FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh Class A) to 8 matched controls and 8 patients with moderate hepatic impairment (Child-Pugh Class B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Danish: I et studie, der sammenlignede 8 patienter med let nedsat leverfunktion (Child-Pugh-klasse A) med 8 matchede kontroller og 8 patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) med 8 matchede kontroller, var flerdosis eksponering for rilpivirin 47 % højere hos patienter med let nedsat leverfunktion og 5 % højere hos patienter med moderat nedsat leverfunktion.
English: Studies conducted with other medicinal products Based on drug-drug interaction studies conducted with the components of Odefsey, no clinically significant interactions are expected when Odefsey is combined with the following medicinal products: buprenorphine, naloxone and norbuprenorphine.
Danish: På baggrund af lægemiddelinteraktionsstudier udført med Odefseys indholdsstoffer forventes der ingen klinisk signifikante interaktioner, når Odefsey kombineres med følgende lægemidler: buprenorphin, naloxon og norbuprenorphin.
English: In this study, the safety profile in adolescent patients was similar to that in adults (see section 5.1).
Danish: I dette studie svarede sikkerhedsprofilen for unge patienter til den for voksne (se pkt.
English: N/A 10.0 (19.6)
Danish: I/R 10,0 (19,6)
English: Do not stop taking Odefsey Do not stop taking Odefsey without talking to your doctor.
Danish: Hold ikke op med at tage Odefsey Hold ikke op med at tage Odefsey uden at tale med Deres læge.
English: Odefsey comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Danish: Odefsey fås i tabletbeholdere med 30 tabletter samt i pakninger med 3 tabletbeholdere hver med 30 tabletter.
English: At supratherapeutic doses (75 mg once daily and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 4.9).
Danish: Ved supraterapeutiske doser (75 mg en gang om dagen og 300 mg en gang om dagen) er rilpivirin blevet forbundet med forlængelse af QTc-intervallet i elektrokardiogrammet (EKG) (se pkt.
English: Film-coating: Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).
Danish: Filmovertræk: Macrogol, polyvinylalkohol, talcum, titandioxid (E171), jernoxid, sort (E172).
English: Patients receiving Odefsey may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Danish: Patienter, som får Odefsey, har fortsat risiko for opportunistiske infektioner eller andre hiv-relaterede komplikationer, og bør derfor følges nøje af læger med erfaring i behandlingen af patienter med hiv-associerede sygdomme.
English: Adolescents 12 years of age and older, who weigh at least 35 kg: one tablet each day with food Do not chew, crush or split the tablet.
Danish: Unge i alderen 12 år og ældre, som vejer mindst 35 kg: en tablet om dagen sammen med mad Tabletten må ikke tygges, knuses eller deles.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Danish: Der bør kun anvendes H2receptorantagonister, som kan doseres en gang dagligt.
English: a n = 24 adolescents (GS-US-292-0106); n = 19 adults (GS-US-292-0102).
Danish: a n = 24 unge (GS-US-292-0106), n = 19 voksne (GS-US-292-0102).
English: Late onset neurological disorders have been reported rarely (hypertonia, convulsion, abnormal behaviour).
Danish: Sent forekommende neurologiske forstyrrelser er blevet rapporteret i sjældne tilfælde (hypertoni, kramper, unormal adfærd).
English: Other medicines and Odefsey Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Odefsey Fortæl altid lægen eller apotekspersonalet, hvis De tager anden medicin eller har gjort det for nylig.
English: Children and adolescents Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Danish: Børn og unge Denne medicin må ikke gives til børn i alderen 11 år eller derunder eller børn, som vejer under
English: The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Danish: K65R- og også K70E-substitution resulterer i nedsat følsomhed for abacavir, didanosin, lamivudin, emtricitabin og tenofovir, men de bevarer følsomhed for zidovudin.
English: Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Danish: Rilpivirinhydrochlorid metaboliseres og elimineres primært i leveren.
English: Interaction not studied with any of the components of Odefsey.
Danish: Interaktion er ikke blevet undersøgt med nogen af Odefseys indholdsstoffer.
English: Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Danish: Rilpivirin er en diarylpyrimidin NNRTI af hiv 1.
