natgillin/translations-raw huggingface dataset:
The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine. 
Zaradi substitucije K65R in tudi K70E se občutljivost na abakavir, didanozin, lamivudin, emtricitabin in tenofovir zmanjša, medtem ko se občutljivost na zidovudin ohrani.
At week 96 the mean changes in CD4+ cell count from baseline were +226 x 106 cells/L and +222 x 106 cells/L for the rilpivirine and efavirenz treatment arms, respectively, of patients receiving the emtricitabine/tenofovir disoproxil background regimen. 
V 96. tednu so bile srednje spremembe števila celic CD4+ od začetka študije +226 × 106 celic/l za skupino zdravljenja z rilpivirinom in +222 × 106 celic/l za skupino zdravljenja z efavirenzom, za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofoviratom.
In combination studies of tenofovir with NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed. 
V študijah kombinacij tenofovira z NRTI-ji (abakavir, didanozin, emtricitabin, lamivudin, stavudin in zidovudin), NNRTI-ji (delavirdin, efavirenz, nevirapin in rilpivirin) in PI-ji (amprenavir, indinavir, nelfinavir, ritonavir in sakvinavir) so opazili aditivne do sinergistične učinke.
If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet. 
Če bruhate več kot 4 ure po zaužitju zdravila Eviplera, vam ni treba vzeti še ene tablete, dokler ni čas za naslednjo tableto po vašem režimu jemanja.
Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, and triacetin. 
Filmska obloga: hipromeloza, barvilo indigotin, laktoza monohidrat, polietilen glikol, rdeč železov oksid, barvilo sončno rumeno FCF (E110), titanov dioksid in triacetin.
Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1). 
Testiranje genotipske rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Eviplera (glejte poglavji 4.4 in 5.1).
In combination studies of emtricitabine with NRTIs (abacavir, didanosine, lamivudine, stavudine, tenofovir, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed. 
V študijah kombinacij emtricitabina z NRTI-ji (abakavir, didanozin, lamivudin, stavudin, tenofovir in zidovudin), NNRTI-ji (delavirdin, efavirenz, nevirapin in rilpivirin) ter PI-ji (amprenavir, nelfinavir, ritonavir in sakvinavir), so opazili aditivne do sinergistične učinke.
Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil 
Eviplera 200 mg/25 mg/245 mg filmsko obložene tablete emtricitabin/rilpivirin/dizoproksiltenofovirat
How to take Eviplera 
Kako jemati zdravilo Eviplera
Breast-feeding should be discontinued during treatment with Eviplera. 
Med zdravljenjem z zdravilom Eviplera je treba dojenje prekiniti.
A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Eviplera should be used. 
Pri jemanju antagonistov receptorjev H2 je treba upoštevati dosleden načrt odmerjanja vsaj 12 ur pred uporabo zdravila Eviplera ali vsaj 4 ure po njej.
By baseline CD4+ cell count (x 106 cells/L) 
Glede na začetno število celic CD4+ (x 106 celic/l)
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 III clinical studies, C209 and C215, for patients receiving the emtricitabine/tenofovir disoproxil background regimen) is presented in Table 5. 
Analiza podskupine virološkega odziva (< 50 HIV-1 RNA kopij/ml) tako v 48. tednu kot tudi v 96. tednu in virološkega neuspeha glede na začetno vrednost virusne obremenitve (združeni podatki iz dveh kliničnih študij faze III, C209 in C215, za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofoviratom) so predstavljeni v preglednici 5.
Maraviroc/Rilpivirine 
maravirok/rilpivirin
In the cumulative week 96 pooled resistance analysis for patients receiving rilpivirine in combination with emtricitabine/tenofovir disoproxil, a greater risk of virologic failure for patients in the rilpivirine arm was observed within the first 48 weeks of these studies (11.5% in the rilpivirine arm and 4.2% in the efavirenz arm) while low rates of virologic failure, similar between the treatment arms, were observed from the week 48 to week 96 analysis (15 patients or 2.7% in the rilpivirine arm and 14 patients or 2.6% in the efavirenz arm). 
V kumulativni analizi združenih podatkov v 96. tednu so pri bolnikih, ki so prejemali rilpivirin v kombinaciji z emtricitabinom/dizoproksiltenofoviratom opazili večje tveganje virološkega neuspeha za bolnike v kraku z rilpivirinom v prvih 48 tednih teh študij (11,5 % v kraku z rilpivirinom in 4,2 % v kraku z efavirenzom), medtem ko so v analizah od 48. tedna do 96. tedna opazili nizke stopnje virološkega neuspeha, ki so si bile v krakih zdravljenja podobne (15 bolnikov ali 2,7 % v kraku z rilpivirinom in 14 bolnikov ali 2,6 % v kraku z efavirenzom).
