natgillin/translations-raw huggingface dataset:
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. 
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.
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. 
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.
Risikoen for dette øges i forbindelse med langvarig behandling, alvorlig svækkelse af immunforsvaret, overvægt eller brug af alkohol eller lægemidler, der kaldes binyrebarkhormoner (kortikosteroider). 
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.
Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle for cobicistat på grund af køn. 
Cobicistat No clinically relevant pharmacokinetic differences due to gender have been identified for cobicistat.
Der foreligger ingen data om virkningen af darunavir eller cobicistat på fertiliteten hos mennesker. 
No human data on the effect of darunavir or cobicistat on fertility are available.
Forsigtighed tilrådes, og monitorering af den terapeutiske koncentration anbefales om muligt, når disse antiarytmika co-administreres med REZOLSTA. 
Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with REZOLSTA.
Co-administration af oral midazolam eller triazolam og REZOLSTA er kontraindiceret (se pkt. 
Co-administration of oral midazolam or triazolam and REZOLSTA is contraindicated (see section 4.3).
Lægemidler, der kan påvirkes af darunavir/cobicistat 
Medicinal products that may be affected by darunavir/cobicistat
Interaktionsstudier med darunavir/cobicistat, darunavir/ritonavir og cobicistat er kun udført hos voksne. 
Interaction trials with darunavir/cobicistat, darunavir/ritonavir and with cobicistat have only been performed in adults.
Co-administration af REZOLSTA og sildenafil til behandling af pulmonal arteriel hypertension er derfor kontraindiceret (se pkt. 
Therefore, co-administration of REZOLSTA and sildenafil when used for the treatment of pulmonary arterial hypertension is contraindicated (see section 4.3).
Pædiatrisk population REZOLSTAs farmakokinetik er ikke blevet undersøgt hos pædiatriske patienter. 
Paediatric population The pharmacokinetics of REZOLSTA in paediatric patients have not been investigated.
Filmovertrukken, lyserød, oval tablet med TG trykt på den ene side og 800 på den anden side. 
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.
Baseret på teoretiske overvejelser kan administration af REZOLSTA og dabigatran eller ticagrelor øge koncentrationen af antikoagulansen. 
Based on theoretical considerations co-administration of REZOLSTA with dabigatran or ticagrelor may increase concentrations of the anticoagulant.
Alternativ eller yderligere prævention anbefales ved coadministration af østrogenbaseret prævention med REZOLSTA. 
Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Der foreligger ingen farmakokinetiske data vedrørende anvendelse af REZOLSTA til patienter med nedsat leverfunktion. 
There are no pharmacokinetic data regarding the use of REZOLSTA in patients with hepatic impairment.
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. 
If you notice after 12 hours, then skip the intake and take the next doses as usual.
REZOLSTA bør ikke anvendes sammen med præparater, der indeholder ritonavir, eller regimer, der indeholder ritonavir eller cobicistat. 
REZOLSTA should not be used concurrently with products containing ritonavir or regimens containing ritonavir or cobicistat.
(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. 
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.
Klinisk monitorering anbefales ved co-administration af REZOLSTA med disse analgetika. 
Clinical monitoring is recommended when co-administering REZOLSTA with these analgesics.
- apixaban, edoxaban, rivaroxaban, warfarin (til at hindre blodpropper), da virkningen eller bivirkningerne af disse lægemidler kan blive ændret. 
- 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.
Samtidig administration af amiodaron, bepridil, dronedaron, ivabradin, quinidin eller ranolazin og REZOLSTA er kontraindiceret (se pkt. 
Co-administration of amiodarone, bepridil, dronedarone, ivabradine, quinidine, or ranolazine and REZOLSTA is contraindicated (see section 4.3).
Hiv 1-inficerede patienter, som var egnede til deltagelse i dette studie, havde en plasma hiv 1-RNA ≥ 1.000 kopier/ml. 
HIV-1 infected patients who were eligible for this trial had a plasma HIV-1 RNA ≥ 1,000 copies/mL.
Da REZOLSTA indeholder darunavir og cobicistat, kan der forventes de samme bivirkninger, der er forbundet med de enkelte stoffer. 
As REZOLSTA contains darunavir and cobicistat, the adverse reactions associated with each of the individual compounds may be expected.
Klinisk monitorering anbefales ved co-administration af REZOLSTA og perphenazin, risperidon eller thioridazin. 
Clinical monitoring is recommended when co-administering REZOLSTA perphenazine, risperidone or thioridazine.
Dosisreduktion af disse neuroleptika bør overvejes ved co-administration med REZOLSTA. 
For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with REZOLSTA.
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. 
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).
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. 
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).
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. 
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.
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. 
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.
Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv 1-inficerede patienter med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min). 
