FrancophonIA/ELRC3.0 huggingface dataset:
English: Tenofovir alafenamide is a nucleotide reverse transcriptase inhibitor (NtRTI) and phosphonamidate prodrug of tenofovir (2'-deoxyadenosine monophosphate analogue).
Slovenian: Tenofoviralafenamid je nukleotidni zaviralec reverzne transkriptaze (nucleotide reverse transcriptase inhibitor, NtRTI) in fosfonamidatno predzdravilo tenofovirja (analog 2'-deoksiadenozin monofosfata).
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6 in vitro.
Slovenian: Tenofoviralafenamid in vitro ni zaviralec CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ali
English: was 4.7 log10 copies/mL, median CD4+ cell count was 456 cells/mm3 (range: 95-1,110), and median CD4+% was 23% (range: 7-45%).
Slovenian: Na začetku je bila mediana plazemska HIV-1 RNA 4,7 log10 kopij/ml, mediano število celic CD4+ je bilo 456 celic/mm3 (razpon: 95-1.110) in mediana CD4+ % je bila 23 % (razpon: 7-45 %).
English: The proportions of patients with plasma HIV-1 RNA < 50 copies/mL and < 20 copies/mL are shown in Table 5.
Slovenian: Deleža bolnikov z RNA HIV-1 < 50 kopij/ml in < 20 kopij/ml v plazmi sta prikazana v preglednici 5.
English: 3.3% (95% CI: -11.4% to 18.1%)
Slovenian: 3,3 % (95-% IZ: -11,4 % do 18,1 %)
English: Clinically relevant changes in the pharmacokinetics of tenofovir alafenamide or its metabolite tenofovir were not observed in patients with mild or moderate hepatic impairment.
Slovenian: Klinično pomembnih sprememb v farmakokinetiki tenofoviralafenamida ali njegovega presnovka tenofovirja pri bolnikih z blago do zmerno jetrno okvaro niso opazili.
English: In Study GS-US-311-1089, the efficacy and safety of switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent were evaluated in a randomised, double-blind study of virologically suppressed HIV-1 infected adults (n = 663).
Slovenian: V študiji GS-US-311-1089 so učinkovitost in varnost prehoda z emtricitabina/dizoproksiltenofovirijev fumarata na zdravilo Descovy ob ohranitvi tretje protiretrovirusne učinkovine ocenili v randomizirani, dvojno slepi študiji odraslih, okuženih s HIV-1, z virološko supresijo (n = 663).
English: The mean baseline CD4+ cell count was 664 cells/mm3 (range: 126-1,813).
Slovenian: Povprečno število celic CD4+ na začetku je bilo 664 celic/mm3 (razpon: 126-1.813).
English: Through 144 weeks of treatment, no subject discontinued E/C/F/TAF due to a treatment-emergent renal adverse event compared with 12 subjects who discontinued E/C/F/TDF (p < 0.001).
Slovenian: Do vključno 144. tedna zdravljenja noben preskušanec ni prekinil z jemanjem E/C/F/TAF zaradi neželenega učinka na ledvice kot posledice zdravljenja, medtem ko je E/C/F/TDF (p < 0,001) prenehalo jemati 12 preskušancev.
English: There are limited clinical data on the use of E/C/F/TAF in HIV/HBV co-infected patients who are treatment-naïve.
Slovenian: Klinični podatki o uporabi E/C/F/TAF pri bolnikih s sočasno okužbo HIV/HBV, ki se predhodno še niso zdravili, so omejeni.
English: Through Week 144, the development of one or more primary emtricitabine, tenofovir alafenamide, or elvitegravir resistance-associated mutations was observed in HIV-1 isolates from 12 of 22 patients with evaluable genotypic data from paired baseline and E/C/F/TAF 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 group (12 of 867 patients [1.4%]).
Slovenian: tenofoviralafenamid ali elvitegravir, pri izolatih HIV-1 pri 12 od 22 bolnikov, pri katerih je bilo mogoče oceniti genotipske podatke parov izolatov ob začetku in izolatov neuspešnega zdravljenja z zdravilom E/C/F/TAF (12 od 866 bolnikov [1,4 %]) v primerjavi z 12 od 20 izolatov neuspešnega zdravljenja pri bolnikih, pri katerih je bilo mogoče oceniti genotipske podatke, v skupini z E/C/F/TDF (12 od 867 bolnikov [1,4 %]).
