FrancophonIA/ELRC3.0 huggingface dataset:
English: The resistance profile of REZOLSTA is supported by two Phase III trials conducted with darunavir/ritonavir in treatment-naïve (ARTEMIS) and treatment-experienced (ODIN) patients and the analysis of 48 week data from trial GS-US-216-130 in treatment-naïve and treatment-experienced patients.
Danish: Resistensprofilen for REZOLSTA understøttes af to fase III-studier udført med darunavir/ritonavir hos behandlingsnaive (ARTEMIS) og behandlingserfarne (ODIN) patienter og af analysen af 48-ugers data i studiet GS-US-216-130 med behandlingsnaive og behandlingserfarne patienter.
English: Concomitant use of REZOLSTA and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Samtidig brug af REZOLSTA og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroid-bivirkninger, herunder Cushings syndrom og binyrebarksuppression.
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 let øget virkning på parametre for røde blodlegemer, lever og skjoldbruskkirtel og øget incidens af fibrose i de langerhanske øer i pancreas (kun hos hanrotter) sammenlignet med behandling med darunavir alene.
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using REZOLSTA, interruption or discontinuation of treatment should be considered promptly.
Danish: Ved nyopstået eller forværret leverdysfunktion (med klinisk signifikant forhøjede leverenzymer og/eller symptomer såsom træthed, anoreksi, kvalme, gulsot, mørk urin, ømhed over leveren, hepatomegali) hos patienter, der tager REZOLSTA, skal det omgående overvejes midlertigt at afbryde eller helt seponere behandlingen.
English: This may be more likely with long-term HIV treatment, more severe damage to the immune system, overweight, or the use of alcohol or other medicines called corticosteroids.
Danish: Risikoen for dette øges i forbindelse med langvarig behandling, alvorlig svækkelse af immunforsvaret, overvægt eller brug af alkohol eller lægemidler, der kaldes binyrebarkhormoner (kortikosteroider).
English: Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle for cobicistat på grund af køn.
English: No human data on the effect of darunavir or cobicistat on fertility are available.
Danish: Der foreligger ingen data om virkningen af darunavir eller cobicistat på fertiliteten hos mennesker.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with REZOLSTA.
Danish: Forsigtighed tilrådes, og monitorering af den terapeutiske koncentration anbefales om muligt, når disse antiarytmika co-administreres med REZOLSTA.
English: Co-administration of oral midazolam or triazolam and REZOLSTA is contraindicated (see section 4.3).
Danish: Co-administration af oral midazolam eller triazolam og REZOLSTA er kontraindiceret (se pkt.
English: Medicinal products that may be affected by darunavir/cobicistat
Danish: Lægemidler, der kan påvirkes af darunavir/cobicistat
English: Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Danish: Interaktionsstudier med darunavir/cobicistat, darunavir/ritonavir og cobicistat er kun udført hos voksne.
English: Therefore, co-administration of REZOLSTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Danish: Co-administration af REZOLSTA og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt.
English: Paediatric population The pharmacokinetics of REZOLSTA in paediatric patients have not been investigated.
Danish: Pædiatrisk population REZOLSTAs farmakokinetik er ikke blevet undersøgt hos pædiatriske patienter.
English: What REZOLSTA looks like and contents of the pack Film-coated, pink, oval shaped tablet, mentioning TG on one side, 800 on the other side.
Danish: Filmovertrukken, lyserød, oval tablet med TG trykt på den ene side og 800 på den anden side.
English: Based on theoretical considerations co-administration of REZOLSTA with dabigatran or ticagrelor may increase concentrations of the anticoagulant.
Danish: Baseret på teoretiske overvejelser kan administration af REZOLSTA og dabigatran eller ticagrelor øge koncentrationen af antikoagulansen.
English: Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Danish: Alternativ eller yderligere prævention anbefales ved coadministration af østrogenbaseret prævention med REZOLSTA.
English: There are no pharmacokinetic data regarding the use of REZOLSTA in patients with hepatic impairment.
Danish: Der foreligger ingen farmakokinetiske data vedrørende anvendelse af REZOLSTA til patienter med nedsat leverfunktion.
English: If you notice after 12 hours, then skip the intake and take the next doses as usual.
Danish: Hvis du kommer i tanke om den glemte dosis efter mere end 12 timer, skal du springe den over og tage de næste doser som sædvanligt.
English: REZOLSTA should not be used concurrently with products containing ritonavir or regimens containing ritonavir or cobicistat.
Danish: REZOLSTA bør ikke anvendes sammen med præparater, der indeholder ritonavir, eller regimer, der indeholder ritonavir eller cobicistat.
English: Prior data with ritonavir-boosted darunavir however showed a decrease in these anti-depressant plasma concentrations (unknown mechanism); the latter may be specific to ritonavir.
