natgillin/translations-raw huggingface dataset:
Virkningen af rilpivirinhydrochlorid ved den anbefalede dosis på 25 mg én gang dagligt på QTcFintervallet blev evalueret i et randomiseret, placebo- og aktivt kontrolleret (moxifloxacin 400 mg én gang dagligt) overkrydsningsstudie med 60 raske voksne, med 13 målinger i løbet af 24 timer ved steady-state.
The effect of rilpivirine hydrochloride at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
I et andet studie resulterede Y188Lsubstitution i 9 gange nedsat følsomhed for rilpivirin hos kliniske isolater og i 6 gange nedsat følsomhed hos mutanter, der er rettet mod et bestemt mål.
In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Der er observeret lavere eksponeringer for rilpivirin under graviditet, hvorfor virusbelastningen bør monitoreres tæt.
Lower exposures of rilpivirine were observed during pregnancy; therefore viral load should be monitored closely.
• Øget kreatinin i blodet
• Increases in creatinine in your blood
Hvis serumphosphat er < 1,5 mg/dl (0,48 mmol/l) eller CrCl er faldende til < 50 ml/min hos patienter, der får Eviplera, skal vurderingen af nyrefunktionen gentages inden for en uge, herunder måling af glucose- og kaliumkoncentration i blodet samt uringlucose (se pkt.
If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or CrCl is decreased to < 50 mL/min in any patient receiving Eviplera, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Rilpivirin udviste aktivitet mod laboratoriestammer af vildtype hiv 1 i en akut inficeret T-cellelinje med en median EC50-værdi for hiv 1/IIIB på 0,73 nM (0,27 ng/ml).
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).
Cmax og AUC for rilpivirin blev øget med hhv. 34 % og 9 % (let måltid) og 26 % og 16 % (standardmåltid).
The Cmax and AUC of rilpivirine increased by 34% and 9% (light meal) and 26% and 16% (standard meal), respectively.
H2-antagonister bør ikke tages to gange dagligt.
H2-antagonists should not be taken twice a day.
Højdensitets-polyethylen (HDPE)-beholder med børnesikret lukke af polypropylen indeholdende 30 filmovertrukne tabletter sammen med silicagel-tørremiddel.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Patienter, hvis hiv 1 udtrykte 3 eller flere TAMs, som omfattede enten M41L- eller L210W-RTsubstitution, udviste reduceret respons over for tenofovirdisoproxil.
Patients with HIV-1 expressing three or more TAMs that included either the M41L or L210W RT substitution showed reduced response to tenofovir disoproxil.
I studie C215 (n = 678) bestod BR af 2 N(t)RTI'er udvalgt af investigatoren: Emtricitabin/tenofovirdisoproxil (60 %, n = 406) eller lamivudin/zidovudin (30 %, n = 204) eller abacavir plus lamivudin (10 %, n = 68).
In study C215 (n = 678), the BR consisted of 2 investigator selected N(t)RTIs: emtricitabine/tenofovir disoproxil (60%, n = 406) or lamivudine/zidovudine (30%, n = 204) or abacavir plus lamivudine (10%, n = 68).
Hvis De kaster op mere end 4 timer efter, De har taget Eviplera, behøver De ikke tage en ny tablet, før Deres næste regelmæssigt skemalagte tablet.
If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet.
Dem en yderligere dosis rilpivirin til behandling af Deres hiv-infektion (se punkt 3, Sådan skal De tage Eviplera).
Your doctor may need to give you an additional dose of rilpivirine to treat your HIV infection (see section 3, How to take Eviplera).
Hyppighedskategorien Ikke almindelig blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for emtricitabin i disse kliniske studier (n = 1.563)
The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
På grund af lighederne med emtricitabin bør Eviplera ikke administreres samtidigt med andre cytidinanaloger, såsom lamivudin (se pkt.
Due to similarities with emtricitabine, Eviplera should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.4).
• Tegn eller symptomer på betændelse eller infektion
• Signs or symptoms of inflammation or infection
Det gennemsnitlige CD4-celletal ved baseline var 584 x 106 celler/l (interval 42-1.484).
The mean baseline CD4 cell count was 584 x 106 cells/L (range 42-1,484).
