FrancophonIA/ELRC3.0 huggingface dataset:
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells,
Danish: Den antivirale aktivitet af tenofoviralafenamid mod isolater af hiv 1 undertype B fra laboratoriet og klinikken blev vurderet i lymfoblastoide cellelinjer, PBMC'er, primære monocyt-/makrofage celler og CD4+ T-lymfocytter.
English: In the pooled Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients, at Week 96, there was an overall mean change from baseline in basal cortisol of -19.1 (-30.85; -7.37) nmol/L in the rilpivirine arm and of -0.6 (-13.29; 12.17) nmol/L in the efavirenz arm. At Week 96, the mean change from baseline in ACTH-stimulated cortisol levels was lower in the rilpivirine arm (+18.4 ± 8.36 nmol/L) than in the efavirenz arm (+54.1 ± 7.24 nmol/L).
Danish: I de samlede fase 3-studier med behandlingsnaive patienter TMC278-C209 og TMC278-C215 var der i uge 96 en generel gennemsnitlig ændring af basal cortisol i forhold til baseline på -19,1 (-30,85;7,37) nmol/l i rilpivirin-armen og på -0,6 (-13,29; 12,17) nmol/l i efavirenz-armen.
English: Median plasma HIV-1 RNA was 5.0 log10 copies/mL and median CD4+ cell count was 255 cells/mm3.
Danish: Median hiv 1-rna i plasma var 5,0 log10 kopier/ml, og median CD4+ celletal var 255 celler/mm3.
English: Sofosbuvir (400 mg once daily)/ Rilpivirine (25 mg once daily)
Danish: Sofosbuvir (400 mg en gang dagligt)/rilpivirin (25 mg en gang dagligt)
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin (40 mg once daily)/ Rilpivirine1
Danish: HMG CO-A-REDUKTASEHÆMMERE Atorvastatin (40 mg en gang dagligt)/rilpivirin1
English: The safety of emtricitabine + tenofovir alafenamide in combination with elvitegravir and cobicistat as a fixed-dose combination tablet (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide [E/C/F/TAF]) was evaluated in 72 HIV/HBV co-infected patients receiving treatment for HIV in an open-label clinical study (GS-US-292-1249), through Week 48, in which patients were switched from another antiretroviral regimen (which included TDF in 69 of 72 patients) to E/C/F/TAF.
Danish: Patienter, som samtidig er inficerede med hiv og HBV Sikkerheden af emtricitabin + tenofoviralafenamid i kombination med elvitegravir og cobicistat som en fastdosis kombinationstablet (elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid [E/C/F/TAF]) blev evalueret hos 72 patienter med samtidig hiv/HBV-infektion, som fik behandling mod hiv i et ublindet klinisk studie (GS-US-292-1249) til og med uge 48, hvor patienterne skiftede fra et andet antiretroviralt regime (som inkluderede TDF hos 69 ud af 72 patienter) til E/C/F/TAF.
English: Non-clinical data on rilpivirine hydrochloride reveal no special hazard for humans based on studies of safety pharmacology, drug disposition, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Danish: Prækliniske data for rilpivirinhydrochlorid viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet samt reproduktions- og udviklingstoksicitet.
English: Laboratory abnormalities
Danish: Anormale laboratorieværdier
English: Emtricitabine + tenofovir alafenamide regimen
Danish: Regime med emtricitabin + tenofoviralafenamid
English: Each Odefsey tablet contains 200 mg of emtricitabine, rilpivirine hydrochloride equivalent to 25 mg of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.
Danish: Hver Odefsey tablet indeholder 200 mg metricitabin, rilpivirinhydrochlorid svarende til 25 mg rilpivirin og tenofoviralafenamidfumarat svarende til 25 mg tenofoviralafenamid.
English:  If you are taking any of these medicines, do not take Odefsey and tell your doctor immediately.
Danish:  Hvis De tager nogen af disse lægemidler, må De ikke tage Odefsey.
English: In Study GS-US-292-1825, the efficacy and safety of E/C/F/TAF were evaluated in a single arm, open-label clinical study in which 55 HIV-1 infected adults with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis for at least 6 months before switching to E/C/F/TAF FDC tablet.
