FrancophonIA/ELRC3.0 huggingface dataset:
English: c Includes patients who had ≥ 50 copies/mL in the Week 48 or 144 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Croatian: c Obuhvatilo bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. ili 144. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu posljedica nuspojava, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
English: In vitro binding of tenofovir to human plasma proteins is < 0.7% and is independent of concentration over the range of 0.01-25 µg/mL.
Croatian: In vitro vezanje tenofovira za humane proteine plazme je < 0,7% i ne ovisi o koncentraciji u rasponu od 0,01-25 µg/ml.
English: 2 This adverse reaction was not observed in the Phase 3 clinical studies for Genvoya but identified from clinical studies for elvitegravir when used with other antiretrovirals.
Croatian: Ova nuspojava nije uočena u fazi 3 kliničkih ispitivanja lijeka Genvoya ali je prepoznata u kliničkim ispitivanjima elvitegravira kad se koristio s drugim antiretrovirusnim lijekovima
English: Ninety-two percent (66/72 patients) had HBV DNA < 29 IU/mL using missing = failure analysis at Week 48.
Croatian: Devedeset dva posto (66/72 bolesnika) imalo je HBV DNA < 29 IU/ml, što je utvrđeno analizom nepoznato = neuspjeh u 48. tjednu.
English: Seventy-six percent were male, 82% were Black and 18% were White.
Croatian: Sedamdeset šest posto bili su muškarci, 82% bili su crnci, a 18% bijelci.
English: atorvastatin and pitavastatin
Croatian: atorvastatin i pitavastatin
English: Voxilaprevir:
Croatian: Voksilaprevir:
English: In phenotypic analyses of patients in the final resistance analysis population, 7 of 22 patients (32%) had HIV-1 isolates with reduced susceptibility to elvitegravir in the Genvoya group compared with HIV-1 isolates from 7 of 20 patients (35%) in the E/C/F/TDF group, HIV-1 isolates from 8 patients (36%) had reduced susceptibility to emtricitabine in the Genvoya group compared with HIV-1 isolates from 7 patients (35%) in the E/C/F/TDF group.
Croatian: U fenotipskim analizama bolesnika iz populacije za analizu konačne rezistencije, 7 od 22 bolesnika (32%) je imalo HIV-1 izolate sa smanjenom osjetljivošću na elvitegravir u skupini liječenoj lijekom Genvoya u usporedbi s HIV-1 izolatima 7 od 20 bolesnika (35%) u skupini koja je primala E/C/F/TDF, HIV-1 izolati 8 bolesnika (36%) imali su smanjenu osjetljivost na emtricitabin u skupini liječenoj lijekom Genvoya u usporedbi s HIV-1 izolatima od 47 bolesnika (35%) u skupini koja je primala E/C/F/TDF.
English: Changes in measures of bone mineral density
Croatian: Promjene u izmjerenoj mineralnoj gustoći kosti
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 4.8).
Croatian: Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali lijek Genvoya (vidjeti dio 4.8).
English: Up to Week 144, the development of one or more primary elvitegravir, emtricitabine, or tenofovir alafenamide resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and Genvoya treatment-failure isolates (12 of 866 patients [1.4%]) compared with 12 of 20 treatment-failure isolates from patients with evaluable genotypic data in the E/C/F/TDF treatment group (12 of 867 patients [1.4%]).
Croatian: Do 144. tjedna uočena je jedna ili više primarnih mutacija povezanih s rezistencijom na elvitegravir, emtricitabin ili tenofoviralafenamid u HIV-1 izolatima 12 od 22 bolesnika s procjenjivim genotipskim podacima iz uparene početne vrijednosti i izolata iz neuspješnog liječenja lijekom Genvoya (12 od 866 bolesnika [1,4%]) u usporedbi s 12 od 20 izolata od bolesnika s procjenjivim genotipskim podacima iz skupine neuspješnog liječenja E/C/F/TDF (12 od 867 bolesnika [1,4%]).
English: Elvitegravir is 98-99% bound to human plasma proteins and binding is independent of drug concentration over the range of 1 ng/mL to 1.6 µg/mL.
Croatian: Elvitegravir je 98-99% vezan za proteine u plazmi ljudi i vezivanje je neovisno o koncentraciji lijeka u rasponu od 1 ng/ml do 1,6 µg/ml.
English: Co-administration of Genvoya and some medicinal products that are primarily metabolised by CYP3A may result in increased plasma concentrations of these products, which are associated with the potential for serious or life-threatening adverse reactions such as peripheral vasospasm or ischaemia (e.g., dihydroergotamine, ergotamine, ergometrine), or myopathy, including rhabdomyolysis (e.g., simvastatin, lovastatin), or prolonged or increased sedation or respiratory depression (e.g., orally administered midazolam or triazolam).
