natgillin/translations-raw huggingface dataset:
K103Nsubstitutionen alene medførte ikke nedsat følsomhed for rilpivirin, men kombinationen af K103N og L100I medført en syvdobbelt reduktion af følsomheden for rilpivirin.
The K103N substitution did not result in reduced susceptibility to rilpivirine by itself, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Erfaringen med overdosering af rilpivirin er begrænset.
Human experience of overdose with rilpivirine is limited.
Der foreligger begrænsede oplysninger om brug af EDURANT til patienter med let til moderat nedsat leverfunktion (Child-Pugh-score A eller B).
There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
I disse studier blev respons ikke påvirket af tilstedeværelsen af mutationerne V90I og V189I ved baseline.
In the trials, the presence of the mutations V90I and V189I, at baseline, did not affect response.
Rilpivirin hæmmer ikke humane cellulære DNApolymeraser α, β og γ.
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Dyrestudier har ikke vist tegn på relevant embryonal eller føtal toksicitet eller påvirkning af den reproduktive funktion.
Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
- Fortæl det straks til lægen, hvis du mærker symptomer på infektion (f.eks. feber, kulderystelser, svedeture).
- Tell your doctor immediately if you notice any symptoms of infections (for example, fever, chills, sweats).
Ligesom for andre antiretrovirale lægemidler bør resistensundersøgelser være vejledende for brugen af EDURANT.
As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
EDURANT er hovedsageligt undersøgt hos patienter med normal nyrefunktion.
EDURANT has mainly been studied in patients with normal renal function.
Rilpivirin hæmmer P-glykoprotein in vitro ((IC50 er 9,2 μM).
Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM).
De farmakokinetiske data påviste, at den samlede eksponering (AUC) for rilpivirin som en del af et antiretroviralt regimen var ca. 30 % lavere under graviditet sammenlignet med postpartum (6-12 uger).
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
På grund af både den potentielle risiko for hiv-smitte og risikoen for bivirkninger hos det ammede barn bør mødre informeres om, at de ikke bør amme, hvis de er i behandling med rilpivirin.
Because of both the potential for HIV transmission and the potential for adverse reactions in breastfed infants, mothers should be instructed not to breast-feed if they are receiving rilpivirine.
Disse resistensassocierede mutationer blev udledt fra in vivo-data, der kun vedrørte behandlingsnaive forsøgspersoner, og de kan derfor ikke anvendes til at forudsige virkningen af rilpivirin hos personer der har haft virologisk svigt i et antiretroviralt behandlingsregime.
These resistance-associated mutations were derived from in vivo data involving treatment-naïve subjects only and therefore cannot be used to predict the activity of rilpivirine in subjects who have virologically failed an antiretroviral-containing regimen.
Forventet forskel i responsrater (95 % CI) for analysen i uge 48: 1,6 % (-2,2 %; 5,3 %) og for analysen i uge 96: -0,4 % (-4,6 %; 3,8 %); begge p-værdi < 0,0001 (noninferioritet ved en margin på 12 %) fra logistisk regressionsmodel, herunder stratificeringsfaktorer og studie.
Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study.
Der blev ikke indberettet nogen grad 3-4 abnorme laboratorieværdier for ASAT/ALAT eller grad 3-4 bivirkninger med relation til forhøjede aminotransferaser.
No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Eksponeringen for rilpivirin var ca. 40 % lavere, når EDURANT blev taget i fastende tilstand sammenlignet med et måltid med et normalt kalorieindhold (533 kcal) eller et måltid med et højt fedtindhold og et højt kalorieindhold (928 kcal).
The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal).
Interaktioner mellem rilpivirin og samtidigt indgivne lægemidler er angivet i tabel 1 (forhøjelse angives med "↑", reduktion angives med "↓", ingen ændring angives med "↔", ikke relevant angives med "IR", konfidensinterval angives med "CI").
Interactions between rilpivirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not applicable as “NA”, confidence interval as “CI”).
FOSFODIESTERASE-5-HÆMMERE (PDE5-HÆMMERE) Sildenafil*
PHOSPHODIESTERASE TYPE 5 (PDE-5) INHIBITORS Sildenafil*
Farmakokinetik for totalrilpivirin (gennemsnit ± SD, tmax: median [interval])
Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range])
H2-receptorantagonister bør ikke tages to gange dagligt.
H2-receptor antagonists should not be taken in a twice a day regimen.
Rilpivirin bibeholdt sensitivitet (FC ≤ BCO) over for 62 % af 4.786 hiv 1-rekombinante kliniske isolater, der var resistente over for efavirenz og/eller nevirapin.
Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Aktiviteten af rilpivirin medieres af ikke-kompetitiv hæmning af hiv 1 revers transcriptase (RT).
