FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 6 months and had HIV-1 with no resistance mutations to any of the components of Genvoya prior to study entry.
Danish: Patienterne skal have haft stabil supprimering (hiv 1-rna < 50 kopier/ml) i deres regime ved baseline i mindst 6 måneder og have hiv 1 uden resistensmutationer for nogen af Genvoyas komponenter, før de indgik i studiet.
English: High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Danish: Højdensitets-polyethylen (HDPE)- tabletbeholder med børnesikret skruelåg af polypropylen foret med induktionsaktiveret aluminiumsfolie indeholdende 30 filmovertrukne tabletter.
English: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg once daily)7/
Danish: Sofosbuvir/Velpatasvir/ Voxilaprevir (400 mg/100 mg/100 mg+100 mg én gang dagligt)7/
English: Black
Danish: Sort
English: Medicinal products that inhibit CYP3A may decrease the clearance of cobicistat, resulting in increased plasma concentrations of cobicistat.
Danish: Lægemidler, der hæmmer CYP3A, kan nedsætte clearance af cobicistat og føre til øgede plasmakoncentrationer af cobicistat.
English: Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least 4 times greater than those expected after administration of Genvoya.
Danish: Knogletoksicitet blev observeret som nedsat knoglemineraltæthed hos rotter og hunde ved eksponeringer for tonofovir, der var mindst fire gange større, end hvad der forventes efter administration af Genvoya.
English: b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex-US).
Danish: b I begge studier blev patienterne stratificeret ved baseline hiv 1-rna (≤ 100.000 kopier/ml, > 100.000 kopier/ml til ≤ 400.000 kopier/ml eller > 400.000 kopier/ml) ved CD4+ celletal (< 50 celler/μl, 50-199 celler/μl eller ≥ 200 celler/μl), og ved region (USA eller uden for USA).
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was ~4.0.
Danish: Ved maksimale plasmakoncentrationer var forholdet mellem gennemsnitlig lægemiddelkoncentration i plasma og blodet ~ 1,0 og forholdet mellem gennemsnitlig lægemiddelkoncentration i sæd og plasma var ~ 4,0.
English: Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Danish: Ved samtidig administration af et teststof, den moderate CYP3A-inducer efavirenz, var eksponeringen af tenofoviralafenamid ikke påvirket signifikant.
English: Co-administration of Genvoya and rifabutin is not recommended.
Danish: Samtidig administration af Genvoya og rifabutin anbefales ikke.
English: Cobicistat is metabolised via CYP3A (major)- and CYP2D6 (minor)-mediated oxidation and does not undergo glucuronidation.
Danish: Cobicistat metaboliseres via CYP3A (primært)- og/eller CYP2D6 (i mindre grad)-medieret oxidation og gennemgår ikke glukuronidation.
English: In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Danish: In vitro metaboliseres tenofoviralafenamid ikke af CYP1A2, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
English: Changes in measures of renal function
Danish: Ændringer i målinger af nyrefunktionen
English:  If any of these applies to you, talk to your doctor before taking Genvoya.
Danish:  Hvis noget af dette gælder for Dem, skal De kontakte lægen, før De tager Genvoya.
English: • anticoagulants, used to prevent and treat blood clots, such as: apixaban, edoxaban, rivaroxaban and warfarin
Danish: • antikoagulantia, anvendes til at forebygge og behandle blodpropper, såsom: apixaban, edoxaban, rivaroxaban og warfarin
English: In studies GS-US-292-0104 and GS-US-292-0111, patients were randomised in a 1:1 ratio to receive either Genvoya (n = 866) once daily or elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (E/C/F/TDF) (n = 867) once daily.
Danish: I studie GS-US-292-0104 og GS-US-292-0111 blev patienterne randomiseret i forholdet 1:1 til at få enten Genvoya (n = 866) én gang daglig eller elvitegravir 150 mg/cobicistat 150 mg/emtricitabin 200 mg/tenofovirdisoproxil (som fumarat) 245 mg (E/C/F/TDF) (n = 867) én gang daglig.
