FrancophonIA/ELRC3.0 huggingface dataset:
English: Edurant should be used during pregnancy only if the potential benefit justifies the potential risk.
Danish: EDURANT bør kun anvendes under graviditet, hvis de potentielle fordele opvejer de potentielle risici.
English: Important information about some of the ingredients of EDURANT EDURANT contains lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i EDURANT EDURANT indeholder lactose.
English: Resistance was defined as the emergence of any resistance-associated mutation at failure.
Danish: Resistens var defineret som enhver mutation forbundet med resistens ved svigt.
English: No mother to child transmission occurred in all 10 infants born to the mothers who completed the trial and for whom the HIV status was available.
Danish: Der sås ingen overførsel fra moder til barn hos nogen af de 10 fødte spædbørn til de mødre, som gennemførte studiet, og for hvem hiv-statussen var tilgængelig.
English: (reduced absorption due to gastric pH increase)
Danish: (reduceret absorption pga. stigning i gastrisk pH)
English: The clinical implications of this finding are currently unknown.
Danish: Den kliniske betydning af dette fund kendes ikke for tiden.
English: For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.
Danish: Til resistensanalysen anvendtes en bredere definition på virologisk svigt end i den primære effektanalyse.
English: In dogs, cholestasis-like effects were noted.
Danish: Hos hunde er der set kolestaselignende virkninger.
English: However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient's ability to drive or operate machinery.
Danish: Der foreligger dog rapporter om træthed, svimmelhed og døsighed hos nogle patienter, der fik EDURANT, og dette bør tages i betragtning ved vurdering af en patients evne til at køre bil eller betjene maskiner.
English: Rilpivirine is approximately 99.7% bound to plasma proteins in vitro, primarily to albumin.
Danish: Rilpivirin er ca. 99,7 % bundet til plasmaproteiner in vitro, primært til albumin.
English: If you take didanosine (a medicine to treat HIV infection), no dose adjustment is required.
Danish: Hvis du tager didanosin (medicin til behandling af hiv-infektion), er der ikke behov for justering af dosis.
English: Rilpivirine is primarily metabolised and eliminated by the liver.
Danish: Rilpivirin metaboliseres og elimineres primært af leveren.
English: There was no teratogenicity with rilpivirine in rats and rabbits.
Danish: Der var ingen teratogenicitet med rilpivirin hos rotter eller kaniner.
English: C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Danish: C-rilpivirin kunne gennemsnitligt 85 % og 6,1 % af radioaktiviteten genfindes i henholdsvis fæces og urin.
English: This analysis included 36 patients who had completed at least 48 weeks of treatment or discontinued earlier.
Danish: Denne analyse inkluderede 36 patienter, der havde gennemført mindst 48 ugers behandling eller havde afbrudt behandlingen tidligere.
English: Paediatric population (less than 18 years of age)
Danish: Pædiatrisk population (under 18 år)
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Danish: E138K-substitutionen fremkom hyppigst under behandling med rilpivirin og sædvanligvis i kombination med M184I-substitutionen.
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Danish: Efter peroral indgift opnås den maksimale plasmakoncentration af rilpivirin normalt inden for 4-5 timer.
English: Instructions for proper use in adults and adolescents (12 to less than 18 years of age) The recommended dose of EDURANT is one tablet once a day.
Danish: Vejledning i brug til voksne og unge (fra 12 til under 18 år) Den sædvanlige dosis af EDURANT er én tablet dagligt.
English: Fluconazole Itraconazole Posaconazole Voriconazole
Danish: Fluconazol Itraconazol Posaconazol Voriconazol
English: The 36 subjects had a median age of 14.5 years (range: 12 to 17 years), and were 55.6% female, 88.9% Black and 11.1% Asian.
Danish: De 36 forsøgspersoner havde en gennemsnitsalder på 14,5 år (interval 12 til 17 år) og omfattede 55,6 % kvinder, 88,9 % sorte og 11,1 % asiater.
English: This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier.
