natgillin/translations-raw huggingface dataset:
In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system. 
Poskusi in vitro kažejo, da se rilpivirinijev klorid presnavlja predvsem oksidativno preko sistema CYP3A.
H2-antagonists should not be taken twice a day. 
Antagonistov H2 ne jemljite dvakrat dnevno.
2 Adverse reaction identified for rilpivirine hydrochloride. 
2 Neželeni učinek, ki so ga zabeležili za rilpivirinijev klorid.
HIV/HBV or HCV co-infected patients 
Bolniki s hkratno okužbo HIV/HBV ali HCV
When your supply of Eviplera starts to run low, get more from your doctor or pharmacist. 
Ko se vaše zaloge zdravila Eviplera manjšajo, si ga priskrbite pri zdravniku ali farmacevtu.
• If you are taking an antacid (such as medicines containing magnesium or potassium), take it at least 2 hours before or at least 4 hours after Eviplera (see section 3, How to take Eviplera). 
• Če jemljete antacid (kot so zdravila, ki vsebujejo magnezij ali kalij), ga vzemite vsaj 2 uri pred zdravilom Eviplera ali najmanj 4 ure po tem (glejte poglavje 3, Kako jemati zdravilo Eviplera).
• If you are taking an H2-antagonist (also used to treat stomach acid or acid reflux disease), take it at least 12 hours before or at least 4 hours after Eviplera. 
• Če jemljete antagonist H2 (uporablja se tudi za zdravljenje čezmernega izločanja želodčne kisline ali refluksne bolezni), ga vzemite vsaj 12 ur pred zdravilom Eviplera ali najmanj 4 ure po tem.
Before and during treatment, your doctor may order blood tests to measure kidney function. 
Pred zdravljenjem in v času zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic.
If Eviplera is co-administered with an NSAID, renal function should be monitored adequately. 
Pri sočasnem jemanju zdravila Eviplera z NSAID je treba ustrezno nadzorovati ledvično funkcijo.
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI-CCR5 cell line, and peripheral blood mononuclear cells. 
Protiretrovirusno aktivnost emtricitabina pri laboratorijskih in kliničnih izolatih HIV-1 so ocenili v limfoblastoidnih celičnih linijah, celični liniji MAGI-CCR5 in v mononuklearnih celicah v periferni krvi.
One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48. 
En bolnik z obstoječo K103N na začetku je imel virološki neuspeh z dodatno rezistenco, nastalo med zdravljenjem, do 48. tedna.
Emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited. 
Jetrni encimi emtricitabina ne presnavljajo v večji meri, zato je učinek na okvaro jeter verjetno omejen.
• dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment) 
• deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components 
Preglednica 2: Povzetek neželenih učinkov zdravila Eviplera na podlagi izkušenj iz kliničnih študij in izkušenj v obdobju trženja za zdravilo Eviplera in njegove posamezne učinkovine
This medicine can decrease the amount of rilpivirine (a component of Eviplera) in your blood. 
To zdravilo lahko zmanjša količino rilpivirina (sestavina zdravila Eviplera) v vaši krvi.
• Decrease in haemoglobin in your blood (low red blood cell count) 
• znižanje hemoglobina v krvi (nizko število rdečih krvnih celic)
Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin). 
Nekateri primeri vključujejo aminoglikozide, amfotericin B, foskarnet, ganciklovir, pentamidin, vankomicin, cidofovir ali interlevkin-2 (imenovan tudi aldeslevkin), vendar pa niso omejeni nanje.
The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes. 
Protiretrovirusna aktivnost tenofovira proti laboratorijskim in kliničnim izolatom virusa HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, primarnih monocitičnih/makrofagnih celicah in limfocitih v periferni krvi.
Protease inhibitors (PIs) - boosted (with co-administration of low-dose ritonavir) Atazanavir/Ritonavir/Emtricitabine Interaction not studied. 
Zaviralci proteaze (PI) - okrepljeni (s sočasnim dajanjem nizkih odmerkov ritonavira) atazanavir/ritonavir/emtricitabin
EU/1/11/737/002 90 (3 bottles of 30) film-coated tablets. 