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).
Alvorlige bivirkninger var diabetes mellitus, (lægemiddel-) overfølsomhed, immunrekonstitutionsinflammatorisk syndrom (IRIS), udslæt, Stevens-Johnsons syndrom og opkastning. 
Serious adverse reactions were diabetes mellitus, (drug) hypersensitivity, immune reconstitution inflammatory syndrome, rash, Stevens-Johnson syndrome, and vomiting.
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. 
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).
Samtidig administration af REZOLSTA og dabigatran eller ticagrelor er kontraindiceret. 
Concomitant administration of REZOLSTA with dabigatran or ticagrelor is contraindicated.
Pakningsstørrelser med én beholder. 
Pack size of one bottle.
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. 
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.
Patienter, der tager REZOLSTA, kan udvikle hududslæt. 
People taking REZOLSTA may develop a skin rash.
Stevens-Johnsons syndrom #, angioødem, 
Stevens-Johnson syndrome
REZOLSTA 800 mg/150 mg filmovertrukne tabletter 
REZOLSTA 800 mg/150 mg film-coated tablets
Hos raske frivillige blev den maksimale plasmakoncentration af cobicistat observeret 2-5 timer efter oral administration af REZOLSTA. 
Following oral administration of REZOLSTA in healthy volunteers, maximum plasma concentrations of cobicistat were observed 2 to 5 hours post-dose.
De hyppigste alvorlige bivirkninger er akut nyresvigt, myokardieinfarkt, immunrekonstitutionsinflammatorisk syndrom (IRIS), trombocytopeni, osteonekrose, diarré, hepatitis og pyreksi. 
The most frequent serious reactions are acute renal failure, myocardial infarction, immune reconstitution inflammatory syndrome, thrombocytopenia, osteonecrosis, diarrhoea, hepatitis, and pyrexia.
Samtidig brug af everolimus og REZOLSTA frarådes. 
Concomitant use of everolimus and REZOLSTA is not recommended.
Samtidig brug af en HMG-CoAreduktasehæmmer og REZOLSTA øger muligvis plasmakoncentrationen af det lipidsænkende stof, hvilket kan medføre bivirkninger så som myopati. 
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.
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. 
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).
Farmakoterapeutisk klassifikation: Antivirale stoffer til systemisk brug, antivirale stoffer til behandling af hiv-infektion, kombinationer. 
Pharmacotherapeutic group: Antivirals for systemic use, antivirals for treatment of HIV infection, combinations ATC code: J05AR14
Det reproduktive system og mammae ikke almindelig gynækomasti* 
Reproductive system and breast disorders Uncommon gynaecomastia*
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. 
Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for glecaprevir og pibrentasvir. 
Based on theoretical considerations REZOLSTA may increase the exposure to glecaprevir and pibrentasvir.
(P-glykoproteinhæmning) 
(P-glycoprotein inhibition)
Non-nukleos(t)id-revers-transkriptase-hæmmere (NNRTI'er) mod hiv Efavirenz 
HIV Non-nucleo(s/t)ide reverse transcriptase inhibitors (NNRTIs) Efavirenz
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 
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
REZOLSTA bør ikke anvendes sammen med præparater eller regimer, der indeholder ritonavir eller cobicistat. 
REZOLSTA should not be used concurrently with products or regimens containing ritonavir or cobicistat.
Darunavir indeholder en sulfonamid-del. REZOLSTA skal anvendes med forsigtighed hos patienter med kendt sulfonamidallergi. 
REZOLSTA should be used with caution in patients with a known sulphonamide allergy.
I modsætning til ritonavir inducerer cobicistat ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller UGT1A1. 
Unlike ritonavir, cobicistat is not an inducer of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 or UGT1A1.
REZOLSTA kan coadministreres med protonpumpehæmmere uden dosisjustering. 
REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.
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. 
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).
Baseret på teoretiske overvejelser forventes REZOLSTA at øge eksponeringen for lomitapid ved co-administration. 
Based on theoretical considerations, REZOLSTA is expected to increase the exposure of lomitapide when coadministered.
Primære (major) PImutationer 
Primary (major) PI mutations PI RAMs
Hududslæt, eventuelt med kløe, er en almindelig bivirkning i forbindelse med REZOLSTA (ses oftere ved anvendelse sammen med raltegravir). 
A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Op til det samme dosisniveau udviste darunavir ingen teratogenicitet administreret alene hos rotter og kaniner eller i kombination med ritonavir hos mus. 
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.
Co-administration af REZOLSTA og disse antikoagulantia frarådes. 
Co-administration of REZOLSTA and these anticoagulants is not recommended.
Samtidig brug af REZOLSTA og elbasvir/grazoprevir er kontraindiceret (se pkt. 
