natgillin/translations-raw huggingface dataset:
Once you start taking Genvoya, look out for: 
Ko začnete jemati zdravilo Genvoya, bodite pozorni na:
A potential risk of nephrotoxicity resulting from chronic exposure to low levels of tenofovir due to dosing with tenofovir alafenamide cannot be excluded (see section 5.3). 
Morebitnega tveganja nefrotoksičnosti kot posledice kronične izpostavljenosti nizkim ravnem tenofovirja zaradi odmerjanja tenofoviralafenamida ni mogoče izključiti (glejte poglavje 5.3).
The pharmacokinetics of emtricitabine have not been studied in patients with hepatic impairment; however, emtricitabine is not significantly metabolised by liver enzymes, so the impact of liver impairment should be limited. 
Farmakokinetičnih lastnosti emtricitabina pri bolnikih z jetrno okvaro niso proučevali, vendar jetrni encimi emtricitabina ne presnavljajo v pomembnem obsegu, zato je vpliv jetrne okvare verjetno omejen.
Genvoya is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows: 
Zdravilo Genvoya je indicirano za zdravljenje virusa humane imunske pomanjkljivosti tipa 1 (HIV-1) brez kakršnih koli znanih mutacij, povezanih z rezistenco proti skupini zaviralcev integraze, emtricitabinu ali tenofovirju, kot sledi:
Table 7: Changes in pharmacokinetic parameters from the IMPAACT P1026s study for elvitegravir and cobicistat in women receiving cobicistat and elvitegravir-containing regimens during the second and third trimesters of pregnancy compared to paired postpartum data 
Preglednica 7: Spremembe farmakokinetičnih parametrov iz študije IMPAACT P1026s za elvitegravir in kobicistat pri ženskah, ki so prejemale režime s kobicistatom in elvitegravirjem v drugem in tretjem trimestru nosečnosti, v primerjavi z sparjenimi podatki iz poporodnega obdobja
Integrase is an HIV-1 encoded enzyme that is required for viral replication. 
Integraza je kodiran encim HIV-1, potreben za razmnoževanje virusa.
Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia. 
Ustrezni primeri vključujejo citomegalovirusni retinitis, generalizirane in/ali žariščne okužbe z mikobakterijami in s Pneumocystis jirovecii povzročeno pljučnico.
If you have difficulty swallowing the tablet whole, you can split it in half. 
Če tablete ne morete pogoltniti cele, jo lahko prepolovite.
Talk to your doctor if you are taking: 
Druge vrste zdravil: Obvestite svojega zdravnika, če jemljete:
ENDOTHELIN RECEPTOR ANTAGONISTS Bosentan 
ANTAGONISTI RECEPTORJEV ENDOTELINA bosentan
INHALED BETA AGONIST Salmeterol 
INHALIRANI AGONISTI BETA salmeterol
Limited data from population pharmacokinetic analysis (n = 24) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir. 
Omejeni podatki populacijske farmakokinetične analize (n = 24) so pokazali, da sočasna okužba z virusom hepatitisa B in/ali C nima klinično pomembnega učinka na izpostavljenost okrepljenemu elvitegravirju.
These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown aetiology, particularly neurologic findings. 
Te ugotovitve je treba upoštevati pri vseh otrocih, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, pri katerih se pojavijo resne klinične ugotovitve neznanega vzroka, še zlasti nevrološke.
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8). 
V primeru prevelikega odmerka je potrebno pri bolniku nadzorovati znake toksičnosti (glejte poglavje 4.8).
Contains lactose, see leaflet for further information. 
SEZNAM POMOŽNIH SNOVI Vsebuje laktozo, za dodatne informacije glejte navodilo za uporabo.
Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH. 
Koncentracije elvitegravirja v plazmi so z antacidi nižje zaradi lokalne kompleksacije v prebavilih in ne zaradi sprememb vrednosti pH
Elvitegravir, emtricitabine, and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture. 
Elvitegravir, emtricitabin in tenofoviralafenamid so pokazali sinergijsko protivirusno aktivnost v celični kulturi.
Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin. 
Potrebno je povečano spremljanje neželenih učinkov, povezanih rifabutinom, vključno z nevtropenijo in uveitisom, zaradi pričakovane večje izpostavljenosti desacetil-rifabutinu.
There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya. 
Klinično pomembnih sprememb v laboratorijskih preiskavah lipidov na tešče pri bolnikih, ki so prešli na zdravilo Genvoya, ni bilo.
The safety and efficacy of Genvoya in patients co-infected with HIV-1 and hepatitis C virus (HCV) have not been established. 
Varnost in učinkovitost zdravila Genvoya pri bolnikih s hkratno okužbo s HIV-1 in hepatitisa C (HCV) nista bili dokazani.
Following oral administration, the elimination half-life of emtricitabine is approximately 10 hours. 
Po peroralni uporabi zdravila je razpolovni čas izločanja emtricitabina približno 10 ur.
Genvoya comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets). 
Zdravilo Genvoya je na voljo v plastenkah po 30 tablet (s silikagelskim sušilnim sredstvom, ki mora ostati v vsebniku zaradi zaščite tablet).
Tenofovir alafenamide is transported by P-gp and BCRP. 
Tenofoviralafenamid se prenaša s P-gp in BCRP.
However increased post-implantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day. 
Vendar pa so pri podganah opazili večjo izgubo po ugnezditvi in manjšo telesno maso plodov, povezano z značilnimi zmanjšanji materine telesne mase s 125 mg/kg/dan.
Do not take antacids or multivitamins at the same time as Genvoya. 
Antacidov ali multivitaminskih dopolnil ne jemljite hkrati z zdravilom Genvoya.
• antidepressants, used to treat depression: medicines containing trazodone or escitalopram 
• antidepresive, ki se uporabljajo za zdravljenje depresije: zdravila, ki vsebujejo trazodon ali escitalopram
Therefore, information regarding drug-drug interactions with other antiretroviral products (including protease inhibitors [PIs] and non-nucleoside reverse transcriptase inhibitors [NNRTIs]) is not provided (see section 4.4). 
Zato informacije o medsebojnem delovanju z drugimi protiretrovirusnimi zdravili (vključno s PI in nenukleozidnimi zaviralci reverzne transkriptaze [NNRTI- non-nucleoside reverse transcriptase inhibitors]) niso navedene (glejte poglavje 4.4).
Comparison to paired postpartum data, n 
Primerjava s sparjenimi poporodnimi podatki, n
In clinical trials, the incidence of SAEs related to suicide for Genvoya was 0.6% (26/4137 subjects), therefore, the frequency proposed is “uncommon”. 
V kliničnih preskušanjih je bila pojavnost resnih neželenih dogodkov v povezavi s samomorom za zdravilo Genvoya 0,6 % (26/4137 oseb), zato je predlagana pogostnost »občasna«.
Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5 mm, debossed with “GSI” on one side of the tablet and “510” on the other side of the tablet. 
Zelena filmsko obložena tableta v obliki kapsule, z dimenzijami 19 mm x 8,5 mm, z vtisnjenim znakom “GSI” na eni strani tablete in “510” na drugi strani tablete.
Inhibition of integrase prevents the integration of HIV-1 deoxyribonucleic acid (DNA) into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the viral infection. 
Zaviranje integraze preprečuje integracijo deoksiribonukleinske kisline (DNA- deoxyribonucleic acid) virusa HIV-1 v genomsko DNA gostitelja in prepreči nastanek provirusa HIV-1 ter širjenje virusne okužbe.
When your supply of Genvoya starts to run low, get more from your doctor or pharmacist. 
Ko se vaše zaloge zdravila Genvoya manjšajo, si ga priskrbite pri svojem zdravniku ali farmacevtu.
It is recommended to separate Genvoya and antacid administration by at least 4 hours. 
Priporoča se, da se dajanje zdravila Genvoya in antacida loči za vsaj 4 ure.