English: EU/1/16/1099/003 30 film-coated tablets EU/1/16/1099/004 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/16/1099/003 30 filmsko obloženih tablet EU/1/16/1099/004 90 (3 plastenke po 30) filmsko obloženih tablet
English: ANTICONVULSANTS Oxcarbazepine Phenobarbital Phenytoin
Slovenian: ANTIKONVULZIVI okskarbazepin fenobarbital fenitoin
English: The mean age was 36 years (range: 18-76), 85% were male, 57% were White, 25% were Black, and 10% were Asian.
Slovenian: Povprečna starost je bila 36 let (razpon: 18-76), 85 % je bilo moških, 57 % je bilo belcev, 25 % je bilo črncev in 10 % je bilo Azijcev.
English: EU/1/16/1099/001 30 film-coated tablets EU/1/16/1099/002 90 (3 bottles of 30) film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/16/1099/001 30 filmsko obloženih tablet EU/1/16/1099/002 90 (3 plastenke po 30) filmsko obloženih tablet
English: Patients co-infected with HIV and HBV who discontinue Descovy should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Slovenian: Descovy, je potrebno pozorneje opazovati in opravljati potrebne klinične in laboratorijske preiskave še vsaj nekaj mesecev po prenehanju zdravljenja.
English: Tenofovir alafenamide is a substrate of OATP1B1 and OATP1B3 in vitro.
Slovenian: Tenofoviralafenamid je in vitro substrat OATP1B1
English: -10.7% (95% CI: -26.3% to 4.8%)
Slovenian: -10,7 % (95-% IZ: -26,3 % do 4,8 %)
English: Co-administration of Descovy and oxcarbazepine, phenobarbital or phenytoin is not recommended.
Slovenian: Sočasno dajanje zdravila Descovy in okskarbazepina, fenobarbitala ali fenitoina se ne priporoča.
English: In a study of virologically suppressed patients switching from emtricitabine/tenofovir disoproxil fumarate to Descovy while maintaining the third antiretroviral agent (Study GS-US-311-1089), increases from baseline were observed in the fasting lipid parameters total cholesterol, direct LDL cholesterol and triglycerides in the Descovy arm compared with little change in the emtricitabine/tenofovir disproxil fumarate arm (p ≤ 0.009 for the difference between groups in changes from baseline).
Slovenian: V študiji pri bolnikih z virusno supresijo, ki so prešli z emtricitabina/dizoproksiltenofovirijevega fumarata na zdravilo Descovy, pri čemer so obdržali tretje protiretrovirusno zdravilo (študija GS-US-311-1089), so opazili zvišanja od začetne vrednosti pri parametrih maščob na tešče za skupni holesterol, direktni LDL holesterol in trigliceride v kraku z zdravilom Descovy v primerjavi z le majhnimi spremembami v kraku z emtricitabinom/dizoproksiltenofovirijevim fumaratom (p ≤ 0,009 za razliko med skupinama v spremembi od začetne vrednosti).
English: In a pooled analysis of antiretroviral-naïve patients receiving emtricitabine and tenofovir alafenamide (10 mg) given with elvitegravir and cobicistat as a fixed-dose combination tablet in Phase 3 studies GS-US-292-0104 and GS-US-292-0111, genotyping was performed on plasma HIV-1 isolates from all patients with HIV-1 RNA ≥ 400 copies/mL at confirmed virological failure, at Week 144, or at the time of early study drug discontinuation.
Slovenian: Pri predhodno nezdravljenih bolnikih V združeni analizi pri bolnikih, predhodno nezdravljenih s protiretrovirusnimi zdravili, ki so dobivali emtricitabin in tenofoviralafenamid (10 mg) z elvitagravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov v študijah faze 3 GS-US-292-0104 in GS-US-292-0111, so genotipizacijo opravili na izolatih HIV-1 iz plazme vseh bolnikov s HIV-1 RNA ≥ 400 kopij/ml s potrjenim virološkim neuspehom, v 144. tednu ali v času predčasne prekinitve študijskega zdravila.
English: Blue, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “225” on the other side of the tablet.
