FrancophonIA/ELRC3.0 huggingface dataset:
English: Less than 0.7 % of tenofovir binds to human plasma proteins in vitro over the range of 0.01 to 25 micrograms per mL.
Danish: Mindre end 0,7% tenofovir bindes til humane plasmaproteiner in vitro over intervallet 0,01 til 25 µg pr. ml.
English: If bone abnormalities are suspected, then appropriate consultation should be obtained.
Danish: Hvis der er mistanke om knogleabnormiteter, skal der søges råd i relevant omfang.
English: Steady state was generally achieved by Day 2 of once daily dosing, with accumulation ratios of 1.2 to 1.4 for AUC0-24, Cmax, and C24.
Danish: Steady state blev generelt nået på dag 2 ved dosering en gang dagligt, med akkumuleringsforhold på 1,2 til 1,4 for AUC0-24, Cmax og C24.
English: The marketing authorization holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Co-administration with other antiviral products
Danish: Administration sammen med andre antivirale lægemidler
English: In HIV-1-infected subjects, total clearance was 398.5 ± 69.1 mL per min (mean ± SD).
Danish: Hos hiv-1-inficerede forsøgspersoner var total-clearance 398,5 ± 69,1 ml pr. min (gennemsnit ± SD).
English: Table 5: Efficacy response (Snapshot approach) in the DRIVE-SHIFT study
Danish: Tabel 5: Virkningsrespons (Snapshot-metode) i DRIVE-SHIFT-studiet
English: Cystic Fibrosis Treatment lumacaftor
Danish: Cystisk fibrose-behandling lumacaftor
English: You should not take Delstrigo if your doctor has told you that the virus causing your infection is resistant to any of the medicines in Delstrigo.
Danish: Du må ikke tage Delstrigo, hvis lægen har fortalt dig, at det virus, som forårsager din infektion, er resistent (modstandsdygtigt) over for et eller flere af lægemidlerne i Delstrigo.
English: Talk to your doctor before taking the following medicines with Delstrigo as your doctor may need to change the dose of your medicines:
Danish: Kontakt lægen, før du tager følgende lægemidler sammen med Delstrigo, da lægen kan blive nødt til at ændre på dosis af din medicin:
English: Patients who are co-infected with HIV-1 and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with Delstrigo.
Danish: Patienter, der er co-inficerede med hiv-1 og hbv, skal monitoreres nøje med både klinisk og laboratoriemæssig opfølgning i minimum flere måneder efter endt behandling med Delstrigo.
English: Consider more frequent monitoring of HIV-1 viral load when chronic co-administration cannot be avoided.
Danish: Overvej hyppigere overvågning af hiv-1-virusmængde, når vedvarende samtidig administration ikke kan undgås.
English: The effects of tenofovir disoproxil associated changes in BMD and biochemical markers on long-term bone health and future fracture risk are unknown.
Danish: Indvirkningen af tenofovirdisoproxil-associerede ændringer i BMD og biokemiske markører på den langsigtede knoglesundhed og den fremtidige risiko for fraktur er ukendt.
English: • rifampicin, rifapentine
Danish: • rifampicin, rifapentin
English: Tenofovir Cmax decreased by 12 % and AUC increased by 27 % with a high fat meal.
Danish: Tenofovirs Cmax faldt med 12%, og AUC steg med 27% med et fedtholdigt måltid.
English: It is not known whether the exposure to doravirine will increase in patients with severe hepatic impairment.
Danish: Det er ukendt, om eksponeringen for doravirin vil stige hos patienter med svært nedsat leverfunktion.
English: If you accidentally take more, contact your doctor.
Danish: Hvis du kommer til at tage mere, skal du kontakte lægen.
English: Approximately 71 % of an intravenous dose of lamivudine is recovered as unchanged medicinal product in the urine.
Danish: Ca. 71% af en intravenøs dosis lamivudin genvindes som uomdannet lægemiddel i urinen.
English: Expected:  lisinopril
Danish: Forventet:  lisinopril
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Danish: Behandling skal initieres af en læge med erfaring i behandling af hiv-infektion.
English: Delstrigo is used to treat HIV infection in people 18 years of age and older.
Danish: Delstrigo anvendes til behandling af hiv-infektion hos personer i alderen 18 år og derover.
English: Based on the results of in vitro experiments and the known elimination pathway of tenofovir, the potential for CYP-mediated interactions involving tenofovir with other medicinal products is low.
Danish: På baggrund af resultaterne i in vitro-eksperimenter og tenofovirs kendte eliminationsvej er potentialet for CYP-medierede interaktioner, hvor tenofovir bliver involveret med andre lægemidler, lille.