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Der findes ingen data om rilpivirins virkning på fertiliteten hos mennesker.
No human data on the effect of rilpivirine on fertility are available.
Der er ikke set klinisk relevante virkninger på fertiliteten i dyrestudier (se pkt.
No clinically relevant effects on fertility were seen in animal studies (see section 5.3).
Reduktionen i de farmakokinetiske parametre for ubundet (dvs. aktiv) rilpivirin under graviditet sammenlignet med postpartum var mindre udtalt end for total-rilpivirin.
The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.
ANDRE LÆGEMIDLER ANTIEPILEPTIKA Carbamazepin Oxcarbazepin Phenobarbital Phenytoin
OTHER AGENTS ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Det kan dog ikke helt udelukkes, at rilpivirin kan øge eksponeringen for andre lægemidler, der transporteres af P-glykoprotein, og som er mere følsomme for hæmning af P-glykoprotein i tarmen, f.eks. dabigatranetexilat.
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate.
- Fortæl det til lægen, hvis du tager lægemidler, der kan give livstruende uregelmæssig hjerterytme (torsades de pointes).
- Tell your doctor if you are taking any medicines that may cause a life-threatening irregular heartbeat (Torsade de Pointes).
Meget almindelige: - hovedpine - kvalme - vanskelighed ved at falde i søvn (søvnløshed) - svimmelhed - ændringer i resultatet af dine rutinemæssige leverprøver (aminotransferaser) - stigning i blodets indhold af kolesterol og/eller pancreas-amylase
Very common: - headache - nausea - difficulty falling asleep (insomnia) - dizziness - changes in one of your routine liver tests (transaminase) - increase in cholesterol and/or pancreatic amylase in your blood
Rilpivirin-resistente stammer blev selekterede i cellekultur startende fra vildtype hiv 1 af forskellig oprindelse og undertyper samt NNRTI-resistent hiv 1.
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI resistant HIV-1.
EDURANT er ikke blevet evalueret hos patienter, som tidligere har oplevet virologisk svigt af anden retroviral behandling.
EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Patienterne i kontrolgruppen fik efavirenz 600 mg x 1 som tillæg til BR i begge dele af studiet.
Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Det tilhører en gruppe af hiv-medicin, som kaldes non-nukleosid reverse transcriptasehæmmere (NNRTI).
It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Disse rilpivirin resistensassocierede mutationer bør kun anvendes til at vejlede brug af EDURANT i den behandlingsnaive population.
These rilpivirine resistance-associated mutations should only guide the use of EDURANT in the treatment-naïve population.
Hvis du tager ribabutin (medicin til behandling af visse infektioner, der skyldes bakterier): Tag to tabletter EDURANT en gang dagligt.
If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
De hyppigste bivirkninger (samtlige grader, over eller lig med 10 %) var hovedpine (19,4 %), depression (19,4 %), døsighed (13,9 %) og kvalme (11,1 %).
The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%).
Hvis du bemærker det inden for 12 timer efter det tidspunkt, hvor du normalt tager EDURANT, skal du tage tabletten snarest muligt.
If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible.
MAKROLIDANTIBIOTIKA Clarithromycin
MACROLIDE ANTIBIOTICS Clarithromycin
Respons (konfirmeret < 50 hiv-1 RNA kopier/ml)
Response (confirmed < 50 HIV-1 RNA copies/ml)
Rilpivirin er testet negativt ved fravær og tilstedeværelse af et metabolisk aktiveringssystem i in vitro-Ames revers mutationstest og in vitro-clastogenicitetsanalysen af muselymfomer.
Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay.
Rilpivirin udskilles i mælk hos rotter.
Rilpivirine is excreted in the milk of rats.
Der blev ikke identificeret nye sikkerhedsproblemer i analysen i uge 240 i TMC278-C213-studiet hos unge.
There were no new safety concerns identified in the Week 240 analysis of the TMC278-C213 trial in adolescents.
Af disse virologiske svigt forekom henholdsvis 9 ud af 24 og 4 ud af 14 hos forsøgspersoner med en viral load på < 100.000 kopier/ml ved baseline.
Of these virologic failures, 9 out of 24 and 4 out of 14 were in subjects with a baseline viral load < 100,000 copies/ml, respectively.
Eksponeringen for rilpivirin var generelt lavere hos hiv 1-inficerede patienter end hos raske forsøgspersoner.
Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects.
Bivirkningerne er opført efter systemorganklasse og frekvens.
The ADRs are listed by system organ class (SOC) and frequency.