Danish: (CYP2D6- og/eller CYP3A-hæmning) Tidligere data med ritonavir-boostet darunavir har dog vist en nedsat plasmakoncentration af disse antidepressiva (ukendt mekanisme); sidstnævnte kan være specifikt for ritonavir.
English: Clinical monitoring is recommended when co-administering REZOLSTA with these analgesics.
Danish: Klinisk monitorering anbefales ved co-administration af REZOLSTA med disse analgetika.
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 virkningen eller bivirkningerne af disse lægemidler kan blive ændret.
English: Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Danish: Samtidig administration af amiodaron, bepridil, dronedaron, ivabradin, quinidin eller ranolazin og REZOLSTA er kontraindiceret (se pkt.
English: HIV-1 infected patients who were eligible for this trial had a plasma HIV-1 RNA ≥ 1,000 copies/mL.
Danish: Hiv 1-inficerede patienter, som var egnede til deltagelse i dette studie, havde en plasma hiv 1-RNA ≥ 1.000 kopier/ml.
English: As REZOLSTA contains darunavir and cobicistat, the adverse reactions associated with each of the individual compounds may be expected.
Danish: Da REZOLSTA indeholder darunavir og cobicistat, kan der forventes de samme bivirkninger, der er forbundet med de enkelte stoffer.
English: Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Danish: Klinisk monitorering anbefales ved co-administration af REZOLSTA og perphenazin, risperidon eller thioridazin.
English: For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with REZOLSTA.
Danish: Dosisreduktion af disse neuroleptika bør overvejes ved co-administration med REZOLSTA.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 mL/min, n = 20) (see sections 4.2 and 4.4).
Danish: Selvom darunavir ikke er blevet undersøgt hos patienter med nedsat nyrefunktion, viste en populationsfarmakokinetisk analyse, at darunavirs farmakokinetik ikke var signifikant påvirket hos hiv-inficerede patienter med moderat nedsat nyrefunktion (CrCl mellem 30 og 60 ml/min, n=20) (se pkt.
English: Rash occurred more commonly in treatment-experienced patients receiving regimens containing darunavir/ritonavir + raltegravir compared to patients receiving darunavir/ritonavir without raltegravir or raltegravir without darunavir/ritonavir (see section 4.8).
Danish: Udslæt forekom hyppigere hos behandlingserfarne patienter, der blev behandlet med darunavir/ritonavir + raltegravir, end hos patienter, der fik darunavir/ritonavir uden raltegravir eller raltegravir uden darunavir/ritonavir (se pkt.
English: The pooled data of a single-arm trial investigating darunavir 800 mg once daily in combination with cobicistat 150 mg once daily and other antiretrovirals and one arm of a trial in which REZOLSTA 800/150 mg once daily and other antiretrovirals were administered, showed that 1.9% of patients discontinued treatment due to rash.
Danish: De poolede data i et enkelt-armet studie, hvor darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt og andre antiretrovirale lægemidler blev undersøgt, samt i en arm i et studie, hvor REZOLSTA 800/150 mg en gang dagligt og andre antiretrovirale lægemidler blev administreret, viste, at 1,9 % af patienterne måtte afbryde behandlingen på grund af udslæt.
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 for darunavir (område: 23-50 fold), indeholdt 2 til 4 aminosyresubstitutioner i proteasegenet.
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with severe renal impairment (estimated creatinine clearance below 30 mL/min).
Danish: Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv 1-inficerede patienter med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min).
English: Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
Danish: Alvorlige bivirkninger var diabetes mellitus, (lægemiddel-) overfølsomhed, immunrekonstitutionsinflammatorisk syndrom (IRIS), udslæt, Stevens-Johnsons syndrom og opkastning.
English: In these pharmacokinetic trials, the exposure of darunavir 800 mg boosted with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. Darunavir as a component of REZOLSTA is bioequivalent to darunavir 800 mg once daily in combination with cobicistat 150 mg once daily co-administered as single medicinal products (see section 5.2).
Danish: I disse farmakokinetiske studier var eksponeringen for darunavir 800 mg forstærket med cobicistat 150 mg konsistent med den, der blev observeret ved forstærkning med ritonavir 100 mg. Som komponent i REZOLSTA er darunavir bioækvivalent med darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt som individuelle lægemidler (se pkt.
English: Concomitant administration of REZOLSTA with dabigatran or ticagrelor is contraindicated.
Danish: Samtidig administration af REZOLSTA og dabigatran eller ticagrelor er kontraindiceret.
English: Pack size of one bottle.
Danish: Pakningsstørrelser med én beholder.
English: HIV-1 infected patients who were eligible for this trial had a screening genotype showing no darunavir RAMs and plasma HIV-1 RNA ≥ 1,000 copies/mL.