English: Lamivudine-resistant HIV-1 mutants were also cross resistant to didanosine (ddI).
Danish: Lamivudin-resistente hiv-1-mutanter var også krydsresistente over for didanosin (ddI).
English: Rare dyspnoea, tonsillar hypertrophy
Danish: Sjælden dyspnø, tonsillær hypertrofi
English: Mean CD4 change from baseline
Danish: Gennemsnitlig CD4-ændring fra baseline
English: No human data on the effect of Delstrigo on fertility are available.
Danish: Der foreligger ingen data om Delstrigos indvirkning på fertilitet hos mennesker.
English: Studies with lamivudine show that plasma concentrations (AUC) are increased in patients with renal dysfunction due to decreased clearance.
Danish: Studier med lamivudin viser, at plasmakoncentrationen (AUC) øges hos patienter med dysfunktion af nyrerne som følge af nedsat clearance.
English: Safety and efficacy of lamivudine have not been established in the presence of decompensated liver disease.
Danish: Lamivudins sikkerhed og virkning er ikke klarlagt ved tilstedeværelse af dekompenseret leversygdom.
English: Based on administration of an IV microdose, the volume of distribution of doravirine is 60.5 L. Doravirine is approximately 76 % bound to plasma proteins.
Danish: Baseret på administration af en intravenøs mikrodosis er doravirins fordelingsvolumen 60,5 l. Doravirin er ca. 76% bundet til plasmaproteiner.
English: Table 3: Resistance development up to week 96 in protocol defined virologic failure population + early discontinuation population
Danish: Udvikling af resistens op til uge 96 i populationen med protokol-defineret virologisk svigt + populationen med udtræden af studiet før tid
English: Although a limited number of subjects aged 65 years and over has been included (n = 36), no clinically relevant differences in the pharmacokinetics of doravirine have been identified in subjects at least 65 years of age compared to subjects less than 65 years of age in a Phase 1 trial or in a population pharmacokinetic analysis.
Danish: Selvom der er inkluderet et begrænset antal forsøgspersoner i alderen 65 år eller derover (n=36), er ingen klinisk relevante forskelle i doravirins farmakokinetik identificeret hos forsøgspersoner på mindst 65 år sammenlignet med forsøgspersoner under 65 år i et fase 1-studie eller i en farmakokinetisk populationsanalyse.
English: A large amount of data on pregnant women (more than 3,000 outcomes from first trimester) taking the individual active component lamivudine in combination with other antiretrovirals indicates no malformative toxicity.
Danish: Data fra et stort antal gravide kvinder (flere end 3.000 i første trimester), der tog det aktive enkeltstof lamivudin i kombination med andre antiretrovirale midler, indikerer ingen misdannelser.
English: • medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol,
Danish: • lægemidler (oftest opløsninger), der indeholder sorbitol eller andre sukkeralkoholer (som f.eks.
English: NRTI backbone M184I/V only K65R only K65R + M184I/V
Danish: NRTI-backbone Kun M184I/V Kun K65R K65R + M184I/V
English: Doravirine at a dose of 100 mg once daily is not likely to have a clinically relevant effect on the plasma concentrations of medicinal products that are dependent on transport proteins for absorption and/or elimination or that are metabolised by CYP enzymes.
Danish: Det er ikke sandsynligt, at doravirin ved en dosis på 100 mg en gang dagligt har en klinisk relevant indvirkning på plasmakoncentrationen af lægemidler, der er afhængige af transportproteiner for at blive absorberet og/eller elimineret, eller der metaboliseres via CYP-enzymer.
English: Taking this medicine
Danish: Sådan skal du tage denne medicin
English: Because of the potential for HIV-1 transmission and the potential for serious adverse reactions in breast-feeding infants, mothers should be instructed not to breast-feed if they are receiving Delstrigo.
Danish: På grund af risikoen for overførsel af hiv-1 og risikoen for alvorlige bivirkninger hos ammede spædbørn, skal mødre instrueres i, at de ikke må amme, hvis de får Delstrigo.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has worsened after stopping lamivudine or tenofovir disoproxil (two of the three active substances of Delstrigo).
Danish: Nogle patienter har haft blodprøver eller symptomer, der indikerede, at deres hepatitis var blevet forværret, efter at de var stoppet med lamivudin eller tenofovirdisoproxil (to af de tre aktive stoffer i Delstrigo).
English: V106A (yielding a fold change of around 19) appeared as an initial substitution in subtype B virus, and V106A or M in subtype A and C virus.
Danish: V106A (der gav en ca. 19 gange ændring) viste sig som en initial substitution i undertype B-virus og V106A eller M i undertype A- og C-virus.