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/737/001 30 filmsko obloženih tablet EU/1/11/737/002 90 (3 plastenke s po 30) filmsko obloženih tablet
The single-tablet regimen (STR), Eviplera, has been studied in virologically suppressed patients who switched from a regimen containing a ritonavir-boosted PI (Phase III study GS-US-264-0106) or from efavirenz/emtricitabine/tenofovir disoproxil (Phase IIb study GS-US-264-0111). 
Zdravilo Eviplera so z režimom odmerjanja z eno samo tableto preučili pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval PI, okrepljen z ritonavirjem (študija faze III GS-US-264-0106), ali z efavirenza/emtricitabina/dizoproksiltenofovirata (študija IIb.
• Other medicines used for HIV infection: Non-nucleoside reverse transcriptase inhibitors (NNRTIs). 
• Druga zdravila, ki se uporabljajo za zdravljenje okužb s HIV: Nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
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. 
Pri bolnikih z ledvičnim obolenjem v končni fazi (ESRD), ki so potrebovali hemodializo, se je med dializami izpostavljenost zdravilu znatno povišala v obdobju 72 ur na 53 (19 %) µg•h/ml emtricitabina in v obdobju 48 ur na 42.857 (29 %) µg•h/ml tenofovirja.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc. 
Rilpivirin pri priporočenem odmerku 25 mg enkrat dnevno ni povezan s klinično pomembnim vplivom na QTc.
1 Adverse reaction identified for emtricitabine. 
1 Neželeni učinek, ki so ga zabeležili za emtricitabin.
Patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to any of the three components of Eviplera, and must have been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to screening. 
Bolniki so morali biti bodisi na svojem prvem ali drugem protiretrovirusnem režimu brez virološkega neuspeha v anamnezi, brez sedanje ali pretekle anamneze rezistence na katero koli od treh učinkovin zdravila Eviplera in s stabilno supresijo (HIV-1 RNA < 50 kopij/ml) vsaj 6 mesecev pred presejanjem.
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. 
Bolniki so morali imeti stabilno supresijo vsaj 8 tednov pred vstopom v študijo in biti brez sedanje ali pretekle anamneze rezistence na katero koli od treh učinkovin zdravila Eviplera ter imeti HIV-1 RNA < 50 kopij/ml ob presejanju.
• proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, 
• zaviralci protonske črpalke, kot so omeprazol, esomeprazol, lansoprazol, pantoprazol,
Patients with HIV-1 expressing three or more TAMs that included either the M41L or L210W RT substitution showed reduced response to tenofovir disoproxil. 
Bolniki, pri katerih je HIV-1 izražal tri ali več TAM-e, ki so vsebovali ali M41L ali L210W substitucijo RT, so kazali zmanjšani odziv na dizoproksiltenofovirat.
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). 
Pri bolnikih z virološko supresijo, ki so prešli na zdravljenje z zdravilom Eviplera, so bili najpogostejši neželeni učinki, ki so bili verjetno oziroma morda povezani z zdravilom Eviplera, utrujenost (3 %), driska (3 %), navzea (2 %) in nespečnost (2 %) (podatki za 48. teden iz študije faze III GS-US-264-0106).
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). 
Kategorija pogostnosti (občasni) je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih emtricatibinu v teh kliničnih študijah (n = 1563).
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets 
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 plastenke s po 30) filmsko obloženih tablet
Monitoring of renal function is recommended for patients receiving Eviplera (see section 4.4). 
Nadziranje ledvične funkcije se priporoča pri bolnikih, ki prejemajo zdravilo Eviplera (glejte poglavje 4.4).
Eviplera is not recommended if you have moderate to severe kidney disease. 
Uporaba zdravila Eviplera se ne priporoča, če imate zmerno do hudo bolezen ledvic.
In patients receiving tenofovir disoproxil, rare events of renal impairment, renal failure and uncommon events of proximal renal tubulopathy (including Fanconi syndrome) sometimes leading to bone abnormalities (infrequently contributing to fractures) have been reported. 
Pri bolnikih, ki so prejemali dizoproksiltenofovirat, so poročali o redkih dogodkih ledvične okvare, ledvične odpovedi in občasnih dogodkih proksimalne ledvične tubulopatije (vključno s Fanconijevim sindromom), ki včasih vodijo k anomalijam na kosteh (redko prispevajo k zlomom).
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. 
