FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Slovenian: Izpostavljenost rilpivirinu je bila za približno 40% manjša pri odmerjanju zdravila EDURANT na tešče v primerjavi z zaužitjem zdravila skupaj z obrokom z normalno kalorično vrednostjo (533 kcal) ali z obrokom z visoko kalorično vrednostjo in z visoko vsebnostjo maščob (928 kcal).
English: If you forget to take EDURANT
Slovenian: Če ste pozabili vzeti zdravilo EDURANT
English: The European Medicines Agency has deferred the obligation to submit the results of studies with rilpivirine in one or more subsets of the paediatric population in the treatment of Human Immunodeficiency Virus (HIV-1) infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij zdravljenja okužbe s humanim virusom imunske pomanjkljivosti (HIV-1) z rilpivirinom za eno ali več podskupin pediatrične populacije bolnikov (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: After oral administration, the maximum plasma concentration of rilpivirine is generally achieved within 4-5 hours.
Slovenian: Po peroralnem odmerjanju doseže rilpivirin najvišjo koncentracijo v plazmi večinoma po 4-5 urah.
English: Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections and Pneumocystis jiroveci pneumonia.
Slovenian: Primeri takih reakcij so citomegalovirusni retinitis, generalizirane in/ali fokalne mikobakterijske okužbe in pljučnica, ki jo povzroča gliva Pneumocystis jirovecii.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Slovenian: Nadaljne ukrepe je potrebno izvesti glede na klinične indikacije ali priporočila Nacionalnega centra za zastrupitve.
English: Rilpivirine does not inhibit the human cellular DNA polymerases α, β and γ.
Slovenian: Rilpivirin ne zavira človeških celičnih polimeraz DNA α, β in γ.
English: In a clinical study, rilpivirine did not significantly affect the pharmacokinetics of digoxin.
Slovenian: V klinični študiji rilpivirin ni pomembno vplival na farmakokinetiko digoksina.
English: ANTIMYCOBACTERIALS Rifabutin*
Slovenian: ZDRAVILA PROTI MIKOBAKTERIJAM rifabutin*
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.
Slovenian: Zdravilo EDURANT se uporablja v kombinaciji z drugimi zdravili proti HIV za zdravljenje mladostnikov in odraslih, starih 12 let in več, okuženih s HIV, ki še nikoli niso prejemali zdravil proti HIV.
English: Manufacturer Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italy
Slovenian: Izdelovalec Janssen-Cilag SpA Via C. Janssen Borgo San Michele 04100 Latina Italija
English: GLUCOCORTICOIDS Dexamethasone (systemic, except for single dose use)
Slovenian: GLUKOKORTIKOIDI deksametazon (apliciran sistemsko, razen v enkratnem odnerku)
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10) and uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti neželenih učinkov so opredeljene kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).V vsaki skupini pogostnosti so neželeni učinki navedeni po padajoči stopnji resnosti.
English: EDURANT must be taken orally, once daily with a meal (see section 5.2).
Slovenian: Zdravilo EDURANT je treba jemati peroralno, enkrat na dan, z obrokom (glejte poglavje 5.2).
English: Excipient with known effect Each film-coated tablet contains 56 mg lactose monohydrate.
Slovenian: Pomožne snovi z znanim učinkom Ena filmsko obložena tableta vsebuje 56 mg laktoze monohidrata.
English: common decreased appetite increased triglycerides (fasted)
Slovenian: pogosti zmanjšan apetit zvečana koncentracija trigliceridov (na tešče)
English: Other boosted PIs (atazanavir/ritonavir, fosamprenavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir)
Slovenian: drugi okrepljeni zaviralci proteaze (atazanavir/ritonavir, fosamprenavir/ritonavir, sakvinavir/ritonavir, tipranavir/ritonavir)
English: There were no safety concerns identified in the week 240 analyses.
Slovenian: V analizi podatkov po 240 tednih se niso pojavila nobena vprašanja glede varnosti zdravila.
English: Medicinal products that induce or inhibit CYP3A may thus affect the clearance of rilpivirine (see section 5.2).
Slovenian: Zdravila, ki inducirajo ali zavirajo encim CYP3A, lahko vplivajo na izločanje rilpivirina (glejte poglavje 5.2).
English: A meal is important to get the right levels of active substance in your body.
Slovenian: Obrok je pomemben, da učinkovina v telesu lahko doseže pravo koncentracijo.
English: Rilpivirine is primarily metabolised and eliminated by the liver.
Slovenian: Rilpivirin se presnavlja in izloča predvsem preko jeter.
English: 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.