Danish: Denne analyse omfattede 690 patienter i ECHO og 678 patienter i THRIVE, som havde gennemført 96 ugers behandling, eller som var udtrådt tidligere.
English: The most frequent serious treatment-related ADRs were reported in 7 (1.0%) patients receiving rilpivirine.
Danish: De hyppigste alvorlige behandlingsrelaterede bivirkninger blev rapporteret hos 7 (1,0 %) patienter, der fik rilpivirin.
English: Hepatitis B and/or hepatitis C virus co-infection
Danish: Hepatitis B- og/eller hepatitis C-virus co-infektion
English: * The interaction between rilpivirine and the medicinal product was evaluated in a clinical study.
Danish: Interaktionen mellem rilpivirin og lægemidlet blev vurderet i et klinisk studie.
English: Cimetidine Nizatidine Ranitidine
Danish: Cimetidin Nizatidin Ranitidin
English: Some medicines may affect the levels of EDURANT in the blood when they are taken at the same time as EDURANT.
Danish: Nogle former for medicin kan påvirke niveauet af EDURANT i blodet, når de samtidig tages med EDURANT.
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Danish: Kun spor af uforandret rilpivirin (< 1 % af dosis) blev påvist i urin.
English: EDURANT has only been used in a limited number of patients of 65 years or older.
Danish: EDURANT er kun blevet anvendt til et begrænset antal patienter over 65 år.
English: EDURANT works by reducing the amount of HIV in your body.
Danish: EDURANT virker ved at reducere mængden af hiv-virus i kroppen.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Danish: Kun H2receptorantagonister, der kan doseres en gang dagligt, bør anvendes.
English: There is no specific antidote for overdose with EDURANT.
Danish: Der findes ingen specifik modgift mod overdosering af EDURANT.
English: A bottle with child resistant closure containing 30 film-coated tablets.
Danish: En beholder med børnesikret lukning, der indeholder 30 filmovertrukne tabletter.
English: - Tell your doctor if you have or have had problems with your liver, including hepatitis B and/or C, and/or problems with your kidneys.
Danish: - Fortæl det til lægen, hvis du har eller har haft leverproblemer, herunder hepatitis B og/eller C (leverbetændelse) og/eller nyreproblemer.
English: Each carton contains one bottle of 30 tablets.
Danish: Hver karton indeholder en beholder med 30 tabletter.
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Danish: Klinisk monitorering anbefales dog, da det hos nogle patienter kan være nødvendigt at justere vedligeholdelsesbehandling med methadon.
English: common decreased appetite increased triglycerides (fasted)
Danish: Almindelige nedsat appetit forhøjede triglycerider (fastende)
English: The effects of EDURANT or other medicines might be influenced if you take EDURANT together with any of the following medicines.
Danish: Virkningen af EDURANT eller af anden medicin kan blive påvirket, hvis du tager EDURANT sammen med nedenstående medicin.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactase mangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
Danish: Behandlingen af overdosering med rilpivirin består af generelle understøttende tiltag, herunder monitorering af vitale tegn og EKG (QT-interval) samt observation af klinisk status.
English: EDURANT must be taken with a meal to obtain optimal absorption.
Danish: EDURANT skal tages i forbindelse med et måltid for at opnå optimal absorption.
English: There is limited information regarding the use of EDURANT in patients > 65 years of age.
Danish: Der er begrænset dokumentation for brugen af EDURANT til patienter > 65 år.
English: This leaflet was last revised in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest ændret{ MM/ÅÅÅÅ }
English: Pharmacotherapeutic group: Antiviral for systemic use, non-nucleoside reverse transcriptase inhibitors, ATC code: J05AG05.
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug, non-nukleosid reverse transcriptasehæmmere, ATC-kode: J05AG05.
English: EDURANT should be used with caution in this population.
Danish: EDURANT bør anvendes med forsigtighed til denne population.
English: The distribution of rilpivirine into compartments other than plasma (e.g., cerebrospinal fluid, genital tract secretions) has not been evaluated in humans.
