FrancophonIA/ELRC3.0 huggingface dataset:
English: • If you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsades de Pointes).
Danish: • Hvis De tager lægemidler, der kan medføre livstruende uregelmæssigt hjerteslag (Torsades de Pointes).
English: A negative impact by NNRTI mutations other than those listed above (e.g., mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Danish: Andre negative virkninger af NNRTI-mutationer end de ovennævnte (f.eks. mutationerne K103N eller L100I som enkelte mutationer) kan ikke udelukkes, da de ikke er blevet undersøgt in vivo hos et tilstrækkeligt antal patienter.
English: Baseline regimen (n = 477)
Danish: Regime ved baseline (n = 477)
English: Findings in adolescents (12 to less than 18 years of age) in Study C213 were generally in line with these data (for details see section 5.1).
Danish: Resultaterne for unge (i alderen 12 til under 18 år) i studiet C213 var generelt på linje med disse data (se pkt.
English: increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
Danish: øget total kolesterol (fastende)1, øget LDL-kolesterol (fastende)1
English: N/A = not applicable 1 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product.
Danish: I/R = ikke relevant 1 Dette interaktionsstudie er blevet udført med en højere dosis en den anbefalede dosis af rilpivirinhydrochlorid med henblik på at vurdere den maksimale virkning på det samtidigt administrerede lægemiddel.
English: A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
Danish: Data fra et stort antal gravide kvinder (mere end 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin.
English: It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
Danish: Det er vigtigt ikke at holde op med at tage Odefsey uden at tale med lægen: se punkt 3, Hold ikke op med at tage Odefsey.
English: 3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Danish: 3 Studie udført med yderligere 100 mg voxilaprevir for at opnå de voxilaprevir-eksponeringer, der forventes hos HCVinficerede patienter.
English: Odefsey should be taken orally, once daily with food (see section 5.2).
Danish: Odefsey skal tages oralt, én gang dagligt, sammen med mad (se pkt.
English: The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Danish: Rilpivirins farmakokinetik hos pædiatriske patienter < 12 år er ved at blive undersøgt.
English: At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Danish: Ved baseline var median eGFRCG 56 ml/min, og 33 % af patienterne havde en eGFRCG fra 30 til 49 ml/min.
English: Emtricitabine did not inhibit in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Danish: Emtricitabin hæmmede ikke lægemiddelmetabolisme in vitro medieret af nogen af de større humane CYP-isoformer, der er involveret i lægemiddelbiotransformation.
English: If you are on dialysis, take your daily dose of Odefsey following completion of dialysis.
Danish: Hvis De er i dialyse, skal De tage Deres daglige dosis Odefsey, efter De har fuldført Deres dialyse.
English: H2-antagonists can only be taken once a day if you take Odefsey.
Danish: H2-antagonister må kun tages en gang om dagen, hvis De tager Odefsey.
English: If you accidentally take more than the recommended dose of Odefsey you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Danish: Hvis De ved et uheld tager mere end den anbefalede dosis Odefsey, kan De have større risiko for at få bivirkninger med denne medicin (se punkt 4, Bivirkninger).
English: However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Danish: Det kan dog ikke udelukkes, at eksponering for farmakologisk aktiv, ubundet rilpivirin øges markant ved moderat nedsat funktion.
English: The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
Danish: Den kombination af NRTI'er, der hyppigst blev anvendt sammen med rilpivirin, var FTC/TDF (24 forsøgspersoner [66,7 %]).
English: • increased fatty acids (triglycerides), bilirubin or lipase in the blood
Danish: • øget antal fedtsyrer (triglycerider), bilirubin eller lipase i blodet
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 viser, at samlet eksponering (AUC) for rilpivirin som del af et antiretroviralt program var cirka 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger).
English: Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Danish: Normalisering af alanintransaminase (ALAT) blev opnået hos 40 % (4/10) af forsøgspersoner med ALAT over den øvre normalgrænse (ULN) ved baseline.
English: Table 6: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Danish: Tabel 6: Farmakokinetik for emtricitabin og tenofoviralafenamid hos antiretroviral-naive unge og voksne
English: Induction of P-gp
Danish: Induktion af P-gp
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Danish: Da rilpivirin er stærkt proteinbundet, er det usandsynligt, at dialyse i signifikant grad kan fjerne det aktive stof.
English: In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Danish: Hos nogle patienter med fremskreden hiv-infektion (aids) og tidligere opportunistiske infektioner (infektioner, der forekommer hos personer med et svagt immunsystem) kan der forekomme tegn og symptomer på betændelse fra tidligere infektioner kort tid efter hiv-behandlingen startes.
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Danish: Rilpivirins terminale eliminationshalveringstid er ca. 45 timer.
