natgillin/translations-raw huggingface dataset:
Det anbefales også, at De ikke ammer for at undgå at overføre virus til barnet via mælken. 
It is also recommended that you do not breast-feed to avoid passing the virus to the baby in breast milk.
Hvis De har taget Odefsey under graviditeten, kan lægen anmode om regelmæssige blodprøver og andre prøver for at overvåge, hvordan barnet udvikler sig. 
If you have taken Odefsey during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Dette vil forbedre Deres immunforsvar og nedsætte risikoen for at De udvikler sygdomme forbundet med hiv-infektionen. 
This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection.
• Anvend effektiv prævention, mens De tager Odefsey. 
• Use effective contraception while taking Odefsey.
Hvis der er tegn på, at leversygdommen forværres hos sådanne patienter, skal det overvejes at afbryde eller seponere behandlingen. 
If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Disse resultater påvirker ikke de aktuelle nationale anbefalinger vedrørende antiretroviral behandling hos gravide med henblik på at undgå vertikal hiv-overførsel. 
These findings do not affect current national recommendations to use antiretroviral therapy in pregnant women to prevent vertical transmission of HIV.
Disse stigninger afspejler ikke en ændring af den faktiske glomerulære filtreringshastighed (GFR). 
These increases do not reflect a change in actual glomerular filtration rate (GFR).
Der er ikke nok data til at berettige anvendelse til patienter med tidligere NNRTI-svigt. 
There are insufficient data to justify the use in patients with prior NNRTI failure.
Hos hunde blev der set kolestaselignende virkninger. 
In dogs cholestasis-like effects were noted.
Hvis De har en hepatitis B-infektion, vil Deres læge nøje overveje, hvilken behandling der er den bedste for Dem. 
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
c Én patient, der ikke fik FTC/RPV/TDF forud for screening, blev udelukket fra analysen. 
c One patient who was not on FTC/RPV/TDF prior to screening was excluded from the analysis.
b Forskellen i responsrate ved uge 48 er 1 % (95 % konfidensinterval 3 % til 6 %) ved hjælp af normal tilnærmelse. 
b The difference of response rate at Week 48 is 1% (95% confidence interval -3% to 6%) using normal approximation.
Odefsey-regime 
Odefsey regimen
Manglende data under vinduet, men fortsat i behandling 
Missing data during window but on study drug
Skift fra et TDF-baseret regime til Odefsey kan medføre små stigninger i lipidparametrene. 
Switching from a TDF-based regimen to Odefsey may lead to slight increases in lipid parameters.
Anbefalinger vedrørende samtidig administration med Odefsey 
Recommendation concerning co-administration with Odefsey
Tal med lægen om en alternativ doseringsplan. 
Talk to your doctor about an alternative regimen.
De gennemsnitlige værdier for rilpivirin-armen for såvel basal som ACTH-stimuleret cortisol i uge 96 var inden for normalområdet. 
Mean values for the rilpivirine arm for both basal and ACTH-stimulated cortisol at Week 96 were within the normal range.
Odefsey, kan det i alvorlig grad påvirke Deres reaktion på fremtidig behandling. 
Stopping Odefsey can seriously affect your response to future treatment.
ODE = Odefsey a Uge 48-vinduet var mellem dag 295 og 378 (inklusive). 
ODE = Odefsey a Week 48 window was between Day 295 and 378 (inclusive).
Der er ingen tilgængelige data til at lave dosisanbefalinger hos børn under 18 år med nyresygdom i slutstadiet. 
No data are available to make dose recommendations in children less than 18 years with end stage renal disease.
Der blev ikke detekteret nogen nyudvikling af resistens over for E/C/F/TAF til og med uge 48. 
No emergent resistance to E/C/F/TAF was detected through Week 48.
I fæces udgjorde uændret rilpivirin i gennemsnit 25 % af den administrerede dosis. 
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Karcinogenicitetsstudier med rilpivirin hos mus og rotter afslørerede et tumorigent potentiale specifikt for disse arter, men det anses som uden relevans for mennesker. 
Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Mens De tager Odefsey, kan De stadig udvikle infektioner eller andre sygdomme, der er forbundet med hiv-infektion. 
While taking Odefsey you may still develop infections or other illnesses associated with HIV infection.
