FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir: comparison of atazanavir/ritonavir 300/100 mg once daily vs. atazanavir 300 mg once daily in combination with darunavir/ritonavir 400/100 mg twice daily.
Danish: Atazanavir: sammenligning af atazanavir/ritonavir 300/100 mg en gang daglig vs atazanavir 300 mg en gang daglig i kombination med darunavir/ritonavir 400/100 mg to gange daglig.
English: Darunavir Krka 600 mg film-coated tablets
Danish: Darunavir Krka 600 mg filmovertrukne tabletter
English: One ritonavira dose is between 15 and 30 kilograms 600 milligram
Danish: En dosis ritonavir a er mellem 15 og 30 kg
English: General disorders and administration site conditions common fatigue uncommon asthenia
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig træthed ikke almindelig asteni
English: (see section 4.1) a regimen of 800 mg once daily with ritonavir 100 mg once daily taken with food may be used.
Danish: 4.1), kan der anvendes et regime med 800 mg en gang dagligt sammen med ritonavir 100 mg en gang dagligt i forbindelse med et måltid.
English: The combination of avanafil and darunavir with low dose ritonavir is contraindicated (see section 4.3).
Danish: Kombinationen af avanafil og darunavir med lavdosis ritonavir er kontraindiceret (se pkt.
English: No dose adjustment is required for darunavir/ritonavir in patients with renal impairment (see sections 4.4 and 5.2).
Danish: Dosisjustering af darunavir/ritonavir er ikke nødvendig hos patienter med nedsat nyrefunktion (se pkt.
English: Boosted darunavir and rilpivirine can be used without dose adjustments.
Danish: Boostet darunavir og rilpivirin kan administreres uden dosisjusteringer.
English: Darunavir Krka might increase the risk of bleeding.
Danish: Darunavir Krka kan øge risikoen for blødning.
English: Simeprevir simeprevir AUC ↑ 159% simeprevir Cmin ↑ 358% simeprevir Cmax ↑ 79%
Danish: Simeprevir simeprevir AUC ↑ 159% simeprevir Cmin ↑ 358% simeprevir Cmax ↑ 79% darunavir AUC ↑ 18% darunavir Cmin ↑ 31%
English: Etravirine 100 mg twice daily etravirine AUC ↓ 37% etravirine Cmin ↓ 49% etravirine Cmax ↓ 32% darunavir AUC ↑ 15% darunavir Cmin ↔ darunavir Cmax ↔
Danish: Etravirin 100 mg to gange daglig etravirin AUC ↓ 37% etravirin Cmin ↓ 49% etravirin Cmax ↓ 32% darunavir AUC ↑ 15%
English: The Summary of Product Characteristics of cobicistat or ritonaviras appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Danish: Produktresuméet for cobicistat eller ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med darunavir påbegyndes.
English: In women receiving darunavir/ritonavir 800/100 mg once daily during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 33%, 31% and 30% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 29%, 32% and 50% lower, respectively, as compared with postpartum.
Danish: Hos kvinder, der fik 800/100 mg darunavir/ritonavir en gang dagligt i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24t og Cmin for total-darunavir hhv. 33 %, 31 % og 30 % lavere i forhold til post partum.
English: HIV Protease inhibitors (PIs) - with co-administration of low dose ritonavir
Danish: HIV-proteasehæmmere (PI) - med co-administration af lavdosis ritonavir†
English: Darunavir Krka 400 mg film-coated tablets Darunavir Krka 800 mg film-coated tablets
Danish: Darunavir Krka 400 mg filmovertrukne tabletter Darunavir Krka 800 mg filmovertrukne tabletter
English: Darunavir Krka 400 mg film-coated tablets:
Danish: Darunavir Krka 400 mg filmovertrukne tabletter:
English: Clinical monitoring is recommended when co-administering darunavir with low dose ritonavir with these antidepressants and a dose adjustment of the antidepressant may be needed.