Slovenian: Modra filmsko obložena tableta v obliki štirikotnika, z dimenzijami 12,5 mm x 6,4 mm, z vtisnjenim znakom “GSI” na eni strani in “225” na drugi strani tablete.
English: -6.2% (95% CI: -19.9% to 7.4%)
Slovenian: -6,2 % (95-% IZ: -19,9 % to 7,4 %)
English: -3.5% (95% CI: -19.8% to 12.7%)
Slovenian: -3,5 % (95-% IZ: -19,8 % do 12,7 %)
English: Clinical efficacy of Descovy was established from studies conducted with emtricitabine and tenofovir alafenamide when given with elvitegravir and cobicistat as the fixed-dose combination tablet E/C/F/TAF.
Slovenian: Klinično učinkovitost zdravila Descovy so dokazali v študijah, ki so jih opravili z emtricitabinom in tenofoviralafenamidom v kombinaciji z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov E/C/F/TAF.
English: No dose adjustment of ledipasvir or sofosbuvir is required.
Slovenian: Odmerka ledipasvirja ali sofosbuvirja ni treba prilagajati.
English: Descovy containing regimen (n = 333)
Slovenian: (n = 333)
English: Medicinal products that induce P-gp activity (e.g., rifampicin, rifabutin, carbamazepine, phenobarbital) are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentration of tenofovir alafenamide, which may lead to loss of therapeutic effect of Descovy and development of resistance.
Slovenian: Pričakuje se, da zdravila, ki inducirajo aktivnost P-gp (npr. rifampicin, rifabutin, karbamazepin, fenobarbital), zmanjšajo absorpcijo tenofoviralafenamida, kar povzroči zmanjšanje koncentracije tenofoviralafenamida v plazmi ter lahko povzroči izgubo terapevtskega učinka zdravila Descovy in razvoj rezistence.
English: Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg.
Slovenian: Otrokom, starim 11 let ali manj, ali s telesno maso manj kot 35 kg, ne dajajte tega zdravila.
English: • emtricitabine, an antiretroviral medicine of a type known as a nucleoside reverse transcriptase inhibitor (NRTI)
Slovenian: • emtricitabin, vrsta protiretrovirusnega zdravila, znana kot zaviralec nukleozidne reverzne transkriptaze (nucleoside reverse transcriptase inhibitor, NRTI)
English: The mean Cmax and AUClast, (mean ± SD) under fed conditions following a single 25 mg dose of tenofovir alafenamide administered in Descovy were 0.21 ± 0.13 μg/mL and 0.25 ± 0.11 μg•h/mL, respectively.
Slovenian: Povprečni vrednosti Cmax oz. AUClast, (povprečje ± SD) na poln želodec po enem odmerku 25 mg tenofoviralafenamida, uporabljenega v zdravilu Descovy, sta bili 0,21 ± 0,13 μg/ml oz.
English: In Study GS-US-311-1717, patients who were virologically suppressed (HIV-1 RNA <50 copies/mL) on their abacavir/lamivudine containing regimen for at least 6 months were randomised in a 1:1 ratio to either switch to Descovy (N=280) while maintaining their third agent at baseline or stay on their baseline abacavir/lamivudine -containing regimen (N=276).
Slovenian: V študiji GS-US-311-1717 so bili bolniki, ki so morali biti pred vstopom v študijo vsaj 6 mesecev virološko supresirani (HIV-1 RNA < 50 kopij/ml) na režimu, ki je vseboval abakavir/lamivudin, randomizirani v razmerju 1:1 bodisi za prehod na zdravilo Descovy (n = 280) ob ohranitvi tretjega zdravila na izhodiščni vrednosti ali za nadaljevanje začetnega režima, ki je vseboval abakavir/lamivudin (n = 276).
English: At Week 144, 83.1% (197/237 patients) maintained HIV-1 RNA < 50 copies/mL after switching to emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Slovenian: V 144. tednu je 83,1 % (197/237 bolnikov) ohranilo HIV-1 RNA < 50 kopij/ml po prehodu na emtricitabin in tenofoviralafenamid v kombinaciji z elvitegravirjem in kobicistatomom v obliki tablete s fiksno kombinacijo odmerkov.
