FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequent adverse reactions reported during the darunavir/ritonavir clinical development program and as spontaneous reports are diarrhoea, nausea, rash, headache, and vomiting.
Danish: De hyppigste bivirkninger indberettet under det kliniske udviklingsprogram med darunavir/ritonavir og som spontane indberetninger er diarré, kvalme, udslæt, hovedpine og opkastning.
English: The most frequent adverse reactions reported in the pooled data of the Phase 3 study GS-US-216-130 and the REZOLSTA arm of Phase 3 study TMC114FD2HTX3001 were diarrhoea (23%), nausea (17%), rash (13%), and headache (10%).
Danish: De hyppigst rapporterede bivirkninger i de poolede data fra fase 3-studiet GS-US-216-130 og REZOLSTA-armen i fase 3-studiet TMC114FD2HTX3001 var diarré (23 %), kvalme (17 %), udslæt (13 %) og hovedpine (10 %).
English: Virologic failures selected for resistance testing were defined as: never suppressed: HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/mL at week 8, confirmed at the following visit; rebound: HIV-1 RNA < 50 copies/mL followed by confirmed HIV-1 RNA to ≥ 400 copies/mL or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/mL at last visit Virologic failures based on TLOVR non-VF censored algorithm (HIV-1 RNA > 50 copies/mL) IAS-USA lists
Danish: Virologiske svigt udvalgt til resistenstest blev defineret som: aldrig supprimeret: hiv-1-RNA < 1 log10-reduktion fra baseline og ≥ 50 kopier/ml ved uge 8, bekræftet ved det efterfølgende besøg; rebound: hiv-1-RNA < 50 kopier/ml efterfulgt af bekræftet hiv-1-RNA ≥ 400 kopier/ml eller bekræftet > 1 log10-stigning i hiv-1-RNA over nadir-niveau; seponeringer med hiv-1 RNA ≥ 400 kopier/ml ved sidste besøg Virologisk svigt baseret på TLOVR (time to loss of viral response) non-virologisk svigt censorerede algoritme (hiv-1 RNA > 50 kopier/ml) IAS-USA-lister
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Danish: De kan omfatte gulfarvning af huden og det hvide i øjnene, mørk (tefarvet) urin, bleg afføring, kvalme, opkastning, appetitløshed eller smerter, jag eller smerter og ubehag i din højre side under ribbenene.
English: Expected interactions between REZOLSTA and antiretroviral and non-antiretroviral medicinal products are listed in the table below and are based on the identified interactions with darunavir/ritonavir, darunavir/cobicistat and with cobicistat.
Danish: Forventede interaktioner mellem REZOLSTA og antiretrovirale og non-antiretrovirale lægemidler er anført i tabellen nedenfor og er baseret på de identificerede interaktioner med darunavir/ritonavir, med darunavir/cobicistat og med cobicistat.
English: In a pre- and postnatal development assessment in rats, darunavir with and without ritonavir, caused a transient reduction in body weight gain of the offspring pre-weaning and there was a slight delay in the opening of eyes and ears.
Danish: I en vurdering af præ- og postnatal udvikling hos rotter medførte darunavir med og uden ritonavir en forbigående langsommere vægtstigning hos afkommet inden fravænning, og åbning af øjne og ører skete lidt senere end normalt.
English: REZOLSTA is not recommended for use in paediatric patients (3 to 17 years of age).
Danish: REZOLSTA anbefales ikke til pædiatriske patienter (3 til 17 år).
English: Based on theoretical considerations co-administration of REZOLSTA with these anticoagulants may increase concentrations of the anticoagulant, which may lead to an increased bleeding risk.
Danish: Baseret på teoretiske overvejelser kan co-administration af REZOLSTA med disse antikoagulantia øge koncentrationen af antikoagulansen, hvilket kan medføre en øget blødningsrisiko.
English: C-darunavir trial in healthy volunteers showed that a majority of the radioactivity in plasma after a single 400/100 mg darunavir with ritonavir dose was due to the parent active substance.
Danish: C-darunavir-studie med raske, frivillige forsøgspersoner viste, at størstedelen af radioaktiviteten i plasma efter en enkelt dosis darunavir med ritonavir på 400/100 mg skyldtes det aktive moderstof.
English: Based on theoretical considerations REZOLSTA is expected to increase the plasma concentrations of fluvastatin, pitavastatin, pravastatin, lovastatin and simvastatin.