Der var ingen tilgængelige data for en patient (2 %) i uge 48-perioden; studielægemidlet blev seponeret pga. protokolovertrædelse (dvs. en anden årsag end bivirkninger eller død); i den sidst tilgængelige analyse var hiv 1-rna < 50 kopier/ml.
One patient (2%) did not have data available in the week 48 window; study drug was discontinued due to a protocol violation (i.e. reason other than AE or death) and the last available HIV-1 RNA was < 50 copies/mL.
Nyreudskillelsen af rilpivirin er ubetydelig.
Renal elimination of rilpivirine is negligible.
• Fald i phosphatniveauet i blodet
• Decreases in phosphate levels in the blood
Posaconazol2 Voriconazol2
Posaconazole2 Voriconazole2
Eviplera 200 mg/25 mg/245 mg filmovertrukne tabletter
Eviplera 200 mg/25 mg/245 mg film-coated tablets
Den blev også identificeret som en bivirkning for emtricitabin under sikkerhedsovervågningen efter markedsføring, men den blev ikke observeret i randomiserede, kontrollerede kliniske studier af emtricitabin til voksne eller pædiatriske hiv-patienter.
It was also identified as an adverse reaction for emtricitabine through post-marketing surveillance but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
Efter oral indgivelse af de enkelte komponenter emtricitabin og tenofovirdisoproxil fordeles emtricitabin og tenofovir i stort omfang i hele legemet.
After oral administration of the single components emtricitabine and tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Hos virologisk supprimerede hiv 1-inficerede patienter I studie GS-US-264-0106 havde 4 af de 469 patienter, som skiftede fra et ritonavir-PI-baseret program til Eviplera, hiv 1 med nedsat følsomhed for mindst et af stofferne i Eviplera til og med uge 48.
In virologically suppressed HIV-1 infected patients In study GS-US-264-0106, 4 of the 469 patients who switched from a ritonavir-PI-based regimen to Eviplera had HIV-1 with reduced susceptibility to at least one component of Eviplera through week 48.
Resistens over for rilpivirin1 Krydsresistens2 over for etravirin efavirenz nevirapin
Resistance to rilpivirine2 Cross-resistance3 to etravirine efavirenz nevirapine
4 Anæmi var almindelig og misfarvning af huden (øget pigmentering) meget almindelig, når emtricitabin blev indgivet til pædiatriske patienter (se pkt.
4 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients (see section 4.8, Paediatric population).
Ved uge 48 havde 89 % (283/317) af patienterne, som blev randomiseret til skift til Eviplera ved baseline (Eviplera), hiv 1-rna < 50 kopier/ml, 3 % (8/317) blev anset som havende virologiske svigt (hiv-rna ≥ 50 kopier/ml), og 8 % (26/317) havde ikke tilgængelige data i uge 48-perioden.
At week 48, 89% (283/317) of patients randomised to switch to Eviplera at baseline (Eviplera) had HIV-1 RNA < 50 copies/mL, 3% (8/317) were considered virologic failures (HIV RNA ≥ 50 copies/mL), and 8% (26/317) did not have data available in the week 48 window.
Hiv-patienter med leversygdom (herunder kronisk hepatitis B eller C), som behandles med antiretrovirale lægemidler, har en højere risiko for alvorlige og potentielt dødelige leverkomplikationer.
HIV patients with liver disease (including chronic hepatitis B or C), who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Lilla-lyserøde kapselformede, filmovertrukne tabletter, der måler 19 mm x 8,5 mm, og som er præget med „GSI” på den ene side og glatte på den anden side.
Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed on one side with “GSI” and plain on the other side.
Det er vigtigt, at De husker at tage hver dosis af Eviplera.
It is important not to miss a dose of Eviplera.
Patienterne skulle være stabilt supprimerede i mindst 8 uger inden deltagelse i studiet, ikke have nuværende eller tidligere resistens over for nogen af de tre stoffer i Eviplera i anamnesen og have hiv 1-rna < 50 kopier/ml ved screening.
Patients had to be stably suppressed for at least 8 weeks prior to study entry, have no current or past history of resistance to any of the three components of Eviplera, and have HIV-1 RNA < 50 copies/mL at screening.
Eviplera frarådes til patienter med moderat eller svært nedsat nyrefunktion (CrCl < 50 ml/min).
