FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of bictegravir with medicinal products that potently inhibit both CYP3A and UGT1A1, such as atazanavir, may significantly increase plasma concentrations of bictegravir, therefore co-administration is not recommended.
Slovenian: Sočasna uporaba biktegravirja in zdravil, ki močno zavirajo CYP3A in UGT1A1, kot je atazanavir, lahko močno poveča koncentracije biktegravirja v plazmi, zato sočasna uporaba ni priporočljiva.
English: Biktarvy [Outer packaging only]
Slovenian: Biktarvy [samo na zunanji ovojnini]
English: The multiple dose pharmacokinetics of emtricitabine are dose proportional over the dose range of 25 to 200 mg. Tenofovir alafenamide exposures are dose proportional over the dose range of 8 mg to 125 mg.
Slovenian: Farmakokinetika večkratnega odmerjanja biktegravirja je sorazmerna z odmerkom v razponu odmerka od 25 do 100 mg. Farmakokinetika večkratnega odmerjanja emtricitabina je sorazmerna z odmerkom v razponu odmerka od 25 do 200 mg. Izpostavljenosti alafenamidtenofoviratu so sorazmerne z odmerkom v razponu odmerka od 8 mg do 125 mg.
English: When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist.
Slovenian: Ko se vaše zaloge zdravila Biktarvy manjšajo, si ga priskrbite pri zdravniku ali farmacevtu.
English: Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine triphosphate.
Slovenian: Celični encimi fosforilirajo emtricitabin v emtricitabin trifosfat.
English: HIV-1 RNA < 20 copies/mL
Slovenian: HIV-1 RNA < 50 kopij/ml
English: Nineteen percent of patients identified as Hispanic/Latino.
Slovenian: Devetnajst odstotkov bolnikov je bilo hispanskega/latinskoameriškega porekla.
English: - azithromycin, clarithromycin, rifabutin or rifapentine
Slovenian: - azitromicin, klaritromicin, rifabutin ali rifapentin
English: What Biktarvy looks like and contents of the pack
Slovenian: Izgled zdravila Biktarvy in vsebina pakiranja
English: 0.0% (-2.5% to 2.5%)
Slovenian: 0,0 % (-2,5 % do 2,5 %)
English: No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Slovenian: Ledvična okvara Odmerka zdravila Biktarvy pri bolnikih z ocenjenim očistkom kreatinina (CrCl - creatinine clearance) ≥ 30 ml/min ni treba prilagoditi.
English: In treatment-naïve (Studies GS-US-380-1489 and GS-US-380-1490) and virologically-suppressed patients (Studies GS-US-380-1844 and GS-US-380-1878), no patient receiving Biktarvy had HIV-1 with treatment-emergent genotypic or phenotypic resistance to bictegravir, emtricitabine, or tenofovir alafenamide in the final resistance analysis population (n = 10) with HIV-1 RNA ≥ 200 copies/mL at the time of confirmed virologic failure, Week 48, Week 96 (treatment naïve studies only) or early study drug discontinuation.
Slovenian: Pri predhodno nezdravljenih bolnikih (študiji GS-US-380-1489 in GS-US-380-1490) in bolnikih z virološko supresijo (študiji GS-US-380-1844 in GS-US-380-1878), ni imel noben bolnik, ki je dobival zdravilo Biktarvy, HIV-1 z genotipsko ali fenotipsko rezistenco na biktegravir, emtricitabin ali alafenamidtenofovirat v končni populacijski analizi rezistence (n = 10) s HIV-1 RNA ≥ 200 kopij/ml v času potrjenega virološkega neuspeha, v 48. tednu, 96. tednu (samo študije s predhodno nezdravljenimi bolniki) ali predčasne prekinitve zdravljenja z zdravilom.
English: In vitro studies have shown that tenofovir alafenamide is metabolised to tenofovir (major metabolite) by cathepsin A in PBMCs (including lymphocytes and other HIV target cells) and macrophages; and by carboxylesterase-1 in hepatocytes.
