natgillin/translations-raw huggingface dataset:
Hiv-proteasehæmmere - uden samtidig indgift af lavdosis ritonavir Ikke-boostede PI (atazanavir, fosamprenavir, indinavir, nelfinavir)
HIV PIs - without co-administration of low dose ritonavir Unboosted PIs (atazanavir, fosamprenavir, indinavir, nelfinavir)
I betragtning af alle de tilgængelige in vitro- og in vivo-data hos behandlingsnaive forsøgspersoner kan følgende resistensassocierede mutationer påvirke aktiviteten af rilpivirin, når de er til stede ved baseline: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I og M230L.
Considering all of the available in vitro and in vivo data in treatment-naïve subjects, the following resistance-associated mutations, when present at baseline, may affect the activity of rilpivirine: K101E, K101P, E138A, E138G, E138K, E138R, E138Q, V179L, Y181C, Y181I, Y181V, Y188L, H221Y, F227C, M230I, and M230L.
3 om, hvordan du skal tage EDURANT: "Vejledning i brug til voksne og unge (fra 12 til under 18 år)".
EDURANT, please carefully read how to take EDURANT in section 3 “Instructions for proper use in adults and adolescents (12 to less than 18 years of age)”.
Samtidig brug af EDURANT og azol-antimykotika kan øge plasmakoncentrationen af rilpivirin.
Concomitant use of EDURANT with azole antifungal agents may cause an increase in the plasma concentrations of rilpivirine.
Der kræves ingen dosisjustering af EDURANT til ældre patienter (se pkt.
No dose adjustment of EDURANT is required in older patients (see section 5.2).
EDURANT 25 mg filmovertrukne tabletter rilpivirin
EDURANT 25 mg film-coated tablets rilpivirine
En populationsfarmakokinetisk analyse af rilpivirin hos hiv-inficerede patienter viste, at etnisk tilhørsforhold ikke havde nogen klinisk relevant effekt på eksponeringen for rilpivirin.
Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
(reduceret absorption pga. stigning i gastrisk pH) H2-RECEPTORANTAGONISTER Famotidin* 40 mg enkeltdosis taget 12 timer før rilpivirin rilpivirin AUC ↓ 9 % rilpivirin Cmin IR rilpivirin Cmax ↔
(reduced absorption due to gastric pH increase) H2-RECEPTOR ANTAGONISTS Famotidine* 40 mg single dose taken 12 hours before rilpivirine rilpivirine AUC ↓ 9% rilpivirine Cmin NA rilpivirine Cmax ↔
Forsøgspersonerne opnåede virologisk respons (to konsekutive virale belastninger < 50 kopier/ml) og opretholdt respons til og med uge 48 og uge 240.
Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48 and week 240.
EDURANT skal tages i forbindelse med et måltid.
EDURANT must be taken with a meal.
6 celler/l).
6 cells/l).
6 celler/l)
6 cells/l)
Andre NRTI'er (abacavir, emtricitabin, lamivudin, stavudin og zidovudin)
Other NRTIs (abacavir, emtricitabine, lamivudine, stavudine and zidovudine)
Til patienter med svært nedsat nyrefunktion eller terminal nyresygdom bør kombinationen af rilpivirin og en stærk CYP3A-hæmmer (f.eks. en ritonavir-boostet hiv-proteasehæmmer) kun anvendes, hvis fordelen opvejer risikoen (se pkt.
In patients with severe renal impairment or end-stage renal disease, the combination of rilpivirine with a strong CYP3A inhibitor (e.g., ritonavir-boosted HIV protease inhibitor) should only be used if the benefit outweighs the risk (see section 5.2).
Medianvarigheden af eksponering var henholdsvis 104,3 og 104,1 uger hos patienterne i rilpivirin-gruppen og efavirenz-gruppen.
The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively.
Hos patienter i samtidig behandling med rifabutin skal dosis af EDURANT øges til 50 mg (to tabletter a 25 mg) 1 gang dagligt.
For patients concomitantly receiving rifabutin, the EDURANT dose should be increased to 50 mg (two tablets of 25 mg each) taken once daily.