Changes in measures of bone mineral density 
Spremembe v meritvah mineralne gostote kosti
If you are taking an antacid such as aluminium/magnesium hydroxide or a multivitamin supplement, take it at least 4 hours before or at least 4 hours after Genvoya. 
Če jemljete antacid, kot je aluminijev/magnezijev hidroksid ali multivitaminsko dopolnilo, ga vzemite vsaj 4 ure pred uporabo zdravila Genvoya ali najmanj 4 ure po tem.
• immunosuppressants, used to control your body's immune response after a transplant, such as: ciclosporin, sirolimus and tacrolimus 
• imunosupresive, ki se uporabljajo za nadzor imunskega odziva telesa po presaditvi, kot so: ciklosporin, sirolimus in takrolimus
Tenofovir has activity against HIV-1, HIV-2, and HBV. 
Tenofovir je aktiven proti HIV-1, HIV-2 in HBV.
Cobicistat increases serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. 
Kobicistat zvišuje serumski kreatinin zaradi zaviranja tubularne sekrecije kreatinina, kar pa ne vpliva na ledvično glomerularno funkcijo.
In vitro studies indicate that emtricitabine is not an inhibitor of human CYP enzymes. 
Študije in vitro kažejo, da emtricitabin ne zavira humanih encimov CYP.
However, tenofovir disoproxil reduced the viability index and weight of pups in a peri-postnatal toxicity study at maternally toxic doses. 
Vendar pa je dizoproksiltenofovirat zmanjšal indeks viabilnosti in telesno maso mladičev v peri- in postnatalni študiji toksičnosti pri odmerkih, toksičnih za mater.
Genvoya should be avoided in patients with estimated CrCl ≥ 15 mL/min and < 30 mL/min, or < 15 mL/min who are not on chronic haemodialysis, as the safety of Genvoya has not been established in these populations. 
Zdravilu Genvoya se je treba izogniti pri bolnikih z ocenjenim CrCl ≥ 15 ml/min in < 30 ml/min ali < 15 ml/min, ki niso na kronični hemodializi, saj varnosti zdravila Genvoya pri teh populacijah niso dokazali.
sildenafil, tadalafil and vardenafil 
kot so: sildenafil, tadalafil in vardenafil
2 These studies were performed with ritonavir boosted elvitegravir. 
2 Te študije so izvedli z elvitegravirjem, okrepljenim z ritonavirjem.
At Week 48, the virologic response rate to Genvoya in treatment-naïve HIV-1 infected adolescents was similar to response rates in studies of treatment-naïve HIV-1 infected adults. 
V 48. tednu je bila stopnja virološkega odziva na zdravilo Genvoya pri predhodno nezdravljenih mladostnikih, okuženih s HIV-1, podobna stopnjam odziva v študijah predhodno nezdravljenih odraslih, okuženih s HIV-1.
Tenofovir alafenamide is active against hepatitis B virus (HBV). 
Tenofoviralafenamid je aktiven proti virusu hepatitisa B (HBV).
When administering with Genvoya, the maximum daily dose of itraconazole should not exceed 200 mg per day. 
Pri dajanju z zdravilom Genvoya največji dnevni odmerek itrakonazola ne sme preseči 200 mg dnevno.
Genvoya contains lactose monohydrate. 
Zdravilo Genvoya vsebuje laktozo monohidrat.
As such, tenofovir alafenamide exposures following administration of Genvoya are not expected to be further increased when used in combination with another P-gp and/or BCRP inhibitor (e.g., ketoconazole). 
Ne pričakuje se, da bi se izpostavljenosti tenofoviralafenamida kot take po dajanju zdravila Genvoya še povečale, če se uporablja v kombinaciji z drugim zaviralcem P-gp in/ali BCRP (npr. ketokonazolom).
Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya. 
Sočasno dajanje je kontraindicirano z zdravili, ki so močni induktorji CYP3A zaradi potencialne izgube virološkega odziva in možne rezistence na zdravilo Genvoya.
What you need to know before you take Genvoya Do not take Genvoya: 
Kaj morate vedeti, preden boste vzeli zdravilo Genvoya Ne jemljite zdravila Genvoya:
The safety and efficacy of Genvoya in children younger than 6 years of age, or weighing < 25 kg, have not yet been established. 
Pediatrična populacija Varnost in učinkovitost zdravila Genvoya pri otrocih, mlajših od 6 let, ali s telesno maso < 25 kg, še nista bili dokazani.
In animal studies it has been shown that elvitegravir, cobicistat, and tenofovir are excreted in milk. 
Študije na živalih so pokazale, da se elvitegravir, kobicistat in tenofovir izločajo v mleko.
If Genvoya is stopped for any reason, speak to your doctor before you restart taking Genvoya tablets. 
Če zaradi katerega koli razloga prenehate jemati zdravilo Genvoya, se pogovorite s svojim zdravnikom, preden začnete ponovno jemati tablete zdravila Genvoya.
No patient qualified for resistance analysis through Week 48. 
Do konca 48. tedna noben bolnik ni bil primeren za analizo rezistence.
• cobicistat, a booster (pharmacokinetic enhancer) of the effects of elvitegravir 
• kobicistat, ojačevalec (farmakokinetični ojačevalec) učinkov elvitegravirja
Genvoya demonstrated statistical superiority in achieving HIV-1 RNA < 50 copies/mL when compared to E/C/F/TDF at Week 144. 
Zdravilo Genvoya je izkazalo statistično superiornost pri doseganju HIV-1 RNA < 50 kopij/ml v primerjavi z E/C/F/TDF v 144. tednu.
Elvitegravir is primarily metabolised by CYP3A, and medicinal products that induce or inhibit CYP3A may affect the exposure of elvitegravir. 
Elvitegravir se pretežno presnavlja s CYP3A, zdravila, ki lahko inducirajo ali zavirajo CYP3A, pa lahko vplivajo na izpostavljenost elvitegravirju.
Medicinal products that are highly dependent on CYP3A metabolism and have high first pass metabolism are the most susceptible to large increases in exposure when co-administered with cobicistat (see “Concomitant use contraindicated” and section 4.3). 
Zdravila, ki so močno odvisna od presnove CYP3A in imajo obsežno presnovo prvega prehoda, so najbolj občutljiva na velika povečanja v izpostavljenosti pri sočasnem dajanju s kobicistatom (glejte "Kontraindicirana sočasna uporaba" in poglavje 4.3).
In a separate Phase 1 study of emtricitabine alone, mean systemic emtricitabine exposure was higher in patients with severe renal impairment (estimated CrCl < 30 mL/min) (33.7 µg•h/mL) than in subjects with normal renal function (11.8 µg•h/mL). 
V ločeni študiji 1. faze samo z emtricitabinom je bila povprečna sistemska izpostavljenost emtricitabinu večja pri bolnikih s hudo okvaro ledvic (ocenjeni CrCl < 30 ml/min) (33,7 µg•h/ml) kot pri preskušancih z normalnim delovanjem ledvic (11,8 µg•h/ml).
Cobicistat is also a weak CYP2D6 inhibitor and is metabolised, to a minor extent, by CYP2D6. 
Kobicistat je tudi šibak zaviralec CYP2D6 in se v manjšem obsegu presnavlja s CYP2D6.
N/A = not applicable 
n/v = ne velja
Pregnant women should not take Genvoya. 
Nosečnice zdravila Genvoya ne smejo jemati.
At screening, 42% of patients were receiving FTC/tenofovir disoproxil plus atazanavir (boosted by either cobicistat or ritonavir), 32% of patients were receiving E/C/F/TDF, and 26% of patients were receiving EFV/FTC/tenofovir disoproxil. 
Pri presejanju je 42 % bolnikov prejemalo FTC/dizoproksiltenofovirat z atazanavirjem (ojačanim s kobicistatom ali ritonavirjem), 32 % bolnikov je prejemalo E/C/F/TDF in 26 % bolnikov je prejemalo EFV/FTC/dizoproksiltenofovirat.
Genvoya may interact with other medicines. 
Zdravilo Genvoya lahko medsebojno deluje z drugimi zdravili.
Cobicistat and tenofovir alafenamide are not inhibitors of human UGT1A1 in vitro. 
Kobicistat in tenofoviralafenamid in vitro nista zaviralca humanega UGT1A1.
If you forget to take Genvoya 
Če ste pozabili vzeti zdravilo Genvoya
Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir. 
Lahek obrok ni vplival na izpostavljenost kobicistatu in čeprav je bilo pri obroku z visoko vsebnostjo maščobe vidno zmerno zmanjšanje Cmax za 24 % in AUC za 18 %, razlike v učinku farmakokinetične krepitve elvitegravirja niso opazili.
Tenofovir alafenamide is minimally metabolised by CYP3A4. 
Tenofoviralafenamid se minimalno presnavlja s CYP3A4.
For information on other acid reducing agents (e.g., H2-receptor antagonists and proton pump inhibitors), see “Studies conducted with other medicinal products”. 
antagonisti receptorjev H2 in zaviralci protonske črpalke) glejte “Študije, opravljene z drugimi zdravili”.
• If you notice within 18 hours of the time you usually take Genvoya, you must take the tablet as soon as possible. 
• Če to opazite v roku 18 ur od časa, ko zdravilo Genvoya običajno vzamete, morate tableto vzeti čim prej.
The mean age was 58 years (range 24-82), with 63 patients (26%) who were ≥ 65 years of age. 
Povprečna starost je bila 58 let (razpon 24-82), s 63 bolniki (26 %), starimi ≥ 65 let.
Of the 62 patients who were HBV suppressed at baseline, 59 remained suppressed and 3 had missing data. 
Med 62 bolniki, ki so imeli ob izhodišču supresijo HBV, je 59 ohranilo supresijo, za 3 pa so podatki manjkali.
b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex-US). 
b V obeh študijah so bili bolniki stratificirani glede na začetno vrednost HIV-1 RNA (≤ 100.000 kopij/ml, > 100.000 kopij/ml do ≤ 400.000 kopij/ml ali > 400.000 kopij/ml), po številu celic CD4+ (< 50 celic/μl, 50-199 celic/μl ali ≥ 200 celic/μl) in po regiji (ZDA ali zunaj ZDA).
• antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin 
• antibiotike, ki se uporabljajo za zdravljenje bakterijskih okužb, vključno s tuberkulozo, ki vsebujejo: rifabutin, klaritromicin in telitromicin
• If you notice 18 hours or more after the time you usually take Genvoya, then do not take the missed dose. 
• Če to opazite po 18 urah ali več od časa, ko običajno vzamete zdravilo Genvoya, pozabljenega odmerka ne vzemite.
Based on these limited data, the safety profile of Genvoya in patients with HIV/HBV co-infection was similar to that in patients with HIV-1 monoinfection. 
Na podlagi teh omejenih podatkov je bil varnostni profil zdravila Genvoya pri bolnikih s sočasno okužbo s HIV/HBV podoben kot pri bolnikih z okužbo samo s HIV-1.
Genvoya film-coated tablets are green, capsule-shaped tablets, debossed on one side with “GSI” and the number “510” on the other side of the tablet. 
Zdravilo Genvoya filmsko obložene tablete so zelene tablete kapsulne oblike z vtisnjenim znakom “GSI” na eni strani in številko “510” na drugi strani.
• sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam 
• sedative in hipnotike, ki se uporabljajo za zdravljenje tesnobe: buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem in lorazepam
Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2). 
Zdravila Genvoya niso preučili pri bolnikih s hudo jetrno okvaro (stopnje C po Child-Pughu); zato se uporaba zdravila Genvoya pri bolnikih s hudo jetrno okvaro ne priporoča (glejte poglavji 4.4 in 5.2).
Tenofovir is eliminated from the body by the kidneys by both glomerular filtration and active tubular secretion. 
Tenofovir se iz telesa izloča z ledvicami s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
While taking Genvoya you may still develop infections or other illnesses associated with HIV infection. 
Med jemanjem zdravila Genvoya se lahko pojavijo okužbe ali druge bolezni, povezane z okužbo z virusom HIV.
What Genvoya is and what it is used for What you need to know before you take Genvoya How to take Genvoya 
Kaj je zdravilo Genvoya in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Genvoya Kako jemati zdravilo Genvoya Možni neželeni učinki
Viruses expressing elvitegravir or raltegravir resistance mutations maintain susceptibility to dolutegravir. 
Virusi, ki izražajo mutacije, povezane z odpornostjo na elvitegravir ali raltegravir, ohranjajo občutljivost za dolutegravir.
Relative to fasting conditions, the administration of Genvoya with a light meal (~400 kcal, 20% fat) or high-fat meal (~800 kcal, 50% fat) did not affect overall exposures of tenofovir alafenamide to a clinically meaningful extent (approximately 15% and 18% higher AUC with a light or high-fat meal, respectively, versus fasted). 
Relativno glede na pogoje na tešče dajanje zdravila Genvoya z lahkim obrokom (~400 kcal, 20 % maščobe) ali obrokom z visoko vsebnostjo maščobe (~800 kcal, 50 % maščobe) ni vplivalo na splošno izpostavljenost tenofoviralafenamidu v klinično pomembnem obsegu (približno 15 % oz. 18 % višja vrednost AUC z lahkim obrokom oz. z obrokom z visoko vsebnostjo maščobe v primerjavi s stanjem na tešče).
Tricyclic antidepressants (TCAs) Trazodone 
triciklični antidepresivi (TCA
When administering with Genvoya, the maximum daily dose of ketoconazole should not exceed 200 mg per day. 
Pri dajanju z zdravilom Genvoya največji dnevni odmerek ketokonazola ne sme preseči 200 mg dnevno.
Following oral administration with food in HIV-1 infected patients, peak plasma concentrations were observed approximately 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 1 hour post-dose for tenofovir alafenamide. 
Po peroralnem dajanju s hrano bolnikom, okuženim z virusom HIV-1, so najvišje plazemske koncentracije opazili približno 4 ure po odmerku za elvitegravir, 3 ure po odmerku za kobicistat, 3 ure po odmerku za emtricitabin in 1 uro po odmerku za tenofoviralafenamid.
In a human clinical study of 35 healthy subjects, echocardiograms performed at baseline and after receiving 150 mg cobicistat once daily for at least 15 days indicated no clinically significant change in left ventricular function. 
V klinični študiji pri človeku s 35 zdravimi osebami ehokardiogrami, opravljeni ob začetku in po vsaj 15-dnevnem prejemanju 150 mg kobicistata enkrat dnevno ne kažejo klinično pomembnih sprememb delovanja levega prekata.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported; however, the reported time to onset is more variable, and these events can occur many months after initiation of treatment (see section 4.4). 
Poročali so tudi o pojavu avtoimunskih bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), vendar pa je poročani čas do pojava različen in se ti dogodki lahko pojavijo več mesecev po uvedbi zdravljenja (glejte poglavje 4.4).
Based on this, section 4.8 of the SmPC of medicinal products containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC has been updated to add suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) as new adverse drug reactions. 
Na podlagi tega je bilo posodobljeno poglavje 4.8 povzetka glavnih značilnosti zdravila za zdravila, ki vsebujejo elvitegravir/kobicistat/emtricitabin/afenamidtenofovirat v obliki FDC, kjer sta bila dodana samomorilne misli in samomorilno vedenje (pri bolnikih s predhodno anamnezo depresije ali psihiatrične bolezni) kot nova neželena učinka zdravila.
Following administration of tenofovir alafenamide, plasma [14C]-radioactivity showed a time-dependent profile with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period. 
Po dajanju tenofoviralafenamid je plazemska [14C]-radioaktivnost pokazala od časa odvisni profil, pre tem je bil tenofoviralafenamid najbolj zastopana vrsta radioaktivnosti v prvih nekaj urah in sečna kislina v preostalem obdobju.