natgillin/translations-raw huggingface dataset:
• Tell your doctor immediately and stop taking Eviplera if you develop a skin rash with the following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth or body.
• Takoj obvestite zdravnika in prenehajte jemati zdravilo Eviplera, če se pojavi kožni izpuščaj z naslednjimi simptomi: zvišana telesna temperatura, mehurji, rdečina v očeh in oteklost obraza, ust ali telesa.
In some cases, your doctor may need to adjust your dose or check your blood levels.
V nekaterih primerih bo moral zdravnik prilagoditi vaš odmerek ali opraviti preiskave ravni v krvi.
Switching from an efavirenz-based regimen
Prehod z režima na podlagi efavirenza
• Problems with digestion resulting in discomfort after meals, wind (flatulence)
• težave s prebavo, ki privedejo do slabega počutja po zaužitem obroku, vetrovi (flatulenca)
• Softening of the bones (with bone pain and sometimes resulting in fractures)
• mehčanje kosti (z bolečinami v kosteh, včasih tudi zlom)
The recommended dose of Eviplera is one tablet, taken orally, once daily.
Priporočeni odmerek zdravila Eviplera je ena tableta, peroralno, enkrat dnevno.
Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter 1 [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Tenofovir se primarno izloča preko ledvic tako s filtracijo kot z aktivnim tubularnim transportnim sistemom (humani prenašalec organskih anionov 1 [hOAT1]), pri čemer se po intravenskem vnosu približno 70-80 % odmerka izloči nespremenjenega z urinom.
Rilpivirine was well tolerated during pregnancy and postpartum.
Bolnice so rilpivirin dobro prenašale med nosečnostjo in po porodu.
Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Študije kancerogenosti z rilpivirinom pri miših in podganah so razkrile tumorogeni potencial, specifičen za te vrste, za katerega velja, da za ljudi ni pomemben.
It is recommended that Eviplera be swallowed whole with water.
Priporočljivo je, da se zdravilo Eviplera pogoltne celo z vodo.
Your doctor may need to give you an additional dose of rilpivirine to treat your HIV infection (see section 3, How to take Eviplera).
Vaš zdravnik vam bo morda moral dati dodatni odmerek rilpivirina za zdravljenje vaše okužbe s HIV (glejte poglavje 3, Kako jemati zdravilo Eviplera).
• H2-antagonists (famotidine, cimetidine, nizatidine or ranitidine) These medicines can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
• antagonisti H2 (famotidin, cimetidin, nizatidin ali ranitidin) Ta zdravila lahko zmanjšajo količino rilpivirina (sestavina zdravila Eviplera) v vaši krvi.
The absolute bioavailability of rilpivirine is unknown.
Absolutna biološka uporabnost rilpivirina ni znana.
• Medicines containing didanosine (for HIV infection): Taking Eviplera with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4+ cell counts.
• Zdravila, ki vsebujejo didanozin (za okužbe z virusom HIV): Jemanje zdravila Eviplera z drugimi protivirusnimi zdravili, ki vsebujejo didanozin, lahko zviša nivoje didanozina v krvi in zmanjša število celic CD4+.
The efficacy of Eviplera is based on the analyses of 96 week data from two randomised, double-blind, controlled studies C209 and C215.
Učinkovitost zdravila Eviplera temelji na analizah podatkov 96 tednov iz dveh randomiziranih, dvojno slepih, kontroliranih študij C209 in C215.
Eviplera contains three active substances that are used to treat Human Immunodeficiency Virus (HIV) infection:
Zdravilo Eviplera vsebuje tri učinkovine, ki se uporabljajo za zdravljenje okužbe z virusom človeške imunske pomanjkljivosti (HIV):
The European Medicines Agency has waived the obligation to submit the results of studies with Eviplera in all subsets of the paediatric population in the treatment of HIV-1 (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Eviplera za vse podskupine pediatrične populacije za zdravljenje okužbe z virusom HIV-1 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Farmakokinetični podatki kažejo, da je bila skupna izpostavljenost (AUC) rilpivirinu kot del protiretrovirusnega režima približno 30 % nižja med nosečnostjo v primerjavi z obdobjem po porodu (6-12 tednov).
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.
Virološki odziv je bil v celotni študiji na splošno ohranjen: od 12 bolnic, ki so zaključile študijo, je imelo na koncu študije supresijo 10 bolnic; pri drugih 2 bolnicah pa so povišanje virusne obremenitve opazili samo v obdobju po nosečnosti, pri čemer je bil pri najmanj 1 bolnici razlog domnevno neoptimalno sodelovanje z zdravljenjem.
52% of patients with virologic failure in the rilpivirine arm developed concomitant NNRTI and NRTI mutations.
52 % bolnikov z virološkim neuspehom v kraku z rilpivirinom je razvilo sočasne mutacije NNRTI in NRTI.
5 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in hepatitis C virus
5 Študijo so izvedli z dodatnim voksilaprevirjem 100 mg za doseganje izpostavljenosti voksilaprevirju, ki se pričakuje pri bolnikih z okužbo z virusom hepatitisa C (HCV).
Lactic acidosis occurs more often in women - particularly if they are overweight, and in people with liver disease.
Laktacidoza se pogosteje pojavi pri ženskah, zlasti tistih s prekomerno telesno maso in pri ljudeh z jetrno boleznijo.
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicinal products transported by P-gp that are more sensitive to intestinal P-gp inhibition (e.g. dabigatran etexilate).
Vendar pa ni mogoče povsem izključiti, da lahko rilpivirin zviša izpostavljenost drugim zdravilom, ki jih prenaša P-gp in so bolj občutljiva na zaviranje črevesnega P-gp (npr. dabigatran eteksilat).
The decrease in the unbound free fraction of rilpivirine exposure (i.e. active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Zmanjšanje izpostavljenosti nevezani prosti frakciji rilpivirina (tj. aktivna) med nosečnostjo je bilo v primerjavi s poporodnim obdobjem manj izraženo kot za skupno izpostavljenost rilpivirinu.
The triple combination of emtricitabine, rilpivirine, and tenofovir demonstrated synergistic antiviral activity in cell culture.
Pri trojni kombinaciji emtricitabina, rilpivirina in tenofovirja je bila dokazana sinergistična protivirusna aktivnost v celični kulturi.
• Increased fatty acids (triglycerides), bilirubin or sugar in the blood
• povišanje maščobnih kislin (trigliceridov), bilirubina ali sladkorja v krvi
Treatment with Eviplera resulted in an early small increase of mean serum creatinine levels which remained stable over time and is not considered clinically relevant (see section 4.8).
Zdravljenje z zdravilom Eviplera je povzročilo zgodnje majhno povečanje povprečnih ravni kreatinina v serumu, ki so ostale stabilne, zato se ne obravnavajo kot klinično pomembne (glejte poglavje 4.8).
AUC: ↑ Cmax: ↑ Cmin: ↑
tenofovir: AUC: ↑ Cmax: ↑ Cmin: ↑
If Eviplera for any reason is stopped, speak to your doctor before you restart taking Eviplera tablets.
Če zaradi katerega koli razloga prenehate jemati zdravilo Eviplera, se pogovorite z zdravnikom, preden začnete ponovno jemati tablete zdravila Eviplera.
• Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose.
• Metadon, zdravilo, ki se uporablja za zdravljenje zasvojenosti z opiati, saj bo moral zdravnik morda prilagoditi vaš odmerek metadona.
The breakdown of muscle, softening of the bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness and decreases in potassium or phosphate in the blood may occur due to damage to kidney tubule cells.
Razpad mišičnega tkiva, mehčanje kosti (z bolečinami v kosteh, kar včasih vodi v zlom), bolečine v mišicah, mišična oslabelost in zmanjšanje količine kalija ali fosfatov v krvi se lahko pojavijo zaradi poškodbe celic ledvičnih tubulov.
The incidence of virologic failure was higher in the rilpivirine arm than in the efavirenz arm at week 96; however, most of the virologic failures occurred within the first 48 weeks of treatment.
Incidenca virološkega neuspeha je bila v 96. tednu višja v kraku z rilpivirinom, kot v kraku z efavirenzom; vendar pa se je večina viroloških neuspehov pojavila v prvih 48 tednih zdravljenja.
During the time period of declining efavirenz plasma levels and increasing rilpivirine plasma levels after switching, none of the patients had efavirenz or rilpivirine levels below their respective IC90 levels at the same time.
V obdobju upadanja ravni efavirenza v plazmi in povečevanja ravni rilpivirina v plazmi po prehodu ni imel noben od bolnikov ravni efavirenza ali rilpivirina pod vsakokratnimi ravnmi IC90 sočasno.
hypokalaemia3, 5
hipokaliemija3, 5
e Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
e Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
V urinu so bili odkriti le sledovi nespremenjenega rilpivirina (< 1 % odmerka).
Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Populacijska farmakokinetična analiza je pokazala, da sočasna okužba z virusom hepatitisa B in/ali C nima klinično pomembnega učinka na izpostavljenost rilpivirinu.
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).
V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8) in mu nuditi standardno podporno zdravljenje, vključno z opazovanjem kliničnega stanja bolnika in nadziranjem vitalnih znakov in EKG-ja (interval QT).
Macrolide antibiotics Clarithromycin Erythromycin
Makrolidni antibiotiki klaritromicin eritromicin
• Tell your doctor if you had kidney disease, or if tests have shown kidney problems.
• Obvestite zdravnika, če ste imeli težave z ledvicami ali če so preiskave pokazale, da imate težave z ledvicami.
No clinically relevant drug-drug interaction is expected.
Klinično pomembnih interakcij zdravil se ne pričakuje.
Eviplera is not usually taken with other medicines that can damage your kidneys (see Other medicines and Eviplera).
Zdravila Eviplera se ponavadi ne jemlje z drugimi zdravili, ki bi lahko poškodovala ledvice (glejte Druga zdravila in zdravilo Eviplera).
A negative impact by NNRTI mutations other than those listed above (e.g. mutations K103N or L100I as single mutations) cannot be excluded, since this was not studied in vivo in a sufficient number of patients.
Drugega negativnega vpliva mutacij NNRTI, razen zgoraj navedenih (npr. mutacije K103N ali L100I kot samostojni mutaciji) ni mogoče izključiti, saj študije in vivo niso bile izvedene pri zadostnem številu bolnikov.
This may result in loss of therapeutic effect of Eviplera (see section 4.3).
To lahko povzroči izgubo terapevtskega učinka zdravila Eviplera (glejte poglavje 4.3).
• Low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• nizko število belih krvnih celic (zmanjšanje števila belih krvnih celic lahko povzroči večjo nagnjenost k okužbam)
In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
V primeru spremljajoče protivirusne terapije hepatitisa B ali C upoštevajte tudi ustrezne povzetke glavnih značilnosti teh zdravil.
2 Phenotypic resistance to rilpivirine (> 3.7-fold change compared to control).
1 Fenotipska rezistenca na rilpivirin (> 3,7-kratna sprememba glede na kontrolo).
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Večja izpostavljenost tenofovirju lahko potencira neželene reakcije, ki so povezane z dizoproksiltenofoviratom, vključujoč ledvične motnje.
The resistance outcome for patients with protocol defined virological failure and phenotypic resistance at week 96 are shown in Table 6:
Izid rezistence za bolnike, ki imajo v protokolu definiran virološki neuspeh in fenotipsko rezistenco je prikazan v preglednici 6 za 96. teden:
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
Pri nekaterih bolnikih z napredovalo okužbu s HIV (AIDS-om) in oportunističnimi okužbami v anamnezi (okužbe, ki se pojavijo pri ljudeh z oslabljenim imunskim sistemom), se lahko znaki in simptomi vnetja zaradi prejšnjih okužb pojavijo kmalu po začetku zdravljenja HIV.
As a precautionary measure, it is preferable to avoid the use of Eviplera during pregnancy.
Iz previdnosti se je med nosečnostjo bolje izogibati uporabi zdravila Eviplera.
Contact your doctor or nearest emergency department immediately for advice.
Takoj se posvetujte z zdravnikom ali poiščite najbližjo urgentno ambulanto.
The difference in the rate of new virologic failures from the week 48 to week 96 analysis between rilpivirine and efavirenz arms was not statistically significant.
Razlika v stopnji novih viroloških neuspehov v analizi od 48. do 96. tedna med krakoma z rilpivirinom in efavirenzom ni bila statistično značilna.
Eviplera contains an NNRTI (rilpivirine) and so Eviplera is not to be combined with other medicines of this type.
Zdravilo Eviplera vsebuje NNRTI (rilpivirin), zato se zdravila Eviplera ne sme kombinirati z drugimi zdravili te vrste.
No other pathways of resistance to emtricitabine or tenofovir have been identified.
Drugih poti razvoja rezistence na emtricitabin ali tenofovir niso ugotovili.
Do not give this medicine to children and adolescents under 18 years of age.
Otrokom in mladostnikom, starim pod 18 let, ne dajajte tega zdravila.
In other studies (prospective and cross-sectional), the most pronounced decreases in BMD were seen in patients treated with tenofovir disoproxil as part of a regimen containing a boosted protease inhibitor (PI).
V drugih študijah (prospektivne in presečne) so najbolj izrazito zmanjšanje MGK opazili pri bolnikih, zdravljenih z dizoproksiltenofoviratom kot del režima, ki je vseboval okrepljenega zaviralca proteaze (PI, protease inhibitor).
Your doctor may consider giving you the components of Eviplera separately if you are having problems or need your dose adjusted.
Vaš zdravnik vam bo morda učinkovine zdravila Eviplera predpisal ločeno, če imate težave ali je treba odmerek prilagoditi.
The K103N substitution alone did not result in reduced susceptibility to rilpivirine, but the combination of K103N and L100I resulted in a 7-fold reduced susceptibility to rilpivirine.
Samo substitucija K103N ni povzročila manjše občutljivosti na rilpivirin, vendar pa je kombinacija K103N in L100I povzročila 7-krat manjšo občutljivost na rilpivirin.
The safety profile of emtricitabine and tenofovir disoproxil in these studies was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Varnostni profil emtricitabina in dizoproksiltenofovirata v teh študijah je bil skladen s predhodnimi izkušnjami s tema učinkovinama, ko so bolniki vsako od njiju prejemali z drugimi protiretrovirusnimi zdravili.
Each of these active substances, also known as antiretroviral medicines, works by interfering with an enzyme (a protein called ‘reverse transcriptase') that is essential for the virus to multiply.
Vsaka od teh učinkovin, znanih kot protiretrovirusna zdravila, deluje tako, da vpliva na encim (na beljakovino, imenovano ‘reverzna transkriptaza'), ki je nujen za razmnoževanje virusa.
However, in some patients, declines in CrCl did not completely resolve despite tenofovir disoproxil discontinuation.
Vendar pa pri nekaterih bolnikih upad CrCl ni povsem izzvenel, kljub prekinitvi dizoproksiltenofovirata.
• Pain, stomach pain or discomfort, feeling bloated, dry mouth
• bolečina, bolečine ali nelagodje v trebuhu, občutek napihnjenosti, suha usta
While taking Eviplera you may still develop infections or other illnesses associated with HIV infection.
Kljub jemanju zdravila Eviplera se lahko pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three active substances of Eviplera).
Krvne preiskave ali simptomi pri nekaterih bolnikih so kazali, da se je njihov hepatitis poslabšal po prenehanju zdravljenja z emtricitabinom ali dizoproksiltenofoviratom (dve od treh učinkovin zdravila Eviplera).
Dosing recommendations for paediatric patients cannot be made due to insufficient data (see section 4.2).
Priporočil o odmerjanju za pediatrično populacijo ni mogoče dati zaradi nezadostnih podatkov (glejte poglavje 4.2).
Table 1: Interactions between Eviplera or its individual component(s) and other medicinal products
Preglednica 1: Interakcije med zdravilom Eviplera ali njegovo(-imi) posamično(-imi) učinkovino(-ami) in drugimi zdravili
The K65R, M184V, and K65R+M184V mutants of HIV-1 remain fully susceptible to rilpivirine.
Mutanti K65R, M184V in K65R+M184V virusa HIV-1 ostajajo povsem občutljivi na rilpivirin.
The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P and Y181V/I.
Edini mutaciji, povezani z rezistenco, ki sta bili povezani z izgubo občutljivosti na rilpivirin, sta bili: K101P in Y181V/I.
d Includes patients who discontinued due to AE or death at any time point from day 1 through the week 24 window resulting in no virologic data on treatment during the specified window.
d Vključuje bolnike, ki so prenehali sodelovati zaradi neželenih učinkov ali smrti, kadar koli od 1. dne do konca časovnega okna 24. tedna, če zaradi tega v določenem oknu ni bilo viroloških podatkov o zdravljenju.
No dose adjustment is recommended.
Prilagoditev odmerka se ne priporoča.
Patients had to have previously only received efavirenz/emtricitabine/tenofovir disoproxil as their first antiretroviral regimen for at least three months, and wished to switch regimens due to efavirenz intolerance.
Bolniki so morali predhodno vsaj tri mesece prejemati le efavirenz/emtricitabin/dizoproksiltenofovirat kot svoj prvi protiretrovirusni režim za vsaj tri mesece in so želeli preiti na drug režim zaradi neprenašanja efavirenza.
Ethnicity No clinically important pharmacokinetic differences due to ethnicity have been identified.
Etnična pripadnost Klinično pomembnih farmakokinetičnih razlik glede na etnično pripadnost niso ugotovili.
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.
Pred začetkom zdravljenja z zdravilom Eviplera se priporoča izračun CrCl pri vseh bolnikih in nadzor delovanja ledvic (CrCl in vrednost serumskega fosfata) po dveh do štirih tednih zdravljenja, po treh mesecih zdravljenja in zatem vsake tri do šest mesecev pri bolnikih brez dejavnikov tveganja za ledvice.
Any signs of inflammation or infection.
Vsakršni znak vnetja ali okužbe.
• Tell your doctor if you have an allergy to sunset yellow aluminium lake (E110).
• Obvestite zdravnika, če imate alergijo na barvilo sončno rumeno FCF (E110).
• If you are allergic to emtricitabine, rilpivirine, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
• Če ste alergični na emtricitabin, rilpivirin, dizoproksiltenofovirat ali na katero koli sestavino tega zdravila (navedeno v poglavju 6 tega navodila).
At a dose of 25 mg of rilpivirine, no dose adjustment is required.
Pri odmerku 25 mg rilpivirina odmerka ni treba prilagajati.
hypertriglyceridaemia1, 2, hyperglycaemia1, decreased appetite2
hipertrigliceridemija1, 2, hiperglikemija1, zmanjšanje apetita2
Eviplera must be taken orally, once daily with food (see section 5.2).
Zdravilo Eviplera se mora jemati peroralno, enkrat dnevno s hrano (glejte poglavje 5.2).
In the Phase III studies (C209 and C215), lower rilpivirine exposure, similar to that seen during pregnancy, has been associated with an increased risk of virological failure, therefore viral load should be monitored closely (see sections 4.6, 5.1 and 5.2).
V študijah faze III (C209 in C215) je bila nižja izpostavljenost rilpivirinu, podobna kot je bila opažena med nosečnostjo, povezana s povečanim tveganjem za virološki neuspeh, zato je treba skrbno spremljati virusno obremenitev (glejte poglavja 4.6, 5.1 in 5.2).
Emtricitabine triphosphate and tenofovir diphosphate competitively inhibit HIV-1 RT, resulting in DNA chain termination.
Emtricitabin trifosfat in tenofovir difosfat kompetitivno inhibirata RT HIV-1, kar rezultira v prekinitvi verige DNA.
Eviplera may interact with other medicines.
Zdravilo Eviplera lahko medsebojno deluje z drugimi zdravili.
• Women must not get pregnant while taking Eviplera.
• Ženske ne smejo zanositi, medtem ko se zdravijo z zdravilom Eviplera.
• Joint aches and pains (especially of the hip, knee and shoulder)
• bolečine (zlasti v kolkih, kolenih in ramenih)
Study GS-US-264-0106
Študija GS-US-264-0106
DXA substudies showed that small but statistically significant decreases from baseline in whole body BMD and BMC were similar for rilpivirine and control at week 48 and week 96.
Podštudije z DXA so pokazale, da so bila majhna, a statistično značilna zmanjšanja od začetne vrednosti BMD in BMC celega telesa podobna za rilpivirin in kontrolno skupino v 48. in 96. tednu.
• Breakdown of muscle, muscle pain or weakness
• razpad mišičnega tkiva, bolečine v mišicah ali mišična oslabelost
Since emtricitabine and tenofovir are primarily eliminated by the kidneys, co-administration of Eviplera with medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.
Ker se emtricitabin in tenofovir izločata predvsem preko ledvic, sočasna uporaba zdravila Eviplera in zdravil, ki zmanjšujejo delovanje ledvic ali tekmujejo za aktivno tubularno sekrecijo (npr. cidofovir), lahko poveča serumske koncentracije emtricitabina, tenofovirja in/ali sočasno uporabljenih zdravil.
The dosing recommendation is applicable to the recommended dose of rilpivirine of 25 mg once daily.
Priporočilo za odmerjanje velja za priporočen odmerek rilpivirina 25 mg enkrat dnevno.
The administration of Eviplera to healthy adult subjects with either a light meal (390 kcal) or a standard meal (540 kcal) resulted in increased exposures of rilpivirine and tenofovir relative to fasting conditions.
Dajanje zdravila Eviplera zdravim odraslim osebam z lahkim obrokom (390 kcal) ali standardnim obrokom (540 kcal) je povzročila večjo izpostavljenost rilpivirinu in tenofovirju v primerjavi z izpostavljenostjo na tešče.