FrancophonIA/ELRC3.0 huggingface dataset:
English: Applicable to darunavir boosted with cobicistat, not when boosted with ritonavir: Darunavir boosted with cobicistat is more sensitive for CYP3A induction than darunavir boosted with ritonavir.
Danish: Gælder for darunavir boostet med cobicistat, men ikke hvis darunavir er boostet med ritonavir: - Darunavir boostet med cobicistat er mere følsomt for CYP3A-induktion end darunavir boostet med ritonavir.
English: Patients received a weight-based twice daily treatment regimen, patients weighing 10 kg to < 15 kg received darunavir/ritonavir 25/3 mg/kg twice daily, and patients weighing 15 kg to < 20 kg received darunavir/ritonavir 375/50 mg twice daily.
Danish: Patienterne fik et vægtbaseret behandlingsregime to gange dagligt; patienter med en legemsvægt på 10 kg til < 15 kg fik darunavir/ritonavir 25/3 mg/kg to gange dagligt og patienter med en legemsvægt på 15 kg til < 20 kg fik darunavir/ritonavir 375/50 mg to gange dagligt.
English: POWER 1 and POWER 2 are randomised, controlled trials comparing darunavir co-administered with ritonavir (600/100 mg twice daily) with a control group receiving an investigator-selected PI(s) regimen in HIV-1 infected patients who had previously failed more than 1 PI containing regimen.
Danish: POWER 1 og POWER 2 er randomiserede, kontrollerede studier, der sammenligner darunavir, når det gives sammen med ritonavir (600/100 mg to gange dagligt) med en kontrolgruppe, der får et eller flere PI-regimer valgt af investigator, hos hiv-1inficerede patienter, som tidligere har oplevet svigt i mere end et PI-regime.
English: Treatment with darunavir/cobicistat 800/150 mg once daily during pregnancy results in low darunavir exposure.
Danish: Behandling med darunavir/cobicistat 800/150 mg en gang dagligt under graviditet fører til lav eksponering for darunavir.
English: Ritonavir may decrease plasma concentrations of voriconazole.
Danish: Ritonavir kan nedsætte plasmakoncentrationen af voriconazol.
English: These can include, but are not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Danish: Disse reaktioner kan omfatte, men er ikke begrænset til, alvorligt udslæt eller udslæt ledsaget af feber, almen utilpashed, træthed, muskel- eller ledsmerter, blæredannelse, mundsår, konjunktivitis, hepatitis og/eller eosinofili.
English: Cobicistat 150 mg given with darunavir 800 mg once daily enhances darunavir pharmacokinetic parameters in a comparable way to ritonavir (see section 5.2).
Danish: Cobicistat 150 mg givet sammen med darunavir 800 mg en gang dagligt forstærker darunavirs farmakokinetiske parametre på en måde, som er sammenlignelig med ritonavir (se pkt.
English: Therefore, darunavir tablets should be taken with cobicistat or ritonavir and with food.
Danish: Darunavir skal derfor tages med cobicistat eller ritonavir og med mad.
English: Concomitant treatment with any of the following medicinal products given the expected decrease in plasma concentrations of darunavir, ritonavir and cobicistat and the potential for loss of therapeutic effect (see sections 4.4 and 4.5).
Danish: Samtidig behandling med et eller flere af følgende lægemidler på grund af den forventede reduktion af plasmakoncentration af darunavir, ritonavir og cobicistat og potentialet for tab af terapeutisk effekt (se pkt.
English: (↑ clarithromycin from CYP3A inhibition and possible P-gp inhibition)
Danish: (↑ clarithromycin fra CYP3Ahæmning og mulig P-gphæmning)
English: Apixaban, edoxaban, rivaroxaban, warfarin (to reduce clotting of the blood) as their therapeutic effect or side effects may be altered; your doctor may have to check your blood.
Danish: - Apixaban, edoxaban, rivaroxaban, warfarin (til at hindre blodpropper), da behandlingsvirkningen eller bivirkninger af denne medicin kan blive ændret.
English: Pravastatin 40 mg single dose pravastatin AUC ↑ 81% pravastatin Cmin ND pravastatin Cmax ↑ 63% an up to five-fold increase was seen in a limited subset of subjects
Danish: Pravastatin 40 mg som enkeltdosis pravastatin AUC ↑ 81%¶ pravastatin Cmin ND pravastatin Cmax ↑ 63% ¶ en op til femdobling blev set hos en begrænset undergruppe af forsøgspersoner
English: Number of subjects with virologic failure and paired baseline/endpoint genotypes, developing mutations b at endpoint, n/N
Danish: Antal deltagere med virologisk svigt og parrede genotyper ved baseline og endepunkt, der udviklede mutationer b ved endepunktet, n/N
English: The weight-based dose regimen for darunavir and ritonavir is provided in the tables above.