Eviplera should be used with caution in patients with moderate hepatic impairment. 
Zdravilo Eviplera je treba pri bolnikih z zmerno jetrno okvaro uporabljati previdno.
somnolence2 
somnolenca2
When Eviplera is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended to be taken concomitantly with Eviplera, for the duration of the rifabutin coadministration. 
Pri sočasnem dajanju zdravila Eviplera z rifabutinom se priporoča dodatna 25 mg tableta rilpivirina na dan, ki naj se jemlje sočasno z zdravilom Eviplera ves čas trajanja sočasne uporabe rifabutina.
Of the 24 patients treated with Eviplera who had the NNRTI-associated K103N substitution pre-existing at baseline in their HIV-1, 17 of 18 patients in the Eviplera arm and 5 of 6 patients in the SBR arm maintained virologic suppression after switching to Eviplera through 48 weeks and 24 weeks of treatment, respectively. 
Med 24 bolniki, zdravljenimi z zdravilom Eviplera, ki so imeli z NNRTI povezano obstoječo substitucijo K103N na začetku v svojem HIV-1, je 17 od 18 bolnikov v kraku z zdravilom Eviplera in 5 od 6 bolnikov v kraku z ohranitvijo začetnega režima ohranilo virološko supresijo po prehodu na zdravilo Eviplera do konca 48. tedna oz. 24. tedna zdravljenja.
• Severe skin reactions including rash accompanied by fever, swelling and liver problems 
• hude kožne reakcije, vključno z izpuščajem, ki jih spremljajo zvišana telesna temperatura,
Eviplera contains lactose and sunset yellow aluminium lake (E110) 
Zdravilo Eviplera vsebuje laktozo in barvilo sončno rumeno FCF (E110)
Recommendation concerning co-administration with Eviplera 
Priporočilo glede sočasne uporabe z zdravilom Eviplera
In this analysis, the NNRTI resistance-associated mutations that developed most commonly in these patients were: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y and F227C. 
V teh analizah so bile mutacije, povezane z rezistenco na NNRTI, ki so se najpogosteje razvile pri teh bolnikih: V90I, K101E, E138K/Q, V179I, Y181C, V189I, H221Y in F227C.
Emtricitabine-resistant viruses with the M184V/I mutation were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, zalcitabine and zidovudine. 
Virusi, rezistentni na emtricitabin z mutacijo M184V/I, so bili navzkrižno rezistentni na lamivudin, a so ohranili občutljivost za didanozin, stavudin, tenofovir, zalcitabin in zidovudin.
Rabeprazole2 
rabeprazol2
In the pooled analysis for C209 and C215 of patients who received a background regimen of emtricitabine/tenofovir disoproxil, demographic and baseline characteristics were balanced between the rilpivirine and efavirenz arm. Table 4 displays selected demographic and baseline disease characteristics. 
V skupni analizi za C209 in C215 za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofoviratom, so demografske in začetne značilnosti uravnotežili med krakoma rilpivirina in efavirenza.
Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (CrCl 50-80 mL/min). 
Omejeni podatki iz kliničnih študij podpirajo odmerjanje zdravila Eviplera enkrat dnevno pri bolnikih z blago ledvično okvaro (CrCl 50-80 ml/min).
Rilpivirine hydrochloride 
Rilpivirinijev klorid
As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera. 
Zdravilo Eviplera vsebuje emtricitabin, rilpivirinijev klorid in dizoproksiltenofovirat zato se pri uporabi zdravila Eviplera lahko pojavijo katerekoli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
vesiculobullous rash1, pustular rash1, urticaria1, skin discolouration (increased pigmentation)1, 4, maculopapular rash1, pruritus1 
vezikulobulozni izpuščaj1, pustulozni izpuščaj1, urtikarija1, sprememba obarvanosti kože (povečana pigmentacija)1, 4, makulopapulozni izpuščaj1, pruritus1
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). 
Kategorija pogostnosti je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih zdravilu Eviplera ali njegovim sestavinam v randomiziranih kontroliranih kliničnih študijah (n = 1261).