Eviplera is not recommended for patients with moderate or severe renal impairment (CrCl < 50 mL/min).
Der er observeret lavere eksponeringer for rilpivirin (et af indholdsstofferne i Eviplera) under graviditet, hvorfor virusbelastningen bør monitoreres tæt.
Lower exposures of rilpivirine (one of the components of Eviplera) were observed during pregnancy; therefore viral load should be monitored closely.
Disse former for medicin kan øge mængden af rilpivirin (en komponent i Eviplera) i Deres blod.
These medicines can increase the amount of rilpivirine (a component of Eviplera) in your blood.
H2-RECEPTORANTAGONISTER Famotidin/Emtricitabin
H2-RECEPTOR ANTAGONISTS Famotidine/Emtricitabine
Antacida bør kun administreres enten mindst 2 timer før eller mindst 4 timer efter Eviplera.
Antacids should only be administered either at least 2 hours before or at least 4 hours after Eviplera.
Mens De tager Eviplera
While you take Eviplera
• Beskadigelse af celler i nyrerne (de tubulære celler)
• Damage to kidney tubule cells
Hiv 1-inficerede patienter, der er behandlingsnaive med hensyn til antiretroviral behandling, blev inkluderet (n = 1.368), hvis de havde en plasma hiv 1-rna ≥ 5.000 kopier/ml, og blev screenet for følsomhed for N(t)RTI og for fravær af specifikke mutationer, der er NNRTI-resistensassocierede.
Antiretroviral treatment-naïve HIV-1 infected patients were enrolled (n = 1,368) who had a plasma HIV-1 RNA ≥ 5,000 copies/mL and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Fluconazol2
Fluconazole2
Nukleosid- eller nukleotid-revers transkriptase-hæmmere (NRTI'er/N[t]RTI'er) Didanosin/Emtricitabin
Nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs/N[t]RTIs) Didanosine/Emtricitabine
5 Denne bivirkning kan forekomme som resultat af proksimal renal tubulopati.
5 This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Hvis Deres læge beslutter at ophøre med at give et af indholdsstofferne i Eviplera eller ændre Evipleras dosis, kan De få emtricitabin, rilpivirin og/eller tenofovirdisoproxil hver for sig eller sammen med anden medicin til behandling af hiv-infektion.
If your doctor decides to stop one of the components of Eviplera or change the dose of Eviplera, you may be given emtricitabine, rilpivirine and/or tenofovir disoproxil separately or with other medicines for the treatment of HIV infection.
Der er rapporteret om sjældne tilfælde af betændelse i bygspytkirtlen og laktatacidose (overskud af mælkesyre i blodet), der somme tider medførte dødsfald, når medicin, der indeholder tenofovirdisoproxil og didanosin, blev indtaget samtidigt.
Inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes caused death, have been reported rarely when medicines containing tenofovir disoproxil and didanosine were taken together.
Amning skal ophøre under behandling med Eviplera.
Breast-feeding should be discontinued during treatment with Eviplera.
• Smerter i abdomen (maven), forårsaget af betændelse i bugspytkirtlen
• Pain in the abdomen (tummy) caused by inflammation of the pancreas
Levertoksicitet forbundet med leverenzyminduktion blev observeret hos gnavere.
Liver toxicity associated with liver enzyme induction was observed in rodents.
De må ikke amme, mens De er i behandling med Eviplera:
Do not breast-feed during treatment with Eviplera:
depression2, nedtrykthed2, søvnforstyrrelser2, unormale drømme1, 2
depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders
Hyppighedskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for tenofovirdisoproxil i randomiserede, kontrollerede kliniske studier og i programmet for forlænget adgang (n = 7.319).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Rilpivirin hæmmer MATE-2K-transportøren in vitro med en IC50 på < 2,7 nM.
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Virkningen og sikkerheden af skift fra en ritonavir-boosted PI i kombination med to NRTI'er til Eviplera STR blev evalueret i et randomiseret open-label studie hos virologisk supprimerede hiv 1-inficerede voksne.
The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to Eviplera STR was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
• antimykobakterielle midler som rifampicin, rifapentin
• the antimycobacterials rifampicin, rifapentine
Hver filmovertrukket tablet indeholder 277 mg lactosemonohydrat og 4 mikrogram Sunset yellow FCF aluminium lak (E110).
Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110).
Som for andre antiretrovirale lægemidler skal resistenstest og/eller historiske resistensdata være vejledende for anvendelsen af Eviplera (se pkt.
As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Eviplera (see section 4.4).
• Lavt antal blodplader (en type blodceller, der er involveret i blodets størkning)
• Low platelet count (a type of blood cell involved in clotting blood)
• Nyrebetændelse, udskillelse af store mængder urin og en fornemmelse af at være tørstig
• Inflammation of the kidney, passing a lot of urine and feeling thirsty
Hos virologisk supprimerede patienter, som skiftede til Eviplera, var de hyppigst indberettede bivirkninger, som blev anset for at have en mulig eller sandsynlig forbindelse til Eviplera, træthed (3 %), diarré (3 %), kvalme (2 %) og insomni (2 %) (data fra uge 48 fra fase III-studiet GS-US-264-0106).
In virologically suppressed patients switching to Eviplera, the most frequently reported adverse reactions considered possibly or probably related to Eviplera were fatigue (3%), diarrhoea (3%), nausea (2%) and insomnia (2%) (48 week data from the Phase III study GS-US-264-0106).
Dyreforsøg indikerer hverken direkte eller indirekte skadelige virkninger hvad angår reproduktionstoksicitet (se pkt.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3) with the components of Eviplera.
Der var 7/317 patienter (2 %) i Eviplera-armen og 6/152 patienter (4 %) i armen med sent skift, som seponerede studielægemidlet permanent pga. en bivirkning opstået under behandlingen (treatmentemergent adverse event (TEAE)).
There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse event (TEAE).
Hyppighedskategorien blev estimeret ud fra en statistisk beregning baseret på det totale antal patienter eksponeret for Eviplera og alle dets komponenter i randomiserede, kontrollerede kliniske studier (n = 1.261).
The frequency category was estimated from a statistical calculation based on the total number of patients exposed to Eviplera or all of its components in randomised controlled clinical studies (n = 1,261).
Vira, der indeholder substitutioner, der giver reduceret følsomhed for stavudin og zidovudin (thymidin-analog-associerede mutationer-TAMs; M41L, D67N, K70R, L210W, T215Y/F, K219Q/E) eller didanosin (L74V) vedblev med at være følsomme for emtricitabin.
Viruses harbouring substitutions conferring reduced susceptibility to stavudine and zidovudine-thymidine analogue-associated mutations-TAMs (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E), or didanosine (L74V) remained sensitive to emtricitabine.
En reduceret dosis på 250 mg didanosin administreret samtidig med tenofovirdisoproxilbehandling er blevet forbundet med store hyppigheder af virologisk svigt for flere testede kombinationer til behandling af hiv 1-infektion.
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Hos patienter med nyresygdom i slutstadiet (End Stage Renal Disease, ESRD), som havde behov for hæmodialyse, steg lægemiddelkoncentrationen betragteligt imellem dialyserne over et tidsrum på 72 timer til 53 µg•t/ml (19 %) med emtricitabin og over 48 timer til 42.857 ng•t/ml (29 %) med tenofovir.
In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/mL (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/mL (29%) of tenofovir.
Virologisk supprimerede hiv 1-inficerede patienter
Virologically suppressed HIV-1 infected patients
Eviplera-tabletter skal tages oralt én gang dagligt sammen med mad (se pkt.
Eviplera must be taken orally, once daily with food (see section 5.2).
Køn Mand Kvinde Etnisk oprindelse Hvid Sort/afrikansk amerikaner Asiatisk Andet Ikke tilladt at spørge om ifølge lokale krav Baseline sygdomskarakteristika Median baseline plasma hiv 1-rna (interval) log10 kopier/ml Median baseline CD4+ celletal (interval), × 106 celler/l
Sex Male Female Ethnicity White Black/African American Asian Other Not allowed to ask per local regulations Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/mL Median baseline CD4+ cell count (range), x 106 cells/L Percentage of patients with HBV/HCV co-infection
Croscarmellosenatrium Lactosemonohydrat Magnesiumstearat Mikrokrystallinsk cellulose Polysorbat 20
Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20
Hvis samtidig anvendelse af Eviplera og nefrotoksiske stoffer ikke kan undgås, skal nyrefunktionen overvåges ugentligt (se pkt.