Danish: Klinisk monitorering anbefales ved co-administration af darunavir med lavdosis ritonavir og disse antidepressiva, og det kan være nødvendigt at justere
English: For clinical trial results in ART-naïve adult patients, refer to the Summary of Product Characteristics for Darunavir Krka 400 mg and 800 mg tablets.
Danish: Vedrørende yderligere kliniske studieresultater hos ART-naive voksne henvises til produktresumeet for Darunavir Krka 400 mg og 800 mg tabletter.
English: once daily N=294
Danish: N=294
English: Darunavir must always be given orally with low dose ritonavir as a pharmacokinetic enhancer and in combination with other antiretroviral medicinal products (see section 5.2).
Danish: Darunavir skal altid gives oralt sammen med lavdosis ritonavir som en farmakokinetisk forstærker og i kombination med andre antiretrovirale lægemidler (se pkt.
English: The recommendations given for concomitant use of darunavir and other medicinal products may therefore differ depending on whether darunavir is boosted with ritonavir or cobicistat (see sections 4.3 and 4.4), and caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Danish: 4.3 og 4.4), og der skal ligeledes udvises forsigtighed i den første tid af behandlingen, hvis den farmakokinetiske forstærker ændres fra ritonavir til cobicistat (se pkt.
English: Human experience of acute overdose with darunavir co-administered with low dose ritonavir is limited.
Danish: Der er kun begrænset erfaring med akut overdosering af darunavir, co-administreret med lavdosis ritonavir, hos mennesker.
English: Third trimester of pregnancy (n=6)
Danish: Tredje trimester af graviditeten (n = 6)
English: If efavirenz is to be used in combination with darunavir /ritonavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.4).
Danish: Hvis efavirenz skal anvendes i kombination med darunavir/ritonavir, bør der anvendes et regime med darunavir/ritonavir 600/100 mg to gange daglig (se pkt.
English: At 48 weeks, virologic response, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, with darunavir/ritonavir 800/100 mg once daily treatment was demonstrated to be non-inferior (at the pre-defined 12% non-inferiority margin) compared to darunavir/ritonavir 600/100 mg twice daily for both ITT and OP populations.
Danish: Efter 48 uger blev der påvist non-inferioritet (ved den forud definerede 12% grænse for non-inferioritet) af det virologiske respons, defineret som procentdelen af patienter med plasmahiv-1-RNA < 50 kopier/ml, på behandling med darunavir/ritonavir 800/100 mg en gang dagligt sammenlignet med darunavir/ritonavir 600/100 mg to gange dagligt hos både ITT- og OP-populationer.
English: Do not combine Darunavir Krka with products that contain St John's wort (Hypericum perforatum).
Danish: Darunavir Krka må ikke kombineres med naturlægemidler, der indeholder perikon (Hypericum perforatum).
English: Concomitant use of everolimus and darunavir co-administered with low dose ritonavir is not recommended.
Danish: Samtidig brug af everolimus og darunavir co-administreret med lavdosis ritonavir frarådes.
English: Bleeding in haemophiliac patients
Danish: Blødninger hos hæmofilipatienter
English: Musculoskeletal and connective tissue disorders common myalgia uncommon osteonecrosis*
Danish: Knogler, led, muskler og bindevæv almindelig myalgi ikke almindelig osteonekrose*
English: (n=16)
Danish: d (-25; 16)
English: Boosted darunavir can be expected to increase the plasma concentrations of calcium channel
Danish: Boostet darunavir kan forventes at øge plasmakoncentrationen af calciumantagonisterne.
English: Darunavir co-administered with low dose ritonavir can be co-administered with H2-receptor antagonists without dose adjustments.
Danish: Darunavir kan administreres sammen med lavdosis ritonavir og H2-receptorantagonister uden dosisjusteringer.
English: Co-administration with the combination product lopinavir/ritonavir (see section 4.5).
Danish: Samtidig administration af kombinationsproduktet lopinavir/ritonavir (se pkt.
