FrancophonIA/ELRC3.0 huggingface dataset:
English: In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
Danish: Hos rotter medførte kombinationen af darunavir og ritonavir en lille stigning i virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtlen og øget incidens af pankreasfibrose (kun hos hanrotter) sammenlignet med behandling med darunavir alene.
English: Co-administration with darunavir/ritonavir may cause a large increase in the concentration of these medicines.
Danish: Co-administration med darunavir/ritonavir kan give anledning til en kraftig forøgelse af koncentrationen af disse lægemidler.
English: Mexiletine
Danish: Mexiletin
English: In patients taking darunavir and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Danish: Patienter, som tager darunavir og raltegravir (for HIV-infektioner), kan udvikle et udslæt (oftest mildt eller moderat) oftere end i patienter, som tager et af lægemidlerne separat.
English: If parenteral midazolam is coadministered with boosted darunavir, it should be done in an intensive care unit (ICU) or similar setting, which ensures close clinical monitoring and appropriate medical management in case of respiratory depression and/or prolonged sedation.
Danish: Hvis parenteral midazolam coadministreres med boostet darunavir, skal det foregå på en intensivafdeling (ITA) eller i lignende rammer, der sikrer tæt klinisk monitorering og passende medicinsk håndtering i tilfælde af respirationsdepression og/eller forlænget sedation.
English: Not studied with darunavir/ritonavir.
Danish: Ikke undersøgt med darunavir/ ritonavir.
English: The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group.
Danish: Simeprevirdosis i dette interaktionsstudie var 50 mg ved coadministration med darunavir/ritonavir, sammenlignet med 150 mg i den gruppe, der blev behandlet med simeprevir alene.
English: Propafenone
Danish: Propafenon
English: If a once daily dose of darunavir and/or cobicistat 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 cobicistat or ritonavir with food as soon as possible.
Danish: Hvis en daglig dosis af darunavir og/eller cobicistat 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 cobicistat eller ritonavir sammen med et måltid.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction
Danish: PHOSPHODIESTERASE-TYPE 5 (PDE-5)-HÆMMERE Til behandling af erektil dysfunktion Avanafil Sildenafil Tadalafil Vardenafil
English: The evidence of efficacy of darunavir co-administered with ritonavir (600/100 mg twice daily) in ART-experienced patients is based on the 96 weeks analysis of the Phase III trial TITAN in ART-experienced lopinavir naïve patients, on the 48 week analysis of the Phase III trial ODIN in ART-experienced patients with no DRV-RAMs, and on the analyses of 96 weeks data from the Phase IIb trials POWER 1 and 2 in ART-experienced patients with high level of PI resistance.
Danish: Dokumentationen for virkning af darunavir co-administreret med ritonavir (600/100 mg to gange dagligt), hos ART-erfarne patienter er baseret på 96-ugers-analysen af fase III-studiet TITAN hos ART-erfarne, lopinavir-naive patienter, på analysen efter 48 uger i fase III-studiet ODIN hos ART-erfarne patienter uden DRV-RAMs og på analysen af 96-ugers-data fra fase IIb-studierne POWER 1 og 2 hos ART-erfarne patienter med høj grad af PI-resistens.
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, rabdomyolyse i forbindelse med brug af proteasehæmmere, især i kombination med NRTI'er.
English: NARCOTIC ANALGESICS / TREATMENT OF OPIOID DEPENDENCE Methadone individual dose ranging from 55 mg to 150 mg once daily
Danish: NARKOTISKE ANALGETIKA / BEHANDLING AF OPIOIDAFHÆNGIGHED Methadon individuel dosering fra 55 mg-150 mg x 1
English: The most frequent adverse reactions reported in clinical trials and as spontaneous reports are diarrhoea, nausea, rash, headache and vomiting.
Danish: De hyppigste bivirkninger indberettet under kliniske studier og som spontane indberetninger er diarré, kvalme, udslæt, hovedpine og oplastning.
English: Co-administration of darunavir/cobicistat with weak to moderate CYP3A inducers (e.g. efavirenz, etravirine, nevirapine, boceprevir, fluticasone, and bosentan) is not recommended (see interaction table below).
Danish: Co-administration af darunavir/cobicistat med svage til moderate CYP3A-induktorer (f.eks. efavirenz, etravirin, nevirapin, boceprevir, fluticason og bosentan) frarådes (se interaktionstabel nedenfor).
English: (CYP3A and OATP1B inhibition).
Danish: (CYP3A- og OATP1B-hæmning).
English: 480 film-coated tablets
Danish: 480 filmovertrukne tabletter
English: Darunavir Mylan contains the active substance darunavir.
Danish: Darunavir Mylan indeholder det aktive stof darunavir.