English: Table 1 shows the established and other potential medicinal product interactions with the individual components of Delstrigo but is not all inclusive (increase is indicated as ↑, decrease is indicated as , and no change as ).
Danish: Tabel 1 viser de dokumenterede og andre potentielle lægemiddelinteraktioner med de individuelle komponenter i Delstrigo, men er ikke udtømmende (stigning angives med , fald angives med ↓ og ingen ændring med ↔).
English: Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl lægen, apotekspersonalet eller sygeplejersken, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: EU/1/18/1333/001 EU/1/18/1333/002 90 (3 x 30) tablets
Danish: EU/1/18/1333/001 EU/1/18/1333/002 90 (3 x 30) tabletter
English: Delstrigo is used to treat HIV (‘human immunodeficiency virus') infection.
Danish: Delstrigo anvendes til behandling af infektion med hiv (‘humant immundefekt-virus').
English: *This adverse reaction was not identified as an adverse reaction associated with doravirine from the Phase 3 clinical studies (DRIVE-FORWARD, DRIVE-AHEAD, DRIVE-SHIFT), but is included in this table as an adverse reaction based on the Summary of Product Characteristics of 3TC and/or TDF.
Danish: *Denne bivirkning blev ikke identificeret som en bivirkning associeret med doravirin i kliniske fase 3-studier (DRIVEFORWARD, DRIVE-AHEAD, DRIVE-SHIFT), men er inkluderet i denne tabel som en bivirkning baseret på produktresuméerne for 3TC og/eller TDF.
English: Doravirine was excreted into the milk of lactating rats following oral administration, with milk concentrations approximately 1.5 times that of maternal plasma concentrations.
Danish: Doravirin blev udskilt i mælken hos diegivende rotter efter oral administration og gav mælkekoncentrationer, der var ca. 1,5 gange plasmakoncentrationerne hos moderdyrene.
English: Genotypic analysis showed that the resistance was due to a specific amino acid substitution in the HIV-1 RT at codon 184 changing the methionine to either isoleucine or valine (M184V/I).
Danish: Genotypeanalyse viste, at resistensen skyldtes en specifik aminosyresubstitution i hiv-1-RT ved kodon 184, der ændrer methionin til enten isoleucin eller valin (M184V/I).
English: • cough, nasal symptoms
Danish: • hoste, nasale symptomer
English: Joint or muscle pain or muscle weakness may also occur.
Danish: Led- eller muskelsmerter eller muskelsvaghed kan også forekomme.
English: Carcinogenesis
Danish: Karcinogenese
English: In a population pharmacokinetic analysis, which included subjects with CrCl between 17 and 317 mL/min, renal function did not have a clinically relevant effect on doravirine pharmacokinetics.
Danish: I en farmakokinetisk populationsanalyse, der omfattede forsøgspersoner med CrCl mellem 17 og 317 ml/min, havde nyrefunktionen ingen klinisk relevant indvirkning på doravirins farmakokinetik.
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Danish: Den anses ikke for at have kausal sammenhæng med tenofovirdisoproxil, hvis denne tilstand ikke er til stede.
English: Expected:  rosuvastatin  simvastatin
Danish: Forventet:  rosuvastatin  simvastatin
English: Subsequently F227(L/C/V) or L234I emerged in addition to V106 substitutions (double mutants yielding a fold change of > 100).
Danish: Efterfølgende opstod F227(L/C/V) eller L234I ud over V106-substitutionerne (dobbeltmutanter, der gav en > 100 gange ændring).
English: Method of administration Delstrigo must be taken orally, once daily with or without food and swallowed whole (see section 5.2).
Danish: Delstrigo skal tages oralt, en gang dagligt med eller uden mad og sluges hel (se pkt.
English: If you have both HIV and hepatitis B virus infections, your hepatitis B may get worse if you stop taking Delstrigo.
Danish: Hvis du både har hiv- og hepatitis B-virus-infektion, kan din hepatitis B forværres, hvis du stopper med at tage Delstrigo.
English: • increased levels of amylase
Danish: • forhøjet indhold af amylase
English: Medicinal Product by Therapeutic Area
Danish: Lægemiddel i henhold til terapeutisk område
English: If the patient misses a dose of Delstrigo within 12 hours of the time it is usually taken, the patient should take Delstrigo as soon as possible and resume the normal dosing schedule.
Danish: Hvis patienten glemmer en dosis Delstrigo inden for 12 timer efter det tidspunkt, hvor den normalt tages, skal patienten tage Delstrigo så hurtigt som muligt og genoptage den normale doseringsplan.