Danish: Baseret på teoretiske overvejelser forventes REZOLSTA at øge plasmakoncentrationen af fluvastatin, pitavastatin, pravastatin, lovastatin og simvastatin.
English: If this is noticed later than 12 hours of the time it is usually taken, the missed dose should not be taken and the patient should resume the usual dosing schedule.
Danish: Hvis det bliver opdaget senere end 12 timer efter det sædvanlige tidspunkt for indtagelse af en dosis, skal den glemte dosis springes over, og patienten skal fortsætte efter den sædvanlige doseringssplan.
English: When also taking into account the clinical trial data of DRV/COBI/emtricitabine/tenofovir alafenamide, StevensJohnson syndrome occurred rarely (in 1 out of 2,551 subjects) consistent with the DRV/rtv clinical trial program (see Severe skin reactions in Section 4.4).
Danish: Hvis man også tager de kliniske studiedata for DRV/COBI/emtricitabin/tenofoviralafenamid med i betragtning, forekom Stevens-Johnsons syndrom sjældent (hos 1 ud af 2.551 patienter), hvilket stemmer overens med det kliniske studieprogram for DRV/rtv (se Alvorlige hudreaktioner under pkt.
English: In the darunavir/cobicistat fixed-dose combination treament arm, 363 HIV-1 infected, adult, treatment-naïve patients were treated.
Danish: I behandlingsarmen med fastdosis-kombination af darunavir/cobicistat fik 363 hiv 1-inficerede voksne behandlingsnaive patienter behandling.
English: Some clinical trials suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Danish: Visse kliniske studier tyder på, at raltegravir kan forårsage et beskedent fald i darunavirs plasmakoncentration.
English: If these anti-depressants are to be used with REZOLSTA clinical monitoring is recommended and a dose adjustment of the anti-depressant may be needed.
Danish: Hvis det påtænkes at anvende disse antidepressiva sammen med REZOLSTA, anbefales klinisk monitorering, og det kan være nødvendigt at justere dosis af det pågældende antidepressivum.
English: HIV-1 RNA < 50 copies/mL Virologic failure No virologic data in 48-week window
Danish: Hiv 1-RNA < 50 kopier/ml Virologisk svigt Ingen virologiske data i 48ugers vinduet
English: Your doctor will evaluate which cholesterol lowering regimen is best for your specific situation.
Danish: Din læge vil vurdere, hvilken kolesterolsænkende behandling der egner sig bedst til dig.
English: Plasma concentrations of these medicinal products may be increased when co-administered with REZOLSTA, resulting in reduced serum cortisol concentrations.
Danish: Plasmakoncentrationen af disse lægemidler kan øges ved samtidig administration af REZOLSTA, hvilket medfører nedsat serumkortisol.
English: Change of estimated glomerular filtration rate calculated by Cockcroft-Gault method (eGFRCG) from baseline was observed within 7 days after start of treatment with cobicistat 150 mg among subjects with normal renal function (-9.9 ± 13.1 mL/min) and mild to moderate renal impairment (-11.9 ± 7.0 mL/min).
Danish: Ændringen i den estimerede glomerulære filtrationshastighed udregnet ved hjælp af Cockcroft-Gault-metoden (eGFRCG) fra baseline blev observeret inden for 7 dage efter behandlingsstart med cobicistat 150 mg blandt patienter med normal nyrefunktion (9,9 ± 13,1 ml/min) og let til moderat nedsat nyrefunktion (-11,9 ± 7,0 ml/min).
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Danish: Darunavir udviser aktivitet mod laboratoriestammer og kliniske isolater af hiv-1 og laboratoriestammer af hiv-2 i akut inficerede T-cellelinjer, mononukleære celler fra perifert humant blod og humane monocytter/makrofager med mediane EC50-værdier fra 1,2 til 8,5 nM (0,7 til 5,0 ng/ml).
English: REZOLSTA might increase sugar levels in the blood.
Danish: REZOLSTA kan forhøje blodsukkerniveauet.
English: Population pharmacokinetic analysis in HIV infected patients showed that darunavir pharmacokinetics are not considerably different in the age range (18 to 75 years) evaluated in HIV infected patients (n = 12, age  65 years) (see section 4.4).
Danish: En populationsfarmakokinetisk analyse af hiv-inficerede patienter viste, at darunavirs farmakokinetik ikke er meget forskellig i aldersintervallet 18-75 år vurderet hos hiv-inficerede patienter (n=12, alder  65 år) (se pkt.
English: No treatment related mortalities were noted in juvenile rats dosed at 1,000 mg/kg darunavir (single dose) on day 26 of age or at 500 mg/kg (repeated dose) from day 23 to 50 of age, and the exposures and toxicity profile were comparable to those observed in adult rats.
Danish: Der blev ikke konstateret behandlingsrelateret mortalitet hos unge rotter, der fik en dosis på 1.000 mg/kg darunavir (enkeltdosis) i en alder på 26 dage eller doser på 500 mg/kg (gentagne doser) i alderen fra 23 til 50 dage, og eksponeringen og toksicitetsprofilen var sammenlignelige med dem, der blev observeret hos voksne rotter.
English: It is not recommended to co-administer REZOLSTA with glecaprevir/pibrentasvir.
Danish: Det frarådes at co-administrere REZOLSTA og glecaprevir/pibrentasvir.
English: ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Danish: Den anbefalede dosis REZOLSTA er en filmovertrukken tablet en gang dagligt i forbindelse med et måltid.
English: Clinical monitoring of therapeutic and adverse effects is recommended when these medicines are co-administered with REZOLSTA.
Danish: Klinisk monitorering af terapeutisk virkning og bivirkninger anbefales, når disse lægemidler co-administreres med REZOLSTA.
English: Life-threatening and fatal drug interactions have been reported in patients treated with colchicine and strong inhibitors of CYP3A and P-glycoprotein (see section 4.5).
Danish: Der er indberettet livstruende og dødelige lægemiddelinteraktioner hos patienter, der blev behandlet med colchicin og potente CYP3A- og P-glykoprotein (P-gp)-hæmmere (se pkt.
English: GS-US-216-130 is a single-arm, open-label, Phase III trial evaluating the pharmacokinetics, safety, tolerability, and efficacy of darunavir with cobicistat in 313 HIV-1 infected adult patients (295 treatment-naïve and 18 treatment-experienced).
Danish: GS-US-216-130 er et åbent, enkeltarmet fase III-studie, som evaluerede farmakokinetik, sikkerhed, tolerabilitet og virkning af darunavir sammen med cobicistat hos 313 hiv-1-inficerede voksne patienter (295 behandlingsnaive og 18 behandlingserfarne).
English: Concomitant use of everolimus or irinotecan and REZOLSTA is not recommended.
Danish: Samtidig brug af everolimus eller irinotecan og REZOLSTA frarådes.
English: No dosage adjustment of REZOLSTA is necessary for patients with mild to moderate hepatic impairment.
Danish: Justering af REZOLSTA-dosis er ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: How to take REZOLSTA
Danish: Sådan skal du tage REZOLSTA
English: These results were confirmed in the analyses of data at 96 weeks of treatment in the ARTEMIS trial.
Danish: Disse resultater blev bekræftet af analysedata efter 96 ugers behandling i ARTEMISstudiet og blev opretholdt i op til 192 ugers behandling i ARTEMIS-studiet.
English: In clinical trials with darunavir/ritonavir and darunavir/cobicistat, rash was mostly mild to moderate, often occurring within the first four weeks of treatment and resolving with continued dosing (see section 4.4).
Danish: I kliniske studier med darunavir/ritonavir og darunavir/cobicistat var udslættet for det meste let til moderat og debuterede ofte i løbet af de første fire behandlingsuger, hvorefter det fortog sig under den fortsatte behandling (se pkt.
English: Concomitant use of salmeterol and REZOLSTA is not recommended.
Danish: Samtidig brug af salmeterol og REZOLSTA frarådes.
English: Do not take REZOLSTA - if you are allergic to darunavir, cobicistat or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke REZOLSTA - hvis du er allergisk over for darunavir, cobicistat eller et af de øvrige indholdsstoffer i
English: Refer to the Summary of Product Characteristics for PREZISTA for further information.
Danish: Se produktresuméet for PREZISTA for yderligere oplysninger.
English: Concentrations of these medicinal products may be increased when co-administered with REZOLSTA resulting in the potential for increased adverse events usually associated with these medicinal products.
Danish: Koncentrationen af disse lægemidler øges muligvis ved co-administration med REZOLSTA og kan således muligvis resultere i en øget forekomst af de bivirkninger, som normalt er forbundet med disse lægemidler.
English: - Atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (to lower cholesterol levels).
Danish: - atorvastatin, fluvastatin, pitavastatin, pravastatin, rosuvastatin (til nedsættelse af kolesterol i blodet).
English: The table below shows the efficacy data of the 48 week analyses from the GS-US-216-130 trial:
Danish: Tabellen nedenfor viser effektdata fra 48 ugers-analysen fra GS-US-216-130-studiet:
English: - The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone and magnesium stearate.
Danish: - Øvrige indholdsstoffer: hypromellose, silicificeret mikrokrystallinsk cellulose, kolloid silica, crospovidon og magnesiumstearat.
English: C-darunavir with ritonavir dose, approximately 79.5% and 13.9% of the administered dose of
Danish: C-darunavir med ritonavir i en dosis på 400/100 mg kunne ca. 79,5 % og 13,9 % af det administrerede
English: Refer to the Summary of Product Characteristics of other antiretroviral medicinal products for dosing information.
Danish: Se produktresuméerne for andre antiretrovirale lægemidler for yderligere oplysninger om dosering.
English: (CYP3A induction) REZOLSTA is expected to increase bosentan plasma concentrations.
Danish: (CYP3A-induktion) REZOLSTA forventes at øge plasmakoncentrationen af bosentan.
English: These patients received darunavir 800 mg once daily in combination with cobicistat 150 mg once daily with an investigator selected optimised background regimen (OBR) consisting of 2 active NRTIs.
Danish: Disse patienter fik darunavir 800 mg en gang dagligt i kombination med cobicistat 150 mg en gang dagligt sammen med et optimeret baggrundsregime (OBR) valgt af investigator bestående af 2 aktive NRTI'er.
English: Co-administration of REZOLSTA and other medicinal products that inhibit CYP3A may decrease the clearance of darunavir and cobicistat and may result in increased plasma concentrations of darunavir and cobicistat (e.g. azole antifungals such as clotrimazole).
Danish: Co-administration af REZOLSTA og andre lægemidler, der hæmmer CYP3A, kan nedsætte clearance af darunavir og cobicistat og medføre øgede plasmakoncentrationer af darunavir og cobicistat (f.eks. antimykotiske azoler som clotrimazol).
English: No adjustment of methadone dosage is expected when initiating co-administration with REZOLSTA.
Danish: Justering af methadondosis forventes ikke at være nødvendig, når behandling med REZOLSTA påbegyndes.
English: In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used.
Danish: Hos alle andre ART-erfarne patienter eller i tilfælde, hvor der ikke foreligger hiv-1genotypebestemmelse, er REZOLSTA ikke egnet.
English: In HIV infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Danish: Hos hiv-inficerede patienter med svær immuninsufficiens på tidspunktet for påbegyndelse af antiretroviral kombinationsbehandling (CART) kan der opstå en inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske patogener, som kan forårsage alvorlige kliniske tilstande eller forværring af symptomer.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Danish: Nogle patienter, der tager flere forskellige lægemidler mod hiv, kan udvikle en knoglesygdom, hvor knoglevævet dør på grund af manglende blodforsyning til knoglen (osteonekrose).
English: A trial of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Danish: Et farmakokinetisk studie af cobicistat blev udført hos ikke-hiv 1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
English: As REZOLSTA contains darunavir and cobicistat, interactions that have been identified with darunavir (in combination with cobicistat or with low dose ritonavir) or with cobicistat determine the interactions that may occur with REZOLSTA.
Danish: Da REZOLSTA indeholder darunavir og cobicistat, kan interaktioner, som er identificeret med darunavir (i kombination med cobicistat eller med lavdosis ritonavir) eller med cobicistat, muligvis forekommer med REZOLSTA.
English: Tell your doctor if you take: - Bosentan (to treat heart disease) - Dexamethasone (injectable) (corticosteroid) - Efavirenz, etravirine, nevirapine (to treat HIV infection) - Rifapentine, rifabutin (to treat bacterial infections).
Danish: Du skal fortælle det til din læge, hvis du tager: - Bosentan (til behandling af hjertesygdomme) - Dexamethason (til injektion) (kortikosteroid) - Efavirenz, etravirin, nevirapin (til behandling af hiv-infektion) - Rifapentin, rifabutin (til behandling af bakterieinfektioner)
English: No special precautions or dose adjustments are required in patients with renal impairment.
Danish: Der gælder ingen særlige forholdsregler eller dosisjusteringer hos patienter med nedsat nyrefunktion.
English: Therefore, therapy with REZOLSTA should not be initiated during pregnancy, and women who become pregnant during therapy with REZOLSTA should be switched to an alternative regimen (see sections 4.4 and 4.6).
Danish: Behandling med REZOLSTA bør derfor ikke påbegyndes under graviditet, og kvinder, som bliver gravide under behandling med REZOLSTA, bør skiftes til et alternativt regime (se pkt.
English: Tell your doctor if you take: - Amlodipine, carvedilol, diltiazem, disopyramide, felodipine, flecainide, lidocaine, metoprolol, mexiletine, nicardipine, nifedipine, propafenone, timolol, verapamil (for heart disease) as the therapeutic effect or side effects of these medicines may be increased.
Danish: Du skal fortælle det til din læge, hvis du tager: - amlodipin, carvedilol, diltiazem, disopyramid, felodipin, flecainid, lidocain, metoprolol, mexiletin, nicardipin, nifedipin, propafenon, timolol, verapamil (til hjertesygdomme), da virkningen eller bivirkningerne af disse lægemidler kan blive forstærket.
English: ODIN is a Phase III, randomised, open-label trial comparing darunavir/ritonavir 800/100 mg once daily versus darunavir/ritonavir 600/100 mg twice daily in ART-experienced HIV-1 infected patients with screening genotype resistance testing showing no darunavir RAMs (i.e. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V) and a screening HIV-1 RNA > 1,000 copies/mL.
Danish: ODIN er et randomiseret, åbent fase III-studie, der sammenligner darunavir/ritonavir 800/100 mg en gang dagligt med darunavir/ritonavir 600/100 mg to gange dagligt hos ART-erfarne hiv-1-inficerede patienter, hvor screening for genotype-resistens ikke har vist darunavir-RAM (dvs. V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V, L89V), og screening for hiv-1 RNA viste > 1.000 kopier/ml.
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Danish: Disse reaktioner kan omfatte, men er ikke begrænset til, alvorligt udslæt eller udslæt ledsaget af feber, almen utilpashed, træthed, muskel- eller ledsmerter, blæredannelse, mundsår, konjunktivitis, hepatitis og/eller eosinofili.
English: Alternative corticosteroids which are less dependent on CYP3A metabolism e.g. beclomethasone for intranasal or inhalational use should be considered, particularly for long term use.
Danish: Kortikosteroider, som er mindre afhængige af CYP3Ametabolisering, f.eks. nasal eller inhaleret beclomethason, bør overvejes, navnlig ved langvarig brug.
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, kidney or lung].
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) samt påvirkning af lever, nyrer eller lunger].
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Danish: Kortikosteroider, der primært metaboliseres via CYP3A (bl.a. betamethason, budesonid, fluticason, mometason, prednison og triamcinolon).
English: The effect of cobicistat on serum creatinine was investigated in a Phase I trial in subjects with normal renal function (eGFR ≥ 80 mL/min, n = 12) and mild to moderate renal impairment (eGFR:50-79 mL/min, n = 18).
Danish: Cobicistats virkning på serumkreatinin blev undersøgt i et fase I-studie med patienter med normal nyrefunktion (eGFR ≥ 80 ml/min, n=12) og let til moderat nedsat nyrefunktion (eGFR 50-79 ml/min, n=18).
English: * These adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Danish: * Disse bivirkninger er ikke blevet rapporteret i kliniske studier med darunavir/cobicistat, men er blevet observeret ved behandling med darunavir/ritonavir og kan også forventes med darunavir/cobicistat.
English: In a multiple dose trial with darunavir/ritonavir (600/100 mg) twice daily, it was demonstrated that the total plasma concentrations of darunavir in subjects with mild (Child-Pugh Class A, n = 8) and moderate (Child-Pugh Class B, n = 8) hepatic impairment were comparable with those in healthy subjects.
Danish: I et flerdosisstudie med darunavir/ritonavir (600/100 mg) to gange dagligt blev det vist, at de totale plasmakoncentrationer af darunavir hos forsøgspersoner med let (Child-Pugh klasse A, n=8) og moderat (Child-Pugh klasse B, n=8) nedsat leverfunktion var sammenlignelige med dem, der sås hos raske forsøgspersoner.
English: ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
Danish: ANTIMYKOTIKA Clotrimazol Fluconazol Itraconazol Isavuconazol Posaconazol
English: REZOLSTA contains the active substances darunavir and cobicistat.
Danish: REZOLSTA indeholder de aktive stoffer darunavir og cobicistat.