• Ethvert lægemiddel, der anvendes til behandling af hiv • Ethvert lægemiddel, som indeholder: 
• Any medicines used for treating HIV • Any medicines containing:
EU/1/16/1112/001 30 filmovertrukne tabletter EU/1/16/1112/002 90 (3 beholdere med 30) filmovertrukne tabletter 
EU/1/16/1112/001 30 film-coated tablets EU/1/16/1112/002 90 (3 bottles of 30) film-coated tablets
Som et resultat heraf kan mængden af Odefsey eller anden medicin i Deres blod blive påvirket. 
As a result, the amounts of Odefsey or other medicines in your blood may be affected.
Klinisk monitorering anbefales, da vedligeholdelsesbehandling med metadon muligvis kan kræve justering for visse patienter. 
Clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Hvis De har en hepatitis B-infektion, kan leverproblemerne blive værre, efter De holder op med at tage Odefsey. 
If you have hepatitis B infection, liver problems may become worse after you stop taking Odefsey.
Der er ingen specifik antidot mod overdosering med Odefsey. 
There is no specific antidote for overdose with Odefsey.
Reduceret absorption, stigning i gastrisk pH 
Reduced absorption, increase in gastric pH
Odefsey er et antiviralt lægemiddel, som bruges til at behandle infektion med humant immundefektvirus (hiv). 
Odefsey is an antiviral medicine used to treat infection by the Human Immunodeficiency Virus (HIV).
Hos børn, hvis mødre tog nucleosid-revers transkriptasehæmmeres (NRTI'er) under graviditeten, opvejede fordelen ved beskyttelse mod hiv risikoen for bivirkninger. 
In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Odefsey er indiceret til brug som et komplet regime til behandling af hiv 1-infektion, og det bør ikke administreres sammen med andre antiretrovirale lægemidler. 
Odefsey is indicated for use as a complete regimen for the treatment of HIV-1 infection and should not be co-administered with other antiretroviral medicinal products.
Efter oral administration opnås den højeste plasmakoncentration af rilpivirin generelt inden for 4 til 5 timer. 
After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4 to 5 hours.
Tal med lægen om en alternativ doseringsform (se Sådan skal De tage Odefsey). 
Talk to your doctor about an alternative regimen (see How to take Odefsey).
Samtidig brug, hvor forsigtighed tilrådes 
Concomitant use where caution is recommended
Hvis De har både hiv-infektion og hepatitis B, er det særlig vigtigt ikke at ophøre med behandlingen med Odefsey uden først at konsultere Deres læge. 
If you have both HIV infection and hepatitis B, it is especially important not to stop your Odefsey treatment without talking to your doctor first.
Den absolutte biotilgængelighed af rilpivirin kendes ikke. 
The absolute bioavailability of rilpivirine is unknown.
b Uge 96-vinduet var mellem dag 631 og 714 (inklusive). 
b Week 96 window was between Day 631 and 714 (inclusive).
Der var også omklassificeringer i den primære analyse i uge 48, hvor den mest almindelige omklassificering var fra virologisk svigt til afbrydelse af behandlingen af andre årsager end AE. 
There were also reclassifications in the Week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Der var ingen kliniske tegn eller symptomer, som tydede på adrenal eller gonadal dysfunktion hos voksne. 
There were no clinical signs or symptoms suggestive of adrenal or gonadal dysfunction in adults.
Hvert af disse aktive stoffer virker ved at påvirke et enzym, som kaldes ”revers transcriptase”, der er vigtigt for, at hiv 1-virus kan formere sig. 
Each of these active substances works by interfering with an enzyme called ‘reverse transcriptase', which is essential for the HIV-1 virus to multiply.
Efter enkeltdosis oral administration af [14C]-rilpivirin kunne i gennemsnit hhv. 85 % og 6,1 % af radioaktiviteten genfindes i fæces og urin. 
After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
dyspepsi3 
dyspepsia3
Rilpivirins binding in vitro til humane plasmaproteiner er cirka 99,7 %, primært til albumin. 
In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
• Hvis De tager lægemidler, der kan medføre livstruende uregelmæssigt hjerteslag (Torsades de Pointes). 
• If you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsades de Pointes).
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. 
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.
Regime ved baseline (n = 477) 
Baseline regimen (n = 477)
Resultaterne for unge (i alderen 12 til under 18 år) i studiet C213 var generelt på linje med disse data (se pkt. 
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).