If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly (see sections 4.5 and 4.8).
Ved administration af emtricitabin (en af komponenterne i Eviplera) til pædiatriske patienter, blev de følgende bivirkninger observeret hyppigere ud over de bivirkninger, der blev indrapporteret for voksne: anæmi var almindelig (9,5 %) og misfarvning af huden (øget pigmentering) var meget almindelig (31,8 %) hos pædiatriske patienter (se pkt.
When emtricitabine (one of the components of Eviplera) was administered to paediatric patients, the following adverse reactions were observed more frequently in addition to the adverse reactions reported in adults: anaemia was common (9.5%) and skin discolouration (increased pigmentation) was very common (31.8%) in paediatric patients (see section 4.8, Tabulated summary of adverse reactions).
4.8), og der skal gives støttende standardbehandling efter behov, herunder observation af patientens kliniske status og overvågning af vitale tegn og EKG (QT-interval).
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
• Rygsmerter på grund af nyreproblemer, inklusive nyresvigt.
• Back pain caused by kidney problems, including kidney failure.
Antacida (f.eks. aluminium- eller magnesiumhydroxid, calciumcarbonat)
Antacids (e.g. aluminium or magnesium hydroxide, calcium carbonate)
Hvis De kaster op mindre end 4 timer efter, De har taget Eviplera, skal De tage en ny tablet sammen med mad.
If you vomit less than 4 hours after taking Eviplera, take another tablet with food.
Eviplera frarådes, hvis De har moderat til svær nyresygdom.
Eviplera is not recommended if you have moderate to severe kidney disease.
GLUKOKORTIKOIDER Dexamethason (systemisk, undtagen enkeltdosisbehandling)
GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Sikkerhedsdata fra langtidsbrug for emtricitabin- og tenofovirdisoproxil-komponenterne af Eviplera er imidlertid ikke evalueret hos patienter med let nedsat nyrefunktion.
However, long-term safety data for the emtricitabine and tenofovir disoproxil components of Eviplera have not been evaluated in patients with mild renal impairment.
Af de 469 Eviplera-behandlede patienter [317 patienter, som skiftede til Eviplera ved baseline (Eviplera-arm), og 152 patienter, som skiftede ved uge 24 (arm med sent skift)], blev i alt 7 patienter undersøgt for udvikling af resistens, og der var genotype- og fænotype-data tilgængelige for alle.
Of the 469 Eviplera-treated patients [317 patients who switched to Eviplera at baseline (Eviplera arm) and 152 patients who switched at week 24 (Delayed Switch arm)], a total of 7 patients were analysed for resistance development and all had genotypic and phenotypic data available.
Det virologiske respons bevaredes generelt under hele studiet: Af de 12 patienter, som gennemførte studiet, havde 10 patienter suppression ved slutningen af studiet.
The virologic response was generally preserved throughout the study: of the 12 patients that completed the study, 10 patients were suppressed at the end of the study; in the other 2 patients an increase in viral load was observed only postpartum, for at least 1 patient due to suspected suboptimal adherence.
H2-antagonister kan kun tages én gang dagligt, hvis De tager Eviplera.
H2-antagonists can only be taken once a day if you take Eviplera.
Eviplera indeholder Sunset yellow FCF aluminium lak, som også kaldes „E110”, der kan medføre allergiske reaktioner.
Eviplera contains sunset yellow aluminium lake also called “E110” which may cause allergic reactions.
Desuden skal nyrefunktionen (CrCl og serumphosphat) monitoreres efter to til fire ugers behandling, efter tre måneders behandling og derefter hver tredje til sjette måned hos patienter uden renale risikofaktorer.
It is recommended that CrCl is calculated in all patients prior to initiating therapy with Eviplera and renal function (CrCl and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
forhøjet amylase, herunder forhøjet pancreasamylase1, forhøjet serumlipase1, 2, abdominalsmerter1, 2, 3, mavebesvær2, abdominal distension3, dyspepsi1, flatulens3, mundtørhed2
elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, 2, abdominal pain1, 2, 3, abdominal discomfort2, abdominal distension3, dyspepsia1, flatulence3, dry mouth2