Če zdravnik odloči, da boste prenehali jemati eno od sestavin zdravila Eviplera, ali da bo spremenil odmerek zdravila Eviplera, boste morda za zdravljenje okužbe s HIV dobivali emtricitabin, rilpivirin in/ali dizoproksiltenofovirat ločeno ali z drugimi zdravili.
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. 
Stopnja odziva (potrjena nezaznavna virusna obremenitev < 50 HIV-1 RNA kopij/ml) v 96. tednu med krakoma z rilpivirnom in efavirenzom je bila primerljiva.
[outer packaging only] 
[Samo na zunanji ovojnini]
Didanosine: 
didanozin:
If you take more Eviplera than you should 
Če ste vzeli večji odmerek zdravila Eviplera, kot bi smeli
If a patient misses a dose of Eviplera within 12 hours of the time it is usually taken, the patient should take Eviplera with food as soon as possible and resume the normal dosing schedule. 
Če bolnik izpusti odmerek zdravila Eviplera v roku 12 ur od časa, ko ga običajno vzame, bi moral bolnik vzeti zdravilo Eviplera s hrano takoj, ko je mogoče, nato pa nadaljevati z običajnim režimom odmerjanja.
Emtricitabine and tenofovir disoproxil are excreted in human milk. 
Emtricitabin in tenofovir se izločata v materino mleko.
Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any patient with renal impairment treated with Eviplera (see sections 4.2, 4.4 and 5.2). 
Ker lahko dizoproksiltenofovirat povzroči ledvično toksičnost, se priporoča skrbno nadziranje ledvične funkcije pri vseh bolnikih z ledvično okvaro, ki se zdravijo z zdravilom Eviplera (glejte poglavja 4.2, 4.4 in 5.2).
Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class. 
Bolniki z začetno virusno obremenitvijo > 100.000 HIV-1 RNA kopij/ml, pri katerih se je pojavil virološki neuspeh, so imeli višjo stopnjo rezistence na NNRTI, nastale med zdravljenjem.
Due to similarities with emtricitabine, Eviplera should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.4). 
Zaradi podobnosti z emtricitabinom se zdravilo Eviplera ne sme uporabljati sočasno z drugimi analogi citidina, kot je lamivudin (glejte poglavje 4.4).
• Decreases in phosphate levels in the blood 
• zmanjšanje ravni fosfata v krvi
In a study comparing 8 patients with mild hepatic impairment (CPT Score A) to 8 matched controls and 8 patients with moderate hepatic impairment (CPT 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. 
V študiji so primerjali 8 bolnikov z blago jetrno okvaro (stopnje A po CPT) z 8 ustreznimi kontrolnimi preiskovanci in 8 bolnikov z zmerno jetrno okvaro (stopnje B po CPT) z 8 ustreznimi kontrolnimi preiskovanci, pri čemer je bila izpostavitev rilpivirinu iz več odmerkov za 47 % višja pri bolnikih z blago jetrno okvaro in 5 % višja pri bolnikih z zmerno jetrno okvaro.
Considering all of the available in vitro data and data generated in previously untreated patients, the following resistance-associated mutations in HIV-1 RT, when present at baseline, may affect the activity of Eviplera: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L and the combination of L100I and K103N. 
Glede na vse podatke in vitro in podatke za predhodno nezdravljene bolnike, lahko naslednje mutacije RT HIV-1, povezane z rezistenco, če so prisotne na začetku, vplivajo na delovanje zdravila Eviplera: K65R, K70E, K101E, K101P, E138A, E138G, E138K, E138Q, E138R, V179L, Y181C, Y181I, Y181V, M184I, M184V, Y188L, H221Y, F227C, M230I, M230L in kombinacija L100I in K103N.
Neither emtricitabine nor tenofovir inhibited in vitro drug metabolism mediated by any of the major human CYP450 isoforms involved in drug biotransformation. 
Niti emtricitabin niti tenofovir in vitro nista zavirala presnavljanja zdravil, ki se biotransformirajo s katerokoli od pomembnejših izooblik glavnega humanega CYP450.
5 This adverse reaction may occur as a consequence of proximal renal tubulopathy. 
5 Ta neželeni učinek se lahko pojavi kot posledica proksimalne ledvične tubulopatije.
Median plasma HIV-1 RNA was 5.0 and 5.0 log10 copies/mL and median CD4+ count was 247 x 106 cells/L and 261 x 106 cells/L for patients randomised to rilpivirine and efavirenz arm, respectively. 
