FrancophonIA/ELRC3.0 huggingface dataset:
English: Higher concentrations could potentiate tenofovir-associated adverse reactions, including renal disorders.
Danish: Forhøjede koncentrationer kan forstærke tenofovir-associerede bivirkninger, herunder nyresygdomme.
English: Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced exposures to atazanavir and ritonavir.
Danish: Samtidig administration af boceprevir og atazanavir/ritonavir medførte lavere atazanavir og ritonavir-eksponering.
English: Table 2: Tabulated summary of adverse reactions
Danish: Tabel 2: Tabel over bivirkninger
English: PDE5 inhibitors used for the treatment of erectile dysfunction
Danish: PDE5-hæmmere til behandling af erektil dysfunktion
English: Atazanavir is a weak to moderate inhibitor of CYP2C8.
Danish: Atazanavir er en svag til moderat CYP2C8-hæmmer.
English: 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: Caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Danish: Der bør ligeledes udvises forsigtighed, hvis der under den første behandling skiftes farmakoforstærker fra ritonavir til cobicistat (se pkt.
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A, CYP2C8, CYP2D6 and/or UGT1A1 are expected when co-administered with EVOTAZ.
Danish: Forhøjede plasmakoncentrationer af lægemidler, der metaboliseres af CYP3A, CYP2C8, CYP2D6 og/eller UGT1A1 forventes ved samtidig administration med EVOTAZ.
English: Atazanavir with ritonavirf (n = 348)
Danish: Atazanavir med ritonavirf (n = 348)
English: When co-administering with EVOTAZ, titrate the digoxin dose and monitor digoxin concentrations.
Danish: Ved samtidig administration med EVOTAZ bør digoxin-dosis titreres og digoxin-koncentrationen bør monitoreres.
English: The median baseline CD4+ cell count was 352 cells/mm3 (range: 1-1455) and 16.9% had CD4+ cell counts ≤200 cells/mm3.
Danish: Median CD4+ celletal ved baseline var 352 celler/mm3 (1-1.455) og 16,9% havde CD4+
English: The safety and efficacy of atazanavir with cobicistat in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Danish: Sikkerheden og virkningen af atazanavir med cobicistat hos hiv-1 inficerede patienter blev evalueret i et randomiseret, dobbeltblindet, aktivt-kontrolleret fase 3 studie GS-US-216-0114 hos hiv-1-inficerede patienter med estimeret kreatininclearance ved baseline over 70 ml/min, som var behandlingsnaive (n = 692).
English: Patients should be warned about these possible side effects when using PDE5 inhibitors for erectile dysfunction with EVOTAZ (see section 4.4).
Danish: Patienterne bør advares om risikoen for disse bivirkninger ved brug af PDE5-hæmmere mod erektil dysfunktion samtidig med EVOTAZ (se pkt.
English: EVOTAZ 300 mg/150 mg film-coated tablets atazanavir/cobicistat
Danish: EVOTAZ 300 mg/150 mg filmovertrukne tabletter atazanavir/cobicistat
English: Amiodarone, dronedarone, quinidine and systemic lidocaine have a narrow therapeutic window and are contraindicated due to potential inhibition of CYP3A by EVOTAZ (see section 4.3).
Danish: Amiodaron, dronedaron, quinidin og systemisk lidocain har et snævert terapeutisk indeks og er kontraindiceret pga. EVOTAZ's potentielle CYP3A-hæmning (se pkt.
English: In an ex vivo rabbit pharmacology study, isolated hearts were exposed to atazanavir, cobicistat, or atazanavir and cobicistat in combination.
Danish: I et ex vivo farmakologistudie i kaniner blev isolerede hjerter eksponeret for atazanavir, cobicistat eller en kombination af disse to.
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Danish: Maraviroc er et CYP3A-substrat og dets plasmakoncentration øges ved samtidig administration med potente CYP3A-hæmmere.
English: Human experience of acute overdose with EVOTAZ is limited.
Danish: Der er begrænset erfaring med akut human overdosering med EVOTAZ.
English: Metabolism and nutrition disorders common increased appetite uncommon weight decreased, weight gain, anorexia
Danish: Metabolisme og ernæring almindelig øget appetit ikke almindelig vægttab, vægtstigning, anoreksi
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4)
Danish: Regelmæssig overvågning af patienternes nyrefunktion bør opretholdes igennem hele behandlingsforløbet (se pkt.
English: Ethinyloestradiol AUC: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Not calculated
Danish: Ethinylestradiol AUC: ↔ Ethinylestradiol Cmax: ↔ Ethinylestradiol Cmin: Ikke beregnet
English: Limited data are available on the development of resistance to atazanavir boosted with cobicistat.