Danish: I studie GS-US-292-1825 blev virkning og sikkerhed af E/C/F/TAF evalueret i et ublindet klinisk studie med én behandlingsarm hos 55 hiv 1-inficerede voksne med nyresygdom i slutstadiet (eGFRCG < 15 ml/min) i kronisk hæmodialyse i mindst 6 måneder, inden de skiftede til E/C/F/TAF fastdosis kombinationstablet.
English: CYP enzyme inhibitors
Danish: CYP-enzymhæmmere
English: Paracetamol (500 mg single dose)/ Rilpivirine1
Danish: ANALGETIKA Paracetamol (enkelt dosis på 500 mg)/rilpivirin1
English: The mean baseline CD4+ cell count was 709 cells/mm3 (range 104-2,527).
Danish: Det gennemsnitlige CD4+-celletal ved baseline var 709 celler/mm3 (104-2.527).
English: Co-administration of ketoconazole is expected to increase plasma concentrations of tenofovir alafenamide (inhibition of P-gp).
Danish: Samtidig administration af ketoconazol forventes at øge plasmakoncentrationerne af tenofoviralafenamid (hæmning af P-gp).
English: The median baseline plasma HIV-1 RNA was 4.8 log10 copies/mL, and the median baseline CD4+ cell count was 414 cells/mm3.
Danish: Median hiv 1-rna i plasma ved baseline var 4,8 log10 kopier/ml, og median CD4+ celletal ved baseline var 414 celler/mm3.
English: Cmax: ↔* *based on historic controls
Danish: *baseret på historiske kontroller
English: Simeprevir (150 mg once daily)/ Rilpivirine
Danish: Simeprevir (150 mg en gang dagligt)/rilpivirin
English: headache1, 3, dizziness1, 3
Danish: hovedpine1,3, svimmelhed1,3
English: HIV-1 RNA < 50 copies/mL Treatment difference
Danish: Hiv 1-RNA < 50 kopier/ml Behandlingsforskel
English: HIV-1 RNA ≥ 50 copies/mLd
Danish: Hiv 1-RNA ≥ 50 kopier/mld
English: Although the aetiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV disease and/or long-term exposure to CART.
Danish: Ætiologien anses dog for at være multifaktoriel (herunder anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, forhøjet Body Mass Index (BMI)).
English: Emtricitabine + tenofovir alafenamide
Danish: Emtricitabi + tenofoviralafenamid
English: Rifampicin:
Danish: Rilpivirin:
English: PROTON PUMP INHIBITORS Omeprazole (20 mg once daily)/ Rilpivirine1
Danish: PROTONPUMPEHÆMMERE Omeprazol (20 mg en gang dagligt)/rilpivirin1
English: Ketoconazole (400 mg once daily)/ Rilpivirine1
Danish: Ketoconazol (400 mg en gang dagligt)/rilpivirin1
English: Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Danish: Ingen virologiske data i uge 48 eller 96 vinduet Behandling afbrudt pga. bivirkninger eller død og sidste tilgængelige hiv 1-RNA < 50 kopier/ml Behandling afbrudt af andre grunde og sidste tilgængelige hiv 1-RNA < 50 kopier/mle
English: Sofosbuvir/Velpatasvir (400 mg/100 mg once daily)/ Rilpivirine2
Danish: Sofosbuvir/velpatasvir (400 mg/100 mg en gang dagligt)/rilpivirin2
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Danish: Den rapporterede tidsperiode før sådanne opstår er imidlertid variabel og disse tilstande kan opstå mange måneder efter påbegyndelse af behandlingen (se pkt.
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving emtricitabine + tenofovir alafenamide, given with elvitegravir + cobicistat as a fixed-dose combination tablet (see section 5.2).
Danish: Der identificeredes ingen nye sikkerhedsproblemer hos patienter med nyresygdom i slutstadiet i kronisk hæmodialyse, som fik emtricitabin + tenofoviralafenamid sammen med elvitegravir + cobicistat som en fastdosis kombinationstablet (se pkt.
English: immune reactivation syndrome1 Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig:
English: The mean baseline CD4+ cell count was 700 cells/mm3 (range 140-1,862).