English: Odefsey contains lactose
Danish: Odefsey indeholder lactose
English: Changes in lipid laboratory tests
Danish: Ændringer i lipidværdier i laboratorieprøver
English: The decrease in the unbound free fraction of rilpivirine exposure (i.e., active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Danish: Faldet i den ubundne frie fraktion ved eksponering for rilpivirin (dvs. aktiv) under graviditet sammenlignet med postpartum var mindre udtalt end for samlet eksponering for rilpivirin.
English: • signs or symptoms of inflammation or infection
Danish: • tegn eller symptomer på betændelse eller infektion
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Odefsey in one or more subsets of the paediatric population in the treatment of human HIV-1 infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Odefsey i en eller flere undergrupper af den pædiatriske population ved behandlingen af human hiv 1-infektion (se pkt.
English: • low white blood cell count (a reduced white blood cell count can make you more prone to infection)
Danish: • et lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig for infektioner)
English: • If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Danish: • Hvis De er allergisk over for emtricitabin, rilpivirin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Talk to your doctor before taking Odefsey: • If you have liver problems or a history of liver disease, including hepatitis.
Danish: Kontakt lægen, før De tager Odefsey: • Hvis De har leverproblemer, eller hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot).
English: • Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
Danish: • Metadon, et lægemiddel der bruges til at behandle afhængighed af opiater, da det kan være nødvendigt for Deres læge at ændre metadondosis.
English: Pooled treatment outcomes at 48 weeks are shown in Table 3.
Danish: Samlede behandlingsresultater efter 48 uger vises i tabel 3.
English: The combinations of emtricitabine, rilpivirine, and tenofovir alafenamide were not antagonistic and showed synergistic effects with each other in cell culture combination antiviral activity assays.
Danish: Kombinationerne af emtricitabin, rilpivirin og tenofoviralafenamid var ikke antagonistiske og viste synergistiske virkninger med hinanden i kombinationsanalyser af antiviral aktivitet i cellekultur.
English: In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Danish: I et andet studie resulterede Y188L-substitution i en reduceret følsomhed over for rilpivirin på 9 gange for kliniske isolater og 6 gange for site-directed mutanter.
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Danish: Der blev kun påvist spormængder af uændret rilpivirin (< 1 % af dosis) i urin.
English: Small improvements in BMD were noted at 48 weeks after switching to E/C/F/TAF compared to maintaining the tenofovir disoproxil fumarate-containing regimen.
Danish: Der blev set små forbedringer i BMD ved 48 uger efter skift til E/C/F/TAF sammenlignet med opretholdelse af regimet med tenofovirdisoproxilfumarat.
English: Odefsey [Outer packaging only]
Danish: Odefsey [Kun på den ydre emballage]
English: The difference in the rate of new virologic failures from the Week 48 to Week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Danish: Forskellen i forekomst af nye virologiske svigt fra uge 48 til uge 96 var ikke statistisk signifikant mellem rilpivirin-armen og efavirenz-armen.
English: Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
Danish: Lægemidler, der påvirker P-gp- og BCRP-aktiviteten, kan føre til ændringer i tenofoviralafenamids absorption (se tabel 1).
English: • Antibiotics used to treat bacterial infections containing:
Danish: • Antibiotika, der anvendes til at behandle bakterieinfektioner, som indeholder:
English: Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Odefsey, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød forårsaget af manglende blodforsyning til knoglerne).
English: Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Danish: Rilpivirin er ved den anbefalede dosis på 25 mg en gang om dagen ikke forbundet med en klinisk relevant indvirkning på QTc.
English: Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Danish: Kvinder i den fertile alder/kontraception til mænd og kvinder Anvendelsen af Odefsey bør ledsages af anvendelse af sikker kontraception.
English: Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Danish: Tenofovir elimineres renalt, både ved glomerulær filtration og aktiv tubulær sekretion.
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Danish: Rilpivirin hæmmer P-glycoprotein (P-gp) in vitro (50 % hæmningskoncentration [IC50] er 9,2 µM).
English: Induction of CYP3A Expected:
Danish: Hæmning af CYP3A Forventet:
English: The mean steady-state plasma trough concentration at 24 hours post-dose was equal to or greater than the mean in vitro IC90 value for anti-HIV-1 activity.
Danish: Den gennemsnitlige steady-state minimale plasmakoncentration 24 timer efter dosering var lig med eller større end den gennemsnitlige in vitro IC90-værdi for anti-hiv 1-aktivitet.
English: • Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
Danish: • Dabigatranetexilat, et lægemiddel der bruges til at behandle hjertelidelser, da det kan være nødvendigt for Deres læge at overvåge niveauerne af dette lægemiddel i Deres blod.
English: Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Danish: Meget hyppigt forekommende bivirkninger (alle grader) var hovedpine, depression, døsighed og kvalme.