English: Following oral dosing, peak plasma concentrations are achieved 2 hours after dosing.
Danish: Efter oral dosering nås peak-plasmakoncentrationen 2 timer efter dosering.
English: A documented absence of genotypic resistance (prior to starting first therapy) to doravirine, lamivudine, and tenofovir was part of the inclusion criteria for patients who switched from a PI- or INI-based regimen.
Danish: Dokumenteret fravær af genotypisk resistens (forud for start af første behandling) over for doravirin, lamivudin og tenofovir var en del af inklusionskriterierne for de patienter, der skiftede fra et PI- eller INI-baseret regime.
English: Findings in repeat-dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Danish: Resultater fra toksicitetsstudier efter gentagne doser hos rotter, hunde og aber ved eksponeringsniveauer større end eller lig med de kliniske eksponeringsniveauer og med mulig relevans for klinisk anvendelse omfattede nyre- og knogleforandringer og et fald i serumkoncentrationen af fosfat.
English: Documentation of pretreatment resistance genotyping was not required for patients who switched from a NNRTI-based regimen.
Danish: Dokumentation for genotypebestemmelse vedrørende resistens forud for behandling var ikke påkrævet for patienter, der skiftede fra et NNRTI-baseret regime.
English: Not all pack sizes may be available in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført.
English: Tenofovir disoproxil is efficiently removed by haemodialysis with an extraction coefficient of approximately 54 %.
Danish: Tenofovirdisoproxil fjernes effektivt via hæmodialyse med en ekstraktionskoefficient på ca. 54%.
English: Placental transfer of lamivudine has been shown to occur in humans.
Danish: Overførsel af lamivudin via placenta har vist sig at forekomme hos mennesker.
English: Week 48 N=447
Danish: Uge 48 N=447
English: CD4 count, cells/µL
Danish: CD4-tal, celler/µl
English: Doravirine There is no information on potential acute symptoms and signs of overdose with doravirine.
Danish: Der findes ingen information vedrørende potentielle akutte symptomer og tegn på overdosering med doravirin.
English: There were no effects on fertility, mating performance or early embryonic development when doravirine was administered to rats at up to 7 times the exposure in humans at the RHD.
Danish: Der var ingen indvirkning på fertilitet, formeringsevne eller tidlig embryonal udvikling, når doravirin blev administreret til rotter ved op til 7 gange eksponeringen hos mennesker ved RHD.
English: It is preferable to avoid the use of Delstrigo during pregnancy.
Danish: Det bør undgås at anvende Delstrigo under graviditet.
English: • The bottle contains desiccant protecting the tablets from moisture.
Danish: • Flasken indeholder et tørremiddel, som beskytter tabletterne mod fugt.
English: Lamivudine Lamivudine does not inhibit or induce CYP enzymes.
Danish: Lamivudin Lamivudin hverken hæmmer eller inducerer CYP-enzymer.
English: DOR + NRTIs*
Danish: DOR + NRTIer*
English: Oral Contraceptives
Danish: Orale kontraceptiva
English: Monitor blood concentrations of tacrolimus and sirolimus as the dose of these agents may need to be adjusted.
Danish: Koncentrationen af tacrolimus og sirolimus i blodet skal monitoreres, da det kan være nødvendigt at justere dosis af disse stoffer.
English: • muscle weakness, weakening of the bones (with bone pain and sometimes resulting in fractures)
Danish: • muskelsvaghed, svækkelse af knoglerne (med knoglesmerter og nogle gange med knoglebrud til følge)
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Danish: Studier af reproduktionstoksicitet hos rotter og kaniner viste ingen indvirkning på formerings-, fertilitets-, graviditets- eller føtale parametre.
English: The administration of a single Delstrigo tablet with a high-fat meal to healthy subjects resulted in a 26 % increase in doravirine C24, while AUC and Cmax were not significantly affected.
Danish: Administration af en enkelt Delstrigo-tablet sammen med et fedtholdigt måltid til raske forsøgspersoner resulterede i en stigning i doravirins C24 på 26%, mens AUC og Cmax ikke blev påvirket signifikant.
English: Bone loss and mineralisation defects
Danish: Knogletab og mineraliseringsdefekter
English: The following de novo resistance was seen in the resistance analysis subset (subjects with HIV-1 RNA greater than 400 copies per mL at virologic failure or at early study discontinuation and having resistance data).
Danish: Følgende de novo resistens blev set i resistensanalyse-subgruppen (forsøgspersoner med hiv-1-RNA større end 400 kopier pr. ml ved virologisk svigt eller ved udtræden af studiet før tid, og hvor der var resistensdata).