øget total kolesterol (fastende)1, øget LDL-kolesterol (fastende)1 
increased total cholesterol (fasted)1, increased LDL-cholesterol (fasted)1
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. 
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.
Data fra et stort antal gravide kvinder (mere end 1.000) indikerer ingen misdannelser eller føtal/neonatal toksicitet i forbindelse med emtricitabin. 
A large amount of data on pregnant women (more than 1,000 exposed outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine.
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. 
It is important not to stop taking Odefsey without talking to your doctor: see section 3, Do not stop taking Odefsey.
3 Studie udført med yderligere 100 mg voxilaprevir for at opnå de voxilaprevir-eksponeringer, der forventes hos HCVinficerede patienter. 
3 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV infected patients.
Odefsey skal tages oralt, én gang dagligt, sammen med mad (se pkt. 
Odefsey should be taken orally, once daily with food (see section 5.2).
Rilpivirins farmakokinetik hos pædiatriske patienter < 12 år er ved at blive undersøgt. 
The pharmacokinetics of rilpivirine in paediatric patients < 12 years of age is under investigation.
Ved baseline var median eGFRCG 56 ml/min, og 33 % af patienterne havde en eGFRCG fra 30 til 49 ml/min. 
At baseline, median eGFRCG was 56 mL/min, and 33% of patients had an eGFRCG from 30 to 49 mL/min.
Emtricitabin hæmmede ikke lægemiddelmetabolisme in vitro medieret af nogen af de større humane CYP-isoformer, der er involveret i lægemiddelbiotransformation. 
Emtricitabine did not inhibit in vitro drug metabolism mediated by any of the major human CYP isoforms involved in drug biotransformation.
Hvis De er i dialyse, skal De tage Deres daglige dosis Odefsey, efter De har fuldført Deres dialyse. 
If you are on dialysis, take your daily dose of Odefsey following completion of dialysis.
H2-antagonister må kun tages en gang om dagen, hvis De tager Odefsey. 
H2-antagonists can only be taken once a day if you take Odefsey.
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). 
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).
Det kan dog ikke udelukkes, at eksponering for farmakologisk aktiv, ubundet rilpivirin øges markant ved moderat nedsat funktion. 
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate impairment.
Den kombination af NRTI'er, der hyppigst blev anvendt sammen med rilpivirin, var FTC/TDF (24 forsøgspersoner [66,7 %]). 
The combination of NRTIs most frequently used together with rilpivirine was FTC/TDF (24 subjects [66.7%]).
• øget antal fedtsyrer (triglycerider), bilirubin eller lipase i blodet 
• increased fatty acids (triglycerides), bilirubin or lipase in the blood
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). 
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).
Normalisering af alanintransaminase (ALAT) blev opnået hos 40 % (4/10) af forsøgspersoner med ALAT over den øvre normalgrænse (ULN) ved baseline. 
Alanine aminotransferase (ALT) normalisation was achieved in 40% (4/10) of subjects with ALT greater than upper limit of normal (ULN) at baseline.
Tabel 6: Farmakokinetik for emtricitabin og tenofoviralafenamid hos antiretroviral-naive unge og voksne 
Table 6: Pharmacokinetics of emtricitabine and tenofovir alafenamide in antiretroviral-naïve adolescents and adults
Induktion af P-gp 
Induction of P-gp
Da rilpivirin er stærkt proteinbundet, er det usandsynligt, at dialyse i signifikant grad kan fjerne det aktive stof. 
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
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. 
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.
Rilpivirins terminale eliminationshalveringstid er ca. 45 timer. 
The terminal elimination half-life of rilpivirine is approximately 45 hours.
Odefsey indeholder lactose 
Odefsey contains lactose
Ændringer i lipidværdier i laboratorieprøver 
Changes in lipid laboratory tests
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. 
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.
• tegn eller symptomer på betændelse eller infektion 
• signs or symptoms of inflammation or infection
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. 
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).
• et lavt antal hvide blodlegemer (et nedsat antal hvide blodlegemer kan gøre Dem mere modtagelig for infektioner) 
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• Hvis De er allergisk over for emtricitabin, rilpivirin, tenofoviralafenamid eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6). 
• If you are allergic to emtricitabine, rilpivirine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
Kontakt lægen, før De tager Odefsey: • Hvis De har leverproblemer, eller hvis De tidligere har haft en leversygdom, herunder hepatitis (gulsot). 