English: Virologically suppressed adults in Study GS-US-292-0109
Danish: Virologisk supprimerede voksne i studiet GS-US-292-0109
English: No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
Danish: Ingen virologiske data ved uge 48- eller uge 144-vinduet Seponerede studiemedicin som følge af AE eller døde
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Danish: For monitorering af lipider og glucose i blodet henvises der til eksisterende retningslinjer om behandling af hiv.
English: Contents of the pack and other information What Odefsey contains
Danish: Pakningsstørrelser og yderligere oplysninger Odefsey indeholder:
English: Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
Danish: Tenofoviralafenamid transporteres af P-gp og brystcancer-resistensprotein (BCRP).
English: • increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
Danish: • forhøjede niveauer af kolesterol og/eller pankreatisk amylase (et fordøjelsesenzym) i blodet
English: The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Danish: K103N-substitutionen alene resulterede ikke i reduceret modtagelighed for rilpivirin, men kombinationen af K103N og L100I resulterede i en 7 gange reduceret følsomhed over for rilpivirin.
English: increased transaminases (AST and/or ALT)1
Danish: forhøjede transaminaser (ASAT og/eller ALAT)1
English: There is insufficient information on the effects of all the components of Odefsey in newborns/infants, therefore Odefsey should not be used during breast-feeding.
Danish: Der foreligger utilstrækkelige data for virkningen af alle indholdsstofferne i Odefsey hos nyfødte/spædbørn, og derfor bør Odefsey ikke bruges under amning.
English: No human data on the effect of Odefsey on fertility are available.
Danish: Der foreligger ingen data om Odefseys virkning på menneskers fertilitet.
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 vurderes at kunne udvise compliance i forbindelse med antiretroviral terapi, bør behandles med rilpivirin, da suboptimal compliance kan føre til udvikling af resistens og tab af behandlingsmuligheder i fremtiden.
English: Once you start taking Odefsey, look out for:
Danish: Når De begynder med at tage Odefsey, skal De holde øje med:
English: The biotransformation of emtricitabine includes oxidation of the thiol moiety to form the 3'-sulfoxide diastereomers (approximately 9% of dose) and conjugation with glucuronic acid to form 2'-O-glucuronide (approximately 4% of dose).
Danish: Emtricitabins biotransformation omfatter oxidation af thioldelen, hvorved der dannes 3'-sulfoxiddiastereomerer (cirka 9 % af dosen) og konjugering med glucuronsyre til at danne 2'-O-glucuronid (cirka 4 % af dosen).
English: decreased appetite1, increased triglycerides (fasted)1
Danish: nedsat appetit1, øget antal triglycerider (fastende)1
English: nausea1, 3, increased pancreatic amylase1
Danish: kvalme1,3, forhøjet pankreatisk amylase1
English: Odefsey is a grey, capsule-shaped, film-coated tablet debossed on one side with “GSI” and “255” on the other side.
Danish: Odefsey er en grå, kapselformet, filmovertrukken tablet, som er præget med ”GSI” på den ene side og tallet ”255” på den anden side.
English: a Week 48 window was between Day 294 and 377 (inclusive); Week 144 window was between Day 966 and 1,049 (inclusive).
Danish: a Uge 48-vinduet var fra dag 294 til 377 (inklusive), uge 144-vinduet var fra dag 966 til 1049 (inklusive).
English: In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Danish: Eksperimenter in vitro indikerer, at rilpivirinhydrochlorid primært undergår oxidativ metabolisme medieret af CYP3A-systemet.
English: If Odefsey is stopped for any reason, speak to your doctor before you restart taking Odefsey tablets.
Danish: Hvis Odefsey stoppes uanset årsagen, skal De tale med Deres læge, før De igen begynder at tage Odefsey tabletter.
English: Interactions between Odefsey or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Danish: Interaktioner mellem Odefsey eller de individuelle indholdsstoffer i Odefsey og mulige samtidigt administrerede lægemidler ses i tabel 1 nedenfor (stigning er angivet som ”↑”, fald som ”↓”, ingen ændring som ”↔”).
English: • rifabutin, rifampicin, rifapentine
Danish: • rifabutin, rifampicin, rifapentin
English: 1 Adverse reactions identified from rilpivirine clinical studies.
Danish: 1 Bivirkninger identificeret i kliniske studier af rilpivirin.
English: As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Odefsey (see section 4.4).
Danish: Som med andre antiretrovirale lægemidler bør resistenstest og/eller historiske resistensdata vejlede brugen af Odefsey (se pkt.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with < 1% of the dose eliminated in urine.
Danish: Renal udskillelse af intakt tenofoviralafenamid er en mindre metaboliseringsvej med < 1 % af dosen elimineret i urinen.