Danish: Der foreligger kun begrænsede data om udvikling af resistens over for atazanavir boostet med cobicistat.
English: EVOTAZ is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir (see sections 4.4 and 5.1).
Danish: EVOTAZ er indiceret i kombination med andre antiretrovirale lægemidler til behandling af hiv-1inficerede voksne uden kendte mutationer associeret med resistens over for atazanavir (se pkt.
English: Other marked clinical laboratory abnormalities (Grade 3 or 4) reported in ≥ 2% of patients receiving regimens containing atazanavir and one or more NRTIs included: elevated creatine kinase (7%), elevated alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT) (5%), low neutrophils (5%), elevated aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT) (3%), and elevated lipase (3%).
Danish: Andre markante, kliniske laboratoriemæssige anormaliteter (grad 3 eller 4) rapporteret hos ≥2% af patienterne, der fik regimer indeholdende atazanavir og én eller flere NRTIer omfattede: forhøjet kreatinkinase (7%), forhøjet alaninaminotransferase/serum-glutamin-pyrudrue transaminase (ALAT/SGPT) (5%), lav neutrofiltælling (5%), forhøjet aspartataminotransferase/serumglutamin-oxalsyretransaminase (ASAT/SGOT) (3%) og forhøjet lipase (3%).
English: Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Danish: Samtidig administration af EVOTAZ hos patienter, der får lægemidler som er substrater af transportproteinerne P-gp, BCRP, MATE1, OATP1B1 og OATP1B3 kan resultere i forhøjede plasmakoncentrationer af de samtidigt administrerede lægemidler (se pkt.
English: A study 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 farmakokinetikstudie af cobicistat blev udført hos ikke-hiv-1-inficerede personer med svært nedsat nyrefunktion (estimeret kreatininclearance under 30 ml/min).
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: Hos hiv-inficerede patienter med svær immuninsufficiens kan der ved påbegyndelse af antiretroviral kombinationsbehandling (CART) opstå inflammatorisk reaktion på asymptomatiske eller residuale opportunistiske infektioner.
English: f Plus background regimen of emtricitabine 200 mg and tenofovir DF 300 mg fixed-dose combination.
Danish: f. Plus baggrundsbehandlingsplan med emtricitabin 200 mg og tenofovir DF 300 mg i fastdosiskombination.
English: Co-administration of EVOTAZ and tenofovir alafenamide 25 mg for treatment of HBV infection is not recommended
Danish: Samtidig administration af EVOTAZ og tenofoviralafenamid 25 mg til behandling af HBVinfektion frarådes
English: The antiretroviral effect of EVOTAZ is due to the atazanavir component.
Danish: EVOTAZ's antiretrovirale effekt skyldes indholdsstoffet atazanavir.
English: Pink, oval, biconvex, film-coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed with "3641" on one side and plain on the other side.
Danish: Pink, oval, bikonveks, filmovertrukket tablet med omtrentlig dimension på 19 mm x 10,4 mm og præget med ”3641” på den ene side og glat på den anden side.
English: PHARMACEUTICAL FORM AND CONTENTS 30 film-coated tablets.
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) 30 filmovertrukne tabletter.
English: Serious skin rash, including Stevens-Johnson syndrome, may develop in patients taking EVOTAZ.
Danish: Der er rapporteret alvorligt hududslæt, herunder Stevens-Johnsons syndrom, hos patienter, der tager EVOTAZ.
English: If you notice any of these symptoms please inform your doctor.
Danish: Hvis du bemærker et eller flere af disse symptomer, skal du fortælle det til lægen.
English: Concentrations of atazanavir were not significantly affected.
Danish: Atazanavir-koncentrationen påvirkes ikke signifikant.
English: Atazanavir with cobicistat and emtricitabine and tenofovir DF fixed-dose combination was non-inferior in achieving HIV-1 RNA <50 copies/ml when compared to atazanavir with ritonavir and emtricitabine and tenofovir DF fixed-dose combination.
Danish: Atazanavir + cobicistat + emtricitabin og tenofovir DF i fastdosiskombination var non-inferiøre med hensyn til at opnå hiv-1-RNA <50 kopier/ml, sammenlignet med atazanavir + ritonavir + emtricitabin og tenofovir DF i fastdosiskombination.
