FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased plasma concentrations of lovastatin or simvastatin may cause myopathy, including rhabdomyolysis.
Danish: Øgede plasmakoncentrationer af lovastatin eller simvastatin kan forårsage myopati, herunder rabdomyolyse.
English: Your doctor should do blood tests before you start darunavir.
Danish: Din læge bør udføre nogle blodprøverr, før du starter på darunavir.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n=12, age ≥ 65) (see section 4.4).
Danish: En populationsfarmakokinetisk analyse af hiv-inficerede patienter viste, at farmakokinetikken for darunavir ikke er meget anderledes i aldersgruppen 18-75 år vurderet hos hiv-inficerede patienter (n=12, alder  65 år) (se pkt.
English: Darunavir FC was less than 10 for 90% of 3,309 clinical isolates resistant to amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir and/or tipranavir showing that viruses resistant to most PIs remain susceptible to darunavir.
Danish: Darunavir FC var mindre end 10 for 90% af 3.309 kliniske isolater, der var resistente over for amprenavir, atazanavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir og/eller tipranavir.
English: Concomitant use with strong CYP3A inducers is contraindicated, since these may reduce the exposure to cobicistat and darunavir leading to loss of therapeutic effect.
Danish: Samtidig anvendelse med potente CYP3A-induktorer er kontraindiceret, eftersom disse kan reducere eksponeringen for cobicistat og darunavir med efterfølgende tab af terapeutisk effekt.
English: Cobicistat inhibits the tubular secretion of creatinine and may cause modest increases in serum creatinine and modest declines in creatinine clearance.
Danish: Cobicistat hæmmer den tubulære sekretion af kreatinin og kan forårsage mindre stigninger i serumkreatinin og mindre fald i kreatinin-clearance.
English: Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
Danish: Tag altid dette lægemiddel præcis som angivet i denne indlægsseddel eller efter din læges, apotekspersonalets eller sygeplejerskens anvisninger.
English: - if you are allergic to darunavir or any of the other ingredients of this medicine (listed in section 6) or to cobicistat or ritonavir.
Danish: - hvis du er allergisk over for darunavir eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6) eller over for cobicistat eller ritonavir.
English: Darunavir Mylan 400 mg film-coated tablets This medicinal product does not require any special storage conditions.
Danish: Darunavir Mylan 400 mg filmovertrukne tabletter Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: Cobicistat as a pharmacokinetic enhancer of darunavir should, therefore, not be initiated in patients with creatine clearance less than 70 ml/min if any co-administered agent requires dose adjustment based on creatinine clearance: e.g. emtricitabine, lamivudine, tenofovir disoproxil (as fumarate, phosphate or succinate) or adefovir dipovoxil.
Danish: Administration af cobicistat som farmakokinetisk forstærker af darunavir må derfor ikke indledes hos patienter med kreatinin-clearance under 70 ml/min., hvis samtidigt administrerede stoffer kræver dosisjustering baseret på kreatininclearance, f.eks. emtricitabin, lamivudin, tenofovirdisoproxil (som fumarat, fosfat eller succinat) eller adefovirdipovoxil.
English: The rash is usually mild to moderate.
Danish: Udslættet er sændvanligvis mildt til moderat.
English: The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
Danish: Tabellen nedenfor viser effektdata for analyserne ved uge 48 fra GS-US-216-130-studiet:
English: In a single arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals 2.2% of patients discontinued treatment due to rash.
Danish: I et enkeltarmet studie, som undersøgte darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt og andre antiretrovirale midler, afbrød 2,2% af patienterne behandlingen på grund af udslæt.
English: These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial.
Danish: Disse resultater blev bekræftet ved analyserne af data efter 96 ugers behandling i ARTEMIS-studiet og blev opretholdt i op til 192 ugers behandling i ARTEMISstudiet.
English: Skin rash (more often when used in combination with raltegravir), itching.
Danish: Hududslæt (ses oftere i kombination med raltegravir), kløe.