Slovenian: Študije in vitro so pokazale, da se alafenamidtenofovirat presnavlja v tenofovir (glavni presnovek) s pomočjo katepsina A v PBMC (vključno z limfociti in drugimi ciljnimi celicami HIV) in makrofagih ter s karboksilesterazo-1 v hepatocitih.
English: B/F/TAF was non-inferior in achieving HIV-1 RNA < 50 copies/mL at both Weeks 48 and 96 when compared to abacavir/dolutegravir/lamivudine and to dolutegravir + emtricitabine/tenofovir alafenamide, respectively.
Slovenian: Učinkovitost B/F/TAF pri doseganju HIV-1 RNA < 50 kopij/ml tako v 48. kot tudi 96. tednu ni bila slabša v primerjavi z abakavirjem/dolutegravirjem/lamivudinom in dolutegravirjem + emtricitabinom/alafenamidtenofoviratom.
English: If the patient misses a dose of Biktarvy within 18 hours of the time it is usually taken, the patient should take Biktarvy as soon as possible and resume the normal dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Biktarvy v roku 18 ur od časa, ko ga običajno vzame, naj vzame zdravilo Biktarvy takoj, ko je mogoče, nato pa nadaljuje z običajnim režimom odmerjanja.
English: Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Slovenian: Alafenamidtenofovirat in vivo ni zaviralec ali induktor CYP3A.
English: HIV-1 isolates with the K65R mutation have low level reduced susceptibility to abacavir, emtricitabine, tenofovir, and lamivudine.
Slovenian: HIV-1 z mutacijo K65R imajo nizko zmanjšano občutljivost za abakavir, emtricitabin, tenofovir in lamivudin.
English: In Studies GS-US-380-1489 and GS-US-380-1490, total bilirubin increases were observed in 15% of treatment-naïve patients administered Biktarvy through Week 96.
Slovenian: V študijah GS-US-380-1489 in GS-US-380-1490 so opazili povečane vrednosti skupnega bilirubina pri 15 % predhodno nezdravljenih bolnikov, ki so dobivali zdravilo Biktarvy do konca 96. tedna.
English: Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment.
Slovenian: Jetrna okvara Klinično pomembnih sprememb v farmakokinetiki biktegravirja pri preskušancih z zmerno jetrno okvaro niso opazili.
English: Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Slovenian: Predklinične študije alafenamidtenofovirata pri podganah in psih so pokazale, da sta primarna ciljna organa toksičnosti kosti in ledvice.
English: Patients were randomised in a 1:1 ratio to either switch to B/F/TAF at baseline (n = 282), or stay on their baseline antiretroviral regimen (n = 281).
Slovenian: Bolniki so bili randomizirani v razmerju 1:1 za prehod na B/F/TAF ob izhodišču (n = 282) ali za nadaljevanje izhodiščnega protiretrovirusnega režima (n = 281).
English: Biktarvy should not be administered concomitantly with medicinal products containing tenofovir alafenamide, tenofovir disoproxil, lamivudine or adefovir dipivoxil used for the treatment of HBV infection.
Slovenian: Zdravila Biktarvy se ne sme dajati skupaj z zdravili, ki vsebujejo alafenamidtenofovirat, dizoproksiltenofovirat, lamivudin ali dipivoksiladefovirat in se uporabljajo za zdravljenje okužbe s
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Slovenian: In vivo se alafenamidtenofovirat hidrolizira v celicah v tenofovir (glavni presnovek), ki se fosforilizira v aktivni presnovek tenofovir difosfat.
English: The efficacy and safety of Biktarvy in virologically-suppressed HIV-1 infected adults are based on 48-week data from a randomised, double-blind, active-controlled study, GS-US-380-1844 (n = 563); and a randomised, open label, active-controlled study, GS-US-380-1878 (n = 577).
Slovenian: Učinkovitost in varnost zdravila Biktarvy pri odraslih bolnikih z virusno supresijo, okuženih z virusom HIV-1, temelji na 48-tedenskih podatkih iz randomizirane, dvojno slepe študije, nadzorovane z učinkovino, GS-US-380-1844 (n = 563); in iz randomizirane, odprte študije, nadzorovane z učinkovino, GS-US-380-1878 (n = 577).