Danish: Det vægtbaserede dosisregime for darunavir og ritonavir til pædiatriske patienter fremgår af tabellerne ovenfor.
English: Oral use
Danish: Til oral anvendelse.
English: Ciclosporin, everolimus, tacrolimus, sirolimus (for dampening down your immune system) as the therapeutic effect or side effects of these medicines might be increased.
Danish: - Ciclosporin, everolimus, tacrolimus, sirolimus (til dæmpning af immunforsvaret), da behandlingsvirkningen eller bivirkninger af denne medicin kan blive forstærket.
English: Tablet dimension: 17 x 8.5 mm.
Danish: Tabletdimension: 17 × 8.5 mm.
English: During the darunavir/ritonavir clinical development program (N=3,063), hepatitis was reported in 0.5% of patients receiving combination antiretroviral therapy with darunavir/ritonavir.
Danish: Under det kliniske udviklingsprogram med darunavir/ritonavir (N=3.063) rapporteredes hepatitis hos 0,5 % af patienterne, der fik antiretroviral kombinationsbehandling med darunavir/ritonavir.
English: At least 3 oxidative metabolites of darunavir have been identified in humans; all showed activity that was at least 10-fold less than the activity of darunavir against wild type HIV.
Danish: De viste alle aktivitet, der var mindst 10 gange mindre end aktiviteten af darunavir over for vildtype hiv.
English: Darunavir and cobicistat are metabolised by CYP3A, and co-administration with CYP3A inducers may therefore result in subtherapeutic plasma exposure to darunavir.
Danish: Darunavir og cobicistat metaboliseres via CYP3A, og co-administration med CYP3Ainduktorer kan derfor medføre subterapeutisk plasmaeksponering for darunavir.
English: In a multiple dose study with darunavir co-administered with ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n=8) and moderate (ChildPugh Class B, n=8) hepatic impairment were comparable with those in healthy subjects.
Danish: I et flerdosisstudie med darunavir co-administreret med ritonavir (600/100 mg) to gange daglig, blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med mild (ChildPugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
English: When administered without food, the relative bioavailability of darunavir in the presence of cobicistat or low dose ritonavir is lower as compared to intake with food.
Danish: Ved administration uden indtagelse af mad er den relative biotilgængelighed af darunavir ved tilstedeværelse af cobicistat eller lavdosis ritonavir lavere sammenlignet med administration med mad.
English: film-coated tablet
Danish: Filmovertrukken tablet
English: Darunavir co-administered with low dose ritonavir should not be used in combination with these medicines.
Danish: Darunavir administreret sammen med lavdosis ritonavir bør ikke anvendes i kombination med disse lægemidler.
English: It is not recommended to alter the dose of cobicistat or ritonavir.
Danish: Det frarådes at ændre dosis af cobicistat eller ritonavir.
English: There have been reports of increased spontaneous bleeding in haemophiliac patients receiving antiretroviral protease inhibitors (see section 4.4).
Danish: Der har været rapporter om øget spontan blødningstendens hos patienter med hæmofili, der fik antiretrovirale proteasehæmmere (se pkt.
English: Not studied with darunavir/ritonavir.
Danish: Ikke undersøgt med darunavir/ritonavir.
English: No special precautions or dose adjustments for darunavir/ritonavir are required in patients with renal impairment.
Danish: Der gælder ingen særlige sikkerhedsregler eller dosisjusteringer for darunavir/ritonavir for patienter med nedsat nyrefunktion.
English: Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone)
Danish: KORTIKOSTEROIDER Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison, triamcinolon)
English: There is an increased potential for sildenafil-associated adverse events (including visual disturbances, hypotension, prolonged erection and syncope).
Danish: Der er øget risiko for sildenafilrelaterede bivirkninger (inklusive synsforstyrrelser, hypotension, forlænget erektion og synkope).
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Danish: 150 mg to gange daglig maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavirkoncentrationer er i overensstemmelse med de historiske data.
English: 20 mg once daily darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
Danish: 20 mg en gang daglig darunavir AUC ↔ darunavir Cmin ↔ darunavir Cmax ↔
English: Darunavir should be used with caution in patients with a known sulphonamide allergy.