English: No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af køn eller etnicitet for cobicistat-boosted elvitegravir, cobicistat, emtricitabin eller tenofoviralafenamid.
English: The safety of Genvoya has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Danish: Sikkerheden af Genvoya er ikke klarlagt hos patienter med svær nedsat nyrefunktion (estimeret CrCl ≥ 15 ml/min og < 30 ml/min).
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Danish: Tenofoviralafenamid er ikke en hæmmer af CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
English: Elvitegravir is 98-99% bound to human plasma proteins and binding is independent of drug concentration over the range of 1 ng/mL to 1.6 µg/mL.
Danish: Elvitegravir er 98-99 % bundet til humane plasmaproteiner, og bindingen er uafhængig af lægemiddelkoncentrationer i intervallet fra 1 ng/ml til 1,6 µg/ml.
English: ANTI-INFECTIVES Antifungals
Danish: ANTIINFEKTIVA Antimykotika
English: • antifungals, used to treat fungal infections, such as: ketoconazole, itraconazole, voriconazole, posaconazole and fluconazole
Danish: • antimykotika, anvendes til at behandle svampeinfektioner, såsom: ketoconazol, itraconazol, voriconazol, posaconazol og fluconazol
English: Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Genvoya er ikke blevet undersøgt hos patienter med svært nedsat leverfunktion (Child-Pugh klasse C), derfor frarådes det at bruge Genvoya hos patienter med svært nedsat leverfunktion (se pkt.
English: In a pooled analysis, genotyping was performed on plasma HIV-1 isolates from antiretroviral-naïve patients receiving Genvoya in Phase 3 studies GS-US-292-0104 and GS-US-292-0111 with HIV-1 RNA ≥ 400 copies/mL at confirmed virologic failure, Week 144, or time of early study drug discontinuation.
Danish: I en samlet analyse blev der foretaget genotypebestemmelse af plasma hiv 1-isolater af antiretroviral-naive patienter, der fik Genvoya i fase 3-studierne GS-US-292-0104 og GS-US-292-0111 med hiv 1-rna ≥ 400 kopier/ml ved bekræftet virologisk svigt, uge 144 eller på tidspunktet for tidlig seponering af studiemedicinen.
English: Plasma concentrations of these medicinal products may be increased when co-administered with Genvoya, resulting in reduced serum cortisol concentrations.
Danish: Plasmakoncentrationen af disse lægemidler kan øges ved samtidig administration af Genvoya, hvilket medfører nedsat serumkortisol.
English: The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the Genvoya group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Danish: Den mediane (Q1, Q3) ændring fra baseline i forholdet mellem total kolesterol og HDL-kolesterol ved uge 144 var 0,2 (-0,3; 0,7) i Genvoya-gruppen og 0,1 (-0,4; 0,6) i E/C/F/TDF-gruppen (p = 0,006 for forskellen mellem behandlingsgrupperne).
English: Discontinuation of Genvoya therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Danish: Seponering af behandlingen med Genvoya hos patienter, som samtidig er inficerede med hiv og HBV, kan forekomme i forbindelse med svær, akut eksacerbation af hepatitis.
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed without activation.
Danish: I en in vitro kromosomal aberrationstest var elvitegravir negativ med metabolisk aktivering.
English: Genvoya should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Danish: Genvoya bør generelt undgås, men kan anvendes hos voksne med nyresygdom i slutstadiet (estimeret CrCl < 15 ml/min) i kronisk hæmodialyse, hvis de potentielle fordele opvejer de potentielle risici (se pkt.
English: Co-administration with Genvoya may result in increased plasma concentrations of this medicinal product.
Danish: Samtidig administration af Genvoya kan føre til øgede plasmakoncentrationer af dette lægemiddel.
English: In phenotypic analyses of patients in the final resistance analysis population, 7 of 22 patients (32%) had HIV-1 isolates with reduced susceptibility to elvitegravir in the Genvoya group compared with HIV-1 isolates from 7 of 20 patients (35%) in the E/C/F/TDF group, HIV-1 isolates from 8 patients (36%) had reduced susceptibility to emtricitabine in the Genvoya group compared with HIV-1 isolates from 7 patients (35%) in the E/C/F/TDF group.