English: Oxcarbazepine Phenobarbital Phenytoin
Slovenian: okskarbazepin fenobarbital fenitoin
English: (Induction of CYP3A and P-gp)
Slovenian: (indukcija CYP3A in P-gp)
English: Co-administration is contraindicated due to the effect of rifampicin on the bictegravir component of Biktarvy.
Slovenian: Sočasno dajanje je kontraindicirano zaradi učinka rifampicina na sestavino biktegravir v zdravilu
English: Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide
Slovenian: Biktarvy 50 mg/200 mg/25 mg filmsko obložene tablete biktegravir/emtricitabin/ alafenamidtenofovirat
English: Interactions between Biktarvy or its individual component(s) and co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓” and no change as “↔”; all No
Slovenian: Interakcije med zdravilom Biktarvy ali posamičnimi učinkovinami in sočasno uporabljenimi zdravili so navedene v preglednici 1 spodaj (povečanje je označeno z znakom »↑«, zmanjšanje z »↓«, brez spremembe z »↔«; vse meje brez učinka (No Effect Boundaries) so 70 %-143 %).
English: If a patient misses a dose of Biktarvy by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Slovenian: Če bolnik izpusti odmerek zdravila Biktarvy za več kot 18 ur, naj ne nadomesti izpuščenega odmerka in preprosto nadaljuje z jemanjem po običajnem režimu odmerjanja.
English: ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Slovenian: PERORALNI KONTRACEPTIVI norgestimat (0,180/0,215/0,250 mg enkrat dnevno)/etinilestradiol (0,025 mg enkrat dnevno), biktegravir1
English: No dose adjustment is required upon co-administration.
Slovenian: Prilagoditev odmerka pri sočasni uporabi ni potrebna.
English: Bictegravir has activity against HIV-1 and HIV-2.
Slovenian: Biktegravir deluje proti HIV-1 in HIV-2.
English: In Study GS-US-380-1489, patients were randomised in a 1:1 ratio to receive either bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (n = 314) or abacavir/dolutegravir/lamivudine (600/50/300 mg) (n = 315) once daily.
Slovenian: V študiji GS-US-380-1489 so bolnike randomizirali v razmerju 1:1 za biktegravir/emtricitabin/ alafenamidtenofovirat (B/F/TAF) (n = 314) ali abakavir/dolutegravir/lamivudin (600/50/300 mg) (n = 315) enkrat dnevno.
English: headache, dizziness
Slovenian: glavobol, omotičnost
English: HIV-1 isolates with reduced susceptibility to tenofovir alafenamide have been selected in cell culture and had the K65R mutation in HIV-1 RT; in addition, a K70E mutation in HIV-1 RT has been transiently observed.
Slovenian: V celični kulturi so bili izbrani izolati HIV-1 z zmanjšano občutljivostjo na alafenamidtenofovirat in mutacijo K65R v RT HIV-1; poleg tega so prehodno opazili mutacijo K70E v HIV-1 RT. Izolati
English: • bictegravir, an antiretroviral medicine known as an integrase strand transfer inhibitor (INSTI)
Slovenian: • biktegravir, protiretrovirusno zdravilo, znano kot zaviralec prenosa zapisa integraze (INSTIintegrase strand transfer inhibitor)
English: If you vomit more than 1 hour after taking Biktarvy you do not need to take another tablet until your next regularly scheduled tablet.
Slovenian: Če bruhate več kot 1 uro po zaužitju zdravila Biktarvy, vam ni treba vzeti še ene tablete, dokler ni čas za naslednjo tableto po vašem urniku.
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Slovenian: Emtricitabin je nukleozidni zaviralec reverzne transkriptaze (NRTI - nucleoside reverse transcriptase inhibitor) in analog 2'-deoksicitidina.
English: DTG = dolutegravir 3TC = lamivudine F/TAF = emtricitabine/tenofovir alafenamide a Week 48 window was between Day 295 and 378 (inclusive).
Slovenian: DTG = dolutegravir 3TC = lamivudin F/TAF = emtricitabin/alafenamidtenofovirat a Okno v 48. tednu je med 295. in 378. dnevom (vključno z njima).