English: Therefore, protein displacement of medicinal products highly bound to α1-acid glycoprotein cannot be ruled out (see section 4.5).
Danish: Derfor kan fortrængning af lægemidler, der i udstrakt grad bindes til surt 1-glykoprotein, ikke udelukkes (se pkt.
English: The absolute oral bioavailability of a single 600 mg dose of darunavir alone was approximately 37% and increased to approximately 82% in the presence of 100 mg twice daily ritonavir.
Danish: Den absolutte, orale biotilgængelighed af en enkeltdosis darunavir på 600 mg var ca. 37%, og den steg til ca. 82% ved tilstedeværelse af 100 mg ritonavir to gange dagligt.
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 8289%).
Danish: Fluticason: I et klinisk studie hvor ritonavir 100 mg kapsler to gange dagligt blev administreret samtidig med 50 µg intranasalt fluticasonpropionat (4 gange dagligt) i 7 dage hos raske forsøgspersoner, steg plasmaniveauerne af fluticasonpropionat signifikant, hvorimod de naturlige kortisolniveauer faldt med ca. 86% (90% konfidensinterval 82-89%).
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended.
Danish: Det anbefales at bruge andre trombocythæmmende midler, som ikke påvirkes af CYPhæmning eller -induktion (f.eks. prasugrel).
English: Concentrations of voriconazole may increase or decrease when coadministered with darunavir coadministered with cobicistat.
Danish: Koncentrationen af voriconazol kan øges eller nedsættes ved coadministration med darunavir coadministreret med cobicistat.
English: The combination product lopinavir/ritonavir this anti-HIV medicine belongs to the same class as darunavir
Danish: Kombinationsproduktet lopinavir/ritonavir denne medicin mod hiv tilhører samme gruppe som darunavir
English: During the darunavir/ritonavir clinical development program (N=3,063), severe skin reactions, which may be accompanied with fever and/or elevations of transaminases, have been reported in 0.4% of patients.
Danish: I løbet af det kliniske udviklingsprogram for darunavir/ritonavir (N=3.063) rapporteredes alvorlige hudreaktioner, som kunne være ledsaget af feber og/eller forhøjede aminotransferaser, hos 0,4% af patienterne.
English: The below list of examples of drug drug interactions is not comprehensive and therefore the label of each drug that is co-administered with darunavir should be consulted for information related to the route of metabolism, interaction pathways, potential risks, and specific actions to be taken with regards to co-administration.
Danish: Derfor skal mærkningen af hvert lægemiddel, som administreres sammen med Darunavir Mylan, gennemgås for information releteret til metabolismevejen, interaktions mekanismerne, potentielle riscici og konkrete forholdsregler, som skal tages i forbindelse med co-administration.
English: Instructions for adults - Take one 800 milligram tablet at the same time, once a day, every day.
Danish: Anvisninger for voksne - Tag hver dag 1 tablet a 800 mg én gang om dagen og på samme tidspunkt.
English: The table below shows the efficacy data of the 48-week and 96-week analyses from the pooled POWER 1 and POWER 2 trials.
Danish: Tabellen nedenfor viser virkningsdataene fra 48-ugers- og 96-ugers-analyserne fra de samlede POWER 1- og POWER 2-studierne.
English: For bottles: Once opened, use within 90 days.
Danish: Für Flaschen: Nach dem Öffnen innerhalb von 90 Tagen aufbrauchen.
English: toxic epidermal necrolysis*, acute generalised exanthematous pustulosis*
Danish: Ikke kendt toksisk epidermal nekrolyse*, akut generaliseret eksantematøs pustulose*
English: These patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily with an investigator selected background regimen consisting of 2 active NRTIs.
Danish: Disse patienter fik darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt med et investigatorvalgt baggrundsregime bestående af 2 aktive NRTI'er.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Smid ikke medicinrester i afløbet, toilettet eller skraldespanden.