English: Immune reactivation syndrome and autoimmune disorders
Danish: Immunreaktiveringssyndrom og autoimmune lidelser
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Danish: Nukleosid/nukleotid reverse transkriptasehæmmere (NRTI'er)
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: En opdateret RMP skal fremsendes: på anmodning fra Det Europæiske Lægemiddelagentur når risikostyringssystemet ændres, særlig som følge af, at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i benefit/risk-forholdet, eller som følge af, at en vigtig milepæl (lægemiddelovervågning eller risikominimering) er nået.
English: Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening adverse reactions.
Danish: Samtidig administration af EVOTAZ kan potentielt medføre alvorlige og/eller livstruende bivirkninger.
English: Although not studied, there is a potential for an increase in pravastatin or fluvastatin exposure when co-administered with protease inhibitors.
Danish: Selvom det ikke er undersøgt, er der risiko for en øget pravastatineller fluvastatin-eksponering ved administration sammen med proteasehæmmere.
English: Co- administration of EVOTAZ and ticagrelor may increase concentrations of the anticoagulant.
Danish: Samtidig administration af EVOTAZ og ticagrelor kan øge koncentrationen af antikoagulanten.
English: Administration of a single dose of EVOTAZ with a high fat meal (1,038 kcal, 59 g fat, 37 g protein) resulted in a 14% reduction in atazanavir Cmax with no change in atazanavir AUC or cobicistat exposures (Cmax, AUC) relative to the fasting state.
Danish: Administration af en enkeltdosis EVOTAZ med et fedtrigt måltid (1.038 kcal, 59 g fedt, 37 g protein) medførte en 14% reduktion i atazanavir Cmax men ingen ændringer i atazanavir AUC eller cobicistat-eksponering (Cmax, AUC) i forhold til fastende tilstand.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as atazanavir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Danish: Cobicistats hæmning af CYP3A-medieret metabolisme øger den systemiske eksponering over for CYP3A-substrater, såsom atazanavir, som har begrænset biotilgængelighed og en kort halveringstid på grund af den CYP3A-afhængige metabolisme.
English: Caution is warranted.
Danish: Forsigtighed anbefales.
English: Clinical and laboratory monitoring for hyperbilirubinaemia is recommended.
Danish: Klinisk monitorering og laboratoriemonitorering for hyperbilirubinæmi anbefales.
English: Subjects with significant liver function test abnormalities generally had abnormal baseline transaminases (AST or ALT), underlying chronic or acute hepatitis B or C co-infection, concomitant hepatotoxic medications (e.g., isoniazid), or a medical history of alcoholism or alcohol abuse.
Danish: Forsøgspersoner, der udviste signifikante anormaliteter i leverfunktionstests, havde generelt abnorme baseline transaminase-værdier (ASAT eller ALAT), underliggende kronisk eller akut hepatitis B eller -C-infektion, fik samtidig hepatotoksiske lægemidler (f.eks. isoniazid) eller havde alkoholisme eller alkoholmisbrug i anamnesen.
English: EVOTAZ is a fixed-dose combination of the antiviral drug atazanavir boosted by the pharmacokinetic enhancer cobicistat.
Danish: EVOTAZ er en fastdosiskombination af det antivirale lægemiddel atazanavir boostet med den farmakokinetiske forstærker cobicistat.
English: Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics.
Danish: Samtidig administration af neuroleptika og EVOTAZ kan medføre øgede plasmakoncentrationer af neuroleptika.
English: Other medicines and EVOTAZ
Danish: Brug af anden medicin sammen med EVOTAZ
English: Concomitant administration of EVOTAZ with ticagrelor is contraindicated.
Danish: Samtidig administration af EVOTAZ og ticagrelor er kontraindiceret.
English: EVOTAZ is not recommended for co-administration with efavirenz.
Danish: EVOTAZ frarådes til samtidig administration med efavirenz.
English: The use of EVOTAZ is contraindicated in patients with moderate to severe hepatic impairment.
Danish: Anvendelse af EVOTAZ er kontraindiceret hos patienter med moderat til svært nedsat leverfunktion.
English: Moderate to severe hepatic impairment.
Danish: Moderat til svært nedsat leverfunktion.
English: Each single agent produced effects on left ventricular contractility and PR prolongation at concentrations at least 35-fold higher than the free atazanavir and cobicistat concentrations at the recommended human dose (RHD) Cmax.
Danish: Hvert enkelt lægemiddelstof påvirkede venstre ventrikulær kontraktilitet og PR-forlængelse ved koncentrationer mindst 35 gange højere end frie atazanavir- og cobicistat-koncentrationer ved den anbefalede humane dosis (RHD) Cmax.
English: Virologic success
Danish: Virologisk svigtc
English: Increased plasma concentrations of medicinal products that are metabolised by CYP3A (including atazanavir) are observed on co-administration with cobicistat.
