FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients at risk of renal impairment (such as patients with baseline renal risk factors, advanced HIV disease, or patients receiving concomitant nephrotoxic medications) are at increased risk of experiencing incomplete recovery of renal function despite tenofovir disoproxil discontinuation (see section 4.4).
Croatian: Bolesnici s rizikom od oštećenja bubrega (kao što su bolesnici s početnim bubrežnim čimbenicima rizika, uznapredovalom HIV bolešću ili bolesnici koji istovremeno primaju nefrotoksične lijekove) pod povećanim su rizikom od nepotpunog oporavka funkcije bubrega usprkos prekidu terapije tenofovirdizoproksilom (vidjeti dio 4.4).
English: In a 144-week controlled clinical study that compared tenofovir disoproxil with stavudine in combination with lamivudine and efavirenz in antiretroviral-naïve patients, small decreases in BMD of the hip and spine were observed in both treatment groups.
Croatian: U kontroliranom kliničkom ispitivanju koje je trajalo 144 tjedna i u kojemu je uspoređivan tenofovirdizoproksil sa stavudinom u kombinaciji s lamivudinom i efavirenzom u bolesnika koji prethodno nisu bili liječeni antiretrovirusnim lijekovima, u obje ispitne skupine primijećena su mala sniženja BMD-a kuka i kralježnice.
English: 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.
Croatian: Jedan bolesnik (2%) nije imao dostupne podatke u razdoblju 48. tjedna; prekinuto je davanje ispitivanog lijeka zbog kršenja protokola (tj. razlog prekida nije bio štetni događaj ili smrt), a posljednji je dostupni uzorak sadržavao HIV-1 RNK < 50 kopija/ml.
English: Rifapentine2
Croatian: Rifapentin2
English: Genotoxicity and repeated dose toxicity studies of one month or less with the combination of emtricitabine and tenofovir disproxil found no exacerbation of toxicological effects compared to studies with the separate components.
Croatian: Ispitivanjima genotoksičnosti i toksičnosti ponovljenih doza u trajanju od jednog mjeseca ili manje s kombinacijom emtricitabina i tenofovirdizproksila nije se našla egzacerbacija toksikoloških učinaka u usporedbi s ispitivanjima tih komponenti zasebno.
English: • products that contain St. John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
Croatian: • pripravci koji sadrže gospinu travu (Hypericum perforatum) (biljni lijek koji se primjenjuje kod depresije i tjeskobe)
English: If concomitant use of Eviplera and nephrotoxic agents is unavoidable, renal function must be monitored weekly (see sections 4.5 and 4.8).
Croatian: Ako se istovremena primjena lijeka Eviplera i nefrotoksičnog lijeka ne može izbjeći, funkcija bubrega mora se provjeravati svakog tjedna (vidjeti dijelove 4.5 i 4.8).
English: In patients with BL VL1 > 100,000 copies/mL (n = 44)
Croatian: U bolesnika s BL VL1 > 100 000 kopija/ml (n = 44)
English: 6 This was a rare adverse reaction for tenofovir disoproxil.
Croatian: 6 Ovo je bila rijetka nuspojava tenofovirdizoproksila.
English: Rilpivirine exhibited activity against laboratory strains of wild-type HIV-1 in an acutely infected T-cell line with a median EC50 value for HIV-1/IIIB of 0.73 nM (0.27 ng/mL).
Croatian: Rilpivirin je pokazao djelovanje protiv laboratorijskih sojeva divljeg tipa HIV-1 u akutno zaraženoj liniji T-stanica uz medijan EC50 za HIV-1/IIIB od 0,73 nM (0,27 ng/ml).
English: • Tiredness, feeling sleepy (somnolence)
Croatian: • umor, osjećaj pospanosti (somnolencija)
English: 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.
Croatian: c Obuhvaća bolesnike koji su imali HIV-1 RNK ≥ 50 kopija/ml u okviru 24-tjedna, bolesnici s ranim prekidom zbog nedostatka ili gubitka djelotvornosti, bolesnici koji su prekinuli iz razloga koji nisu posljedica nuspojave ili smrt te su u vrijeme prekida imali vrijednost virusnu vrijednost ≥ 50 kopija/ml.
English: The oral bioavailability of tenofovir from tenofovir disoproxil tablets in fasted patients was approximately 25%.
Croatian: Bioraspoloživost tenofovira iz tableta tenofovirdizoproksila nakon peroralne primjene u bolesnika natašte bila je približno 25%.
English: • any other antiviral medicines that contain lamivudine or adefovir dipivoxil
Croatian: • neke druge antiretrovirusne lijekove koji sadrže lamivudin ili adefovirdipivoksil
English: No human data on the effect of Eviplera on fertility are available.
Croatian: Nema dostupnih podataka o učinku lijeka Eviplera na plodnost u ljudi.
English: The Cmax and AUC of rilpivirine increased by 34% and 9% (light meal) and 26% and 16% (standard meal), respectively.
Croatian: Cmax i AUC rilpivirina povećali su se za 34% odnosno 9% (lagani obrok) te za 26% odnosno 16% (standardni obrok).
English: 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.
Croatian: Rilpivirin (koji je kao Evipleru uzimalo 16 od 19 bolesnica te kao drugi osnovni režim koji su uzimale 3 od 19 bolesnica) procijenjen je u ispitivanju TMC114HIV3015 provedenom u trudnica tijekom 2. i 3. tromjesečja i poslije porođaja.
English: Eviplera must be taken with food (see section 5.2).
Croatian: Eviplera se mora uzimati s hranom (vidjeti dio 5.2).
English: The single-tablet regimen (STR), Eviplera, has been studied in virologically suppressed patients who switched from a regimen containing a ritonavir-boosted PI (Phase III study GS-US-264-0106) or from efavirenz/emtricitabine/tenofovir disoproxil (Phase IIb study GS-US-264-0111).
Croatian: Kao režim liječenja jednom tabletom, Eviplera je ispitana u virološki suprimiranih bolesnika prebačenih s režima koji je sadržavao ritonavirom pojačan IP (ispitivanje III. faze GS-US-264-0106) ili s kombinacije efavirenza/emtricitabina/tenofovirdizoproksila (ispitivanje IIb. faze GS-US-264-0111).
English: Do not stop your treatment without contacting your doctor.
Croatian: Nemojte prestati s liječenjem bez prethodnog savjetovanja s liječnikom.
English: In another study, the Y188L substitution resulted in a reduced susceptibility to rilpivirine of 9-fold for clinical isolates and 6-fold for site-directed mutants.
Croatian: U drugom ispitivanju, supstitucija Y188L dovela je do deveterostruko smanjene osjetljivosti kliničkih izolata na rilpivirin i šesterostruko smanjene osjetljivosti izolata s ciljanom (engl. site-directed) mutagenezom.
English: If Eviplera is co-administered with an NSAID, renal function should be monitored adequately.
Croatian: Ako se Eviplera primjenjuje istovremeno s NSAILom, potrebno je provjeravati funkciju bubrega na odgovarajući način.
English: • clarithromycin
Croatian: • klaritromicin
English: Do not stop taking Eviplera Do not stop taking Eviplera without talking to your doctor.
Croatian: Nemojte prestati uzimati Evipleru bez prethodnog razgovora sa svojim liječnikom.
English: As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera.
Croatian: Budući da Eviplera sadrži emtricitabin, rilpivirinklorid i tenofovirdizoproksil, sve interakcije koje su utvrđene za svaku od tih djelatnih tvari zasebno mogu nastati i s lijekom Eviplera.
English: P-glycoprotein substrates
Croatian: Supstrati P-glikoproteina
English: Through week 48, no emergent resistance developed in the 2 patients who failed virologically among patients who switched to Eviplera from efavirenz/emtricitabine/tenofovir disoproxil (0 of 49 patients).
Croatian: Do 48. tjedna, rezistencija na liječenje nije se razvila u 2 bolesnika s virološkim neuspjehom među bolesnicima koji su s efavirenza/emtricitabina/tenofovirdizoproksila bili prebačeni na lijek Eviplera (0 od 49 bolesnika).
English: Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Croatian: Budući da je rilpivirin u visokom postotku vezan za proteine plazme, nije vjerojatno da će dijaliza rezultirati značajnim uklanjanjem te djelatne tvari.
English: If you vomit less than 4 hours after taking Eviplera, take another tablet with food.
Croatian: Ako povraćate kad je prošlo manje od 4 sata od uzimanja Eviplere, uzmite drugu tabletu s hranom.
English: It was also identified as an adverse reaction for emtricitabine through post-marketing surveillance but was not observed in randomised controlled clinical studies in adults or paediatric HIV clinical studies of emtricitabine.
Croatian: Također je bila uvrđena kao nuspojava za emtricitabin tijekom praćenja nakon stavljanja lijeka u promet, no nije zabilježena u randomiziranim kontroliranim kliničkim ispitivanjima emtricitabina u odraslih ili pedijatrijskih bolesnika s HIV-om.
English: Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Croatian: Djelovanje rilpivirina posredovano je nekompetitivnom inhibicijom HIV-1 reverzne transkriptaze (RT).
English: Lower exposures of rilpivirine were observed during pregnancy; therefore viral load should be monitored closely.
Croatian: Tijekom trudnoće su opažene manje izloženosti rilpivirinu; stoga je potrebno pažljivo pratiti virusno opterećenje.
English: • Dizziness, headache
Croatian: • omaglica, glavobolja
English: At week 48, 89% (283/317) of patients randomised to switch to Eviplera at baseline (Eviplera) had HIV-1 RNA < 50 copies/mL, 3% (8/317) were considered virologic failures (HIV RNA ≥ 50 copies/mL), and 8% (26/317) did not have data available in the week 48 window.
Croatian: U 48. tjednu, 89% (283/317) bolesnika randomizirano za prebacivanje na lijek Eviplera na početku (Eviplera) imalo je HIV-1 RNK < 50 kopija/ml, 3% (8/317) smatralo se virološkim neuspjehom (HIV RNK ≥ 50 kopija/ml), dok 8% (26/317) nije imalo dostupne podatke u 48. tjednu.
English: CCR5 antagonists Maraviroc/Emtricitabine
Croatian: Antagonisti CCR5 Maravirok/emtricitabin
English: Viruses harbouring substitutions conferring reduced susceptibility to stavudine and zidovudine-thymidine analogue-associated mutations-TAMs (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E), or didanosine (L74V) remained sensitive to emtricitabine.
Croatian: Virusi sa supstitucijama koje izazivaju smanjenu osjetljivost na stavudin i mutacijama povezanima s analogom timidina (TAM) zidovudinom (M41L, D67N, K70R, L210W, T215Y/F, K219Q/E) ili na didanozin (L74V) ostali su osjetljivi na emtricitabin.
English: Emtricitabine/tenofovir disoproxil + rilpivirine hydrochloride has been shown to be non-inferior in achieving HIV-1 RNA < 50 copies/mL compared to emtricitabine/tenofovir disoproxil + efavirenz.
Croatian: Pokazalo se da emtricitabin/tenofovirdizoproksil + rilpivirinklorid nisu inferiorni u postizanju HIV-1 RNK < 50 kopija/ml u usporedbi s emtricitabinom/tenofovirdizoproksilom + efavirenzom.
English: Purplish-pink, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed on one side with “GSI” and plain on the other side.
Croatian: Ljubičasto-ružičasta filmom obložena tableta u obliku kapsule, veličine 19 mm x 8,5 mm, s utisnutom oznakom „GSI” na jednoj strani i bez oznake na drugoj strani.
English: Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Croatian: Sniženja BMD-a kralježnice i promjene vrijednosti koštanih bioloških biljega u odnosu na početne bila su značajno veća u terapijskoj skupini koja je primala tenofovirdizoproksil u 144. tjednu.
English: depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders
Croatian: depresija2, depresivno raspoloženje2, poremećaji spavanja2, abnormalni snovi1, 2
English: Pantoprazole2
Croatian: Pantoprazol2
English: Patients with a baseline viral load > 100,000 HIV-1 RNA copies/mL who experienced virologic failure exhibited a higher rate of treatment-emergent resistance to the NNRTI class.
Croatian: Bolesnici s početnim virusnim opterećenjem > 100 000 HIV-1 RNK kopija/ml koji su imali virološki neuspjeh pokazali su višu stopu rezistencije koja se pojavila na liječenje skupinom NNRTI-jeva.
English: Eviplera should be used with caution in patients with moderate hepatic impairment (CPT Score B) and is not recommended in patients with severe hepatic impairment (CPT Score C).
Croatian: Eviplera se treba primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetre (CPT stadij B), a ne preporučuje se u bolesnika s teškim oštećenjem jetre (CPT stadij C).
English: • the systemic glucocorticoid dexamethasone, except as a single dose treatment
Croatian: • sistemski glukokortikoid deksametazon, osim kao liječenje jednostrukom dozom
English: Very common: increased transaminases (AST and/or ALT)1, 2, 3 Common:
Croatian: povišene transaminaze (AST i/ili ALT)1, 2, 3
English: Due to similarities with emtricitabine, Eviplera should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.4).
Croatian: Zbog sličnosti s emtricitabinom, Eviplera se ne smije primjenjivati istovremeno s drugim analozima citidina, kao što je lamivudin (vidjeti dio 4.4).
English: One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48.
Croatian: Jedan bolesnik s prisutnom K103N na početku imao je virološki neuspjeh uz dodatnu rezistenciju koja se pojavila na liječenje do 48. tjedna.
English: Eviplera is a purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and plain on the other side.
Croatian: Eviplera je ljubičasto-ružičasta filmom obložena tableta u obliku kapsule s utisnutom oznakom „GSI” na jednoj strani i bez oznake na drugoj.
English: The frequency category was estimated from a statistical calculation based on the total number of patients exposed to tenofovir disoproxil in randomised controlled clinical studies and the expanded access program (n = 7,319).
Croatian: Kategorija učestalosti procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih tenofovirdizoproksilu u randomiziranim kontroliranim kliničkim ispitivanjima i programu proširenog pristupa (n = 7319).
English:  If you notice any symptoms of inflammation or infection, tell your doctor immediately.
Croatian:  Ako primijetite bilo koji simptom upale ili infekcije, odmah o tome obavijestite liječnika.
English: The frequency category of uncommon was estimated from a statistical calculation based on the total number of patients exposed to emtricitabine in these clinical studies (n = 1,563).
Croatian: Kategorija učestalosti manje često procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih emtricitabinu u ovim kliničkim ispitivanjima (n=1563).
English: 52% of patients with virologic failure in the rilpivirine arm developed concomitant NNRTI and NRTI mutations.
Croatian: U skupini koja je primala rilpivirin, 52% bolesnika s virološkim neuspjehom istovremeno je razvilo mutacije na NNRTI i NRTI.
English: In a study comparing 8 patients with mild hepatic impairment (CPT Score A) to 8 matched controls and 8 patients with moderate hepatic impairment (CPT 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.
Croatian: U ispitivanju u kojem se uspoređivalo 8 bolesnika s blagim oštećenjem jetre (CPT stadij A) s 8 odgovarajućih kontrolnih ispitanika te 8 bolesnika s umjerenim oštećenjem jetre (CPT stadij B) s 8 odgovarajućih kontrolnih ispitanika, izloženost nakon višestrukih doza rilpivirina bila je 47% veća u bolesnika s blagim oštećenjem jetre i 5% veća u bolesnika s umjerenim oštećenjem jetre.
English: 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).
Croatian: Budući da je Eviplera kombinirani lijek i ne može se mijenjati interval doziranja pojedinih komponenti, u bolesnika s potvrđenim CrCl sniženim na < 50 ml/min ili sa sniženjem fosfata u serumu na < 1,0 mg/dl (0,32 mmol/l) liječenje lijekom Eviplera mora se prekinuti.
English: In virologically suppressed patients switching to Eviplera, the most frequently reported adverse reactions considered possibly or probably related to Eviplera were fatigue (3%), diarrhoea (3%), nausea (2%) and insomnia (2%) (48 week data from the Phase III study GS-US-264-0106).
Croatian: U virološki suprimiranih bolesnika koji su prebačeni na lijek Eviplera, najčešće zabilježene nuspojave za koje se smatra da su moguće ili vjerojatno povezane s lijekom Eviplera bile su umor (3%), proljev (3%), mučnina (2%) i nesanica (2%) (podaci iz 48. tjedna ispitivanja III. faze GS-US-264-0106).
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 boce s 30) filmom obloženih tableta
English: In study C215 (n = 678), the BR consisted of 2 investigator selected N(t)RTIs: emtricitabine/tenofovir disoproxil (60%, n = 406) or lamivudine/zidovudine (30%, n = 204) or abacavir plus lamivudine (10%, n = 68).
Croatian: U ispitivanju C215 (n = 678), osnovni terapijski režim sastojao se od 2 N(t)RTI po izboru ispitivača: emtricitabin/tenofovirdizoproksil (60%, n = 406) ili lamivudin/zidovudin (30%, n=204) ili abakavir plus lamivudin (10%, n = 68).
English: The adverse reactions considered at least possibly related to treatment with the components of Eviplera from clinical study and post-marketing experience are listed in Table 2, below, by body system organ class and frequency.
Croatian: Nuspojave za koje se smatra da su barem moguće povezane s liječenjem komponentama lijeka Eviplera u kliničkim ispitivanjima i iskustvu nakon praćenja nakon stavljanja u promet navedene su u sljedećoj tablici 2 prema klasifikaciji organskih sustava i učestalosti.
English: The effect of rilpivirine hydrochloride at the recommended dose of 25 mg once daily on the QTcF interval was evaluated in a randomised, placebo and active (moxifloxacin 400 mg once daily) controlled crossover study in 60 healthy adults, with 13 measurements over 24 hours at steady-state.
Croatian: Učinak rilpivirinklorida u preporučenoj dozi od 25 mg jedanput na dan na QTcF interval procijenjen je u randomiziranom križnom ispitivanju placeba i aktivne kontrole (moksifloksacin 400 mg jedanput na dan) u 60 zdravih odraslih ispitanika, uz 13 mjerenja tijekom 24 sata u stanju dinamičke ravnoteže.
English: H2-antagonists should not be taken twice a day.
Croatian: H2antagoniste ne treba uzimati dvaput na dan.
English: 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.
Croatian: U bolesnika s teškim oštećenjem bubrega ili terminalnom stadiju bolesti bubrega, koncentracije u plazmi mogu biti povećane zbog promjena u apsorpciji, distribuciji i/ili metabolizmu lijeka koje nastaju sekundarno poremećaju funkcije bubrega.
English: 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).
Croatian: Podaci o primjeni rilpivirina u trudnica su ograničeni (manje od 300 trudnoća) (vidjeti dijelove 4.4, 5.1 i 5.2).
English: Didanosine:
Croatian: Didanozin:
English: Resistance to emtricitabine or tenofovir has been seen in vitro and in some HIV-1 infected patients due to the development of the M184V or M184I substitution in RT with emtricitabine, or the K65R substitution in RT with tenofovir.
Croatian: Rezistencija na emtricitabin ili tenofovir ustanovljena je in vitro te u nekih bolesnika inficiranih virusom HIV-1 zbog razvoja supstitucije M184V ili M184I u RT s emtricitabinom ili supstitucije K65R u RT s tenofovirom.
English: Take it at least 2 hours before or at least 4 hours after Eviplera.
Croatian: Uzmite ga najmanje 2 sata prije ili najmanje 4 sata poslije Eviplere.
English: High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Croatian: Boca od polietilena visoke gustoće (HDPE) s polipropilenskim sigurnosnim zatvaračem za djecu koja sadrži 30 filmom obloženih tableta i silika gel kao sredstvo za sušenje.
English: In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended as this may lead to worsening of your hepatitis, which may be lifethreatening.
Croatian: U nekih bolesnika s uznapredovalom bolešću jetre ili cirozom ne preporučuje se prekinuti liječenje, jer to može dovesti do pogoršanja hepatitisa što može biti životno opasno.
English: The median change in CD4+ cell count at week 48 was +17 x 106 cells/L, in the on-treatment analysis.
Croatian: Medijan promjene broja CD4 stanica u 48. tjednu iznosio je +17 x 106 stanica/l u analizi skupine na liječenju.
English: • Increases in creatinine in your blood
Croatian: • povišenje kreatinina u krvi
English: What you need to know before you take Eviplera Do not take Eviplera
Croatian: Što morate znati prije nego počnete uzimati lijek Eviplera
English: In patients with end-stage renal disease (ESRD) requiring haemodialysis, between dialysis drug exposures substantially increased over 72 hours to 53 µg•h/mL (19%) of emtricitabine, and over 48 hours to 42,857 ng•h/mL (29%) of tenofovir.
Croatian: U bolesnika u terminalnom stadiju bolesti bubrega kojima je bila potrebna hemodijaliza izloženost lijekovima između dijaliza znatno je porasla i to na 53 µg•h/ml (19%) za emtricitabin tijekom 72 sata i na 42 857 ng•h/ml (29%) za tenofovir tijekom 48 sati.
English: As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).
Croatian: Budući da Eviplera može prouzročiti oštećenje bubrega, preporučuje se nadzirati funkciju bubrega (vidjeti dijelove 4.4 i 4.8 Sažetak sigurnosnog profila).
English: The Cmax and AUC for tenofovir increased by 12% and 28% (light meal) and 32% and 38% (standard meal), respectively.
Croatian: Cmax i AUC tenofovira povećali su se za 12% odnosno 28% (lagani obrok) te za 32% odnosno 38% (standardni obrok).
English: elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, 2, abdominal pain1, 2, 3, abdominal discomfort2, abdominal distension3, dyspepsia1, flatulence3, dry mouth2
Croatian: povišena amilaza uključujući povišenu pankreasnu amilazu1, povišenu serumsku lipazu1, 2, bolovi u abdomenu1, 2, 3, nelagoda u abdomenu2, distenzija abdomena3, dispepsija1, vjetrovi3, suha usta2
English: Eviplera is not recommended if you have moderate to severe kidney disease.
Croatian: Eviplera se ne preporučuje ako imate umjerenu do tešku bolest bubrega.
English: 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).
Croatian: Ako su u nekog bolesnika koji prima lijek Eviplera fosfati u serumu < 1,5 mg/dl (0,48 mmol/l) ili je CrCl snižen na < 50 ml/min, funkciju bubrega treba ponovno procijeniti u roku od tjedan dana, uključujući mjerenje koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: 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.
Croatian: Od 49 bolesnika koji su primili barem jednu dozu lijeka Eviplera, 100% bolesnika ostalo je suprimirano (HIV-1 RNK < 50 kopija/ml) u 12. i 24. tjednu.