FrancophonIA/ELRC3.0 huggingface dataset:
English: Antiretroviral treatment-naïve HIV-1 infected patients were enrolled (n = 1,368) who had a plasma HIV-1 RNA ≥ 5,000 copies/mL and were screened for susceptibility to N(t)RTI and for absence of specific NNRTI resistance-associated mutations.
Slovenian: V zdravljenje so bili vključeni bolniki, okuženi z virusom HIV-1, ki se predhodno še niso zdravili s protiretrovirusno terapijo (n = 1.368), ki so imeli plazemski HIV-1 RNA ≥ 5.000 kopij/ml in pri katerih so opravili presejalne teste za občutljivost na N(t)RTI in odsotnost specifičnih mutacij, povezanih z rezistenco na NNRTI.
English: In treatment-naïve patients, the most frequently reported adverse reactions considered possibly or probably related to rilpivirine hydrochloride and emtricitabine/tenofovir disoproxil were nausea (9%), dizziness (8%), abnormal dreams (8%), headache (6%), diarrhoea (5%) and insomnia (5%) (pooled data from the Phase III clinical studies C209 and C215, see section 5.1).
Slovenian: Pri predhodno nezdravljenih bolnikih so bili najpogostejši neželeni učinki, ki so bili verjetno oziroma morda povezani z rilpivirinijevim kloridom in emtricitabinom/dizoproksiltenofoviratom, navzea (9 %), omotičnost (8 %), nenavadne sanje (8 %), glavobol (6 %), driska (5 %) in nespečnost (5 %) (podatki so združeni iz kliničnih študij faze III C209 in C215, glejte poglavje 5.1).
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Slovenian: Pri bolnikih s kroničnim hepatitisom B ali C, ki se zdravijo s protiretrovirusno terapijo, obstaja povečano tveganje za hude in potencialno usodne neželene učinke v delovanju jeter.
English: Eviplera must be taken with food (see section 5.2).
Slovenian: Zdravilo Eviplera se mora jemati s hrano (glejte poglavje 5.2).
English: These medicines can increase the amount of rilpivirine (a component of Eviplera) in your blood.
Slovenian: Ta zdravila lahko zvišajo količino rilpivirina (učinkovina v zdravilu Eviplera) v vaši krvi.
English: 1 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product.
Slovenian: 1 To študijo interakcij so opravili z višjim odmerkom od priporočenega za rilpivirinijev klorid za ocenitev največjega učinka na sočasno dano zdravilo.
English: Eviplera is not recommended in this population (see section 4.2).
Slovenian: Uporaba zdravila Eviplera pri tej populaciji ni priporočljiva (glejte poglavje 4.2).
English: neutropenia1, decreased white blood cell count2, decreased haemoglobin2, decreased platelet count2
Slovenian: nevtropenija1, zmanjšanje števila belih krvnih celic2, znižanje hemoglobina2, zmanjšanje števila krvnih ploščic2
English: Eviplera should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).
Slovenian: Zdravila Eviplera se ne sme dajati skupaj z drugimi zdravili, ki vsebujejo emtricitabin, dizoproksiltenofovirat, tenofoviralafenamidijev fumarat ali druge analoge citidina, kot je lamivudin (glejte poglavje 4.5).
English: • Back pain caused by kidney problems, including kidney failure.
Slovenian: • bolečine v križu zaradi ledvične okvare, vključno z ledvično odpovedjo.
English: A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV-1 infection.
Slovenian: Sočasna uporaba zmanjšanega odmerka didanozina (250 mg) in zdravljenje z dizoproksiltenofoviratom je bilo v več preizkušenih kombinacijah za zdravljenje okužbe z virusom HIV-1 povezano s poročili o visoki stopnji virološkega neuspeha.
English: Eviplera 200 mg/25 mg/245 mg film-coated tablets
Slovenian: IME ZDRAVILA Eviplera 200 mg/25 mg/245 mg filmsko obložene tablete
English: • Use effective contraception while taking Eviplera.
Slovenian: • Med jemanjem zdravila Eviplera morate uporabljati učinkovito kontracepcijo.
English: HIV-1 containing the K103N substitution or other substitutions associated with resistance to rilpivirine and other NNRTIs was susceptible to emtricitabine.
