natgillin/translations-raw huggingface dataset:
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.
V drugi študiji je substitucija Y188L povzročila 9-krat manjšo občutljivost kliničnih izolatov in 6-krat manjšo občutljivost lokacijsko usmerjenih mutantov na rilpivirin.
Patients were switched from efavirenz/emtricitabine/tenofovir disoproxil to Eviplera without a washout period.
Bolniki so prešli z zdravljenja z efavirenzom/ emtricitabinom/dizoproksiltenofoviratom na zdravilo Eviplera brez obdobja izpiranja.
• foscarnet, ganciclovir, cidofovir (for viral infections)
• foskarnet, ganciklovir, cidofovir (za virusne okužbe)
Lower exposures of rilpivirine were observed during pregnancy; therefore viral load should be monitored closely.
Med nosečnostjo so opazili nižje izpostavljenosti rilpivirinu, zato je treba skrbno spremljati virusno obremenitev.
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.
V 144 tednov trajajoči kontrolirani klinični študiji, v kateri sta bila primerjana dizoproksiltenofovirat in stavudin v kombinaciji z lamivudinom in efavirenzom pri bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, so pri obeh zdravljenih skupinah opazili manjše zmanjšanje BMD kolka in hrbtenice.
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).
V študiji C215 (n = 678) je bil BR sestavljen iz 2 N(t)RTI-jev, ki ju je izbral raziskovalec: emtricitabin/dizoproksiltenofovirat (60 %, n = 406) ali lamivudin/zidovudin (30 %, n = 204) ali abakavir in lamivudin (10 %, n = 68).
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.
Učinek rilpivirinijevega klorida pri priporočenem odmerku 25 mg enkrat dnevno na interval QTcF je bil ocenjen v randomizirani, s placebom in aktivno (moksifloksacin 400 mg enkrat dnevno) kontrolirani navzkrižni študiji s 60 zdravimi odraslimi, s 13 meritvami v 24 urah v stanju dinamičnega ravnovesja.
Eviplera has not been studied in patients over the age of 65 years.
Zdravila Eviplera niso proučevali pri bolnikih, starejših od 65 let.
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.
Pri nekaterih bolnikih z napredovalim obolenjem jeter ali cirozo prenehanje zdravljenja ni priporočeno, saj lahko to povzroči poslabšanje hepatitisa, ki je lahko življenjsko nevarno.
Rilpivirine-resistant strains were selected in cell culture starting from wild-type HIV-1 of different origins and subtypes as well as NNRTI-resistant HIV-1.
V celični kulturi so bili izbrani na rilpivirin rezistentni sevi, od divjega tipa virusa HIV-1 različnih izvorov in podtipov ter proti NNRTI rezistenten virus HIV-1.
Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4+ cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine.
Sočasna uporaba dizoproksiltenofovirata in didanozina pri odmerku 400 mg dnevno je bila povezana s pomembnim zmanjšanjem števila celic CD4+, morda zaradi znotrajceličnih interakcij, ki so povečale količino fosforiliranega (to je aktivnega) didanozina.
P-glycoprotein substrates
Substrati P-glikoproteina
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).
Rilpivirin je pokazal aktivnost proti laboratorijskim sevom divjega tipa HIV-1 v akutno okuženi liniji T-celic z mediano vrednostjo EC50 za virus HIV-1/IIIB 0,73 nM (0,27 ng/ml).
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.
V študijah genotoksičnosti in študijah toksičnosti s ponavljajočim se odmerkom, ki so trajale en mesec ali manj z uporabo kombinacije emtricitabina in dizoproksiltenofovirata niso ugotovili poslabšanja toksikoloških vplivov, v primerjavi s posameznima učinkovinama.
If you vomit less than 4 hours after taking Eviplera, take another tablet with food.
Če bruhate manj kot 4 ure po zaužitju zdravila Eviplera, vzemite še eno tableto s hrano.
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.
Vijolično-rožnata filmsko obložena tableta v obliki kapsule z dimenzijami 19 mm x 8,5 mm, z vtisnjenim znakom “GSI” na eni strani in prazna na drugi strani.
Rilpivirine activity is mediated by non-competitive inhibition of HIV-1 reverse transcriptase (RT).
Aktivnost rilpivirina poteka s pomočjo nekompetitivnega zaviranja reverzne transkriptaze (RT) HIV-1.