Croatian: Istodobna primjena lijeka Genvoya i nekih lijekova koje prvenstveno metabolizira CYP3A može rezultirati povećanim koncentracijama tih lijekova u plazmi, koje su povezane s potencijalno ozbiljnim ili životno opasnim nuspojavama, kao što su periferni vazospazam ili ishemija (npr. dihidroergotamin, ergotamin, ergometrin) ili miopatija, uključujući i rabdomiolizu (npr. simvastatin, lovastatin) ili dugotrajna ili povećana sedacija ili respiratorna depresija (npr. midazolam primijenjen peroralno,
English: In studies in treatment-naïve patients, Genvoya was associated with smaller reductions in bone mineral density (BMD) compared to E/C/F/TDF as measured by DXA analysis of hip (mean change: -0.8% versus -3.4%, p < 0.001) and lumbar spine (mean change: -0.9% versus -3.0%, p < 0.001) after 144 weeks of treatment.
Croatian: U ispitivanjima u bolesnika koji prethodno nisu bili liječeni, lijek Genvoya bio je povezan s manjim smanjenjima mineralne gustoće kosti (BMD) u usporedbi s E/C/F/TDF izmjereno DXA analizom kuka (srednja vrijednost promjene: -0,8% naspram -3,4%, p < 0,001) i lumbalne kralježnice (srednja vrijednost promjene: -0,9% naspram -3,0%, p < 0,001) nakon 144 tjedna liječenja.
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chain-termination.
Croatian: Tenofovirdifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK pomoću HIV RT što dovodi do prekida lanca DNK.
English: Nineteen percent of patients were identified as Hispanic/Latino.
Croatian: Devetnaest posto bolesnika identificirano je kao Hispanoamerikanci/Latinoamerikanci.
English: All corticosteroids excluding cutaneous products Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Croatian: Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Croatian: Tenofoviralafenamid je nukleotidni inhibitor reverzne transkriptaze (NtRTI) i fosforoamidatni prolijek tenofovira (analog 2'-deoksiadenozin monofosfata).
English: Carbamazepine decreases plasma concentrations of elvitegravir and cobicistat, which may result in loss of therapeutic effect and development of resistance.
Croatian: Karbamazepin smanjuje koncentracije elvitegravira i kobicistata u plazmi, što može dovesti do gubitka terapijskog učinka i razvoja rezistencije.
English: Based on data from an in vitro study, co-administration of tenofovir alafenamide and xanthine oxidase inhibitors (e.g., febuxostat) is not expected to increase systemic exposure to tenofovir in vivo.
Croatian: Na temelju podataka in vitro ispitivanja ne očekuje se da će istodobna primjena tenofoviralafenamida i inhibitora ksantin oksidaze (npr. febuksostata) povećati sistemsku izloženost tenofoviru in vivo.
English: The median (Q1, Q3) change from baseline in total cholesterol to HDL-cholesterol ratio at Week 144 was 0.2 (-0.3, 0.7) in the Genvoya group and 0.1 (-0.4, 0.6) in the E/C/F/TDF group (p = 0.006 for the difference between treatment groups).
Croatian: Medijan (Q1, Q3) promjene omjera ukupnog kolesterola i HDL kolesterola od početne vrijednosti u 144. tjednu bio je 0,2 (-0,3; 0,7) u skupini liječenoj lijekom Genvoya i 0,1 (-0,4; 0,6) u skupini liječenoj E/C/F/TDF (p = 0,006 za razliku između liječenih skupina).
English: Thirteen percent of patients were identified as Hispanic/Latino.
Croatian: Trinaest posto su identificirani kao Hispanoamerikanci/Latinoamerikanci.
English: Dose modifications are not necessary when administered in combination with Genvoya.
Croatian: Izmjene doze nisu potrebne kada se primjenjuje u kombinaciji s lijekom Genvoya.
English: In vitro and clinical pharmacokinetic drug-drug interaction studies have shown that the potential for CYP-mediated interactions involving emtricitabine with other medicinal products is low.
Croatian: In vitro i klinička farmakokinetička ispitivanja interakcija lijekova pokazala su da je mogućnost interakcija posredovanih CYP sustavom za emtricitabin s drugim lijekovima mala.
English: However, upon co-administration with cobicistat in Genvoya, near maximal inhibition of P-gp by cobicistat is achieved leading to increased availability of tenofovir alafenamide with resulting exposures comparable to tenofovir alafenamide 25 mg administered alone.
Croatian: Ipak, pri istodobnoj primjeni s kobicistatom u lijeku Genvoya, dostigne se gotovo maksimalna inhibicija P-gp-a kobicistatom te dolazi do porasta raspoloživosti tenofoviralafenamida, što dovodi do izloženosti koja je usporediva s izloženošću pri primjeni 25 mg tenofoviralafenamida u monoterapiji.
English: • anticoagulants, used to prevent and treat blood clots, such as: apixaban, edoxaban, rivaroxaban and warfarin
Croatian: • antikoagulanse, primjenjuju se za sprječavanje i liječenje krvnih ugrušaka, kao što su: apiksaban, edoksaban, rivaroksaban i varfarin
English: Upon co-administration with the moderate CYP3A inducer probe efavirenz, tenofovir alafenamide exposure was not significantly affected.
Croatian: Nakon istodobne primjene s efavirenzom, umjerenim induktorom CYP3A, kao testom, izloženost tenofoviralafenamidu se nije značajno promijenila.
English: Indigo carmine aluminium lake (E132) Iron oxide yellow (E172)
Croatian: boja indigo carmine aluminium lake (E132)
English: d Includes patients who had ≥ 50 copies/mL in the Week 48 or Week 96 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Croatian: d Obuhvatilo bolesnika koji su imali ≥ 50 kopija/ml u okviru 48. ili 96. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu posljedica nuspojava, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusnu vrijednost ≥ 50 kopija/ml.
English: Co-administration of apixaban, rivaroxaban or edoxaban is not recommended with Genvoya.
Croatian: Ne preporučuje se istodobna primjena apiksabana, rivaroksabana ili edoksabana s Genvoyom.
English: No clinically relevant pharmacokinetic differences due to gender or ethnicity have been identified for cobicistat-boosted elvitegravir, cobicistat, emtricitabine, or tenofovir alafenamide.
Croatian: Klinički značajne farmakokinetičke razlike vezane uz spol ili etničku pripadnost nisu ustanovljene za kobicistatom pojačani elvitegravir, kobicistat, emtricitabin ili tenofoviralafenamid.
English: On days of haemodialysis, Genvoya should be administered after completion of haemodialysis treatment.
Croatian: Na dane hemodijalize, lijek Genvoya treba primijeniti nakon završetka postupka hemodijalize.
English: 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 PBMCs.
Croatian: Antivirusna aktivnost emtricitabina na laboratorijske i kliničke izolate virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC.
English: • erectile dysfunction medicines, used to treat impotence, such as:
Croatian: • kontracepcijske pilule, primjenjuju se za sprječavanje trudnoće • lijekove za erektilnu disfunkciju, primjenjuju se za liječenje impotencije, kao što su:
English: Disopyramide Flecainide Systemic lidocaine Mexiletine Propafenone
Croatian: Flekainid Sistemski lidokain
English: Co-administration of Genvoya and other medicinal products primarily metabolised by CYP3A such as amiodarone, quinidine, cisapride, pimozide, lurasidone, alfuzosin and sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
Croatian: Kontraindicirana je i istodobna primjena lijeka Genvoya i drugih lijekova koje prvenstveno metabolizira CYP3A, kao što su amiodaron, kinidin, cisaprid, pimozid, lurasidon, alfuzozin i sildenafil za plućnu arterijsku hipertenziju (vidjeti dio 4.3).
English: Lactose (as monohydrate), microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, silicon dioxide, sodium lauryl sulfate, magnesium stearate.
Croatian: Laktoza (u obliku hidrata), mikrokristalična celuloza, umrežena karmelozanatrij, hidroksipropilceluloza, silicijev dioksid, natrijev laurilsulfat, magnezijev stearat.
English: Concentrations of calcium channel blockers may be increased when co-administered with cobicistat.
Croatian: Koncentracije blokatora kalcijevih kanala mogu se povećati s istodobnom primjenom kobicistata.
English: Exposures of emtricitabine and tenofovir in 12 patients with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis who received Genvoya in Study GS-US-292-1825 were significantly higher than in patients with normal renal function.
Croatian: Izloženost emtricitabinu i tenofoviru u 12 bolesnika sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi koji su primali lijek Genvoya u ispitivanju GS-US-292-1825 bila je značajno veća nego u bolesnika s normalnom funkcijom bubrega.
English: For information on other acid reducing agents (e.g., H2-receptor antagonists and proton pump inhibitors), see “Studies conducted with other medicinal products”.
Croatian: Informacije o drugim lijekovima koji reduciraju kiselinu (npr. antagonisti H2-receptora i inhibitori protonske pumpe)
English: Genvoya should not be co-administered with other antiretroviral medicinal products (see section 4.5).
Croatian: Genvoya se ne smije primjenjivati istodobno s drugim antiretrovirusnim lijekovima (vidjeti dio 4.5).
English: While you are taking Genvoya
Croatian: Dok uzimate lijek Genvoya
English: • Do not breast-feed during treatment with Genvoya.
Croatian: • Nemojte dojiti tijekom liječenja lijekom Genvoya.
English: • medicines used to treat diabetes:
Croatian: • lijekove za liječenje dijabetesa:
English: Genvoya should generally be avoided but may be used in adults with end stage renal disease (estimated CrCl < 15 mL/min) on chronic haemodialysis if the potential benefits outweigh the potential risks (see section 4.2).
Croatian: Iako liek Genvoya općenito treba izbjegavati u odraslih sa završnim stadijem bolesti bubrega (procijenjeni CrCl < 15 ml/min) na kroničnoj hemodijalizi, može ga se primijeniti ako se smatra da su moguće koristi veće od mogućih rizika (vidjeti dio 4.2).
English: Co-administration of Genvoya with dabigatran is contraindicated.
Croatian: Istodobna primjena Genvoye s dabigatranom je kontraindicirana.
English: There were no clinically significant changes in fasting lipid laboratory tests in patients who switched to Genvoya.
Croatian: Nije bilo klinički značajnih promjena u laboratorijskim vrijednostima lipida izmjerenih natašte u bolesnika koji su prebačeni na lijek
English: In animal studies there were no effects of elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide on mating or fertility parameters (see section 5.3).
Croatian: U ispitivanjima na životinjama nije bilo učinaka elvitegravira, kobicistata, emtricitabina i tenofoviralafenamida na parenje ili parametre plodnosti (vidjeti dio 5.3).
English: In a clinical study (GS-US-292-0106) in which Genvoya was administered to 23 HIV-1 infected paediatric patients with a mean age of 10 years (range 8 to 11 years), the mean exposures of elvitegravir, cobicistat, emtricitabine, tenofovir, and tenofovir alafenamide were higher (20 to 80%) than the mean exposures achieved in adults (see sections 4.1 and 5.2).
Croatian: U kliničkom ispitivanju (GS-US-292-0106) u kojem su 23 pedijatrijska bolesnika zaražena virusom HIV-1 srednje vrijednosti dobi od 10 godina (u rasponu od 8 do 11 godina) primala lijek Genvoya, srednje vrijednosti izloženosti elvitegraviru, kobicistatu, emtricitabinu, tenofoviru i tenofoviralafenamidu su bile više (od 20% do 80%) od srednjih vrijednosti izloženosti postignutih u odraslih (vidjeti dijelove 4.1 i 5.2).
English: Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets.
Croatian: Genvoya 150 mg/150 mg/200 mg/10 mg filmom obložene tablete.
English: A minimal infiltration of histiocytes was present in the eye in dogs at tenofovir alafenamide and tenofovir exposures of approximately 4 and 17 times greater, respectively, than those expected after administration of Genvoya.
Croatian: U oku pasa bila je prisutna minimalna infiltracija histiocitima kod izloženosti tenofoviralafenamidu i tenofoviru koja je bila približno 4 odnosno 17 puta veća od one očekivane nakon primjene lijeka Genvoya.
English: The mean baseline plasma HIV-1 RNA was 4.5 log10 copies/mL (range 1.3-7.0) and 23% had baseline viral loads > 100,000 copies/mL.
Croatian: Srednja početna vrijednost HIV-1 RNK u plazmi bila je 4,5 log10 kopija/ml (raspon1,3-7,0), a 23% imalo je početno virusno opterećenje > 100 000 kopija/ml.
English: Cobicistat is a strong mechanism-based inhibitor of CYP3A and is also a CYP3A substrate.
Croatian: Kobicistat je snažan inhibitor CYP3A temeljeno na mehanizmu te također i supstrat za CYP3A.
English: If alternatives cannot be used, its use should only take place after medical evaluation and under close monitoring by your doctor for corticosteroid side effects.
Croatian: potrebno je započeti s primjenom tih lijekova tek nakon medicinske procjene i pod pomnim praćenjem liječnika radi eventualnih nuspojava kortikosteroida.
English: There were no new safety issues identified in patients with end stage renal disease on chronic haemodialysis receiving Genvoya (see section 5.2).
Croatian: Nije bilo utvrđenih novih sigurnosnih pitanja u bolesnika sa završnim stadijem bolesti bubrega na kroničnoj hemodijalizi koji su primali lijek Genvoya (vidjeti dio 5.2).
English: 5.4% (95% CI: 1.5% to 9.2%)
Croatian: 5,4% (95% CI: 1,5% do 9,2%)
English: The median increase from baseline for those parameters was greater in the Genvoya group compared with the E/C/F/TDF group at Week 144 (p < 0.001 for the difference between treatment groups for fasting total cholesterol, direct LDL- and HDL-cholesterol, and triglycerides).
Croatian: Medijan porasta ovih parametara od početnih vrijednosti bio je veći u skupini liječenoj lijekom Genvoya u usporedbi sa skupinom liječenom E/C/F/TDF u 144. tjednu (p < 0,001 za razliku između liječenih skupina u vrijednostima ukupnog kolesterola, LDL i HDL kolesterola te triglicerida natašte).
English: f Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy; e.g., withdrew consent, loss to follow-up, etc.
Croatian: f Obuhvaća bolesnike s prekidom iz razloga koji nisu posljedica nuspojava, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
English: d Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Croatian: d Obuhvaća bolesnike koji su prekinuli liječenje zbog nuspojava ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskiog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
English: Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno životno opasnih jetrenih nuspojava.
English: The use of Genvoya should be accompanied by the use of effective contraception (see sections 4.4 and 4.5).
Croatian: Uz primjenu lijeka Genvoya mora se koristiti učinkovita kontracepcija (vidjeti dijelove 4.4 i 4.5).
English: Genvoya should be discontinued in patients with estimated CrCl that declines below 30 mL/min during treatment (see section 5.2).
Croatian: Potrebno je prekinuti liječenje lijekom Genvoya u bolesnika u kojih procijenjeni CrCl tijekom liječenja opada na vrijednosti ispod 30 ml/min (vidjeti dio 5.2).
English: 6 This study was conducted using emtricitabine/tenofovir alafenamide.
Croatian: To je ispitivanje provedeno pomoću emtricitabina/tenofoviralafenamida.
English: e Includes patients who discontinued due to AE or death at any time point from Day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Croatian: e Obuhvaća bolesnike koji su prekinuli liječenje zbog nuspojava ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskog okvira, ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
English: Co-administration of carbamazepine, a potent CYP3A inducer, may significantly decrease cobicistat plasma concentrations.
Croatian: Istodobna primjena karbamazepina, snažnog induktora CYP3A, može značajno smanjiti koncentracije kobicistata u plazmi.
English: Concentrations of itraconazole, fluconazole and posaconazole may be increased when co-administered with cobicistat.
Croatian: Koncentracije itrakonazola, flukonazola i posakonazola mogu se povećati s istodobnom primjenom kobicistata.
English: The steady-state mean Cmax, AUCtau, and Ctrough (mean ± SD) in HIV-1 infected patients, respectively, were 1.7 ± 0.39 µg/mL, 23 ± 7.5 µg•h/mL, and 0.45 ± 0.26 µg/mL for elvitegravir, which provides inhibitory quotient of ~10 (ratio of Ctrough: protein binding-adjusted IC95 for wild-type HIV-1 virus).
Croatian: Srednje vrijednosti Cmax, AUCtau i Ctrough (srednja vrijednost ± SD) u stanju dinamičke ravnoteže u bolesnika zaraženih virusom HIV-1 bile su 1,7 ± 0,39 µg/ml, 23 ± 7,5 µg•h/ml, i 0,45 ± 0,26 µg/ml za elvitegravir, što omogućuje inhibitorski kvocijent od ~ 10 (omjer Ctrough: IC95 s prilagođenim proteinskim vezivanjem za divlji tip virusa HIV-1).
English: Treatment with cobicistat and elvitegravir during pregnancy results in lower elvitegravir exposure (see sections 4.4 and 5.2).
Croatian: Liječenje kobicistatom i elvitegravirom tijekom trudnoće rezultirat će manjom izloženošću elvitegraviru (vidjeti dijelove 4.4 i 5.2).
English: As the effect of cationic complexation of elvitegravir cannot be excluded when Genvoya is co-administered with multivitamin supplements, it is recommended to separate Genvoya and multivitamin supplements dosing by at least 4 hours.
Croatian: Kako se učinak kationske kompleksacije elvitegravira ne može isključiti kada se Genvoya istodobno primjenjuje s multivitaminskim dodacima,