Danish: Det gennemsnitlige CD4+-celletal ved baseline var 700 celler/mm3 (140-1.862).
English: Co-administration of Odefsey with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Danish: Administration af Odefsey sammen med protonpumpehæmmere er blevet vist at nedsætte plasmakoncentrationerne af rilpivirin (grundet en stigning i gastrisk pH), hvilket potentielt kan medføre svigtende virologisk respons på Odefsey (se pkt.
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 144 weeks in an open-label clinical study (GS-US-292-0112), in which 248 HIV-1 infected patients who were either treatment-naïve (n = 6) or virologically suppressed (n = 242) with mild to moderate renal impairment (estimated glomerular filtration rate by Cockcroft-Gault method [eGFRCG]: 30-69 mL/min) received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Danish: Sikkerheden af emtricitabin + tenofoviralafenamid blev evalueret til og med 144 uger i et ublindet klinisk studie (GS-US-292-0112), hvor 248 hiv 1-inficerede patienter, der enten var behandlingsnaive (n = 6) eller virologisk supprimerede (n = 242) med let til moderat nedsat nyrefunktion (estimeret glomerulær filtrationshastighed via Cockcroft-Gault-metoden [eGFRCG]: 30-69 ml/min) fik emtricitabin + tenofoviralafenamid i kombination med elvitegravir + cobicistat som en fastdosis kombinationstablet.
English: omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers, heartburn, acid reflux disease) dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Danish: (anvendes til at forebygge og behandle mavesår, halsbrand og opstød) dexamethason (et kortikosteroid-lægemiddel, som anvendes til at behandle betændelse og undertrykke immunforsvaret), hvis det indtages gennem munden eller indsprøjtes (undtagen hvis behandlingen kun består af en enkelt dosis) produkter, der indeholder perikon (Hypericum perforatum) (et naturlægemiddel, der anvendes til depression og angst)
English: In open-label Study GS-US-292-1249, the efficacy and safety of E/C/F/TAF were evaluated in adult patients co-infected with HIV-1 and chronic hepatitis B. Sixty-nine of the 72 patients were on prior TDF-containing antiretroviral therapy.
Danish: Sikkerheden og virkningen af E/C/F/TAF blev evalueret i det ublindede studie GS-US-292-1249 hos voksne patienter med samtidig infektion med hiv-1 og kronisk hepatitis B. 69 ud af de 72 patienter havde tidligere fået TDF-baseret antiretroviral behandling.
English: Patients had a mean age of 45 years (range 23-72), 90% were male, 75% were White, and 19% were Black.
Danish: Patienterne havde en gennemsnitsalder på 45 år (23-72), 90 % var mænd, 75 % var hvide, og 19 % var sorte.
English: 0% (95% CI: -4.8% to 4.8%)
Danish: 0 % (95 % CI: -4,8 % til 4,8 %)
English: Virologically suppressed HIV-1 infected adult patients In Study GS-US-366-1216, the efficacy and safety of switching from FTC/RPV/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Danish: Virologisk supprimerede hiv 1-inficerede voksne patienter Studie GS-US-366-1216, et randomiseret, dobbeltblindt studie hos virologisk supprimerede hiv 1inficerede voksne, evaluerede effekten og sikkerheden ved skift fra FTC/RVP/TDF til Odefsey.
English: -0.3% (95% CI: -4.2% to 3.7%)
Danish: -0,3 % (95 % CI: -4,2 % til 3,7 %)
English: Patients had a mean age of 48 years (range 19-76), 87% were male, 67% were White, and 27% were Black.
Danish: Patienterne havde en gennemsnitsalder på 48 år (19-76), 87% var mænd, 67 % var hvide, og 27 % var sorte.
English: The combination of Odefsey with these macrolide antibiotics may cause an increase in the plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Danish: Kombinationen af Odefsey og disse makrolidantibiotika kan medføre et fald i plasmakoncentrationerne af rilpivirin (hæmning af CYP3A) og tenofoviralafenamid (hæmning af P-gp).
English: The mean baseline CD4+ cell count was 664 cells/mm3 (range 126-1,813).