English: As a precautionary measure, it is preferable to avoid the use of Odefsey during pregnancy.
Danish: For en sikkerheds skyld bør anvendelse af Odefsey under graviditet undgås.
English: Odefsey should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Odefsey has not been established in these populations.
Danish: Odefsey frarådes til patienter med en estimeret CrCl ≥ 15 ml/min og < 30 ml/min, eller < 15 ml/min, som ikke er i kronisk hæmodialyse, da Odefseys sikkerhed hos disse populationer ikke er klarlagt.
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Danish: Der skal tages hensyn til disse resultater for alle børn, der er blevet eksponeret for nukleoside/nukleotide analoger in utero, og som præsenterer svære kliniske fund af ukendt ætiologi, især neurologiske fund.
English: Among these 12 HIV-1 isolates, the mutations that emerged were M184V/I (n = 11) and K65R/N (n = 2) in RT and T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1), and N155H (n = 2) in integrase.
Danish: Blandt disse 12 hiv 1-isolater var de mutationer, der opstod, M184V/I (n = 11) og K65R/N (n = 2) i RT og T66T/A/I/V (n = 2), E92Q (n = 4), Q148Q/R (n = 1) og N155H (n = 2) i integrase.
English: Patients co-infected with HIV and HBV who discontinue Odefsey should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Danish: Patienter med hiv-infektion, som samtidig er inficerede med HBV, og som ophører med Odefsey, bør monitoreres tæt med opfølgning både klinisk og i laboratoriet i flere måneder eller længere efter ophør af behandlingen.
English: H2-antagonists should not be taken twice a day.
Danish: H2-antagonister må ikke tages to gange om dagen.
English: N/A 10.6 (28.5)
Danish: I/R 10,6 (28,5)
English: Also, emtricitabine did not inhibit uridine-5'-diphosphoglucuronyl transferase (UGT), the enzyme responsible for glucuronidation.
Danish: Desuden hæmmede emtricitabin ikke uridine-5'-diphosphoglucuronyltransferase (UGT), det enzym, der er ansvarligt for glucuronidation.
English: Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy (CART) and should be monitored according to standard practice.
Danish: Hos patienter med allerede eksisterende leverdysfunktion, herunder kronisk aktiv hepatitis, er der en forhøjet forekomst af unormal leverfunktion under antiretroviral kombinationsbehandling (CART, combination antiretroviral therapy), og disse patienter bør monitoreres i henhold til standardprocedurer.
English: Following administration of tenofovir alafenamide, plasma [14C] -radioactivity showed a time-dependent profile, with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Danish: Efter administration af tenofoviralafenamid viste plasma [14C]-radioaktivitet en tidsafhængig profil med tenofoviralafenamid som det hyppigste stof i de første par timer og urinsyre i den resterende periode.
English: arthralgia3
Danish: artralgi3
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Danish: GLUKOKORTIKOIDER Dexamethason (systemisk, med undtagelse af anvendelse af en enkelt dosis)
English: In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02-200 µg/mL.
Danish: Emtricitabins binding in vitro til humane plasmaproteiner var < 4 % og uafhængig af koncentrationen i intervallet 0,02-200 µg/ml.
English: Fifty-two percent of HIV-1 isolates with emergent resistance in the rilpivirine arm developed concomitant NNRTI and NRTI mutations, most frequently E138K and M184V.
Danish: 52 % af hiv 1-isolater med nyopstået resistent i rilpivirin-armen udviklede samtidige NNRTI- og NRTI-mutationer, oftest E138K og M184V.
English: Sofosbuvir metabolite GS-331007:
Danish: Sofosbuvirmetabolit GS-331007:
English: e e.g., lost to follow up, non-compliance, withdrew consent.
Danish: e f.eks. manglende opfølgning, manglende compliance, samtykke trukket tilbage.
English: Grey, capsule-shaped, film-coated tablets, of dimensions 15 mm x 7 mm, debossed with “GSI” on one side of the tablet and “255” on the other side of the tablet.
Danish: Grå, kapselformede, filmovertrukne tabletter, der måler 15 mm x 7 mm, præget med ”GSI” på den ene side af tabletten og med ”255” på den anden side af tabletten.