Der var flere patienter, som svigtede virologisk med rilpivirin, end patienter som svigtede virologisk med efavirenz, der udviklede lamivudin/emtricitabin associeret resistens (se pkt.
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Rilpivirin bør ikke indgives samtidig med andre NNRTI.
It is not recommended to co-administer rilpivirine with other NNRTIs.
Almindelige: - unormale drømme - udslæt - mavesmerter - depression - træthed - opkastning
Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth
- cimetidin, famotidin, nizatidin, ranitidin (H2-receptorantagonister til behandling af mavesår eller sår på tarmen eller til lindring af halsbrand, der skyldes tilbageløb af syre).
- clarithromycin, erythromycin (antibiotics) - cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
Eftersom rilpivirin i høj grad er bundet til plasmaproteiner, er det usandsynligt, at stoffet vil kunne elimineres signifikant ved hæmodialyse eller peritonealdialyse (se pkt.
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Hvis du har taget for mange tabletter, kan du få hovedpine, kvalme, svimmelhed og/eller unormale drømme.
In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
Tag H2-receptorantagonisten mindst 12 timer før eller mindst 4 timer efter EDURANT (se "Brug af anden medicin sammen med EDURANT" under pkt.
Take the H2-receptor antagonist at least 12 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
I den puljede effektanalyse efter 96 uger i fase III-studierne hos voksne havde patienter behandlet med rilpivirin, som havde en viral load på > 100.000 hiv 1-RNA-kopier/ml ved baseline, en større risiko for virologisk svigt (18,2 % med rilpivirin versus 7,9 % med efavirenz) sammenlignet med patienter med en viral load på ≤ 100.000 hiv 1-RNA-kopier/ml ved baseline (5,7 % med rilpivirin versus 3,6 % med efavirenz).
In the pooled efficacy analysis from the Phase III trials in adults through 96 weeks, patients treated with rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/ml had a greater risk of virologic failure (18.2% with rilpivirine versus 7.9% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/ml (5.7% with rilpivirine versus 3.6% with efavirenz).
Behandlingsnaive hiv 1-inficerede voksne patienter Evidensen for effekten af rilpivirin er baseret på analyserne af data efter 96 uger fra 2 randomiserede, dobbeltblinde, aktivt kontrollerede fase III-studier, TMC278-C209 (ECHO) og TMC278-C215 (THRIVE).
The evidence of efficacy of rilpivirine is based on the analyses of 96 week data from 2 randomised, double-blinded, active-controlled, Phase III trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE).
Indtagelse af EDURANT i fastende tilstand eller kun sammen med en ernæringsdrik kan reducere plasmakoncentrationen af rilpivirin, hvilket muligvis kan reducere den terapeutiske effekt af EDURANT (se pkt.
Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Virologisk svigt i effektanalyse: Omfatter forsøgspersoner med rebound (konfirmeret viral belastning ≥ 50 kopier/ml efter respons) eller som aldrig var supprimerede (ingen konfirmeret viral belastning < 50 kopier/ml, enten i behandling eller efter seponering af behandling pga. manglende eller tabt virkning).
Virologic failure in efficacy analysis: includes subjects who were rebounder (confirmed viral load ≥ 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load < 50 copies/ml, either ongoing or discontinued due to lack or loss of efficacy).
Manglende respons Virologisk svigt I alt
Non-response Virologic failure
I den poolede resistensanalyse fra uge 48 i fase III-studierne havde 62 (ud af i alt 72) med virologiske svigt i rilpivirin-gruppen resistensdata ved baseline og på tidspunktet for svigt.
In the week 48 pooled resistance analysis from the Phase III trials, 62 (of a total of 72) virologic failures in the rilpivirine arm had resistance data at baseline and time of failure.
