FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you notice symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, tell your doctor immediately.
Danish: • Hvis du bemærker symptomer såsom muskelsvaghed, svaghed begyndende i hænder og fødder, og som bevæger sig op igennem kroppen, hjertebanken, rysten eller hyperaktivitet, skal du straks fortælle det til din læge.
English: Virologic response was defined as < 50 copies/mL using the snapshot approach (see Table 5).
Danish: Virologisk respons blev defineret som < 50 kopier/ml ved hjælp af snapshot-metoden (se tabel 5).
English: These patients received darunavir/ritonavir 800/100 mg once daily in combination with other antiretroviral agents.
Danish: Disse patienter fik darunavir/ritonavir 800/100 mg én gang dagligt i kombination med andre antiretrovirale midler.
English: Emtricitabine can be removed by haemodialysis, which removes approximately 30% of the emtricitabine dose over a 3 hour dialysis period starting within 1.5 hours of emtricitabine dosing.
Danish: Emtricitabin kan fjernes ved hæmodialyse, hvorved cirka 30 % af emtricitabindosis fjernes ved dialyse over 3 timer startende inden for 1,5 time efter doseringen af emtricitabin.
English: All components were rapidly absorbed following oral administration of Symtuza in healthy subjects.
Danish: Alle komponenterne blev absorberet hurtigt efter oral administration af Symtuza hos raske forsøgspersoner.
English: Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
Danish: Tenofovir fjernes effektivt ved hæmodialyse med en ekstraktionskoefficient på cirka 54 %.
English: Whether the neurological disorders are transient or permanent is currently unknown.
Danish: Det er uvist, om disse neurologiske forstyrrelser er forbigående eller vedvarende.
English: Patients had no history of virologic failure on darunavir-based regimens, and if historical genotypes were available, absence of darunavir RAMs.
Danish: Patienterne havde ingen virologiske svigt i anamnesen på darunavir-baserede regimer og havde, hvis historiske genotyper var tilgængelige, ingen darunavir-RAM'er.
English: If you forget to take Symtuza It is important not to miss a dose of Symtuza.
Danish: Hvis du har glemt at tage Symtuza Det er vigtigt, at du ikke springer en dosis Symtuza over.
English: • If you have hepatitis B infection, your liver problems may become worse after you stop taking Symtuza.
Danish: • Hvis du har en hepatitis B-infektion, kan leverproblemerne blive værre, når du holder op med at tage Symtuza.
English: Patients were allowed in the study if they had previous failure on any non-darunavir ARV regimen.
Danish: Patienterne kunne deltage i studiet, hvis de tidligere havde haft svigt på et ARV-regime uden darunavir.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR22
Danish: Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, antivirale stoffer til behandling af hiv-infektion, kombinationer, ATC-kode: J05AR22
English: Some side effects are typical for anti-HIV medicines similar to Symtuza.
Danish: Visse bivirkninger er typiske for anti-hiv-medicin ligesom Symtuza.
English: Emtricitabine had demonstrated low carcinogenic potential in mice and rats.
Danish: Emtricitabin har vist lavt karcinogent potentiale hos mus og rotter.
English: Emtricitabine did not inhibit the glucuronidation reaction of a non-specific UGT substrate in vitro.
Danish: Emtricitabin hæmmede ikke glukuronideringsreaktionen af et ikke-specifikt UGT-substrat in vitro.
English: A long term carcinogenicity study in mice did not show any carcinogenic potential.
Danish: Et langvarigt karcinogenicitetsstudie af mus viste intet karcinogent potentiale.
English: The bioavailability of the components of Symtuza was not affected when administered orally as a split tablet compared to administration as a tablet swallowed whole.
Danish: Biotilgængeligheden af komponenterne i Symtuza blev ikke påvirket ved oral administration af en delt tablet sammenlignet med administration af en tablet, der synkes hel.
English: Darunavir and cobicistat
Danish: Darunavir og cobicistat
English: Skin rash may affect more than 1 in 10 patients receiving Symtuza.
Danish: Hududslæt kan forekomme hos flere end 1 ud af 10 patienter, der får Symtuza.
English: Clinical monitoring is recommended, as maintenance therapy may need to be adjusted in some patients.
Danish: Klinisk monitorering anbefales, da justering af vedligeholdelsesdosis kan være nødvendig hos nogle patienter.