English: If you do miss a dose:
Slovenian: Če ste pozabili vzeti odmerek:
English: Biktarvy can cause dizziness.
Slovenian: Zdravilo Biktarvy lahko povzroči omotičnost.
English: Thirty-five percent of the dose was recovered from urine and consisted primarily of the glucuronide of bictegravir and other minor oxidative metabolites and their phase II conjugates.
Slovenian: Pretežno so ga sestavljali glukuronidi biktegravirja in drugi manj pomembni oksidativni presnovki in njihovi konjugati faze II.
English: • itching (pruritus)
Slovenian: • srbečica (pruritus)
English: Cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to CART.
Slovenian: Opisani so bili primeri osteonekroze, še zlasti pri bolnikih s splošno znanimi dejavniki tveganja,
English: (Inhibition of CYP3A)
Slovenian: (zaviranje CYP3A)
English: HIV-1 RNA ≥ 50 copies/mLb Treatment difference (95% CI)
Slovenian: HIV-1 RNA ≥ 50 kopij/mlb Razlika zdravljenja (95-% IZ)
English: HIV-1 isolates with reduced susceptibility to emtricitabine have been selected in cell culture and had M184V/I mutations in HIV-1 RT.
Slovenian: V celični kulturi so bili izbrani izolati HIV-1 z zmanjšano občutljivostjo na emtricitabin in mutacijo M184V/I v RT HIV-1 .
English: The prevalence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Slovenian: Prevalenca različnih podtipov je bila primerljiva v vseh skupinah zdravljenja, pri čemer je v obeh skupinah prevladoval podtip B; 11 % jih ni bilo podtipov B. Bolniki so bili stratificirani glede na predhodni režim zdravljenja.
English: Reproductive toxicity studies in rats and rabbits showed no effects on mating, fertility, pregnancy or foetal parameters.
Slovenian: Študije o vplivu na sposobnost razmnoževanja pri podganah in kuncih niso pokazale učinkov na parjenje, plodnost, nosečnost ali plod.
English: The protein-adjusted EC95 of bictegravir was 361 nM (0.162 µg/mL) for wild type HIV-1 virus.
Slovenian: Vrednosti 50-odstotno učinkovite koncentracije (EC50) za biktegravir so bile v razponu od < 0,05 do 6,6 nM. Za protein prilagojena vrednost EC95 biktegravirja je bila 361 nM (0,162 µg/ml) za divji tip virusa HIV-1.
English: ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4
Slovenian: ANTIKONVULZIVI karbamazepin (titriran s 100 mg na 300 mg dvakrat dnevno), emtricitabin/ alafenamidtenofovirat4
English: Norgestimate (0.180/0.215/0.250 mg once daily), Ethinylestradiol (0.025 mg once daily), Emtricitabine/Tenofovir alafenamide4
Slovenian: norgestimat (0,180/0,215/0,250 mg enkrat dnevno), etinilestradiol (0,025 mg enkrat dnevno), emtricitabin/ alafenamidtenofovirat
English: Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black.
Slovenian: (razpon 20-79), 83 % je bilo moških, 66 % je bilo belcev in 26 % je bilo črncev.
English: In Study GS-US-380-1844, the efficacy and safety of switching from a regimen of dolutegravir + abacavir/lamivudine or abacavir/dolutegravir/lamivudine to B/F/TAF were evaluated in a randomised, double-blind study of virologically-suppressed (HIV-1 RNA < 50 copies/mL) HIV-1 infected adults (n = 563).
Slovenian: V študiji GS-US-380-1844 so učinkovitost in varnost prehoda z režima dolutegravir + abakavir/lamivudin ali abakavir/dolutegravir/lamivudin na B/F/TAF ocenili v randomizirani, dvojno slepi študiji odraslih z virološko supresijo (HIV-1 RNA < 50 kopij/ml), okuženih z virusom HIV-1 (n = 563).