English: Ribavirin (50 microM) used in the treatment of chronic HCV infection decreased the anti-HIV-1 activity of lamivudine by 3.5-fold in MT-4 cells.
Danish: Ribavirin (50 µM), der anvendes i behandlingen af kronisk hcv-infektion, nedsatte lamivudins anti-hiv-1-aktivitet 3,5 gange i MT-4celler.
English: Renal and urinary disorders Uncommon increased creatinine*, proximal renal tubulopathy (including Fanconi syndrome)*
Danish: Nyrer og urinveje Ikke almindelig forhøjet kreatinin*, proksimal renal tubulopati (herunder Fanconis syndrom)*
English: DRV+r + NRTIs*
Danish: DRV+r + NRTIer*
English: Lamivudine Cmax decreased by 19 % with a high fat meal, while AUC was not significantly affected.
Danish: Lamivudins Cmax faldt med 19% med et fedtholdigt måltid, mens AUC ikke blev påvirket signifikant.
English: There are limited data available on the use of doravirine, lamivudine, and tenofovir disoproxil in patients aged 65 years and over.
Danish: Der foreligger begrænsede data om anvendelse af doravirin, lamivudin og tenofovirdisoproxil hos patienter i alderen 65 år og derover.
English: If a patient misses a dose of Delstrigo by more than 12 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time.
Danish: Hvis en patient glemmer en dosis Delstrigo i mere end 12 timer, skal patienten ikke tage den glemte dosis og i stedet tage den næste dosis på det sædvanlige planlagte tidspunkt.
English: Lamivudine There are no significant or clinically relevant racial differences in pharmacokinetics of lamivudine.
Danish: Lamivudin Der er ingen signifikante eller klinisk relevante racemæssige forskelle i lamivudins farmakokinetik.
English: Doravirine has been evaluated in a limited number of patients with NNRTI resistance (K103N n = 7, G190A n = 1); all patients were suppressed to < 40 copies/mL at Week 48.
Danish: Doravirin er blevet evalueret hos et begrænset antal patienter med NNRTI-resistens (K103N n=7, G190A n=1); alle patienter havde suppression til < 40 kopier/ml i uge 48.
English: Studies in pregnant rats and rabbits showed that doravirine is transferred to the foetus through the placenta, with foetal plasma concentrations of up to 40 % (rabbits) and 52 % (rats) that of maternal concentrations observed on gestation Day 20.
Danish: Studier med drægtige rotter og kaniner viste, at doravirin overføres til fosteret via placenta og gav føtale plasmakoncentrationer på op til 40% (kaniner) og 52% (rotter) af de koncentrationer, der blev observeret hos moderdyrene på dag 20 i drægtighedsperioden.
English: During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment.
Danish: I den initiale fase af antiretroviral kombinationsbehandling kan patienter med et responderende immunsystem udvikle et inflammatorisk respons på indolente eller residuale opportunistiske infektioner (f.eks. Mycobacterium avium-infektion, cytomegalovirus, Pneumocystis jirovecii-pneumoni [PCP] eller tuberkulose), hvilket kan nødvendiggøre yderligere vurdering og behandling.
English: Delstrigo contains doravirine, lamivudine, and tenofovir disoproxil, therefore any interactions identified for these individually are relevant to Delstrigo and are presented in Table 1.
Danish: Delstrigo indeholder doravirin, lamivudin og tenofovirdisoproxil, og derfor er interaktioner set for disse individuelt relevante for Delstrigo og er vist i tabel 1.
English: Some patients required hospitalisation and renal replacement therapy.
Danish: Nogle patienter krævede indlæggelse og nyresubstitutionsterapi.
English: The pharmacokinetics of lamivudine and tenofovir have not been studied in subjects older than 65 years.
Danish: Lamivudins og tenofovirs farmakokinetik er ikke undersøgt hos forsøgspersoner over 65 år.
English: Immune reactivation syndrome has been reported in patients treated with combination antiretroviral therapy.
Danish: Immunreaktiveringssyndrom er rapporteret hos patienter, der blev behandlet med antiretroviral kombinationsbehandling.
English: • Swallow the tablet whole (do not crush or chew).
Danish: • Slug tabletten hel (du må ikke knuse eller tygge tabletten).
English: Doravirine has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Danish: Doravirin er ikke blevet vurderet hos patienter med tidligere virologisk svigt ved anden antiretroviral behandling.
English: The recommended dose of Delstrigo is one 100/300/245 mg tablet taken orally once daily with or without food.
Danish: Den anbefalede dosis Delstrigo er en 100/300/245 mg tablet oralt en gang dagligt med eller uden mad.