English: Grey, rectangular-shaped, film-coated tablet of dimensions 12.5 mm x 6.4 mm debossed with “GSI” on one side and “210” on the other side of the tablet.
Slovenian: Siva filmsko obložena tableta v obliki štirikotnika, z dimenzijami 12,5 mm x 6,4 mm, z vtisnjenim znakom “GSI” na eni strani in “210” na drugi strani tablete.
English: Co-administration of Descovy and carbamazepine is not recommended.
Slovenian: Sočasno dajanje zdravila Descovy in karbamazepina se ne priporoča.
English: The safety of emtricitabine and tenofovir alafenamide has not been established in patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min).
Slovenian: Učinkovitost in varnost emtricitabina in tenofoviralafenamida pri bolnikih s hudo ledvično okvaro (ocenjeni CrCl ≥ 15 ml/min in < 30 ml/min) nista bili dokazani.
English: Look out for any symptoms of infection or other symptoms such as: muscle weakness weakness beginning in the hands and feet and moving up towards the trunk of the body palpitations, tremor or hyperactivity
Slovenian: Bodite pozorni na kakršne koli simptome okužbe ali druge simptome, kot so: - oslabelost mišic
English: d 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.
Slovenian: d Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
English: 4 Study conducted with emtricitabine/rilpivirine/tenofovir alafenamide fixed-dose combination tablet.
Slovenian: 4 Študija je bila opravljena z emtricitabinom/rilpivirinom/tenofoviralafenamidom s tabletami s fiksno kombinacijo odmerkov.
English: 1.3% (95% CI: -2.5% to 5.1%)
Slovenian: 1,3 % (95-% IZ: -2,5 % do 5,1 %)
English: No clinically relevant differences in tenofovir alafenamide, or tenofovir pharmacokinetics were observed between healthy subjects and patients with severe renal impairment (estimated CrCl ≥ 15 mL/min and < 30 mL/min) in a Phase 1 study of tenofovir alafenamide.
Slovenian: Klinično pomembnih razlik v farmakokinetičnih lastnostih tenofoviralafenamida ali tenofovirja med zdravimi osebami in bolniki s hudo ledvično okvaro (ocenjeni CrCl ≥ 15 ml/min in < 30 ml/min) v študiji 1. faze s tenofoviralafenamidom niso opazili.
English: Recommendation concerning co-administration with Descovy
Slovenian: Priporočilo glede sočasne uporabe z zdravilom Descovy
English: Efavirenz (600 mg once daily), tenofovir alafenamide (40 mg once daily)4
Slovenian: efavirenz (600 mg enkrat dnevno), tenofoviralafenamid (40 mg enkrat dnevno)4
English: Seventy-nine percent were male, 63% were White, 18% were Black, and 14% were Asian.
Slovenian: Devetinsedemdeset odstotkov je bilo moških, 63 % je bilo belcev, 18 % je bilo črncev in 14 % je bilo Azijcev.
English: The median increase from baseline for those parameters was greater in the E/C/F/TAF group compared with the elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg (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).
Slovenian: E/C/F/TAF v primerjavi s skupino z elvitegravirjem 150 mg/kobicistatom 150 mg/emtricitabinom200 mg/dizoproksiltenofoviratom (v obliki fumarata) 245 mg (E/C/F/TDF) (p < 0,001 za razliko med skupinama zdravljenja za skupni holesterol na tešče, direktni LDL in HDL holesterol in trigliceride).
English: The pharmacokinetics of emtricitabine and tenofovir alafenamide have not been fully evaluated in patients co-infected with HBV and/or HCV.
Slovenian: Sočasna okužba z virusom hepatitisa B in/ali hepatitisa C Farmakokinetične lastnosti emtricitabina in tenofoviralafenamida pri bolnikih s hkratno okužbo s HBV in/ali HCV niso v celoti ovrednotili.
English: There are no pharmacokinetic data on emtricitabine or tenofovir alafenamide in patients with end stage renal disease (estimated CrCl < 15 mL/min) not on chronic haemodialysis.
Slovenian: Farmakokinetičnih podatkov o emtricitabinu in tenofoviralafenamidu pri bolnikih s končno ledvično odpovedjo (ocenjeni CrCl < 15 ml/min), ki niso na kronični hemodializi, ni.