English: No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, rilpivirine or tenofovir alafenamide.
Danish: Der er ikke blevet identificeret klinisk relevante farmakokinetiske forskelle på grund af alder, køn eller etnicitet for emtricitabin, rilpivirin eller tenofoviralafenamid.
English: The safety and efficacy of Odefsey in patients with significant underlying liver disorders have not been established.
Danish: Odefseys sikkerhed og virkning hos patienter med signifikant underliggende leversygdom er ikke klarlagt.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Odefsey.
Danish: En minimal infiltration af histiocytter var til stede i øjet på hunde ved eksponeringer over for hhv. tenofoviralafenamid og tenofovir, der var ca. 4 og 17 gange større, end hvad der forventes efter administration af Odefsey.
English: Odefsey 200 mg/25 mg/25 mg film-coated tablets
Danish: Odefsey 200 mg/25 mg/25 mg filmovertrukne tabletter
English: H2-antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines can decrease the amount of rilpivirine (a component of Odefsey) in your blood.
Danish: H2-antagonister (famotidin, cimetidin, nizatidin eller ranitidin) Disse lægemidler kan mindske mængden af rilpivirin (et indholdsstof i Odefsey) i Deres blod.
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Danish: Patienter med en virusbelastning ved baseline > 100.000 hiv 1-rna-kopier/ml, som fik virologisk svigt, havde en højere forekomst af resistens over for NNRTI-klassen som følge af behandlingen.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og tabletbeholderen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: c n = 539 (TAF) or 841 (TFV) adults (GS-US-292-0111 and GS-US-292-0104, population PK analysis).
Danish: c n = 539 (TAF) eller 841 (TFV) voksne (GS-US-292-0111 og GS-US-292-0104, populationsfarmakokinetisk analyse).
English: The use of Odefsey in children aged 11 years or under or weighing less than 35 kg has not yet been studied.
Danish: Anvendelsen af Odefsey til børn i alderen 11 år eller derunder, eller som vejer under 35 kg, er endnu ikke undersøgt.
English: The mutations associated with NRTI resistance that developed in 3 or more patient isolates were: K65R, K70E, M184V/I and K219E.
Danish: De mutationer associeret med NRTI-resistens, der udviklede sig i 3 eller flere patientisolater, var: K65R, K70E, M184V/I og K219E.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Danish: Rilpivirin udviste aktivitet mod laboratoriestammer af vildtype hiv 1 i en stærkt inficeret T-cellelinje med en median EC50-værdi for hiv 1/IIIB på 0,73 nM (0,27 ng/ml).
English: No dose adjustments are required.
Danish: Dosisjusteringer er ikke nødvendige.
English: It is possible that in the future, long-term users of Odefsey may get kidney problems.
Danish: Det er muligt, at patienter i fremtiden, der har brugt Odefsey gennem længere tid, kan få nyreproblemer.
English: • Medicines for stomach ulcers, heartburn or acid reflux such as:
Danish: • Lægemidler mod mavesår, halsbrand og sure opstød som f.eks.:
English: Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir alafenamide on fertility (see section 5.3).
Danish: Dyrestudier tyder ikke på skadelige virkninger af emtricitabin, rilpivirinhydrochlorid eller tenofoviralafenamid på fertiliteten (se pkt.
English: The median increase from baseline for these parameters was greater in patients receiving FTC + TAF compared with patients receiving FTC + TDF (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Danish: Den mediane stigning fra baseline for disse parametre var større hos patienter, der fik FTC + TAF, sammenlignet med patienter, der fik FTC + TDF (p < 0,001 for forskellen mellem behandlingsgrupperne angående fasteværdier for total-kolesterol, direkte LDL- og HDL-kolesterol samt triglycerider).
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Danish: Lægemidler, der inducerer eller hæmmer CYP3A, kan således påvirke rilpivirin-clearance (se pkt.
English: AUC: ↑ Cmax: ↑
Danish: Cmax: ↑
English: Treatment-naïve adults in Studies GS-US-292-0104 and GS-US-292-0111b
Danish: Behandlingsnaive voksne i studierne GS-US-292-0104 og GS-US-292-0111b
English: Nucleos(t)ide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine.