Resistance testing and/or historical resistance data should guide the use of Eviplera (see section 5.1). 
Testiranje rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Eviplera (glejte poglavje 5.1).
Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (creatinine clearance (CrCl) 50-80 mL/min). 
Omejeni podatki iz kliničnih študij podpirajo odmerjanje zdravila Eviplera enkrat dnevno pri bolnikih z blago ledvično okvaro (očistek kreatinina (CrCl, creatinine clearance) 50-80 ml/min).
Severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia (see section 4.4). 
Iz izkušenj v obdobju trženja zdravila Eviplera so poročali o hudih kožnih reakcijah s sistemskimi simptomi, vključno z izpuščaji, ki jih spremljajo zvišana telesna temperatura, mehurji, konjunktivitis, angioedem, zvišani rezultati testov jetrne funkcije in/ali eozinofilija (glejte poglavje 4.4).
If a patient vomits within 4 hours of taking Eviplera another Eviplera tablet should be taken with food. 
Če bolnik v roku 4 ur od jemanja zdravila Eviplera bruha, bi moral vzeti drugo tableto zdravila Eviplera s hrano.
Eviplera should be used with caution when co-administered with medicinal products with a known risk of Torsade de Pointes. 
Zdravilo Eviplera je treba uporabljati previdno, če se uporablja sočasno z zdravili z znanim tveganjem za Torsade de Pointes.
No human data on the effect of Eviplera on fertility are available. 
Ni podatkov o učinkih zdravila Eviplera na sposobnost razmnoževanja pri ljudeh.
Eviplera should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil or tenofovir alafenamide. 
Zdravila Eviplera ne sme sočasno uporabljati z drugimi zdravili, ki vsebujejo emtricitabin, dizoproksiltenofovirat ali tenofoviralafenamidijev fumarat.
H2-RECEPTOR ANTAGONISTS Famotidine/Emtricitabine 
ANTAGONISTI RECEPTORJEV H2
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see sections 4.2 and 4.5). 
Zdravila Eviplera se ne sme dajati skupaj z rilpivirinijevim kloridom, razen če je to potrebno za prilagoditev odmerka pri uporabi z rifabutinom (glejte poglavji 4.2 in 4.5).
Rilpivirine hydrochloride has not been studied in patients with severe hepatic impairment (CPT Score C). 
Rilpivirinijevega klorida niso proučevali pri bolnikih s hudo jetrno okvaro (stopnje C po CPT).
The pharmacokinetics of emtricitabine has not been studied in patients with varying degrees of hepatic insufficiency. 
Farmakokinetične lastnosti emtricitabina še niso bile proučevane na bolnikih z različnimi stopnjami jetrne insuficience.
Co-administration of Eviplera and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5). 
Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva, saj povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60 %, kar lahko poveča tveganje za pojav neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
Co-administration of Eviplera and didanosine is not recommended (see section 4.4). 
Sočasna uporaba zdravila Eviplera in didanozina se ne priporoča (glejte poglavje 4.4).
Cmin: N/A Tenofovir: 
Cmin: ni bilo ovrednoteno tenofovir:
Eviplera must be administered with food to ensure optimal absorption (see section 4.2). 
Za zagotavljanje optimalne absorpcije je treba zdravilo Eviplera jemati s hrano (glejte poglavje 4.2).
Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine. 
Na emtricitabin rezistentni virusi s substitucijo M184V/I so bili navzkrižno rezistentni na lamivudin, vendar so ohranili občutljivost na didanozin, stavudin, tenofovir in zidovudin.
• Tenofovir disoproxil, a nucleotide reverse transcriptase inhibitor (NtRTI). 
• dizoproksiltenofovirat, nukleotidni zaviralec reverzne transkriptaze (NtRTI)
Discontinued study drug due to AE or deathd 
Prekinitev uporabe študijskega zdravila zaradi neželenega učinka ali smrtid
• Rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI). 
• rilpivirin, nenukleozidni zaviralec reverzne transkriptaze (NNRTI)
Adverse reaction Metabolism and nutrition disorders Very common: increased total cholesterol (fasted)2, increased LDL-cholesterol (fasted)2, hypophosphataemia3, 5 
zvišanje skupnega holesterola (na tešče)2, zvišanje holesterola LDL (na tešče)2, hipofosfatemija3, 5
Studies in animals have shown limited placenta passage of rilpivirine. 