Mediana plazemska koncentracija HIV-1 RNA je bila 5,0 in 5,0 log10 kopij/ml in mediano število CD4+ je bilo 247 × 106 in 261× 106 celic/l za bolnike, randomizirane v krak rilpivirina oziroma efavirenza.
What Eviplera looks like and contents of the pack 
Izgled zdravila Eviplera in vsebina pakiranja
At supratherapeutic doses (75 mg and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5 and 5.1). 
Pri odmerkih, višjih od terapevtskih (75 mg in 300 mg enkrat dnevno), rilpivirin povezujejo s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavji 4.5 in 5.1).
No significant cross-resistance has been demonstrated between rilpivirine-resistant HIV-1 variants and emtricitabine or tenofovir, or between emtricitabine- or tenofovir-resistant variants and rilpivirine. 
Značilne navzkrižne rezistence med različicami virusa HIV-1, rezistentnimi na rilpivirin in emtricitabin ali tenofovir, ali med različicami, rezistentnimi na emtricitabin ali tenofovir in rilpivirinom, niso dokazali.
The adverse reaction profile of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil in patients co-infected with HIV/HBV or HIV/HCV was similar to that observed in patients infected with HIV without co-infection. 
Neželeni učinki emtricitabina, rilpivirinijevega klorida in dizoproksiltenofovirata pri bolnikih, ki so hkrati okuženi še s HIV/HBV ali HIV/HCV, so bili podobni tistim, ki jih imajo bolniki, okuženi z virusom HIV brez hkratne okužbe.
6 Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet. 
6 Študijo so izvedli s tabletami s fiksno kombinacijo emtricitabina/rilpivirina/tenofoviralafenamida.
As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Eviplera (see section 4.4). 
Kot pri vseh drugih protiretrovirusnih zdravilih morajo biti testiranje rezistence in/ali podatki o rezistenci v anamnezi vodilo za uporabo zdravila Eviplera (glejte poglavje 4.4).
When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine hydrochloride were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively. 
Pri preučevanju odmerkov, višjih od terapevtskih odmerkov rilpivirinijevega klorida 75 mg enkrat dnevno in 300 mg enkrat dnevno pri zdravih odraslih, so bile največje povprečne časovno usklajene (95 % zgornja meja zaupanja) razlike intervala QTcF od placeba po popravku začetne vrednosti 10,7 (15,3) in 23,3 (28,4) ms.
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). 
4 Pri pediatričnih bolnikih je bila anemija pogosta, sprememba obarvanosti kože (povečana pigmentacija) pa zelo pogosta (glejte poglavje 4.8, Pediatrična populacija) ob jemanju emtricitabina.
• omeprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (proton pump inhibitors that are medicines used to prevent and treat stomach ulcers, heartburn, acid reflux disease) 
• omeprazol, lansoprazol, rabeprazol, pantoprazol in esomeprazol (zaviralci protonske črpalke, zdravila, ki se uporabljajo za preprečevanje in zdravljenje razjed na želodcu, zgage in refluksne bolezni)
Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. 
Med nosečnostjo so pri jemanju 25 mg rilpivirina enkrat dnevno opazili nižje izpostavljenosti rilpivirinu.
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). 
Kategorija pogostnosti je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih dizoproksiltenofoviratu v randomiziranih kontroliranih kliničnih študijah in podaljšanem programu dostopanja (n = 7319).
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. 
Prekinitev zdravljenja z zdravilom Eviplera pri bolnikih s hkratno HIV in HBV okužbo je lahko povezana s hudimi akutnimi poslabšanji hepatitisa.
The virologic failure rate in patients treated with emtricitabine/tenofovir disoproxil + rilpivirine at week 48 and week 96 was 9.5% and 11.5% respectively, and 4.2% and 5.1% in the emtricitabine/tenofovir disoproxil + efavirenz arm. 