Danish: Hiv-1-inficerede patienter, der var egnede til at indgå i dette studie, havde en screening-genotype, der ikke viste darunavir-RAM, og plasma hiv-1 RNA ≥ 1.000 kopier/ml.
English: People taking REZOLSTA may develop a skin rash.
Danish: Patienter, der tager REZOLSTA, kan udvikle hududslæt.
English: Stevens-Johnson syndrome
Danish: Stevens-Johnsons syndrom #, angioødem,
English: REZOLSTA 800 mg/150 mg film-coated tablets
Danish: REZOLSTA 800 mg/150 mg filmovertrukne tabletter
English: Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
Danish: Hos raske frivillige blev den maksimale plasmakoncentration af cobicistat observeret 2-5 timer efter oral administration af REZOLSTA.
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: Concomitant use of everolimus and REZOLSTA is not recommended.
Danish: Samtidig brug af everolimus og REZOLSTA frarådes.
English: Concomitant use of a HMG CoA reductase inhibitor and REZOLSTA may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy.
Danish: Samtidig brug af en HMG-CoAreduktasehæmmer og REZOLSTA øger muligvis plasmakoncentrationen af det lipidsænkende stof, hvilket kan medføre bivirkninger så som myopati.
English: Medicinal products that induce CYP3A activity would be expected to increase the clearance of darunavir and cobicistat, resulting in lowered plasma concentrations of darunavir and cobicistat (e.g. efavirenz, carbamazepine, phenytoin, phenobarbital, rifampicin, rifapentine, rifabutin, St John's wort) (see section 4.3 and interaction table below).
Danish: Lægemidler, der inducerer CYP3A-aktivitet, må forventes at øge clearance af darunavir og cobicistat, hvilket kan medføre en lavere plasmakoncentration af darunavir og cobicistat (f.eks. efavirenz, carbamazepin, phenytoin, phenobarbital, rifampicin, rifapentin, rifabutin, perikon) (se pkt.
English: Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR14
Danish: Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, antivirale stoffer til behandling af hiv-infektion, kombinationer.
English: Reproductive system and breast disorders Uncommon gynaecomastia*
Danish: Det reproduktive system og mammae ikke almindelig gynækomasti*
English: Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Danish: Der har været rapporter om forhøjet CPK (kreatinkinase), myalgi, myositis og, i sjældne tilfælde, rabdomyolyse i forbindelse med hiv-proteasehæmmere, især i kombination med NRTI'er.
English: Based on theoretical considerations REZOLSTA may increase the exposure to glecaprevir and pibrentasvir.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for glecaprevir og pibrentasvir.
English: (P-glycoprotein inhibition)
Danish: (P-glykoproteinhæmning)
English: HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
Danish: Non-nukleos(t)id-revers-transkriptase-hæmmere (NNRTI'er) mod hiv Efavirenz
English: One film-coated tablet of REZOLSTA once daily taken with food may be used in patients with prior exposure to antiretroviral medicinal products, but without darunavir resistance associated mutations (DRV-RAMs)* and who have plasma HIV-1 RNA < 100,000 copies/mL and CD4+ cell count ≥ 100 cells x 10
Danish: En REZOLSTA filmovertrukken tablet, en gang dagligt, i forbindelse med et måltid, kan anvendes til patienter, der tidligere har været eksponeret for antiretrovirale lægemidler, men ikke har mutationer associeret med darunavirresistens (DRV-RAM)*, og som har plasma-hiv-1 RNA < 100.000 kopier/ml og CD4+-celletal ≥ 100 x 10
English: REZOLSTA should not be used concurrently with products or regimens containing ritonavir or cobicistat.
Danish: REZOLSTA bør ikke anvendes sammen med præparater eller regimer, der indeholder ritonavir eller cobicistat.
English: REZOLSTA should be used with caution in patients with a known sulphonamide allergy.
Danish: Darunavir indeholder en sulfonamid-del. REZOLSTA skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi.
English: Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
Danish: I modsætning til ritonavir inducerer cobicistat ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller UGT1A1.
English: REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
Danish: REZOLSTA kan coadministreres med protonpumpehæmmere uden dosisjustering.
English: As darunavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Danish: Da darunavir og cobicistat i høj grad bindes til plasmaproteiner, er det usandsynligt, at disse lægemidler vil blive fjernet i signifikant grad ved hæmodialyse eller peritonealdialyse (se pkt.
English: Based on theoretical considerations, REZOLSTA is expected to increase the exposure of lomitapide when coadministered.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge eksponeringen for lomitapid ved co-administration.
English: Primary (major) PI mutations PI RAMs
Danish: Primære (major) PImutationer
English: A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Danish: Hududslæt, eventuelt med kløe, er en almindelig bivirkning i forbindelse med REZOLSTA (ses oftere ved anvendelse sammen med raltegravir).