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 600/100 mg twice daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Danish: Farmakokinetiske resultater for total-darunavir efter administration af 600/100 mg darunavir/ritonavir to gange dagligt som del af et antiretroviralt regime i andet og tredje trimester af graviditeten og post partum
English: Second trimester of pregnancy (n=7)
Danish: Andet trimester af graviditeten (n = 7)
English: The combination of rifampicin and darunavir with concomitant low dose ritonavir is contraindicated (see section 4.3).
Danish: Kombinationen af rifampicin og darunavir med samtidig lavdosis ritonavir er kontraindiceret (se pkt.
English: The Summary of Product Characteristics of ritonavir as appropriate, must therefore be consulted prior to initiation of therapy with darunavir.
Danish: Produktresuméet for ritonavir, som det måtte være relevant, skal derfor læses, inden behandling med darunavir påbegyndes.
English: Combination of rifampicin with darunavir with concomitant low dose ritonavir (see section 4.5).
Danish: Kombination af rifampicin og darunavir sammen med lavdosis ritonavir (se pkt.
English: Therefore, darunavir must only be used in combination with low dose ritonavir as a pharmacokinetic enhancer (see sections 4.4 and 5.2).
Danish: Darunavir bør derfor kun anvendes i kombination med lavdosis ritonavir som en farmakokinetisk forstærker (se pkt.
English: Darunavir may therefore have different contraindications and recommendations for concomitant medications depending on whether the compound is boosted with ritonavir (see sections 4.3, 4.4 and
Danish: Der kan derfor være forskellige kontraindikationer og anbefalinger for darunavir og samtidige lægemidler afhængigt af, om darunavir er boostet med ritonavir (se pkt.
English: Thyroid follicular cell adenomas were noted in male rats.
Danish: Follikelcelleadenomer i skjoldbruskkirtlen blev observeret hos hanrotter.
English: HIV-1 RNA < 50 copies/ml median CD4+ cell count change from baseline (x 10
Danish: Hiv-1-RNA <50 kopier/ml gennemsnitlig CD4+celletals ændring fra baseline (×10
English: It is not recommended to coadminister boosted darunavir and simeprevir.
Danish: Det frarådes at co-administrere boostet darunavir og simeprevir.
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily.
Danish: Den samlede farmakokinetiske, forstærkende effekt af ritonavir medførte en ca. 14fold stigning i den systemiske eksponering for darunavir ved administration af en oral enkeltdosis darunavir på 600 mg i kombination med ritonavir 100 mg to gange daglig.
English: The combination of avanafil and boosted darunavir is contraindicated (see section 4.3).
Danish: Kombinationen af avanafil og boostet darunavir er kontraindiceret (se pkt.
English: Darunavir/ritonavir should be used during pregnancy only if the potential benefit justifies the potential risk (see sections 4.4, 4.6 and 5.2).
Danish: Darunavir/ritonavir bør kun anvendes under graviditet, hvis den mulige fordel opvejer den mulige risiko (se pkt.
English: Recommended dose for treatment-naïve paediatric patients (3 to 17 years) with darunavir and ritonavir
Danish: Anbefalet dosis af darunavir tabletter og ritonavir a til behandlingsnaive pædiatriske patienter (3 til 17 år)
English: Second trimester of pregnancy (n=17)
Danish: Andet trimester af graviditeten (n=17)
English: concomitantly administered with boosted darunavir.
Danish: lægemidler ved co-administration med boostet darunavir.
English: 800 milligram Darunavir Krka (2 tablets containing 400 milligram of Darunavir Krka or 1 tablet containing 800 milligram of Darunavir Krka) together with 100 milligram ritonavir once daily.
Danish: ELLER - 800 mg Darunavir Krka (2 tabletter a 400 mg Darunavir Krka eller 1 tablet a 800 mg Darunavir Krka) sammen med 100 mg ritonavir en gang dagligt.
English: (CYP3A and/or CYP2D6 inhibition)
Danish: (CYP3A og/eller CYP2D6hæmning)
English: Other corticosteroids: interaction not studied.