Danish: I fænotypeanalyser af patienter i den sidste resistensanalysepopulation havde 7 ud af 22 patienter (32 %) isolater af hiv 1 med nedsat følsomhed for elvitegravir i Genvoya-gruppen sammenlignet med isolater af hiv 1 fra 7 ud af 20 patienter (35 %) i E/C/F/TDF-gruppen, isolater af hiv 1 fra 8 patienter (36 %) havde nedsat følsomhed for emtricitabin i Genvoya-gruppen sammenlignet med isolater af hiv 1 fra 7 patienter (35 %) i E/C/F/TDF-gruppen.
English: Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.
Danish: Lactose (som monohydrat), mikrokrystallinsk cellulose, croscarmellosenatrium, hydroxypropylcellulose, siliciumdioxid, natriumlaurilsulfat, magnesiumstearat.
English: c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Danish: c Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48- eller 144-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, patienter, som afbrød behandlingen af andre årsager end en adverse event (AE), død eller manglende eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥ 50 kopier/ml.
English: Therefore, Genvoya should not be co-administered with medicinal products that include, but are not limited to, the following (see sections 4.4 and 4.5):
Danish: Derfor bør Genvoya ikke administreres sammen med lægemidler, der omfatter, men ikke er begrænset til, de følgende (se pkt.
English: In studies in treatment-naïve patients, Genvoya was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF as measured by DXA analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001) after 144 weeks of treatment.
Danish: I studier af behandlingsnaive patienter var Genvoya forbundet med mindre reduktioner i knoglemineraltæthed (BMD [bone mineral density] sammenlignet med E/C/F/TDF, målt ved DXAanalyse af hofte (gennemsnitlig ændring: -0,8 % versus-3,4 %, p < 0,001) og lænderyggen (gennemsnitlig ændring: -0,9 % versus -3,0 %, p < 0,001) efter 144 ugers behandling.
English: Co-administration of Genvoya with dabigatran is contraindicated.
Danish: Samtidig administration af Genvoya og dabigatran er kontraindiceret.
English: Three patients with emergent HIV-1 resistance to Genvoya were identified (M184M/I; M184I+E92G; M184V+E92Q) up to Week 96 in a clinical study of virologically suppressed patients who switched from a regimen containing emtricitabine/tenofovir disoproxil and a third agent (GS-US-292-0109, n = 959).
Danish: Tre patienter med nyopstået hiv 1-resistens over for Genvoya blev identificeret (M184M/I; M184I+E92G; M184V+E92Q) op til uge 96 i et klinisk studie af virologisk supprimerede patienter, der skiftede fra et regime indeholdende emtricitabin/tenofovirdisoproxil og et tredje stof (GS-US-292-0109, n = 959).
English: Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Danish: Samtidig administration af CYP3A-metaboliserede kortikosteroider anbefales ikke, medmindre den potentielle fordel for patienten opvejer risikoen.
English: 6 This study was conducted using emtricitabine/tenofovir alafenamide.
Danish: 6 Dette studie blev udført med emtricitabin/tenofoviralafenamid.
English: When corrected for protein binding, unbound (free) plasma concentrations of tenofovir alafenamide in severe hepatic impairment and normal hepatic function are similar.
Danish: Når der korrigeres for proteinbinding, er plasmakoncentrationerne af ubundet (frit) tenofoviralafenamid sammenlignelige ved svært nedsat leverfunktion og normal leverfunktion.
English: Concurrent administration of salmeterol and Genvoya is not recommended.
Danish: Samtidig administration af salmeterol og Genvoya anbefales ikke.
English: d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Danish: d Omfattede patienter, som havde ≥ 50 kopier/ml i uge 48 eller uge 96-vinduet, patienter, som afbrød behandlingen tidligt som følge af manglende eller svigtende virkning, patienter, som afbrød behandlingen af andre årsager end en adverse event (AE), død eller manglende eller svigtende virkning, og som på tidspunktet for seponering havde en viral load på ≥ 50 kopier/ml.