Talk to your doctor before taking Odefsey: • If you have liver problems or a history of liver disease, including hepatitis.
• Metadon, et lægemiddel der bruges til at behandle afhængighed af opiater, da det kan være nødvendigt for Deres læge at ændre metadondosis. 
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
Samlede behandlingsresultater efter 48 uger vises i tabel 3. 
Pooled treatment outcomes at 48 weeks are shown in Table 3.
Kombinationerne af emtricitabin, rilpivirin og tenofoviralafenamid var ikke antagonistiske og viste synergistiske virkninger med hinanden i kombinationsanalyser af antiviral aktivitet i cellekultur. 
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.
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. 
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.
Der blev kun påvist spormængder af uændret rilpivirin (< 1 % af dosis) i urin. 
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Der blev set små forbedringer i BMD ved 48 uger efter skift til E/C/F/TAF sammenlignet med opretholdelse af regimet med tenofovirdisoproxilfumarat. 
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.
Odefsey [Kun på den ydre emballage] 
Odefsey [Outer packaging only]
Forskellen i forekomst af nye virologiske svigt fra uge 48 til uge 96 var ikke statistisk signifikant mellem rilpivirin-armen og efavirenz-armen. 
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.
Lægemidler, der påvirker P-gp- og BCRP-aktiviteten, kan føre til ændringer i tenofoviralafenamids absorption (se tabel 1). 
Medicinal products that affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 1).
• Antibiotika, der anvendes til at behandle bakterieinfektioner, som indeholder: 
• Antibiotics used to treat bacterial infections containing:
Nogle patienter, der tager antiretroviral kombinationsmedicin, såsom Odefsey, kan udvikle en knoglesygdom, der kaldes osteonekrose (knoglevævsdød forårsaget af manglende blodforsyning til knoglerne). 
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).
Rilpivirin er ved den anbefalede dosis på 25 mg en gang om dagen ikke forbundet med en klinisk relevant indvirkning på QTc. 
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Kvinder i den fertile alder/kontraception til mænd og kvinder Anvendelsen af Odefsey bør ledsages af anvendelse af sikker kontraception. 
Women of childbearing potential/contraception in males and females The use of Odefsey should be accompanied by the use of effective contraception.
Tenofovir elimineres renalt, både ved glomerulær filtration og aktiv tubulær sekretion. 
Tenofovir is renally eliminated by both glomerular filtration and active tubular secretion.
Rilpivirin hæmmer P-glycoprotein (P-gp) in vitro (50 % hæmningskoncentration [IC50] er 9,2 µM). 
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (50% inhibitory concentration [IC50] is 9.2 µM).
Hæmning af CYP3A Forventet: 
Induction of CYP3A Expected:
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. 
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.
• 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. 
• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor the levels of this medicine in your blood.
Meget hyppigt forekommende bivirkninger (alle grader) var hovedpine, depression, døsighed og kvalme. 
Adverse reactions (all grades) of very common frequency were headache, depression, somnolence and nausea.
Virologisk supprimerede voksne i studiet GS-US-292-0109 
Virologically suppressed adults in Study GS-US-292-0109
Ingen virologiske data ved uge 48- eller uge 144-vinduet Seponerede studiemedicin som følge af AE eller døde 
No virologic data in Week 48 or 144 window Discontinued study drug due to AE or deathe
For monitorering af lipider og glucose i blodet henvises der til eksisterende retningslinjer om behandling af hiv. 
For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Pakningsstørrelser og yderligere oplysninger Odefsey indeholder: 
Contents of the pack and other information What Odefsey contains
Tenofoviralafenamid transporteres af P-gp og brystcancer-resistensprotein (BCRP). 
Tenofovir alafenamide is transported by P-gp and breast cancer resistance protein (BCRP).
• forhøjede niveauer af kolesterol og/eller pankreatisk amylase (et fordøjelsesenzym) i blodet 
• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
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. 
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.
forhøjede transaminaser (ASAT og/eller ALAT)1 
increased transaminases (AST and/or ALT)1
Der foreligger utilstrækkelige data for virkningen af alle indholdsstofferne i Odefsey hos nyfødte/spædbørn, og derfor bør Odefsey ikke bruges under amning. 
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.
Der foreligger ingen data om Odefseys virkning på menneskers fertilitet. 
No human data on the effect of Odefsey on fertility are available.
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. 
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.