Danish: Interaktion er ikke undersøgt.
English: 375 mg darunavir /50 mg ritonavir twice daily
Danish: 375 mg darunavir/50 mg ritonavir to gange dagligt
English: based on published data with darunavir/ritonavir
Danish: Darunavir/ritonavir
English: Co-administration of boosted darunavir and alfuzosin is contraindicated (see section 4.3).
Danish: boostet darunavir og alfuzosin er kontraindiceret (se pkt.
English: In women receiving darunavir/cobicistat during the second trimester of pregnancy, mean intra-individual values for total darunavir Cmax, AUC24h and Cmin were 49%, 56% and 92% lower, respectively, as compared with postpartum; during the third trimester of pregnancy, total darunavir Cmax, AUC24h and Cmin values were 37%, 50% and 89% lower, respectively, as compared with postpartum.
Danish: Hos kvinder, der fik darunavir/cobicistat i andet trimester af graviditeten, var de gennemsnitlige intraindividuelle værdier for Cmax, AUC24t og Cmin for total-darunavir hhv. 49 %, 56 % og 92 % lavere i forhold til post partum.
English: It is not recommended to combine darunavir co-administered with low dose ritonavir with saquinavir.
Danish: Det anbefales ikke at kombinere saquinavir med darunavir administreret sammen med lavdosis ritonavir.
English: If efavirenz is to be used in combination with darunavir, the darunavir/ritonavir 600/100 mg twice daily regimen should be used (see section 4.5).
Danish: Hvis efavirenz skal anvendes i kombination med darunavir, bør der anvendes et regime med darunavir/ritonavir 600/100 mg to gange daglig (se pkt.
English: Pharmacokinetic results of total darunavir after administration of darunavir/ritonavir at 800/100 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy and postpartum
Danish: Farmakokinetiske resultater for total-darunavir efter administration af 800/100 mg darunavir/ritonavir en gang dagligt som del af et antiretroviralt regime i andet og tredje trimester af graviditeten og post partum
English: Darunavir Krka 800 mg film-coated tablets:
Danish: Darunavir Krka 800 mg filmovertrukne tabletter:
English: Hence, concomitant use of boosted darunavir and the combination product lopinavir/ritonavir is contraindicated (see section 4.3).
Danish: Derfor er samtidig brug af kombinationsproduktet lopinavir/ritonavir og boostet darunavir kontraindiceret (se pkt.
English: The combination of rifampicin and boosted darunavir is contraindicated (see section 4.3).
Danish: Kombinationen af rifampicin og boostet darunavir er kontraindiceret (se pkt.
English: darunavir/ ritonavir 800/100 mg once daily N=343
Danish: Darunavir/ ritonavir 800/100 mg en gang dagligt N=343
English: Based on theoretical considerations darunavir is expected to increase alfuzosin plasma concentrations.
Danish: Baseret på teoretiske overvejelser forventes darunavir at øge plasmakoncentrationerne af alfuzosin (CYP3A-hæmning)
English: Take Darunavir Krka always together with ritonavir.
Danish: Anvisninger for voksne - Tag altid Darunavir Krka sammen med ritonavir.
English: Each film-coated tablet contains 800 mg darunavir.
Danish: Hver filmovertrukken tablet indeholder 800 mg darunavir.
English: 100 milligram between 30 and 40 kilograms 675 milligram
Danish: 100 mg mellem 30 og 40 kg
English: ART-experienced paediatric patients (3 to 17 years of age and weighing at least 40 kg) In ART-experienced patients without DRV-RAMs* and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 10
Danish: ART-erfarne pædiatriske patienter (3 til 17 år og legemsvægt mindst 40 kg) Hos ART-erfarne patienter, der ikke har DRV-RAMs*, og som har plasma-hiv-1
English: silica, colloidal anhydrous ) and magnesium stearate (E470b)in the tablet core and poly(vinyl alcohol), macrogol, titanium dioxide (E171), talc (E553b), yellow iron oxide (E172) and red iron oxide (E172) in film coating.