English: Proportion (%) of patients with response (HIV-1 RNA < 50 copies/ml at week 24) to darunavir coadministered with ritonavir (600/100 mg twice daily) by baseline genotype a, and baseline darunavir FC and by use of enfuvirtide (ENF): As treated analysis of the POWER and DUET trials.
Danish: Patientandelen (%) med respons(hiv-1-RNA < 50 kopier/ml ved uge 24) over for darunavir co-administreret med ritonavir (600/100 mg to gange dagligt) efter genotype ved baseline a og darunavir FC ved baseline og efter brug af enfuvirtid (ENF): Som behandlede resultater fra POWERog DUET-studierne.
English: The concomitant use with darunavir and low dose ritonavir may require to lower the dose of alfentanil and requires monitoring for risks of prolonged or delayed respiratory depression.
Danish: Samtidig brug med boostet darunavir og lavdosis ritonavir kan nødvendiggøre nedsættelse af alfentanildosis og kræver monitorering for risici i forbindelse med forlænget eller forsinket respirationsdepression.
English: The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child.
Danish: Lægen vil afgøre, om barnet skal tage dosen én gang dagligt eller to gange dagligt.
English: - The child must swallow the tablets with a drink such as water or milk.
Danish: - Barnet skal sluge tabletter med noget at drikke som f.eks. vand eller mælk.
English: < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Danish: < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
English: Even when you feel better, do not stop taking Darunavir Mylan.
Danish: Selvom du har det bedre, må du ikke stoppe med at tage Darunavir Mylan.
English: Voriconazole should not be combined with darunavir coadministered 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/benefit-vurdering retfærdiggør brug af voriconazol.
English: No new safety findings were identified in the 192 week analysis of the treatment-naïve subjects in which the mean treatment duration of darunavir/ritonavir 800/100 mg once daily was 162.5 weeks.
Danish: Ingen nye sikkerhedsfund blev identifieret i 192ugers-analysen af behandlingsnaive patienter, hvor den gennemsnitlige behandlingstid med darunavir/ritonavir 800/100 mg en gang dagligt var 162,5 uger.
English: ● In all other ART-experienced patients or if HIV-1 genotype testing is not available, the recommended dose regimen described in the Summary of Product Characteristics for darunavir 75 mg, 150 mg, 300 mg and 600 mg tablets.
Danish: ● Hos alle andre ART-erfarne patienter, eller i tilfælde af, at der ikke foreligger en hiv-1genotypebestemmelse, er det anbefalede behandlingsregime beskrevet i produktresuméet for darunavir 75 mg, 150 mg, 300 mg og 600 mg tabletter.
English: Rosuvastatin 10 mg once daily rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144% ║ based on published data with darunavir/ritonavir
Danish: rosuvastatin AUC ↑ 48%║ rosuvastatin Cmax ↑ 144%║ ║ baseret på offentliggjorte data med darunavir/ritonavir
English: Darunavir might increase the risk of bleeding.
Danish: Darunavir kan øge risikoen for blødning.
English: 150 mg twice daily maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir concentrations were consistent with historical data
Danish: maraviroc AUC ↑ 305% maraviroc Cmin ND maraviroc Cmax ↑ 129% darunavir, ritonavir-koncentrationer er i overensstemmelse med de historiske data.
English: Rare side effects (may affect up to 1 in 1,000 people) - a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver,
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) - en reaktion kaldet DRESS [et alvorligt udslæt, der kan være ledsaget af feber, træthed, hævelser i ansigt eller lymfekirtler, øgning i antallet af eosinofile celler (en type hvide blodlegemer),
English: The film-coating contains polyvinyl alcohol partially hydrolysed, titanium dioxide (E171), macrogol and talc.
Danish: Filmovertrækningen indeholder delvist hydrolyseret polyvinylalkohol, titaniumdioxid (E171), macrogol og talkum.
English: Viruses isolated from patients on darunavir/ritonavir 600/100 mg twice daily experiencing virologic failure by rebound that were susceptible to tipranavir at baseline remained susceptible to tipranavir after treatment in the vast majority of cases.
Danish: Virusisolater fra patienter i behandling med darunavir/ritonavir 600/100 mg to gange dagligt, som fik virologisk svigt ved rebound, og som var følsomme for tipranavir ved baseline, forblev følsomme for tipranavir efter behandling i langt de fleste tilfælde.
English: After therapy with darunavir has been initiated, patients should be advised not to alter the dosage, dose form or discontinue therapy without discussing with their health care provider.
Danish: Efter indledning af behandling med darunavir skal patienterne rådgives om ikke at ændre doseringen eller lægemiddelformen eller stoppe med behandlingen undtagen efter aftale med lægen.
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: Darunavir co-administered with low dose ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk.
Danish: Darunavir, co-administreret med lavdosis ritonavir, bør kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko.