Decreases in BMD of spine and changes in bone biomarkers from baseline were significantly greater in the tenofovir disoproxil treatment group at 144 weeks.
Zmanjšanje mineralne gostote kosti hrbtenice in spremembe kostnih biomarkerjev od začetne vrednosti so bile v 144 tednih pomembno večje v skupini, ki se je zdravila z dizoproksiltenofoviratom.
Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Specifičnega antidota za preveliko odmerjanje zdravila Eviplera ni. Do 30 % odmerka emtricitabina in približno 10 % odmerka tenofovirja se lahko odstrani s hemodializo.
Women of childbearing potential / contraception in males and females The use of Eviplera must be accompanied by the use of effective contraception.
Ženske v rodni dobi/uporaba kontracepcije pri moških in ženskah Pri uporabi zdravila Eviplera je treba uporabljati učinkovito kontracepcijo.
The mutations associated with NRTI resistance that developed in 3 or more patients were: K65R, K70E, M184V/I and K219E during the treatment period.
Mutacije, povezane z rezistenco na NRTI, ki so se razvile pri 3 ali več bolnikih, so bile: K65R, K70E, M184V/I in K219E v obdobju zdravljenja.
The usual dose is one tablet taken each day by mouth.
Običajen odmerek je ena tableta peroralno vsak dan. Tableto morate vzeti vsak dan s hrano.
• amphotericin B, pentamidine (for fungal infections)
• amfotericin B, pentamidin (za glivične okužbe)
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.
V 48. tednu je imelo 89 % (283/317) bolnikov, randomiziranih za prehod na zdravilo Eviplera na začetku (Eviplera), HIV-1 RNA < 50 kopij/ml, 3 % (8/317) so bili obravnavani kot virološki neuspehi (HIV RNA ≥ 50 kopij/ml) in za 8 % (26/317) v oknu 48. tedna ni bilo razpoložljivih podatkov.
• Increases in creatinine in your blood
• povišan kreatinin v krvi
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.
Rezistenca na emtricitabin ali tenofovir je bila opažena in vitro in pri nekaterih bolnikih, okuženih s HIV-1, zaradi razvoja substitucije M184V ali M184I na RT pri emtricitabinu ali substituciji K65R na RT pri tenofovirju.
Only H2-receptor antagonists that can be dosed once daily should be used.
Uporabljajte samo receptorje H2, ki jih je mogoče odmerjati enkrat dnevno.
There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil.
Razlike v spremembi od začetne vrednosti BMD ali BMC za rilpivirin v primerjavi s kontrolno skupino, splošno populacijo ali bolniki z osnovno shemo zdravljenja, vključno z dizoproksiltenofoviratom, ni bilo.
If you accidentally take more than the recommended dose of Eviplera you may be at increased risk of experiencing possible side effects with this medicine (see section 4, Possible side effects).
Če ste pomotoma zaužili odmerek zdravila Eviplera, višji od priporočenega, obstaja povečano tveganje za pojav možnih neželenih učinkov (glejte poglavje 4, Možni neželeni učinki).
In women receiving rilpivirine 25 mg once daily during the 2nd trimester of pregnancy, mean intraindividual values for total rilpivirine Cmax, AUC24h and Cmin values were 21%, 29% and 35% lower, respectively, as compared to postpartum; during the 3rd trimester of pregnancy, Cmax, AUC24h and Cmin values were 20%, 31% and 42% lower, respectively, as compared to postpartum.
Pri ženskah, ki so prejemale 25 mg rilpivirina enkrat dnevno med 2. trimesečjem nosečnosti, so bile srednje vrednosti med posameznicami za vrednosti celokupnega rilpivirina Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 21 %, 29 % in 35 %; med 3. trimesečjem nosečnosti pa so bile vrednosti Cmax, AUC24h in Cmin v primerjavi s poporodnim obdobjem nižje za 20 %, 31 % in
Eviplera may affect your kidneys.
Zdravilo Eviplera lahko vpliva na ledvice.
Adverse reaction Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema
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 s substitucijami, ki so pomenile zmanjšano občutljivost na TAM-e (mutacijske povezane z analogi stavudina in zidovudin-timidina, npr. M41L, D67N, K70R, L210W, T215Y/F, K219Q/E) ali didanozin (L74V) so ostali občutljivi na emtricitabin.