English: No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Slovenian: Odmerka zdravila Biktarvy pri bolnikih z blago (stopnje A po Child-Pughu) ali zmerno (stopnje B po
English: In Studies GS-US-380-1489 and GS-US-380-1490, the mean increase from baseline in CD4+ cell count at Week 96 was 262, 288, and 281 cells/mm3 in the pooled B/F/TAF, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
Slovenian: V študijah GS-US-380-1489 in GS-US-380-1490 je bilo povprečno povečanje števila celic CD4+ od izhodišča do 96. tedna 262, 288 oz. 281 celic/mm3 za združene skupine B/F/TAF , abakavirja/dolutegravirja/lamivudina oz. dolutegravirja + emtricitabina/alafenamidtenofovirata.
English: Tenofovir alafenamide is transported by P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Slovenian: Alafenamidtenofovirat Alafenamidtenofovirat se prenaša s P-glikoproteinom (P-gp) in proteinom, odpornim na raka dojke
English: Co-administration of Biktarvy with other medicinal products that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.
Slovenian: Sočasno dajanje zdravila Biktarvy z drugimi zdravili, ki zavirajo P-gp in BCRP, lahko poveča absorpcijo in koncentracije alafenamidtenofovirata v plazmi.
English: If a patient vomits more than 1 hour after taking Biktarvy they do not need to take another dose of Biktarvy until the next regularly scheduled dose.
Slovenian: Če bolnik bruha več kot 1 uro po jemanju zdravila Biktarvy, mu do naslednjega rednega odmerka ni treba vzeti drugega odmerka.
English: The EC50 values for tenofovir alafenamide were in the range of 2.0 to 14.7 nM. Tenofovir alafenamide displayed antiviral activity in cell culture against all HIV-1 groups (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from 0.10 to 12.0 nM) and activity against HIV-2 (EC50 values ranged from 0.91 to 2.63 nM).
Slovenian: Vrednosti EC50 za alafenamidtenofovirat so bile v razponu od 2,0 do 14,7 nM. Alafenamidtenofovirat je pokazal protivirusno aktivnost v celični kulturi vseh skupin HIV-1 (M, N in O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu od 0,10 do 12,0 nM) in je pokazal aktivnost proti virusu HIV-2 (vrednosti EC50 so bile v razponu od 0,91 do 2,63 nM).
English: Emtricitabine is rapidly and extensively absorbed following oral administration with peak plasma concentrations occurring at 1.5-2.0 hours after administration of B/F/TAF.
Slovenian: Emtricitabin se po peroralni uporabi hitro in obsežno absorbira, z največjimi koncentracijami v plazmi od 1,5 do 2,0 uri po uporabi B/F/TAF.
English: No human data on the effect of Biktarvy on fertility are available.
Slovenian: Podatkov o učinkih uporabe zdravila Biktarvy na sposobnost razmnoževanja pri ljudeh ni.
English: Relative to fasting conditions, the administration of B/F/TAF with either a moderate fat (~600 kcal, 27% fat) or high fat meal (~800 kcal, 50% fat) resulted in an increase in bictegravir AUC (24%).
Slovenian: Glede na pogoje na tešče je dajanje B/F/TAF z obrokom z zmerno vsebnostjo maščobe (~ 600 kcal, 27 % maščobe) ali veliko vsebnostjo maščobe (~ 800 kcal, 50 % maščobe)
English: (may affect up to 1 in 100 people)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov)
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.
Slovenian: Protivirusna aktivnost emtricitabina proti laboratorijskim in kliničnim izolatom HIV-1 je bila ocenjena v limfoblastoidnih celičnih linijah, celični liniji MAGI CCR5 in PBMC.
English: Bictegravir displayed antiviral activity in cell culture against HIV-1 group (M, N, O), including subtypes A, B, C, D, E, F, and G (EC50 values ranged from < 0.05 to 1.71 nM), and activity against HIV-2 (EC50 = 1.1 nM).
Slovenian: Biktegravir je pokazal protivirusno aktivnost v celični kulturi proti skupini HIV-1 (M, N, O), vključno s podtipi A, B, C, D, E, F in G (vrednosti EC50 so bile v razponu < 0,05 do 1,71 nM), in aktivnost proti HIV-2 (EC50 = 1,1 nM).