Lactosemonohydrat Croscarmellosenatrium Povidon K30
Lactose monohydrate Croscarmellose sodium Povidone K30
I studie TMC278-C204 blev der inkluderet 368 hiv 1-inficerede behandlingsnaive voksne patienter, som havde hiv 1-RNA ≥ 5.000 kopier/ml i plasma, tidligere havde fået ≤ 2 ugers behandling med en N(t)RTI eller proteasehæmmer, ikke tidligere havde taget NNRTI og blev screenet for følsomhed over for N(t)RTI og for fravær af specifikke NNRTI-resistensassocierede mutationer.
Study TMC278-C204 enrolled 368 HIV-1 infected treatment-naïve adult patients who had a plasma HIV-1 RNA ≥ 5,000 copies/ml, previously received ≤ 2 weeks of treatment with an N(t)RTI or protease inhibitor, had no prior use of NNRTIs and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Farmakokinetiske resultater for total-rilpivirin efter administration af rilpivirin 25 mg én gang daglig som del af et antiretroviralt regimen under graviditetens 2. trimester, 3. trimester og postpartum
Pharmacokinetic Results of Total Rilpivirine After Administration of Rilpivirine 25 mg Once Daily as Part of an Antiretroviral Regimen, During the 2
Tenofovirdisoproxilfumarat*
Tenofovir disoproxil fumarate*
Sikkerhedsvurderingen er baseret på analysen efter 48 uger af det åbne, enkeltarmede fase II-studie TMC278-C213, i hvilket 36 antiretroviral-naive hiv 1-inficerede unge patienter, der vejede mindst 32 kg, fik rilpivirin (25 mg én gang dagligt) i kombination med andre antiretrovirale midler (se pkt.
The safety assessment is based on the week 48 analysis of the single-arm, open-label, Phase II trial, TMC278-C213, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1).
Virologisk svigt i poolet effektanalyse: Omfatter forsøgspersoner med rebound (konfirmeret viral load ≥ 50 kopier/ml efter respons) eller som aldrig var supprimerede (ingen konfirmeret viral load < 50 kopier/ml, enten i behandling eller efter seponering af behandling pga. manglende eller tab af virkning).
Virologic failure in pooled efficacy analysis: includes subjects who were rebounder (confirmed viral load ≥ 50 copies/ml after being responder) or who were never suppressed (no confirmed viral load < 50 copies/ml, either ongoing or discontinued due to lack or loss of efficacy).
Det virologiske respons blev generelt bevaret under hele studiet: Ud af de 12 forsøgspersoner, der gennemførte studiet, var der viral hæmning hos 10 forsøgspersoner ved slutningen af studiet.
The virologic response was generally preserved throughout the study: of the 12 subjects that completed the study, 10 subjects were suppressed at the end of the study; in the other 2 subjects an increase in viral load was observed only postpartum, for at least 1 subject due to suspected suboptimal adherence.
Hvis du bemærker det efter 12 timer, skal du springe denne dosis over og derefter blot fortsætte med den sædvanlige dosis.
If you notice after 12 hours, then skip that dose and take the next doses as usual.
Tabel 2: Bivirkninger rapporteret hos antiretroviral-naive hiv 1-inficerede voksne patienter behandlet med rilpivirin (poolede data fra analysen i uge 96 i fase III-studierne ECHO og THRIVE) N = 686 Systemorganklasse
Table 2: ADRs reported in antiretroviral treatment-naïve HIV-1 infected adult patients treated with Rilpivirine (pooled data from the week 96 analysis of the Phase III ECHO and THRIVE trials) N=686 System Organ Class (SOC) Frequency Category ADRs (Rilpivirine + BR)
Rilpivirins farmakokinetiske egenskaber er ikke undersøgt hos patienter med nyreinsufficiens.
The pharmacokinetics of rilpivirine have not been studied in patients with renal insufficiency.
Det er ikke sandsynligt, at rilpivirin i en dosis på 25 mg x 1 vil have en klinisk relevant effekt på eksponeringen for lægemidler, der metaboliseres af CYP-enzymer.
Medicinal products that are affected by the use of rilpivirine Rilpivirine at a dose of 25 mg once daily is not likely to have a clinically relevant effect on the exposure of medicinal products metabolised by CYP enzymes.