There is insufficient information on the effects of Eviplera in newborns/infants.
Podatki o učinku zdravila Eviplera na dojene novorojence/otroke so nezadostni.
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 je, da emtricitabin/dizoproksiltenofovirat + rilpivirinijevim kloridom nista slabša pri doseganju HIV-1 RNA < 50 kopij/ml v primerjavi z emtricitabinom/dizoproksiltenofoviratom + efavirenzom.
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).
Stopnja ledvične okvare je bila določena glede na začetno vrednost CrCl (normalna ledvična funkcija je pri CrCl > 80 ml/min; blaga ledvična okvara pri CrCl = 50-79 ml/min; zmerna ledvična okvara pri CrCl = 30-49 ml/min in huda ledvična okvara pri CrCl = 10-29 ml/min).
Once you start taking Eviplera, look out for:
Med jemanjem zdravila Eviplera Ko začnete jemati zdravilo Eviplera, bodite pozorni na:
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.
Opredeljen je bil tudi kot neželeni učinek emtricitabina v okviru nadzora v obdobju trženja, niso pa ga zabeležili v razdomiziranih kontroliranih kliničnih študijah pri odraslih ali pediatričnih bolnikih z okužbo z virusom HIV.
The following pack sizes are available: outer cartons containing 1 bottle of 30 film-coated tablets and outer cartons containing 90 (3 bottles of 30) film-coated tablets.
Na voljo so naslednje velikosti pakiranj: škatle s po 1 plastenko s 30 filmsko obloženimi tabletami in škatle z 90 (3 plastenke s po 30) filmsko obloženimi tabletami.
After oral administration of the single components emtricitabine and tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Po peroralnem vnosu posamezne sestavine emtricitabina in dizoproksiltenofovirata sta emtricitabin in tenofovir v telesu široko distribuirana.
Sex Male Female Ethnicity White Black/African American Asian Other Not allowed to ask per local regulations Baseline disease characteristics Median baseline plasma HIV-1 RNA (range), log10 copies/mL Median baseline CD4+ cell count (range), x 106 cells/L Percentage of patients with HBV/HCV co-infection
Spol Moški Ženski Etničnost Belci Črnci/afriški Američani Azijci Drugo Ni dovoljeno vprašati v skladu z lokalno zakonodajo Začetne značilnosti bolezni Mediana začetna vrednost HIV-1 RNA (razpon) log10 kopij/ml v plazmi Mediana začetna vrednost CD4+ število celic (razpon), × 106 celic/l Odstotek bolnikov s sočasno okužbo s HBV/HCV
Emtricitabine exposures were not affected by food.
Hrana ni vplivala na izpostavljenost emtricitabinu.
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 konca 48. tedna se rezistenca, nastala med zdravljenjem, ni razvila pri 2 bolnikih, ki sta imela virološki neuspeh, med bolniki, ki so prešli na zdravljenje z zdravilom Eviplera z efavirenza/emtricitabina/dizoproksiltenofovirja (0 od 49 bolnikov).
H2-antagonists should not be taken in a twice a day regimen.
Antagonistov H2 ne jemljite z režimom dvakrat dnevno.
Contains lactose monohydrate and sunset yellow aluminium lake (E110), see leaflet for further information.
Vsebuje laktozo monohidrat in barvilo sončno rumeno FCF (E110), za dodatne informacije glejte navodilo za uporabo.
High density polyethylene (HDPE) bottle with a polypropylene child-resistant closure containing 30 film-coated tablets and a silica gel desiccant.
Plastenka iz polietilena visoke gostote (HDPE), s polipropilensko, za otroke varno zaporko, ki vsebuje 30 filmsko obloženih tablet in silikagelsko sušilno sredstvo.
CCR5 antagonists Maraviroc/Emtricitabine
Antagonisti CCR5 maravirok/emtricitabin
In vitro experiments indicate that rilpivirine hydrochloride primarily undergoes oxidative metabolism mediated by the CYP3A system.
Poskusi in vitro kažejo, da se rilpivirinijev klorid presnavlja predvsem oksidativno preko sistema CYP3A.
H2-antagonists should not be taken twice a day.
Antagonistov H2 ne jemljite dvakrat dnevno.