Danish: Nukleosid/nukleotid-analoger kan påvirke mitokondriefunktionen i varierende grad; dette er mest udtalt ved stavudin, didanosin og zidovudin.
English: severe skin reactions with systemic symptoms4, angioedema5, 6, pruritus3, urticaria6 Musculoskeletal and connective tissue disorders Uncommon:
Danish: svære hudreaktioner med systemiske symptomer4, angioødem5,6, pruritus3, urticaria6 Knogler, led, muskler og bindevæv Ikke almindelig:
English: In Studies GS-US-292-0104 and GS-US-292-0111, the rate of virologic success was similar across patient subgroups (age, gender, race, baseline HIV-1 RNA, or baseline CD4+ cell count).
Danish: I studierne GS-US-292-0104 og GS-US-292-0111 var den virologiske succesrate den samme i alle patientundergruppe (alder, køn, race, hiv 1-rna ved baseline eller CD4+ celletal ved baseline).
English: • increased levels of liver enzymes in the blood
Danish: • forhøjede niveauer af leverenzymer i blodet
English: The virologic failure rate in patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine at Week 48 and Week 96 was 9.5% and 11.5% respectively, and 4.2% and 5.1% in the emtricitabine/tenofovir disoproxil fumarate + efavirenz arm.
Danish: Forekomsten af virologisk svigt hos patienter behandlet med emtricitabin/tenofovirdisoproxilfumarat + rilpivirin var i uge 48 og uge 96 henholdsvis 9,5 % og 11,5 %, og 4,2 % og 5,1 % i armen med emtricitabin/tenofovirdisoproxilfumarat + efavirenz.
English: depression1, abnormal dreams1, 3, sleep disorders1, depressed mood1
Danish: depression1, unormale drømme1,3, søvnforstyrrelser1, forsænket stemningsleje1
English: On days of haemodialysis, Odefsey should be administered after completion of haemodialysis treatment.
Danish: På dage med hæmodialyse, skal Odefsey administreres efter fuldført hæmodialysebehandling.
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Danish: Rilpivirin er en hæmmer af transportøren MATE-2K in vitro med en IC50 på < 2,7 nM.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Danish: Tenofovirs binding in vitro til humane plasmaproteiner var < 0,7 % og er uafhængig af koncentrationen i intervallet 0,01-25 µg/ml.
English: The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Danish: Den farmakokinetiske eksponering for rilpivirin hos patienter med samtidig infektion, var sammenlignelig med den hos patienter uden samtidig infektion.
English: Due to increased plasma stability and intracellular activation through hydrolysis by cathepsin A, tenofovir alafenamide is more efficient than tenofovir disoproxil fumarate in loading tenofovir into peripheral blood mononuclear cells (PBMCs) (including lymphocytes and other HIV target cells) and macrophages.
Danish: Som følge af en øget plasmastabilitet og intracellulær aktivering via hydrolyse af cathepsin A er tenofoviralafenamid mere effektivt end tenofovirdisoproxilfumarat til indføring af tenofovir i mononukleære celler i perifert blod (PBMC'er, peripheral blood mononuclear cells) (herunder lymfocytter og andre hiv-målceller) og makrofager.
English: In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, the only single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were K101P and Y181V/I.
Danish: I et panel med 67 hiv 1-rekombinante laboratoriestammer med én resistensassocieret mutation på RT-positioner associeret med NNRTI-resistens var de eneste enkeltresistensassocierede mutationer associeret med tab af modtagelighed for rilpivirin K101P og Y181V/I.
English: Odefsey should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Danish: Odefsey bør ikke administreres sammen med andre antiretrovirale lægemidler (se pkt.
English: Lower exposures of rilpivirine (one of the components of Odefsey) were observed during pregnancy; therefore viral load should be monitored closely.
Danish: Der er observeret lavere eksponeringer for rilpivirin (et af indholdsstofferne i Odefsey) under graviditet, hvorfor virusbelastningen bør monitoreres tæt.
English: It is not known whether rilpivirine or tenofovir alafenamide are excreted in human milk.
Danish: Det er ukendt, om rilpivirin eller tenofoviralafenamid udskilles i human mælk.