EDURANT bør anvendes med forsigtighed, når det indgives samtidigt med et lægemiddel med kendt risiko for torsades de pointes.
EDURANT should be used with caution when co-administered with a medicinal product with a known risk of Torsade de Pointes.
Efter indgift som en enkelt peroral dosis af
After single dose oral administration of
Median CD4+ celletal (interval), x 10
Median baseline CD4+ cell count (range), x 10
Hos både han- og hunmus var rilpivirin positivt for hepatocellulære neoplasmer.
In mice, rilpivirine was positive for hepatocellular neoplasms in both males and females.
Hvide til offwhite, filmovertrukne, runde, bikonvekse tabletter præget med "TMC" på den ene side og "25" på den anden side.
What EDURANT looks like and contents of the pack White to off-white, film-coated, round, biconvex tablet, with “TMC” on one side and “25” on the other side.
Der pågår undersøgelser af rilpivirins farmakokinetiske egenskaber hos pædiatriske patienter under 12 år.
The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation.
PROTONPUMPEHÆMMERE Omeprazol*
PROTON PUMP INHIBITORS Omeprazole*
Tag medicinen enten mindst 2 timer før eller mindst 4 timer efter EDURANT (se "Brug af anden medicin sammen med EDURANT" under pkt.
Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Stigning i CD4+ celletal (middel)
Increase in CD4+ cell count (mean)
Antacida bør kun indgives enten mindst 2 timer før eller mindst 4 timer efter rilpivirin.
Antacids should only be administered either at least 2 hours before or at least 4 hours after rilpivirine.
Tabel 3: Sygdomskarakteristika ved baseline for antiretroviralnaive hiv 1-inficerede voksne forsøgspersoner i studierne ECHO og THRIVE (poolet analyse)
Baseline disease characteristics of antiretroviral treatment-naïve HIV-1 infected adult subjects in the ECHO and THRIVE trials (pooled analysis)
Sygdomskarakteristika ved baseline Median hiv 1-RNA (interval), log10 kopier/ml i plasma ved baseline
Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/ml
Forsøgspersonerne opnåede virologisk respons (to konsekutive viral loads < 50 kopier/ml) og opretholdt respons til og med uge 48.
Subjects achieved virologic response (two consecutive viral loads < 50 copies/ml) and maintained it through week 48/96.
Der forventes dosisafhængige fald i rilpivirins plasmakoncentration.
Dose dependent decreases in rilpivirine plasma concentrations are expected.
I denne analyse var de resistensassocierede mutationer (RAM) forbundet med NNRTI-resistens, der blev udviklet i mindst 2 af tilfældene med virologisk svigt af rilpivirin, V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y og F227C.
In this analysis, the resistance-associated mutations (RAMs) associated with NNRTI resistance that developed in at least 2 rilpivirine virologic failures were: V90I, K101E, E138K, E138Q, V179I, Y181C, V189I, H221Y, and F227C.
Didanosin bør indgives mindst 2 timer før eller mindst 4 timer efter rilpivirin.
Didanosine should be administered at least two hours before or at least four hours after rilpivirine.
Hvis du kaster op over 4 timer efter, at du har taget EDURANT, behøver du ikke at tage en tablet, før du skal tage den næste dosis til sædvanlig tid.
If you vomit more than 4 hours after taking EDURANT you do not need to take another tablet until your next regularly scheduled tablet.
Antiretroviralnaive hiv 1-inficerede patienter, som havde hiv 1-RNA ≥ 5.000 kopier/ml i plasma og blev screenet for følsomhed over for N(t)RTI-præparater og for fravær af specifikke NNRTIresistensassocierede mutationer, blev inkluderet.
Antiretroviral treatment-naïve HIV-1 infected patients were enrolled who had a plasma HIV-1 RNA ≥ 5,000 copies/ml and were screened for susceptibility to N(t)RTIs and for absence of specific NNRTI resistance-associated mutations.
Hvis opkastningen finder sted over 4 timer efter indtagelse af lægemidlet, behøver patienten ikke at tage en til dosis EDURANT før den næste planlagte dosis.