Slovenian: Virus HIV-1 s substitucijo K103N ali drugimi substitucijami, povezanimi z rezistenco na rilpivirin ali druge NNRTI-je, je bil občutljiv na emtricitabin.
English: Rilpivirine hydrochloride at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Slovenian: Rilpivirinijev klorid pri priporočenem odmerku 25 mg enkrat dnevno ni povezan s klinično pomembnimi učinki na QTc.
English: In a study of healthy subjects, supratherapeutic doses of rilpivirine (75 mg once daily and 300 mg once daily) have been shown to prolong the QTc interval of the ECG (see section 5.1).
Slovenian: V študiji pri zdravih osebah se je pokazalo, da odmerki rilpivirina, višji od terapevtskih (75 mg enkrat dnevno in 300 mg enkrat dnevno), podaljšujejo interval QTc na EKG-ju (glejte poglavje 5.1).
English: Through week 96, fewer patients in the rilpivirine arm with baseline viral load ≤ 100,000 copies/mL had emerging resistance-associated substitutions and/or phenotypic resistance to rilpivirine (7/288) than patients with baseline viral load > 100,000 copies/mL (30/262).
Slovenian: Do konca 96. tedna se je pri manj bolnikih v kraku z rilpivirinom z začetno virusno obremenitvijo ≤ 100.000 kopij/ml pojavila z rezistenco povezana substitucija in/ali fenotipska rezistenca na rilpivirin (7/288) kot pri bolnikih z začetno virusno obremenitvijo > 100.000 kopij/ml (30/262).
English: Table 7: Outcomes of randomised treatment in study GS-US-264-0106 at week 24a
Slovenian: Preglednica 7: Izidi randomiziranega zdravljenja za študijo GS-US-264-0106 v 24. tednua Krak z zdravilom Eviplera n = 317
English: Patients were randomised in a 2:1 ratio to either switch to Eviplera at baseline (Eviplera arm, n = 317), or stay on their baseline antiretroviral regimen for 24 weeks (SBR arm, n = 159) before switching to Eviplera for an additional 24 weeks (Delayed Switch arm, n = 152).
Slovenian: Bolniki so bili randomizirani v razmerju 2:1 bodisi v skupino s prehodom na zdravilo Eviplera na začetku (krak z zdravilom Eviplera, n = 317) ali v skupino, ki je ostala na svojem začetnem protiretrovirusnem režimu še 24 tednov (krak z ohranitvijo začetnega režima, n = 159) pred prehodom na zdravilo Eviplera za dodatnih 24 tednov (krak s kasnejšim prehodom, n = 152).
English: Through week 24, two patients who switched to Eviplera at baseline (2 of 317 patients, 0.6%) and one patient who maintained their ritonavir-boosted PI-based regimen [Stayed on Baseline Regimen (SBR) arm] (1 of 159 patients, 0.6%) developed genotypic and/or phenotypic resistance to study drugs.
Slovenian: Do konca 24. tedna se je pri dveh bolnikih, ki sta na začetku prešla na zdravilo Eviplera (2 od 317 bolnikov, 0,6 %), in pri enem bolniku, ki je ohranil režim zdravljenja s PI, okrepljenim z ritonavirjem (krak z ohranitvijo začetnega režima) (1 od 159 bolnikov, 0,6 %) razvila genotipska in/ali fenotipska rezistenca na študijsko zdravilo.
English: Lower exposures of rilpivirine (one of the components of Eviplera) were observed during pregnancy; therefore viral load should be monitored closely.
Slovenian: Med nosečnostjo so opazili nižje izpostavljenosti rilpivirinu (ena izmed učinkovin zdravila Eviplera), zato je treba skrbno spremljati virusno obremenitev.
English: Patients with HIV and hepatitis B or C virus co-infection
Slovenian: Bolniki, hkrati okuženi z virusom HIV in virusom hepatitisa B ali C
English: If a patient misses a dose of Eviplera by more than 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Eviplera za več kot 12 ur, naj bolnik ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: Discontinuations due to adverse events were higher in the efavirenz arm at week 96 than in the rilpivirine arm.
Slovenian: Prekinitev zaradi neželenih učinkov je bilo v 96. tednu več v kraku z efavirenzom kot v kraku z rilpivirinom.
English: NARCOTIC ANALGESICS Methadone/Emtricitabine
Slovenian: NARKOTIČNI ANALGETIKI metadon/emtricitabin
English: 3 This interaction study has been performed with a dose higher than the recommended dose for rilpivirine hydrochloride assessing the maximal effect on the co-administered medicinal product.
Slovenian: 3 To študijo interakcij so opravili z višjim odmerkom od priporočenega za rilpivirinijev klorid za ocenitev največjega učinka na sočasno dano zdravilo.
English: However, long-term safety data for the emtricitabine and tenofovir disoproxil components of Eviplera have not been evaluated in patients with mild renal impairment.
Slovenian: Vendar pa dolgoročni podatki o varnosti sestavin zdravila Eviplera emtricitabina in dizoproksiltenofovirata, pri bolnikih z blago ledvično okvaro niso bili ovrednoteni.
English: In addition, a K70E substitution in HIV-1 RT has been selected by tenofovir and results in low-level reduced susceptibility to abacavir, emtricitabine, tenofovir and lamivudine.
Slovenian: Poleg tega je bila s tenofovirjem izbrana substitucija K70E pri RT HIV-1, kar je povzročilo nizko raven zmanjšane občutljivosti za abakavir, emtricitabin, tenofovir in lamivudin.
English: In the pooled efficacy analysis from the two Phase III clinical studies (C209 [ECHO] and C215 [THRIVE]) through 96 weeks, patients treated with emtricitabine/tenofovir disoproxil + rilpivirine with a baseline viral load > 100,000 HIV-1 RNA copies/mL had a greater risk of virologic failure (17.6% with rilpivirine versus 7.6% with efavirenz) compared to patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL (5.9% with rilpivirine versus 2.4% with efavirenz).
Slovenian: V skupni analizi učinkovitosti iz dveh kliničnih študij faze III (C209 [ECHO] in C215 [THRIVE]) do vključno 96. tedna je bilo pri bolnikih, zdravljenih z emtricitabinom/dizoproksiltenofoviratom + rilpivirinom z začetno virusno obremenitvijo > 100.000 HIV-1 RNA kopij/ml tveganje za virološki neuspeh (17,6 % z rilpivirinom v primerjavi s 7,6 % z efavirenzom) v primerjavi z bolniki z začetno virusno obremenitvijo ≤ 100.000 HIV-1 RNA kopij/ml (5,9 % z rilpivirinom v primerjavi z 2,4 % z efavirenzom) večje.
English: • the antimycobacterials rifampicin, rifapentine
Slovenian: • zdravila za zdravljenje okužb z mikobakterijami rifampicin, rifapentin
English: depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders
Slovenian: depresija2, depresivno razpoloženje2, motnje spanja2, nenavadne sanje1, 2
English: If Eviplera is discontinued in patients co-infected with HIV and hepatitis B virus (HBV), these patients should be closely monitored for evidence of exacerbation of hepatitis (see section 4.4).
Slovenian: Če se jemanje zdravila Eviplera prekine pri bolnikih s hkratno okužbo z virusom HIV in virusom hepatitisa B (HBV), je treba pri teh bolnikih skrbno nadzorovati znake poslabšanja hepatitisa (glejte poglavje 4.4).
English: • Yellow skin or eyes, itching or pain in the abdomen (tummy) caused by inflammation of the liver
Slovenian: • rumena obarvanost kože ali oči, srbečica ali bolečine v trebuhu zaradi vnetja jeter
English: 8 This adverse reaction was identified through post-marketing surveillance for tenofovir disoproxil but not observed in randomised controlled clinical studies or the expanded access program for tenofovir disoproxil.
Slovenian: 8 Ta neželeni učinek je bil opredeljen v okviru nadzora v obdobju trženja za dizoproksiltenofovirat, niso pa ga zabeležili v randomiziranih kontroliranih kliničnih študijah ali v programu razširjenega dostopa za dizoproksiltenofovirat.
English: Where discontinuation of therapy with one of the components of Eviplera is indicated or where dose modification is necessary, separate preparations of emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil are available.
Slovenian: Kjer je indicirana prekinitev zdravljenja z eno ali več sestavinami zdravila Eviplera ali potrebna prilagoditev odmerka, so na voljo posamezni pripravki emtricitabina, rilpivirinijevega klorida in dizoproksiltenofovirata.
English: The K65R mutation can also be selected by abacavir or didanosine and results in reduced susceptibility to these agents plus to lamivudine, emtricitabine, and tenofovir.
Slovenian: Mutacijo K65R lahko izberemo tudi z abakavirjem ali didanozinom, kar povzroči zmanjšano občutljivost na ta zdravila ter na lamivudin, emtricitabin in tenofovir.
English: CD4+ median increase from baseline (x 106 cells/L)
Slovenian: Mediana zvišanja CD4+ od začetka (x 106 celic/l)
English: Eviplera should not be co-administered with the following medicinal products as significant decreases in rilpivirine plasma concentrations may occur (due to cytochrome P450 [CYP]3A enzyme induction or gastric pH increase), which may result in loss of therapeutic effect of Eviplera:
Slovenian: Zdravila Eviplera ni dovoljeno dajati sočasno z naslednjimi zdravili, saj lahko pride do znatnega zmanjšanja koncentracij rilpivirina v plazmi (zaradi indukcije encima citokroma P450 [CYP]3A ali povečanja vrednosti pH v želodcu), kar lahko izniči terapevtski učinek zdravila Eviplera:
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Slovenian: Med zdravljenjem okužbe z virusom HIV lahko pride do povečanja telesne mase ter zvišanja koncentracij lipidov in glukoze v krvi.
English: The efficacy and safety of switching from a ritonavir-boosted PI in combination with two NRTIs to Eviplera STR was evaluated in a randomised, open-label study in virologically suppressed HIV-1 infected adults.
Slovenian: Učinkovitost in varnost prehoda s PI, okrepljenega z ritonavirjem, v kombinaciji z dvema NRTI, na zdravilo Eviplera z režimom odmerjanja z eno samo tableto, so ocenili v randomizirani, odprti študiji pri odraslih z virološko supresijo, okuženih z virusom HIV-1.
English: Among those patients who developed resistance to rilpivirine, 4/7 patients with baseline viral load ≤ 100,000 copies/mL and 28/30 patients with baseline viral load > 100,000 copies/mL had cross-resistance to other NNRTIs.
Slovenian: Med bolniki, pri katerih se je razvila rezistenca na rilpivirin, je imelo 4/7 bolnikov z začetno virusno obremenitvijo ≤ 100.000 kopij/ml in 28/30 bolnikov z začetno virusno obremenitvijo > 100.000 kopij/ml navzkrižno rezistenco na druge NNRTI.
English: H2-antagonists can only be taken once a day if you take Eviplera.
Slovenian: Antagoniste H2 lahko vzamete le enkrat dnevno, če jemljete zdravilo Eviplera.
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: Rilpivirin je dokazal tudi protiretrovirusno aktivnost proti velikemu naboru primarnih izolatov virusa HIV-1 skupine M (podtip A, B, C, D, F, G, H) z vrednostmi EC50 v razponu od 0,07 do 1,01 nM (0,03 do 0,37 ng/ml) in primarnih izolatov skupine O z vrednostmi EC50 v razponu od 2,88 do 8,45 nM (1,06 do 3,10 ng/ml).
English: The most commonly observed resistanceassociated mutations that emerged included L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C and M230I.
Slovenian: Najpogosteje opažene mutacije, povezane z rezistenco, ki so se pojavile, so vključevale L100I, K101E, V108I, E138K, V179F, Y181C, H221Y, F227C in M230I.
English: 7 This adverse reaction was identified through post-marketing surveillance for Eviplera (fixed-dose combination) but not observed in randomised controlled clinical studies for Eviplera.
Slovenian: 7 Ta neželeni učinek je bil opredeljen v okviru nadzora v obdobju trženja zdravila Eviplera (fiksna kombinacija odmerkov), niso pa gazabeležili v randomiziranih kontroliranih kliničnih študijah zdravila Eviplera.
English: The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose adjustment is required in these patients.
Slovenian: Farmakokinetične lastnosti tenofovirja so proučevali pri bolnikih z jetrno okvaro in ugotovili, da pri teh bolnikih prilagoditev odmerka ni potrebna.
English: 6 This was a rare adverse reaction for tenofovir disoproxil.
Slovenian: 6 To je bil redek neželeni učinek dizoproksiltenofovirata.
English: Then take the next dose as usual.
Slovenian: Nato vzemite naslednji odmerek z obrokom ob vašem običajnem času.
English: There were 7/317 patients (2%) in the Eviplera arm and 6/152 patients (4%) in the Delayed Switch arm who permanently discontinued study drug due to a treatment-emergent adverse event (TEAE).
Slovenian: V kraku z zdravilom Eviplera je bilo 7/317 bolnikov (2 %) in v kraku s kasnejšim prehodom 6/152 bolnikov (4 %), ki so se trajno prenehali zdraviti s študijskim zdravilom zaradi neželenega učinka, ki se je pojavil med zdravljenjem.
English: Eviplera is a purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and plain on the other side.
Slovenian: Zdravilo Eviplera so vijolično-rožnate filmsko obložene tablete v obliki kapsule z vtisnjeno besedo “GSI” na eni strani in prazne na drugi strani.
English:  If any of the side effects get serious tell your doctor.
Slovenian:  Če postane kateri koli od teh neželenih učinkov resen, obvestite zdravnika.
English: Co-administration of tenofovir disoproxil and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosinerelated adverse reactions.
Slovenian: Sočasna uporaba dizoproksiltenofovirata in didanozina povzroča povečanje sistemske izpostavljenosti didanozinu za 40-60 %, kar lahko poveča tveganje pojava neželenih učinkov, povezanih z didanozinom.
English: • Feeling weak
Slovenian: • občutek oslabelosti
English: • Tiredness, feeling sleepy (somnolence)
Slovenian: • utrujenost, zaspanost (somnolenca)
English: The bioequivalence of one Eviplera film-coated tablet with one emtricitabine 200 mg hard capsule, one rilpivirine (as hydrochloride) 25 mg film-coated tablet and one tenofovir disoproxil 245 mg film-coated tablet was established following single dose administration to fed, healthy subjects.
Slovenian: Bioekvivalenca ene Eviplera filmsko obložene tablete z eno 200 mg trdo kapsulo emtricitabina, eno 25 mg filmsko obloženo tableto rilpivirina (v obliki klorida) in eno 245 mg filmsko obloženo tableto dizoproksiltenofovira je bila ugotovljena po zaužitju enkratnega odmerka pri zdravih osebah po hrani.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)3, 5, 8, myopathy3, 5 Renal and urinary disorders Uncommon:
Slovenian: osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom)3, 5, 8, miopatija3, 5
English: • Tiredness or drowsiness
Slovenian: • utrujenost ali omotica
English: In virologically suppressed HIV-1 infected patients In study GS-US-264-0106, 4 of the 469 patients who switched from a ritonavir-PI-based regimen to Eviplera had HIV-1 with reduced susceptibility to at least one component of Eviplera through week 48.
Slovenian: V študiji GS-US-264-0106 so 4 od 469 bolnikov, ki so prešli z režima zdravljenja na podlagi PI z ritonavirjem na zdravilo Eviplera, imeli HIV-1 z zmanjšano občutljivostjo na vsaj eno od učinkovin zdravila Eviplera do konca 48. tedna.
English: The K65R and also the K70E substitution result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Slovenian: Zaradi substitucije K65R in tudi K70E se občutljivost na abakavir, didanozin, lamivudin, emtricitabin in tenofovir zmanjša, medtem ko se občutljivost na zidovudin ohrani.
English: At week 96 the mean changes in CD4+ cell count from baseline were +226 x 106 cells/L and +222 x 106 cells/L for the rilpivirine and efavirenz treatment arms, respectively, of patients receiving the emtricitabine/tenofovir disoproxil background regimen.
Slovenian: V 96. tednu so bile srednje spremembe števila celic CD4+ od začetka študije +226 × 106 celic/l za skupino zdravljenja z rilpivirinom in +222 × 106 celic/l za skupino zdravljenja z efavirenzom, za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofoviratom.
English: In combination studies of tenofovir with NRTIs (abacavir, didanosine, emtricitabine, lamivudine, stavudine, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, indinavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed.
Slovenian: V študijah kombinacij tenofovira z NRTI-ji (abakavir, didanozin, emtricitabin, lamivudin, stavudin in zidovudin), NNRTI-ji (delavirdin, efavirenz, nevirapin in rilpivirin) in PI-ji (amprenavir, indinavir, nelfinavir, ritonavir in sakvinavir) so opazili aditivne do sinergistične učinke.
English: If you vomit more than 4 hours after taking Eviplera you do not need to take another tablet until your next regularly scheduled tablet.
Slovenian: Če bruhate več kot 4 ure po zaužitju zdravila Eviplera, vam ni treba vzeti še ene tablete, dokler ni čas za naslednjo tableto po vašem režimu jemanja.
English: Hypromellose, indigo carmine aluminium lake, lactose monohydrate, polyethylene glycol, red iron oxide, sunset yellow aluminium lake (E110), titanium dioxide, and triacetin.
Slovenian: Filmska obloga: hipromeloza, barvilo indigotin, laktoza monohidrat, polietilen glikol, rdeč železov oksid, barvilo sončno rumeno FCF (E110), titanov dioksid in triacetin.
English: Genotypic resistance testing and/or historical resistance data should guide the use of Eviplera (see sections 4.4 and 5.1).
Slovenian: Testiranje genotipske rezistence in/ali podatki o rezistenci v anamnezi morajo biti vodilo pri uporabi zdravila Eviplera (glejte poglavji 4.4 in 5.1).
English: In combination studies of emtricitabine with NRTIs (abacavir, didanosine, lamivudine, stavudine, tenofovir, and zidovudine), NNRTIs (delavirdine, efavirenz, nevirapine, and rilpivirine), and PIs (amprenavir, nelfinavir, ritonavir, and saquinavir), additive to synergistic effects were observed.
Slovenian: V študijah kombinacij emtricitabina z NRTI-ji (abakavir, didanozin, lamivudin, stavudin, tenofovir in zidovudin), NNRTI-ji (delavirdin, efavirenz, nevirapin in rilpivirin) ter PI-ji (amprenavir, nelfinavir, ritonavir in sakvinavir), so opazili aditivne do sinergistične učinke.
English: Eviplera 200 mg/25 mg/245 mg film-coated tablets emtricitabine/rilpivirine/tenofovir disoproxil
Slovenian: Eviplera 200 mg/25 mg/245 mg filmsko obložene tablete emtricitabin/rilpivirin/dizoproksiltenofovirat
English: How to take Eviplera
Slovenian: Kako jemati zdravilo Eviplera
English: Breast-feeding should be discontinued during treatment with Eviplera.
Slovenian: Med zdravljenjem z zdravilom Eviplera je treba dojenje prekiniti.
English: A strict dosing schedule with intake of the H2-receptor antagonists at least 12 hours before or at least 4 hours after Eviplera should be used.
Slovenian: Pri jemanju antagonistov receptorjev H2 je treba upoštevati dosleden načrt odmerjanja vsaj 12 ur pred uporabo zdravila Eviplera ali vsaj 4 ure po njej.
English: By baseline CD4+ cell count (x 106 cells/L)
Slovenian: Glede na začetno število celic CD4+ (x 106 celic/l)
English: A subgroup analysis of the virologic response (< 50 HIV-1 RNA copies/mL) at both 48 weeks and 96 weeks, and virologic failure by baseline viral load (pooled data from the two Phase III clinical studies, C209 and C215, for patients receiving the emtricitabine/tenofovir disoproxil background regimen) is presented in Table 5.
Slovenian: Analiza podskupine virološkega odziva (< 50 HIV-1 RNA kopij/ml) tako v 48. tednu kot tudi v 96. tednu in virološkega neuspeha glede na začetno vrednost virusne obremenitve (združeni podatki iz dveh kliničnih študij faze III, C209 in C215, za bolnike, ki so prejemali osnovno shemo zdravljenja z emtricitabinom/dizoproksiltenofoviratom) so predstavljeni v preglednici 5.