English: The increased exposure to darunavir in HIV-1 infected patients compared to healthy subjects may be explained by the higher concentrations of α1-acid 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 1- glykoprotein (AAG) hos hiv-1- inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma-AAG og derfor i højere plasmakoncentrationer.
English: Rare myocardial infarction, angina pectoris, prolonged electrocardiogram QT, tachycardia acute myocardial infarction, sinus bradycardia, palpitations
Danish: Sjælden myokardieinfarkt, angina pectoris, elektrokardiogram, der viser QT-forlængelse, takykardi akut myokardieinfarkt, sinus bradykardi, hjertebanken
English: Rare insomnia depression, disorientation, anxiety, sleep disorder, abnormal dreams, nightmare, decreased libido confusional state, altered mood, restlessness
Danish: Sjælden depression, desorientering, angst, søvnforstyrrelser, unormale drømme, mareridt, nedsat libido konfusion, humørændring, rastløshed
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 with no/non-naïve use of ENFc
Danish: Patienter, som ikke bruger, eller som er non-naive over for brug af ENF
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 1-glykoprotein (AAG) hos hiv-1-inficerede patienter, hvilket resulterer i højere binding af darunavir til plasma-AAG og derfor i højere plasmakoncentrationer.
English: Saquinavir 1,000 mg twice daily
Danish: Saquinavir 1.000 mg x 2
English: In an interaction study #, a comparable systemic exposure to sildenafil was observed for a single intake of 100 mg sildenafil alone and a single intake of 25 mg sildenafil co-administered with darunavir and low dose ritonavir.
Danish: I et interaktionsstudie blev der observeret samme systemiske eksponering for sildenafil ved en enkeltdosis sildenafil på 100 mg alene og en enkeltdosis sildenafil på 25 mg administreret sammen med darunavir og lavdosis ritonavir.
English: The weight-based dose of darunavir and ritonavir in paediatric patients is provided in the table below.
Danish: Den vægtbaserede dosis af darunavir og ritonavir til pædiatriske patienter fremgår af tabellen nedenfor.
English: Darunavir is not a cure for HIV infection.
Danish: Darunavir kan ikke helbrede hiv-infektion.
English: [On carton only:]
Danish: Kun på pap:
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 4.4 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: Medicinal products that may be affected by darunavir boosted with ritonavir Darunavir and ritonavir are inhibitors of CYP3A, CYP2D6 and P-gp.
Danish: Lægemidler, som kan blive påvirket af darunavir boostet med ritonavir Darunavir og ritonavir er hæmmere af CYP3A, CYP2D6 og P-gp.
English: Patients should be instructed to take Darunavir Mylan with cobicistat or low dose ritonavir within 30 minutes after completion of a meal.
Danish: Patienterne bør vejledes i at tage Darunavir Mylan sammen med cobicistat eller lavdosis ritonavir inden for 30 minutter efter indtagelse af et måltid.
English: Based on theoretical considerations boosted darunavir may increase the exposure to glecaprevir and pibrentasvir.
Danish: Baseret på teoretiske overvejelser kan boostet Darunavir Mylan øge eksponeringen for glecaprevir og pibrentasvir.
English: The exposure to total darunavir and ritonavir after intake of darunavir/ritonavir 600/100 mg twice daily and darunavir/ritonavir 800/100 mg once daily as part of an antiretroviral regimen was generally lower during pregnancy compared with postpartum.
Danish: Eksponeringen for total-darunavir og ritonavir efter indtagelse af 600/100 mg darunavir/ritonavir to gange dagligt og 800/100 mg darunavir/ritonavir en gang dagligt som del af et antiretroviralt regime var generelt lavere under graviditet i forhold til post partum.
English: Therapeutic drug monitoring of the immunosuppressive agent must be done when co-administration occurs.
Danish: Der skal i forbindelse med co-administration foretages terapeutisk lægemiddelmonitorering af det immunsupprimerende middel.
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: Nedenstående vejledning er baseret på halveringstiden for darunavir i tilstedeværelse af ritonavir på 15 timer og på et anbefalet dosisinterval på ca. 12 timer.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Danish: Spørg din læge, apotekspersonalet eller din sygeplejerske til råds, hvis du er i tvivl.
English: Darunavir is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection.
Danish: Darunavir er et antiretroviralt lægemiddel, der bruges til behandling af en infektion af human immundefekt-virus (hiv).
English: Your child's doctor will determine the appropriate dosing regimen for your child. - The child must take darunavir with food.
Danish: Dit barns læge vil fastsætte den korrekte administration af dosis til dit barn.
English: Co-administration of darunavir with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Danish: Co-administration af boostet darunavir med disse antikoagulantia kan øge koncentrationerne af antikoagulanset, hvilket kan medføre en øget blødningsrisiko.