Danish: Der er observeret øgede plasmakoncentrationer af lægemidler, som metaboliseres af CYP3A (herunder atazanavir) ved samtidig administration af cobicistat.
English: Simvastatin and lovastatin are highly dependent on CYP3A4 for their metabolism and co-administration with EVOTAZ may result in increased concentrations.
Danish: Simvastatin og lovastatin metaboliseres i høj grad via CYP3A4 og samtidig administration med EVOTAZ kan medføre øgede koncentrationer.
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 beclometason, bør overvejes, navnlig ved langvarig brug.
English: The combination of pimozide, quetiapine or lurasidone and EVOTAZ is contraindicated (see section 4.3).
Danish: Kombinationen af pimozid, quetiapin eller lurasidon og EVOTAZ er kontraindiceret (se pkt.
English: Naloxone AUC: ↓28% Naloxone Cmax: ↓28%
Danish: Naloxon AUC: ↓28% Naloxon Cmax: ↓28%
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36%
Danish: Atazanavir, doseret 1 time efter ddI+d4T (fastende) Atazanavir AUC ↔3% (↓36%
English: Caution is warranted and therapeutic concentration monitoring of these medicinal products is recommended if they are used concomitantly with EVOTAZ.
Danish: Der bør udvises forsigtighed, og monitorering af terapeutiske koncentrationer for disse lægemidler anbefales ved samtidig anvendelse med EVOTAZ.
English: Rifabutin AUC ↑48% (↑19% Rifabutin Cmax ↑149% (↑103% Rifabutin Cmin ↑40% (↑5% 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin Cmax 25-O-desacetyl-rifabutin Cmin *When compared to rifabutin 150 mg once daily alone.
Danish: Rifabutin AUC ↑48% (↑19% Rifabutin Cmax ↑149% (↑103% Rifabutin Cmin ↑40% (↑5% ↑87%)* 25-O-desacetyl-rifabutin AUC 25-O-desacetyl-rifabutin Cmax 25-O-desacetyl-rifabutin Cmin *Sammenlignet med rifabutin 150 mg 1 gang dagligt.
English: A decrease in the dose of neuroleptics metabolized by CYP3A or CYP2D6 may be required when co-administered with EVOTAZ.
Danish: Dosisnedsættelse af neuroleptika, som metaboliseres af CYP3A eller CYP2D6, kan være nødvendig ved samtidig administration med EVOTAZ.
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir or protease inhibitor associated resistance substitutions.
Danish: Blandt de 19 patienter udviklede 1 den emtricitabine-relaterede resistenssubstitution M184V uden nogen resistenssubstitioner associeret med tenofovir eller proteasehæmmere.
English: When compared to their single-agent profiles all findings could be attributed to either atazanavir or cobicistat.
Danish: Sammenlignet med profilen for det enkelte lægemiddelstof kunne alle fund tilskrives enten atazanavir eller cobicistat.
English: Co-administration with EVOTAZ can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Danish: Samtidig administration med EVOTAZ kan øge plasmakoncentrationerne af lægemidler, der metaboliseres af CYP2D6 (se pkt.
English: In a trial where HIV-infected subjects (n=22) were instructed to take atazanavir 300 mg with cobicistat 150 mg once daily with food, the steady-state atazanavir Cmax, AUCtau and Ctau (mean ± SD) values were 3.9 ± 1.9 μg/ml, 46.1 ± 26.2 μg•hr/ml and 0.80 ± 0.72 μg/ml, respectively.
Danish: I et forsøg, hvor hiv-inficerede forsøgspersoner (n=22) blev instrueret i at tage atazanavir 300 mg med cobicistat 150 mg 1 gang dagligt med føde, var steady-state atazanavir Cmax, AUCtau and Ctau (gennemsnitlig ± SD) værdierne henholdsvis 3,9 ± 1,9 μg/ml, 46,1 ± 26,2 μg•hr/ml og 0,80 ± 0,72 μg/ml.
English: Administration of a single dose of EVOTAZ with a light meal (336 kcal, 5.1 g fat, 9.3 g protein) resulted in a 42% increase in atazanavir Cmax, a 28% increase in atazanavir AUC, a 31% increase in cobicistat Cmax, and a 24% increase in cobicistat AUC relative to the fasting state.
Danish: Administration af en enkeltdosis EVOTAZ med et let måltid (336 kcal, 5,1 g fedt, 9,3 g protein) medførte en 42% stigning i atazanavir Cmax, en 28% stigning i atazanavir AUC, en 31% stigning i cobicistat Cmax og en 24% stigning i cobicistat AUC i forhold til fastende tilstand.
