FrancophonIA/ELRC3.0 huggingface dataset:
English: Atazanavir and cobicistat are metabolised by the hepatic system.
Danish: Atazanavir og cobicistat metaboliseres via leveren.
English: Skin and subcutaneous tissue disorders common rash uncommon pruritus, erythema multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia rare
Danish: Hud og subkutane væv almindelig udslæt ikke almindelig pruritus, erythema multiformea,b, toksiske huderuptionera,b, lægemiddelfremkaldt udslæt med eosinofili og systemiske symptomer (DRESS-syndrom)a,b, angiødema, urticaria, alopeci sjælden
English: The co-administration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Danish: Samtidig administration af EVOTAZ og stavudin forventes ikke at påvirke stavudin-eksponeringen signifikant.
English: Cardiac disorders uncommon torsades de pointesa rare
Danish: Hjerte ikke almindelig torsades de pointesa sjælden
English: Nervous system disorders common headache, dizziness, somnolence, dysgeusia uncommon peripheral neuropathy, syncope, amnesia
Danish: Nervesystemet almindelig hovedpine, svimmelhed, døsighed, dysgeusi ikke almindelig perifer neuropati, synkope, amnesi
English: Co-administration of EVOTAZ with these medicinal products is expected to substantially increase their concentrations and may result in PDE5-associated adverse reactions such as hypotension, visual changes and priapism (see section 4.5).
Danish: Samtidig administration af EVOTAZ og disse lægemidler forventes at øge deres koncentrationer væsentligt og kan resultere i PDE5-relaterede bivirkninger såsom hypotension, synsforstyrrelser og priapisme (se pkt.
English: The active substances are atazanavir and cobicistat.
Danish: Aktive stoffer: atazanavir og cobicistat.
English: Immune system disorders uncommon hypersensitivity
Danish: Immunsystemet ikke almindelig overfølsomhed
English: Clinical monitoring is recommended when co-administered with EVOTAZ and a dose reduction of the beta-blocker may be necessary.
Danish: Klinisk monitorering anbefales ved samtidig administration af EVOTAZ, og dosisreducering af betablokkeren kan være nødvendig.
English: In particular, atazanavir boosted with cobicistat is more sensitive for CYP3A induction (see section 4.3 and the interaction table).
Danish: Især atazanavir boostet med cobicistat er mere følsom over for CYP3A-induktion (se pkt.
English: Clinical monitoring may be needed upon co-administration with EVOTAZ.
Danish: Klinisk monitorering kan være nødvendig ved samtidig administration med EVOTAZ.
English: What you need to know before you take EVOTAZ
Danish: Det skal du vide, før du begynder at tage EVOTAZ
English: The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group and -8.0 ± 16.8 ml/min in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Danish: Middelændringen (± SD) i estimeret glomerulær filtrationsrate (eGFR) efter Cockcroft-Gault-metoden efter 144 ugers behandling var15,1 ± 16,5 ml/min i cobicistat-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen og -8,0 ± 16,8 ml/min i ritonavir-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen.
English: EVOTAZ must not be co-administered with colchicine to patients with renal or hepatic impairment.
Danish: EVOTAZ må ikke administreres sammen med colchicin til patienter med nedsat nyre- eller leverfunktion.
English: Contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations (see section 4.3)
Danish: Kontraindiceret på grund af den potentielle forøgelse i risiko for ALAT-stigninger grundet en signifikant stigning i plasmakoncentrationerne af glecaprevir og pibrentasvir (se pkt.
English: The resistance profile of EVOTAZ is driven by atazanavir.
Danish: Resistensprofilen for EVOTAZ tilskrives atazanavir.
English: Atazanavir plasma concentrations may decrease as a consequence of a reduction in cobicistat plasma concentrations, which may result in loss of therapeutic effect and development of resistance.
Danish: Plasmakoncentrationerne for atazanavir kan nedsættes som følge af en reduktion af cobicistats plasmakoncentrationer, hvilket kan betyde tab af terapeutisk effekt og udvikling af resistens.
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Danish: Dyrestudier er utilstrækkelige med hensyn til reproduktionstoksicitet (se pkt.
