natgillin/translations-raw huggingface dataset:
These medicines can increase the amount of rilpivirine (a component of Eviplera) in your blood. 
Ovi lijekovi mogu povećati količinu rilpivirina (sastavnog dijela lijeka Eviplera) u Vašoj krvi.
The studies are identical in design with the exception of the background regimen (BR). 
Ispitivanja imaju potpuno jednak ustroj uz izuzetak osnovnog terapijskog režima.
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. 
Kad se Eviplera primjenjuje istovremeno s rifabutinom, preporučuje se dodatno uzimati tabletu rilpivirina od 25 mg na dan istovremeno s Eviplerom, tijekom cijelog trajanja istovremene primjene rifabutina.
ANTI-INFECTIVES 
ANTIINFEKCIJSKI LIJEKOVI
The mutations associated with NRTI resistance that developed in 3 or more patients were: K65R, K70E, M184V/I and K219E during the treatment period. 
Mutacije povezane s rezistencijom na nukleozidne inhibitore reverzne transkriptaze koje su se razvile u 3 ili više bolesnika tijekom razdoblja liječenja bile su: K65R, K70E, M184V/I i K219E.
Eviplera contains a colourant called sunset yellow aluminium lake (E110), which may cause allergic reactions. 
Eviplera sadrži boju pod nazivom sunset yellow aluminium lake (E110), koja može prouzročiti alergijske reakcije.
Rifampicin/Emtricitabine 
Rifampicin/emtricitabin
The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine. 
Supstitucije K65R i K70E rezultiraju smanjenom osjetljivošću na abakavir, didanozin, lamivudin, emtricitabin i tenofovir, ali zadržavaju osjetljivost na zidovudin.
Monitoring of renal function is recommended for patients receiving Eviplera (see section 4.4). 
Preporučuje se nadzirati funkciju bubrega u bolesnika koji primaju lijek Eviplera (vidjeti dio 4.4).
Tenofovir pharmacokinetics was not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects. 
Farmakokinetika tenofovira nije se bitno izmijenila u ispitanika s oštećenjem jetre, što navodi na zaključak da u tih ispitanika nije potrebno prilagođavati dozu.
1 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product. 
1 Ovo ispitivanje interakcije provedeno je s dozom rilpivirinklorida koja je veća od preporučene da bi se procijenio maksimalni učinak na istovremeno primijenjeni lijek.
In the pooled efficacy analysis from the two Phase III clinical studies (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil + 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). 
Prema analizi objedinjenih podataka o djelotvornosti iz dvaju kliničkih ispitivanja III. faze (C209 [ECHO] i C215 [THRIVE]) u trajanju od 96 tjedana, u bolesnika liječenih emtricitabinom/tenofovirdizoproksilom + rilpivirinom s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml rizik od virološkog neuspjeha bio je veći (17,6% uz rilpivirin nasuprot 7,6% uz efavirenz) nego u bolesnika s početnim virusnim opterećenjem ≤ 100 000 HIV-1 RNK kopija/ml (5,9% uz rilpivirin nasuprot 2,4% uz efavirenz).
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. 
Bolesnici istovremeno zaraženi HIV-om i HBV-om ili HCV-om Profil nuspojava emtricitabina, rilpivirinklorida i tenofovirdizoproksila u bolesnika s istovremenom infekcijom HIV/HBV ili HIV/HCV bio je sličan profilu koji je zapažen u bolesnika zaraženih virusom HIV-a bez istovremene druge infekcije.
Methadone (60-100 mg once daily, individualised dose)/Rilpivirine 
Metadon (60 - 100 mg jedanput na dan, individualizirana doza)/rilpivirin
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). 
Ako se Eviplera istovremeno primjenjuje s rifabutinom, preporučuje se dodatno uzimati tabletu rilpivirina od 25 mg na dan istovremeno s Eviplerom, tijekom cijelog trajanja istovremene primjene rifabutina (vidjeti dio 4.5).
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. 