Danish: - Øvrige indholdsstoffer: mikrokrystallinsk cellulose, crospovidon, hydroxypropylcellulose, silica, kolloid vandfri, silicificeret mikrokrystallinsk cellulose (mikrokrystallinsk cellulose; silica, kolloid vandfri) og magnesiumstearat (E470b) i tabletkernen og polyvinylalkohol, macrogol, titandioxid (E171), talcum (E553b), jernoxid, gul (E172) og jernoxid, rød (E172) i filmovertrækket.
English: Darunavir Krka 800 mg film-coated tablets darunavir
Danish: Darunavir Krka 800 mg filmovertrukne tabletter darunavir
English: Darunavir Krka 400 mg film-coated tablets darunavir
Danish: Darunavir Krka 400 mg filmovertrukne tabletter darunavir
English: Carbamazepine 200 mg twice daily carbamazepine AUC ↑ 45% carbamazepine Cmin ↑ 54% carbamazepine Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
Danish: Carbamazepin AUC ↑ 45% Carbamazepin Cmin ↑ 54% Carbamazepin Cmax ↑ 43% darunavir AUC ↔ darunavir Cmin ↓ 15% darunavir Cmax ↔
English: Co-administration of darunavir with low dose ritonavir and alfuzosin is contraindicated (see section 4.3).
Danish: Samtidig administration af darunavir med lavdosis ritonavir og alfuzosin er kontraindiceret (se pkt.
English: Second trimester of pregnancy (n=12)
Danish: Andet trimester af graviditeten (n=12)
English: darunavir/ ritonavir 800/100 mg once daily N=294
Danish: Darunavir/ ritonavir 800/100 mg en gang dagligt N=294
English: Non-inferiority in virologic response to the darunavir/ritonavir treatment, defined as the percentage of patients with plasma HIV-1 RNA level < 50 copies/ml, was demonstrated (at the pre-defined 12% non-inferiority margin) for both Intent-To-Treat (ITT) and On Protocol (OP) populations in the 48 week analysis.
Danish: Ved 48-ugers-analysen blev non-inferioritet i virologisk respons over for darunavir/ritonavir behandlingen, defineret som procentdelen af patienter med plasma hiv-1-RNA niveau < 50 kopier/ml, blev påvist (ved den forud definerede 12 % noninferioritetsgrænse) hos begge populationer (”Intent-To-Treat” og ”On Protocol”).
English: What Darunavir Krka is and what it is used for What you need to know before you take Darunavir Krka How to take Darunavir Krka Possible side effects
Danish: Det skal du vide, før du begynder at tage Darunavir Krka Sådan skal du tage Darunavir Krka Bivirkninger
English: The overall pharmacokinetic enhancement effect by ritonavir was an approximate 14-fold increase in the systemic exposure of darunavir when a single dose of 600 mg darunavir was given orally in combination with ritonavir at 100 mg twice daily (see section 4.4).
Danish: Den samlede farmakokinetiske, forstærkende effekt af ritonavir medførte en ca. 14fold stigning i den systemiske eksponering for darunavir ved administration af en oral enkeltdosis darunavir på 600 mg i kombination med 100 mg ritonavir to gange daglig (se pkt.
English: Clinical monitoring is recommended when co-administering boosted darunavir and clonazepam.
Danish: Klinisk monitorering anbefales, når boostet darunavir administreres sammen med lavdosis ritonavir og clonazepam.
English: Darunavir Krka 400 and 800 milligram tablets are only to be used to construct the once daily 800 milligram regimen.
Danish: Darunavir Krka 400 og 800 mg tabletter anvendes kun til at sammensætte en daglig dosis på 800 mg.
English: The pharmacokinetics of darunavir in combination with ritonavir taken once daily in 12 ART-naïve paediatric patients, aged 12 to < 18 years and weighing at least 40 kg, showed that darunavir/ritonavir 800/100 mg once daily results in darunavir exposure that was comparable to that achieved in adults receiving darunavir/ritonavir 800/100 mg once daily.
