FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of INTELENCE and atorvastatin can be given without any dose adjustments, however, the dose of atorvastatin may need to be altered based on clinical response.
Slovenian: Kombinacija zdravila INTELENCE z atorvastatinom, se lahko daje brez prilagoditve odmerkov, vendar pa bo morda potrebna prilagoditev odmerka atorvastatina glede na bolnikov klinični odziv.
English: Patients co-infected with hepatitis B and/or hepatitis C virus In the pooled analysis for DUET-1 and DUET-2, the incidence of hepatic events tended to be higher in co-infected subjects treated with etravirine compared to co-infected subjects in the placebo group.
Slovenian: Bolniki, ki so sočasno okuženi z virusom hepatitisa B in/ali virusom hepatitisa C V združeni analizi izsledkov preskušanj DUET-1 in DUET-2 je bila pojavnost jetrnih neželenih učinkov pri sočasno okuženih bolnikih, ki so jih zdravili z etravirinom, večja v primerjavi s sočasno okuženimi bolniki, ki so prejemali placebo.
English: Co-administration with systemic immunosuppressants should be done with caution because plasma concentrations of cyclosporin, sirolimus and tacrolimus may be affected when co-administered with INTELENCE.
Slovenian: Pri sočasni uporabi s sistemskimi imunosupresivi je potrebna previdnost, ker so lahko plazemske koncentracije ciklosporina, sirolimusa in takrolimusa spremenjene pri njihovi sočasni uporabi z zdravilom INTELENCE.
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS Sildenafil 50 mg single dose
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 (PDE-5) sildenafil 50 mg enkraten odmerek tadalafil vardenafil sildenafil
English: Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
Slovenian: Bolnikom zato naročite, naj se posvetujejo z zdravnikom, če se pojavijo bolečine v sklepih, okorelost sklepov ali težave z gibanjem.
English: Immune reconstitution syndrome
Slovenian: Sindrom imunske obnove
English: Paediatric population (6 years to less than 18 years of age) The recommended dose of etravirine for paediatric patients (6 years to less than 18 years of age and weighing at least 16 kg) is based on body weight (see table below).
Slovenian: Pediatrična populacija (od 6 let do manj kot 18 let) Priporočeni odmerek etravirina pri pediatričnih bolnikih (od 6 let do manj kot 18 let in s telesno maso najmanj 16 kg) temelji na telesni masi (glejte spodnjo preglednico).
English: Cardiac disorders common myocardial infarction uncommon atrial fibrillation, angina pectoris
Slovenian: Srčne bolezni pogosti miokardni infarkt občasni atrijska fibrilacija, angina pektoris
English: Rash was mostly self-limiting, and generally resolved within 1-2 weeks on continued therapy (see section 4.4).
Slovenian: Izpuščaj je večinoma izzvenel brez dodatnih ukrepov in je običajno minil po 1 do 2 tednih nadaljnjega zdravljenja (glejte poglavje 4.4).
English: Manufacturer Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italy
Slovenian: Izdelovalec Janssen-Cilag SpA, Via C. Janssen, 04100 Borgo San Michele, Latina, Italija
English: Follow your doctor's advice on the type of meal you should be taking with INTELENCE.
Slovenian: Upoštevajte zdravnikova navodila glede vrste obroka, ki ga je treba zaužiti skupaj z zdravilom INTELENCE.
English: There are insufficient data at this time to recommend a dose in paediatric patients less than 6 years of age or weighing less than 16 kg (see section 4.2).
Slovenian: Za sedaj ni zadostnih podatkov, da bi lahko navedli priporočeni odmerek tega zdravila pri pediatričnih bolnikih, mlajših od 6 let in s telesno maso manjšo od 16 kg (glejte poglavje 4.2).
English: - Treatment: Etravirine vs. placebo, in addition to a background regimen (BR) including darunavir/ritonavir (DRV/rtv), investigator-selected N(t)RTIs and optional enfuvirtide (ENF).
Slovenian: - Zdravljenje: etravirin v primerjavi s placebom, poleg osnovne sheme (BR - background regimen) z darunavirjem/ritonavirjem (DRV/rtv), N(t)RTI, ki jih izbere raziskovalec, in enfuvirtidom (ENF) po izbiri.
English: Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped.
Slovenian: Zdravnik vam bo svetoval glede vaših simptomov in se odločil ali je potrebno zdravljenje z zdravilom INTELENCE prekiniti.
English: Etravirine is primarily metabolised and eliminated by the liver.
Slovenian: Etravirin se presnavlja in izloča predvsem prek jeter.
English: P-value < 0.0001 for mean decrease in HIV-1 RNA; P-value = 0.0006 for mean change in CD4 cell count.
Slovenian: Vrednost p < 0,0001 velja za srednjo vrednost zmanjšanja HIV-1 RNK, vrednost p = 0,0006 pa za srednjo vrednost spremembe v številu celic CD4.
English: No significant effect on didanosine and etravirine PK parameters is seen.
Slovenian: Niso opazili pomembnih učinkov na FK parametre didanozina in etravirina.
English: Systemic dexamethasone should be used with caution or alternatives should be considered, particularly for chronic use.
Slovenian: Sistemski deksametazon je treba uporabljati previdno ali namesto njega uporabiti druga zdravila, še posebej pri dolgotrajnem zdravljenju.
English: Your doctor will advise you how to deal with your symptoms and whether INTELENCE must be stopped; - headache; - diarrhoea, nausea.
Slovenian: Zdravnik vam bo svetoval kako ravnati ob pojavu opisanih znakov in se odločil ali je treba zdravljenje z zdravilom INTELENCE prekiniti - glavobol - driska, navzea (občutek slabosti).
English: Patients who are diagnosed with a hypersensitivity reaction whilst on therapy must discontinue INTELENCE immediately.
Slovenian: Bolniki, katerim diagnosticirajo preobčutljivostno reakcijo med zdravljenjem, morajo takoj prekiniti zdravljenje z zdravilom INTELENCE.
English: 300/100 mg once daily atazanavir
Slovenian: 300/100 mg enkrat na dan atazanavir
English: In all the other trials conducted with etravirine in HIV-1 infected patients, the following mutations emerged most commonly: L100I, E138G, V179F, V179I, Y181C and H221Y.
Slovenian: V vseh drugih preskušanjih, opravljenih z etravirinom pri bolnikih, okuženih s HIV-1, so se najpogosteje pojavljale naslednje mutacije: L100I, E138G, V179F, V179I, Y181C in H221Y.
English: Baseline HIV-1 RNA < 30,000 copies/ml ≥ 30,000 and < 100,000 copies/ml ≥ 100,000 copies/ml Baseline CD4 count (x 10
Slovenian: Začetna vrednost HIV-1 RNK < 30.000 kopij/ml ≥ 30.000 in < 100.000 kopij/ml ≥ 100.000 kopij/ml Začetna vrednost števila celic CD4 (x 10
English: 40 mg once daily atorvastatin
Slovenian: 40 mg enkrat na dan atorvastatin
English: Etravirine has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and its use is therefore not recommended in this group of patients (see sections 4.2 and 5.2).
Slovenian: Etravirina niso preučevali pri bolnikih s hudo okvaro jeter (razred C po klasifikaciji Child-Pugh) in zato pri tej skupini bolnikov njegova uporaba ni priporočljiva (glejte poglavji 4.2 in 5.2).
English: • HIV-1 plasma viral load > 5,000 HIV-1 RNA copies/ml at screening
Slovenian: • virusno breme HIV-1 v plazmi > 5.000 HIV-1 RNK kopij/ml pri presejalnem testiranju,
English: Make sure that you check the following points and tell your doctor if any of these apply to you.
Slovenian: Preberite spodnje točke in obvestite svojega zdravnika, če karkoli od navedenega velja za vas: - Povejte svojemu zdravniku, če se pojavi izpuščaj.
English: OESTROGEN-BASED CONTRACEPTIVES Ethinylestradiol
Slovenian: ESTROGENSKI KONTRACEPTIVI etinilestradiol
English: The recommended dose of INTELENCE is one tablet twice a day.
Slovenian: Priporočeni odmerek zdravila INTELENCE je ena tableta dvakrat na dan.
English: Pooled DUET Studies ≥ 18 years ETR N = 599
Slovenian: združeni podatki preskušanj DUET ≥ 18 let ETR N = 599
English: What INTELENCE contains - The active substance is etravirine.
Slovenian: Kaj vsebuje zdravilo INTELENCE - Učinkovina je etravirin.
English: Exposure in mice was equivalent to human exposure while in rats it was below the clinical exposure at the recommended dose.
Slovenian: Stopnja izpostavljenosti zdravilu pri miših je bila enaka kot pri človeku, medtem ko je bila pri podganah manjša od klinične stopnje izpostavljenosti pri uporabi priporočenega odmerka.
English: The systemic exposure (AUC) to etravirine was decreased by about 50% when etravirine was administered under fasting conditions, as compared to administration following a meal.
Slovenian: Stopnja sistemske izpostavljenosti etravirinu (AUC) je bila zmanjšana za približno 50% pri jemanju etravirina na tešče v primerjavi z jemanjem po jedi, zato je treba zdravilo INTELENCE jemati po jedi.
English: Rash was reported more frequently in female subjects than in male subjects (rash ≥ grade 2 was reported in 13/64 [20.3%] females versus 2/37 [5.4%] males; discontinuations due to rash were reported in 4/64 [6.3%] females versus 0/37 [0%] males) (see section 4.4).
Slovenian: Izpuščaj je bil pri deklicah poročan pogosteje, kot pri dečkih (izpuščaj ≥ 2. stopnje so poročali pri 13/64 [20,3%] deklic v primerjavi z 2/37 [5,4%] dečkov; o prekinitvi zdravljenja zaradi izpuščaja so poročali pri 4/64 [6,3%] deklic v primerjavi z 0/37 [0%] dečkov) (glejte poglavje 4.4).
English: INTELENCE should be used in combination with a boosted PI. Rifampicin is contraindicated in combination with boosted PIs.
Slovenian: Zdravilo INTELENCE je treba uporabljati skupaj z okrepljenimi PI. Sočasna uporaba rifampicina in okrepljenih PI je kontraindicirana.
English: Patients who have stopped treatment due to hypersensitivity reactions should not restart therapy with INTELENCE.
Slovenian: Bolniki, ki so zdravljenje prekinili zaradi preobčutljivostnih reakcij, zdravljenja z zdravilom INTELENCE ne smejo ponovno začeti.
English: The plastic bottle comes with a child resistant cap and should be opened as follows: Push the plastic screw cap down while turning it counter clockwise.
Slovenian: Plastenka ima za otroke varno zaporko, ki jo lahko odprete na naslednji način: Plastično navojno zaporko potisnite navzdol in jo pri tem obračajte v nasprotni smeri urinega kazalca.
English: The recommended dose of INTELENCE is two tablets twice a day.
Slovenian: Priporočeni odmerek zdravila INTELENCE sta dve tableti dvakrat na dan.
English: Very rare side effects (may affect up to 1 in 10,000 people) - severe hypersensitivity reactions characterised by rash accompanied by fever and organ inflammation such as hepatitis.
Slovenian: Zelo redki neželeni učinki (pojavijo se pri največ 1 od 10.000 bolnikov) - hude preobčutljivostne reakcije, za katere je značilen izpuščaj z zvišano telesno temperaturo in vnetjem organov, kot je hepatitis.
English: Results from a mass balance study with radioactive
Slovenian: Izsledki študije masne bilance s pomočjo radioaktivnega etravirina-C
English: Adverse reactions reported in patients treated with etravirine are summarised in Table 2.
Slovenian: Povzetek neželenih učinkov zdravila v preglednici Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z etravirinom, so povzeti v preglednici 2.
English: Close monitoring of antimalarial response is warranted when co-administering INTELENCE and artemether/lumefantrine as a significant decrease in exposure of artemether and its active metabolite, dihydroartemisinin, may result in decreased antimalarial efficacy.
Slovenian: Pri sočasni uporabi zdravila INTELENCE in kombinacije artemeter/ lumefantrin je potrebno skrbno spremljanje odgovora na antimalarik, ker opažena zmanjšana izpostavljenost artemetru in/ali njegovemu aktivnemu presnovku dihidroartemisininu lahko povzroči zmanjšano antimalarično učinkovitost.
English: INTELENCE might interact with other medicines.
Slovenian: Pri jemanju zdravila INTELENCE lahko pride do medsebojnega delovanja z drugimi zdravili.
English: Medicinal products that are affected by the use of etravirine
Slovenian: Zdravila, na katera vpliva sočasna uporaba etravirina
English: C-etravirine showed that < 1.2% of the administered dose of etravirine is excreted in the urine.
Slovenian: so pokazali, da se < 1,2% danega odmerka etravirina izloči s sečem.
English: Virologic responses (ITT - TLOVR), change from baseline in log10 viral load (NC = F), and change from baseline in CD4 percentage and cell count (NC = F) at week 24 in the TMC125-C213 and pooled DUET studies
Slovenian: Virološki odgovor (ITT - TLOVR), sprememba virusnega bremena log10 (NC = F) in sprememba deleža in števila CD4 celic po 24. tednu glede na začetek (NC = F) (združeni podatki preskušanj TMC125-C213 in DUET)
English: The dosages of some medicines might need to be changed since their therapeutic effect or side effects may be influenced when combined with INTELENCE.
Slovenian: Odmerjanje nekaterih zdravil bo morda treba spremeniti, saj sočasno zdravljenje z zdravilom INTELENCE lahko vpliva na njihove terapevtske ali neželene učinke.
English: INTELENCE can be co-administered with H2-receptor antagonists without dose adjustments.
Slovenian: Zdravilo INTELENCE se lahko uporablja sočasno z antagonisti receptorjev H2 brez prilagoditve odmerka.
English: The effects of INTELENCE or other medicines might be influenced if you take INTELENCE together with any of the following medicines.
Slovenian: Učinki zdravila INTELENCE ali drugih zdravil so lahko spremenjeni, če bolnik jemlje zdravilo INTELENCE skupaj s katerim od spodaj naštetih zdravil.
English: No significant pharmacokinetic differences have been observed between males and females.
Slovenian: Med moškimi in ženskami niso opazili bistvenih razlik v farmakokinetiki zdravila.
English: HIV PIs - Boosted with low-dose ritonavir Atazanavir/ritonavir
Slovenian: HIV PI (zaviralci proteaze) - okrepljeni z majhnim odmerkom ritonavirja atazanavir/ritonavir
English: (based on AUC) to etravirine were 0.6-fold (mice) and between 0.2- and 0.7-fold (rats), relative to those observed in humans at the recommended therapeutic dose (200 mg twice daily).
Slovenian: Pri najvišjih preskušanih odmerkih je bila sistemska izpostavljenost etravirinu (na osnovi AUC) 0,6-kratna (miši) in 0,2-0,7-kratna (podgane), glede na izpostavljenosti opažene pri ljudeh pri priporočenem terapevtskem odmerku (200 mg dvakrat na dan).
English: It is therefore important to contact your doctor immediately if you develop a rash.
Slovenian: Zato je pomembno da se ob pojavu izpuščaja takoj obrnete na svojega zdravnika.
English: Carbazamepine, phenobarbital and phenytoin are expected to decrease plasma concentrations of etravirine.
Slovenian: Pričakovati je, da karbamazepin, fenobarbital in fenitoin znižajo plazemske koncentracije etravirina.
English: - If you are unable to swallow the INTELENCE tablet(s) whole, you may do the following: place the tablet(s) in 5 ml (1 teaspoon) of water, or at least enough liquid to cover the medicine, stir well until the water looks milky, if desired, add more water or alternatively orange juice or milk (do not place the tablets directly in orange juice or milk), drink it immediately, rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure you take the entire dose.
Slovenian: - Če tablet zdravila INTELENCE ne morete pogoltniti celih, jih lahko: - date v 5 ml (1 čajna žlička) ali toliko vode, ta so tablete pokrite, - dobro premešate, da bo tekočina po videzu podobna mleku, - po želji dodate vodo, pomarančni sok ali mleko (tablet ne smete že takoj dati v pomarančni sok ali mleko), - takoj popijte, - kozarec večkrat sperite z vodo, pomarančnim sokom ali mlekom in vsakič popijte tudi vso vodo s katero ste sprali kozarec, da boste zagotovo prejeli celotni odmerek zdravila.
English: Co-administration with medicinal products primarily metabolised by CYP2C9 or CYP2C19, or transported by P-glycoprotein, may result in increased plasma concentrations of such medicinal products, which could increase or prolong their therapeutic effect or alter their adverse events profile.
Slovenian: Njegova sočasna uporaba z zdravili, ki se presnavljajo predvsem s pomočjo CYP2C9 ali CYP2C19 ali se vežejo na P-glikoprotein, lahko povzroči zvečanje plazemske koncentracije teh zdravil, kar bi lahko vodilo do okrepitve ali daljšega trajanja njihovih terapevtskih učinkov ali spremenilo njihov profil neželenih učinkov.
English: In the TMC125-C227 study, etravirine (N = 59) was administered with 2 investigator-selected NRTIs (i.e. without a ritonavir-boosted PI) and compared to an investigator-selected combination of a PI with 2 NRTIs (N = 57).
Slovenian: V študiji TMC125-C227 so etravirin (N = 59) uporabljali skupaj z dvema NRTI, ki ju je izbral raziskovalec (t.j.
English: Not studied, but no interaction expected based on the primary renal elimination route for other NRTIs (e.g., abacavir, emtricitabine, lamivudine, stavudine and zidovudine).
Slovenian: Medsebojnih delovanj niso preučevali, vendar jih ni pričakovati glede na to, da se ostali NRTI (npr. abakavir, emtricitabin, lamivudin, stavudin in zidovudin) izločajo predvsem skozi ledvice.
English: In mice, the key target organs identified were the liver and the coagulation system.
Slovenian: Pri miših sta bila glavna ugotovljena tarčna organa jetra in sistem strjevanja krvi.
English: Etravirine (200 mg twice daily), evaluated in combination with other antiretroviral medicinal products in a study of 15 pregnant women during the second and third trimesters of pregnancy and postpartum, demonstrated that exposure to total etravirine was generally higher during pregnancy compared with postpartum, and less so for unbound etravirine exposure (see section 5.2).
Slovenian: Ocena etravirina (200 mg dvakrat na dan) v kombinaciji z drugimi protiretrovirusnimi zdravili v študiji pri 15 nosečnicah med drugim in tretjim trimesečjem nosečnosti in v obdobju po porodu je pokazala, da je bila celokupna izpostavljenost etravirinu na splošno večja med nosečnostjo kot po porodu, razlika v izpostavljenosti pri nevezanem etravirinu pa je bila manjša (glejte poglavje 5.2).
English: No significant effect on tenofovir and etravirine PK parameters is seen.
Slovenian: Niso opazili pomembnih učinkov na FK parametre tenofovirja in etravirina.
English: Etravirine had no effect on offspring development during lactation or post weaning at maternal exposures equivalent to those observed at the recommended clinical dose.
Slovenian: Etravirin tudi ni vplival na razvoj potomcev med dojenjem ali po odstavitvi mladičev pri enakih stopnjah izpostavljenosti samic, kot so jih ugotovili pri dajanju priporočenega kliničnega odmerka.
English: Cases of severe hypersensitivity syndromes, including DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) and TEN (toxic epidermal necrolysis), sometimes fatal, have been reported with the use of etravirine (see section 4.8).
Slovenian: Pri uporabi etravirina so poročali o primerih hudih preobčutljivostnih sindromov, vključno s sindromom DRESS (Drug Rash with Eosinophilia and Systemic Symptoms - kožni izpuščaj z eozinofilijo in s sistemskimi simptomi kot posledica zdravljenja) in toksično epidermalno nekrolizo (TEN - Toxic Epidermal Necrolysis), ki so lahko tudi smrtni (glejte poglavje 4.8).
English: The combination of etravirine with simeprevir, daclatasvir, atazanavir/cobicistat or darunavir/cobicistat is not recommended (see section 4.5).
Slovenian: Kombinacije etravirina s simeprevirjem, daklatasvirjem, s kombinacijo atazanavir/kobicistat ali darunavir/kobicistat niso priporočljive (glejte poglavje 4.5).
English: The adverse reactions are listed by system organ class (SOC) and frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in po pogostnosti.
English: Cmax ↑ 1.76 (1.60-1.94) etravirine
Slovenian: Cmax ↑ 1,76 (1,60-1,94) etravirin
English: In a study conducted in rats, there were no effects on mating or fertility at exposure levels equivalent to those in humans at the clinically recommended dose.
Slovenian: V študiji, opravljeni pri podganah, ni bilo nobenih učinkov zdravila na parjenje ali plodnost pri stopnjah izpostavljenosti, ki so ustrezale človekovim stopnjam izpostavljenosti pri uporabi klinično priporočenih odmerkov.
English: Renal impairment No dose adjustment is required in patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic prilagajanje odmerka ni potrebno (glejte poglavje 5.2).
English: Blood and lymphatic system disorders common thrombocytopaenia, anaemia, decreased neutrophils uncommon decreased white blood cell count
Slovenian: Bolezni krvi in limfatičnega sistema pogosti trombocitopenija, anemija, zmanjšanje števila nevtrofilcev občasni zmanjšanje števila levkocitov
English: No dose adjustment is suggested but caution is advised in patients with moderate hepatic impairment.
Slovenian: Za prilagajanje odmerkov ni priporočil, vendar je pri bolnikih z zmerno okvaro jeter potrebna previdnost.
English: The observed hepatocellular findings in female mice are generally considered to be rodent specific, associated with liver enzyme induction, and of limited relevance to humans.
Slovenian: Opažene hepatocelularne spremembe so najverjetneje značilne za glodalce, povezane z indukcijo jetrnih encimov in omejenega pomena za ljudi.
English: These adverse reactions have been identified through postmarketing experience with etravirine.
Slovenian: Navedene neželene učinke so ugotovili pri spremljanju izkušenj z etravirinom po prihodu zdravila na trg.
English: Change from baseline in CD4 cell count (x 10
Slovenian: Sprememba števila CD4 celic (x 10
English: Imputations according to the TLOVR algorithm (TLOVR = Time to Loss of Virologic Response).
Slovenian: Pripisane vrednosti po algoritmu TLOVR (Time to Loss of Virologic Response - TLOVR = čas do izginotja virološkega odziva)
English: Table 9: Pharmacokinetic results of total etravirine after administration of etravirine 200 mg twice daily as part of an antiretroviral regimen, during the 2
Slovenian: Preglednica 9: Farmakokinetični rezultati skupnega etravirina po jemanju 200 mg etravirina dvakrat na dan kot dela protiretrovirusnega zdravljenja med 2. in 3.
English: Etravirine is metabolised by CYP3A4, CYP2C9 and CYP2C19 followed by glucuronidation of the metabolites by uridine diphosphate glucuronosyl transferase (UDPGT).
Slovenian: Etravirin se presnavlja z encimi CYP3A4, CYP2C9 in CYP2C19, temu sledi glukuronidacija nastalih presnovkov z uridin difosfat glukuronozil transferazo (UDPGT).
English: Placental transfer has been seen in pregnant rats, but it is not known whether placental transfer of etravirine also occurs in pregnant women.
Slovenian: Prehajanje etravirina preko posteljice so opazili pri brejih podganah, ni pa znano, ali se to zgodi tudi pri nosečnicah.
English: Table 4: DUET-1 and DUET-2 pooled data
Slovenian: Preglednica 4: Združeni podatki iz preskušanj DUET-1 in DUET-2
English: No dose adjustment for INTELENCE is necessary.
Slovenian: Prilagajanje odmerka zdravila INTELENCE ni potrebno.
English: Pregnancy and postpartum
Slovenian: Nosečnost in obdobje po porodu
English: ≥ 1 log10 decrease from baseline at week 24, n (%)
Slovenian: ≥ 1 log10 zmanjšanje v 24. tednu (glede na začetek), n (%)
English: Paediatric population (less than 6 years of age)
Slovenian: Pediatrična populacija (mlajši od 6 let)
English: Therapy should be initiated by a physician experienced in the management of HIV infection.
Slovenian: Zdravljenje sme uvesti samo zdravnik z izkušnjami z zdravljenjem okužbe s HIV.
English: Table 5: Proportion of subjects with < 50 HIV-1 RNA copies/ml at week 48 by baseline number of etravirine RAMs in the non-viral failure excluded population of pooled DUET-1 and DUET-2 trials Baseline number of Etravirine RAMs*
Slovenian: Preglednica 5: Odstotek preiskovancev z < 50 HIV-1 RNK kopij/ml v 48. tednu po začetnem številu RAMov etravirina v populaciji, iz katere niso izključevali virološko neuspešnih preiskovancev, iz združenih preskušanj DUET-1 in DUET-2 Začetno število RAM za etravirin
English: If you vomit less than 4 hours after taking INTELENCE, take another dose following a meal.
Slovenian: Če bruhate v manj kot 4 urah po zaužitja zdravila INTELENCE, vzemite dodaten odmerek po jedi.
English: Summary of efficacy results
Slovenian: Povzetek izsledkov o učinkovitosti zdravila