Uključeni su bolesnici inficirani virusom HIV-1 koji prethodno nisu bili liječeni antiretrovirusnom terapijom (n = 1368), koji su u plazmi imali HIV-1 RNK ≥ 5000 kopija/ml i koji su bili probrani na osjetljivost na N(t)RTI i odsutnost mutacija specifično povezanih s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze.
*based on historic controls 
Cmax: ↔* *na temelju povijesnih kontrola
3 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product. 
3 Ovo ispitivanje interakcije provedeno je s dozom rilpivirinklorida koja je veća od preporučene da bi se procijenio maksimalni učinak na istovremeno primijenjeni lijek.
Resistance to tenofovir (K65R) 
Rezistencija na emtricitabin/ lamivudin (M184I/V) Rezistencija na tenofovir (K65R) 2/66
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. 
Stopa virološkog neuspjeha u bolesnika liječenih emtricitabinom/tenofovirdizoproksilom + rilpivirinom iznosila je 9,5% u 48. tjednu i 11,5% u 96. tjednu, dok su u skupini liječenoj emtricitabinom/tenofovirdizoproksilom + efavirenzom odgovarajuće stope iznosile 4,2% odnosno 5,1%.
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. 
Medijan HIV-1 RNK u plazmi bila je 5,0 odnosno 5,0 log10 kopija/ml a medijan broja CD4+ bila je 247 × 106 stanica/l odnosno 261 x 106 stanica/l u bolesnika randomiziranih u skupinu koja je primala rilpivirin odnosno skupinu koja je primala efavirenz.
Rilpivirine has not been studied in patients with severe hepatic impairment (CPT Score C) (see section 4.2). 
Rilpivirin nije ispitivan u bolesnika s teškim oštećenjem jetre (CPT stadij C) (vidjeti dio 4.2).
The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus to lamivudine, emtricitabine, and tenofovir. 
Mutacija K65R također se može selektivno izdvojiti abakavirom ili didanozinom i rezultirati smanjenom osjetljivošću na ove lijekove i na lamivudin, emtricitabin i tenofovir.
This medicine can decrease the amount of rilpivirine (a component of Eviplera) in your blood. 
Ovaj lijek može smanjiti količinu rilpivirina (sastavnog dijela lijeka Eviplera) u Vašoj krvi.
Eviplera should be used with caution in patients with moderate hepatic impairment. 
Eviplera se treba primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre.
Discontinuation of Eviplera therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis. 
Prekid terapije lijekom Eviplera u bolesnika istovremeno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
Contains lactose monohydrate and sunset yellow aluminium lake (E110), see leaflet for further information. 
Sadrži laktozu hidrat i boju sunset yellow aluminium lake (E110), vidjeti uputu o lijeku za dodatne informacije.
Eviplera should not be administered concomitantly with adefovir dipivoxil. 
Eviplera se ne smije primjenjivati istovremeno s adefovirdipivoksilom.
Randomisation was stratified by use of tenofovir disoproxil and/or lopinavir/ritonavir in the baseline regimen. 
Randomizacija je bila stratificirana prema primjeni tenofovirdizoproksila i/ili lopinavira/ritonavira u početnom liječenju.
vesiculobullous rash1, pustular rash1, urticaria1, skin discolouration (increased pigmentation)1, 4, maculopapular rash1, pruritus1 
vezikulo-bulozni osip1, pustulozni osip1, urtikarija1, promjena boje kože (pojačana pigmentacija)1, 4, makulopapularan osip1, pruritus1
HIV-1 containing the K103N substitution or other substitutions associated with resistance to rilpivirine and other NNRTIs was susceptible to emtricitabine. 
HIV-1 koji sadrži supstituciju K103N ili druge supstitucije povezane s rezistencijom na rilpivirin i druge nenukleozidne inhibitore reverzne transkriptaze bio je osjetljiv na emtricitabin.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3) with the components of Eviplera. 
Ispitivanja na životinjama s djelatnim tvarima lijeka Eviplera ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju (vidjeti dio 5.3).
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). 
Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina, jer rezultira 40 - 60%-tnim povećanjem sistemske izloženosti didanozinu što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
Limited data from clinical studies support once daily dosing of Eviplera in patients with mild renal impairment (CrCl 50-80 mL/min). 
Ograničeni podaci iz kliničkih ispitivanja podupiru doziranje lijeka Eviplera jedanput na dan u bolesnika s blagim oštećenjem bubrega (CrCl 50 - 80 ml/min).
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). 
Tenofovirdizoproksil može prouzročiti bubrežnu toksičnost pa se preporučuje pomno nadziranje funkcije bubrega u svakog bolesnika s oštećenjem bubrega koji se liječi lijekom Eviplera (vidjeti dijelove 4.2, 4.4 i 5.2).
Ethinylestradiol (0.035 mg once daily)/Rilpivirine 
Etinilestradiol (0,035 mg jedanput na dan)/ rilpivirin
Eviplera contains sunset yellow aluminium lake also called “E110” which may cause allergic reactions. 
Eviplera sadrži boju sunset yellow aluminium lake, koja se još zove „E110” i može prouzročiti alergijske reakcije.
Itraconazole2 
Itrakonazol2
No dose adjustment is required for rilpivirine hydrochloride in patients with mild or moderate hepatic impairment (CPT Score A or B). 
Nije potrebna prilagodba doze rilpivirinklorida u bolesnika s blagim ili umjerenim oštećenjem jetre (CPT stadij A ili B).
In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1). 
U ispitivanju zdravih ispitanika pokazalo se da doze rilpivirina iznad terapijskih (75 mg jedanput na dan i 300 mg jedanput na dan) produljuju QTc interval na EKG-u (vidjeti dio 5.1).
Posaconazole2 Voriconazole2 
Posakonazol2 Vorikonazol2
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1. 
U staničnoj kulturi izabrani su sojevi rezistentni na rilpivirin, počevši s divljim tipom virusa HIV-1 različitog porijekla i podtipa te s virusom HIV-1 rezistentnim na nenukleozidne inhibitore reverzne transkriptaze.
Eviplera 200 mg/25 mg/245 mg film-coated tablets 
NAZIV LIJEKA Eviplera 200 mg/25 mg/245 mg filmom obložene tablete
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 s mutacijom M184V/I bili su križno rezistentni na lamivudin, ali su zadržali osjetljivost na didanozin, stavudin, tenofovir, zalcitabin i zidovudin.
As with other antiretroviral medicinal products, resistance testing and/or historical resistance data should guide the use of Eviplera (see section 4.4). 
Kao i s drugim antiretrovirusnim lijekovima, u primjeni lijeka Eviplera treba se rukovoditi nalazima ispitivanja rezistencije i/ili prethodno dobivenim podacima o rezistenciji (vidjeti dio 4.4).
Raltegravir (400 mg twice daily)/ Tenofovir disoproxil 
Raltegravir (400 mg dvaput na dan)/ tenofovirdizoproksil
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see section 4.2). 
Lijek Eviplera ne smije se primjenjivati istovremeno s rilpivirinkloridom osim ako je potrebna prilagodba doze zbog rifabutina (vidjeti dio 4.2).
You must remain under the care of your doctor while taking Eviplera. 
Za vrijeme uzimanja lijeka Eviplera morate ostati pod skrbi svog liječnika.
If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. 
Ako bolesnik propusti uzeti dozu lijeka Eviplera a prošlo je više od 12 sati, bolesnik ne smije uzeti propuštenu dozu nego jednostavno treba nastaviti uzimati doze prema uobičajenom rasporedu.
Stayed on Baseline Regimen (SBR) arm n = 159 
Skupina ostala na početnom režimu liječenja n = =159
Resistance to emtricitabine/lamivudine Resistance to rilpivirine Resistance to efavirenz 
Rezistencija na rilpivirin Rezistencija na efavirenz
3 Adverse reaction identified for tenofovir disoproxil. 
3 Nuspojava utvrđena tenofovirdizoproksil.
Eviplera should not be administered concomitantly with rilpivirine hydrochloride unless needed for dose adjustment with rifabutin (see sections 4.2 and 4.5). 
