natgillin/translations-raw huggingface dataset:
HIV-1 RNA < 50 copies/mL
HIV-1 RNA < 50 kopij/ml
No mother to child transmission occurred in all 10 infants born to the mothers who completed the study and for whom the HIV status was available.
Pri nobenem od 10 novorojencev, ki so se rodili materam, ki so zaključile študijo in pri katerih je bil na voljo podatek glede HIV statusa, ni prišlo do prenosa z matere na otroka.
The film-coated tablet should not be chewed, crushed or split as it may impact the absorption of Eviplera.
Filmsko obložene tablete ni dovoljeno žvečiti, zdrobiti ali razpoloviti, saj lahko to vpliva na absorpcijo zdravila Eviplera.
If you forget to take Eviplera
Če ste pozabili vzeti zdravilo Eviplera
• If you notice within 12 hours of the time you usually take Eviplera, you must take the tablet as soon as possible.
• Če opazite v roku 12 ur od časa, ko zdravilo Eviplera običajno vzamete, morate tableto vzeti čim prej.
What you need to know before you take Eviplera Do not take Eviplera
Kaj morate vedeti, preden boste vzeli zdravilo Eviplera Ne jemljite zdravila Eviplera
Study GS-US-264-0111
Študija GS-US-264-0111
proximal renal tubulopathy including Fanconi syndrome3, increased creatinine3, proteinuria3
proksimalna ledvična tubulopatija, vključujoč Fanconijev sindrom3, povišan kreatinin3, proteinurija3
A subgroup of patients with baseline CrCl between 50 and 60 mL/min, receiving once daily dosing, had a 2- to 4-fold increase in tenofovir exposure and worsening renal function.
Podskupina bolnikov z začetno vrednostjo CrCl med 50 in 60 ml/min, ki so ji zdravilo odmerjali enkrat dnevno, je imela 2 do 4-kratno povečanje izpostavljenosti tenofovirju in poslabšanje delovanja ledvic.
Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Zdravila Eviplera niso ovrednotili pri bolnikih s predhodnim virološkim neuspehom na drugo protiretrovirusno zdravljenje.
If you have hepatitis B infection, liver problems may become worse after you stop taking Eviplera.
Če imate okužbo s hepatitisom B, se lahko težave z jetri poslabšajo, ko prenehate jemati zdravilo Eviplera.
renal failure (acute and chronic)3, acute tubular necrosis3, nephritis (including acute interstitial nephritis)3, 8, nephrogenic diabetes insipidus3
ledvična odpoved (akutna in kronična)3, akutna tubularna nekroza3, nefritis (vključno z akutnim intersticijskim nefritisom)3, 8, nefrogeni insipidusni diabetes3
In study C209 (n = 690), the BR was emtricitabine/tenofovir disoproxil.
V študiji C209 (n = 690), je bil BR emtricitabin/dizoproksiltenofovirat.
Of the 26 patients without data available in the week 48 window, 7 patients discontinued due to adverse event (AE) or death, 16 patients discontinued for other reasons, and 3 patients were missing data but remained on study drug.
Med 26 bolniki, ki v oknu 48. tedna niso imeli razpoložljivih podatkov, se je 7 bolnikov prenehalo zdraviti zaradi neželenega učinka ali smrti, 16 bolnikov se je prenehalo zdraviti zaradi drugih razlogov, pri 3 bolnikih pa ni bilo podatkov, vendar so se še naprej zdravili s študijskim zdravilom.
Following intravenous administration the volume of distribution of the single components emtricitabine and tenofovir was approximately 1,400 mL/kg and 800 mL/kg, respectively.
Po intravenskem odmerku je volumen porazdelitve posameznih sestavin emtricitabina znašal približno 1,400 ml/kg in volumen porazdelitve tenofovirja približno 800 ml/kg.
 If you notice any symptoms of inflammation or infection, tell your doctor immediately.
 Če opazite kakršne koli simptome vnetja ali okužbe, takoj obvestite zdravnika.
Take the rilpivirine tablet at the same time you take Eviplera.
Tableto rilpivirina vzemite sočasno z zdravilom Eviplera.