English: Other medicines and Darunavir Mylan Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Brug af anden medicin sammen med Darunavir Mylan Fortæl det til din læge eller apotekspersonalet, hvis du tager andre lægemidler eller har gjort det for nylig.
English: - Tell your doctor if you notice any musculoskeletal problems.
Danish: - Giv din læge besked, hvis du oplever muskelproblemer.
English: Dose (twice daily with food)
Danish: Dosis (to gange dagligt i forbindelse med et måltid)
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Darunavir Mylan.
Danish: Advarsler og forsigtighedsregler Kontakt din læge, apotekspersonalet eller din sygeplejerske, før du tager Darunavir Mylan.
English: Your doctor will advise you how to deal with your symptoms or whether darunavir must be stopped.
Danish: Din læge vil rådgive dig om, hvordan du skal forholde dig i forhold til dine symptomer, eller om du skal stoppe med at tage darunavir.
English: Please discuss with your doctor which dose is right for you.
Danish: Tal med din læge om, hvilken dosis der er den korrekte for dig.
English: After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor.
Danish: Når behandlingen er gået i gang, må dosen eller doseringsformen ikke ændres, og behandlingen må ikke stoppes, uden din læge har bedt dig om det.
English: Darunavir cannot work properly without cobicistat or ritonavir and food.
Danish: darunavir kan ikke virke korrekt uden cobicistat eller ritonavir og mad.
English: These are mentioned above under the heading ‘Do not combine Darunavir Mylan with any of the following medicines:'
Danish: De er angivet herover under overskriften 'Kombinér ikke Darunavir Mylan med nogen af følgende lægemidler:'
English: If you notice within 6 hours, you must take the tablets immediately.
Danish: Hvis du opdager det inden for 6 timer, skal du skynde dig at tage tabletterne.
English: Flecainide
Danish: Flecainid
English: The efficacy and safety of the use of darunavir with 100 mg ritonavir and any other HIV PI (e.g. (fos)amprenavir, nelfinavir and tipranavir) has not been established in HIV patients.
Danish: † Darunavirs sikkerhed og virkning sammen med 100 mg ritonavir og andre PI (f.eks. (fos)amprenavir, nelfinavir og tipranavir) er ikke klarlagt hos hiv-patienter.
English: angioedema, pruritus, urticaria drug reaction with eosinophilia and systemic symptoms*, Stevens-Johnson syndrome*
Danish: Sjælden lægemiddelreaktion med eosinofili og systemiske symptomer*, Stevens-Johnson syndrom*
English: Emtricitabine/tenofovir alafenamide
Danish: Emtricitabin/tenofovir - alafenamid
English: However, when HIV genotypic testing is not feasible, the darunavir/ritonavir once daily dosing regimen is recommended in HIV protease inhibitor-naïve paediatric patients and the twice daily dosing regimen is recommended in HIV protease inhibitor-experienced patients.
Danish: Hvis hivgenotypebestemmelse ikke er gennemførlig, anbefales dosisregimet med darunavir/ritonavir en gang dagligt til hiv-proteasehæmmer-naive pædiatriske patienter, og regimet med to daglige doseringer til hiv-proteasehæmmer-erfarne patienter.
English: Latvija*
Danish: Lietuva*
English: Perphenazine Risperidone Thioridazine
Danish: Perphenazin Risperidon Thioridazin
English: The effects on co-administered medicinal products may thus be underestimated and clinical monitoring of safety may be indicated.
Danish: Virkningen på co-administrerede lægemidler kan således være undervurderet, og klinisk monitorering af sikkerhed kan være indiceret.
English: The table below shows the efficacy data of the 48 week and 96 week analyses from the ARTEMIS trial:
Danish: Tabellen nedenfor viser effektdata fra 48 ugers og 96 ugers analyserne af ARTEMIS-studiet:
English: GS-US-216-130 is a single arm, open-label, Phase III trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with cobicistat in 313 HIV-1 infected adult patients (295 treatment-naïve and 18 treatment-experienced).