Slovenian: Rilpivirin v kombinaciji z osnovno shemo zdravljenja so ocenjevali v klinični študiji pri 19 nosečnicah med drugim in tretjim trimesečjem, in po porodu.
English: If you belong to this age group, please discuss the use of EDURANT with your doctor.
Slovenian: Če spadate v to starostno skupino, se o uporabi zdravila EDURANT pogovorite z zdravnikom.
English: There are limited amount of data (less than 300 pregnancy outcomes) from the use of rilpivirine in pregnant women (see sections 4.4, 5.1 and 5.2).
Slovenian: Podatki o uporabi rilpivirina pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti) (glejte poglavja 4.4, 5.1 in 5.2).
English: Studies in animals have shown no evidence of relevant embryonic or foetal toxicity or an effect on reproductive function.
Slovenian: V študijah na živalih ni bilo nobenih znakov za pomembno toksično delovanje na zarodek oziroma plod ali za vpliv na sposobnost razmnoževanja.
English: It is not known whether rilpivirine is excreted in human milk.
Slovenian: Ni znano, ali se rilpivirin izloča v materino mleko.
English: 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.
Slovenian: Pri nekaterih bolnikih, ki so jemali zdravilo EDURANT, so poročali o utrujenosti, omotici in somnolenci, kar je treba upoštevati pri ocenjevanju bolnikovih sposobnosti vožnje ali upravljanja strojev.
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).
Slovenian: Pri odmerkih, večjih od terapevtskih (75 in 300 mg enkrat na dan) je bil rilpivirin povezan s podaljšanjem intervala QTc na elektrokardiogramu (EKG) (glejte poglavja 4.5, 4.8 in 5.2).
English: QT prolonging medicinal products
Slovenian: Zdravila, ki podaljšujejo interval QT
English: - In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Slovenian: - Poleg oportunističnih okužb se lahko po začetku jemanja zdravil za zdravljenje okužbe s HIV pojavijo tudi avtoimunske bolezni (stanje, do katerega pride, ko imunski sistem napade zdravo telesno tkivo).
English: In case of overdose, you may have a headache, nausea, dizziness, and/or abnormal dreams.
Slovenian: V primeru prevelikega odmerka se lahko pojavi glavobol, slabost, omotica in/ali nenormalne sanje.
English: The decrease in unbound (ie, active) rilpivirine pharmacokinetic parameters during pregnancy compared to postpartum was less pronounced than for total rilpivirine.
Slovenian: Farmakokinetični parametri za nevezani (aktivni) rilpivirin so bili med nosečnostjo, v primerjavi z obdobjem po porodu, manj zmanjšani kot za celokupni rilpivirin.
English: (induction of CYP3A due to high rilpivirine dose in the study)
Slovenian: (indukcija encimov CYP3A zaradi velikega odmerka rilpivirina v študiji)
English: In a study comparing 8 patients with mild hepatic impairment (Child-Pugh score A) to 8 matched controls, and 8 patients with moderate hepatic impairment (Child-Pugh score B) to 8 matched controls, the multiple dose exposure of rilpivirine was 47% higher in patients with mild hepatic impairment and 5% higher in patients with moderate hepatic impairment.
Slovenian: V študiji, v kateri so primerjali 8 bolnikov z blago okvaro jeter (Child-Pugh stopnje A) z 8 ustreznimi kontrolnimi bolniki in 8 bolnikov z zmerno okvaro jeter (Child-Pugh stopnje B) z 8 ustreznimi kontrolnimi bolniki, je bila izpostavljenost rilpivirinu po večkratnem odmerjanju za 47% večja pri bolnikih z blago okvaro jeter in za 5% večja pri bolnikih z zmerno okvaro jeter.
English: Symptoms of overdose may include headache, nausea, dizziness and/or abnormal dreams.
Slovenian: Simptomi prevelikega odmerjanja lahko vključujejo glavobol, navzeo, vrtoglavico, in/ali nenormalne sanje.
English: You must take EDURANT together with other HIV medicines.
Slovenian: Zdravilo EDURANT morate jemati skupaj z drugimi zdravili za okužbo s HIV.
English: A bottle with child resistant closure containing 30 film-coated tablets.
Slovenian: Vsebnik z za otroke varno zaporko s 30 filmsko obloženimi tabletami.
English: Patients in the control arm received efavirenz 600 mg once daily in addition to a BR in both parts of the study.
Slovenian: Bolniki v kontrolni skupini so v obeh delih študije prejemali efavirenz 600 mg enkrat na dan poleg zdravil po osnovni shemi.
English: This analysis included 690 patients in ECHO and 678 patients in THRIVE who had completed 96 weeks of treatment or discontinued earlier.
Slovenian: V analizo so bili vključeni podatki 690 bolnikov iz študije ECHO in 678 bolnikov iz študije THRIVE, in sicer podatki bolnikov, ki so zaključili 96 tednov zdravljenja, in tistih, ki so predčasno prekinili zdravljenje.
English: There is no specific antidote for overdose with EDURANT.
Slovenian: Za zdravljenje v primeru prevelikega odmerjanja zdravila EDURANT ni specifičnega antidota.
English: 75 ml high density polyethylene (HDPE) bottle with a polypropylene (PP) child resistant closure and induction seal liner.
Slovenian: 75 ml vsebnik iz polietilena visoke gostote (HDPE) s polipropilensko (PP) za otroke varno zaporko in indukcijsko zataljeno folijo.
English: Uncommon: - signs or symptoms of inflammation or infection, for example fever, chills, sweats (immune reactivation syndrome)
Slovenian: Občasni neželeni učinki: - znaki ali simptomi vnetja ali okužbe, na primer vročina, mrazenje, potenje (sindrom obnove imunskega odgovora)
English: Virologic outcome in adolescent subjects in the TMC278-C213 trial - week 48 and week 240 analysis; ITT-TLOVR* Week 48 N=36
Slovenian: Virološki izid pri mladostnikih v študiji TMC278-C213 - analiza podatkov po 48. in 240 tednih; ITT-TLOVR* 48. teden n=36
English: The safety and efficacy of EDURANT in children aged < 12 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila EDURANT pri otrocih, mlajših od 12 let, še nista bili dokazani.
English: No grade 3-4 laboratory abnormalities for AST/ALT or grade 3-4 ADRs of transaminase increased were reported.
Slovenian: nenormalnih laboratorijskih izvidih AST/ALT ali zvečanju koncentracije transaminaz, stopnje 3-4, niso poročali.
English: HIV Integrase Strand Transfer Inhibitors Raltegravir*
Slovenian: zaviralci prenosa zapisa integraze HIV raltegravir*
English: * compared to 25 mg once daily rilpivirine alone
Slovenian: * v primerjavi s samo 25 mg rilpivirina enkrat na dan
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.
Slovenian: Bolniki, ki imajo sočasno okužbo z virusom hepatitisa B in/ali virusom hepatitisa C Pri bolnikih, ki so imeli sočasno okužbo z virusom hepatitisa B in/ali virusom hepatitisa C in so prejemali rilpivirin, je bila pojavnost povečanja koncentracij jetrnih encimov večja, kot pri bolnikih, ki so prejemali rilpivirin, vendar niso imeli sočasne okužbe.
English: Psychiatric disorders very common insomnia common abnormal dreams depression sleep disorders depressed mood
Slovenian: Psihiatrične motnje zelo pogosti nespečnost pogosti nenormalne sanje depresija motnje spanja depresivno razpoloženje
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.
Slovenian: Sevi, odporni na rilpivirin, so bili selekcionirani v celičnih kulturah, ki so izhajale iz divjega tipa HIV-1 različnega izvora in podvrst, pa tudi iz HIV-1, ki so bili odporni na NNRTI.
English: Lansoprazole Rabeprazole Pantoprazole Esomeprazole
Slovenian: lansoprazol rabeprazol pantoprazol esomeprazol
English: BR=background regimen N=number of subjects
Slovenian: BR = (angl.: background regimen) osnovna shema zdravljenja N = število preiskovancev
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo posrednih ali neposrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: If you notice within 12 hours of the time you usually take EDURANT, you must take the tablet as soon as possible.
Slovenian: Če to opazite v 12 urah od takrat, ko običajno vzamete zdravilo EDURANT, morate tableto vzeti čimprej.
English: Resistance to rilpivirine was determined as a fold change in EC50 value (FC) above the biological cut-off (BCO) of the assay.
Slovenian: Rezistenco na rilpivirin so določili kot spremembo stopnje (FC - fold change) v vrednosti EC50 nad biološko zgornjo mejo (BCO - biological cut-off) testa občutljivosti.
English: (reduced absorption due to gastric pH increase)
Slovenian: (zmanjšana absorpcija zaradi zvečanja pH v želodcu)
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).
Slovenian: Poleg tega se je pokazalo, da rilpivirin deluje tudi proti celi vrsti primarnih izolatov HIV-1 skupine M (podvrste A, B, C, D, F, G, H), in sicer z vrednostmi EC50 od 0,07 do 1,01 nmol/l (0,03 do 0,37 ng/ml), in primarnih izolatov skupine O, in sicer z vrednostmi EC50 od 2,88 do 8,45 nmol/l (1,06 do 3,10 ng/ml).
English: In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after HIV treatment is started.
Slovenian: Pri nekaterih bolnikih z napredovalo okužbo s HIV, ki so imeli oportunistično okužbo kdaj prej, se lahko kmalu po začetku zdravljenja okužbe s HIV pojavijo simptomi in znaki vnetja, povezani s prejšnjimi okužbami.
English: Six subjects discontinued due to virological failure up to week 48 and 3 subjects discontinued beyond week 48.
Slovenian: Šest preiskovancev je zaradi virološkega neuspeha zdravljenje prekinilo do 48 tedna, 3 preiskovanci pa po 48. tednu.
English: As with other antiretroviral medicinal products, resistance testing should guide the use of EDURANT.
Slovenian: Tako, kot pri drugih protiretrovirusnih zdravilih se je treba pri zdravljenju z zdravilom EDURANT ravnati po rezultatih testiranja odpornosti.
English: The observed hepatocellular findings in mice may be rodent-specific.
Slovenian: Hepatocelularne spremembe, ki so jih opažali pri miših, so lahko specifične za glodalce.
English: Metabolism and nutrition disorders very common increased total cholesterol (fasted) increased LDL cholesterol (fasted)
Slovenian: Presnovne in prehranske motnje zelo pogosti zvečana celokupna koncentracija holesterola (na tešče) zvečana celokupna koncentracija LDL (na tešče)
English: BR=background regimen
Slovenian: BR = (angl.: background regimen) osnovna shema zdravljenja
English: 300 mg once daily (+ 50 mg once daily rilpivirine)
Slovenian: 300 mg enkrat na dan (+ 50 mg rilpivirina enkrat na dan)
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.
Slovenian: V analizi podatkov po 48 tednih je imelo 31 od 62 bolnikov pomanjkljiv virološki odziv na rilpivirin sočasno z NNRTI in NRTI RAMs, od teh 31 bolnikov jih je imelo 17 kombinacijo E138K in M184I.
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.
Slovenian: V tej interakcijski študiji so uporabljali višji odmerek rilpivirina od priporočenega, da bi lahko ocenili največji učinek na sočasno uporabljano zdravilo.
English: 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.
Slovenian: Te mutacije, povezane z odpornostjo, so določili na osnovi in vivo podatkov samo pri bolnikih, ki še niso prejemali protiretrovirusnih zdravil in jih zato ne moremo uporabljati za napovedovanje aktivnosti rilpivirina pri bolnikih, ki so bili virološko neuspešni na shemah zdravljenja z drugimi protiretrovirusnimi zdravili.
English: R(-) methadone AUC ↓ 16% R(-) methadone Cmin ↓ 22% R(-) methadone Cmax ↓ 14% rilpivirine AUC ↔* rilpivirine Cmin ↔* rilpivirine Cmax ↔* * based on historic controls
Slovenian: R(-) metadon AUC ↓ 16% R(-) metadon Cmin ↓ 22% R(-) metadon Cmax ↓ 14% rilpivirin AUC ↔* rilpivirin Cmin ↔* rilpivirin Cmax ↔* * na podlagi podatkov kontrolnih oseb iz preteklih študij
English: Response (confirmed < 50 HIV-1 RNA copies/ml)
Slovenian: Potrjen odziv na zdravljenje (< 50 kopij RNK virusa HIV-1/ml)
English: In the week 96 pooled resistance analysis, lower rates of virologic failure were observed in the second 48 weeks than in the first 48 weeks of treatment.
Slovenian: V združeni analizi rezistence po 96 tednih zdravljenja so opazili nižjo stopnjo virološke odpovedi v drugih 48 tednih kot v prvih 48 tednih zdravljenja.
English: Trimester of pregnancy (n=13)
Slovenian: tretje trimesečje nosečnosti (n=13)
English: As with other antiretroviral medicinal products, resistance testing should guide the use of rilpivirine (see section 5.1).
Slovenian: Tako, kot pri drugih protiretrovirusnih zdravilih, se je o uporabi rilpivirina treba odločiti na osnovi rezultatov testiranja odpornosti (glejte poglavje 5.1).
English: No human data on the effect of rilpivirine on fertility are available.
Slovenian: O vplivu rilpivirina na plodnost pri ljudeh ni podatkov.
English: Most of these discontinuations occurred in the first 48 weeks of treatment.
Slovenian: Do večine prekinitev je prišlo v prvih 48 tednih zdravljenja.
English: - The other ingredients of the film-coated tablet core are lactose monohydrate, croscarmellose sodium, povidone K30, polysorbate 20, silicified microcrystalline cellulose and magnesium stearate.
Slovenian: - Druge sestavine zdravila v sredici filmsko obložene tablete so laktoza monohidrat, premrežen natrijev karmelozat, povidon K30, polisorbat 20, silicificirana mikrokristalna celuloza in magnezijev stearat.
English: The pharmacokinetic exposure of rilpivirine in co-infected patients was comparable to that in patients without co-infection.
Slovenian: Farmakokinetika izpostavljenosti rilpivirinu je pri bolnikih s sočasno okužbo primerljiva s tisto pri bolnikih brez sočasne okužbe.
English: Renal elimination of rilpivirine is negligible.
Slovenian: Izločanje rilpivirina skozi ledvice je zanemarljivo.
English: Do not stop using EDURANT
Slovenian: Ne prenehajte jemati zdravila EDURANT
English: Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Slovenian: Rilpivirin ni induciral kromosomskih okvar pri in vivo mikronukleusnem testu pri miših.
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).
Slovenian: - klaritromicin, eritromicin (antibiotiki) - cimetidin, famotidin, nizatidin ali ranitidin (antagonisti histaminskih receptorjev H2, ki jih uporabljamo pri zdravljenju razjed v želodcu ali črevesju ali za lajšanje zgage zaradi kislega refluksa).
English: EDURANT contains lactose
Slovenian: Zdravilo EDURANT vsebuje laktozo
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).
Slovenian: V razvojnem kliničnem programu (1.368 bolnikov iz dveh nadzorovanih študij faze III TMC278-C209 (ECHO) in TMC278-C215 (THRIVE)) se je najmanj en neželen učinek pojavil pri 55,7% preiskovancev (glejte poglavje 5.1).
English: There is limited information regarding the use of EDURANT in patients with mild or moderate hepatic impairment (Child-Pugh score A or B).
Slovenian: Podatki o uporabi zdravila EDURANT pri bolnikih z blago ali zmerno okvaro jeter (Child-Pugh stopnje A ali B) so omejeni.
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in table 1.
Slovenian: V preglednici 1 so našteta ugotovljena in teoretična medsebojna delovanja z izbranimi protiretrovirusnimi in drugimi zdravili.
English: The median duration of exposure for patients in the rilpivirine arm and efavirenz arm was 104.3 and 104.1 weeks, respectively.
Slovenian: Mediana vrednost trajanja izpostavljenosti bolnika je bila 104,3 tedna v skupini, ki je prejemala rilpivirin in 104,1 tedna v skupini, ki je prejemala efavirenz.
English: HIV PIs - with co-administration of low dose ritonavir Darunavir/ritonavir*
Slovenian: zaviralci HIV proteaze (HIV PI) - pri sočasni uporabi nizkih odmerkov ritonavirja darunavir/ritonavir*
English: In patients with a baseline viral load ≤ 100,000 copies/ml, 9 out of 27 patients with virologic failure on rilpivirine showed treatment-emergent resistance to rilpivirine (genotypic analysis), with the following frequency of phenotypic cross-resistance: etravirine 4/9, efavirenz 3/9, and nevirapine 1/9.
Slovenian: Pri bolnikih z začetnim virusnim bremenom ≤ 100.000 kopij/ml, je 9 od 27 bolnikov z virološkim neuspehom zdravljenja z rilpivirinom pokazalo zaradi zdravljenja nastalo rezistenco na rilpivirin (genotipska analiza) z naslednjo pogostnostjo fenotipske navzkrižne rezistence: na etravirin 4/9, na efavirenz 3/9 in na nevirapin 1/9.
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).
Slovenian: Ker se rilpivirin v velikem obsegu veže na proteine v plazmi, ga v večji meri skorajda ni mogoče odstraniti s hemodializo ali s peritonealno dializo (glejte poglavje 4.2).
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.
Slovenian: Od teh jih je bilo 9 od 24 oziroma 4 od 14 pri bolnikih z začetnim virusnim bremenom < 100.000 kopij/1 ml.
English: Efavirenz + BR N=682
Slovenian: efavirenz + zdravila po osnovni shemi n=682
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje mora uvesti zdravnik, ki ima izkušnje z obravnavo bolnikov s HIV.
English: As a precautionary measure, it is preferable to avoid the use of EDURANT during pregnancy.
Slovenian: Zaradi zagotovitve varnosti, se je uporabi rilpivirina med nosečnostjo bolje izogibati.