In vitro binding of emtricitabine to human plasma proteins was < 4% and independent of concentration over the range of 0.02 to 200 µg/mL.
In vitro je bila vezava emtricitabina na humane plazemske proteine manj kot < 4 % in je neodvisna od koncentracije v razponu med 0,02 in 200 µg/ml.
Other medicines and Eviplera Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Following oral administration of tenofovir disoproxil to HIV infected patients, tenofovir disoproxil is rapidly absorbed and converted to tenofovir.
Po peroralnem dajanju dizoproksiltenofovirata bolnikom, okuženim z virusom HIV, se dizoproksiltenofovirat hitro absorbira in pretvori v tenofovir.
Rilpivirine hydrochloride is primarily metabolised and eliminated by the liver.
Rilpivirinijev klorid se pretežno presnavlja in izloča z jetri.
In patients with severe renal impairment or ESRD, plasma concentrations may be increased due to alteration of drug absorption, distribution and/or metabolism secondary to renal dysfunction.
Pri bolnikih s hudo ledvično okvaro ali z ESRD so lahko koncentracije v plazmi povišane zaradi spremenjene absorpcije, porazdelitve in/ali presnove zdravila kot posledica ledvične disfunkcije.
(≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000).
Pogostnost je definirana kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki neželeni učinki (≥ 1/10.000 do < 1/1.000).
Eviplera comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Zdravilo Eviplera je na voljo v plastenkah po 30 tablet in v pakiranjih s po 3 plastenkami, od katerih vsaka vsebuje 30 tablet.
Findings in repeated dose toxicity studies in rats, dogs and monkeys at exposure levels greater than or equal to clinical exposure levels and with possible relevance to clinical use included kidney and bone changes and a decrease in serum phosphate concentration.
Izsledki iz študij toksičnosti pri ponavljajočih odmerkih pri podganah, psih in opicah pri stopnjah izpostavljenosti, ki so bile večje ali enake stopnjam klinične izpostavljenosti, in ki so morda pomembne za klinično uporabo, vključujejo spremembe ledvic in kosti in zmanjšanje koncentracije serumskega fosfata.
In faeces, unchanged rilpivirine accounted for on average 25% of the administered dose.
V blatu je bil delež nespremenjenega rilpivirina povprečno 25 % danega odmerka.
Interactions between Eviplera or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”).
Interakcije med zdravilom Eviplera ali njegovo(-imi) posamično(-imi) učinkovino(-ami) sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom “↑”, zmanjšanje z “↓” in brez spremembe z “↔”).
If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly (see sections 4.5 and 4.8).
Če je sočasna uporaba zdravila Eviplera in nefrotoksičnega zdravila neizogibna, je treba tedensko nadzorovati ledvično funkcijo (glejte poglavji 4.5 in 4.8).
The remaining 3 Eviplera-treated patients did not have emergent resistance.
Preostali 3 bolniki, zdravljeni z zdravilom Eviplera, niso imeli rezistence, nastale med zdravljenjem.
c Includes patients who had HIV-1 RNA ≥ 50 copies/mL in the week 24 window, patients who discontinued early due to lack or loss of efficacy, patients who discontinued for reasons other than an adverse event (AE) or death, and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
c Vključuje bolnike, ki so imeli v oknu 24. tedna HIV-1 RNA ≥ 50 kopij/ml, bolnike, ki so predčasno prekinili sodelovanje zaradi pomanjkanja ali izgube učinka, bolnike, ki so sodelovanje prekinili zaradi drugih razlogov, kot so neželeni učinki, smrt ali pomanjkanje oz. izguba učinka, in so imeli v času prekinitve virološko vrednost ≥ 50 kopij/ml.
Patients were randomised in a 1:1 ratio to receive either rilpivirine hydrochloride 25 mg (n = 686) once daily or efavirenz 600 mg (n = 682) once daily in addition to a BR.
Bolniki so bili randomizirani v razmerju 1:1 za prejemanje bodisi rilpivirinijevega klorida 25 mg (n = 686) enkrat dnevno ali efavirenza 600 mg (n = 682) enkrat dnevno kot dodatek k BR.