Danish: GS-US-216-130 er et enkeltarmet, åbent, fase III-studie, som evaluerer farmakokinetik, sikkerhed, tolerabilitet og effekt af darunavir med cobicistat hos 313 hiv-1-inficerede voksne patienter (295 behandlingsnaive og 18 behandlingserfarne).
English: Co-administration with boosted darunavir may lead to a substantial increase in exposure to dabigatran or ticagrelor.
Danish: Co-administration af boostet Darunavir Mylan kan medføre en markant stigning i eksponeringen for dabigatran eller ticagrelor.
English: Do not combine Darunavir Mylan with any of the following medicines If you are taking any of these, ask your doctor about switching to another medicine.
Danish: Kombinér ikke Darunavir Mylan med nogle af følgende lægemidler Hvis du tager nogle af disse, skal du spørge din læge, om du kan skifte til andre lægemidler.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed in case digoxin is given to patients on darunavir/ritonavir therapy.
Danish: Da digoxin har et snævert terapeutisk indeks, anbefales det at starte med at udskrive den lavest mulige dosis digoxin, hvis der skal gives digoxin til patienter i behandling med darunavir/ritonavir.
English: Carvedilol Metoprolol Timolol
Danish: BETABLOKERE Carvedilol Metoprolol Timolol
English: Given that digoxin has a narrow therapeutic index, it is recommended that the lowest possible dose of digoxin should initially be prescribed in case digoxin is given to patients on boosted darunavir therapy.
Danish: Da digoxin har et snævert terapeutisk indeks, anbefales det at starte med at udskrive den lavest mulige dosis digoxin, hvis der skal gives digoxin til patienter i behandling med boostet darunavir .
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige natriumfri.
English: ● For the treatment of HIV-1 infection in paediatric patients from the age of 3 years and at least
Danish: ● til behandling af hiv-1-infektion hos pædiatriske patienter fra 3 år med en legemsvægt på mindst 15 kg.
English: Dose adjustment for buprenorphine may not be necessary when coadministered with darunavir/ritonavir but a careful clinical monitoring for signs of opiate toxicity is recommended.
Danish: Dosisjustering af buprenorphin er måske ikke nødvendig ved administration sammen med darunavir/ritonavir, men en omhyggelig klinisk monitorering for tegn på opioidtoksicitet anbefales.
English: This should be taken into consideration if darunavir with cobicistat is administered to patients in whom the estimated creatinine clearance is used to adjust doses of co-administered medicinal products (see section 4.2 and cobicistat SmPC).
Danish: Der skal tages højde for dette, hvis darunavir med cobicistat administreres til patienter, hvor den estimerede kreatinin-clearance benyttes dosisjustering af samtidigt administrerede lægemidler (se pkt.
English: Even when you feel better, do not stop taking darunavir.
Danish: Selvom du har det bedre, må du ikke stoppe med at tage darunavir.
English: Pregnant or breast-feeding mothers must not take darunavir with ritonavir unless specifically directed by the doctor.
Danish: Gravide og ammende mødre må ikke tage Darunavir med ritonavir, medmindre det specifikt er ordineret af lægen.
English: - Tell your doctor if you are allergic to sulphonamides (e.g. used to treat certain infections).
Danish: - Fortæl din læge, hvis du er allergisk over for sulfonamider (anvendes f.eks. til behandling af visse infektioner).
English: Ritonavir inhibits the transporters P-glycoprotein, OATP1B1 and OATP1B3, and co-administration with substrates of these transporters can result in increased plasma concentrations of these compounds (e.g. dabigatran etexilate, digoxin, statins and bosentan; see the Interaction table below).
Danish: Ritonavir hæmmer transportørerne P-glykoprotein, OATP1B1 og OATP1B3, og co-administration med substrater for disse transportører kan medføre øgede plasmakoncentrationer af disse stoffer (f.eks. dabigatranetexilat, digoxin, statiner og bosentan - se interaktionstabellen nedenfor).