English: The following viral load values were observed for these subjects at Week 96: 54 copies/mL, 78 copies/mL, 111 copies/mL, 152 copies/mL, and 210 copies/mL.
Danish: Der blev set følgende virusbelastningsværdier hos disse forsøgsdeltagere ved uge 96: 54 kopier/ml, 78 kopier/ml, 111 kopier/ml, 152 kopier/ml og 210 kopier/ml.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with Symtuza.
Danish: Det anbefales at monitorere International Normalised Ratio (INR), når warfarin administreres samtidigt med Symtuza.
English: Therapeutic drug monitoring of voriconazole, posaconazole or itraconazole is recommended.
Danish: Terapeutisk lægemiddelmonitorering af voriconazol, posaconazol eller itraconazol anbefales.
English: Prior data with ritonavir-boosted darunavir however showed a decrease in these anti-depressant plasma concentrations (unknown mechanism); the latter may be specific to ritonavir.
Danish: Tidligere data med ritonavir-boostet darunavir har dog vist en nedsat plasmakoncentration af disse antidepressiva (ukendt mekanisme); sidstnævnte kan være specifikt for ritonavir.
English: Co-administration of Symtuza and budesonide or fluticasone is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid side effects.
Danish: Co-administration af Symtuza og budesonid eller fluticason frarådes, medmindre den potentielle fordel ved behandlingen opvejer risikoen for systemiske kortikosteroidbivirkninger.
English: p < 0.001 for all 4 lipid parameters when comparing D/C/F/TAF versus D/C + F/TDF at Week 48 No comparator data available beyond Week 48
Danish: p < 0,001 for alle 4 lipidparametre ved sammenligning af D/C/F/TAF vs. D/C + F/TDF ved uge 48 Ingen tilgængelige komparatordata efter uge 48
English: Tenofovir has a median plasma half-life of approximately 32 hours.
Danish: Tenofovir har en median halveringstid i plasma på cirka 32 timer.
English: MedDRA system organ class Frequency category
Danish: Systemorganklasser i henhold til MedDRA Hyppighedskategori
English: This subject harbored a K103N mutation at screening, indicating transmitted NNRTI resistance.
Danish: Denne forsøgsdeltager havde en K103Nmutation ved screening, hvilket tyder på overført NNRTI-resistens.
English: The decreased susceptibility to darunavir of the emerging viruses in the selection experiment could not be explained by the emergence of these protease mutations.
Danish: De nye viras nedsatte følsomhed over for darunavir i selektionseksperimentet kunne ikke forklares på baggrund af fremkomsten af disse proteasemutationer.
English: Isavuconazole Posaconazole
Danish: Isavuconazol Posaconazol
English: If switching from ritonavir as a pharmacoenhancer to this regimen with cobicistat, caution is required during the first two weeks of treatment with Symtuza, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir.
Danish: Hvis der skiftes fra ritonavir som farmakokinetisk forstærker til dette regime med cobicistat, skal der udvises forsigtighed i løbet af de første to ugers behandling med Symtuza, især hvis doseringen af eventuelle samtidigt administrerede lægemidler er blevet titreret eller justeret under anvendelsen af ritonavir.
English: * DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
Danish: * DRV-RAM'er: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V.
English: Symtuza should be taken orally, once daily with food (see section 5.2).
Danish: Symtuza skal tages oralt én gang dagligt sammen med mad (se pkt.
English: No comparator data available beyond Week 48
Danish: Der foreligger ingen komparatordata efter uge 48
English: Some patients taking anti-HIV medicines may develop a bone disease called osteonecrosis (bone damage caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager lægemidler mod hiv, kan udvikle en knoglesygdom, der kaldes osteonekrose (knogleskader forårsaget af manglende blodforsyning til knoglen).
English: Discontinued trial due to adverse event or death
Danish: Afbrød studiet på grund af bivirkning eller dødsfald
English: • if you notice any symptoms of infection (e.g. swollen lymph nodes and fever).
Danish: • Hvis du bemærker nogen symptomer på infektion (f.eks. hævede lymfeknuder og feber).
English: Therapy should be initiated by a physician experienced in the management of HIV-1 infection.
Danish: Behandlingen bør påbegyndes af en læge, der har erfaring med håndtering af hiv-1-infektion.