Danish: Darunavir indeholder en sulfonamid-del. Darunavir skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi.
English: The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis and pyrexia.
Danish: De hyppigste alvorlige bivirkninger er akut nyresvigt, myokardieinfarkt, immunrekonstitutionsinflammatorisk syndrom (IRIS), trombocytopeni, osteonekrose, diarre, hepatitis og pyreksi.
English: The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1acid glycoprotein (AAG) in HIV-1 infected patients, resulting in higher darunavir binding to plasma AAG and, therefore, higher plasma concentrations.
Danish: Den øgede eksponering for darunavir hos hiv-1-inficerede patienter sammenlignet med raske forsøgspersoner kan muligvis forklares ved de højere koncentrationer af surt α1-glykoprotein (AAG) hos hiv-1inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma-AAG og derfor i højere plasmakoncentrationer.
English: No dose adjustment is required for darunavir/ritonavir during pregnancy and postpartum.
Danish: Dosisjustering af darunavir/ritonavir er ikke nødvendig under graviditet og post partum.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is combined with boosted darunavir.
Danish: Det anbefales at monitorere INR (International normaliseret ratio), når warfarin kombineres med boostet darunavir.
English: There were no new clinically relevant safety findings compared with the known safety profile of darunavir/ritonavir in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Danish: Der var ingen nye klinisk relevante sikkerhedsfund i forhold til den kendte sikkerhedsprofil for darunavir/ritonavir hos hiv 1-inficerede voksne (se pkt.
English: In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen is 600 mg twice daily taken with ritonavir 100 mg twice daily taken with food.
Danish: - Hos alle andre ART-erfarne patienter eller i tilfælde af, at der ikke foreligger en hiv-1-genotypebestemmelse er det anbefalede behandlingsregime 600 mg to gange dagligt sammen med ritonavir 100 mg to gange dagligt i forbindelse med et måltid.
English: Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are: antiretroviral therapy (ART)-naïve (see section 4.2).
Danish: Darunavir Krka 400 mg og 800 mg tabletter kan anvendes til at sammensætte passende behandlingsregimer til behandling af hiv-1-infektion hos voksne og pædiatriske patienter fra en alder af 3 år og en legemsvægt på mindst 40 kg hos: - ART-naive (som ikke tidligere har fået antiretroviral behandling) (se pkt.
English: It is not recommended to alter the dose of ritonavir.
Danish: Det frarådes at ændre dosis af ritonavir.
English: If a once daily dose of darunavir and/or ritonavir is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of darunavir and ritonavir with food as soon as possible.
Danish: Hvis en daglig dosis af darunavir og/eller ritonavir glemmes i op til 12 timer efter det tidspunkt, hvor den sædvanligvis tages, skal patienterne informeres om snarest muligt at tage den ordinerede dosis darunavir og ritonavir sammen med et måltid.
English: Darunavir Krka is not a cure for HIV infection.
Danish: Darunavir Krka kan ikke helbrede hiv-infektion.
English: Darunavir in combination with cobicistat or ritonavir has no or negligible influence on the ability to drive and use machines.
Danish: Darunavir i kombination med cobicistat eller ritonavir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is important to talk to your doctor if you develop a rash.
Danish: Det er vigtigt at tale med lægen, hvis du får udslæt.
English: Vascular disorders uncommon hypertension, flushing
Danish: Vaskulære forstyrrelser ikke almindelig hypertension, rødmen
English: Co-administration of darunavir with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Danish: Coadministration af darunavir med disse antikoagulantia kan øge koncentrationerne af antikoagulanset, hvilket kan medføre en øget blødningsrisiko.
English: Therapeutic drug monitoring of the immunosuppressive agent must be done when co-administration occurs.
Danish: Der skal i forbindelse med coadministration foretages terapeutisk lægemiddelmonitorering af det immunsupprimerende middel.
English: When used in combination with darunavir co-administered with low dose ritonavir, dose adjustment of indinavir from 800 mg twice daily to 600 mg twice daily may be warranted in case of intolerance.
Danish: Ved kombination af indinavir og darunavir administreret sammen med lavdosis ritonavir kan dosisjustering af indinavir fra 800 mg to gange daglig til 600 mg to gange daglig være nødvendig pga. intolerans.