2 Adverse reaction identified for rilpivirine hydrochloride.
2 Neželeni učinek, ki so ga zabeležili za rilpivirinijev klorid.
HIV/HBV or HCV co-infected patients
Bolniki s hkratno okužbo HIV/HBV ali HCV
When your supply of Eviplera starts to run low, get more from your doctor or pharmacist.
Ko se vaše zaloge zdravila Eviplera manjšajo, si ga priskrbite pri zdravniku ali farmacevtu.
• If you are taking an antacid (such as medicines containing magnesium or potassium), take it at least 2 hours before or at least 4 hours after Eviplera (see section 3, How to take Eviplera).
• Če jemljete antacid (kot so zdravila, ki vsebujejo magnezij ali kalij), ga vzemite vsaj 2 uri pred zdravilom Eviplera ali najmanj 4 ure po tem (glejte poglavje 3, Kako jemati zdravilo Eviplera).
• If you are taking an H2-antagonist (also used to treat stomach acid or acid reflux disease), take it at least 12 hours before or at least 4 hours after Eviplera.
• Če jemljete antagonist H2 (uporablja se tudi za zdravljenje čezmernega izločanja želodčne kisline ali refluksne bolezni), ga vzemite vsaj 12 ur pred zdravilom Eviplera ali najmanj 4 ure po tem.
Before and during treatment, your doctor may order blood tests to measure kidney function.
Pred zdravljenjem in v času zdravljenja bo zdravnik morda naredil krvne preiskave, da bo ocenil delovanje ledvic.
If Eviplera is co-administered with an NSAID, renal function should be monitored adequately.
Pri sočasnem jemanju zdravila Eviplera z NSAID je treba ustrezno nadzorovati ledvično funkcijo.
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.
Protiretrovirusno aktivnost emtricitabina pri laboratorijskih in kliničnih izolatih HIV-1 so ocenili v limfoblastoidnih celičnih linijah, celični liniji MAGI-CCR5 in v mononuklearnih celicah v periferni krvi.
One patient with pre-existing K103N at baseline had virologic failure with additional emergent resistance by week 48.
En bolnik z obstoječo K103N na začetku je imel virološki neuspeh z dodatno rezistenco, nastalo med zdravljenjem, do 48. tedna.
Emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited.
Jetrni encimi emtricitabina ne presnavljajo v večji meri, zato je učinek na okvaro jeter verjetno omejen.
• dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) when taken by mouth or injected (except as a single dose treatment)
• deksametazon (kortikosteroid, ki se uporablja za zdravljenje vnetij in zaviranje imunskega sistema) pri peroralnem jemanju ali injiciran (razen v obliki enkratnega odmerka)
Table 2: Tabulated summary of adverse reactions to Eviplera based on clinical study and post-marketing experience with Eviplera and its individual components
Preglednica 2: Povzetek neželenih učinkov zdravila Eviplera na podlagi izkušenj iz kliničnih študij in izkušenj v obdobju trženja za zdravilo Eviplera in njegove posamezne učinkovine
This medicine can decrease the amount of rilpivirine (a component of Eviplera) in your blood.
To zdravilo lahko zmanjša količino rilpivirina (sestavina zdravila Eviplera) v vaši krvi.
• Decrease in haemoglobin in your blood (low red blood cell count)
• znižanje hemoglobina v krvi (nizko število rdečih krvnih celic)
Some examples include, but are not limited to, aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2 (also called aldesleukin).
Nekateri primeri vključujejo aminoglikozide, amfotericin B, foskarnet, ganciklovir, pentamidin, vankomicin, cidofovir ali interlevkin-2 (imenovan tudi aldeslevkin), vendar pa niso omejeni nanje.
The antiviral activity of tenofovir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, primary monocyte/macrophage cells and peripheral blood lymphocytes.
Protiretrovirusna aktivnost tenofovira proti laboratorijskim in kliničnim izolatom virusa HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, primarnih monocitičnih/makrofagnih celicah in limfocitih v periferni krvi.
Protease inhibitors (PIs) - boosted (with co-administration of low-dose ritonavir) Atazanavir/Ritonavir/Emtricitabine Interaction not studied.
Zaviralci proteaze (PI) - okrepljeni (s sočasnim dajanjem nizkih odmerkov ritonavira) atazanavir/ritonavir/emtricitabin
EU/1/11/737/002 90 (3 bottles of 30) film-coated tablets.