Lijek Eviplera ne smije se primjenjivati istovremeno s rilpivirinkloridom osim ako je potrebna prilagodba doze zbog rifabutina (vidjeti dijelove 4.2 i 4.5).
Elderly patients are more likely to have decreased renal function, therefore caution should be exercised when treating elderly patients with Eviplera (see section 4.4). 
U starijih bolesnika postoji veća vjerojatnost da imaju smanjenu funkciju bubrega pa je stoga potreban oprez kad se starije bolesnike liječi lijekom Eviplera (vidjeti dio 4.4).
Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available. 
Kada je indiciran prekid terapije jednom od djelatnih tvari lijeka Eviplera ili ako je potrebno prilagoditi dozu, postoje odvojeni pripravci emtricitabina, rilpivirinklorida i tenofovirdizoproksila.
Eviplera should not be administered concomitantly with adefovir dipivoxil (see section 4.5). 
Eviplera se ne smije primjenjivati istovremeno s adefovirdipivoksilom (vidjeti dio 4.5).
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). 
Stoga se u bolesnika s blagim oštećenjem bubrega Eviplera treba primjenjivati samo ako se smatra da je moguća korist liječenja veća od mogućih rizika (vidjeti dijelove 4.2 i 4.4).
Didanosine The co-administration of Eviplera and didanosine is not recommended (see section 4.4 and Table 1). 
Ne preporučuje se istovremena primjena lijeka Eviplera i didanozina (vidjeti dio 4.4 i tablicu 1).
The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment. 
U normalnih ispitanika srednje vrijednosti (%CV) Cmax i AUC0-∞ tenofovira bile su 223 (34,8%) ng/ml odnosno 2.050 (50,8%) ng•h/ml, u usporedbi s 289 (46,0%) ng/ml i 2.310 (43,5%) ng•h/ml u ispitanika s umjerenim oštećenjem jetre te 305 (24,8%) ng/ml i 2.740 (44,0%) ng•h/ml u ispitanika s teškim oštećenjem jetre.
No dose adjustments are required when initiating co-administration of methadone with Eviplera. 
Nije potrebna prilagodba doze kad se metadon počinje istovremeno primjenjivati s lijekom Eviplera.
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). 
Istovremena primjena lijeka Eviplera i didanozina ne preporučuje se, budući da je izloženost didanozinu značajno povećana nakon istovremene primjene tenofovirdizoproksila, što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
Missing data during window but on study drug 
Podaci o ispitivanom lijeku nedostaju iz okvira ispitivanja, ali lijek se primjenjuje
HIV-1 containing the K103N, Y181C, or rilpivirine-associated substitutions with resistance to NNRTIs were susceptible to tenofovir. 
Virusi HIV-1 koji su sadržavali K103N, Y181C ili supstitucije povezane s rilpivirinom s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze bili su osjetljivi na tenofovir.
By baseline CD4+ cell count (x 106 cells/L) 
Prema početnom broju stanica CD4+ (x 106 stanica/l)
The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215. 
Bolesnici zaraženi virusom HIV-1 koji prethodno nisu bili liječeni Djelotvornost lijeka Eviplera temelji se na analizama podataka iz 96. tjedna prikupljenih u dva randomizirana, dvostruko slijepa, kontrolirana ispitivanja C209 i C215.
EU/1/11/737/001 30 film-coated tablets. 
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/737/001 30 filmom obloženih tableta.
angioedema1, 3, 6, severe skin reactions with systemic symptoms7 Musculoskeletal and connective tissue disorders Very common: elevated creatine kinase1 
angioedem1, 3, 6, teške kožne reakcije sa sistemskim simptomima7
Only H2-receptor antagonists that can be dosed once daily should be used. 
H2-receptora koji se mogu dozirati jedanput na dan.
Metformin (850 mg single dose)/ Rilpivirine 
Metformin (850 mg jednostruka doza)/ rilpivirin
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. 