English: This guidance is based on the half-life of darunavir in the presence of cobicistat or ritonavir and the recommended dosing interval of approximately 24 hours.
Danish: Nedenstående vejledning er baseret på halveringstiden for darunavir i tilstedeværelse af cobicistat eller ritonavir og på et anbefalet dosisinterval på ca. 24 timer.
English: 100 milligram between 30 and 40 kilograms
Danish: 100 mg mellem 30 og 40 kg
English: In addition, patients on a stable dose of these antidepressants who start treatment with darunavir with low dose ritonavir should be monitored for antidepressant response.
Danish: Ydermere skal patienter, der får en stabil dosis af disse antidepressiva, og som starter behandling med darunavirmed lavdosis ritonavir, monitoreres for antidepressivt respons.
English: Baseline DRV FC
Danish: Baseline-DARUNAVIR FC
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: Patients should be instructed to take Darunavir Mylan with low dose ritonavir within 30 minutes after completion of a meal.
Danish: Patienterne bør vejledes i at tage Darunavir Mylan sammen med lavdosis ritonavir inden for 30 minutter efter indtagelse af et måltid.
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: The pharmacokinetic enhancing effect of cobicistat on darunavir was evaluated in a Phase I study in healthy subjects that were administered darunavir 800 mg with either cobicistat at 150 mg or ritonavir at 100 mg once daily.
Danish: Den farmakokinetiske forstærkningseffekt af cobicistat på darunavir blev evalueret i et fase I-studie med raske forsøgspersoner, som fik administreret darunavir 800 mg med enten cobicistat 150 mg eller ritonavir 100 mg en gang dagligt.
English: - Take your other HIV medicines used in combination with darunavir and cobicistat or ritonavir as recommended by your doctor.
Danish: - Tag din anden hiv-medicin, som du bruger i kombination med darunavir og cobicistat eller ritonavir, som anbefalet af din læge.
English: The recommended dose of darunavir with low dose ritonavir should not exceed the recommended adult dose (600/100 mg twice daily or 800/100 mg once daily).
Danish: Den anbefalede dosis af darunavir sammen med lavdosis ritonavir bør ikke overstige den anbefalede dosis til voksne (600/100 mg to gange dagligt eller 800/100 mg en gang dagligt).
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 dagligt, blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med mild (Child-Pugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
English: Data on comparison with a 150 mg once daily reference dose is lacking.
Danish: Der mangler data på sammenligning med en referencedosis på 150 mg x 1.
English: Darunavir might increase sugar levels in the blood.
Danish: Darunavir kan øge blodsukkerniveauerne i blodet.
English: Driving and using machines Do not operate machines or drive if you feel dizzy after taking darunavir.
Danish: Trafik- og arbejdssikkerhed Du bør ikke betjene maskiner eller køre bil, hvis du føler dig svimmel efter indtagelse af darunavir.
English: UROLOGICAL DRUGS Fesoterodine
Danish: UROLOGISKE LÆGEMIDLER Fesoterodin
English: The effects of other medicines might be influenced if you take darunavir.
Danish: Effekten af andre lægemidler kan blive påvirket, når du tager darunavir.
English: - Take your other HIV medicines used in combination with darunavir and ritonavir as recommended by your doctor.
Danish: - Tag din anden hiv-medicin, der skal bruges sammen med darunavir og ritonavir, som din læge anbefaler det.
English: Uncommon hepatic enzyme increased hepatitis*, cytolytic hepatitis*
Danish: Ikke almindelig hepatitis*, cytolytisk hepatitis*
English: Some side effects are typical for anti-HIV medicines in the same family as darunavir.
Danish: Nogle bivirkninger er typiske for anti-hiv-lægemidler i samme familie som darunavir.
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, diarré, hepatitis og pyreksi.
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-1-inficerede patienter, som tidligere har oplevet svigt i mere end et PI-regime.