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/11/737/001 30 filmsko obloženih tablet EU/1/11/737/002 90 (3 plastenke s po 30) filmsko obloženih tablet
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).
Zdravilo Eviplera so z režimom odmerjanja z eno samo tableto preučili pri bolnikih z virološko supresijo, ki so prešli z režima, ki je vseboval PI, okrepljen z ritonavirjem (študija faze III GS-US-264-0106), ali z efavirenza/emtricitabina/dizoproksiltenofovirata (študija IIb.
• Other medicines used for HIV infection: Non-nucleoside reverse transcriptase inhibitors (NNRTIs).
• Druga zdravila, ki se uporabljajo za zdravljenje okužb s HIV: Nenukleozidni zaviralci reverzne transkriptaze (NNRTI).
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.
Pri bolnikih z ledvičnim obolenjem v končni fazi (ESRD), ki so potrebovali hemodializo, se je med dializami izpostavljenost zdravilu znatno povišala v obdobju 72 ur na 53 (19 %) µg•h/ml emtricitabina in v obdobju 48 ur na 42.857 (29 %) µg•h/ml tenofovirja.
Rilpivirine at the recommended dose of 25 mg once daily is not associated with a clinically relevant effect on QTc.
Rilpivirin pri priporočenem odmerku 25 mg enkrat dnevno ni povezan s klinično pomembnim vplivom na QTc.
1 Adverse reaction identified for emtricitabine.
1 Neželeni učinek, ki so ga zabeležili za emtricitabin.
Patients had to be on either their first or second antiretroviral regimen with no history of virologic failure, have no current or past history of resistance to any of the three components of Eviplera, and must have been stably suppressed (HIV-1 RNA < 50 copies/mL) for at least 6 months prior to screening.
Bolniki so morali biti bodisi na svojem prvem ali drugem protiretrovirusnem režimu brez virološkega neuspeha v anamnezi, brez sedanje ali pretekle anamneze rezistence na katero koli od treh učinkovin zdravila Eviplera in s stabilno supresijo (HIV-1 RNA < 50 kopij/ml) vsaj 6 mesecev pred presejanjem.
Patients had to be stably suppressed for at least 8 weeks prior to study entry, have no current or past history of resistance to any of the three components of Eviplera, and have HIV-1 RNA < 50 copies/mL at screening.
Bolniki so morali imeti stabilno supresijo vsaj 8 tednov pred vstopom v študijo in biti brez sedanje ali pretekle anamneze rezistence na katero koli od treh učinkovin zdravila Eviplera ter imeti HIV-1 RNA < 50 kopij/ml ob presejanju.
• proton pump inhibitors, such as omeprazole, esomeprazole, lansoprazole, pantoprazole,
• zaviralci protonske črpalke, kot so omeprazol, esomeprazol, lansoprazol, pantoprazol,
Patients with HIV-1 expressing three or more TAMs that included either the M41L or L210W RT substitution showed reduced response to tenofovir disoproxil.
Bolniki, pri katerih je HIV-1 izražal tri ali več TAM-e, ki so vsebovali ali M41L ali L210W substitucijo RT, so kazali zmanjšani odziv na dizoproksiltenofovirat.
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).
Pri bolnikih z virološko supresijo, ki so prešli na zdravljenje z zdravilom Eviplera, so bili najpogostejši neželeni učinki, ki so bili verjetno oziroma morda povezani z zdravilom Eviplera, utrujenost (3 %), driska (3 %), navzea (2 %) in nespečnost (2 %) (podatki za 48. teden iz študije faze III GS-US-264-0106).
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 pogostnosti (občasni) je bila ocenjena s statističnim izračunom na podlagi skupnega števila bolnikov, izpostavljenih emtricatibinu v teh kliničnih študijah (n = 1563).
30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 30 filmsko obloženih tablet 90 (3 plastenke s po 30) filmsko obloženih tablet
Monitoring of renal function is recommended for patients receiving Eviplera (see section 4.4).
Nadziranje ledvične funkcije se priporoča pri bolnikih, ki prejemajo zdravilo Eviplera (glejte poglavje 4.4).
Eviplera is not recommended if you have moderate to severe kidney disease.
Uporaba zdravila Eviplera se ne priporoča, če imate zmerno do hudo bolezen ledvic.