Danish: Fordelingen af rilpivirin i andre kompartmenter end plasma (f.eks. cerebrospinalvæske, genitalsekreter) er ikke vurderet hos mennesker.
English: HIV infected mothers must not breastfeed, as there is a possibility of infecting the baby with HIV via breast milk.
Danish: Hiv-inficerede kvinder må ikke amme, da der er risiko for, at hiv-smitten kan blive overført til barnet via modermælken.
English: 60-100 mg once daily, individualised dose
Danish: 60-100 mg x 1, individuel dosis
English: Your doctor will advise on which HIV medicines can be combined with EDURANT and together you will decide which combination fits your needs best.
Danish: Lægen vil rådgive dig om, hvilken hiv-medicin du kan kombinere med EDURANT, så I sammen kan finde frem til den kombination, der bedst dækker dine behov.
English: All other drug-drug interactions shown are predicted.
Danish: Alle andre viste lægemiddelinteraktioner er forventede.
English: Renal elimination of rilpivirine is negligible.
Danish: Renal elimination af rilpivirin er ubetydelig.
English: Your doctor may evaluate how severe your liver or kidney disease is before deciding if you can take EDURANT.
Danish: Lægen vil vurdere, hvor alvorlig din lever- eller nyresygdom er, før vedkommende beslutter, om du kan tage EDURANT.
English: Paediatric population (12 to less than 18 years of age)
Danish: Pædiatrisk population (fra 12 til under 18 år)
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Danish: GLUKOKORTIKOIDER Dexamethason (systemisk, undtagen ved enkeltdosering)
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Danish: Metabolisme og ernæring meget almindelige forhøjet totalkolesterol (fastende) forhøjet LDL-kolesterol (fastende)
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG.
Danish: Der er kun begrænsede oplysninger tilgængelige om muligheden for en farmakodynamisk interaktion mellem rilpivirin og lægemidler, der forlænger QTc-intervallet på EKG'et.
English: NARCOTIC ANALGESICS Methadone*
Danish: NARKOTISKE ANALGETIKA Methadon*
English: Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT.
Danish: Nogle patienter kan blive trætte, svimle eller sløve under behandlingen med EDURANT.
English: Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum.
Danish: Rilpivirin kombineret med et baggrundsregimen blev evalueret i et klinisk studie med 19 gravide kvinder i løbet af andet og tredje trimester og postpartum.
English: Tell your doctor if you take: - rifabutin (a medicine to treat some bacterial infections).
Danish: Fortæl det til lægen, hvis du tager: - rifabutin (medicin til behandling af visse infektioner, der skyldes bakterier).
English: Dosing recommendations for paediatric patients less than 12 years of age cannot be made due to insufficient data (see section 4.2).
Danish: Der kan ikke gives dosisanbefalinger for pædiatriske patienter under 12 år på grund af utilstrækkelige data (se pkt.
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Danish: I fæces udgjorde uforandret rilpivirin gennemsnitligt 25 % af den indgivne dosis.
English: ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.
Danish: Bivirkninger, som er rapporteret hos voksne patienter i behandling med rilpivirin, er opsummeret i tabel 2.
English: EDURANT contains lactose
Danish: EDURANT indeholder lactose
English: Rilpivirine was well tolerated during pregnancy and postpartum.
Danish: Der var god tolerans over for rilpivirin under graviditet og postpartum.
English: Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Danish: Rilpivirin er blevet vurderet med hensyn til karcinogent potentiale ved tvangsfodring per os af mus og rotter i op til 104 uger.
English: Pooled data from the ECHO and THRIVE trials
Danish: Poolede data fra studierne ECHO og THRIVE
English: Pregnancy and Postpartum
Danish: Graviditet og postpartum
English: The observed hepatocellular findings in mice may be rodent-specific.
Danish: De observerede hepatocellulære fund hos mus kan være gnaverspecifikke.
English: Abacavir/lamivudine
Danish: Abacavir/lamivudin
English: Do not stop using EDURANT
Danish: Du må ikke holde op med at tage EDURANT
English: When you stop taking rifabutin, take one tablet of EDURANT once a day.