Od 24 bolesnika liječena lijekom Eviplera koji su imali supstituciju K103N povezanu s NNRTI koja je kod njihovog virusa HIV-1 postojala već na početku, virološka supresija bila je održana tijekom 48 tjedana u 17 od 18 bolesnika u skupini prebačenoj na lijek Eviplera i tijekom 24 tjedna u 5 od 6 bolesnika u skupini bolesnika koji su ostali na početnom režinu.
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. 
U analizi objedinjenih podataka iz ispitivanja C209 i C215 za bolesnike koji su primali osnovni terapijski režim emtricitabinom/tenofovirdizoproksilom, demografske značajke i početne značajke bolesti bile su uravnotežene između skupine na rilpivirinu i skupine na efavirenzu.
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. 
U ispitivanjima kombinacije tenofovira s nukleozidnim inhibitorima reverzne transkriptaze (abakavir, didanozin, emtricitabin, lamivudin, stavudin i zidovudin), nenukleozidnim inhibitorima reverzne transkriptaze (delavirdin, efavirenz, nevirapin i rilpivirin) i inhibitorima proteaze (amprenavir, indinavir, nelfinavir, ritonavir i sakvinavir) primijećeni su aditivni do sinergistički učinci.
The bioequivalence of one Eviplera film-coated tablet with one emtricitabine 200 mg hard capsule, one rilpivirine (as hydrochloride) 25 mg film-coated tablet and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fed, healthy subjects. 
Bioekvivalencija jedne Eviplera filmom obložene tablete s jednom emtricitabin 200 mg tvrdom kapsulom, jednom rilpivirin (u obliku klorida) 25 mg filmom obložene tablete i jedne tenofovirdizoproksil 245 mg filmom obložene tablete utvrđena je nakon primjene jednostruke doze zdravim ispitanicima na pun želudac.
How to take Eviplera 
Kako uzimati Evipleru
8 This adverse reaction was identified through post-marketing surveillance for tenofovir disoproxil but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil. 
Ova nuspojava je bila identificirana tijekom praćenja lijeka nakon stavljanja lijeka u promet tenofovirdizoproksila no nije zabilježena u randomiziranim kontroliranim kliničkim ispitivanjima ili programu proširenog pristupa tenofovirdizoproksila.
If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet. 
Ako povraćate kad je prošlo više od 4 sata od uzimanja Eviplere, ne uzimajte drugu tabletu sve dok ne bude vrijeme za sljedeću prema uobičajenom rasporedu.
Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil 
Eviplera 200 mg/25 mg/245 mg filmom obložene tablete emtricitabin/rilpivirin/tenofovirdizoproksil
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). 
Prekid terapije lijekom Eviplera u bolesnika istovremeno inficiranih HIV-om i HBV-om može biti povezan s teškim akutnim pogoršanjima hepatitisa (vidjeti dio 4.4).
Co-administration of Eviplera with proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect of Eviplera (see section 4.3). 
Primijećeno je da istovremena primjena lijeka Eviplera s inhibitorima protonske pumpe smanjuje koncentracije rilpivirina u plazmi (zbog povišenja želučanog pH), što potencijalno može dovesti do gubitka terapijskog učinka lijeka Eviplera (vidjeti dio 4.3).
Sildenafil (50 mg single dose)/ Rilpivirine1 
Sildenafil (50 mg jednostruka doza)/ rilpivirin1
If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4). 
Ako se prekine liječenje lijekom Eviplera u bolesnika istovremeno zaraženih HIV-om i virusom hepatitisa B (HBV) te bolesnike treba pomno nadzirati zbog praćenja pojave znakova egzacerbacije hepatitisa (vidjeti dio 4.4).
Therefore, Eviplera is not recommended in patients with severe hepatic impairment (see sections 4.2 and 4.4). 
Stoga se Eviplera ne preporučuje u bolesnika s teškim oštećenjem jetre (vidjeti dijelove 4.2 i 4.4).
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. 
Ako bolesnik povraća nakon više od 4 sata od uzimanja lijeka Eviplera, ne treba uzeti drugu dozu lijeka Eviplera sve do sljedeće doze prema uobičajenom rasporedu.