Danish: De farmakokinetiske egenskaber af darunavir i kombination med ritonavir en gang daglig hos 12 ART-naive pædiatriske patienter i alderen 12 til <18 år med en legemsvægt på mindst 40 kg viste, at darunavir/ritonavir 800/100 mg en gang daglig resulterede i en darunavireksponering, der var sammenlignelig med eksponeringen hos voksne, der fik darunavir/ritonavir 800/100 mg en gang daglig.
English: How to take Darunavir Krka
Danish: Sådan skal du tage Darunavir Krka
English: 675 mg darunavir/100 mg ritonavir once daily
Danish: 675 mg darunavir/100 mg ritonavir en gang dagligt
English: Darunavir/ritonavir 800/100 mg once daily in ART-experienced patients should not be used in patients with one or more darunavir resistance associated mutations (DRV-RAMs) or HIV-1 RNA ≥ 100,000 copies/ml or CD4+ cell count < 100 cells x 10
Danish: Darunavir/ritonavir 800/100 mg en gang dagligt hos ART-erfarne patienter bør ikke anvendes til patienter med en eller flere mutationer associeret med darunavirresistens (DRV-RAMs) eller hiv-1 RNA ≥ 100.000 kopier/ml eller CD4+-celletal < 100 x 10 celler/l (se pkt.
English: C-darunavir with ritonavir showed that approximately 7.7% of the administered dose of darunavir is excreted in the urine unchanged.
Danish: 7,7% af den administrerede dosis darunavir udskilles uomdannet i urinen.
English: It is not recommended to coadminister darunavir with low dose ritonavir and simeprevir.
Danish: Det frarådes at co-administrere darunavir med lavdosis ritonavir simeprevir.
English: Boosted darunavir and raltegravir can be used without dose adjustments.
Danish: Boostet darunavir og raltegravir kan administreres uden dosisjusteringer.
English: ART-naïve paediatric patients from the age of 12 years to < 18 years, and weighing at least 40 kg DIONE is an open-label, Phase II trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with low dose ritonavir in 12 ART-naïve HIV-1 infected paediatric patients aged 12 to less than 18 years and weighing at least 40 kg.
Danish: DIONE er et åbent fase II-studie til evaluering af farmakokinetik, sikkerhed, tolerabilitet og effekt af darunavir sammen med lavdosis ritonavir hos 12 ART-naive hiv-1-smittede pædiatriske patienter i alderen 12 år til < 18 år med en legemsvægt på mindst 40 kg.
English: A dosage reduction of rifabutin by 75% of the usual dose of 300 mg/day (i.e. rifabutin 150 mg once every other day) and increased monitoring for rifabutin related adverse events is warranted in patients receiving the combination with darunavir co-administered with ritonavir.
Danish: For patienter, der får kombinationsbehandling med darunavir co-administreret med ritonavir, er det nødvendigt at reducere dosis af rifabutin med 75% af den sædvanlige dosis på 300 mg/dag (f.eks. rifabutin 150 mg hver anden dag) samt en skærpelse i overvågningen af rifabutinrelaterede bivirkninger.
English: Dose for children 3 years of age and above, weighing more than 40 kilograms who have taken antiretroviral medicines before (your child's doctor will determine this) The dose is either:
Danish: Dosis til børn fra 3 år og opefter med en legemsvægt på mindst 40 kg, som tidligere har fået medicin mod hiv-infektion (barnets læge vil afgøre dette)
English: St John's wort is expected to decrease the plasma concentrations of darunavir or its pharmacoenhancers.
Danish: Perikon forventes at nedsætte plasmakoncentrationen af darunavir eller dets farmakoforstærkere.
English: Boosted darunavir and dolutegravir can be used without dose adjustment.
Danish: Boostet darunavir og dolutegravir kan bruges uden dosisjustering.