Danish: Når du stopper med at tage rifabutin, skal du kun tage én tablet EDURANT en gang dagligt.
English: In ECHO, randomisation was stratified by screening viral load.
Danish: I ECHO blev randomiseringen stratificeret ud fra viral load ved screening.
English: It is not known whether rilpivirine is excreted in human milk.
Danish: Det er ukendt, om rilpivirin udskilles i human mælk.
English: Only adolescents deemed likely to have good adherence to antiretroviral therapy should be treated with rilpivirine, as suboptimal adherence can lead to development of resistance and the loss of future treatment options.
Danish: Kun unge, der må formodes at kunne overholde den antiretrovirale behandling, bør behandles med rilpivirin, eftersom suboptimal behandlingsoverholdelse kan føre til resistensudvikling og tab af fremtidige behandlingsmuligheder.
English: Do not take EDURANT if you are allergic to rilpivirine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke EDURANT, hvis du er allergisk over for rilpivirin eller et af de øvrige indholdsstoffer i EDURANT (angivet i punkt 6).
English: There were no patients who discontinued treatment due to ADRs.
Danish: Der var ingen patienter, som afbrød behandlingen på grund af bivirkninger.
English: Warnings and precautions Talk to your doctor or pharmacist before taking EDURANT.
Danish: Advarsler og forsigtighedsregler Kontakt lægen eller apotekspersonalet, før du tager EDURANT.
English: In these patients, phenotypic cross-resistance to other NNRTIs was noted as follows: etravirine 32/42, efavirenz 30/42, and nevirapine 16/42.
Danish: Hos disse patienter blev der observeret fænotypekrydsresistens over for andre NNRTI med følgende hyppighed: etravirin 32/42, efavirenz 30/42 og nevirapin 16/42.
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Danish: Rilpivirins terminale elimineringshalveringstid er ca. 45 timer.
English: CCR5 Antagonists Maraviroc
Danish: CCR5-hæmmere Maraviroc
English: BR=background regimen N=number of subjects
Danish: BR = baggrundsregime N = antal forsøgspersoner
English: Treatment with rilpivirine resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).
Danish: Behandling med rilpivirin førte til en tidlig mindre stigning i gennemsnitligt serumkreatinin, som forblev stabilt over tid og ikke anses for klinisk relevant (se pkt.
English: 6 cells/l in the efavirenz arm in the pooled analysis of the ECHO and THRIVE trials [estimated treatment difference (95% CI): 11.3 (-6.8; 29.4)].
Danish: 6 celler/l i efavirenz-gruppen i den poolede analyse af studierne ECHO og THRIVE [estimeret behandlingsforskel (95 % CI): 11,3 (-6,8; 29,4)].
English: Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams.
Danish: Symptomer på en overdosis kan omfatte hovedpine, kvalme, svimmelhed og/eller unormale drømme.
English: All subjects with rilpivirine RAMs also had at least 1 treatment-emergent NRTI RAM at the last post-baseline time point with genotypic data.
Danish: Alle forsøgspersoner med rilpivirin-RAM havde også mindst 1 behandlingsrelateret NRTI RAM på det sidste tidspunkt efter baseline med genotypedata.
English: Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
Danish: Eftersom rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at dialyse kan medføre signifikant eliminering af det aktive stof.
English: EDURANT is used in combination with other HIV medicines to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Danish: EDURANT anvendes sammen med andre former for hiv-medicin til behandling af voksne og unge over 12 år med hiv-infektion, som aldrig tidligere har fået behandling med hiv-medicin.
English: Contact your doctor if 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 har glemt en dosis eller kastet op.
English: The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Danish: K103Nsubstitutionen alene medførte ikke nedsat følsomhed for rilpivirin, men kombinationen af K103N og L100I medført en syvdobbelt reduktion af følsomheden for rilpivirin.
English: Human experience of overdose with rilpivirine is limited.
Danish: Erfaringen med overdosering af rilpivirin er begrænset.
