FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients must have been stably suppressed on their baseline regimen for at least 6 months and must not have been previously treated with any INSTI.
Croatian: U bolesnika je HIV-1 morao biti stabilno suprimiran početnim režimom najmanje 6 mjeseci i oni nisu smjeli biti prethodno liječeni pomoću INSTI.
English: Biktarvy contains tenofovir alafenamide, which is active against hepatitis B virus (HBV).
Croatian: Biktarvy sadrži tenofoviralafenamid, koji djeluje protiv virusa hepatitisa B (HBV).
English: Studies of bictegravir in monkeys revealed the liver as the primary target organ of toxicity.
Croatian: Ispitivanja biktegravira na majmunima pokazala su da je jetra primarni ciljni organ toksičnog djelovanja.
English: Biktarvy should not be co-administered with other antiretroviral medicinal products.
Croatian: Biktarvy se ne smije primjenjivati istodobno s drugim antiretrovirusnim lijekovima.
English: Following a single dose oral administration of [14C]-bictegravir, ~60% of the dose from faeces included unchanged parent, desfluoro-hydroxy-BIC-cysteine-conjugate, and other minor oxidative metabolites.
Croatian: Nakon peroralne primjene jedne doze [14C]-biktegravira, ~60% doze iz stolice uključilo je nepromijenjeni izvorni lijek, konjugat desfluoro-hidroksi-BIC-cisteina i druge manje oksidativne metabolite.
English: No human data on the effect of Biktarvy on fertility are available.
Croatian: Nisu dostupni podaci o učinku lijeka Biktarvy na plodnost u ljudi.
English: The K65R and K70E mutations result in reduced susceptibility to abacavir, didanosine, lamivudine, emtricitabine, and tenofovir, but retain sensitivity to zidovudine.
Croatian: Mutacije K65R i K70E dovode do smanjene osjetljivosti na abakavir, didanozin, lamivudin, emtricitabin i tenofovir, ali zadržavaju osjetljivost na zidovudin.
English: Although kidney problems have not been observed with Biktarvy, there is a possibility that you may experience kidney problems when taking Biktarvy over a long period of time.
Croatian: Iako uz Biktarvy nisu opažene tegobe s bubrezima, postoji mogućnost da Vam se jave tegobe s bubrezima ako uzimate Biktarvy tijekom dugog vremenskog razdoblja.
English: In patients with moderate renal impairment, close monitoring should be considered when starting co-administration of bictegravir with metformin, due to the increased risk for lactic acidosis in these patients.
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega, potrebno je razmotriti pomno praćenje kada se počinje s istodobnom primjenom biktegravira i metformina, zbog povećanog rizika od laktacidoze u ovih bolesnika.
English: At screening, 15% of patients were receiving abacavir/lamivudine plus atazanavir or darunavir (boosted by either cobicistat or ritonavir) and 85% of patients were receiving emtricitabine/tenofovir disoproxil fumarate plus atazanavir or darunavir (boosted by either cobicistat or ritonavir).
Croatian: Na probiru, 15% bolesnika primalo je abakavir/lamivudin plus atazanavir ili darunavir (pojačane kobicistatom ili ritonavirom), a 85% bolesnika primalo je emtricitabin/tenofovirdizoproksilfumarat plus atazanavir ili darunavir (pojačan kobicistatom ili ritonavirom).
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown etiology, particularly neurologic findings.
Croatian: Te nalaze treba uzeti u obzir u svakog djeteta koje je in utero bilo izloženo analozima nukleozida/nukleotida, a koje je imalo tešku kliničku sliku nepoznate etiologije, osobito neurološke nalaze.
English: • If you notice 18 hours or more after the time you usually take Biktarvy, then do not take the missed dose.
Croatian: • Ako to primijetite kada je prošlo 18 sati ili više od vremena kad obično uzimate lijek Biktarvy, onda nemojte uzeti propuštenu dozu.
English: (Inhibition of P-gp/BCRP)
Croatian: (inhibicija P-gp/BCRP)
English: In vitro binding of bictegravir to human plasma proteins was > 99% (free fraction ~0.25%).
Croatian: In vitro vezanje biktegravira za proteine ljudske plazme bilo je > 99% (slobodna frakcija ~0,25%).
English: Changes in bilirubin
Croatian: Promjene bilirubina
English: Based on drug interaction studies conducted with Biktarvy or the components of Biktarvy, no clinically significant drug interactions are expected with: amlodipine, atorvastatin, buprenorphine, drospirenone, famciclovir, famotidine, fluticasone, methadone, naloxone, norbuprenorphine, omeprazole or rosuvastatin.
Croatian: Na temelju ispitivanja interakcija lijekova provedenih s lijekom Biktarvy ili komponentama lijeka Biktarvy, ne očekuju se klinički značajne interakcije s: amlodipinom, atorvastatinom, buprenorfinom, drospirenonom, famciklovirom, famotidinom, flutikazonom, metadonom, naloksonom, norbuprenorfinom, omeprazolom ili rosuvastatinom.
English: Co-administration of emtricitabine with medicinal products that are eliminated by active tubular secretion may increase concentrations of emtricitabine, and/or the co-administered medicinal product.
Croatian: Istodobna primjena emtricitabina s lijekovima koji se eliminiraju aktivnom tubularnom sekrecijom može povećati koncentracije emtricitabina i/ili istodobno primijenjenog lijeka.
English: Stopping Biktarvy can seriously affect how future treatment works.
Croatian: Prestanak uzimanja lijeka Biktarvy može ozbiljno utjecati na djelovanje budućeg liječenja.
English: Studies in animals with bictegravir have shown no evidence of teratogenicity or an effect on reproductive function.
Croatian: Ispitivanja biktegravira na životinjama nisu pokazala znakove tetragenosti ili djelovanja na reproduktivnu funkciju.
English: ABC = abacavir
Croatian: ABC = abakavir
English: While you are taking Biktarvy
Croatian: Dok uzimate lijek Biktarvy
English: In human clinical studies, a 25 mg oral dose of tenofovir alafenamide resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 300 mg oral dose of tenofovir disoproxil fumarate.
Croatian: U kliničkim ispitivanjima u ljudi, peroralna doza od 25 mg tenofoviralafenamida rezultirala je koncentracijama tenofovirdifosfata > 4 puta većima u PBMC-ovima i > 90% manjim koncentracijama tenofovira u plazmi u usporedbi s 300 mg peroralne doze tenofovirdizoproksilfumarata.
English: - adefovir dipivoxil, atazanavir, bictegravir, emtricitabine, lamivudine, tenofovir alafenamide, or tenofovir disoproxil
Croatian: - adefovirdipivoksil, atazanavir, biktegravir, emtricitabin, lamivudin, tenofoviralafenamid ili tenofovirdizoproksil
English: No dose adjustment of Biktarvy is required in patients with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Croatian: Nije potrebna prilagodba doze lijeka Biktarvy u bolesnika s procijenjenim klirensom kreatinina (CrCl) ≥ 30 ml/min.
English: Renal excretion of intact bictegravir is a minor pathway (~1% of dose).
Croatian: Bubrežna ekskrecija nepromijenjenog biktegravira predstavlja put izlučivanja koji je od malog značaja (~1% doze).
English: 2 This adverse reaction was not observed in the clinical studies of emtricitabine + tenofovir alafenamide-containing products but identified from clinical studies or post-marketing experience for emtricitabine when used with other antiretrovirals.
Croatian: 2 Ova nuspojava nije opažena u kliničkim ispitivanjima lijekova koji sadrže emtricitabin + tenofoviralafenamid, ali je prepoznata u kliničkim ispitivanjima emtricitabina i nakon njegova stavljanja u promet kad se primjenjivao s drugim antiretrovirusnim lijekovima.
English: In Studies GS-US-380-1489 and GS-US-380-1490, the mean age was 35 years (range 18-77), 89% were male, 58% were White, 33% were Black, and 3% were Asian.
Croatian: U ispitivanjima GS-US-380-1489 i GS-US-380-1490, srednja vrijednost dobi bila je 35 godina (raspon 18-77), bilo je 89% muškaraca, 58% bili su bijelci, 33% crnci i 3% azijati.