English: C]-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Danish: C]-cobicistat stammede 99 % af den cirkulerende radioaktivitet i plasma fra uomdannet cobicistat.
English: In vitro experiments with human liver microsomes (HLMs) indicate that darunavir primarily undergoes oxidative metabolism.
Danish: In vitro-eksperimenter med humane levermikrosomer (HLM'er) indikerer, at darunavir primært gennemgår oxidativ metabolisme.
English: Based on theoretical considerations, no mechanistic interaction is expected.
Danish: Baseret på teoretiske overvejelser forventes der ingen mekanistisk interaktion.
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Danish: Patienterne skal informeres om at søge læge, hvis de oplever ømhed, smerter eller stivhed i led eller bevægelsesbesvær.
English: If Symtuza is co-administered with parenteral midazolam, it should be done in an intensive care unit or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis Symtuza co-administreres med parenteral midazolam, skal det foregå på en intensivafdeling eller i lignende rammer, der sikrer en tæt klinisk monitorering og passende medicinsk håndtering i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Triazolam or midazolam (taken by mouth)
Danish: Triazolam eller midazolam (taget gennem munden)
English: Due to uncertainties regarding the rate of development of the human blood brain barrier and liver enzymes Symtuza should not be used in paediatric patients below 3 years of age.
Danish: På grund af usikkerheden omkring udviklingshastigheden af blod-hjernebarrieren og leverenzymer hos mennesket bør Symtuza ikke bruges til pædiatriske patienter under 3 år.
English: The type of food does not affect exposure to Symtuza.
Danish: Typen af mad påvirker ikke eksponeringen for Symtuza.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. dosisenhed, dvs. det er i det væsentlige natriumfrit.
English: Symtuza comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Danish: Symtuza leveres i beholdere med 30 tabletter (med et silicagel-tørremiddel, der skal opbevares i beholderen for at hjælpe med at beskytte tabletterne).
English: A long term carcinogenicity study of cobicistat in rats revealed tumourigenic potential specific for this species, that is regarded as of no relevance for humans.
Danish: Et langvarigt karcinogenicitetsstudie med cobicistat hos rotter viste tumorigent potentiale specifikt for denne art, hvilket ikke betragtes som relevant for mennesker.
English: The EC50 values for emtricitabine were in the range of 0.0013 to 0.64 μM.
Danish: EC50-værdierne for emtricitabin var i intervallet fra 0,0013 til 0,64 μM.
English: C]-cobicistat, 86% and 8.2% of the dose were recovered in feces and urine, respectively.
Danish: C]-cobicistat blev 86 % og 8,2 % af dosis genfundet i henholdsvis fæces og urin.
English: Population pharmacokinetic analysis showed a slightly higher darunavir exposure (16.8%) in HIV-1 infected females compared to males.
Danish: En populationsfarmakokinetisk analyse viste en lidt højere eksponering for darunavir (16,8 %) hos hiv-1-inficerede kvinder sammenlignet med mænd.
English: Subjects with PDVF evaluated for resistance, n (%)
Danish: Forsøgsdeltagere med PDVF evalueret for resistens, n (%)
English: The effects of other medicines might be influenced if you take Symtuza.
Danish: Virkningen af anden medicin kan blive påvirket, hvis du tager Symtuza.
English: The plastic bottle comes with a child resistant cap and must be opened as follows:
Danish: Plastbeholderen er forsynet med et børnesikret låg og skal åbnes således:
English: Darunavir has no effect on fertility or early embryonic development and DRV shows no teratogenic potential, at exposure levels below those at the recommended clinical dose in humans.
Danish: Darunavir har ingen indvirkning på fertilitet eller tidlig fosterudvikling, og DRV udviser intet teratogent potentiale ved eksponeringsniveauer under dem, der følger af den anbefalede kliniske dosis hos mennesker.
English: Additional adverse drug reactions only seen with darunavir/ritonavir in other trials or postmarketing experience
Danish: Yderligere bivirkninger, der kun er set med darunavir/ritonavir i andre studier eller efter markedsføringen
English: EXP Do not use after 6 weeks of first opening the bottle.
Danish: EXP Anvendes inden 6 uger efter første åbning af beholderen.
English: • if you have had problems with your kidneys.
Danish: • Hvis du før har haft problemer med nyrerne.