English: Descovy 200/25 mg once daily
Slovenian: Descovy 200/25 mg enkrat dnevno
English: Co-administration with Descovy is not recommended.
Slovenian: Sočasno dajanje z zdravilom Descovy se ne priporoča.
English: Patients receiving Descovy or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and, therefore, should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Descovy ali s katero koli drugo obliko protiretrovirusne terapije, se lahko še naprej razvijajo oportunistične okužbe in drugi zapleti okužbe z virusom HIV.
English: Descovy film-coated tablets are grey, rectangular-shaped tablets, debossed on one side with “GSI” and the number “210” on the other side of the tablet.
Slovenian: Zdravilo Descovy filmsko obložene tablete so sive tablete pravokotne oblike z vtisnjenim znakom “GSI” na eni strani in številko “210” na drugi strani.
English: At Week 48, 92% of patients (66/72) maintained HIV-1 RNA < 50 copies/mL after switching to emtricitabine and tenofovir alafenamide, given with elvitegravir and cobicistat as a fixed-dose combination tablet.
Slovenian: V 48. tednu je 92 % bolnikov (66/72) ohranilo HIV-1 RNA < 50 kopij/ml po prehodu na emtricitabin in tenofoviralafenamid, uporabljena z elvitegravirjem in kobicistatom v obliki tablete s fiksno kombinacijo odmerkov.
English: ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily), ethinylestradiol (0.025 mg once daily), emtricitabine/tenofovir alafenamide (200/25 mg once daily)5
Slovenian: PERORALNI KONTRACEPTIVI norgestimat (0,180/0,215/0,250 mg enkrat dnevno), etinilestradiol (0,025 mg enkrat dnevno), emtricitabin/ tenofoviralafenamid (200/25 mg enkrat dnevno)5
English: Table 6: Virological outcomes of Study GS-US-311-1089 at Weeks 48a and 96b
Slovenian: Preglednica 6: Virološki izidi v študiji GS-US-311-1089 do vključno 48. tednaa in 96. tednab
English: Of the HIV-1 isolates from 12 patients with resistance development in the E/C/F/TDF group, the mutations that emerged were M184V/I (n = 9), K65R/N (n = 4), and L210W (n = 1) in RT and E92Q/V (n = 4) and Q148R (n = 2), and N155H/S (n=3) in integrase.
Slovenian: V skupini E/C/F/TDF so se pri izolatih HIV-1 12 bolnikov, pri katerih se je razvila rezistenca, pojavile mutacije M184V/I (n = 9), K65R/N (n = 4) in L210W (n = 1) v RT ter E92Q/V
English: Virologic success rates at Week 48 were: Descovy Containing Regimen: 89.7% (227 of 253 subjects); Abacavir/lamivudine Containing Regimen: 92.7%% (230 of 248 subjects).
Slovenian: Stopnje virološkega uspeha v 48. tednu so bile: režim, ki je vseboval zdravilo Descovy: 89,7 % (227
English: Clinical efficacy of Descovy in treatment-naïve patients was also established from a study conducted with emtricitabine and tenofovir alafenamide (10 mg) when given with darunavir (800 mg) and cobicistat as a fixed-dose combination tablet (D/C/F/TAF).
Slovenian: Klinično učinkovitost zdravila Descovy pri predhodno nezdravljenih bolnikih so dokazali tudi v študiji, opravljeni z emtricitabinom in tenofoviralafenamidom (10 mg) v kombinaciji z darunavirjem (800 mg) in kobicistatom v obliki tablete s kombinacijo fiksnih odmerkov (D/C/F/TAF).
English: e 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.
Slovenian: e Vključuje bolnike, ki so sodelovanje prekinili zaradi drugih razlogov kot so neželeni učinki, smrt ali pomanjkanje ali izguba učinka, npr. umik soglasja, izgubljeni za spremljanje itd.
English: -0.5% (95% CI: -5.3% to 4.4%)
Slovenian: -0,5% (95 % IZ: -5,3 % do 4,4 %)
English: Descovy 200/10 mg once daily
Slovenian: Descovy 200/10 mg enkrat dnevno
English: Descovy 200 mg/25 mg film-coated tablets
Slovenian: IME ZDRAVILA Descovy 200 mg/25 mg filmsko obložene tablete
English: • tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Slovenian: • tenofoviralafenamid, vrsta protiretrovirusnega zdravila, znana kot zaviralec nukleotidne reverzne transkriptaze (nucleotide reverse transcriptase inhibitor, NtRTI)
English: PI = protease inhibitor a Week 48 window was between Day 294 and 377 (inclusive).