English: Clinical monitoring of therapeutic effect and adverse events is recommended when these medicinal products are co-administered with EVOTAZ.
Danish: Klinisk monitorering af den terapeutiske effekt og bivirkninger anbefales, hvis disse lægemidler administreres samtidig med EVOTAZ.
English: Exposure to diltiazem and a metabolite, desacetyl-diltiazem, is increased when diltiazem is co-administered with atazanavir, a component of EVOTAZ.
Danish: Eksponering for diltiazem og dets metabolit, desacetyl-diltiazem, øges ved samtidig administration af atazanavir, et af indholdsstofferne i EVOTAZ.
English: For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to severe, life-threatening or fatal events (see sections 4.3 and 4.5).
Danish: For lægemidler, der metaboliseres af CYP3A kan disse øgede plasmakoncentrationer potentielt medføre alvorlige, livstruende eller dødelige bivirkninger (se pkt.
English: Effect of cobicistat on atazanavir pharmacokinetics
Danish: Cobicistats effekt på atazanavirs farmakokinetik
English: In 2 controlled clinical studies for combination therapy with other antiretroviral medicinal products 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg boosted with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration), the most frequently reported adverse reactions were nausea, diarrhoea and jaundice.
Danish: kombinationsterapi med andre antiretrovirale lægemidler, hvor 1.806 voksne patienter fik atazanavir 400 mg 1 gang dagligt (1.151 patienter, 52 ugers median varighed og 152 ugers maksimal varighed) eller atazanavir 300 mg boostet med ritonavir 100 mg 1 gang dagligt (655 patienter, 96 ugers median varighed og 108 ugers maksimal varighed), var de hyppigst rapporterede bivirkninger kvalme, diarre og gulsot.
English: Plasma concentrations of these medicinal products may be increased when co-administered with EVOTAZ, resulting in reduced serum cortisol concentrations.
Danish: Plasmakoncentrationerne af disse lægemidler kan øges ved samtidig administration af EVOTAZ, hvilket medfører nedsat serumkortisolkoncentrationer.
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Danish: Itraconazol er i lighed med ketoconazol en potent CYP3A4-hæmmer og et CYP3A4-substrat.
English: However, atazanavir must not be used in patients with moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
Danish: Atazanavir må dog ikke anvendes hos patienter med moderat (Child-Pugh klasse B) til svært (Child-Pugh klasse C) nedsat leverfunktion.
English: Co-administration of EVOTAZ with warfarin has the potential to produce serious and/or life-threatening bleeding due to increased warfarin plasma concentrations, and it is recommended that the INR (International Normalized Ratio) be monitored (see section 4.5).
Danish: Samtidig administration af EVOTAZ og warfarin kan potentielt medføre alvorlig og/eller livstruende blødning på grund af øgede plasmakoncentrationer af warfarin, og monitorering af INR (International Normalized Ratio) tilrådes (se pkt.
English: The mechanism of interaction is CYP3A induction by the antiepileptic.
Danish: Interaktionsmekanismen er CYP3A-induktion af antiepileptika.
English: There are no pharmacokinetic data regarding the use of EVOTAZ in patients with hepatic impairment.
Danish: Der foreligger ingen farmakokinetiske data vedrørende anvendelse af EVOTAZ til patienter med nedsat leverfunktion.
English: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: Not determined
Danish: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: Ikke bestemt
English: Maraviroc is not expected to have an impact on concentrations of atazanavir and cobicistat.
Danish: Maraviroc forventes ikke at påvirke atazanavir- og cobicistat-koncentrationer.
English: Simeprevir may increase atazanavir and/or cobicistat plasma concentrations.
Danish: Simeprevir kan øge atazanavir og/eller cobicistat plasmakoncentrationerne.
English: These antiepileptics are expected to decrease atazanavir and/or cobicistat plasma concentrations.
Danish: Disse antiepileptika forventes at nedsætte atazanavirs og/eller cobicistats plasmakoncentrationer.
English: Atazanavir inhibits UGT and may interfere with the metabolism of irinotecan, resulting in increased irinotecan toxicities.
Danish: Atazanavir hæmmer UGT og kan interferere med irinotecanmetabolismen og medføre øget irinotecantoksicitet.
English: Vascular disorders uncommon hypertension
Danish: Vaskulære sygdomme ikke almindelig hypertension
English: Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions (see section 4.8).
Danish: Patienter med kronisk hepatitis B eller C, som er behandlet med antiretroviral kombinationsbehandling, har øget risiko for svære og potentielt dødelige leverbivirkninger (se pkt.
English: Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ.
Danish: Eksponering af clarithromycin forventes at stige ved samtidig administration af EVOTAZ.
English: Cobicistat Cobicistat has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).
Danish: Cobicistat Cobicistat er ikke undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C).
English: Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Danish: Atazanavir bør anvendes med forsigtighed hos patienter med let (Child-Pugh klasse A) nedsat leverfunktion.
English: Cobicistat is a selective, mechanism-based inhibitor of cytochromes P450 of the CYP3A subfamily.
Danish: Cobicistat er en selektiv, mekanisme-baseret hæmmer af cytokrom P450 fra CYP3A-undergruppen.
English: Cmax: ↑41% Cmin: not determined
Danish: AUC: ↔ Cmax: ↑41% Cmin: ikke bestemt
English: As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
Danish: Da EVOTAZ indeholder atazanavir og cobicistat, kan der forventes bivirkninger, som er associeret med hver enkelt af de to indholdsstoffer.
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
Danish: Udslæt er ofte lette til moderate makulopapuløse huderuptioner, der optræder inden for de første 3 uger efter påbegyndelse af behandling med atazanavir.
English: No dose adjustment of cobicistat is required in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering af cobicistat er ikke nødvendig hos patienter med let eller moderat nedsat leverfunktion.
English: Respiratory, thoracic and mediastinal disorders uncommon dyspnoea
Danish: Luftveje, thorax og mediastinum ikke almindelig dyspnø
English: No meaningful differences in cobicistat pharmacokinetics were observed between subjects with severe renal impairment and healthy subjects, consistent with low renal clearance of cobicistat.
Danish: Der blev ikke observeret nogen betydningsfulde forskelle i farmakokinetikken for cobicistat hos personer med svært nedsat nyrefunktion og hos raske personer, hvilket er i overensstemmelse med cobicistats lave nyreclearance.
English: Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Danish: Samtidig brug af EVOTAZ og fluticason, eller andre glukokortikoider, som metaboliseres af CYP3A4, frarådes, medmindre de potentielle fordele ved behandlingen opvejer risikoen for systemiske bivirkninger forårsaget af kortikosteroider, herunder Cushings syndrom og binyrebarksuppression (se pkt.
English: Co-administration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Danish: Samtidig administration af EVOTAZ kan medføre højere koncentration af salmeterol og øget risiko for salmeterol-relaterede bivirkninger.
English: Cobicistat has been shown to decrease estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function.
Danish: Cobicistat har vist sig at nedsætte estimeret kreatininclearance på grund af hæmningen af tubulær kreatininudskillelse uden påvirkning af den egentlige renale glomerulære funktion.
English: Clinical monitoring is recommended when dabigatran is co-administered with P-gp inhibitors.
Danish: Klinisk monitorering anbefales, når dabigatran administreres med P-gp-hæmmere.
English: A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Danish: Et farmakokinetikstudie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med moderat nedsat leverfunktion (Child-Pugh klasse B).
English: Didanosine (with food) Didanosine AUC ↓34% (↓40%
Danish: Didanosin (med mad) Didanosin AUC ↓34% (↓40%
English: Buprenorphine AUC: ↑35% Buprenorphine Cmax: ↑66% Buprenorphine Cmin: ↑12%
Danish: Buprenorphin AUC: ↑35% Buprenorphin Cmax: ↑66% Buprenorphin Cmin: ↑12%
English: In study GS-US-216-0114, the mean increase from baseline in CD4+ cell count at weeks 48 and 144 were 213 and 310 cells/mm3 in patients receiving atazanavir boosted with cobicistat and 219 and 332 cells/mm3 in patients receiving atazanavir boosted with ritonavir, respectively.