ANTIINFEKTIVA Antiretrovirale midler Hiv-NRTI/N[t]RTI Didanosin*
ANTI-INFECTIVES Antiretrovirals HIV NRTIs/N[t]RTIs
Hvis du har glemt at tage EDURANT
If you forget to take EDURANT
Den større risiko for virologisk svigt hos patienter i rilpivirin-gruppen blev observeret i løbet af de først 48 uger af disse studier (se pkt.
The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials (see section 5.1).
Lægemidler, som påvirkes af rilpivirin
Medicinal products that affect rilpivirine exposure
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med rilpivirin i en eller flere undergrupper af den pædiatriske population til behandling af humant immundefektvirus type 1-(hiv 1-) infektion (se pkt.
The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus (HIV-1) infection (see section 4.2 for information on paediatric use).
Sammenlignelig effekt blev påvist for rilpivirin i hvert af studierne, hvilket påviste noninferioritet i forhold til efavirenz.
Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
EDURANT indeholder: - Aktivt stof: rilpivirin i form af rilpivirinhydrochlorid.
What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Hvis du tilhører denne aldersgruppe, skal du tale med lægen om, hvorvidt du kan tage EDURANT.
If you belong to this age group, please discuss the use of EDURANT with your doctor.
Det kan ikke udelukkes, at der er risiko for øget dabigatran-plasmakoncentration.
A risk for increases in dabigatran plasma concentrations cannot be excluded.
Resultaterne for unge (fra 12 til under 18 år) i TMC278-C213-studiet var generelt på linje med disse data (se pkt.
Findings in adolescents (12 to less than 18 years of age) in trial TMC278-C213 were generally in line with these data (for details see section 5.1).
Selv om der med rilpivirin er påvist begrænset in vitro-aktivitet mod hiv-2 med EC50-værdier fra 2.510 til 10.830 nM (920 til 3.970 ng/ml), anbefales behandling af hiv-2-infektion med rilpivirin ikke, på grund af fraværet af kliniske data.
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/ml), treatment of HIV-2 infection with rilpivirine is not recommended in the absence of clinical data.
Der blev observeret lavere eksponering for rilpivirin, når rilpivirin 25 mg blev taget én gang daglig under graviditet.
Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy.
EDURANT indeholder rilpivirin, der anvendes til behandling af hiv-infektion (dvs. smitte med humant immundefektvirus).
EDURANT contains rilpivirine that is used for the treatment of Human Immunodeficiency Virus (HIV) infection.
Andre boostede PI (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
QT-forlængende lægemidler
QT prolonging medicinal products
Det kan dog ikke udelukkes, at eksponering for farmakologisk aktivt, ubundet rilpivirin øges signifikant ved moderat nedsat leverfunktion.
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment.
Inddelt efter viral load ved baseline (kopier/ml)
By baseline viral load (copies/ml)
Der er ikke observeret klinisk relevante forskelle i farmakokinetikken for rilpivirin mellem mænd og kvinder.
No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Under graviditetens 3. trimester var værdierne for Cmax, AUC24h og Cmin henholdsvis 20 %, 31 % og 42 % lavere ved sammenligning med postpartum.
rd trimester of pregnancy, Cmax, AUC24h and Cmin values were, respectively, 20%, 31% and 42% lower as compared to postpartum.
Det samme blev observeret i efavirenz-gruppen.
This observation was the same in the efavirenz arm.
- Øvrige indholdsstoffer i den filmovertrukne tabletkerne: lactosemonohydrat, croscarmellosenatrium, povidon K30, polysorbat 20, silicificeret mikrokrystallinsk cellulose og magnesiumstearat.
- The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Resistens over for rilpivirin blev fastsat som en ændring (i fold) i EC50-værdien over analysens biologiske skæringspunkt.
Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Rilpivirin har også vist antiviral aktivitet mod et bredt panel af hiv 1 gruppe M (undertype A, B, C, D, F, G, H) primære isolater med EC50-værdier fra 0,07 til 1,01 nM (0,03 til 0,37 ng/ml) og gruppe O primære isolater med EC50-værdier fra 2,88 til 8,45 nM (1,06 til 3,10 ng/ml).
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/ml) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/ml).
Der kræves ingen dosisjustering ved påbegyndelse af samtidig indgift af methadon og rilpivirin.
No dose adjustments are required when initiating co-administration of methadone with rilpivirine.
Der blev observeret lavere eksponering for rilpivirin under graviditet, og viral load skal derfor overvåges nøje.
Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
I et klinisk studie sås ingen signifikant påvirkning af digoxins farmakokinetik.
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
EDURANT skal indtages oralt en gang dagligt i forbindelse med et måltid (se pkt.
EDURANT must be taken orally, once daily with a meal (see section 5.2).