Slovenian: Okrepljeni PI Druge tretje učinkovine PI = zaviralec proteaze a Okno v 48. tednu je med 294. in 377. dnevom (vključno z njima).
English: Atazanavir/ritonavir (300/100 mg once daily), tenofovir alafenamide (10 mg)
Slovenian: atazanavir/ritonavir (300/100 mg enkrat dnevno), tenofoviralafenamid (10 mg)
English: No clinically relevant differences in tenofovir alafenamide pharmacokinetics were observed in patients with end stage renal disease on chronic haemodialysis as compared to those with normal renal function.
Slovenian: Pri bolnikih s končno ledvično odpovedjo na kronični hemodializi niso opazili klinično pomembnih razlik v farmakokinetiki tenofoviralafenamida v primerjavi s tistimi z normalnim delovanjem ledvic.
English: Medicines used in treating hepatitis B infection:
Slovenian: Zdravila, ki se uporabljajo za zdravljenje okužbe s hepatitisom B: Zdravila Descovy ne smete jemati z zdravili, ki vsebujejo:
English: In studies in treatment-naïve patients, emtricitabine and tenofovir alafenamide given with elvitegravir and cobicistat as a fixed-dose combination tablet through 144 weeks was associated with a lower impact on renal safety parameters (as measured after 144 weeks treatment by eGFRCG and urine protein to creatinine ratio and after 96 weeks treatment by urine albumin to creatinine ratio) compared to E/C/F/TDF.
Slovenian: V študijah pri predhodno nezdravljenih bolnikih je bil emtricitabin + tenofoviralafenamid v kombinaciji z elvitegravirjem + kobicistatom v obliki tablete s fiksno kombinacijo odmerkov do vključno 144. tedna zdravljenja povezan z manjšim vplivom na parametre varnosti za ledvice (izmerjene po 144 tednih zdravljenja z eGFRCG in razmerjem med beljakovinami in kreatininom v urinu ter po 96 tednih zdravljenja z razmerjem albumina in kreatinina v urinu) kot E/C/F/TDF.
English: Descovy 200 mg/10 mg [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Descovy 200 mg/10 mg [samo na zunanji ovojnini]
English: Rilpivirine (25 mg once daily), tenofovir alafenamide (25 mg once daily)
Slovenian: rilpivirin (25 mg enkrat dnevno), tenofoviralafenamid (25 mg enkrat dnevno)
English: The mean baseline CD4+ cell count was 636 cells/mm3 (range 263-1498).
Slovenian: Povprečno število celic CD4+ ob izhodišču je bilo 636 celic/mm3 (razpon 263-1.498).
English: Descovy 200 mg/25 mg [Outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Descovy 200 mg/25 mg [samo na zunanji ovojnini]
English: Tenofovir alafenamide is not an inhibitor of human uridine diphosphate glucuronosyltransferase (UGT) 1A1 in vitro.
Slovenian: uridine diphosphate glucuronosyltransferase) 1A1.
English: While effective viral suppression with antiretroviral therapy has been proven to substantially reduce the risk of sexual transmission, a residual risk cannot be excluded.
Slovenian: Preobčutljivost na učinkovini ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi Čeprav se je izkazalo, da učinkovita virusna supresija s protiretrovirusno terapijo bistveno zmanjša tveganje spolnega prenosa, preostalega tveganja ni mogoče izključiti.
English: No clinically relevant pharmacokinetic differences due to age, gender or ethnicity have been identified for emtricitabine, or tenofovir alafenamide.
Slovenian: Za emtricitabin ali tenofoviralafenamid ni bilo identificirane klinično pomembne farmakokinetične razlike glede na starost, spol ali etnično pripadnost.
English: Intravenously administered midazolam (1 mg single dose), tenofovir alafenamide (25 mg once daily)
Slovenian: intravenski midazolam (1 mg enkratni odmerek), tenofoviralafenamid (25 mg enkrat dnevno)