English: In an analysis of treatment-failure subjects who received atazanavir 300 mg co-administered with cobicistat 150 mg in study GS-US-216-0114 through Week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in this group (6%, 21/344).
Danish: I en analyse af behandlingsnaive forsøgspersoner, som fik atazanavir 300 mg administreret sammen med cobicistat 150 mg i studie GS-US-216-0114 i uge 144, forelå der evaluerbare genotypiske data fra parvise baseline- og behandlingssvigt-isolater for alle 21 virologiske svigt i denne gruppe (6%, 21/344).
English: ANTIDIABETICS Metformin
Danish: ANTIDIABETIKA Metformin
English: In clinical study GS-US-216-0114, a phase 3 randomised, active-controlled clinical study, in which 692 treatment-naïve patients received at least one dose of atazanavir boosted with cobicistat (n = 344) or atazanavir boosted with ritonavir (n = 348) administered with other antiretroviral medicinal products, the most frequently reported adverse reactions in the atazanavir boosted with cobicistat group during 144 weeks were associated with elevated bilirubin levels (see Table 2).
Danish: I det kliniske studie GS-US-216-0114, et fase 3 randomiseret, aktivt kontrolleret klinisk studie, hvor 692 behandlingsnaive patienter fik mindst en dosis atazanavir boostet med cobicistat (n = 344) eller atazanavir boostet med ritonavir (n = 348) administreret med andre antiretrovirale lægemidler, var de hyppigst rapporterede bivirkninger i gruppen med atazanavir boostet med cobicistat i et forløb på 144 uger associeret med forhøjede bilirubin-niveauer (se Tabel 2).
English: Treatment difference -2.2% (95% CI = -7.4%, 3.0%) -2.1% (95% CI = -8.7%, 4.5%) Virologic failurec
Danish: -2,2% (95% KI = -7,4%; 3,0%) -2,1% (95% KI = -8,7%; 4,5%)
English: Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Danish: Man bør udvise særlig forsigtighed, når EVOTAZ ordineres samtidig med lægemidler, som kan forøge QT-intervallet og/eller til patienter med allerede eksisterende risikofaktorer (bradykardi, medfødt langt QT, elektrolytforstyrrelser (se pkt.
English: Atazanavir with ritonavirf
Danish: Atazanavir med ritonavirf
English: Sildenafil, tadalafil, and vardenafil are metabolised by CYP3A4.
Danish: Sildenafil, tadalafil og vardenafil metaboliseres af CYP3A4.
English: HIV-1 RNA <50 copies/ml
Danish: Virologisk succes hiv-1 RNA <50 kopier/ml
English: Co-administration of voriconazole and EVOTAZ is not recommended unless an assessment of the benefit/risk justifies the use of voriconazole (see section 4.5).
Danish: Samtidig administration af voriconazol og EVOTAZ frarådes, medmindre en vurdering af fordele/risici berettiger brug af voriconazol (se pkt.
English: Clarithromycin may increase concentrations of atazanavir and cobicistat.
Danish: Clarithromycin kan øge koncentrationen af atazanavir og cobicistat.
English: High density polyethylene (HDPE) bottle with a child-resistant polypropylene closure.
Danish: HDPE-beholder (high density polyethylen) med børnesikret polypropylenlåg.
English: Efavirenz decreases atazanavir concentrations and is expected to decrease cobicistat plasma concentrations.
Danish: Efavirenz reducerer atazanavir-koncentrationen og forventes at nedsætte cobicistat-plasmakoncentrationerne.
English: In clinical studies, atazanavir has been shown to induce dyslipidaemia to a lesser extent than comparators.
Danish: Atazanavir har i kliniske studier vist sig at inducere dyslipidæmi i mindre udstrækning end andre sammenlignelige lægemiddelstoffer, der indgik i studierne.
English: Some patients have reported dizziness when taking atazanavir or cobicistat, active substances of EVOTAZ.
Danish: Nogle patienter har oplevet svimmelhed, når de tager atazanavir eller cobicistat, som er de aktive stoffer i EVOTAZ.
English: Co-administration of medicinal products that are substrates of CYP3A and have narrow therapeutic indeces and for which elevated plasma concentrations are associated with serious and/or life-threatening events are contraindicated with EVOTAZ.
Danish: Samtidig administration af lægemidler, der er CYP3A-substrater og har et snævert terapeutisk indeks og med hvilke forhøjede plasmakoncentrationer associeres med alvorlige og/eller livstruende bivirkninger, er kontraindiceret sammen med EVOTAZ.