If a patient vomits more than 4 hours after taking the medicine, the patient does not need to take another dose of EDURANT until the next regularly scheduled dose.
4.4, 4.6, 5.1 og 5.2).
Alternatively, switching to another ART regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Behandling med rilpivirin Resistens
Rilpivirine-treated Resistance
50 mg enkeltdosis sildenafil AUC ↔ sildenafil Cmin IR sildenafil Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
50 mg single dose sildenafil AUC ↔ sildenafil Cmin NA sildenafil Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Interaktion Geometrisk middelværdi ændring
Interaction Geometric mean change (%)
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukket tablet indeholder 56 mg lactosemonohydrat.
Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Samtidig indgift af rilpivirin og ritonavir-boostede PI øger plasmakoncentrationen af rilpivirin, men dosisjustering er ikke nødvendig.
Concomitant use of rilpivirine with ritonavir-boosted PIs causes an increase in the plasma concentrations of rilpivirine, but no dose adjustment is required.
Svarende til det, der observeredes hos voksne, havde legemsvægten ingen indflydelse på rilpivirins farmakokinetiske egenskaber hos pædiatriske patienter i TMC278-C213-studiet (33 til 93 kg).
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial TMC278-C213 (33 to 93 kg), similar to what was observed in adults.
Hver filmovertrukket tablet indeholder rilpivirin-hydrochlorid svarende til 25 mg rilpivirin.
Each film-coated tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Der er observeret levertoksicitet forbundet med leverenzyminduktion hos gnavere.
Liver toxicity associated with liver enzyme induction was observed in rodents.
Hvis du tager et antacidum (medicin, der bruges til behandling af sygdomme, der forbindes med mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat).
If you take an antacid (a medicine to treat diseases related to the acid in the stomach such as aluminium / magnesium hydroxide, calcium carbonate).
Brug af anden medicin sammen med EDURANT Du skal tage EDURANT sammen med anden hiv-medicin.
You must take EDURANT together with other HIV medicines.
Der sås sammenlignelige responsrater (konfirmeret udetekterbar viral load < 50 hiv 1-RNAkopier/ml) i uge 96 i rilpivirin-gruppen og efavirenz-gruppen.
The response rate (confirmed undetectable viral load < 50 HIV-1 RNA copies/ml) at week 96 was comparable between the rilpivirine arm and the efavirenz arm.
I ECHO blev baggrundsregimet fastsat til N(t)RTIpræparaterne tenofovirdisoproxilfumarat plus emtricitabin.
In ECHO, the BR was fixed to the N(t)RTIs, tenofovir disoproxil fumarate plus emtricitabine.
Nervesystemet meget almindelige hovedpine svimmelhed
Nervous system disorders very common headache dizziness common somnolence
I et studie med raske forsøgspersoner har det vist sig, at supraterapeutiske doser af rilpivirin (75 mg x 1 og 300 mg x 1) forlænger QTc-intervallet på EKG'et (se pkt.
In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
I den poolede analyse for ECHO og THRIVE var demografiske karakteristika og baselinekarakteristika afbalanceret mellem rilpivirin-gruppen og efavirenz-gruppen.
In the pooled analysis for ECHO and THRIVE, demographics and baseline characteristics were balanced between the rilpivirine arm and the efavirenz arm. Table 3 displays selected baseline disease characteristics of the patients in the rilpivirine and efavirenz arms.
raltegravir AUC ↑ 9 % raltegravir Cmin ↑ 27 % raltegravir Cmax ↑ 10 % rilpivirin AUC ↔ rilpivirin Cmin ↔ rilpivirin Cmax ↔
raltegravir AUC ↑ 9% raltegravir Cmin ↑ 27% raltegravir Cmax ↑ 10% rilpivirine AUC ↔ rilpivirine Cmin ↔ rilpivirine Cmax ↔
Hver EDURANT tablet indeholder rilpivirinhydrochlorid svarende til 25 mg rilpivirin.
Each tablet of EDURANT contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Lægemidler, som påvirker eksponeringen for rilpivirin Rilpivirin metaboliseres primært af cytokrom P450 (CYP)3A.
Rilpivirine is primarily metabolised by cytochrome P450 (CYP)3A.
ANALGETIKA Paracetamol* 500 mg enkeltdosis paracetamol AUC ↔ paracetamol Cmin IR paracetamol Cmax ↔ rilpivirin AUC ↔ rilpivirin Cmin ↑ 26 % rilpivirin Cmax ↔
ANALGESICS Paracetamol* 500 mg single dose paracetamol AUC ↔ paracetamol Cmin NA paracetamol Cmax ↔ rilpivirine AUC ↔ rilpivirine Cmin ↑ 26% rilpivirine Cmax ↔
rifabutin AUC ↔ rifabutin Cmin ↔ rifabutin Cmax ↔ 25-O-desacetylrifabutin AUC ↔ 25-O-desacetylrifabutin Cmin ↔ 25-O-desacetylrifabutin Cmax ↔
25-O-desacetyl-rifabutin AUC ↔ 25-O-desacetyl-rifabutin Cmin ↔ 25-O-desacetyl-rifabutin Cmax ↔
300 mg x 1 (+ 25 mg rilpivirin x 1)
300 mg once daily (+ 25 mg once daily rilpivirine)
Samtidig behandling med rilpivirin og antacida bør ske med ekstra forsigtighed.
The combination of rilpivirine and antacids should be used with particular caution.
Samtidig indgift af rilpivirin og lægemidler, der øger gastrisk pH, kan reducere plasmakoncentrationen af rilpivirin, hvilket muligvis kan reducere den terapeutiske effekt af EDURANT.
Co-administration of rilpivirine with medicinal products that increase gastric pH may result in decreased plasma concentrations of rilpivirine which could potentially reduce the therapeutic effect of EDURANT.
BR bestod af 2 investigatorvalgte N(t)RTI: zidovudin plus lamivudin eller tenofovirdisoproxilfumarat plus emtricitabin.
The BR consisted of 2 investigator-selected N(t)RTIs: zidovudine plus lamivudine or tenofovir disoproxil fumarate plus emtricitabine.
Eksponeringen for total-rilpivirin efter indtagelse af rilpivirin 25 mg én gang daglig som en del af et antiretroviralt regimen var lavere under graviditet (tilsvarende 2. og 3. trimester) sammenlignet med postpartum (se tabel 7).
The exposure to total rilpivirine after intake of rilpivirine 25 mg once daily as part of an antiretroviral regimen was lower during pregnancy (similar for the 2
ketoconazol AUC ↓ 24 % ketoconazol Cmin ↓ 66 % ketoconazol Cmax ↔
400 mg once daily ketoconazole AUC ↓ 24% ketoconazole Cmin ↓ 66% ketoconazole Cmax ↔
Behandlingsnaive hiv 1-inficerede voksne patienter I den poolede resistensanalyse efter 96 uger i fase III-studierne (ECHO og THRIVE) udviste 42 ud af 86 forsøgspersoner med virologisk svigt på rilpivirin behandlingsudviklet resistens over for rilpivirin (ved genotypeanalyse).
In the week 96 pooled resistance analysis of the Phase III trials (ECHO and THRIVE), 42 out of 86 subjects with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis).
rilpivirin AUC ↓ 42 % rilpivirin Cmin ↓ 48 % rilpivirin Cmax ↓ 31 %
rilpivirine AUC ↓ 42% rilpivirine Cmin ↓ 48% rilpivirine Cmax ↓ 31%
- antacida (bruges til behandling af sygdomme forårsaget af for meget mavesyre; f.eks. aluminium-/magnesiumhydroxid, calciumcarbonat).
- antacids (used to treat diseases related to the acid in the stomach; for example, aluminium / magnesium hydroxide, calcium carbonate).
300 mg x 1 (+ 50 mg rilpivirin x 1)
300 mg once daily (+ 50 mg once daily rilpivirine)
(induktion af CYP3A-enzymer)
(induction of CYP3A enzymes)