English: Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Danish: Op til det samme dosisniveau udviste darunavir ingen teratogenicitet administreret alene hos rotter og kaniner eller i kombination med ritonavir hos mus.
English: Co-administration of REZOLSTA and these anticoagulants is not recommended.
Danish: Co-administration af REZOLSTA og disse antikoagulantia frarådes.
English: Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Danish: Samtidig brug af REZOLSTA og elbasvir/grazoprevir er kontraindiceret (se pkt.
English: Human experience of acute overdose with REZOLSTA or darunavir in combination with cobicistat is limited.
Danish: Der er kun begrænset erfaring med akut overdosering af REZOLSTA eller darunavir administreret i kombination med cobicistat hos mennesker.
English: (CYP3A inhibition, UGT/SULT induction)
Danish: (CYP3A-hæmning, UGT/SULT-induktion)
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 infections may arise.
Danish: Immunrekonstitutionsinflammatorisk syndrom (IRIS) Hos hiv-patienter med alvorlig immundefekt på tidspunktet for initiering af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller resterende opportunistiske infektioner.
English: REZOLSTA might increase the risk for elevated potassium levels by drospirenone.
Danish: REZOLSTA kan øge risikoen for, at drospirenon øger kaliumniveauet.
English: When used for birth control, alternative methods of non-hormonal contraception are recommended.
Danish: I forbindelse med svangerskabsforebyggelse anbefales det, at du i stedet anvender prævention, der ikke indeholder hormoner.
English: Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for grazoprevir.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Danish: Det er vist, at cobicistat nedsætter den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin.
English: Darunavir and cobicistat are metabolised by the hepatic system.
Danish: Darunavir og cobicistat metaboliseres i leveren.
English: Based on theoretical considerations REZOLSTA may increase buprenorphine and/or norbuprenorphine plasma concentrations.
Danish: Baseret på teoretiske overvejelser kan REZOLSTA muligvis øge plasmakoncentrationen af buprenorphin og/eller norbuprenorphin.
English: Low rates of developing resistant HIV-1 virus were observed in ART-naïve patients who are treated for the first time with REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART, and in ART-experienced patients with no darunavir RAMs receiving REZOLSTA or darunavir/ritonavir 800/100 mg once daily in combination with other ART.
Danish: Der blev observeret lav udvikling af resistent hiv-1-virus hos ART-naive patienter, som behandles for første gang med REZOLSTA eller darunavir/ritonavir 800/100 mg en gang dagligt i kombination med et andet antiretroviralt middel, og hos ART-erfarne patienter uden darunavir-RAM, som fik REZOLSTA eller darunavir/ritonavir 800/100 mg en gang dagligt i kombination med et andet antiretroviralt middel.
English: What REZOLSTA contains - The active substances are darunavir and cobicistat.
Danish: REZOLSTA indeholder: - Aktive stoffer: darunavir og cobicistat.
English: Clinical monitoring is recommended when co-administering REZOLSTA with clonazepam.
Danish: Klinisk monitorering anbefales ved co-administration af REZOLSTA og clonazepam.
English: Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Danish: Der foreligger begrænsede data for patienter med andre hiv-1-subtyper end subtype B (se pkt.
English: The combination of lurasidone, pimozide, quetiapine or sertindole and REZOLSTA is contraindicated (see section 4.3).
Danish: Kombination af lurasidon, pimozid, quetiapin eller sertindol og REZOLSTA er kontraindiceret (se pkt.
English: Based on normal approximation to the difference in % response Non-completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Danish: I henhold til TLOVR-algoritmen (time to loss of viral response) Baseret på en normal approksimation til forskellen i % respons Patienter, der ikke fuldførte behandlingen, betragtes som havende behandlingssvigt, dvs. patienter, der afbrød behandlingen i utide, medregnes med en ændring, der tillægges værdien 0
English: If REZOLSTA is missed within 12 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of REZOLSTA with food as soon as possible.
Danish: Patienter skal informeres om, at hvis en dosis REZOLSTA glemmes i op til 12 timer efter det tidspunkt, hvor den sædvanligvis tages, skal den glemte dosis tages tages sammen med mad hurtigst muligt.
English: The bioequivalence between REZOLSTA and darunavir/cobicistat 800/150 mg co-administered as single agents was established under fed and fasted conditions in healthy subjects.
Danish: Der blev vist bioækvivalens mellem REZOLSTA og darunavir/cobicistat 800/150 mg co-administreret som enkelte lægemidler hos ikke-fastende og fastende raske forsøgspersoner.
English: - Tell your doctor if you have had problems with your kidneys.
Danish: - Fortæl din læge, hvis du har haft nyreproblemer.
English: (CYP3A inhibition and/or transport)
Danish: (CYP3A-hæmning og/eller transport)