English: There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
Danish: Der foreligger begrænsede oplysninger om brug af EDURANT til patienter med let til moderat nedsat leverfunktion (Child-Pugh-score A eller B).
English: In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Danish: I disse studier blev respons ikke påvirket af tilstedeværelsen af mutationerne V90I og V189I ved baseline.
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Danish: Rilpivirin hæmmer ikke humane cellulære DNApolymeraser α, β og γ.
English: Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Danish: Dyrestudier har ikke vist tegn på relevant embryonal eller føtal toksicitet eller påvirkning af den reproduktive funktion.
English: - Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats).
Danish: - Fortæl det straks til lægen, hvis du mærker symptomer på infektion (f.eks. feber, kulderystelser, svedeture).
English: As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
Danish: Ligesom for andre antiretrovirale lægemidler bør resistensundersøgelser være vejledende for brugen af EDURANT.
English: EDURANT has mainly been studied in patients with normal renal function.
Danish: EDURANT er hovedsageligt undersøgt hos patienter med normal nyrefunktion.
English: Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM).
Danish: Rilpivirin hæmmer P-glykoprotein in vitro ((IC50 er 9,2 μM).
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Danish: De farmakokinetiske data påviste, at den samlede eksponering (AUC) for rilpivirin som en del af et antiretroviralt regimen var ca. 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger).
English: Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast-feed if they are receiving rilpivirine.
Danish: På grund af både den potentielle risiko for hiv-smitte og risikoen for bivirkninger hos det ammede barn bør mødre informeres om, at de ikke bør amme, hvis de er i behandling med rilpivirin.
English: These resistance-associated mutations were derived from in vivo data involving treatment-naïve subjects only and therefore cannot be used to predict the activity of rilpivirine in subjects who have virologically failed an antiretroviral-containing regimen.
Danish: Disse resistensassocierede mutationer blev udledt fra in vivo-data, der kun vedrørte behandlingsnaive forsøgspersoner, og de kan derfor ikke anvendes til at forudsige virkningen af rilpivirin hos personer der har haft virologisk svigt i et antiretroviralt behandlingsregime.
English: Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study.
Danish: Forventet forskel i responsrater (95 % CI) for analysen i uge 48: 1,6 % (-2,2 %; 5,3 %) og for analysen i uge 96: -0,4 % (-4,6 %; 3,8 %); begge p-værdi < 0,0001 (noninferioritet ved en margin på 12 %) fra logistisk regressionsmodel, herunder stratificeringsfaktorer og studie.
English: No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Danish: Der blev ikke indberettet nogen grad 3-4 abnorme laboratorieværdier for ASAT/ALAT eller grad 3-4 bivirkninger med relation til forhøjede aminotransferaser.
English: The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal).
Danish: Eksponeringen for rilpivirin var ca. 40 % lavere, når EDURANT blev taget i fastende tilstand sammenlignet med et måltid med et normalt kalorieindhold (533 kcal) eller et måltid med et højt fedtindhold og et højt kalorieindhold (928 kcal).
English: Interactions between rilpivirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not applicable as “NA”, confidence interval as “CI”).
Danish: Interaktioner mellem rilpivirin og samtidigt indgivne lægemidler er angivet i tabel 1 (forhøjelse angives med "↑", reduktion angives med "↓", ingen ændring angives med "↔", ikke relevant angives med "IR", konfidensinterval angives med "CI").
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
Danish: FOSFODIESTERASE-5-HÆMMERE (PDE5-HÆMMERE) Sildenafil*
English: Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range])
Danish: Farmakokinetik for totalrilpivirin (gennemsnit ± SD, tmax: median [interval])
English: H2-receptor antagonists should not be taken in a twice a day regimen.
Danish: H2-receptorantagonister bør ikke tages to gange dagligt.
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Danish: Rilpivirin bibeholdt sensitivitet (FC ≤ BCO) over for 62 % af 4.786 hiv 1-rekombinante kliniske isolater, der var resistente over for efavirenz og/eller nevirapin.