English: Musculoskeletal abnormalities
Danish: Muskuloskeletale anomalier
English: Fluticasone: in a clinical study where ritonavir 100 mg capsules twice daily were co-administered with 50 μg intranasal fluticasone propionate (4 times daily) for 7 days in healthy subjects, fluticasone propionate plasma concentrations increased significantly, whereas the intrinsic cortisol levels decreased by approximately 86% (90% CI 82-89%).
Danish: Fluticason: I et klinisk studie hvor ritonavir 100 mg kapsler to gange daglig blev administreret samtidig med 50 μg intranasalt fluticasonpropionat (4 gange daglig) i 7 dage hos raske forsøgspersoner, steg plasmaniveauerne af fluticasonpropionat signifikant, hvorimod de naturlige kortisolniveauer faldt med ca. 86% (90% konfidensinterval 8289%).
English: Monitor for fesoterodine or solifenacin adverse reactions, dose reduction of fesoterodine or solifenacin may be necessary.
Danish: Dosisreduktion af fesoteridin eller solifenacin kan være nødvendig.
English: This was driven by mild intensity nausea.
Danish: Det drejede sig især om lettere kvalme.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of darunavir/ritonavir treatment.
Danish: Monitorering for forhøjet ASAT/ALAT bør overvejes hos patienter med underliggende kronisk hepatitis eller cirrose eller hos patienter, som havde forhøjede aminotransferaser før behandlingen, specielt i de første mange måneders behandling med darunavir/ritonavir.
English: As darunavir and ritonavir are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Danish: Da darunavir og ritonavir i høj grad bindes til plasmaproteiner, er det usandsynligt, at disse lægemidler vil blive fjernet i signifikant grad ved hæmodialyse eller peritonealdialyse.
English: Voriconazole should not be combined with darunavir co-administered with low dose ritonavir unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Danish: Voriconazol bør ikke kombineres med darunavir administreret sammen med lavdosis ritonavir, medmindre en risk/benefitvurdering retfærdiggør brug af voriconazol.
English: Pharmacokinetic enhancer and concomitant medications Darunavir has different interaction profiles depending on whether the compound is boosted with ritonavir or cobicistat:
Danish: Farmakokinetisk forstærker og samtidige lægemidler Darunavir har forskellige interaktionsprofiler afhængigt af, om stoffet boostes med ritonavir eller cobicistat:
English: Flurazepam Midazolam (parenteral) Zoldipem
Danish: Midazolam (parenteral) Zoldipem
English: 400/100 mg twice daily
Danish: 400/100 mg to gange daglig
English: Based on the different elimination pathways of the other NRTIs zidovudine, emtricitabine, stavudine, lamivudine, that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and boosted darunavir.
Danish: På baggrund af de forskellige eliminationsveje for de andre NRTI, zidovudin, emtricitabin, stavudin, lamivudin, der primært udskilles via nyrerne, og abacavir, som ikke metaboliseres via CYP450, forventes der ikke nogle lægemiddelinteraktioner for disse lægemidler og boostet darunavir.
English: Corticosteroids including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone.
Danish: - Kortikosteroider, herunder betamethason, budesonid, fluticason, mometason, prednison, triamcinolon.
English: ART-experienced paediatric patients from the age of 3 to < 6 years The pharmacokinetics, safety, tolerability and efficacy of darunavir/ritonavir twice daily in combination with other antiretroviral agents in 21 ART-experienced HIV-1 infected paediatric patients aged 3 to < 6 years and weighing 10 kg to < 20 kg was evaluated in an open-label, Phase II trial, ARIEL.
Danish: ART-erfarne pædiatriske patienter i alderen 3 til < 6 år Farmakokinetik, sikkerhed, tolerabilitet og virkning af darunavir/ritonavir to gange dagligt i kombination med andre antiretrovirale lægemidler hos 21 ART-erfarne hiv-1 smittede pædiatriske patienter i alderen 3 til < 6 år med en legemsvægt på 10 kg til < 20 kg blev evalueret i et åbent fase IIstudie, ARIEL.
English: Darunavir boosted with either ritonavir or cobicistat inhibits the elimination of active substances that are highly dependent on CYP3A for clearance, which results in increased exposure to the coadministered medicinal product.
Danish: Darunavir boostet med enten ritonavir eller cobicistat hæmmer elimination af aktive stoffer, hvis clearance er stærkt afhængig af CYP3A, hvilket medfører forhøjet eksponering for det samtidigt administrerede lægemiddel.
English: Therefore, therapy with darunavir/cobicistat should not be initiated during pregnancy, and women who become pregnant during therapy with darunavir/cobicistat should be switched to an alternative regimen (see sections 4.2 and 4.6).