English: At 48 weeks, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL, similar to response rates in studies of treatment-naïve HIV-1 infected adults.
Danish: Ved uge 48 opnåede 92 % (46/50) hiv-1 RNA < 50 kopier/ml, svarende til responsraterne i studier af behandlingsnaive hiv-1-inficerede voksne.
English: Patients receiving Symtuza or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Patienter, som får Symtuza eller en anden antiretroviral behandling, kan fortsætte med at udvikle opportunistiske infektioner og andre komplikationer af hiv-infektionen og bør derfor holdes under nøje klinisk observation af læger, som har erfaring med behandling af patienter med hiv-associerede sygdomme.
English: Sulphonamide allergy
Danish: Sulfonamidallergi
English: Virologic Failure
Danish: Virologisk svigt
English: It selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in virus infected cells, thereby preventing the formation of mature infectious virus particles.
Danish: Det er en selektiv hæmmer af spaltningen af hiv-kodede Gag-Pol-polyproteiner i virusinficerede celler, hvorved dannelsen af modne, infektiøse viruspartikler forhindres.
English: • osteonecrosis (bone damage caused by loss of blood supply to the bone)
Danish: • osteonekrose (knogleskader på grund af manglende blodforsyning til knoglen)
English: It is important to talk to your doctor if you develop a rash.
Danish: Det er vigtigt, at du taler med lægen, hvis du får udslæt.
English: Table 7: Virologic Outcome in ART- naïve Adolescents at Week 48 (TLOVR algorithm) TMC114-C230
Danish: Tabel 7: Virologiske resultater hos ART-naive unge ved uge 48 (TLOVR-algoritme) TMC114-C230
English: Metabolism is a major elimination pathway for tenofovir alafenamide in humans, accounting for > 80% of an oral dose.
Danish: Metabolisme er en væsentlig eliminationsvej for tenofoviralafenamid hos mennesker, idet den står for > 80 % af en oral dosis.
English: Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0.
Danish: Ikke-kompletterede er fejlskrivning: Patienter, der afbrød behandlingen i utide, er beregnet med en ændring svarende til 0.
English: Symtuza tablets should be taken with food.
Danish: Symtuza bør indtages sammen med mad.
English: The pharmacologically active metabolite, tenofovir diphosphate, has a half-life of 150-180 hours within PBMCs.
Danish: Den farmakologisk aktive metabolit tenofovirdiphosphat har en halveringstid på 150-180 timer i PBMC'er.
English: Symtuza is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg).
Danish: Symtuza er indiceret til behandling af infektion med humant immundefekt virus type 1 (hiv-1) hos voksne og unge (i alderen 12 år og derover med en legemsvægt på mindst 40 kg).
English: Pack size of one bottle or three bottles per carton.
Danish: Pakningsstørrelser med én beholder eller tre beholdere pr. karton.
English: Second trimester of pregnancy N = 7
Danish: Andet trimester af graviditeten (n = 7)
English: It is used in adults and adolescents aged 12 years and older who weigh at least 40 kg. Symtuza contains four active substances:
Danish: Det anvendes hos voksne og unge i alderen 12 år og ældre med en legemsvægt på mindst 40 kg. Symtuza indeholder fire aktive stoffer:
English: Ex vivo binding of tenofovir alafenamide to human plasma proteins in samples collected during clinical studies was approximately 80%.
Danish: Tenofoviralafenamids binding ex vivo til humane plasmaproteiner i prøver indsamlet under kliniske studier var cirka 80 %.
English: Cobicistat increases serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function as assessed, for instance, by using Cystatin C (Cyst C) as filtration marker.
Danish: Cobicistat øger serumkreatinin på grund af hæmningen af den tubulære sekretion af kreatinin uden at påvirke den renale glomerulære funktion som vurderet f.eks. ved anvendelse af Cystatin C (Cyst C) som filtrationsmarkør.
English: When administration of HMG CoA reductase inhibitors and Symtuza is desired, it is recommended to start with the lowest dose and titrate up to the desired clinical effect while monitoring for safety.
Danish: Ved samtidig administration af HMG-CoA-reduktasehæmmere og Symtuza, anbefales det at starte med den laveste dosis og titrere op til den ønskede kliniske virkning under overvågning for sikkerhed.
English: The effects of Symtuza might be reduced if you take any of the following products.