Danish: Ved uge 48 og 144 i studie GS-US-216-0114 var gennemsnitlig stigning fra baseline i CD4+ celletal henholdsvis 213 og 310 celler/mm3 hos patienter, der fik atazanavir boostet med cobicistat og henholdsvis 219 og 332 celler/mm3 hos patienter, der fik atazanavir boostet med ritonavir.
English: Didanosine Cmax ↓36% (↓45%
Danish: Didanosin Cmax ↓36% (↓45%
English: One EVOTAZ tablet is bioequivalent to one atazanavir capsule (300 mg) plus one cobicistat tablet (150 mg) following single oral dose administration with a light meal in healthy subjects (n=62).
Danish: Hos raske forsøgspersoner er en EVOTAZ tablet bioækvivalent med 1 atazanavir kapsel (300 mg) plus 1 cobicistat tablet (150 mg) efter en enkelt oral dosis sammen med et let måltid (n=62).
English: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Not calculated
Danish: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Ikke beregnet
English: Co-administration of nevirapine and EVOTAZ is expected to increase nevirapine plasma concentrations which may increase the risk of nevirapine-associated toxicity (see section 4.4).
Danish: Samtidig administration af nevirapin og EVOTAZ forventes at øge nevirapin plasmakoncentrationerne, som kan øge risikoen for nevirapin-associeret toksicitet (se pkt.
English: Co-administration of EVOTAZ and rifabutin is not recommended.
Danish: Samtidig administration af EVOTAZ og rifabutin frarådes.
English: Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Danish: Blandt behandlingserfarne patienter som fik atazanavir 300 mg én gang dagligt med 100 mg ritonavir én gang dagligt i gennemsnitligt 95 uger, havde 53% grad 3-4 forhøjelse af total-bilirubin.
English: Co-administration of boceprevir and EVOTAZ is not recommended.
Danish: Samtidig administration af boceprevir og EVOTAZ frarådes.
English: Digoxin (0.5 mg single dose)/cobicistat (150 mg multiple doses)
Danish: Digoxin (0,5 mg som enkeltdosis)/cobicistat (150 mg gentagne doser)
English: PDE5 Inhibitors
Danish: PDE5-hæmmere
English: Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg with cobicistat 150 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir DF 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Danish: Patienterne blev randomiseret i forholdet 1:1 til at modtage enten atazanavir 300 mg + cobicistat 150 mg én gang dagligt eller atazanavir 300 mg + ritonavir 100 mg én gang dagligt, begge administreret med en fastdosisbehandlingsplan, der indeholdt tenofovir DF 300 mg og emtricitabin 200 mg administreret som en fastdosiskombinationstablet.
English: Hepatic transaminase elevations that occur with elevated bilirubin in patients receiving EVOTAZ should be evaluated for alternative etiologies.
Danish: Patienter i behandling med EVOTAZ, som har forhøjede levertransaminaser og forhøjet bilirubin samtidig, bør evalueres for alternative ætiologier.
English: For further details, consult the Summary of Product Characteristics for maraviroc.
Danish: Se produktresuméet for maraviroc for yderligere oplysninger.
English: ANTINEOPLASTICS AND IMMUNOSUPRESSANTS
Danish: ANTINEOPLASTISKE OG IMMUNSUPRIMERENDE MIDLER
English: CORTICOSTEROIDS
Danish: KORTIKOSTEROIDER
English: Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Danish: Glecaprevir AUC: ↑553% (↑424% Glecaprevir Cmax: ↑306% (↑215% Glecaprevir Cmin: ↑1330% (↑885% Pibrentasvir AUC: ↑64% (↑48% Pibrentasvir Cmax: ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC: ↑11% (↑3% Atazanavir Cmax: ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Der er rapporteret effekt af atazanavir og ritonavir på den første dosis af glecaprevir og pibrentasvir.
English: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Danish: Drospirenon AUC: ↑ 130% Drospirenon Cmax: ↔ Drospirenon Cmin: Ikke beregnet
English: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Danish: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Ikke beregnet
English: Co-administration of nevirapine and cobicistat is expected to decrease cobicistat plasma concentrations while nevirapine plasma concentrations may be increased.
Danish: Samtidig administration af nevirapin og cobicistat forventes at nedsætte cobicistat plasmakoncentrationerne, mens nevirapin plasmakoncentrationerne kan øges.
