE (PDE5-HÆMMERE) Sildenafil 50 mg enkeltdosis
English: Virologic responses (ITT - TLOVR), change from baseline in log10 viral load (NC = F), and change from baseline in CD4 percentage and cell count (NC = F) at week 24 in the TMC125-C213 and pooled DUET studies
Danish: Virologisk respons (ITT - TLOVR), ændringer fra baseline i log10 viral load (NC = F) og ændringer fra baseline i CD4 som procent og celletal (NC = F) i uge 24 i TMC125-C213studiet og de poolede DUET-studier
English: Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped.
Danish: Lægen vil fortælle dig, hvordan du skal behandle symptomerne, og om du skal stoppe med at tage INTELENCE.
English: Patients who are diagnosed with a hypersensitivity reaction whilst on therapy must discontinue INTELENCE immediately.
Danish: Patienter, der er diagnostiseret med en alvorlig overfølsomhedsreaktion under behandling med INTELENCE, skal straks afbryde behandlingen.
English: Patients who are unable to swallow the tablet(s) whole may disperse the tablet(s) in a glass of water.
Danish: Patienter, som ikke er i stand til at sluge en hel tablet, kan opløse tabletten/tabletterne i et glas vand.
English: Rifabutin 300 mg once daily
Danish: Rifabutin 300 mg en gang dagligt
English: Table 7: Population pharmacokinetic estimates of etravirine 200 mg twice daily in HIV-1 infected adult subjects (integrated data from Phase III trials at week 48)*
Danish: Tabel 7: Populationsfarmakokinetiske estimater af etravirin 200 mg to gange dagligt hos voksne forsøgspersoner med hiv-1-infektion (integrerede data fra uge 48 i fase IIIstudier)*
English: Very rare side effects (may affect up to 1 in 10,000 people) - severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis.
Danish: Meget sjældne bivirkninger (kan forekomme hos op til 1 ud af 10.000 personer) - alvorlig overfølsomhedsreaktion karakteriseret ved udslæt i forbindelse med feber og betændelsestilstande i organer såsom leverbetændelse (hepatitis).
English: Etravirine retains activity against HIV-1 viral strains resistant to nucleoside reverse transcriptase and/or protease inhibitors.
Danish: Etravirin fastholder aktiviteten mod hiv-1-virusstammer, som er resistente over for nukleosid revers transkriptase- og/eller proteasehæmmere.
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Danish: Der anbefales ingen dosisjustering, men forsigtighed tilrådes hos patienter med moderat nedsat leverfunktion.
English: The recommended dose of etravirine for adults is 200 mg (one 200 mg tablet or two 100 mg tablets) taken orally twice daily following a meal (see section 5.2).
Danish: Den anbefalede dosis af etravirin til voksne er 200 mg (en 200 mg tablet eller to 100 mg tabletter) indtaget peroralt to gange dagligt efter et måltid (se pkt.