Študije na živalih so pokazale, da rilpivirin prehaja skozi placento v omejenih količinah.
angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1 
angioedem1, 3, 6, hude kožne reakcije s sistemskimi simptomi7
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see section 4.2). 
Zdravila Eviplera se ne sme dajati skupaj z rilpivirinijevim kloridom, razen če je to potrebno za prilagoditev odmerka pri uporabi z rifabutinom (glejte poglavje 4.2).
(may affect more than 1 in 10 people) 
Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis (see section 4.4). 
Prekinitev zdravljenja z zdravilom Eviplera pri bolnikih s hkratno HIV in HBV okužbo je lahko povezana s hudimi akutnimi poslabšanji hepatitisa (glejte poglavje 4.4).
There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B). 
Podatkov o uporabi zdravila Eviplera pri bolnikih z blago ali zmerno jetrno okvaro (stopnje A ali B po Child-Pugh-Turcotteovi (CPT) lestvici je malo.
Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment outweigh the potential risks (see sections 4.4 and 5.2). 
Zato naj se zdravilo Eviplera pri bolnikih z blago ledvično okvaro uporablja samo, če morebitne koristi zdravljenja odtehtajo morebitna tveganja (glejte poglavji 4.4 in 5.2).
Therefore, in patients with mild renal impairment Eviplera should only be used if the potential benefits of treatment are considered to outweigh the potential risks (see sections 4.2 and 4.4). 
Zato naj se zdravilo Eviplera pri bolnikih z blago ledvično okvaro uporablja samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja (glejte poglavji 4.2 in 4.4).
Eviplera is indicated for the treatment of adults infected with human immunodeficiency virus type 1 (HIV-1) without known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and with a viral load ≤ 100,000 
Zdravilo Eviplera je indicirano za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1) brez znanih mutacij, povezanih z rezistenco na razred nenukleozidnih zaviralcev reverzne transkriptaze (NNRTI), tenofovir ali emtricitabin in z virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (glejte poglavja 4.2, 4.4 in 5.1).
Exacerbations of hepatitis after discontinuation of treatment In HIV infected patients co-infected with HBV, clinical and laboratory evidence of hepatitis have occurred after discontinuation of treatment (see section 4.4). 
Pri bolnikih, okuženih z virusom HIV, ki imajo hkratno okužbo z virusom HBV, so se po prekinitvi zdravljenja pokazali klinični in laboratorijski znaki hepatitisa (glejte poglavje 4.4).
Other NNRTIs It is not recommended to co-administer Eviplera with other NNRTIs. 
Drugi NNRTI Sočasna uporaba zdravila Eviplera z drugimi NNRTI-ji se ne priporoča.
The pharmacokinetics of rilpivirine has not been studied in patients with renal insufficiency. 
Farmakokinetike rilpivirina niso proučevali pri bolnikih z ledvično insuficienco.
Co-administration of Eviplera and medicinal products that induce CYP3A has been observed to decrease the plasma concentrations of rilpivirine which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3). 
Opazili so, da sočasna uporaba zdravila Eviplera in zdravil, ki inducirajo CYP3A, povzroči zmanjšanje koncentracij rilpivirina v plazmi, kar lahko zmanjša terapevtski učinek zdravila Eviplera (glejte poglavje 4.3).
The efficacy, safety, and pharmacokinetics of switching from efavirenz/emtricitabine/tenofovir disoproxil STR to Eviplera STR were evaluated in an open-label study in virologically suppressed HIV-1 infected adults. 
Učinkovitost, varnost in farmakokinetiko prehoda z režima odmerjanja z eno samo tableto efavirenza/emtricitabina/dizoproksiltenofovirata na zdravilo Eviplera v režimu odmerjanja z eno samo tableto so ocenili v odprti študiji pri bolnikih z virološko supresijo, okuženih z virusom HIV-1.
Cmin: N/A Emtricitabine: 
Cmin: ni bilo ovrednoteno emtricitabin:
If Eviplera is co-administered with rifabutin, an additional 25 mg tablet of rilpivirine per day is recommended to be taken concomitantly with Eviplera, for the duration of the rifabutin coadministration (see section 4.5). 
Pri sočasnem dajanju zdravila Eviplera z rifabutinom se priporoča dodatna 25 mg tableta rilpivirina na dan, ki naj se jemlje sočasno z zdravilom Eviplera ves čas trajanja sočasne uporabe rifabutina (glejte poglavje 4.5).