Danish: Virkningen af Symtuza kan blive nedsat, hvis du tager et eller flere af følgende lægemidler.
English: Week 96* D/C/F/TAF
Danish: Uge 96* D/C/F/TAF
English: Since darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da darunavir og cobicistat i høj grad bindes til plasmaproteiner, er det usandsynligt, at de vil kunne fjernes i signifikant grad ved hæmodialyse eller peritonealdialyse.
English: DRV = darunavir; FTC = emtricitabine; PDVF = protocol-defined virologic failure; PI = protease inhibitor; RAM = resistanceassociated mutation; TDF = tenofovir disoproxil fumarate; TAF = tenofovir alafenamide
Danish: DRV = darunavir; FTC = emtricitabin; PDVF = protokoldefineret virologisk svigt; PI = proteasehæmmer; RAM = resistensassocieret mutation; TDF = tenofovirdisoproxilfumarat; TAF = tenofoviralafenamid
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Symtuza in one or more subsets of the paediatric population in the treatment of 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 Symtuza i en eller flere undergrupper af den pædiatriske population ved behandlingen af hiv-1infektion (se pkt.
English: In addition, reactivation of herpes simplex and herpes zoster has been observed in clinical trials with darunavir co-administered with low dose ritonavir.
Danish: Derudover er der observeret reaktivering af herpes simplex og herpes zoster i kliniske studier med darunavir co-administreret med lavdosis ritonavir.
English: The safety and efficacy of Symtuza or its components have not been established in patients with severe underlying liver disorders.
Danish: Sikkerhed og virkning af Symtuza eller dets aktive indholdsstoffer er ikke blevet fastslået hos patienter med svære underliggende leversygdomme.
English: If you do miss a dose:
Danish: Hvis du har glemt en dosis:
English: Based on theoretical considerations, no clinically relevant interaction is expected.
Danish: Baseret på teoretiske overvejelser forventes der ingen klinisk relevant interaktion.
English: No DRV, primary PI, or TDF/TAF resistance-associated mutations were observed.
Danish: Der blev ikke observeret DRV-, primær PI- eller TDF/TAF-resistensassocierede mutationer.
English: Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Danish: Ethvert barn, som in utero har været eksponeret for nukleosid- og nukleotidanaloger, selv hiv-negative børn, skal monitoreres både med klinisk og laboratoriemæssig opfølgning og undersøges grundigt for mulige mitokondrielle dysfunktion i tilfælde af relevante tegn og symptomer.
English: C]-radioactivity showed a time-dependent profile with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Danish: C]-radioaktiviteten i plasma en tidsafhængig profil med tenofoviralafenamid som det stof, der forekom i størst mængde, i de første par timer og urinsyre i den resterende periode.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Symtuza.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Symtuza.
English: Increased monitoring for rifabutin associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to rifabutin.
Danish: Øget overvågning for rifabutinassocierede bivirkninger, herunder neutropeni og uveitis, er nødvendig på grund af en forventet øget eksponering for rifabutin.
English: Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Danish: Emtricitabin fosforyleres af enzymer i cellerne til dannelse af emtricitabintriphosphat.
English: Medicinal products that strongly affect P-gp activity and BCRP may lead to changes in tenofovir alafenamide absorption.
Danish: Lægemidler, der påvirker P-gp-aktiviteten kraftigt og BCRP, kan føre til ændringer i tenofoviralafenamids absorption.
English: Unchanged darunavir accounted for approximately 41.2% and 7.7% of the administered dose in faeces and urine, respectively.
Danish: Uomdannet darunavir udgjorde ca. 41,2 % og 7,7 % af den administrerede dosis i henholdsvis fæces og urin.
English: Decrease estimated creatinine clearance
Danish: Nedsat estimeret kreatininclearance
English: The concomitant use with Symtuza may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Danish: Samtidig brug med Symtuza kan nødvendiggøre nedsættelse af alfentanildosis og kræver overvågning for risici i forbindelse med forlænget eller forsinket respirationsdepression.
English: ANTIBIOTIC Clarithromycin
Danish: ANTIBIOTIKA Clarithromycin
English: Following oral administration of Symtuza, the median terminal elimination half-life of emtricitabine is 17.2 hours.
Danish: Efter oral administration af Symtuza er emtricitabins mediane eliminationshalveringstid 17,2 timer.