Danish: Det gennemsnitlige CD4+ celletal ved baseline var 664 celler/mm3 (interval: 126-1.813).
English: tenofovir alafenamide tenofovir disoproxil lamivudine adefovir dipivoxil
Danish: tenofoviralafenamid tenofovirdisoproxil lamivudin adefovirdipivoxil
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in an open-label clinical study (GS-US-292-0106) in which 50 HIV-1 infected, treatment-naïve paediatric patients aged 12 to < 18 years received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Danish: Sikkerheden af emtricitabin + tenofoviralafenamid blev evalueret til og med 48 uger i et ublindet klinisk studie (GS-US-292-0106), hvor 50 hiv 1-inficerede, behandlingsnaive pædiatriske patienter i alderen 12 til < 18 år fik emtricitabin + tenofoviralafenamid i kombination med elvitegravir + cobicistat som en fastdosis kombinationstablet.
English: In a study of virologically suppressed patients switching from EFV/FTC/TDF to Odefsey (Study GS-US-366-1160), decreases from baseline were observed in the fasting values of total cholesterol and HDL-cholesterol in the Odefsey arm; no clinically relevant changes from baseline in median fasting values for total cholesterol to HDL-cholesterol ratio, direct LDL-cholesterol or triglycerides were observed in either treatment arm at Week 96.
Danish: I et studie hos virologisk supprimerede patienter, der skiftede fra EFV/FTC/TDF til Odefsey (studie GS-US-366-1160), blev der observeret fald fra baseline i værdier ved faste for total-kolesterol og HDL-kolesterol i Odefsey-armen.
English: AUC: ↔ Cmin: ↓ 15% Cmax: ↑ 35%
Danish: Atorvastatin: AUC: ↔ Cmin: ↓ 15 % Cmax: ↑ 35 %
English: 5 Adverse reaction identified through post-marketing surveillance for emtricitabine-containing products.
Danish: 5 Bivirkning identificeret under sikkerhedsovervågning efter markedsføring for lægemidler indeholdende emtricitabin.. 6 Bivirkning identificeret under sikkerhedsovervågning efter markedsføring for lægemidler indeholdende tenofoviralafenamid.
English: fatigue1, 3
Danish: træthed1,3
English: Co-administration of Odefsey and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of virologic response to Odefsey (see section 4.3) and possible resistance to rilpivirine and to the NNRTI class.
Danish: Administration af Odefsey sammen med lægemidler, der inducerer CYP3A, er blevet vist at nedsætte plasmakoncentrationerne af rilpivirin, hvilket potentielt kan medføre svigtende virologisk respons på Odefsey (se pkt.
English: Antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Rilpivirine
Danish: Antivirale midler Ledipasvir/sofosbuvir (90 mg/400 mg en gang dagligt)/ rilpivirin
English: Rifabutin (300 mg once daily)/ Rilpivirine1
Danish: Rifabutin (300 mg en gang dagligt)/rilpivirin1
English: had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Danish: Indtil uge 96 havde færre patienter i rilpivirin-armen med en virusbelastning ved baseline ≤ 100.000 kopier/ml nyopstået resistens-associerede substitutioner og/eller fænotyperesistens over for rilpivirin (7/288) end patienter med en virusbelastning ved baseline > 100.000 kopier/ml (30/262).
English: Co-administration is likely to cause significant decreases in the plasma concentrations of tenofovir alafenamide (induction of P-gp).
Danish: Samtidig administration medfører sandsynligvis et signifikant fald i plasmakoncentrationerne af tenofoviralafenamid (induktion af P-gp).
English: Ledipasvir/Sofosbuvir (90 mg/400 mg once daily)/ Tenofovir alafenamide
Danish: Ledipasvir/sofosbuvir (90 mg/400 mg en gang dagligt)/ tenofoviralafenamid
English: The pharmacokinetics of emtricitabine have not been studied in patients with varying degrees of hepatic insufficiency; however emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Danish: Imidlertid metaboliseres emtricitabin ikke signifikant af leverenzymer, så påvirkningen af nedsat leverfunktion bør være begrænset.