Lægemidler, der inducerer eller hæmmer CYP3A, kan således påvirke clearance af rilpivirin (se pkt.
Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Patienter, som er co-inficeret med hepatitis B- og/eller hepatitis C-virus Hos patienter, der var co-inficeret med hepatitis B- eller C-virus, og som fik rilpivirin, var forekomsten af forhøjede leverenzymer højere end hos patienter, der fik rilpivirin, og som ikke havde co-infektion.
Patients co-infected with hepatitis B and/or hepatitis C virus In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected.
I et panel af 67 hiv 1-rekombinante laboratoriestammer med en resistensassocieret mutation ved RTpositioner forbundet med NNRTI-resistens, herunder de hyppigst sete K103N og Y181C, viste rilpivirin antiviral aktivitet mod 64 (96 %) af disse stammer.
In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains.
I THRIVE blev randomiseringen stratificeret ud fra viral load ved screening og ud fra N(t)RTI-baggrundsregime.
In THRIVE, randomisation was stratified by screening viral load and by N(t)RTI BR.
Graviditetens 3. trimester (n=13)
Trimester of pregnancy (n=13)
I et studie, hvor 8 patienter med let nedsat leverfunktion (Child-Pugh-score A) blev sammenlignet med 8 matchede kontrolpersoner, og 8 patienter med moderat nedsat leverfunktion (Child-Pugh-score B) blev sammenlignet med 8 matchede kontrolpersoner, var eksponeringen ved flere doser af rilpivirin 47 % højere hos patienter med let nedsat leverfunktion og 5 % højere hos patienter med moderat nedsat leverfunktion.
In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score 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.
EDURANT bør ikke kombineres med andre non-nukleosid reverse transcriptasehæmmere (NNRTI) såsom delavirdin, efavirenz, etravirin og nevirapin.
It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.
EDURANT er i kombination med andre antiretrovirale lægemidler indiceret til behandling af humant immundefektvirus type 1- (hiv 1-) infektion hos antiretroviral-naive patienter fra 12 år med en viral load på ≤ 100.000 hiv 1-RNA-kopier/ml.
EDURANT, in combination with other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-naïve patients 12 years of age and older with a viral load ≤ 100,000 HIV-1 RNA copies/ml.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter frekvens med de hyppigste først.
Within each frequency grouping, ADRs are presented in order of decreasing frequency.
Dette interaktionsstudie blev udført med en højere dosis rilpivirin end den anbefalede dosis til vurdering af den maksimale effekt på det samtidigt indgivne lægemiddel.
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.
Yderligere oplysninger om EDURANT findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
For en sikkerheds skyld bør EDURANT undgås under graviditeten.
As a precautionary measure, it is preferable to avoid the use of EDURANT during pregnancy.
EDURANT kan ikke kurere hiv-infektionen.
EDURANT is not a cure for HIV infection.
Didanosin skal tages på tom mave mindst to timer før eller mindst fire timer efter EDURANT (som skal tages sammen med et måltid).
Didanosine should be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal).
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Dette interaktionsstudie blev udført med en højere dosis rilpivirin end den anbefalede.
This interaction study has been performed with a dose higher than the recommended dose for rilpivirine.
Rilpivirins sikkerhed og virkning hos børn i alderen < 12 år er endnu ikke klarlagt.
The safety and efficacy of rilpivirine in children aged < 12 years have not yet been established.
Eksponeringerne ved embryoføtale niveauer uden observerede negative effekter (NOAEL) hos rotter og kaniner var henholdsvis 15 og 70 gange højere end eksponeringen hos mennesker ved den anbefalede dosis 25 mg x 1
The exposures at the embryo-foetal No Observed Adverse Effects Levels (NOAELs) in rats and rabbits were respectively 15 and 70 times higher than the exposure in humans at the recommended dose of 25 mg once daily.
(induktion af CYP3A pga. høj dosis rilpivirin i studiet)
(induction of CYP3A due to high rilpivirine dose in the study)
Hud og subkutane væv Almindelige udslæt
Skin and subcutaneous tissue disorders common rash
Hvid til offwhite, rund, bikonveks, filmovertrukket tablet, diameter 6,4 mm, præget med "TMC" på den ene side og "25" på den anden side.
White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Virologisk resultat hos unge forsøgspersoner i TMC278-C213-studiet - analyse i uge 48 og uge 240; ITT-TLOVR* Uge 48 N=36
Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
R(-) methadon AUC ↓ 16 % R(-) methadon Cmin ↓ 22 % R(-) methadon Cmax ↓ 14 % rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * baseret på historiske kontroller
R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Silicificeret mikrokrystallinsk cellulose Magnesiumstearat
Silicified microcrystalline cellulose Magnesium stearate