Danish: Behandling med darunavir/cobicistat bør derfor ikke påbegyndes under graviditet, og kvinder, som bliver gravide under behandling med darunavir/cobicistat, bør skiftes til et alternativt regime (se pkt.
English: Darunavir in combination with ritonavir has no or negligible influence on the ability to drive and use machines.
Danish: Darunavir i kombination med ritonavir påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: HMG CO-A REDUCTASE INHIBITORS Lovastatin
Danish: HMG-COA-REDUKTASEHÆMMERE Lovastatin
English: What you need to know before you take Darunavir Krka
Danish: Det skal du vide, før du begynder at tage Darunavir Krka
English: The maraviroc dose should be 150 mg twice daily when co-administered with boosted darunavir.
Danish: Maraviroc-dosis skal være 150 mg to gange daglig, når det administreres sammen med boostet darunavir.
English: Weight
Danish: Legemsvægt
English: Based on the different elimination pathways of the other NRTIs zidovudine, emtricitabine, stavudine, lamivudine, that are primarily renally excreted, and abacavir for which metabolism is not mediated by CYP450, no interactions are expected for these medicinal compounds and darunavir coadministered with low dose ritonavir.
Danish: På baggrund af de forskellige eliminationsveje for de andre NRTI, zidovudin, emtricitabin, stavudin, lamivudin, der primært udskilles via nyrerne, og abacavir, som ikke metaboliseres via CYP450, forventes der ikke nogle lægemiddelinteraktioner for disse lægemidler og darunavir co-administreret med lavdosis ritonavir.
English: Do not stop taking Darunavir Krka without talking to your doctor first Anti-HIV medicine may make you feel better.
Danish: Du må ikke stoppe med at tage Darunavir Krka uden først at tale med din læge Lægemidler til behandling af hiv kan få dig til at føle dig.
English: TITAN is a randomised, controlled, open-label Phase III trial comparing darunavir co-administered with ritonavir (600/100 mg twice daily) versus lopinavir/ritonavir (400/100 mg twice daily) in ARTexperienced, lopinavir naïve HIV-1 infected adult patients.
Danish: TITAN er et randomiseret, kontrolleret, åbent fase III-studie, der sammenligner darunavir co-administreret med ritonavir (600/100 mg to gange dagligt) med lopinavir/ritonavir (400/100 mg to gange dagligt) hos ART-erfarne, lopinavir-naive hiv-1-inficerede voksne patienter.
English: Increased CPK, myalgia, myositis and rarely, rhabdomyolysis have been reported with the use of protease inhibitors, particularly in combination with NRTIs.
Danish: Der har været rapporter om forhøjet CK (kreatinkinase), myalgi, myositis og, i sjældne tilfælde, rhabdomyolyse i forbindelse med brug af proteasehæmmere, især i kombination med NRTI'er.
English: (CYP2D6 inhibition)
Danish: (CYP2D6-hæmning)
English: Cardiac disorders uncommon myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia rare acute myocardial infarction, sinus bradycardia, palpitations
Danish: Hjerte ikke almindelig myokardieinfarkt, angina pectoris, elektrokardiogram, der viser QT-forlængelse, takykardi sjælden akut myokardieinfarkt, sinus bradykardi, hjertebanken
English: ART-naïve paediatric patients (3 to 17 years of age and weighing at least 15 kg) The weight-based dose of darunavir and ritonavir in paediatric patients is provided in the table below.
Danish: ART-naive pædiatriske patienter (3 til 17 år og legemsvægt på mindst 15 kg) Den vægtbaserede dosis af darunavir og ritonavir til pædiatriske patienter fremgår af tabellen nedenfor.
English: This guidance is based on the 15 hour half-life of darunavir in the presence of ritonavir and the recommended dosing interval of approximately 12 hours.
Danish: Denne vejledning er baseret på halveringstiden for darunavir i tilstedeværelse af ritonavir på 15 timer og på et anbefalet dosisinterval på ca. 12 timer.
English: Monitoring of renal function may be indicated when boosted darunavir is given in combination with tenofovir disoproxil, particularly in patients with underlying systemic or renal disease, or in patients taking nephrotoxic agents.
Danish: Monitorering af nyrefunktionen kan være indiceret, når boostet darunavir gives i kombination med tenofovirdisoproxil, især hos patienter med underliggende systemisk eller renal sygdom eller hos patienter, der tager nefrotoksiske midler.