Tenofovir displayed antiviral activity in cell culture against HIV-1 subtype A, B, C, D, E, F, G, and O (EC50 values ranged from 0.5 to 2.2 µM) and strain specific activity against HIV-2 (EC50 values ranged from 1.6 to 5.5 µM). 
Tenofovir je pokazal protiretrovirusno aktivnost v celični kulturi proti podtipom A, B, C, D, E, F, G in O virusa HIV-1 (vrednosti EC50 so bile v razponu od 0,5 do 2,2 µM) in aktivnost, specifično za sev, proti virusu HIV-2 (vrednost EC50 so bile v razponu od 1,6 do 5,5 µM).
Microcrystalline cellulose, lactose monohydrate, povidone, pregelatinised maize starch, polysorbate 20, croscarmellose sodium, and magnesium stearate. 
Jedro tablete: mikrokristalna celuloza, laktoza monohidrat, povidon, predgelirani koruzni škrob, polisorbat 20, premreženi natrijev karmelozat in magnezijev stearat
Lansoprazole2 
lansoprazol2
Interaction not studied with any of the components of Eviplera. 
Interakcij z drugimi sestavinami zdravila Eviplera niso preučevali.
Eviplera should be administered with caution to elderly patients (see sections 4.4 and 5.2). 
Zdravilo Eviplera je treba bolnikom starostnikom dajati previdno (glejte poglavji 4.4 in 5.2).
(rilpivirine) and 5/14 (efavirenz) were in patients with a baseline viral load of ≤ 100,000 copies/mL. 
Med temi virološkimi neuspehi je bilo 5/15 (rilpivirin) in 5/14 (efavirenz) bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml.
If a patient vomits more than 4 hours after taking Eviplera they do not need to take another dose of Eviplera until the next regularly scheduled dose. 
Če bolnik bruha več kot 4 ure po jemanju zdravila Eviplera, mu ni treba vzeti drugega odmerka zdravila Eviplera, dokler ni čas za naslednji odmerek po režimu.
For those patients failing therapy with Eviplera and who developed resistance to Eviplera cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen. 
Rezistenca na emtricitabin/lamivudin Rezistenca na rilpivirin Rezistenca na efavirenz Za bolnike, pri katerih zdravljenje z zdravilom Eviplera ni bilo uspešno in pri katerih se je pojavila rezistenca na zdravilo Eviplera, so praviloma opazili navzkrižno rezistenco na druge odobrene NNRTI (etravirin, efavirenz, nevirapin).
Co-administration of Eviplera and didanosine is not recommended since exposure to didanosine is significantly increased following co-administration with tenofovir disoproxil, which may increase the risk of didanosine-related adverse reactions (see section 4.5). 
Sočasna uporaba zdravila Eviplera in didanozina ni priporočljiva, saj se izpostavljenost didanozinu znatno poveča po sočasnem dajanju dizoproksiltenofovirata, kar lahko poveča tveganje pojava neželenih učinkov, povezanih z didanozinom (glejte poglavje 4.5).
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). 
c Med primarno analizo v 48. tednu in 96. tednom se je pojavilo 17 novih viroloških neuspehov (6 bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 11 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml).
(may affect up to 1 in 100 people) 
Občasni:pojavijo se lahko pri največ 1 od 100 bolnikov
3 Adverse reaction identified for tenofovir disoproxil. 
3 Neželeni učinek, ki so ga zabeležili za dizoproksiltenofovirat.
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4). 
Zato se zdravilo Eviplera ne priporoča pri bolnikih s hudo jetrno okvaro (glejte poglavji 4.2 in 4.4)
Cases of severe skin reactions with systemic symptoms have been reported during post-marketing experience with Eviplera, including but not limited to rashes accompanied by fever, blisters, conjunctivitis, angioedema, elevated liver function tests, and/or eosinophilia. 
Iz izkušenj v obdobju trženja zdravila Eviplera so poročali o primerih hudih kožnih reakcij in sistemskih simptomov, ki med drugim vključujejo izpuščaje, ki jih spremljajo zvišana telesna temperatura, mehurji, konjunktivitis, angioedem, zvišani rezultati testov jetrne funkcije in/ali eozinofilija.
Rilpivirine is primarily metabolised by CYP3A Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2). 
Zato lahko zdravila, ki inducirajo ali zavirajo CYP3A, vplivajo na očistek rilpivirina (glejte poglavje 5.2).
• St. John's wort (Hypericum perforatum) 
(Hypericum perforatum)