Concomitant use of REZOLSTA with elbasvir/grazoprevir is contraindicated (see section 4.3).
Der er kun begrænset erfaring med akut overdosering af REZOLSTA eller darunavir administreret i kombination med cobicistat hos mennesker. 
Human experience of acute overdose with REZOLSTA or darunavir in combination with cobicistat is limited.
(CYP3A-hæmning, UGT/SULT-induktion) 
(CYP3A inhibition, UGT/SULT induction)
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. 
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.
REZOLSTA kan øge risikoen for, at drospirenon øger kaliumniveauet. 
REZOLSTA might increase the risk for elevated potassium levels by drospirenone.
I forbindelse med svangerskabsforebyggelse anbefales det, at du i stedet anvender prævention, der ikke indeholder hormoner. 
When used for birth control, alternative methods of non-hormonal contraception are recommended.
Baseret på teoretiske overvejelser kan REZOLSTA øge eksponeringen for grazoprevir. 
Based on theoretical considerations REZOLSTA may increase the exposure to grazoprevir.
Det er vist, at cobicistat nedsætter den estimerede kreatininclearance på grund af hæmning af den tubulære sekretion af kreatinin. 
Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine.
Darunavir og cobicistat metaboliseres i leveren. 
Darunavir and cobicistat are metabolised by the hepatic system.
Baseret på teoretiske overvejelser kan REZOLSTA muligvis øge plasmakoncentrationen af buprenorphin og/eller norbuprenorphin. 
Based on theoretical considerations REZOLSTA may increase buprenorphine and/or norbuprenorphine plasma concentrations.
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. 
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.
REZOLSTA indeholder: - Aktive stoffer: darunavir og cobicistat. 
What REZOLSTA contains - The active substances are darunavir and cobicistat.
Klinisk monitorering anbefales ved co-administration af REZOLSTA og clonazepam. 
Clinical monitoring is recommended when co-administering REZOLSTA with clonazepam.
Der foreligger begrænsede data for patienter med andre hiv-1-subtyper end subtype B (se pkt. 
Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Kombination af lurasidon, pimozid, quetiapin eller sertindol og REZOLSTA er kontraindiceret (se pkt. 
The combination of lurasidone, pimozide, quetiapine or sertindole and REZOLSTA is contraindicated (see section 4.3).
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 
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
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. 
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.
Der blev vist bioækvivalens mellem REZOLSTA og darunavir/cobicistat 800/150 mg co-administreret som enkelte lægemidler hos ikke-fastende og fastende raske forsøgspersoner. 
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.
- Fortæl din læge, hvis du har haft nyreproblemer. 
- Tell your doctor if you have had problems with your kidneys.
(CYP3A-hæmning og/eller transport) 
(CYP3A inhibition and/or transport)
Patienter, der tager REZOLSTA sammen med raltegravir (mod hiv-infektion), kan hyppigere få udslæt end patienter, der kun får det ene af disse lægemidler. 
In patients taking REZOLSTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Der foreligger ingen data vedrørende anvendelse af darunavir eller cobicistat til patienter med svært nedsat leverfunktion. 
There are no data regarding the use of darunavir or cobicistat in patients with severe hepatic impairment.
Lurasidon Pimozid Sertindol Quetiapin 
Lurasidone Pimozide Sertindole Quetiapine
Silicificeret mikrokrystallinsk cellulose Crospovidon 
Colloidal silicon dioxide Silicified microcrystalline cellulose Crospovidone
Darunavir binder især til surt α1-glykoprotein i plasma. 
Darunavir binds primarily to plasma α1-acid glycoprotein.
Hud og subkutane væv meget almindelig udslæt (herunder makuløst, makulopapuløst, papuløst, erytematøst, kløende udslæt, generaliseret udslæt og allergisk dermatitis) 
Skin and subcutaneous tissue disorders Very common rash (including macular, maculopapular, papular, erythematous, pruritic rash, generalised rash, and allergic dermatitis)
Co-administration af REZOLSTA og naloxegol er kontraindiceret. 
Co-administration of REZOLSTA and naloxegol is contraindicated.
Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer) - allergiske reaktioner såsom kløe - nedsat appetit - unormale drømme - opkastning, mavesmerter eller -udspiling, fordøjelsesbesvær, luft i tarmene - muskelsmerter - træthed - unormale resultater af blodprøver som for eksempel visse undersøgelser af lever eller nyrer; din læge vil forklare dig om dette - svaghed. 
Common side effects (may affect up to 1 in 10 people) - allergic reactions such as itching - decreased appetite - abnormal dreams - vomiting, pain or swelling of the belly, indigestion, flatulence - muscle pain - tiredness - abnormal blood test results such as some tests for your liver or kidney.