English: If you miss a dose and it is more than 12 hours from the time you should have taken EVOTAZ, do not take the missed dose.
Danish: Hvis du har glemt at tage en dosis i 12 timer eller længere efter det tidspunkt, du normalt tager EVOTAZ, skal du ikke tage den glemte dosis.
English: As atazanavir 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: Eftersom atazanavir og cobicistat i udstrakt grad bindes til plasmaproteiner, er det ikke sandsynligt, at de vil fjernes i signifikant grad ved hæmodialyse eller peritonealdialyse (se pkt.
English: Clinical monitoring is recommended upon co-administration with EVOTAZ.
Danish: Klinisk monitorering anbefales ved samtidig administration med EVOTAZ.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Danish: Anvendelse af andre antitrombotiske midler, som ikke påvirkes af CYP-hæmning ellerinduktion (f.eks. prasugrel) anbefales (se pkt.
English: Telaprevir 750 mg three times daily (cobicistat 150 mg once daily in combination with elvitegravir)
Danish: Telaprevir 750 mg tre gange dagligt (cobicistat 150 mg én gang dagligt i kombination med elvitegravir)
English: The activity of cobicistat as a pharmacokinetic enhancer to atazanavir has been demonstrated in pharmacokinetic trials.
Danish: Cobicistats aktivitet som farmakokinetisk forstærker er påvist i farmakokinetiske forsøg.
English: Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Danish: Indinavir er associeret med indirekte ukonjugeret hyperbilirubinæmi pga. UGT-hæmning.
English: Nevirapine AUC ↑25% (↑17%
Danish: Nevirapin AUC ↑25% (↑17%
English: Medicinal products that affect atazanavir/cobicistat exposure Atazanavir is metabolised in the liver through CYP3A4.
Danish: Lægemidler, der påvirker atazanavir/cobicistat-eksponering Atazanavir metaboliseres i leveren via CYP3A4.
English: Tenofovir alafenamide AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
Danish: Tenofoviralafenamid AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
English: In female mice, atazanavir exposure at a dose that produced single-cell necrosis was 12 times the exposure in humans given 400 mg once daily.
Danish: I hunmus var atazanavir-eksponering ved en dosis, der frembragte enkeltcellenekrose, 12 gange optagelsen hos mennesker, der havde fået 400 mg én gang dagligt.
English: In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Danish: I løbet af de 144 ugers behandling i studie GS-US-216-0114 var hyperbilirubinæmi (> 1 x ULN) almindelig: 7% i cobicistat-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen og 97,4% i ritonavir-boostet atazanavir plus emtricitabin og tenofovir DF i fastdosiskombination-gruppen.
English: Atazanavir with cobicistat
Danish: Atazanavir med cobicistat
English: In these pharmacokinetic trials, the exposure of atazanavir 300 mg with cobicistat 150 mg was consistent with that observed when boosted with ritonavir 100 mg. EVOTAZ is bioequivalent to atazanavir 300 mg once daily in combination with cobicistat 150 mg once daily coadministered as single agents (see section 5.2).
Danish: I disse farmakokinetiske forsøg var eksponering for atazanavir 300 mg med cobicistat 150 mg den samme som eksponeringen, når det blev boostet med ritonavir 100 mg. EVOTAZ er bioækvivalent med atazanavir 300 mg 1 gang dagligt i kombination med cobicistat 150 mg 1 gang dagligt administreret som enkeltdosis (se pkt.
English: Rifampicin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir.
Danish: Rifampicin nedsætter i væsentlig grad plasmakoncentrationerne af atazanavir, hvilket kan medføre tab af EVOTAZ's terapeutiske effekt og udvikling af resistens over for atazanavir.
English: This leaflet was last revised in.
Danish: Denne indlægsseddel blev senest ændret <{MM/ÅÅÅÅ}> <{måned ÅÅÅÅ}.>
English: This effect may be due to an induction of CYP3A4.
Danish: Denne effekt kan skyldes CYP3A4induktion.
English: Increase monitoring for adverse reactions.
Danish: Øget monitorering for bivirkninger anbefales.