English: 2 This adverse reaction was not observed in the Phase 3 studies of emtricitabine + tenofovir alafenamide in combination with elvitegravir + cobicistat or in the Phase 3 studies with Odefsey but identified from clinical studies or post-marketing experience of emtricitabine when used with other antiretrovirals.
Danish: 2 Denne bivirkning blev ikke observeret i fase 3-studierne med emtricitabin + tenofoviralafenamid i kombination med elvitegravir + cobicistat eller i fase 3-studierne med Odefsey, men den blev identificeret for emtricitabin i kombination med andre antiretrovirale midler i kliniske studier eller efter markedsføring.
English: Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Danish: Tenofoviralafenamid er ikke en hæmmer eller induktor af CYP3A in vivo.
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 efter 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 efter region (USA eller uden for USA).
English: • Ciclosporin, a medicine used to reduce the strength of the body's immune system: This medicine can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
Danish: • Ciclosporin, et lægemiddel der anvendes til at reducere styrken af kroppens immunsystem: Dette lægemiddel kan øge mængden af rilpivirin og tenofoviralafenamid (indholdsstoffer i Odefsey) i Deres blod.
English: Table 3: Virologic outcomes of Studies GS-US-292-0104, GS-US-292-0111 at Week 48 and Week 144a, and GS-US-292-0109 at Week 48a
Danish: Tabel 3: Virologiske resultater af studierne GS-US-292-0104, GS-US-292-0111 ved uge 48 og uge 96 144a og GS-US-292-0109 ved uge 48a
English:  If any of these applies to you, talk to your doctor before taking Odefsey.
Danish:  Hvis noget af dette gælder for Dem, skal De kontakte lægen, før De tager Odefsey.
English: If you forget to take Odefsey
Danish: Hvis De har glemt at tage Odefsey
English: PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil (50 mg single dose)/ Rilpivirine1
Danish: PHOSPHODIESTERASE TYPE 5 (PDE-5)-HÆMMERE Sildenafil (enkelt dosis på 50 mg)/ rilpivirin1
English: What you need to know before you take Odefsey Do not take Odefsey:
Danish: Det skal De vide, før De begynder at tage Odefsey Tag ikke Odefsey:
English: Additionally, in a clinical drug-drug interaction study with tenofovir alafenamide, which is more sensitive to intestinal P-gp inhibition, rilpivirine did not affect tenofovir alafenamide exposures when administered concurrently, indicating that rilpivirine is not a P-gp inhibitor in vivo.
Danish: I et klinisk lægemiddelinteraktionsstudie med tenofoviralafenamid, som er mere følsomt over for hæmning af P-gp i tarmene, påvirkede rilpivirin desuden ikke eksponering for tenofoviralafenamid ved samtidig administration, hvilket tyder på, at rilpivirin ikke er en P-gphæmmer in vivo.
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole Dexlansoprazole
Danish: Lansoprazol Rabeprazol Pantoprazol Esomeprazol Dexlansoprazol
English: No dose adjustment of Odefsey is required in patients with mild (Child Pugh Class A) or moderate (Child Pugh Class B) hepatic impairment.
Danish: Dosisjustering af Odefsey er ikke nødvendig hos patienter med let nedsat leverfunktion (Child-Pugh klasse A) eller moderat nedsat leverfunktion (Child-Pugh klasse B).
English: In the Phase 3 studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
Danish: I fase III-studierne (C209 og C215) er lavere eksponering for rilpivirin, som ligner den der ses under graviditet, blevet associeret med øget risiko for virologisk svigt, hvorfor virusbelastningen bør monitoreres tæt (se pkt.
English: FTC/TDF + rilpivirine hydrochloride was non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to FTC/TDF + efavirenz.
Danish: FTC/TDF + rilpivirinhydrochlorid var non-inferiørt for så vidt angår hiv 1-rna < 50 kopier/ml sammenlignet med FTC/TDF + efavirenz.
English: Tenofovir alafenamide is a substrate of organic anion transporting polypeptide (OATP) 1B1 and OATP1B3 in vitro.
Danish: Tenofoviralafenamid er et substrat for organisk aniontransporterende polypeptid (OATP) 1B1 og OATP1B3 in vitro.