English: During the clinical development program (N=2,613 treatment-experienced subjects who initiated therapy with darunavir/ ritonavir 600/100 mg twice daily), 51.3% of subjects experienced at least one adverse reaction.
Danish: I løbet af det kliniske udviklingsprogram (N=2.613 behandlingserfarne forsøgspersoner, som indledte behandling med darunavir/ritonavir 600/100 mg to gange dagligt), fik 51,3% af deltagerne mindst en bivirkning.
English: What you need to know before you take Darunavir Mylan
Danish: Det skal du vide, før du begynder at tage Darunavir Mylan
English: Co-administration of darunavir with low dose ritonavir, with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events.
Danish: Samtidig administration af darunavir, med lavdosis ritonavir, og aktive stoffer, der er meget afhængige af CYP3A for eliminering, og for hvilke forhøjede plasmakoncentrationer er forbundet med alvorlige og/eller livstruende hændelser.
English: Phenobarbital and phenytoin are expected to decrease plasma concentrations of darunavir and its pharmacoenhancer.
Danish: Phenobarbital og Phenytoin forventes at nedsætte plasmakoncentrationen af darunavir og dets farmakoforstærker.
English: Viruses selected in these conditions and showing decreased susceptibility to darunavir (range: 23-50-fold) harboured 2 to 4 amino acid substitutions in the protease gene.
Danish: De selekterede vira kunne ikke vokse ved tilstedeværelse af darunavir-koncentrationer over 400 nM. Vira, der blev selekteret under disse betingelser, og som viste reduceret følsomhed over for darunavir (område: 2350-fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet.
English: Darunavir Mylan 400 mg and 800 mg film-coated tablets contain less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Darunavir Mylan 400 mg og 800 mg filmovertrukne tabletter indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. den er i det væsentlige natriumfri.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Der er detaljerede oplysninger tilgængelige på Det Europæiske Lægemiddelagenturs websted: http://www.ema.europa.eu.
English: There are some medicines that you must not combine with darunavir.
Danish: Der er nogle lægemiddeltyper, som du ikke må kombinere med darunavir.
English: - The strong CYP3A inducers rifampicin and herbal preparations containing St John's wort (Hypericum perforatum).
Danish: - De potente CYP3A-induktorer rifampicin og naturlægemidler, som indeholder perikon (Hypericum perforatum).
English: Digoxin 0.4 mg single dose digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin from probable inhibition of P-gp)
Danish: Digoxin 0,4 mg enkeltdosis digoxin AUC ↑ 61% digoxin Cmin ND digoxin Cmax ↑ 29% (↑ digoxin fra en sandsynlig hæmning af P-gp (P-glykoprotein))
English: HDPE bottle pack This medicinal product does not require any special storage conditions.
Danish: HDPE-flaskepakke Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: - The active substance is darunavir.
Danish: Aktivt stof: darunavir.
English: Darunavir may increase antifungal plasma concentrations and posaconazole, isavuconazole, itraconazole, or fluconazole may increase darunavir concentrations.
Danish: Darunavir kan øge plasmakoncentrationen af antimykotika og posaconazol, isavuconazol, itraconazol og fluconazol kan øge koncentrationerne af darunavir.
English: Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases, especially during the first several months of darunavir used in combination with cobicistat or low dose 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 anvendt i kombination med cobicistat eller lavdosis ritonavir.
English: Darunavir co-administered with low dose ritonavir must not be combined with medicinal products that are highly dependent on CYP3A for clearance and for which increased systemic exposure is associated with serious and/or life-threatening events (narrow therapeutic index) (see section 4.3).
Danish: Darunavir, co-administreret med lavdosis ritonavir, må ikke kombineres med lægemidler, der er meget afhængige af CYP3A i forbindelse med clearance, og for hvilke øget systemisk eksponering er forbundet med alvorlige og/eller livstruende hændelser (snævert terapeutisk indeks) (se pkt.
English: DRESS, Stevens-Johnson syndrome, erythema multiforme, dermatitis, seborrhoeic dermatitis, skin lesion, xeroderma toxic epidermal necrolysis, acute generalised exanthematous pustulosis
Danish: DRESS, Stevens-Johnsons syndrom, erythema multiforme, dermatitis, seboroisk dermatitis, hudlæsioner, xeroderma,
English: and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Danish: som har plasma hiv-1-RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
English: Darunavir co-administered with cobicistat should not be used in combination with another antiretroviral agent that requires pharmacoenhancement by means of coadministration with an inhibitor of CYP3A4 (see section 4.5).
Danish: Darunavir co-administreret med cobicistat bør ikke anvendes i kombination med et andet antiretroviralt middel, som kræver farmakoforstærkning med en CYP3A4-hæmmer (se pkt.