natgillin/translations-raw huggingface dataset:
The exposure to rilpivirine was approximately 40% lower when EDURANT was taken in a fasted condition as compared to a normal caloric meal (533 kcal) or high-fat high-caloric meal (928 kcal). 
Izloženost rilpivirinu bila je približno 40% niža kad se EDURANT uzimao natašte nego kad se uzimao uz obrok normalne kalorijske vrijednosti (533 kcal) ili visokokalorični obrok bogat mastima (928 kcal).
However, it may not be completely excluded that rilpivirine can increase the exposure to other medicines transported by P-glycoprotein that are more sensitive to intestinal P-gp inhibition, e.g. dabigatran etexilate. 
Međutim, ne može se potpuno isključiti da rilpivirin može povećati izloženost drugim lijekovima koje transportira P-glikoprotein, a koji su osjetljiviji na intestinalnu P-gp inhibiciju, npr. dabigatran eteksilat.
Rilpivirine inhibits P-glycoprotein in vitro (IC50 is 9.2 μM). 
Rilpivirin inhibira P-glikoprotein in vitro (IC50 je 9,2 μM).
It is not recommended to co-administer rilpivirine with other NNRTIs. 
Ne preporučuje se istovremena primjena rilpivirina s drugim NNRTI-jima.
Pharmacokinetics of total rilpivirine (mean ± SD, tmax: median [range]) 
Farmakokinetika ukupnog rilpivirina (srednja vrijednost ± SD, tmax: medijan [raspon])
Talk to your doctor or pharmacist if you are not sure. 
Razgovarajte sa svojim liječnikom ili ljekarnikom ako niste sigurni.
This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier. 
Ova je analiza uključila 690 bolesnika iz ispitivanja ECHO i 678 bolesnika iz ispitivanja THRIVE koji su završili 96 tjedana liječenja ili su ga prekinuli ranije.
In the Phase III studies, 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). 
U ispitivanjima faze III, niže izloženosti riplivirinu, slične onima viđenima tijekom trudnoće, bile su povezane s povećanim rizikom od virološkog neuspjeha, stoga je virusno opterećenje potrebno pažljivo nadzirati (vidjeti dijelove 4.6, 5.1 i 5.2).
Response (confirmed < 50 HIV-1 RNA copies/ml) 
S odgovorom (potvrđeno < 50 HIV-1 RNA kopija/ml)
In rats, there were no drug-related neoplasms. 
U štakora nije bilo novotvorina povezanih s lijekom.
Common: - abnormal dreams - rash - stomach pain - depression - tiredness - vomiting - drowsiness - decreased appetite - sleep disorders - stomach discomfort - depressed mood - dry mouth 
Česte: - abnormalni snovi - osip - bol u želucu - depresija - umor - povraćanje - omamljenost - smanjen apetit - poremećaj spavanja - nelagoda u želucu
Exposure to rilpivirine was generally lower in HIV-1 infected patients than in healthy subjects. 
Izloženost rilpivirinu općenito je bila niža u bolesnika zaraženih virusom HIV-1 nego u zdravih ispitanika.
Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams. 
Simptomi predoziranja mogu uključivati glavobolju, mučninu, omaglicu i/ili abnormalne snove.
No human data on the effect of rilpivirine on fertility are available. 
Nema dostupnih podataka o učinku rilpivirina na plodnost u ljudi.
The observed hepatocellular findings in mice may be rodent-specific. 
Opaženi hepatocelularni nalazi u miševa mogu biti specifični za glodavce.
The most common ADRs (all grades, greater than or equal to 10%) were headache (19.4%), depression (19.4%), somnolence (13.9%), and nausea (11.1%). 
Najčešće nuspojave (svih stupnjeva, veće ili jednake 10%) bile su glavobolja (19,4%), depresija (19,4%), somnolencija (13,9%), i mučnina (11,1%).
Dosing recommendations for paediatric patients less than 12 years of age cannot be made due to insufficient data (see section 4.2). 
Ne mogu se dati preporuke za doziranje u pedijatrijskih bolesnika mlađih od 12 godina starosti, jer nema dovoljno podataka (vidjeti dio 4.2).
* The interaction between rilpivirine and the medicinal product was evaluated in a clinical study. 
* Interakcija rilpivirina i ovog lijeka ispitana je u kliničkom ispitivanju.
There was no impact of body weight on rilpivirine pharmacokinetics in paediatric subjects in trial TMC278-C213 (33 to 93 kg), similar to what was observed in adults. 
Nije bilo utjecaja tjelesne težine na farmakokinetiku rilpivirina u pedijatrijskih ispitanika u ispitivanju TMC278-C213 (33 do 93 kg), slično kao što je zabilježeno u odraslih.