English: The hormonal contraceptive should contain at least 30 µg ethinyloestradiol and contain drospirenone or norgestimate as the progestogen or patients should use an alternative reliable method of contraception (see sections 4.4 and
Danish: De hormonale antikonceptiva bør indeholde mindst 30 µg ethinylestradiol og indeholde drospirenon eller norgestimat som progestogenet, eller patienterne skal anvende en anden sikker kontraceptionsmetode (se pkt.
English: Interaction not studied with Genvoya.
Danish: Interaktion er ikke undersøgt med Genvoya.
English: Concentrations of sertraline are not affected upon co-administration with Genvoya.
Danish: Koncentrationer af sertralin er ikke påvirket ved samtidig administration med Genvoya.
English: The safety of elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide has not been established in these patients.
Danish: Sikkerheden af elvitegravir, cobicistat, emtricitabin og tenofoviralafenamid er ikke klarlagt hos disse patienter.
English: Following oral administration of [14C]-cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Danish: Efter oral administration af [14C]-cobicistat blev hhv. 86 % og 8,2 % af dosis genfundet i fæces og urin.
English: Co-administration is contraindicated with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious or life-threatening adverse reactions.
Danish: Samtidig administration med lægemidler, som er meget afhængige af CYP3A for clearance, og for hvilke forhøjede plasmakoncentrationer er associeret med alvorlige eller livstruende bivirkninger, er kontraindiceret.
English: Elvitegravir undergoes primarily oxidative metabolism via CYP3A, and is secondarily glucuronidated via UGT1A1/3 enzymes.
Danish: Elvitegravir gennemgår primært oxidativ metabolisme via CYP3A og glukuronideres i mindre grad via UGT1A1/3-enzymer.
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.
Danish: Samtidig administration af apixaban, rivaroxaban eller edoxaban og Genvoya anbefales ikke.
English: Patients co-infected with HIV and HBV
Danish: Patienter, co-inficeret med hiv og HBV
English: This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Danish: Tag altid den dosis, Deres læge har anbefalet for at sikre, at medicinen er fuldt ud effektiv, og for at reducere udviklingen af resistens mod behandlingen.
English: It is important not to miss a dose of Genvoya.
Danish: Det er vigtigt, at De husker at tage hver dosis af Genvoya.
English: f Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
Danish: f Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
English: On days of haemodialysis, Genvoya should be administered after completion of haemodialysis treatment.
Danish: På dage med hæmodialyse, skal Genvoya administreres efter fuldført hæmodialysebehandling.
English: Patients with end stage renal disease on chronic haemodialysis
Danish: Patienter med nyresygdom i slutstadiet i kronisk hæmodialyse
English: Cobicistat is a strong mechanism-based inhibitor of CYP3A and is also a CYP3A substrate.
Danish: Cobicistat er en kraftig mekanismebaseret hæmmer af CYP3A samt et CYP3A-substrat.
English: Co-administration of Genvoya and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Danish: Samtidig administration af Genvoya og andre lægemidler metaboliseres primært af CYP3A, såsom amiodaron, quinidin, cisaprid, pimozid, lurasidon, alfuzosin og sildenafil mod pulmonal arteriel hypertension er kontraindiceret (se pkt.
English: Tenofovir alafenamide is minimally metabolised by CYP3A4.
Danish: Tenofoviralafenamid metaboliseres kun minimalt af CYP3A4.
English: Following oral administration of boosted [14C]-elvitegravir, elvitegravir was the predominant species in plasma, representing ~94% of the circulating radioactivity.
Danish: Efter oral administration af boosted [14C]-elvitegravir var elvitegravir det dominerende stof i plasma og udgjorde ~ 94 % af den cirkulerende radioaktivitet.
English: Therefore, therapy with Genvoya should not be initiated during pregnancy, and women who become pregnant during therapy with Genvoya should be switched to an alternative regimen (see sections 4.2 and 4.4).