English: Famotidine (40 mg single dose taken 12 hours before rilpivirine)/ Rilpivirine1
Danish: Famotidin (enkeltdosis på 40 mg taget 12 timer før rilpivirin)/ rilpivirin1
English: Norethindrone (1 mg once daily)/ Rilpivirine
Danish: Norethindron (1 mg en gang dagligt)/rilpivirin
English: 2.0% (95% CI: -0.7% to 4.7%) 4.2% (95% CI: 0.6% to 7.8%) 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: (78.6%, 22/28) as compared to those with a baseline viral load > 100,000 copies/mL (50.0%, 4/8).
Danish: Andelen af respondere var højere for forsøgspersoner med en virusbelastning ved baseline ≤ 100.000 kopier/ml (78,6 %, 22/28) i forhold til dem med en virusbelastning ved baseline > 100.000 kopier/ml (50,0 %, 4/8).
English: Famotidine (40 mg single dose taken 4 hours after rilpivirine)/ Rilpivirine1
Danish: Famotidin (enkeltdosis på 40 mg taget 4 timer efter rilpivirin)/ rilpivirin1
English: Rifabutin (300 mg once daily)/ Rilpivirine
Danish: Rifabutin (300 mg en gang dagligt)/rilpivirin
English: Famotidine (40 mg single dose taken 2 hours before rilpivirine)/ Rilpivirine1
Danish: Famotidin (enkeltdosis på 40 mg taget 2 timer før rilpivirin)/ rilpivirin1
English: How to take Odefsey
Danish: Sådan skal De tage Odefsey
English: 0.7% (95% CI: -4.3% to 5.8%)
Danish: 0,7 % (95 % CI: -4,3 % til 5,8 %)
English: The safety of emtricitabine + tenofovir alafenamide was evaluated through 48 weeks in a single arm, open-label clinical study (GS-US-292-1825) in which 55 virologically suppressed HIV-1 infected patients with end stage renal disease (eGFRCG < 15 mL/min) on chronic haemodialysis received emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat as a fixed-dose combination tablet.
Danish: Sikkerheden af emtricitabin + tenofoviralafenamid blev evalueret til og med 48 uger i et ublindet klinisk studie med én behandlingsarm (GS-US-292-1825), hvor 55 hiv 1-inficerede patienter, der var virologisk supprimerede med nyresygdom i slutstadiet (eGFRCG < 15 ml/min) i kronisk hæmodialyse fik emtricitabin + tenofoviralafenamid i kombination med elvitegravir + cobicistat som en fastdosis kombinationstablet.
English: AUC: ↑ 8%
Danish: Cmax: ↑ 8 %
English: If you are taking an antacid, take it at least 2 hours before or at least 4 hours after Odefsey.
Danish: Hvis De tager et syreneutraliserende middel, skal De tage det mindst 2 timer før eller mindst 4 timer efter Odefsey.
English: Co-administration may cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Danish: Samtidig administration kan medføre signifikante fald i plasmakoncentrationerne af rilpivirin (induktion af CYP3A) og tenofoviralafenamid (induktion af P-gp).
English: Pharmacotherapeutic group: Antiviral for systemic use; antivirals for treatment of HIV infections, combinations, ATC code: J05AR19
Danish: Farmakoterapeutisk klassifikation: Antiviralt middel til systemisk brug.
English: Mean percent change in AUC,
Danish: Gennemsnitlig procentvis ændring i AUC, Cmax, Cmin
English:  If this applies to you, do not take Odefsey and tell your doctor immediately.
Danish:  Hvis dette gælder for Dem, må De ikke tage Odefsey.
English: AUC: ↓ 16% Cmin: ↓ 21% Cmax: ↓ 13%
Danish: S(+) metadon: AUC: ↓ 16 % Cmin: ↓ 21 % Cmax: ↓ 13 %
English: Co-administration is likely to cause significant decreases in the plasma concentrations of rilpivirine (induction of CYP3A) and tenofovir alafenamide (induction of P-gp).
Danish: Samtidig administration vil sandsynligvis medføre signifikante fald i plasmakoncentrationerne af rilpivirin (induktion af CYP3A) og tenofoviralafenamid (induktion af P-gp).