English: Tenofovir alafenamide is eliminated following metabolism to tenofovir.
Slovenian: Alafenamidtenofovirat se pretežno izloča po presnovi v tenofovir.
English: B/F/TAF (n = 634)c
Slovenian: (n = 634)c
English: Ferrous fumarate (324 mg single dose), Bictegravir
Slovenian: železov fumarat (324 mg enkratni odmerek), biktegravir (kelacija s polivalentnimi kationi)
English: Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild, moderate, or severe hepatic impairment.
Slovenian: Klinično pomembnih sprememb v farmakokinetiki alafenamidtenofovirata ali njegovega presnovka tenofovirja pri bolnikih z blago do zmerno jetrno okvaro niso opazili.
English: In 16 HIV/HBV co-infected adults administered Biktarvy (8 HIV/HBV treatment-naïve adults in Study GS-US-380-1490; 8 HIV/HBV suppressed adults in Study GS-US-380-1878), the safety profile of Biktarvy was similar to that in patients with HIV-1 monoinfection (see section 5.1).
Slovenian: Pri 16 bolnikih, sočasno okuženih s HIV/HBV, ki so dobivali zdravilo Biktarvy (8 predhodno nezdravljenih bolnikov s HIV/HBV v študiji GS-US-380-1490; 8 odraslih s supresijo HIV/HBV v študiji GS-US-380-1878), je bil profil varnosti zdravila Biktarvy podoben kot pri bolnikih, okuženih samo s HIV-1 (glejte poglavje 5.1).
English: 4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Slovenian: 4 Ta neželeni učinek je bil opredeljen v okviru nadzora za zdravila, ki vsebujejo alafenamidtenofovirat, v obdobju trženja zdravil.
English: In Study GS-US-380-1878, at Week 48, 100% (8/8) of the patients co-infected with HIV/HBV at baseline in the B/F/TAF arm maintained HBV DNA < 29 IU/mL (missing = excluded analysis) and HIV RNA < 50 copies/mL.
Slovenian: V študiji GS-US-380-1878 je v 48. tednu 100 % (8/8) bolnikov s sočasno okužbo s HIV/HBV ob izhodišču v kraku z B/F/TAF ohranilo HBV DNA < 29 i.e./ml (manjkajoče = izključena analiza) in
English: [Outer packaging only]
Slovenian: [Samo na zunanji ovojnini]
English: d Study GS-US-380-1489.
Slovenian: d Študija GS-US-380-1489.
English: Tenofovir is eliminated by the kidneys by both glomerular filtration and active tubular secretion.
Slovenian: Tenofovir se iz telesa izloča z ledvicami, s pomočjo glomerularne filtracije in aktivnega tubularnega izločanja.
English: Non-clinical data on emtricitabine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Slovenian: Predklinični podatki za emtricitabin na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala, vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement
Slovenian: togost sklepov bolečine v sklepih (zlasti v kolkih, kolenih in ramenih)
English: 4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily.
Slovenian: 4 Ta študija je bila opravljena z emtricitabinom/ alafenamidtenofoviratom 200/25 mg enkrat dnevno.
English: In clinical studies of treatment-naïve patients receiving
Slovenian: V kliničnih študijah pri bolnikih, ki so prejemali zdravilo Biktarvy, do konca
English: Package leaflet: Information for the user Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Biktarvy 50 mg/200 mg/25 mg filmsko obložene tablete biktegravir/emtricitabin/alafenamidtenofovirat Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: ABC/DTG/ 3TC (n = 315)d
Slovenian: ABC/DTG/3TC
English: 3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products.
Slovenian: 3 Ta neželeni učinek je bil opredeljen v okviru nadzora za zdravila, ki vsebujejo emtricitabin, v obdobju trženja zdravil.
English: Patients must have been stably suppressed (HIV-1 RNA < 50 copies/mL) on their baseline regimen for at least 3 months prior to study entry.
Slovenian: Bolniki so morali biti na izhodiščnem režimu pred vstopom v študijo vsaj 3 mesece stabilno supresirani (HIV-1 RNA < 50 kopij/ml).