Danish: Derfor bør behandling med Genvoya ikke påbegyndes under graviditet, og kvinder, der bliver gravide under behandling med Genvoya, skal skiftes til et andet regime (se pkt.
English: Naloxone:
Danish: Naloxon:
English: Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Danish: Patienter med leversygdom, inklusiv kronisk hepatitis B eller C, som behandles med antiretrovirale midler, har en forhøjet risiko for alvorlige og potentielt livstruende bivirkninger i leveren.
English: Patients with CrCl greater than or equal to 60 mL/min:
Danish: Patienter med CrCl over eller lig med 60 ml/min:
English: Thirteen percent of patients were identified as Hispanic/Latino.
Danish: 13 % procent af patienterne blev identificeret som af spansk/latinsk herkomst.
English: Patients co-infected with HIV and hepatitis B or C virus
Danish: Patienter, co-inficeret med hiv- og hepatitis B- eller C-virus
English: Up to Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir alafenamide resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and Genvoya treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF treatment group (12 of 867 patients [1.4%]).
Danish: Op til uge 144 blev der observeret udvikling af en eller flere primære elvitegravir-, emtricitabin- eller tenofoviralafenamid-resistensassocierede mutationer i isolater af hiv 1 fra 12 ud af 22 patienter med evaluerbare genotypedata fra parrede isolater ved baseline og efter behandlingssvigt med Genvoya (12 ud af 866 patienter [1,4 %]), sammenlignet med 12 ud af 20 isolater efter behandlingssvigt fra patienter med evaluerbare genotypedata i E/C/F/TDF- behandlingsgruppen (12 ud af 867 patienter [1,4 %]).
English: Package leaflet: Information for the user Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Genvoya 150 mg/150 mg/200 mg/10 mg filmovertrukne tabletter
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Danish: Tenofovirdiphosphat hæmmer hiv-replikation via indbygning i viralt dna af hiv-RT, hvilket resulterer i dna-kædeblokering.
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite tenofovir diphosphate.
Danish: In vivo hydrolyseres tenofoviralafenamid i cellerne til at danne tenofovir (primær metabolit), som fosforyleres til den aktive metabolit tenofovirdiphosphat.
English: In patients treated with Genvoya, 92% (46/50) achieved HIV-1 RNA < 50 copies/mL.
Danish: Hos patienter i behandling med Genvoya opnåede 92 % (46/50) hiv 1-rna < 50 kopier/ml.
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
Danish: Indigocarmin aluminiumpigment (E132) Jernoxid, gul (E172)
English: While you are taking Genvoya
Danish: Mens De tager Genvoya
English: The difference in percentage was 4.2% (95% CI: 0.6% to 7.8%).
Danish: Forskellen i procent var 4,2 % (95 % CI: 0,6 % til 7,8 %).
English: Emtricitabine has activity against HIV-1, HIV-2, and HBV.
Danish: Emtricitabin har aktivitet mod hiv 1-, hiv 2- og HBV.
English: Concomitant use of Genvoya and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Danish: Samtidig brug af Genvoya og kortikosteroider, der metaboliseres via CYP3A (f.eks. fluticasonpropionat eller andre inhalerede eller nasale kortikosteroider) kan øge risikoen for systemiske kortikosteroidbivirkninger, herunder Cushings syndrom og binyrebarksuppression.
English: 4.1% (95% CI: 1.6% to 6.7%, p < 0.001c)
Danish: 4,1 % (95 % CI: 1,6 % til 6,7 %, p < 0,001c)
English: Therefore, Genvoya should not be used during breast-feeding.
Danish: Genvoya bør derfor ikke anvendes under amning.
English: Carbamazepine decreases plasma concentrations of elvitegravir and cobicistat, which may result in loss of therapeutic effect and development of resistance.
Danish: Carbamazepin reducerer plasmakoncentrationerne af elvitegravir og cobicistat, hvilket kan forårsage svigtende terapeutisk virkning og udvikling af resistens.