Rilpivirine does not inhibit the human cellular DNA polymerases α, β and mitochondrial DNA polymerase γ.
Rilpivirin ne zavira humanih celičnih DNA polimeraz α, β in mitohondrijske DNA polimeraze γ.
In a panel of 67 HIV-1 recombinant laboratory strains with one resistance-associated mutation at RT positions associated with NNRTI resistance, including the most commonly found K103N and Y181C, rilpivirine showed antiviral activity against 64 (96%) of these strains.
V naboru 67 rekombinantnih laboratorijskih sevov virusa HIV-1 z eno mutacijo, povezano z rezistenco, na položajih RT, povezanih z rezistenco na NNRTI, vključno z najpogosteje najdenima K103N in Y181C, je rilpivirin pokazal protiretrovirusno aktivnost proti 64 (96 %) teh sevov.
Since Eviplera is a combination product and the dosing interval of the individual components cannot be altered, treatment with Eviplera must be interrupted in patients with confirmed CrCl decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Ker je zdravilo Eviplera kombinirano zdravilo in intervala odmerjanja posameznih sestavin ni mogoče spreminjati, je treba zdravljenje z zdravilom Eviplera pri bolnikih s potrjenim zmanjšanjem CrCl na < 50 ml/min ali zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) prekiniti.
Some patients taking combination antiretroviral medicines such as Eviplera may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Pri nekaterih bolnikih, ki jemljejo kombinirana protiretrovirusna zdravila, kot je zdravilo Eviplera, se lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva kot posledica pomanjkanja oskrbe kosti s krvjo).
• aminoglycosides (such as streptomycin, neomycin and gentamicin), vancomycin (for bacterial infections)
• aminoglikozidi (kot so streptomicin, neomicin in gentamicin), vankomicin (za bakterijske okužbe)
Following oral administration of Eviplera with food emtricitabine is rapidly and extensively absorbed with maximum plasma concentrations occurring within 2.5 hours post-dose.
Po peroralnem vnosu zdravila Eviplera s hrano se emtricitabin hitro in znatno absorbira, pri čemer so koncentracije v plazmi najvišje 2,5 ure po odmerku.
As soon as serious skin and/or mucosal reactions are observed, Eviplera must be discontinued and appropriate therapy should be initiated.
Takoj po pojavu resnih kožnih in/ali sluzničnih reakcij je treba zdravljenje z zdravilom Eviplera prekiniti in uvesti ustrezno zdravljenje.
There were also reclassifications in the week 48 primary analysis with the most common being reclassification from virologic failure to discontinued for non-AE reasons.
Pri primarni analizi v 48. tednu je prišlo tudi do prerazvrstitve, pri čemer je bila najpogostejša prerazvrstitev iz skupine virološkega neuspeha v skupino prekinitev, ne zaradi AE.
There were no new safety findings compared with the known safety profile of rilpivirine in HIV-1 infected adults (see sections 4.2, 4.4 and 5.2).
V primerjavi z znanim varnostnim profilom rilpivirina pri odraslih, okuženih s HIV-1, ni bilo nobenih novih varnostnih ugotovitev (glejte poglavja 4.2, 4.4 and 5.2).
Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced BMD (rats and dogs).
Toksičen vpliv na kosti je bil diagnosticiran kot osteomalacija (pri opicah) in kot zmanjšana mineralna gostota kosti (podgane in psi).
• Inflammation of the kidney, passing a lot of urine and feeling thirsty
• vnetje ledvic, izločanje večjih količin urina in občutek žeje
There are a 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).
Podatki o uporabi rilpivirina pri nosečnicah so omejeni (manj kot 300 izidov nosečnosti) (glejte poglavja 4.4, 5.1 in 5.2).
At week 48, 94% (46/49) of patients remained suppressed, and 4% (2/49) were considered virologic failures (HIV-1 RNA ≥ 50 copies/mL).
V 48. tednu je supresijo ohranilo 94 % (46/49) bolnikov, 4 % (2/49) pa so bili obravnavani kot virološki neuspeh (HIV-1 RNA ≥ 50 kopij/ml).
Rilpivirine is a diarylpyrimidine NNRTI of HIV-1.
Rilpivirin je diarilpirimidin NNRTI HIV-1.
b Snapshot analysis.
b Analiza posnetka stanja.
One patient (2%) did not have data available in the week 48 window; study drug was discontinued due to a protocol violation (i.e. reason other than AE or death) and the last available HIV-1 RNA was < 50 copies/mL.
Za enega bolnika (2 %) v oknu 48. tedna ni bilo na voljo podatkov; študijsko zdravilo so ukinili zaradi kršitve protokola (tj. drugi razlogi, kot so neželeni učinki ali smrt) in nazadnja razpoložljiva vrednost HIV-1 RNA je bila < 50 kopij/ml.
Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (IC50 is 9.2 µM).
Rilpivirin in vitro zavira P-glikoprotein (P-gp) (IC50 je 9,2 µM).
Eviplera contains lactose monohydrate.
Zdravilo Eviplera vsebuje laktozo monohidrat.
• Abnormal dreams, sleep disorders
• nenavadne sanje, motnje spanja
Although rilpivirine demonstrated limited in vitro activity against HIV-2 with EC50 values ranging from 2,510 to 10,830 nM (920 to 3,970 ng/mL), treatment of HIV-2 infection with rilpivirine hydrochloride is not recommended in the absence of clinical data.
Čeprav je rilpivirin in vitro pokazal omejeno aktivnost proti virusu HIV-2 z vrednostmi EC50 od 2.510 do 10.830 nM (920 do 3,970 ng/ml), se zdravljenje okužbe z virusom HIV-2 z rilpivirinijevim kloridom v odsotnosti kliničnih podatkov ne priporoča.
If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or CrCl is decreased to < 50 mL/min in any patient receiving Eviplera, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se CrCl zmanjša na < 50 ml/min je pri vsakem bolniku, ki prejema zdravilo Eviplera, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
It is not known whether placental transfer of rilpivirine occurs in pregnant women.
Ni znano, ali pri nosečnicah poteka prehod rilpivirina skozi placento.
Animal studies do not indicate harmful effects of emtricitabine, rilpivirine hydrochloride or tenofovir disoproxil on fertility.
Študije na živalih ne kažejo škodljivih učinkov emtricitabina, rilpivirinijevega klorida ali dizoproksiltenofovirata na plodnost.
Eviplera should be initiated by a physician experienced in the management of HIV infection.
Zdravljenje z zdravilom Eviplera mora začeti zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV.
As rilpivirine is highly bound to plasma proteins, it is unlikely that it will be significantly removed by haemodialysis or peritoneal dialysis (see section 4.9).
Ker se rilpivirin močno veže na plazemske proteine, je malo verjetno, da ga bo hemodializa ali peritonealna dializa pomembno odstranila (glejte poglavje 4.9).
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformative nor foetal/neonatal toxicity associated with emtricitabine and tenofovir disoproxil.
Večje število podatkov pri nosečnicah (več kot 1000 izidov nosečnosti) je pokazalo, da uporaba emtricitabina in dizoproksiltenofovirata ni povzročila nobenih malformacij ali toksičnosti za plod/novorojenčka.
Renal function should be closely monitored (see section 4.4).
Delovanje ledvic je treba natančno spremljati (glejte poglavje 4.4).
After single dose oral administration of [14C]-rilpivirine, on average 85% and 6.1% of the radioactivity could be retrieved in faeces and urine, respectively.
Po enojnem peroralnem odmerku [14C-]rilpivirina se je povprečno 85 % radioaktivnosti izločilo v blatu in 6,1 % v urinu.
In a clinical study rilpivirine did not significantly affect the pharmacokinetics of digoxin.
V klinični študiji rilpivirin ni pomembno vplival na farmakokinetiko digoksina.
rhabdomyolysis3, 5, muscular weakness3, 5
rabdomioliza3, 5, mišična oslabelost3, 5
• If you notice after 12 hours or more of the time you usually take Eviplera, then do not take the missed dose.
• Če opazite po 12 urah ali več od časa, ko običajno vzamete zdravilo Eviplera, pozabljenega odmerka ne vzemite.
• Signs or symptoms of inflammation or infection
• znaki ali simptomi vnetja ali okužbe
Patients co-infected with HIV and HBV who discontinue Eviplera should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolnike s hkratno HIV in HBV okužbo, ki prekinejo zdravljenje z zdravilom Eviplera, je potrebno pozorneje opazovati in opravljati potrebne klinične in laboratorijske teste še vsaj nekaj mesecev po prenehanju zdravljenja.
A risk for increases in dabigatran plasma concentrations cannot be excluded (inhibition of intestinal P-gp.
Tveganja za povečanje koncentracij dabigatrana v plazmi ni mogoče izključiti (zaviranje črevesnega P-gp).
The Cmax and AUC for tenofovir increased by 12% and 28% (light meal) and 32% and 38% (standard meal), respectively.
Cmax tenofovirja se je povečal za 12 % in AUC za 28 % (lahek obrok) oz. za 32 % in 38 % (standardni obrok).
In vitro binding of tenofovir to plasma or serum protein was less than 0.7% and 7.2%, respectively, over the tenofovir concentration range 0.01 to 25 µg/mL.
In vitro vezava tenofovirja na plazemske proteine je bila manjša od 0,7 % oziroma na serumske proteine manjša od 7,2 % v koncentracijskem območju tenofovirja od 0,01 do 25 µg/ml.
After taking rilpivirine 25 mg once daily as part of an antiretroviral regimen, the total exposure of rilpivirine was lower during pregnancy (similar for the 2nd and 3rd trimester) compared with postpartum.
Po jemanju rilpivirina 25 mg enkrat dnevno kot del protiretrovirusnega režima je bila skupna izpostavljenost rilpivirinu v nosečnosti (podobna v 2. in 3. trimesečju) nižja v primerjavi s poporodnim obdobjem.
Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected patients with varying degrees of renal impairment.
Farmakokinetične parametre so v glavnem določili po vzetju enkratnih odmerkov 200 mg emtricitabina ali 245 mg dizoproksiltenofovirata pri bolnikih, ki niso bili okuženi s HIV, z različnimi stopnjami ledvične okvare.
The Cmax and AUC of rilpivirine increased by 34% and 9% (light meal) and 26% and 16% (standard meal), respectively.
Cmax rilpivirina se je povečal za 34 % in AUC za 9 % (lahek obrok) oz. za 26 % in 16 % (standardni obrok).
After week 24, the HIV-1 from 2 additional patients in the Eviplera arm developed resistance by week 48 (total of 4 of 469 patients, 0.9%).
Po 24. tednu se je pri HIV-1 pri 2 dodatnih bolnikih v kraku z zdravilom Eviplera razvila rezistenca do 48. tedna (skupaj 4 od 469 bolnikov, 0,9 %).
Rilpivirine (taken as Eviplera in 16 of 19 patients and another background regimen in 3 of 19 patients) was evaluated in study TMC114HIV3015 in pregnant women during the 2nd and 3rd trimesters, and postpartum.
Rilpivirin (v obliki zdravila Eviplera pri 16 od 19 bolnikov in druge osnovne sheme zdravljenja pri 3 od 19 bolnikov) je bil ocenjen v študiji TMC114HIV3015 pri nosečnicah med 2. in 3. trimesečjem in po porodu.
These symptoms resolved after Eviplera was discontinued.
Ti simptomi so po prekinitvi jemanja zdravila Eviplera izzveneli.
The pharmacokinetics of rilpivirine and tenofovir disoproxil in children and adolescents are under investigation.
Farmakokinetika rilpivirina in dizoproksiltenofovirata pri otrocih in mladostnikih se preučuje.
The mean baseline CD4 cell count was 584 x 106 cells/L (range 42-1,484).
Povprečno število celic CD4 na začetku je bilo 584 x 106 celic/l (razpon 42-1.484).
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Ker se rilpivirin močno veže na beljakovine, ni verjetno, da bi dializa značilno odstranila učinkovino.
Each film-coated tablet contains 277 mg lactose monohydrate and 4 micrograms sunset yellow aluminium lake (E110).
Vsaka filmsko obložena tableta vsebuje 277 mg laktoze monohidrata in 4 mikrograme barvila sončno rumeno FCF (E110).
There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the electrocardiogram.
Podatki o možnem farmakodinamičnem medsebojnem delovanju med rilpivirinom in zdravili, ki podaljšujejo interval QTc na elektrokardiogramu, je malo.
Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLe
Prekinitev uporabe študijskega zdravila zaradi drugih razlogov in nazadnje razpoložljivi HIV-1 RNA < 50 kopij/mle
• antacids (aluminium/magnesium hydroxide or calcium carbonate)
• antacidi (aluminijev/magnezijev hidroksid ali kalcijev karbonat)
Randomisation was stratified by use of tenofovir disoproxil and/or lopinavir/ritonavir in the baseline regimen.
Randomizacija je bila stratificirana z uporabo dizoproksiltenofovirata in/ali lopinavirja/ritonavirja v začetnem režimu.
Among 49 patients who received at least one dose of Eviplera, 100% of patients remained suppressed (HIV-1 RNA < 50 copies/mL) at week 12 and week 24.
ki so prejeli vsaj en odmerek zdravila Eviplera, je 100 % bolnikov ohranilo supresijo (HIV-1 RNA < 50 kopij/ml) v 12. tednu in v 24. tednu.
4 The predominant circulating metabolite of sofosbuvir.
4 Prevladujoči presnovek sofosbuvirja v obtoku.
As a result, the amounts of Eviplera or other medicines in your blood may be affected.
To lahko posledično vpliva na količino zdravila Eviplera ali drugih zdravil v vaši krvi.
Overall response (HIV-1 RNA < 50 copies/mL (TLOVRa))b
Celokupni odziv (HIV-1 RNA < 50 kopij/ml (TLOVRa))b
What Eviplera is and what it is used for What you need to know before you take Eviplera How to take Eviplera
Kaj je zdravilo Eviplera in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Eviplera Kako jemati zdravilo Eviplera Možni neželeni učinki
It is important not to miss a dose of Eviplera.
Pomembno je, da ne pozabite vzeti nobenega odmerka zdravila Eviplera.
Switching to Eviplera was non-inferior in maintaining HIV-1 RNA < 50 copies/mL when compared to patients who stayed on a ritonavir-boosted PI in combination with two NRTIs [treatment difference (95% CI): + 3.8% (-1.6% to 9.1%)].
Prehod na zdravilo Eviplera ni bil slabši pri ohranjanju HIV-1 RNA < 50 kopij/ml v primerjavi z bolniki, ki so ostali na zdravljenju s PI, okrepljenim z ritonavirjem, v kombinaciji z dvema NRTI [razlika zdravljenja (95-% IZ): + 3,8 % (−1,6 % do 9,1 %)].
• Other allergic reactions, such as wheezing, swelling or feeling light-headed
• druge alergijske reakcije, kot so piskanje, otekanje ali omotičnost
Nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs/N[t]RTIs) Didanosine/Emtricitabine
Nukleozidni ali nukleotidni zaviralci reverzne transkriptaze (NRTI/N[t]RTI) didanozin/emtricitabin
As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).
Ker lahko zdravilo Eviplera povzroči ledvično poškodbo, se priporoča nadziranje ledvične funkcije (glejte poglavji 4.4 in 4.8 Povzetek varnostnega profila).
• Anaemia (low red blood cell count)
• anemija (nizko število rdečih krvnih telesc)
The median change in CD4+ cell count at week 48 was +17 x 106 cells/L, in the on-treatment analysis.
Mediana sprememba v številu celic CD4 v 48. tednu je bila +17 x 106 celic/l v analizi med zdravljenjem.
Resistance to rilpivirine2 Cross-resistance3 to etravirine efavirenz nevirapine
Rezistenca na rilpivirin1 Navzkrižna rezistenca2 na etravirin efavirenz nevirapin
• Medicines for stomach ulcers, heartburn or acid reflux such as:
• Zdravila za zdravljenje razjed, zgage ali refluksa kisline, kot so: