FrancophonIA/ELRC3.0 huggingface dataset:
English: 6 This study was conducted using elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg once daily.
Croatian: To je ispitivanje provedeno pomoću elvitegravira/kobicistata/emtricitabina/tenofoviralafenamida od 150/150/200/10 mg jedanput na dan.
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).
Croatian: Djelotvornost i sigurnost lijeka Biktarvy u odraslih virološki suprimiranih bolesnika zaraženih virusom HIV-1 temelje se na podacima prikupljenim tijekom 48 tjedana u randomiziranom, dvostruko slijepom, aktivno kontroliranom ispitivanju GS-US-380-1844 (n = 563) i randomiziranom, otvorenom, aktivno kontroliranom ispitivanju GS-US-380-1878 (n = 577).
English: In Study GS-US-380-1490, 8 patients with HIV/HBV co-infection at baseline were randomised to receive B/F/TAF.
Croatian: U ispitivanju GS-US-380-1490, 8 bolesnika istodobno zaraženih HIV-om i HBV-om na početku bilo je randomizirano da primaju B/F/TAF.
English: Recommendation concerning co-administration with Biktarvy
Croatian: Preporuka za istodobnu primjenu s lijekom Biktarvy
English: In a separate study, site-directed mutants with G118R and T97A+G118R had 3.4- and 2.8-fold reduced susceptibility to bictegravir, respectively.
Croatian: U zasebnom ispitivanju, mutanti s ciljanom mutagenezom G118R i T97A + G118R imali su
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.
Croatian: U ispitivanjima GS-US-380-1489 i GS-US-380-1490, povećanje ukupnog bilirubina opaženo je u 15% bolesnika koji prethodno nisu bili liječeni, a primali su lijek Biktarvy do 96. tjedna.
English:  Do not stop taking Biktarvy if you have hepatitis B. Talk to your doctor first.
Croatian:  Nemojte prestati uzimati lijek Biktarvy ako imate hepatitis B.
English: Tenofovir has activity against HIV-1, HIV-2 and HBV.
Croatian: Tenofovir je aktivan protiv virusa HIV-1, HIV-2 i HBV.
English: Animal studies indicate no effects of bictegravir, emtricitabine or tenofovir alafenamide on mating or fertility (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da biktegravir, emtricitabin i tenofoviralafenamid nemaju učinke na parenje ili plodnost (vidjeti dio 5.3).
English: The prevalence of different HIV-1 subtypes was comparable between treatment groups, with subtype B predominant in both groups; 5% were non-B subtypes.
Croatian: Prevalencija različitih podtipova virusa HIV-1 bila je usporediva u terapijskim skupinama, s time da je podtip B prevladavao u obje skupine; 5% bilo je ne-B podtip.
English: In vivo, tenofovir alafenamide is hydrolysed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate.
Croatian: In vivo, tenofoviralafenamid se hidrolizira u stanicama do tenofovira (glavni metabolit), koji se zatim fosforilira u aktivni metabolit tenofovirdifosfat.
English: Norgestimate (0.180/0.215/0.250 mg once daily), Ethinylestradiol (0.025 mg once daily), Emtricitabine/Tenofovir alafenamide4
Croatian: Norgestimat (0,180/0,215/0,250 mg jedanput na dan), etinilestradiol (0,025 mg jedanput na dan) emtricitabin/tenofoviralafenamid4
English: Tenofovir diphosphate inhibits HIV replication through incorporation into viral DNA by the HIV RT, which results in DNA chaintermination.
Croatian: Tenofovirdifosfat inhibira replikaciju HIV-a ugradnjom u virusnu DNK pomoću HIV-RT-a, što dovodi do prekida lanca DNK.
English: Bictegravir is a substrate of CYP3A and UGT1A1.
Croatian: Biktegravir je supstrat CYP3A i UGT1A1.
English: Interaction not studied with bictegravir.
Croatian: Interakcija s biktegravirom nije ispitana.
English: There is insufficient information on the effects of all the components of Biktarvy in newborns/infants, therefore Biktarvy should not be used during breast-feeding.
Croatian: Nema dovoljno podataka o učincima svih komponenti lijeka Biktarvy na novorođenčad/dojenčad;
English: Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) and analogue of 2'-deoxycytidine.
Croatian: Emtricitabin je nukleozidni inhibitor reverzne transkriptaze (engl. nucleoside reverse transcriptase inhibitor, NRTI) i nukleozidni analog 2'-deoksicitidina.
English: The efficacy and safety of Biktarvy in HIV-1 infected, treatment-naïve adults are based on 48-week and 96-week data from two randomised, double-blind, active-controlled studies, GS-US-380-1489 (n = 629) and GS-US-380-1490 (n = 645).
Croatian: Djelotvornost i sigurnost lijeka Biktarvy u odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni temelje se na podacima prikupljenim tijekom 48 odnosno 96 tjedana u dva randomizirana, dvostruko slijepa, aktivno kontrolirana ispitivanja GS-US-380-1489 (n = 629) i GS-US-380-1490 (n = 645).
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.
Croatian: U ispitivanju GS-US-380-1878, u 48. tjednu, 100% (8/8) bolesnika istodobno zaraženih HIV-om i HBV-om na početku u skupini liječenoj lijekom B/F/TAF-om održalo je HBV DNK < 29 IU/ml (nedostaje = analiza isključena) i HIV RNK < 50 kopija/ml.
English: It is not known whether bictegravir or tenofovir alafenamide is excreted in human milk.
Croatian: Nije poznato izlučuju li se biktegravir ili tenofoviralafenamid u majčino mlijeko.
English: Biktarvy 50 mg/200 mg/25 mg film-coated tablets bictegravir/emtricitabine/tenofovir alafenamide
Croatian: Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete biktegravir/emtricitabin/tenofoviralafenamid
English: (Induction of CYP3A and P-gp)
Croatian: (indukcija CYP3A i P-gp)
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Croatian: 11. NAZIV I ADRESA NOSTELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET
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.
Croatian: Ako povraćate nakon što je prošao 1 sat od uzimanja lijeka Biktarvy, ne trebate uzeti još jednu tabletu prije sljedeće tablete prema redovitom rasporedu
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).
Croatian: Bolesnici su bili randomizirani u omjeru 1:1 kako bi se prebacili na B/F/TAF (n = 282) od početka ispitivanja ili ostali na svom početnom antiretrovirusnom režimu (n = 281).
English: The prevalence of different subtypes was comparable across all three treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Croatian: Prevalencija različitih podtipova bila je usporediva u sve tri terapijske skupine, s time da je podtip B prevladavao u obje skupine; 11% bilo je ne-B podtip.
English: Emtricitabine has activity against HIV-1, HIV-2 and HBV.
Croatian: Emtricitabin je aktivan protiv virusa HIV-1, HIV-2 i HBV.
English: Bictegravir
Croatian: Biktegravir
English: Bictegravir has activity against HIV-1 and HIV-2.
Croatian: Biktegravir je aktivan protiv virusa HIV-1 i HIV-2.
English: Renal excretion of intact tenofovir alafenamide is a minor pathway with less than 1% of the dose eliminated in urine.
Croatian: Bubrežna ekskrecija nerazgrađenog tenofoviralafenamida predstavlja put izlučivanja koji je od malog značaja, a kojim se eliminira < 1% doze u mokraći.
English: At peak plasma concentration, the mean plasma to blood drug concentration ratio was ~1.0 and the mean semen to plasma drug concentration ratio was
Croatian: Kod vršne koncentracije u plazmi, srednja vrijednost omjera koncentracije lijeka u plazmi i krvi bio je ~1,0, a srednja vrijednost omjera koncentracije lijeka u sjemenu i plazmi bila je ~4,0.
English: ORAL CONTRACEPTIVES Norgestimate (0.180/0.215/0.250 mg once daily)/ Ethinylestradiol (0.025 mg once daily), Bictegravir1
Croatian: Norgestimat (0,180/0,215/0,250 mg jedanput na dan)/ etinilestradiol (0,025 mg jedanput na dan), biktegravir1
English: Iron oxide red (E172) Iron oxide black (E172)
Croatian: makrogol talk željezov oksid, crveni (E172) željezov oksid, crni (E172) 6.2 Inkompatibilnosti
English: Atazanavir (400 mg once daily), Bictegravir1
Croatian: Atazanavir (400 mg jedanput na dan), biktegravir1
English: Biktarvy should be administered at least 2 hours before, or with food 2 hours after antacids containing magnesium and/or aluminium.
Croatian: Biktarvy treba davati najmanje 2 sata prije ili s hranom 2 sata poslije antacida koji sadrže magnezij i/ili aluminij.
English: If you vomit less than 1 hour after taking Biktarvy, take another tablet.
Croatian: Ako povraćate unutar 1 sata od uzimanja lijeka Biktarvy, uzmite drugu tabletu.
English: Hepatitis C virus antiviral agents Ledipasvir/Sofosbuvir (90 mg/400 mg once daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide2
Croatian: Antivirusni lijekovi za virus hepatitisa C Ledipasvir/sofosbuvir (90 mg/400 mg jedanput na dan), Biktegravir/emtricitabin/
English: Name and address of the manufacturer(s) responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog(ih) za puštanje lijeka u promet
English: Co-administration of azithromycin or clarithromycin may increase bictegravir plasma concentrations.
Croatian: Istodobna primjena azitromicina ili klaritromicina može povećati koncentracije biktegravira u plazmi.
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).
Croatian: Biktegravir je pokazao antivirusnu aktivnost u staničnoj kulturi protiv skupine HIV-1 (M, N, O) uključujući podtipove A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od < 0,05 do 1,71 nM) i aktivnost protiv virusa HIV-2 (EC50 = 1,1 nM).
English: 2 This study was conducted using bictegravir/emtricitabine/tenofovir alafenamide 75/200/25 mg once daily.
Croatian: 2 To je ispitivanje provedeno primjenom biktegravira/emtricitabina/tenofoviralafenamida od 75/200/25 mg jedanput na dan.
English: ANTICONVULSANTS Carbamazepine (titrated from 100 mg to 300 mg twice a day), Emtricitabine/Tenofovir alafenamide4
Croatian: Karbamazepin (titriran sa 100 mg na 300 mg dvaput na dan), emtricitabin/tenofoviralafenamid4
English: Intracellular tenofovir is subsequently phosphorylated to the pharmacologically active metabolite tenofovir diphosphate.
Croatian: Unutar stanice se tenofovir naknadno fosforilira u farmakološki aktivan metabolit tenofovirdifosfat.
English: AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔
Croatian: Metformin: AUC: ↑ 39% Cmin: ↑ 36% Cmax: ↔
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.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Biktarvy, a proteklo je manje od 18 sati od uobičajenog vremena uzimanja doze, bolesnik mora što prije uzeti lijek Biktarvy i potom ga nastaviti uzimati prema uobičajenom rasporedu.
English: ANTACIDS, SUPPLEMENTS AND BUFFERED MEDICINES Magnesium/aluminium-containing antacid suspension (20 mL single dose5), Bictegravir
Croatian: Otopina antacida koji sadrže magnezij/aluminij (jedna doza od 20 ml5), biktegravir
English: HIV-1 RNA < 50 copies/mL Treatment difference (95% CI) B/F/TAF vs Comparator
Croatian: HIV-1 RNK < 50 kopija/ml Razlika u liječenju (95% CI) B/F/TAF
English: Do not stop taking Biktarvy Do not stop taking Biktarvy without talking to your doctor.
Croatian: Nemojte prestati uzimati lijek Biktarvy bez prethodnog razgovora sa svojim liječnikom.
English: Co-administration of ciclosporin (IV or oral use) is expected to increase plasma concentrations of both bictegravir and tenofovir alafenamide.
Croatian: Očekuje se da će istodobna primjena ciklosporina (i.v. ili peroralno) povećati koncentracije i biktegravira i tenofoviralafenamida u plazmi.
English: Blood and lymphatic system disorders Uncommon:
Croatian: Poremećaji krvi i limfnog sustava
English: Clinically relevant changes in the pharmacokinetics of bictegravir were not observed in subjects with moderate hepatic impairment.
Croatian: Nisu zapažene klinički važne promjene u farmakokinetici biktegravira u bolesnika s umjerenim oštećenjem funkcije jetre.
English: If the patient vomits within 1 hour of taking Biktarvy another tablet should be taken.
Croatian: Ako bolesnik povraća unutar 1 sata od uzimanja lijeka Biktarvy, mora uzeti drugu tabletu.
English: Biktarvy 50 mg/200 mg/25 mg film-coated tablets
Croatian: NAZIV LIJEKA Biktarvy 50 mg/200 mg/25 mg filmom obložene tablete
English: d Study GS-US-380-1489.
Croatian: d Ispitivanje GS-US-380-1489.
English: Seventeen percent of patients identified as Hispanic/Latino.
Croatian: Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 17% bolesnika.
English: Table 3: Pooled virologic outcomes of Studies GS-US-380-1489 and GS-US-380-1490 at Weeks 48a and 96b
Croatian: Tablica 3: Objedinjeni virološki ishodi u ispitivanjima GS-US-380-1489 i GS-US-380-1490 u 48.a i 96.b tjednu
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 protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, staničnoj liniji MAGI CCR5 i PBMC-ovima.
English: Emtricitabine displayed antiviral activity in cell culture against HIV-1 clades A, B, C, D, E, F, and G (EC50 values ranged from 0.007 to 0.075 µM) and showed activity against HIV-2 (EC50 values ranged from 0.007 to 1.5 µM).
Croatian: Emtricitabin je pokazao antivirusnu aktivnost u staničnoj kulturi protiv podtipova virusa HIV-1 A, B, C, D, E, F i G (vrijednosti EC50 bile su u rasponu od 0,007 do 0,075 µM) i aktivnost protiv virusa HIV-2 (vrijednosti EC50 bile su u rasponu od 0,007 do 1,5 µM).
English: The prevalence of different subtypes was comparable across treatment groups, with subtype B predominant in both groups; 11% were non-B subtypes.
Croatian: Prevalencija različitih podtipova bila je usporediva u svim liječenim skupinama, s time da je podtip B prevladavao u obje skupine; 11% bilo je ne-B podtip.
English: Bictegravir (simultaneous administration, fasted):
Croatian: Biktegravir (istodobna primjena, natašte):
English: Biktarvy should not be co-administered simultaneously with magnesium/aluminium-containing antacids or iron supplements under fasted conditions.
Croatian: Lijek Biktarvy ne smije se davati istodobno s antacidima koji sadrže magnezij/aluminij ili s dodacima prehrani koji sadrže željezo uzetim natašte.
English: Twenty-four percent of patients identified as Hispanic/Latino.
Croatian: Kao Hispanoamerikanci/Latinoamerikanci izjasnilo se 24% bolesnika.
English: Treatment outcomes between treatment groups were similar across subgroups by age, sex, race, baseline viral load, baseline CD4+ cell count, and region.
Croatian: Ishodi liječenja u terapijskim skupinama bili su slični u svim podskupinama prema dobi, spolu, etničkoj pripadnosti, početnom virusnom optećenju, početnom broju stanica CD4 + te regiji.
English: headache, dizziness
Croatian: glavobolja, omaglica
English: Psychiatric disorders Common:
Croatian: Psihijatrijski poremećaji
English: rifampicin used to treat some bacterial infections such as tuberculosis St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it.
Croatian: • ako trenutačno uzimate jedan od sljedećih lijekova: rifampicin koji se primjenjuje za liječenje nekih bakterijskih infekcija, kao što je tuberkuloza gospinu travu (Hypericum perforatum), biljni pripravak koji se primjenjuje za depresiju i tjeskobu ili lijekove koji je sadrže.
English: Treatment outcomes of Studies GS-US-380-1844 and GS-US-380-1878 through Week 48 are presented in Table 4.
Croatian: Ishodi liječenja u ispitivanjima GS-US-380-1844 i GS-US-380-1878 do 48. tjedna prikazani su u tablici 4.
English: ANTI-INFECTIVES Antimycobacterials Rifampicin (600 mg once daily), Bictegravir1 (Induction of CYP3A, UGT1A1, and P-gp)
Croatian: Antivirusni lijekovi za HIV-1 Atazanavir (300 mg jedanput na dan), kobicistat (150 mg jedanput na dan), biktegravir1 (inhibicija CYP3A, UGT1A1 i P-gp/BCRP)
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of bictegravir were Cmax = 6.15 µg/mL (22.9%), AUCtau = 102 µg•h/mL (26.9%), and Ctrough = 2.61 µg/mL (35.2%).
Croatian: Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) biktegravira bile su Cmax = 6,15 μg/ml (22,9%), AUCtau = 102 μg •h/ml (26,9%) i Ctrough = 2,61 μg/ml (35,2%).
English: (Inhibition of CYP3A and UGT1A1)
Croatian: (Inhibira CYP3A i UGT1A1)
English: Oxcarbazepine Phenobarbital Phenytoin
Croatian: Okskarbazepin Fenobarbital
English: 4 This study was conducted using emtricitabine/tenofovir alafenamide 200/25 mg once daily.
Croatian: To je ispitivanje provedeno pomoću emtricitabina/tenofoviralafenamida od 200/25 mg jedanput na dan.
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.
Croatian: Ako bolesnik povraća nakon što je prošao 1 sat od uzimanja lijeka Biktarvy, ne treba uzeti još jednu dozu prije sljedeće redovne doze.
English: Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food.
Croatian: Biktarvy treba davati najmanje 2 sata prije dodataka koji sadrže željezo ili zajedno s hranom.
English: ORAL ANTI-DIABETICS Metformin (500 mg twice daily), Bictegravir/Emtricitabine/ Tenofovir alafenamide
Croatian: ORALNI ANTIDIJABETICI Metformin (500 mg dva puta na dan), biktegravir/emtricitabin/
English: B/F/TAF (n = 290)
Croatian: (n = 290)
English: In Studies GS-US-380-1489 and GS-US-380-1490, median (Q1, Q3) serum creatinine increased by 0.09 (0.01, 0.16) mg/dL (8.0 [0.9, 14.1] µmol/L), 0.09 (0.03, 0.17) mg/dL (8.0 [2.6, 15.0] µmol/L), and 0.11 (0.04, 0.18) mg/dL (9.7 [3.5, 15.9] μmol/L) from baseline to Week 96 in the Biktarvy, abacavir/dolutegravir/lamivudine, and dolutegravir + emtricitabine/tenofovir alafenamide groups, respectively.
Croatian: U ispitivanjima GS-US-380-1489 i GS-US-380-1490, medijan (Q1-Q3) serumskog kreatinina povećao se od početne vrijednosti do 96. tjedna za 0,09 (0,01-0,16) mg/dl (8,0 [0,9; 14,1] µmol/l) u skupinama liječenima lijekom Biktarvy; 0,09 (0,03, 0,17) mg/dl (8,0 [2,6;
English: e Study GS-US-380-1490.
Croatian: e Ispitivanje GS-US-380-1490.
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.
Croatian: Nakon peroralne primjene, emtricitabin se brzo i opsežno apsorbira i postiže vršne koncentracije u plazmi 1,5-2,0 sata nakon primjene B/F/TAF-a.
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of emtricitabine were Cmax = 2.13 µg/mL (34.7%), AUCtau = 12.3 µg•h/mL (29.2%), and Ctrough = 0.096 µg/mL (37.4%).
Croatian: Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) emtricitabina bile su Cmax = 2,13 μg/ml (34,7%), AUCtau = 12,3 μg•h/ml (29.2%) i Ctrough = 0,096 μg/ml (37,4%).
English: • tenofovir alafenamide, an antiretroviral medicine of a type known as a nucleotide reverse transcriptase inhibitor (NtRTI)
Croatian: • tenofoviralafenamid, antiretrovirusni lijek poznat kao nukleotidni inhibitor reverzne transkriptaze (NtRTI)
English: The antiviral activity of bictegravir against laboratory and clinical isolates of HIV-1 was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells, and CD4+ T-lymphocytes.
Croatian: Antivirusna aktivnost biktegravira protiv laboratorijskih i kliničkih izolata virusa HIV-1 procijenjena je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4 + T-limfocitima.
English: 4 This adverse reaction was identified through post-marketing surveillance for tenofovir alafenamide-containing products.
Croatian: 4 Ova nuspojava prepoznata je tijekom praćenja lijekova koji sadrže tenofoviralafenamid nakon njihova stavljanja u promet.
English: In Study GS-US-380-1490, patients were randomised in a 1:1 ratio to receive either B/F/TAF (n = 320) or dolutegravir + emtricitabine/tenofovir alafenamide (50+200/25 mg) (n = 325) once daily.
Croatian: U ispitivanju GS-US-380-1490 bolesnici su bili randomizirani u omjeru 1:1 kako bi primali B/F/TAF (n = 320) ili dolutegravir + emtricitabin/tenofoviralafenamid (50 + 200/25 mg) (n = 325) jedanput na dan.
English: 3 This adverse reaction was identified through post-marketing surveillance for emtricitabine-containing products.
Croatian: 3 Ova nuspojava prepoznata je tijekom praćenja lijekova koji sadrže emtricitabin nakon njihova stavljanja u promet.
English: Metabolism is the major clearance pathway for bictegravir in humans.
Croatian: Glavni put eliminacije biktegravira u ljudi je metabolizam.
English: Treatment outcomes of Studies GS-US-380-1489 and GS-US-380-1490 through Weeks 48 and 96 are presented in Table 3.
Croatian: Ishodi liječenja u ispitivanjima GS-US-380-1489 i GS-US-380-1490 do 48. i 96. tjedna prikazani su u tablici 3.
English: How to store Biktarvy
Croatian: Kako čuvati Biktarvy
English: The antiviral activity of tenofovir alafenamide against laboratory and clinical isolates of HIV-1 subtype B was assessed in lymphoblastoid cell lines, PBMCs, primary monocyte/macrophage cells, and CD4+ T-lymphocytes.
Croatian: Antivirusna aktivnost tenofoviralafenamida protiv laboratorijskih i kliničkih izolata virusa HIV-1 podtipa B procijenjena je na limfoblastoidnim staničnim linijama, PBMC-ovima, primarnim monocitnim/makrofagnim stanicama i CD4 + T-limfocitima.
English: AUC: ↑ 315% Cmax: ↔
Croatian: Biktegravir: AUC: ↑ 315% Cmax: ↔
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.
Croatian: Izloženost tenofoviralafenamidu proporcionalna je dozi u rasponu doza od 8 mg to 125 mg.
English: Following oral administration of B/F/TAF with or without food in HIV-1 infected adults, the multiple dose mean (CV%) pharmacokinetic parameters of tenofovir alafenamide were Cmax = 0.121 µg/mL (15.4%), and AUCtau = 0.142 µg•h/mL (17.3%).
Croatian: Nakon peroralne primjene B/F/TAF-a s hranom ili bez nje u odraslih ispitanika zaraženih virusom HIV-1, srednje vrijednosti farmakokinetičkih parametara nakon višestruke doze (CV%) tenofoviralafenamida bile su Cmax = 0,121 μg/ml (15,4%) i AUCtau = 0,142 μg•h/ml (17,3%).
English: HIV-1 RNA < 50 copies/mL Treatment difference (95% CI)
Croatian: HIV-1 RNK < 50 kopija/ml Razlika u liječenju (95% CI)
English: (Induction of CYP3A, UGT1A1, and P-gp)
Croatian: (indukcija CYP3A, UGT1A1, i P-gp)
English: Table 4: Virologic outcomes of Studies GS-US-380-1844 and GS-US-380-1878 at Week 48a
Croatian: Tablica 4: Virološki ishodi ispitivanja GS-US-380-1844 i GS-US-380-1878 u 48. tjednua Ispitivanje GS-US-380-1844
English: Missing data during window but on study drug
Croatian: Podaci iz okvira ispitivanja nedostaju, ali je ispitivani lijek primjenjivan
English: B/F/TAF (n = 282)
Croatian: (n = 282)
English: HIV-1 RNA ≥ 50 copies/mLb Treatment difference (95% CI)
Croatian: HIV-1 RNK ≥ 50 kopija /mlb Razlika u liječenju (95% CI)