FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: No clinically relevant differences in the pharmacokinetics of rilpivirine have been observed between men and women.
Croatian: Spol Nisu primijećene klinički značajne razlike u farmakokinetici rilpivirina između muškaraca i žena.
English: 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.
Croatian: Među tim virološkim neuspjesima, 9 od 24 odnosno 4 od 14 dogodilo se u ispitanika s početnim virusnim opterećenjem < 100 000 kopija/ml.
English: Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely.
Croatian: Niže izloženosti rilpivirinu bile su uočene tijekom trudnoće, stoga je virusno opterećenje potrebno pažljivo nadzirati.
English: 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.
Croatian: 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.
English: If you take rifabutin (a medicine to treat some bacterial infections), take two tablets of EDURANT once a day.
Croatian: Ako uzimate rifabutin (lijek za liječenje nekih bakterijskih infekcija), uzmite dvije tablete EDURANTA jedanput dnevno.
English: C-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Croatian: C-rilpivirina, u prosjeku se 85% radioaktivnosti moglo otkriti u stolici a 6,1% u mokraći.
English: Non-response Virologic failure
Croatian: Bez odgovora Virološki neuspjeh
English: ND 7.0%
Croatian: NO 7,0%
English: Rilpivirine is an in vitro inhibitor of the transporter MATE-2K with an IC50 of < 2.7 nM.
Croatian: Rilpivirin je in vitro inhibitor transportera MATE-2K s IC50 < 2,7 nM.
English: Human experience of overdose with rilpivirine is limited.
Croatian: Iskustvo predoziranja rilpivirinom u ljudi je ograničeno.
English: 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).
Croatian: 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).
English: Rilpivirine retained sensitivity (FC ≤ BCO) against 62% of 4,786 HIV-1 recombinant clinical isolates resistant to efavirenz and/or nevirapine.
Croatian: Osjetljivost na rilpivirin (FC ≤ BCO) zadržala se u 62% od 4 786 rekombinantnih kliničkih izolata virusa HIV-1 rezistentnih na efavirenz i/ili nevirapin.
English: It is not recommended to combine EDURANT with other non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as delavirdine, efavirenz, etravirine, and nevirapine.
Croatian: Ne preporučuje se kombinirati EDURANT s drugim nenukleozidnim inhibitorima reverzne transkriptaze (NNRTI) kao što su delavirdin, efavirenz, etravirin i nevirapin.
English: In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
Croatian: U stolici je neizmijenjeni rilpivirin činio u prosjeku 25% primijenjene doze.
English: Trimester of pregnancy (n=13)
Croatian: 3. tromjesečje trudnoće (n=13)
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Croatian: Aktivnost rilpivirina posredovana je nekompetitivnom inhibicijom reverzne transkriptaze virusa HIV-1 (RT).
English: EDURANT is not a cure for HIV infection.
Croatian: EDURANT neće izliječiti HIV-infekciju.
English: Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48.
Croatian: Šest ispitanika prekinulo je liječenje zbog virološkog neuspjeha do 48. tjedna, a 3 ispitanika prekinula su liječenje nakon 48. tjedna.
English: 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,
Croatian: 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,
English: Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Croatian: 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.
English: 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).
Croatian: 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).
English: How to take EDURANT
Croatian: Kako uzimati EDURANT
English: As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
Croatian: Kao i kod drugih antiretrovirusnih lijekova, u primjeni EDURANTA treba se rukovoditi nalazima testa rezistencije.
English: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
Croatian: Drugi pojačani inhibitori proteaze (atazanavir/ritonavir, fosamprenavir/ritonavir, sakvinavir/ritonavir, tipranavir/ritonavir)
English: Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Croatian: Populacijska farmakokinetička analiza pokazala je da istovremena infekcija virusom hepatitisa B i/ili C nije imala klinički značajan učinak na izloženost rilpivirinu.
English: 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.
Croatian: 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.
English: ND 5.7%
Croatian: NO 5,7%
English: If you belong to this age group, please discuss the use of EDURANT with your doctor.
Croatian: Ako ste u toj dobnoj skupini, razgovarajte o primjeni EDURANTA sa svojim liječnikom.
English: Only H2-receptor antagonists that can be dosed once daily should be used.
Croatian: H2-receptora koji se mogu dozirati jedanput dnevno.
English: The safety and efficacy of EDURANT in children aged < 12 years have not yet been established.
Croatian: Sigurnost i djelotvornost EDURANTA u djece mlađe od 12 godina nisu još ustanovljene.
English: 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).
Croatian: 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).
English: Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks.
Croatian: Kancerogenost rilpivirina procijenila se njegovom primjenom putem želučane sonde miševima i štakorima tijekom 104 tjedna.
English: ADRs reported in adult patients treated with rilpivirine are summarised in Table 2.
Croatian: Nuspojave zabilježene u odraslih bolesnika liječenih rilpivirinom sažete su u tablici 2.
English: In the week 48 analysis, 31 out of 62 of rilpivirine virologic failures had concomitant NNRTI and NRTI RAMs; 17 of those 31 had the combination of E138K and M184I.
Croatian: U analizi iz 48. tjedna, 31 od 62 viroloških neuspjeha rilpivirina imalo je istovremene mutacije povezane s rezistencijom na NNRTI i NRTI; 17 od navedenih 31 imalo je kombinaciju E138K i M184I.
English: If you take more EDURANT than you should Contact your doctor or pharmacist immediately.
Croatian: Ako uzmete više EDURANTA nego što ste trebali Odmah se javite liječniku ili ljekarniku.
English: ND 11.5%
Croatian: NO 11,5%
English: In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
Croatian: U slučaju predoziranja, možete imati glavobolju, mučninu, omaglicu i/ili poremećaj sna.
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Croatian: R(-) metadon AUC ↓ 16% R(-) metadon Cmin ↓ 22% R(-) metadon Cmax ↓ 14% rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * na temelju kontrola iz prethodnih ispitivanja
English: The list of rilpivirine resistance-associated mutations presented in section 5.1 should only guide the use of EDURANT in the treatment-naïve population.
Croatian: Popis mutacija povezanih s rezistencijom na rilpivirin prikazan u dijelu 5.1 treba biti smjernica samo za primjenu EDURANTA u populaciji koja prethodno nije bila liječena.
English: 300 mg once daily (+ 50 mg once daily rilpivirine)
Croatian: 300 mg jedanput dnevno (+ 50 mg rilpivirina jedanput dnevno)
English: Most of these discontinuations occurred in the first 48 weeks of treatment.
Croatian: Do većine navedenih prekida došlo je tijekom prvih 48 tjedana liječenja.
English: Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Croatian: Bolesnici u kontrolnoj skupini primali su efavirenz u dozi od 600 mg jedanput dnevno uz osnovni režim u oba dijela ispitivanja.
English: - clarithromycin, erythromycin (antibiotics) - cimetidine, famotidine, nizatidine, ranitidine (H2-receptor antagonists used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux).
Croatian: - klaritromicin, eritromicin (antibiotici) - cimetidin, famotidin, nizatidin, ranitidin (antagonisti H2-receptora koji se koriste za liječenje čira na želucu ili dvanaesniku ili za ublažavanje žgaravice zbog povrata kiseline iz želuca).
English: EDURANT is used in combination with other HIV medicines to treat adolescents and adults 12 years of age and older who are infected with HIV and who have never been treated before with HIV medicines.
Croatian: EDURANT se primjenjuje u kombinaciji s drugim lijekovima protiv HIV-a za liječenje adolescenata i odraslih u dobi od 12 godina i starijih zaraženih HIV-om i koji se nikad prije nisu liječili lijekovima protiv HIV-a.
English: The single resistance-associated mutations associated with a loss of susceptibility to rilpivirine were: K101P, Y181I and Y181V.
Croatian: Pojedinačne mutacije povezane s rezistencijom i gubitkom osjetljivosti na rilpivirin bile su: K101P, Y181I i Y181V.
English: All subjects with rilpivirine RAMs also had at least 1 treatment-emergent NRTI RAM at the last post-baseline time point with genotypic data.
Croatian: Svi ispitanici s mutacijama povezanim s rezistencijom na rilpivirin također su imali barem 1 NRTI RAM nastao tijekom liječenja u trenutku posljednjeg prikupljanja podataka nakon početka ispitivanja s genotipskim podacima.
English: EDURANT has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Croatian: EDURANT nije ispitan u bolesnika kod kojih je bilo koje prethodno antiretrovirusno liječenje pokazalo virološki neuspjeh.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In patients co-infected with hepatitis B or C virus receiving rilpivirine, the incidence of hepatic enzyme elevation was higher than in patients receiving rilpivirine who were not co-infected.
Croatian: Bolesnici istovremeno zaraženi virusom hepatitisa B i/ili C U bolesnika istovremeno zaraženih virusom hepatitisa B ili C koji primaju rilpivirin, incidencija povišenja jetrenih enzima bila je veća nego u bolesnika koji su primali rilpivirin i nisu bili istovremeno zaraženi tim virusima.
English: Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
Croatian: Budući da je rilpivirin u visokom postotku vezan za proteine plazme, dijalizom se najvjerojatnije neće ukloniti značajna količina djelatne tvari.
English: EDURANT must be taken with a meal.
Croatian: EDURANT se mora uzimati uz obrok.
English: Genotypic resistance testing should guide the use of EDURANT (see sections 4.4 and 5.1).
Croatian: U primjeni EDURANTA treba se rukovoditi nalazima testiranja genotipske rezistencije (vidjeti dijelove 4.4 i 5.1).
English: Do not take EDURANT in combination with any of the following medicines as they may affect the way EDURANT or the other medicine works: - carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines to treat epilepsy and prevent seizures) - rifampicin, rifapentine (medicines to treat some bacterial infections such as tuberculosis) - omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, (proton pump inhibitors that are medicines to prevent and treat stomach ulcers, heartburn or acid reflux disease) - dexamethasone (a corticosteroid used in a variety of conditions such as inflammation and allergic reactions) when taken by mouth or injected, except as a single dose treatment - products that contain St John's wort (Hypericum perforatum) (a herbal product used for depression).
Croatian: Nemojte uzimati EDURANT u kombinaciji s bilo kojim od sljedećih lijekova, jer može utjecati na način djelovanja EDURANTA ili drugog lijeka: - karbamazepin, okskarbazepin, fenobarbital, fenitoin (lijekovi za liječenje epilepsije i sprječavanje napadaja) - rifampicin, rifapentin (lijekovi za liječenje nekih bakterijskih infekcija kao što je tuberkuloza) - omeprazol, esomeprazol, lanzoprazol, pantoprazol, rabeprazol (inhibitori protonske pumpe, koji se primjenjuju za sprječavanje i liječenje čira na želucu, žgaravice ili povrata želučane kiseline iz želuca) - deksametazon (kortikosteroid koji se primjenjuje u raznim stanjima, kao što su upala i alergijske reakcije) kad se uzima kroz usta ili daje injekcijom, osim kao liječenje jednokratnom dozom - pripravci koji sadrže gospinu travu (Hypericum perforatum) (biljni pripravci protiv depresije).
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Croatian: Tako lijekovi koji induciraju ili inhibiraju CYP3A mogu utjecati na klirens rilpivirina (vidjeti dio 5.2).
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Croatian: Rilpivirin nije izazvao oštećenje kromosoma u mikronukleusnom testu in vivo u miševa.
English: If you take an H2-receptor antagonist (medicines used to treat stomach or intestinal ulcers or used to relieve heartburn due to acid reflux (such as cimetidine, famotidine, nizatidine or ranitidine).
Croatian: Ako uzimate antagoniste H2-receptora (lijekovi koji se koriste za liječenje čira želuca ili crijeva ili ublažavanje žgaravice - zbog povrata želučane kiseline iz želuca (kao što su cimetidin, famotidin, nizatidin ili ranitidin).
English: ANTIARRHYTHMICS Digoxin*
Croatian: ANTIARITMICI Digoksin*
English: Other NRTIs (abacavir, emtricitabine, lamivudine, stavudine and zidovudine)
Croatian: Ostali NRTI-ji (abakavir, emtricitabin, lamivudin, stavudin i zidovudin)
English: What EDURANT contains - The active substance is rilpivirine in the form of rilpivirine hydrochloride.
Croatian: Što EDURANT sadrži - Djelatna tvar je rilpivirin u obliku rilpivirinklorida.
English: INTERACTIONS AND DOSE RECOMMENDATIONS WITH OTHER MEDICINAL PRODUCTS
Croatian: Tablica 1: INTERAKCIJE I PREPORUČENE DOZE S DRUGIM LIJEKOVIMA
English: Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Croatian: Psihijatrijski poremećaji vrlo često nesanica često neuobičajeni snovi depresija poremećaji spavanja depresivno raspoloženje
English: This interaction study has been performed with a dose higher than the recommended dose for rilpivirine assessing the maximal effect on the co-administered medicinal product.
Croatian: Ovo ispitivanje interakcija provedeno je s dozom rilpivirina većom od preporučene zbog procjene maksimalnog učinka na istovremeno primijenjeni lijek.
English: Reproductive toxicology studies
Croatian: Ispitivanja reproduktivne toksičnosti
English: At the lowest tested doses in the carcinogenicity studies, the systemic exposures (based on AUC) to rilpivirine were 21-fold (mice) and 3-fold (rats), relative to those observed in humans at the recommended dose (25 mg once daily).
Croatian: Kod najnižih ispitivanih doza u ispitivanjima kancerogenosti, sustavna izloženost (na temelju AUC) rilpivirinu bila je 21 puta (miševi) i 3 puta (štakori) veća u odnosu na onu primijećenu u ljudi pri preporučenoj dozi (25 mg jedanput dnevno).
English: Trimester of pregnancy (n=15)
Croatian: 2. tromjesečje trudnoće (n=15)
English: From the week 96 pooled resistance analysis, the resistance outcome for patients with protocol defined virological failure, and paired genotypes (baseline and failure) is shown in table 5.
Croatian: Na temelju analize objedinjenih podataka 96. tjedna, ishod rezistencije u bolesnika s protokolom definiranim virološkim neuspjehom i spareni genotipovi (početni i neuspjeh) prikazani su u tablici 5.
English: In the open label part of the trial, patients originally randomised to one of the three doses of rilpivirine were all treated with rilpivirine 25 mg once daily in addition to a BR, once the dose for the Phase III studies was selected.
Croatian: U dijelu ispitivanja otvorenog tipa, svi bolesnici prvobitno randomizirani na jednu od tri doze rilpivirina bili su liječeni rilpivirinom u dozi od 25 mg jedanput dnevno uz osnovni režim, nakon što je odabrana doza za ispitivanja faze III.
English: Lactose monohydrate Hypromellose 2910 6 mPa.s Titanium dioxide E171 Macrogol 3000
Croatian: Ovojnica tablete laktoza hidrat hipromeloza 2910 6 mPa.s titanijev dioksid (E171) makrogol 3000 triacetin
English: The most frequently reported adverse drug reactions (ADRs) (≥ 2%) that were at least of moderate intensity were depression (4.1%), headache (3.5%), insomnia (3.5%), rash (2.3%), and abdominal pain (2.0%).
Croatian: Najčešće prijavljene nuspojave (≥ 2%) koje su bile namjanje umjerenog intenziteta bile su depresija (4,1%), glavobolja (3,5%), nesanica (3,5%), osip (2,3%) i bol u abdomenu (2,0%).
English: Only trace amounts of unchanged rilpivirine (< 1% of dose) were detected in urine.
Croatian: U mokraći je neizmijenjeni rilpivirin otkriven samo u tragovima (< 1% doze).
English: The combination of rilpivirine and antacids should be used with particular caution.
Croatian: Kombinaciju rilpivirina i antacida treba primjenjivati s posebnim oprezom.
English: As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.2).
Croatian: Budući da je rilpivirin u visokom postotku vezan za proteine plazme, najvjerojatnije se neće moći značajno ukloniti hemodijalizom ili peritonejskom dijalizom (vidjeti dio 4.2).
English: rabeprazole - the systemic glucocorticoid dexamethasone, except as a single dose treatment - St John's wort (Hypericum perforatum).
Croatian: rabeprazol - sustavni glukokortikoid deksametazon, osim kao liječenje jednokratnom dozom - gospina trava (Hypericum perforatum).
English: White to off-white, round, biconvex, film-coated tablet with a diameter of 6.4 mm, debossed with “TMC” on one side and “25” on the other side.
Croatian: Bijela do gotovo bijela, okrugla, bikonveksna, filmom obložena tableta promjera 6,4 mm s utisnutom oznakom “TMC” na jednoj strani i brojem “25” na drugoj strani.
English: Similar efficacy for rilpivirine was seen in each trial demonstrating non-inferiority to efavirenz.
Croatian: U oba se ispitivanja opazila slična djelotvornost rilpivirina čime se pokazala njegova neinferiornost u odnosu na efavirenz.
English: Take the antacid either at least 2 hours before or at least 4 hours after EDURANT (see section 2 “Other medicines and EDURANT”).
Croatian: Uzmite antacid ili najmanje 2 sata prije ili najmanje 4 sata poslije EDURANTA (pogledajte dio 2 “Drugi lijekovi i EDURANT”).
English: Resistance to rilpivirine % (n/N)
Croatian: Rezistencija na rilpivirin % (n/N)
English: (reduced absorption due to gastric pH increase)
Croatian: (smanjena apsorpcija zbog povišenog želučanog pH)
English: It belongs to a group of HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
Croatian: Pripada skupini lijekova protiv HIV-a koji se zovu nenukleozidni inhibitori reverzne transkriptaze (NNRTI).
English: Population pharmacokinetic analysis of rilpivirine in HIV infected patients indicated that race had no clinically relevant effect on the exposure to rilpivirine.
Croatian: Populacijska farmakokinetička analiza rilpivirina u bolesnika zaraženih HIV-om pokazala je da rasa nema klinički značajan utjecaj na izloženost rilpivirinu.
English: For the resistance analysis, a broader definition of virologic failure was used than in the primary efficacy analysis.
Croatian: U odraslih ispitanika koji prethodno nisu bili liječeni Kod analize rezistencije, primijenjena je šira definicija virološkog neuspjeha nego u primarnoj analizi djelotvornosti.
English: Taking EDURANT in fasted condition or with only a nutritional drink may result in decreased plasma concentrations of rilpivirine, which could potentially reduce the therapeutic effect of EDURANT (see section 4.2).
Croatian: Uzimanje EDURANTA natašte ili samo s hranjivim napitkom može rezultirati smanjenim koncentracijama rilpivirina u plazmi, što potencijalno može smanjiti terapijski učinak EDURANTA (vidjeti dio 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KARTONSKA KUTIJA
English: For those patients failing therapy with rilpivirine and who developed resistance to rilpivirine, cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Croatian: U bolesnika u kojih terapija rilpivirinom nije bila uspješna i koji su razvili rezistenciju na rilpivirin općenito je opažena križna rezistencija na druge odobrene NNRTI-jeve (etravirin, efavirenz, nevirapin).
English: 300 mg once daily (+ 25 mg once daily rilpivirine)
Croatian: 300 mg jedanput dnevno (+ 25 mg rilpivirina jedanput dnevno)