English: At Week 48, 81.8% (45/55 patients) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
Danish: Ved uge 48 havde 81,8 % (45/55 patienter) stadig hiv 1-rna < 50 kopier/ml, efter de var skiftet til E/C/F/TAF, Der var ingen klinisk signifikante ændringer i fastende laboratorieprøver for lipider hos patienter, som skiftede.
English: rash1, 3
Danish: udslæt1,3
English: Sofosbuvir/Velpatasvir/Voxilaprevir (400 mg/100 mg/100 mg + 100 mg once daily)3/
Danish: Sofosbuvir/velpatasvir/voxilapre vir (400 mg/100 mg/100 mg + 100 mg en gang dagligt3)/ emtricitabin/rilpivirin/ tenofoviralafenamid (200 mg/25 mg/25 mg en gang dagligt)
English: AUC: ↓ 80% Cmin: ↓ 89% Cmax: ↓ 69%
Danish: AUC: ↓ 80 % Cmin: ↓ 89 % Cmax: ↓ 69 % Induktion af CYP3A
English: In Study GS-US-366-1160, the efficacy and safety of switching from EFV/FTC/TDF to Odefsey were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults.
Danish: Studie GS-US-366-1160, et randomiseret, dobbeltblindt studie hos virologisk supprimerede hiv 1-inficerede voksne, evaluerede effekten og sikkerheden ved skift fra EVF/FTC/TDF til Odefsey.
English: • If you notice 12 hours or more after the time you usually take Odefsey, then do not take the missed dose.
Danish: • Hvis De kommer i tanker om det 12 timer eller længere efter det tidspunkt, De normalt tager
English: Co-administration of ciclosporin is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Danish: Samtidig administration af ciclosporin forventes at øge plasmakoncentrationerne af rilpivirin (hæmning af CYP3A) og tenofoviralafenamid (hæmning af P-gp).
English: Co-administration of these antifungal agents is expected to increase plasma concentrations of rilpivirine (inhibition of CYP3A) and tenofovir alafenamide (inhibition of P-gp).
Danish: Samtidig administration af disse antimykotika forventes at øge plasmakoncentrationerne af rilpivirin (hæmning af CYP3A) og tenofoviralafenamid (hæmning af P-gp).
English: AUC: ↓ 42% Cmin: ↓ 48% Cmax: ↓ 31%
Danish: AUC: ↓ 42 % Cmin: ↓ 48 % Cmax: ↓ 31 % Induktion af CYP3A
English: AUC: ↑ 49% Cmin: ↑ 76% Cmax: ↑ 30%
Danish: Cmin: ↑76 % Cmax: ↑ 30 %
English: What Odefsey is and what it is used for What you need to know before you take Odefsey How to take Odefsey
Danish: Det skal De vide, før De begynder at tage Odefsey Sådan skal De tage Odefsey Bivirkninger
English: decreased white blood cell count1, decreased haemoglobin1, decreased platelet count1
Danish: nedsat leukocyttal1, nedsat hæmoglobin1, nedsat trombocyttal1
English: AUC: ↓ 16% Cmin: ↓ 22% Cmax: ↓ 14%
Danish: R(-) metadon: AUC: ↓ 16 % Cmin: ↓ 22 % Cmax: ↓ 14 %
English: Ethinylestradiol:
Danish: Ethinylestradiol: AUC: ↔
English: AUC: ↑ 32% Cmax: ↑ 3%
Danish: Tenofoviralafenamid: AUC: ↑ 32 % Cmax: ↑ 3 %
English: AUC: ↔ Cmin: ↑ 26% Cmax: ↔
Danish: AUC: ↔ Cmin: ↑ 26 %
English: Cardiovascular
Danish: Leversygdom
English: • tiredness
Danish: • mundtørhed
English: Cmax: ↑ 21%
Danish: Cmin: ↑ 10 %
English: 0.4% (95% CI: -3.0% to 3.8%) 5.4% (95% CI: 1.5% to 9.2%)
Danish: 5,4 % (95 % CI: 1,5 % til 9,2 %)
English: Hepatobiliary disorders Very common:
Danish: Mave-tarm-kanalen Meget almindelig: