natgillin/translations-raw huggingface dataset:
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).
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).
Do not stop your treatment without contacting your doctor.
Nemojte prestati s liječenjem bez prethodnog savjetovanja s liječnikom.
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.
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.
If Eviplera is co-administered with an NSAID, renal function should be monitored adequately.
Ako se Eviplera primjenjuje istovremeno s NSAILom, potrebno je provjeravati funkciju bubrega na odgovarajući način.
• clarithromycin
• klaritromicin
Do not stop taking Eviplera Do not stop taking Eviplera without talking to your doctor.
Nemojte prestati uzimati Evipleru bez prethodnog razgovora sa svojim liječnikom.
As Eviplera contains emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil, any interactions that have been identified with these active substances individually may occur with Eviplera.
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.
P-glycoprotein substrates
Supstrati P-glikoproteina
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).
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).
Since rilpivirine is highly protein bound, dialysis is unlikely to result in significant removal of the active substance.
Budući da je rilpivirin u visokom postotku vezan za proteine plazme, nije vjerojatno da će dijaliza rezultirati značajnim uklanjanjem te djelatne tvari.
If you vomit less than 4 hours after taking Eviplera, take another tablet with food.
Ako povraćate kad je prošlo manje od 4 sata od uzimanja Eviplere, uzmite drugu tabletu s hranom.
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.
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.
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Djelovanje rilpivirina posredovano je nekompetitivnom inhibicijom HIV-1 reverzne transkriptaze (RT).
Lower exposures of rilpivirine were observed during pregnancy; therefore viral load should be monitored closely.
Tijekom trudnoće su opažene manje izloženosti rilpivirinu; stoga je potrebno pažljivo pratiti virusno opterećenje.
• Dizziness, headache
• omaglica, glavobolja
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.
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.
CCR5 antagonists Maraviroc/Emtricitabine
Antagonisti CCR5 Maravirok/emtricitabin
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.
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.
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.
Pokazalo se da emtricitabin/tenofovirdizoproksil + rilpivirinklorid nisu inferiorni u postizanju HIV-1 RNK < 50 kopija/ml u usporedbi s emtricitabinom/tenofovirdizoproksilom + efavirenzom.
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.
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.
Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
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.
depression2, depressed mood2, sleep disorders2, abnormal dreams1, 2 Nervous system disorders
depresija2, depresivno raspoloženje2, poremećaji spavanja2, abnormalni snovi1, 2
Pantoprazole2
Pantoprazol2
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.
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.
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).
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).
• the systemic glucocorticoid dexamethasone, except as a single dose treatment
• sistemski glukokortikoid deksametazon, osim kao liječenje jednostrukom dozom
Very common: increased transaminases (AST and/or ALT)1, 2, 3 Common:
povišene transaminaze (AST i/ili ALT)1, 2, 3
Due to similarities with emtricitabine, Eviplera should not be administered concomitantly with other cytidine analogues, such as lamivudine (see section 4.4).
Zbog sličnosti s emtricitabinom, Eviplera se ne smije primjenjivati istovremeno s drugim analozima citidina, kao što je lamivudin (vidjeti dio 4.4).
One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48.
Jedan bolesnik s prisutnom K103N na početku imao je virološki neuspjeh uz dodatnu rezistenciju koja se pojavila na liječenje do 48. tjedna.
Eviplera is a purplish-pink, capsule-shaped, film-coated tablet debossed on one side with “GSI” and plain on the other side.
Eviplera je ljubičasto-ružičasta filmom obložena tableta u obliku kapsule s utisnutom oznakom „GSI” na jednoj strani i bez oznake na drugoj.
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).
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).
 If you notice any symptoms of inflammation or infection, tell your doctor immediately.
 Ako primijetite bilo koji simptom upale ili infekcije, odmah o tome obavijestite liječnika.
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).
Kategorija učestalosti manje često procijenjena je na temelju statističkog izračuna na osnovi ukupnog broja bolesnika izloženih emtricitabinu u ovim kliničkim ispitivanjima (n=1563).
52% of patients with virologic failure in the rilpivirine arm developed concomitant NNRTI and NRTI mutations.
U skupini koja je primala rilpivirin, 52% bolesnika s virološkim neuspjehom istovremeno je razvilo mutacije na NNRTI i NRTI.
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.
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.
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).
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.
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).
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).
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 boce s 30) filmom obloženih tableta
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).
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).
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.
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.
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.
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.
H2-antagonists should not be taken twice a day.
H2antagoniste ne treba uzimati dvaput na dan.
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.
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.
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).
Podaci o primjeni rilpivirina u trudnica su ograničeni (manje od 300 trudnoća) (vidjeti dijelove 4.4, 5.1 i 5.2).
Didanosine:
Didanozin:
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.
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.
Take it at least 2 hours before or at least 4 hours after Eviplera.
Uzmite ga najmanje 2 sata prije ili najmanje 4 sata poslije Eviplere.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
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.
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.
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.
The median change in CD4+ cell count at week 48 was +17 x 106 cells/L, in the on-treatment analysis.
Medijan promjene broja CD4 stanica u 48. tjednu iznosio je +17 x 106 stanica/l u analizi skupine na liječenju.
• Increases in creatinine in your blood
• povišenje kreatinina u krvi
What you need to know before you take Eviplera Do not take Eviplera
Što morate znati prije nego počnete uzimati lijek Eviplera
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.
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.
As Eviplera may cause renal damage, monitoring of renal function is recommended (see sections 4.4 and 4.8, Summary of the safety profile).
Budući da Eviplera može prouzročiti oštećenje bubrega, preporučuje se nadzirati funkciju bubrega (vidjeti dijelove 4.4 i 4.8 Sažetak sigurnosnog profila).
The Cmax and AUC for tenofovir increased by 12% and 28% (light meal) and 32% and 38% (standard meal), respectively.
Cmax i AUC tenofovira povećali su se za 12% odnosno 28% (lagani obrok) te za 32% odnosno 38% (standardni obrok).
elevated amylase including elevated pancreatic amylase1, elevated serum lipase1, 2, abdominal pain1, 2, 3, abdominal discomfort2, abdominal distension3, dyspepsia1, flatulence3, dry mouth2
povišena amilaza uključujući povišenu pankreasnu amilazu1, povišenu serumsku lipazu1, 2, bolovi u abdomenu1, 2, 3, nelagoda u abdomenu2, distenzija abdomena3, dispepsija1, vjetrovi3, suha usta2
Eviplera is not recommended if you have moderate to severe kidney disease.
Eviplera se ne preporučuje ako imate umjerenu do tešku bolest bubrega.
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).
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).
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.
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.
The antiviral activity of emtricitabine against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, the MAGI-CCR5 cell line, and peripheral blood mononuclear cells.
Antivirusno djelovanje emtricitabina protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenilo se na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI-CCR5 i mononuklearnim stanicama periferne krvi.
It is not known whether rilpivirine is excreted in human milk.
Nije poznato izlučuje li se rilpivirin u majčino mlijeko.
No dose adjustment of Eviplera is suggested but caution is advised in patients with moderate hepatic impairment.
Ne predlaže se prilagodba doze lijeka Eviplera, ali se savjetuje oprez u bolesnika s umjerenim oštećenjem jetre.
The degree of renal impairment was defined according to baseline CrCl (normal renal function when CrCl > 80 mL/min; mild impairment with CrCl = 50-79 mL/min; moderate impairment with CrCl = 30-49 mL/min and severe impairment with CrCl = 10-29 mL/min).
Stupanj oštećenja bubrega definirao se prema početnom CrCl (funkcija bubrega je normalna kod CrCl > 80 ml/min; blago oštećena kod CrCl = 5079 ml/min; umjereno oštećena kod CrCl = 30 - 49 ml/min i teško oštećena kod CrCl = 1029 ml/min).
Switching from an efavirenz-based regimen
Prebacivanje s režima efavirenza
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Rilpivirin u preporučenoj dozi od 25 mg jedanput na dan nije povezan s klinički važnim učinkom na QTc.
If your doctor decides to stop one of the components of Eviplera or change the dose of Eviplera, you may be given emtricitabine, rilpivirine and/or tenofovir disoproxil separately or with other medicines for the treatment of HIV infection.
Ako liječnik odluči prestati s primjenom jedne od sastavnih tvari Eviplere ili promijeniti dozu lijeka Eviplera, možda ćete dobivati emtricitabin, rilpivirin i/ili tenofovirdizoproksil odvojeno ili s drugim lijekovima za liječenje HIV-infekcije.
Patients with HIV-1 expressing three or more TAMs that included either the M41L or L210W RT substitution showed reduced response to tenofovir disoproxil.
Bolesnici s virusom HIV-1 koji je izražavao tri ili više TAM-ova, među kojima i supstituciju M41L ili L210W na RT, pokazali su smanjeni odgovor na tenofovirdizoproksil.
These symptoms resolved after Eviplera was discontinued.
Ti su se simptomi povukli nakon prekida terapije lijekom Eviplera.
When supratherapeutic doses of 75 mg once daily and 300 mg once daily of rilpivirine hydrochloride were studied in healthy adults, the maximum mean time-matched (95% upper confidence bound) differences in QTcF interval from placebo after baseline correction were 10.7 (15.3) and 23.3 (28.4) ms, respectively.
Kad su se u zdravih odraslih ispitanika ispitivale doze rilpivirinklorida od 75 mg jedanput na dan odnosno 300 mg jedanput na dan koje su bile iznad terapijskih, maksimalne srednje vremenski usklađene (95% gornja granica pouzdanosti) razlike u QTcF intervalu u odnosu na placebo nakon osnovne korekcije bile su 10,7 (15,3) odnosno 23,3 (28,4) ms.
In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
U bolesnika inficiranih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART-a može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
For those patients failing therapy with Eviplera and who developed resistance to Eviplera cross-resistance to other approved NNRTIs (etravirine, efavirenz, nevirapine) was generally seen.
Za one bolesnike u kojih je terapija lijekom Eviplera bila neuspješna i koji su razvili rezistenciju na lijek Eviplera u pravilu se vidjela križna rezistencija na druge odobrene nenukleozidne inhibitore reverzne transkriptaze (etravirin, efavirenz, nevirapin).
• rilpivirine
• rilpivirin
Your doctor will discuss a different medicine if required.
Ako to bude potrebno, liječnik će s Vama razmotriti mogućnost drugog lijeka.
• St. John's wort (Hypericum perforatum)
• gospina trava (Hypericum perforatum)
1 Adverse reaction identified for emtricitabine.
1 Nuspojava utvrđena za emtricitabin.
• erythromycin
• eritromicin
After oral administration of the single components emtricitabine and tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Nakon peroralne primjene emtricitabina i tenofovirdizoproksila kao pojedinačnih komponenti, emtricitabin i tenofovir široko se distribuiraju po cijelom tijelu.
• Talk to your doctor if you are over 65 years of age.
• Ako ste stariji od 65 godina, razgovarajte sa svojim liječnikom.
Immune Reactivation Syndrome
sindrom imunološke reaktivacije
immune reactivation syndrome
Sindrom imunološke reaktivacije
Eviplera is a treatment for Human Immunodeficiency Virus (HIV) infection in adults aged
Eviplera je namijenjena liječenju infekcije virusom humane imunodeficijencije (HIV) u odraslih u dobi od 18 ili više.
• Low platelet count (a type of blood cell involved in clotting blood)
• nizak broj krvnih pločica (vrsta krvnih stanica uključena u zgrušavanje krvi)
The safety and efficacy of Eviplera have not been established in patients with significant underlying liver disorders.
Nije utvrđena sigurnost i djelotvornost primjene lijeka Eviplera u bolesnika sa značajnim temeljnim poremećajima jetre.
The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Povećano izlaganje tenofoviru može pojačati nuspojave povezane s tenofovirdizoproksilom, uključujući poremećaje bubrega.
The mean baseline CD4 cell count was 584 x 106 cells/L (range 42-1,484).
Srednja vrijednost početnog broja CD4 stanica iznosila je 584 x 106 stanica/l (raspon 42 - 1484).
Renal function should be closely monitored (see section 4.4).
Nužno je pomno pratiti funkciju bubrega (vidjeti dio 4.4).