natgillin/translations-raw huggingface dataset:
Hvis patienten glemmer at tage en dosis Odefsey, men kommer i tanker om det inden for 12 timer efter tidspunktet, hvor patienten normalt tager dosen, skal patienten tage Odefsey sammen med mad så snart som muligt og derefter fortsætte med den normale doseringsplan.
If the patient misses a dose of Odefsey within 12 hours of the time it is usually taken, the patient should take Odefsey with food as soon as possible and resume the normal dosing schedule.
f Omfatter patienter, som afbrød behandlingen af andre årsager end en AE, død eller manglende eller svigtende virkning, f.eks. tilbagetrækning af samtykke, tabt for opfølgning osv.
f Includes patients who discontinued for reasons other than an AE, death, or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
HDPE-beholder (højdensitets-polyethylen) med børnesikret skruelåg af polypropylen foret med induktionsaktiveret aluminiumsfolie indeholdende 30 filmovertrukne tabletter.
High density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Tabel 2: Bivirkninger i tabelform
Table 2: Tabulated list of adverse reactions
I studier med Odefsey hos virologisk supprimerede voksne patienter blev der i uge 96 efter skift til Odefsey set stigning i BMD for hofte sammenlignet med minimale ændringer ved fortsat behandling med FTC/RPV/TDF eller EFV/FTC/TDF (middelændring 1,6 % for Odefsey versus -0,6 % for FTC/RPV/TDF, p < 0,001; 1,8 % for Odefsey versus -0,6 % for EFV/FTC/TDF, p < 0,001) og for ryg (middelændring 2,0 % for Odefsey versus -0,3 % for FTC/RPV/TDF, p < 0,001; 1,7 % for Odefsey versus 0,1 % for EFV/FTC/TDF, p < 0,001).
In Odefsey studies in virologically suppressed adult patients, increases in BMD were noted at 96 weeks after switching to Odefsey compared to minimal changes with maintaining FTC/RPV/TDF or EFV/FTC/TDF at the hip (mean change 1.6% for Odefsey versus -0.6% for FTC/RPV/TDF, p < 0.001; 1.8% for Odefsey versus -0.6% for EFV/FTC/TDF, p < 0.001) and the spine (mean change 2.0% for Odefsey versus -0.3% for FTC/RPV/TDF, p < 0.001; 1.7% for Odefsey versus 0.1% for EFV/FTC/TDF, p < 0.001).
syreneutraliserende midler (aluminium-/magnesiumhydroxid eller calciumcarbonat)
antacids (aluminium/magnesium hydroxide or calcium carbonate)
Aktive stoffer: emtricitabin, rilpivirin og tenofoviralafenamid.
The active substances are emtricitabine, rilpivirine and tenofovir alafenamide.
Lægemidler, der aldrig må tages sammen med Odefsey: - carbamazepin, oxcarbazepin, phenobarbital og phenytoin (anvendes til at behandle epilepsi og forebygge krampeanfald) - rifabutin, rifampicin og rifapentin (anvendes til at behandle visse bakterieinfektioner som f.eks. tuberkulose)
Medicines that must never be taken with Odefsey: carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures) rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis)
Hæmning af P-gp
Inhibition of P-gp
Vurderingen af rilpivirins sikkerhed er baseret på data fra uge 48 fra ét åbent studie med en enkelt arm (TMC278-C213) af 36 pædiatriske patienter i alderen 12 til < 18 år, som alle vejede mindst 32 kg. Ingen patienter afbrød behandlingen med rilpivirin på grund af bivirkninger.
The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to < 18 years and weighing at least 32 kg. No patients discontinued rilpivirine due to adverse reactions.
4 Bivirkning identificeret i sikkerhedsovervågningen efter markedsføring af emtricitabin/rilpivirin/tenofovirdisoproxilfumarat.
4 Adverse reaction identified through post-marketing surveillance of emtricitabine/rilpivirine/tenofovir disoproxil fumarate.
Patienter med kronisk hepatitis B eller C, som er i antiretroviral behandling, har en øget risiko for svære og potentielt letale, hepatiske bivirkninger.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Behandlingsnaive hiv 1-inficerede voksne patienter Virkningen af rilpivirin er baseret på analyser af 96 ugers data fra to randomiserede, dobbeltblindede, kontrollerede studier af behandlingsnaive patienter (TMC278-C209 og undersættet med emtricitabin + tenofovirdisoproxilfumarat fra TMC278-C215).
Treatment-naïve HIV-1 infected adult patients The efficacy of rilpivirine is based on the analyses of 96 weeks data from two randomised, double-blind, controlled studies in treatment-naïve patients (TMC278-C209 and emtricitabine + tenofovir disoproxil fumarate subset of TMC278-C215).
Tabel 4: Virologiske resultater af randomiseret behandling i studierne TMC278-C209 og TMC278-C215 (samlede data for patienter, der fik rilpivirinhydrochlorid eller efavirenz i kombination med FTC/TDF) ved uge 48 (primært) og uge 96
Table 4: Virologic outcomes of randomised treatment of Studies TMC278-C209 and TMC278-C215 (pooled data for patients receiving rilpivirine hydrochloride or efavirenz in combination with FTC/TDF) at Week 48 (primary) and Week 96
Emtricitabin er en nukleosid-revers transkriptasehæmmer (NRTI, nucleoside reverse transcriptase inhibitor) og analog til 2'-deoxycytidin.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
I den samlede analyse for TMC278-C209 og TMC278-C215 af 1096 patienter, som fik et baggrundsregime (BR) med FTC/TDF, var demografiske karakteristika og karakteristika ved baseline afbalanceret mellem grupperne med rilpivirin og efavirenz (EFV).
In the pooled analysis for TMC278-C209 and TMC278-C215 of 1,096 patients who received a background regimen (BR) of FTC/TDF, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz (EFV) arms.
Emtricitabin har aktivitet mod hiv 1, hiv 2 og HBV.
Emtricitabine has activity against HIV-1, HIV-2, and HBV.
Der er utilstrækkelige data (færre end 300 gravide forsøgspersoner) fra anvendelse af rilpivirin og tenofoviralafenamid til gravide kvinder (se pkt.
There are a limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine and tenofovir alafenamide in pregnant women (see sections 4.4, 5.1 and 5.2).
Antimykobakterielle lægemidler Rifampicin/rilpivirin
Antimycobacterials Rifampicin/ Rilpivirine
Den kliniske virkning af Odefsey blev klarlagt i studier udført med emtricitabin + tenofoviralafenamid, givet sammen med elvitegravir + cobicistat som en E/C/F/TAFfastdosis-kombinationstablet, i studier med rilpivirin, givet sammen med FTC/TDF som individuelle komponenter eller som en FTC/RPV/TDF-fastdosis-kombinationstablet, og i studier med Odefsey.
Clinical efficacy of Odefsey was established from studies conducted with emtricitabine + tenofovir alafenamide when given with elvitegravir + cobicistat as an E/C/F/TAF FDC tablet, from studies conducted with rilpivirine when given with FTC/TDF as individual components or as a FTC/RPV/TDF FDC tablet, and from studies conducted with Odefsey.
ORALE ANTIKONCEPTIVA Ethinylestradiol (0,035 mg en gang dagligt)/rilpivirin
ORAL CONTRACEPTIVES Ethinylestradiol (0.035 mg once daily)/ Rilpivirine
Cmin: I/R
Cmin: N/A
Der forventes signifikante fald i plasmakoncentrationer af rilpivirin (reduceret absorption, stigning i gastrisk pH).
Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH).
Rilpivirins farmakokinetik hos antiretroviral-naive hiv 1-inficerede pædiatriske patienter i alderen 12 til < 18 år, som fik 25 mg rilpivirin en gang dagligt, kunne sammenlignes med den for behandlingsnaive hiv 1-inficerede voksne, som fik 25 mg rilpivirin en gang dagligt.
The pharmacokinetics of rilpivirine in antiretroviral-naïve HIV-1 infected paediatric patients 12 to < 18 years of age receiving rilpivirine 25 mg once daily was comparable to that in treatment-naïve HIV-1 infected adults receiving rilpivirine 25 mg once daily.
I studierne GS-US-292-0104 og GS-US-292-0111 udviste E/C/F/TAF statistisk superioritet i forhold til E/C/F/TDF i at opnå hiv 1-rna < 50 kopier/ml ved uge 144.
In Studies GS-US-292-0104 and GS-US-292-0111, E/C/F/TAF demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144.
clarithromycin erythromycin Disse lægemidler kan øge mængden af rilpivirin og tenofoviralafenamid (indholdsstoffer i Odefsey) i Deres blod.
clarithromycin erythromycin These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
De hyppigst observerede aminosyresubstitutioner, som opstod, omfattede: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C og M230I.
The most commonly observed amino acid substitutions that emerged included: L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C, and M230I.
Når De snart ikke har mere af Odefsey, skal De bede om mere fra lægen eller på apoteket.
When your supply of Odefsey starts to run low, get more from your doctor or pharmacist.
Disse lægemidler kan øge mængden af rilpivirin og tenofoviralafenamid (indholdsstoffer i Odefsey) i Deres blod.
These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood.
HYPNOTIKA/SEDATIVA Midazolam (2,5 mg enkelt dosis oralt)/tenofoviralafenamid
HYPNOTICS/SEDATIVES Midazolam (2.5 mg, orally, single dose)/ Tenofovir alafenamide
• dexamethason (orale og parenterale doser), undtagen som enkeltdosisbehandling • perikon (Hypericum perforatum).
• dexamethasone (oral and parenteral doses), except as a single dose treatment
Samlet respons og en undergruppeanalyse af virologisk respons (< 50 hiv 1-rna-kopier/ml) ved både 48 uger og 96 uger samt virologisk svigt efter virusbelastning ved baseline (samlede data fra de to kliniske fase 3-studier, TMC278-C209 og TMC278-C215, for patienter, der fik BR FTC/TDF) præsenteres i tabel 4.
Overall response and a subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase 3 clinical studies, TMC278-C209 and TMC278-C215, for patients receiving the FTC/TDF BR) are presented in Table 4.
ANTIDIABETIKA Metformin (850 mg enkeltdosis)/ rilpivirin
ANTIDIABETICS Metformin (850 mg single dose)/ Rilpivirine
Odefsey kan påvirke eller blive påvirket af anden medicin.
Odefsey may interact with other medicines.
Rilpivirin viste også antiviral aktivitet mod et bredt panel af primære isolater af hiv 1 gruppe M (undertype A, B, C, D, F, G, H), med EC50-værdier i intervallet fra 0,07 til 1,01 nM (0,03 til 0,37 ng/ml), primære isolater af gruppe O med EC50-værdier i intervallet fra 2,88 til 8,45 nM (1,06 til 3,10 ng/ml), og det viste begrænset aktivitet in vitro mod hiv 2 med EC50-værdier i intervallet fra 2.510 til 10.830 nM (920 til 3.970 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), group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/mL), and showed limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/mL).
Sikkerheden af emtricitabin + tenofoviralafenamid er ikke klarlagt hos patienter med svært nedsat nyrefunktion (estimeret CrCl ≥ 15 ml/min og < 30 ml/min).
The safety of emtricitabine + tenofovir alafenamide has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
I en samlet virkningsanalyse fra de to kliniske fase 3-studier af voksne (C209 [ECHO] og C215 [THRIVE]) over 96 uger havde patienter, som blev behandlet med emtricitabin/tenofovir disoproxilfumarat + rilpivirin med en virusbelastning ved baseline > 100.000 hiv 1-rna-kopier/ml større risiko for virologisk svigt (17,6 % med rilpivirin kontra 7,6 % med efavirenz) sammenlignet med patienter med en virusbelastning ved baseline ≤ 100.000 hiv 1-rna-kopier/ml (5,9 % med rilpivirin kontra 2,4 % med efavirenz).
In the pooled efficacy analysis from the two Phase 3 clinical studies in adults (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil fumarate + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
Hvis patienten glemmer at tage en dosis Odefsey, og der går mere end 12 timer, skal patienten ikke tage den manglende dosis, men blot fortsætte med den normale doseringsplan.
If a patient misses a dose of Odefsey by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Den observerede stigning i serum-kreatinin hos patienter, som havde let eller moderat nedsat nyrefunktion ved påbegyndelse af studiet, svarede til den stigning, der blev set hos patienter med normal nyrefunktion.
In patients who entered the studies with mild or moderate renal impairment, the serum creatinine increase observed was similar to that seen in patients with normal renal function.
I studiet GS-US-292-0109 var skift fra et regime baseret på tenofovirdisoproxilfumarat til E/C/F/TAF overlegent i forhold til at opretholde hiv 1-rna < 50 kopier/ml sammenlignet med at blive på baselineregimet.
In Study GS-US-292-0109, switching from a tenofovir disoproxil fumarate-based regimen to E/C/F/TAF was superior in maintaining HIV-1 RNA < 50 copies/mL compared to staying on the baseline regimen.
Det gennemsnitlige CD4+ celletal ved baseline var 427 celler/mm3 (interval 0-1.360), og 13 % havde et CD4+ celletal på < 200 celler/mm3.
The mean baseline CD4+ cell count was 427 cells/mm3 (range 0-1,360) and 13% had CD4+ cell counts < 200 cells/mm3.
Emtricitabin viste antiviral aktivitet i cellekultur mod hiv 1 undertype A, B, C, D, E, F og G (EC50-værdier var i intervallet fra 0,007 til 0,075 µM) og viste aktivitet mod hiv 2 (EC50-værdier var i intervallet fra 0,007 til 1,5 µM).
Emtricitabine displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Der blev ikke observeret nogen klinisk relevante forskelle i farmakokinetikken for tenofoviralafenamid eller tenofovir hos raske personer og hos patienter med svært nedsat nyrefunktion (estimeret CrCl ≥ 15 ml/min og < 30 ml/min) i et fase 1-studie af tenofoviralafenamid.
No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
søvnløshed1
insomnia1
Indeholder lactose (som monohydrat).
Contains lactose (as monohydrate), see leaflet for further information.
I studie GS-US-292-0109 blev virkningen og sikkerheden af skift fra enten EFV/FTCTDF, FTC/TDF plus atazanavir (boostet med enten cobicistat eller ritonavir) eller E/C/F/TDF til E/C/F/TAF fastdosis kombinationstablet evalueret i et randomiseret, åbent studie af virologisk supprimerede (hiv 1-rna < 50 kopier/ml) hiv 1-inficerede voksne (n = 959 skiftede til E/C/F/TAF, n = 477 blev på baselineregimet [SBR]).
In Study GS-US-292-0109, the efficacy and safety of switching from either EFV/FTC/TDF, FTC/TDF plus atazanavir (boosted by either cobicistat or ritonavir), or E/C/F/TDF to E/C/F/TAF FDC tablet were evaluated in a randomised, open-label study of virologically suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 959 switching to E/C/F/TAF, n = 477 Stayed on Baseline Regimen [SBR]).
I studier hos behandlingsnaive voksne patienter var 144 ugers behandling med E/C/F/TAF forbundet med mindre reduktioner i knoglemineraltæthed (BMD [bone mineral density] sammenlignet med E/C/F/TDF, målt ved dual-emission X-ray absorptiometry (DXA)-analyse af hofte (gennemsnitlig ændring: -0,8 % versus -3,4 %, p < 0,001) og lænderyg (gennemsnitlig ændring: -0,9 % versus3,0 %), p < 0,001).
In studies in treatment-naïve adult patients, E/C/F/TAF was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF through 144 weeks of treatment as measured by dual energy X ray absorptiometry (DXA) analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001).
Hvis De kaster op mindre end 4 timer efter, at De har taget Odefsey, skal De tage en ny tablet sammen med mad.
If you vomit less than 4 hours after taking Odefsey, take another tablet with food.
Odefsey: Eksponeringer for emtricitabin og tenofoviralafenamid var bioækvivalente ved sammenligning af én 200/25/25 mg Odefsey filmovertrukket tablet med en fastdosis kombinationstablet med elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid (150/150/200/10 mg) efter en enkeltdosis administration til raske forsøgspersoner (n = 82), der havde spist.
Odefsey: Emtricitabine and tenofovir alafenamide exposures were bioequivalent when comparing one Odefsey 200/25/25 mg film-coated tablet to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (150/150/200/10 mg) fixed-dose combination tablet following single dose administration to healthy subjects (n = 82) under fed conditions.
Der var ingen nye sikkerhedsfund i forhold til den kendte sikkerhedsprofil for rilpivirin hos hiv 1-inficerede voksne (se pkt.
There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
Der skal udvises forsigtighed ved brug af Odefsey, når det gives samtidig med lægemidler med en kendt risiko for torsades de pointes.
Odefsey should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes.
NNRTI-resistens-associerede mutationer, som hyppigst udvikledes, var: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y og F227C.
The NNRTI resistance-associated mutations that developed most commonly were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C.
Odefsey bør seponeres hos voksne med estimeret CrCl, der falder til under 30 ml/min under behandlingen (se pkt.
Odefsey should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
I den samlede analyse fra uge 144 af antiretroviral-naive patienter, som fik elvitegravir/cobicistat/emtricitabin/tenofoviralafenamid (E/C/F/TAF) i fase 3-studierne GS-US-292-0104 og GS-US-292-0111, blev der observeret udvikling af en eller flere primære resistens-associerede mutationer i hiv 1-isolater fra 12 af 866 (1,4 %) patienter, der blev behandlet med E/C/F/TAF.
In the Week 144 pooled analysis of antiretroviral-naïve patients receiving elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) in the Phase 3 studies GS-US-292-0104 and GS-US-292-0111, the development of one or more primary resistance-associated mutations was observed in HIV-1 isolates from 12 of 866 (1.4%) patients treated with E/C/F/TAF.
Ved uge 48 havde 92 % af patienterne (66/72) stadig hiv-1 RNA < 50 kopier/ml efter skift til E/C/F/TAF.
At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to E/C/F/TAF.
Antacida (f.eks. aluminiumeller magnesiumhydroxid, calciumcarbonat)
Antacids (e.g., aluminium or magnesium hydroxide, calcium carbonate)
Ved baseline var median hiv 1-rna i plasma 4,7 log10 kopier/ml, median CD4+ celletal var 456 celler/mm3 (interval 95 til 1.110) og median CD4+ var 23 % (interval 7-45).
At baseline, median plasma HIV-1 RNA was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range 95 to 1,110), and median CD4+% was 23% (range 7-45).
Kropsvægt samt lipid- og glucoseniveauerne i blodet kan stige under antiretroviral behandling (se pkt.
Weight and levels of blood lipids and glucose may increase during antiretroviral therapy (see section 4.4).
Tenofoviralafenamid er en nukleotid-revers transkriptasehæmmer (NtRTI, nucleotide reverse transcriptase inhibitor) og et prodrug for tenofovir (2'-deoxyadenosinmonophosphat-analog).
Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Flere patienter, som fik virologisk svigt med rilpivirin, udviklede lamivudin/emtricitabin-forbundet resistens, end det var tilfældet for patienter, der fik virologisk svigt med efavirenz, (se pkt.
More patients who failed virologically on rilpivirine than who failed virologically on efavirenz developed lamivudine/emtricitabine associated resistance (see section 5.1).
Isolater af hiv 1 med nedsat følsomhed for tenofoviralafenamid udtrykte en K65R-mutation i hiv 1 RT.
HIV-1 isolates with reduced susceptibility to tenofovir alafenamide expressed a K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Hvis patienten kaster op mere end 4 timer efter at have taget Odefsey, er det ikke nødvendigt at tage en ny dosis Odefsey, før den næste planlagte dosis.
If a patient vomits more than 4 hours after taking Odefsey they do not need to take another dose of Odefsey until the next regularly scheduled dose.
Ændringer i serum-kreatinin for regimer med rilpivirin De samlede data fra fase 3-studierne TMC278-C209 og TMC278-C215 med behandlingsnaive patienter påviste også, at serum-kreatinin steg, samt at estimeret glomerulær filtreringshastighed (eGFR) mindskedes i løbet af de 96 uger med behandling med rilpivirin.
Changes in serum creatinine for rilpivirine-containing regimens The pooled data from the Phase 3 TMC278-C209 and TMC278-C215 studies of treatment-naïve patients also demonstrate that serum creatinine increased and estimated glomerular filtration rate (eGFR) decreased over 96 weeks of treatment with rilpivirine.
I studie GS-US-366-1216 var den gennemsnitlige ændring fra baseline i CD4+-celletal i uge 96 12 celler/mm3 hos patienter, der skiftede til Odefsey, og 16 celle/mm3 hos dem, der forblev på FTC/RPV/TDF.
In Study GS-US-366-1216, the mean change from baseline in CD4+ cell count at Week 96 was 12 cells/mm3 in patients who switched to Odefsey and 16 cells/mm3 in those who remained on FTC/RPV/TDF.
ANTIARYTMIKA Digoxin/rilpivirin
ANTIARRHYTHMICS Digoxin/ Rilpivirine
Hvis patienten kaster op inden for 4 timer efter at have taget Odefsey, skal der tages en ny tablet sammen med mad.
If the patient vomits within 4 hours of taking Odefsey another tablet should be taken with food.
Eksponeringer for rilpivirin var bioækvivalente ved sammenligning af 200/25/25 mg Odefsey med én filmovertrukket tablet med 25 mg rilpivirin (som hydrochlorid) efter enkeltdosis administration til raske forsøgspersoner (n = 95), der havde spist.
Rilpivirine exposures were bioequivalent when comparing Odefsey 200/25/25 mg to one rilpivirine (as hydrochloride) 25 mg film-coated tablet following single dose administration to healthy subjects (n = 95) under fed conditions.
c Der var 17 nye virologiske svigt mellem den primære analyse i uge 48 og uge 96 (6 patienter med en virusbelastning ved baseline ≤ 100.000 kopier/ml og 11 patienter med en virusbelastning ved baseline > 100.000 kopier/ml).
c There were 17 new virologic failures between the Week 48 primary analysis and Week 96 (6 patients with baseline viral load ≤ 100,000 copies/mL and 11 patients with baseline viral load > 100,000 copies/mL).
Dødsfald Behandling afbrudt på grund af bivirkning (AE) Behandling afbrudt af andre årsager end AEe
Discontinued due to adverse event (AE)
Hvis De kaster op mere end 4 timer efter, at De har taget Odefsey, er det ikke nødvendigt at tage en ny tablet før den sædvanlige planlagte tablet.
If you vomit more than 4 hours after taking Odefsey you do not need to take another tablet until your next regularly scheduled tablet.