English: Rilpivirine (one of the components of Odefsey) in combination with a background regimen was evaluated in Study TMC114HIV3015 in 19 pregnant women during the 2nd and 3rd trimesters, and postpartum.
Danish: Rilpivirin (en af komponenterne i Odefsey) i kombination med et baggrundsprogram evalueredes i studie TMC114HIV3015 hos 19 gravide kvinder i 2. og 3. trimester og postpartum.
English: Eighty-six percent of patients (62/72) were HBV suppressed (HBV DNA < 29 IU/mL) and 42% (30/72) were HBeAg positive at baseline.
Danish: 86 % af patienterne (62/72) var HBV-supprimerede (HBV DNA < 29 IE/ml), og 42 % (30/72) var HBeAg-positive ved baseline.
English: It is important not to miss a dose of Odefsey.
Danish: Det er vigtigt ikke at komme til at springe en dosis af Odefsey over.
English: Up to 30% of the emtricitabine dose can be removed by haemodialysis.
Danish: Op til 30 % af emtricitabindosis kan fjernes ved hæmodialyse.
English: FTC = emtricitabine; TAF = tenofovir alafenamide; TFV = tenofovir, N/A = not applicable Data are presented as mean (%CV).
Danish: FTC = emtricitabin; TAF = tenofoviralafenamid; TFV = tenofovir, I/R = ikke relevant Data vises som gennemsnit (% CV).
English: Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
Danish: Rilpivirin-resistente stammer blev udvalgt i cellekultur startende fra vildtype hiv 1 af forskellig oprindelse og undertyper samt NNRTI-resistent hiv 1.
English: You must remain under the care of your doctor while taking Odefsey.
Danish: De skal fortsætte med at være under lægens opsyn, mens De tager Odefsey.
English: • stomach pain or discomfort
Danish: • mavesmerter eller ubehag
English: Odefsey is used in adults and adolescents aged 12 years and older, who weigh at least 35 kg.
Danish: Odefsey bruges til voksne og unge i alderen 12 år og ældre, der vejer mindst 35 kg.
English: Treatment outcomes of Studies GS-US-366-1216 and GS-US-366-1160 are presented in Table 5.
Danish: Behandlingsresultaterne i studierne GS-US-366-1216 og GS-US-366-1160 vises i tabel 5.
English: Resistance testing and/or historical resistance data should guide the use of Odefsey (see section 5.1).
Danish: Resistenstest og/eller historiske resistensdata bør vejlede brugen af Odefsey (se pkt.
English: Pooled treatment outcomes at 48 and 144 weeks are shown in Table 3.
Danish: De samlede behandlingsresultater efter 48 og 144 uger vises i tabel 3.
English: At the start of treatment with E/C/F/TAF, the 72 patients had been HIV suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months with or without suppression of HBV DNA and had compensated liver function.
Danish: Ved starten af behandlingen med E/C/F/TAF havde 72 patienter været hiv-supprimerede (hiv-1 RNA < 50 kopier/ml) i mindst 6 måneder med eller uden supprimering af HBV DNA, og de havde kompenseret leverfunktion.
English: The proportion of patients with HIV-1 RNA < 50 copies/mL at Week 48 (TLOVR) was 72.2% (26/36).
Danish: Andelen af patienter med hiv 1-rna < 50 kopier/ml ved uge 48 (TLOVR) var 72,2 % (26/36).
English: Patients should be informed that fatigue, dizziness and somnolence have been reported during treatment with the components of Odefsey (see section 4.8).
Danish: Patienterne bør informeres om, at der er rapporteret om træthed, svimmelhed og søvnighed under behandling med indholdsstofferne i Odefsey (se pkt.
English: The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Danish: Dosisanbefalingerne gælder for den anbefalede dosis af rilpivirin på 25 mg en gang dagligt.
English: In patients with severe renal impairment or end-stage renal disease, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Danish: Hos patienter med svært nedsat nyrefunktion eller nyresygdom i sidste stadie kan plasmakoncentrationer være forhøjede på grund af ændret absorption, distribution og/eller metabolisme af lægemidler som følge af renal dysfunktion.
English: A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp).
Danish: Risikoen for stigninger i plasmakoncentrationerne af dabigatran kan ikke udelukkes (hæmning af intestinal P-gp).
English: Titanium dioxide (E171) Iron oxide black (E172)
Danish: Titandioxid (E171) Jernoxid, sort (E172)
English: Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
Danish: Tegn på osteonekrose er: stivhed i led smerter i led (især i hofter, knæ og skuldre) bevægelsesbesvær
English: Odefsey should be used with caution in patients with moderate hepatic impairment.
Danish: Odefsey skal anvendes med forsigtighed hos patienter med moderat nedsat leverfunktion.