Stopnja virološkega neuspeha pri bolnikih, zdravljenih z emtricitabinom/dizoproksiltenofoviratom + rilpivirinom, je bila v 48. tednu 9,5 % in v 96. tednu 11,5 %, v kraku z emtricitabinom/dizoproksiltenofoviratom + efavirenzom pa 4,2 % oz. 5,1 %.
elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, 2, abdominal pain1, 2, 3, abdominal discomfort2, abdominal distension3, dyspepsia1, flatulence3, dry mouth2 
zvišanje amilaze vključno z zvišano pankreasno amilazo1, povišanje serumske lipaze1, 2, bolečine v trebuhu1, 2, 3, nelagodje v trebuhu2, napetost v trebuhu3, dispepsija1, flatulenca3, suha usta2
Eviplera is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged 
Eviplera je zdravilo za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti (HIV) pri odraslih, starih 18 let in več.
Tenofovir pharmacokinetics was not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects. 
Farmakokinetika tenofovirja se pri osebah z jetrno okvaro ni bistveno spremenila, kar nakazuje, da pri teh osebah ni potrebno prilagoditi odmerjanja.
The combination of emtricitabine, rilpivirine and tenofovir disoproxil has been studied as the component products in treatment-naïve patients (Phase III studies C209 and C215). 
Kombinacijo emtricitabina, rilpivirina in dizoproksiltenofovirata so preučili kot posamične učinkovine zdravila pri predhodno nezdravljenih bolnikih (študiji faze III C209 in C215).
• Low platelet count (a type of blood cell involved in clotting blood) 
• nizko število krvnih ploščic (vrsta krvnih celic, ki sodeluje pri strjevanju krvi)
• Dizziness, headache 
• omotičnost, glavobol
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). 
Pri dajanju emtricitabina (ene od učinkovin zdravila Eviplera) pediatričnim bolnikom so pogosteje opazili naslednje neželene učinke, poleg neželenih učinkov, o katerih so poročali pri odraslih: pri pediatričnih bolnikih je bila anemija pogosta (9,5 %) in sprememba obarvanosti kože (povečana pigmentacija) je bila zelo pogosta (31,8 %) (glejte poglavje 4.8, Povzetek neželenih učinkov, prikazan v preglednici).
Antacids (e.g. aluminium or magnesium hydroxide, calcium carbonate) 
antacidi (npr. aluminijev ali magnezijev hidroksid, kalcijev karbonat)
A dual energy X ray absorptiometry (DXA) substudy for both the Phase III studies (C209 and C215) investigated the effect of rilpivirine as compared with control, overall and by background regimen on changes in whole body bone mineral density (BMD) and bone mineral content (BMC) at week 48 and week 96. 
V podštudiji z dvoenergijsko rentgensko absorpciometrijo (DXA) za obe študiji faze III (C209 in C215) so preučevali učinek rilpivirina v primerjavi s kontrolno skupino, celotno populacijo in z bolniki z osnovno shemo zdravljenja, glede na spremembe v mineralni gostoti kosti (bone mineral density, BMD) in vsebnost kostnih mineralov (bone mineral content, BMC) celega telesa v 48. in 96. tednu.
Eviplera should be used with caution in patients with moderate hepatic impairment (CPT Score B) and is not recommended in patients with severe hepatic impairment (CPT Score C). 
Zdravilo Eviplera je treba pri bolnikih z zmerno jetrno okvaro (stopnje B po CPT) uporabljati previdno, pri bolnikih s hudo jetrno okvaro (stopnje C po CPT) pa se ne priporoča.
Very common: increased transaminases (AST and/or ALT)1, 2, 3 Common: 
zvišanje transaminaz (AST in/ali ALT)1, 2, 3
No dose adjustment of Eviplera is suggested but caution is advised in patients with moderate hepatic impairment. 
Prilagoditev odmerka zdravila Eviplera ni potrebna, vendar pa se priporoča previdnost pri bolnikih z zmerno jetrno okvaro.
• Talk to your doctor if you are over 65 years of age. 
• Če ste stari več kot 65 let, se pogovorite z zdravnikom.
No clinically relevant differences in pharmacokinetics of rilpivirine have been observed between men and women. 
Med moškimi in ženskami niso opazili klinično pomembnih razlik v farmakokinetiki rilpivirina.
The safety and efficacy of Eviplera have not been established in patients with significant underlying liver disorders. 
Varnost in učinkovitost zdravila Eviplera nista bili ugotavljani pri bolnikih s pomembnejšimi spremljevalnimi jetrnimi motnjami.