There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the ECG. 
Dostupni su ograničeni podaci o mogućnosti farmakodinamičke interakcije rilpivirina i lijekova koji produljuju QTc interval na EKG-u.
NARCOTIC ANALGESICS Methadone* 
OPIJATNI ANALGETICI Metadon*
Rilpivirine is excreted in the milk of rats. 
Rilpivirin se izlučuje u mlijeko štakora.
If you forget to take EDURANT 
Ako ste zaboravili uzeti EDURANT
Interactions between rilpivirine and co-administered medicinal products are listed in table 1 (increase is indicated as “↑”, decrease as “↓”, no change as “↔”, not applicable as “NA”, confidence interval as “CI”). 
Interakcije između rilpivirina i istovremeno primijenjenih lijekova navedene su u tablici 1 (povećanje je prikazano kao “↑”, smanjenje kao “↓”, bez promjene kao “↔”, nije primjenjivo kao “NP”, a interval pouzdanosti kao “CI”).
Uncommon: - signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome) 
Manje česte: - znakovi ili simptomi upale ili infekcije, na primjer vrućica, zimica, znojenje (sindrom imunološke reaktivacije).
ND 3.8% 
NO 3,8%
Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted) 
Poremećaji metabolizma i prehrane vrlo često povišen ukupni kolesterol (natašte) povišen LDL kolesterol (natašte)
Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia. 
Relevantni primjeri uključuju citomegalovirusni retinitis, generalizirane i/ili fokalne mikobakterijske infekcije i upalu pluća prouzročenu s Pneumocystis jirovecii.
When you stop taking rifabutin, take one tablet of EDURANT once a day. 
Nakon što prestanete uzimati rifabutin, uzimajte jednu tabletu EDURANTA jedanput dnevno.
The pharmacokinetics of rilpivirine in paediatric patients less than 12 years of age are under investigation. 
Farmakokinetika rilpivirina u pedijatrijskih bolesnika mlađih od 12 godina starosti još se ispituje.
ND 18.2% 
NO 18,2%
Predicted difference of response rates (95% CI) for the week 48 analysis: 1.6% (-2.2%; 5.3%) and for the week 96 analysis: -0.4% (-4.6%; 3.8%); both p-value < 0.0001 (non-inferiority at 12% margin) from logistic regression model, including stratification factors and study. 
Predviđena razlika u stopama odgovora (95% CI) za analizu u 48. tjednu: 1,6% (-2,2%; 5,3%) i za analizu u 96. tjednu: -0,4% (-4,6%; 3,8%); p-vrijednost < 0,0001 (neinferiornost uz marginu od 12%) prema modelu logističke regresije, uključujući stratifikacijske čimbenike i ispitivanje.
The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine. 
Smanjenje farmakokinetičkih parametara nevezanog (tj. aktivnog) rilpivirina tijekom trudnoće u usporedbi s postpartalnim razdobljem bilo je manje izraženo nego za ukupni rilpivirin.
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ. 
Rilpivirin ne inhibira ljudske stanične DNK polimeraze α, β i γ.
Treatment with rilpivirine 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). 
Liječenje rilpivirinom rezultiralo je ranim blagim porastom srednje vrijednosti razina kreatinina u serumu koja je ostala stabilna tijekom vremena te se nije smatrala klinički značajnom (vidjeti dio 4.8).
Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics are not different across the age range (18 to 78 years) evaluated, with only 3 subjects aged 65 years or older. 
Populacijska farmakokinetička analiza u bolesnika zaraženih HIV-om pokazala je da nema razlika u farmakokinetici rilpivirina u procijenjenoj dobnoj skupini (18 do 78 godina), s time da je samo troje ispitanika bilo u dobi od 65 ili više godina.
Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 pregnant women during the second and third trimesters, and postpartum. 
Rilpivirin u kombinaciji s pratećim liječenjem bio je procijenjen u kliničkom ispitivanju s 19 trudnih žena tijekom drugog i trećeg tromjesečja, te postpartalno.
In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin. 
U kliničkom ispitivanju, rilpivirin nije značajno utjecao na farmakokinetiku digoksina.
Some patients may experience tiredness, dizziness or drowsiness during treatment with EDURANT. 
Neki bolesnici mogu osjetiti umor, omaglicu ili pospanost tijekom liječenja EDURANTOM.
Renal elimination of rilpivirine is negligible. 
Bubrežna eliminacija rilpivirina je zanemariva.
Didanosine should be administered on an empty stomach at least two hours before or at least four hours after EDURANT (which must be taken with a meal). 
Didanozin treba primijeniti na prazan želudac najmanje dva sata prije ili najmanje 4 sata nakon EDURANTA (koji se mora uzeti uz obrok).
EDURANT must be taken orally, once daily with a meal (see section 5.2). 
EDURANT se mora uzimati peroralno, jedanput dnevno, uz obrok (vidjeti dio 5.2).
Tenofovir disoproxil fumarate* 
Tenofovir dizoproksil fumarat*
However, it may not be excluded that the pharmacologically active, unbound, rilpivirine exposure is significantly increased in moderate hepatic impairment. 
Međutim, ne može se isključiti mogućnost da je izloženost farmakološki aktivnom nevezanom rilpivirinu značajno povećana kod umjerenog oštećenja jetre.
EDURANT has mainly been studied in patients with normal renal function. 
EDURANT je ispitivan uglavnom u bolesnika s normalnom funkcijom bubrega.
Medicinal products that affect rilpivirine exposure 
Lijekovi koji utječu na izloženost rilpivirinu
Talk to your doctor about an alternative regimen. 
Razgovarajte s liječnikom o alternativnom načinu uzimanja lijeka.
The median baseline plasma HIV-1 RNA was 4.8 log10 copies per ml, and the median baseline CD4+ cell count was 414 × 10 
Medijan početne vrijednosti HIV-1 RNA u plazmi bio je 4,8 log10 kopija po ml, a medijan početnog broja CD4+ stanica bio je 414 × 10
Very common: - headache - nausea - difficulty falling asleep (insomnia) - dizziness - changes in one of your routine liver tests (transaminase) - increase in cholesterol and/or pancreatic amylase in your blood 
Vrlo česte: - glavobolja - mučnina - poteškoće s uspavljivanjem (nesanica) - omaglica - promjena jednog nalaza na rutinskim jetrenim pretragama (transaminaze) - povišenje kolesterola i/ili amilaze gušterače u krvi.
# to emtricitabine/lamivudine % (n/N) 
# na emtricitabin/lamivudin % (n/N)
No dose adjustment is required. 
Prilagodba doze nije potrebna.
Lower exposures of rilpivirine were observed when rilpivirine 25 mg once daily was taken during pregnancy. 
Niže izloženosti rilpivirinu bile su uočene kada se uzimalo 25 mg rilpivirina jedanput na dan tijekom trudnoće.
As with other antiretroviral medicinal products, resistance testing should guide the use of rilpivirine (see section 5.1). 
Kao i kod drugih antiretrovirusnih lijekova, u primjeni rilpivirina treba se voditi testom rezistencije (vidjeti dio 5.1).
The EDURANT tablet must be taken with a meal. 
Tableta EDURANTA mora se uzeti uz obrok.
If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible. 
Ako to primijetite unutar 12 sati od vremena kad obično uzimate EDURANT, morate što prije uzeti tabletu.
These resistance-associated mutations were derived from in vivo data involving treatment-naïve subjects only and therefore cannot be used to predict the activity of rilpivirine in subjects who have virologically failed an antiretroviral-containing regimen. 
Ove, s rezistencijom povezane mutacije izvedene su iz in vivo podataka samo onih ispitanika koji prethodno nisu bili liječeni, stoga se ne mogu koristiti za predviđanje djelovanja rilpivirina u ispitanika u kojih je liječenje antiretrovirusnim lijekovima bilo virološki neuspješno.
75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner. 
Boca od 75 ml od polietilena visoke gustoće (HDPE) s polipropilenskim (PP) sigurnosnim zatvaračem za djecu i zaštitnom folijom.
EU/1/11/736/001 
BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/11/736/001
EDURANT should be used with caution in this population. 
U ovoj populaciji EDURANT treba primjenjivati s oprezom.
6 cells/l in patients receiving rilpivirine 25 mg and 160 × 10 
6 stanica/l u bolesnika koji su primali rilpivirin od 25 mg i 160 × 10
In mice, rilpivirine was positive for hepatocellular neoplasms in both males and females. 
Kod miševa, rilpivirin je bio pozitivan na hepatocelularne neoplazme i u ženki i mužjaka.
(induction of CYP3A due to high rilpivirine dose in the study) 
(indukcija CYP3A zbog visoke doze rilpivirina u ispitivanju)
However, fatigue, dizziness and somnolence have been reported in some patients taking EDURANT and should be considered when assessing a patient's ability to drive or operate machinery. 
Međutim, u nekih bolesnika koji su uzimali EDURANT zabilježeni su umor, omaglica i somnolencija, što treba uzeti u obzir kad se procjenjuje sposobnost bolesnika da upravlja vozilima i radi sa strojevima.
There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). 
Dostupni su ograničeni podaci o primjeni EDURANTA u bolesnika s blagim ili umjerenim oštećenjem jetre (Child-Pugh stadij A ili B).
ND 0.1% 
NO 0,1%
You must take EDURANT together with other HIV medicines. 
EDURANT morate uzimati zajedno s drugim lijekovima protiv HIV-a.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake “Rok valjanosti”.
In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains. 
U panelu od 67 rekombinantnih laboratorijskih sojeva virusa HIV-1 s jednom mutacijom povezanom s rezistencijom na položajima na reverznoj transkriptazi (RT) povezanima s rezistencijom na NNRTI, uključujući najčešće prisutne K103N i Y181C, rilpivirin je pokazao antivirusnu aktivnost na 64 (96%) ovih sojeva.
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/ml), treatment of HIV-2 infection with rilpivirine is not recommended in the absence of clinical data. 
Premda je rilpivirin pokazao ograničeno in vitro djelovanje na virus HIV-2 uz vrijednosti EC50 u rasponu od 2 510 do 10 830 nM (920 do 3 970 ng/ml), ne preporučuje se liječenje HIV-2 infekcije rilpivirinom obzirom da nema kliničkih podataka.
The greater risk of virologic failure for patients in the rilpivirine arm was observed in the first 48 weeks of these trials (see section 5.1). 
Veći rizik za virološki neuspjeh uočen je u bolesnika iz skupine koja je primala rilpivirin, tijekom prvih 48 tjedana ovih ispitivanja (vidjeti dio 5.1).
Rilpivirine also demonstrated antiviral activity against a broad panel of HIV-1 group M (subtype A, B, C, D, F, G, H) primary isolates with EC50 values ranging from 0.07 to 1.01 nM (0.03 to 0.37 ng/ml) and group O primary isolates with EC50 values ranging from 2.88 to 8.45 nM (1.06 to 3.10 ng/ml). 
Rilpivirin je također pokazao antivirusnu aktivnost protiv širokog panela primarnih izolata virusa HIV-1 iz skupine M (podtipovi A, B, C, D, F, G, H) uz EC50 vrijednosti u rasponu od 0,07 do 1,01 nM (0,03 do 0,37 ng/ml) i skupine O uz vrijednosti EC50 u rasponu od 2,88 do 8,45 nM (1,06 do 3,10 ng/ml).
No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women. 
Spol Nisu primijećene klinički značajne razlike u farmakokinetici rilpivirina između muškaraca i žena.
Of these virologic failures, 9 out of 24 and 4 out of 14 were in subjects with a baseline viral load < 100,000 copies/ml, respectively. 
Među tim virološkim neuspjesima, 9 od 24 odnosno 4 od 14 dogodilo se u ispitanika s početnim virusnim opterećenjem < 100 000 kopija/ml.
Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely. 
Niže izloženosti rilpivirinu bile su uočene tijekom trudnoće, stoga je virusno opterećenje potrebno pažljivo nadzirati.
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. 
Sojevi rezistentni na rilpivirin selektirani su u staničnoj kulturi počevši od divljeg tipa HIV-1 različitog porijekla i podtipova, kao i HIV-1 rezistentnog na NNRTI.
If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day. 
Ako uzimate rifabutin (lijek za liječenje nekih bakterijskih infekcija), uzmite dvije tablete EDURANTA jedanput dnevno.
C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively. 
C-rilpivirina, u prosjeku se 85% radioaktivnosti moglo otkriti u stolici a 6,1% u mokraći.
Non-response Virologic failure 
Bez odgovora Virološki neuspjeh
ND 7.0% 
NO 7,0%
Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM. 
Rilpivirin je in vitro inhibitor transportera MATE-2K s IC50 < 2,7 nM.
Human experience of overdose with rilpivirine is limited. 
Iskustvo predoziranja rilpivirinom u ljudi je ograničeno.
During the clinical development program (1,368 patients in the Phase III controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE)), 55.7% of subjects experienced at least one adverse drug reaction (see section 5.1). 
Tijekom programa kliničkog razvoja (1368 bolesnika u kontroliranim ispitivanjima faze III TMC278-C209 (ECHO) i TMC278-C215 (THRIVE)), 55,7% ispitanika doživjelo je najmanje jednu nuspojavu (vidjeti dio 5.1).
Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine. 
Osjetljivost na rilpivirin (FC ≤ BCO) zadržala se u 62% od 4 786 rekombinantnih kliničkih izolata virusa HIV-1 rezistentnih na efavirenz i/ili nevirapin.
It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine. 
Ne preporučuje se kombinirati EDURANT s drugim nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI) kao što su delavirdin, efavirenz, etravirin i nevirapin.
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose. 
U stolici je neizmijenjeni rilpivirin činio u prosjeku 25% primijenjene doze.
Trimester of pregnancy (n=13) 
3. tromjesečje trudnoće (n=13)
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT). 
Aktivnost rilpivirina posredovana je nekompetitivnom inhibicijom reverzne transkriptaze virusa HIV-1 (RT).
EDURANT is not a cure for HIV infection. 
EDURANT neće izliječiti HIV-infekciju.
Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48. 
Šest ispitanika prekinulo je liječenje zbog virološkog neuspjeha do 48. tjedna, a 3 ispitanika prekinula su liječenje nakon 48. tjedna.
EDURANT should not be co-administered with the following medicinal products, as significant decreases in rilpivirine plasma concentrations may occur (due to CYP3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of EDURANT (see section 4.5): - the anticonvulsants carbamazepine, oxcarbazepine, phenobarbital, phenytoin - the antimycobacterials rifampicin, rifapentine - proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole, 
EDURANT se ne smije primjenjivati zajedno sa sljedećim lijekovima, jer može nastupiti značajno smanjenje koncentracije rilpivirina u plazmi (zbog indukcije enzima CYP3A ili povišenja želučanog pH), što može rezultirati gubitkom terapijskog učinka EDURANTA (vidjeti dio 4.5): - antikonvulzivi karbamazepin, okskarbazepin, fenobarbital, fenitoin - antimikobakterijski lijekovi rifampicin, rifapentin - inhibitori protonske pumpe, kao što su omeprazol, esomeprazol, lanzoprazol, pantoprazol,
Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay. 
Rezistencija na rilpivirin bila je utvrđena kao promjena EC50 vrijednosti (FC, od engl. fold change) iznad biološke granične vrijednosti (BCO, od engl. biological cut-off) ispitivanja.
At supra-therapeutic doses (75 and 300 mg once daily), rilpivirine has been associated with prolongation of the QTc interval of the electrocardiogram (ECG) (see sections 4.5, 4.8 and 5.2). 
Pri dozama višim od preporučenih (75 i 300 mg jedanput dnevno), rilpivirin je povezan s produljenjem QTc intervala na elektrokardiogramu (EKG) (vidjeti dijelove 4.5, 4.8 i 5.2).
How to take EDURANT 
Kako uzimati EDURANT
As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT. 
Kao i kod drugih antiretrovirusnih lijekova, u primjeni EDURANTA treba se rukovoditi nalazima testa rezistencije.
Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir) 
Drugi pojačani inhibitori proteaze (atazanavir/ritonavir, fosamprenavir/ritonavir, sakvinavir/ritonavir, tipranavir/ritonavir)
Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine. 
Populacijska farmakokinetička analiza pokazala je da istovremena infekcija virusom hepatitisa B i/ili C nije imala klinički značajan učinak na izloženost rilpivirinu.
Rilpivirine has tested negative in the absence and presence of a metabolic activation system in the in vitro Ames reverse mutation assay and the in vitro clastogenicity mouse lymphoma assay. 
Rezultati testiranja rilpivirina bili su negativni u odsutnosti i prisutnosti sustava metaboličke aktivacije u Amesovom testu reverzne mutacije in vitro i testu klastogenosti na mišjem limfomu in vitro.
ND 5.7% 
NO 5,7%
If you belong to this age group, please discuss the use of EDURANT with your doctor. 
Ako ste u toj dobnoj skupini, razgovarajte o primjeni EDURANTA sa svojim liječnikom.
Only H2-receptor antagonists that can be dosed once daily should be used. 
H2-receptora koji se mogu dozirati jedanput dnevno.
The safety and efficacy of EDURANT in children aged < 12 years have not yet been established. 
Sigurnost i djelotvornost EDURANTA u djece mlađe od 12 godina nisu još ustanovljene.
Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/ml). 
Rilpivirin je pokazao aktivnost na laboratorijske sojeve divljeg tipa HIV-1 u akutno zaraženoj liniji Tstanica uz medijan vrijednosti EC50 za HIV-1/IIIB od 0,73 nM (0,27 ng/ml).
Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks. 
Kancerogenost rilpivirina procijenila se njegovom primjenom putem želučane sonde miševima i štakorima tijekom 104 tjedna.
ADRs reported in adult patients treated with rilpivirine are summarised in Table 2. 
Nuspojave zabilježene u odraslih bolesnika liječenih rilpivirinom sažete su u tablici 2.