English: Non-clinical studies of tenofovir alafenamide in rats and dogs revealed bone and kidney as the primary target organs of toxicity.
Croatian: Neklinička ispitivanja tenofoviralafenamida na štakorima i psima otkrila su da su kost i bubreg primarni ciljni organi toksičnog djelovanja.
English: Biktarvy is indicated for the treatment of adults infected with human immunodeficiency virus-1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir (see section 5.1).
Croatian: Lijek Biktarvy indiciran je za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1) bez dokaza o sadašnjoj ili prošloj rezistenciji virusa na skupinu inhibitora integraze, emtricitabin ili tenofovir (vidjeti dio 5.1).
English: Four patients had missing HBV DNA data at Week 96 (one lost to follow-up from Week 48, 1 lost to follow-up after Week 72, 1 with missing HBV data but HIV-1 RNA < 50 copies/mL, and 1 with missing data in Week 96 window).
Croatian: Za četiri bolesnika nedostajali su podaci za HBV DNK u 96. tjednu (jedan je bio izgubljen iz praćenja od 48. tjedna, drugi je bio izgubljen iz praćenja nakon 72. tjedna, za trećeg su nedostajali podaci za HBV, ali imao je HIV-1 RNK < 50 kopija/ml, a za četvrtog su nedostajali podaci u okviru 96. tjedna).
English: Emtricitabine-resistant viruses with the M184V/I substitution were cross-resistant to lamivudine, but retained sensitivity to didanosine, stavudine, tenofovir, and zidovudine.
Croatian: Virusi rezistentni na emtricitabin sa supstitucijom M184V/I bili su križno rezistentni na lamivudin, ali su zadržali osjetljivost na didanozin, stavudin, tenofovir i zidovudin.
English: Medicinal products that induce P-gp activity (e.g. 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 Biktarvy and development of resistance.
Croatian: Očekuje se da će lijekovi koji induciraju aktivnost P-gp-a (npr. rifabutin, karbamazepin, fenobarbital) smanjiti apsorpciju tenofoviralafenamida, što uzrokuje smanjenje koncentracije tenofoviralafenamida u plazmi, koje može dovesti do gubitka terapijskog učinka lijeka Biktarvy i razvoja rezistencije.
English: One patient had missing HBV DNA data at Week 48.
Croatian: Za jednog su bolesnika nedostajali podaci za HBV DNK u
English: Patients had a mean age of 46 years (range 20-79), 83% were male, 66% were White, and 26% were Black.
Croatian: Srednja vrijednost za dob bolesnika bila je 46 godina (raspon 20-79), 83% bili su muškarci, 66% bili su bijelci, a 26% crnci.
English: • antacids to treat stomach ulcers, heartburn, or acid reflux, containing aluminium and/or magnesium hydroxide
Croatian: • antacide za liječenje vrijeda na želucu, žgaravice ili gastroezofagealne refluksne bolesti, koji sadrže aluminijev i/ili magnezijev hidroksid
English: In both studies, patients were stratified by baseline HIV-1 RNA (less than or equal to 100,000 copies/mL, greater than 100,000 copies/mL to less than or equal to 400,000 copies/mL, or greater than 400,000 copies/mL), by CD4+ cell count (less than 50 cells/µL, 50-199 cells/µL, or greater than or equal to 200 cells/µL), and by region (US or ex-US).
Croatian: U oba ispitivanja bolesnici su stratificirani prema početnoj vrijednosti HIV-1 RNK (manje ili jednako 100.000 kopija/ml, više od 100.000 kopija/ml do manje ili jednako 400.000 kopija/ml, ili više od 400.000 kopija/ml), prema broju CD4 + stanica (manje od 50 stanica/µl, 50-199 stanica/µl ili više ili jednako 200 stanica/µl) te po regiji (SAD ili izvan SAD-a).
English: Animal studies do not indicate direct or indirect harmful effects of emtricitabine with respect to fertility parameters, pregnancy, foetal development, parturition or postnatal development.
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak emtricitabina na parametre plodnosti, trudnoću, razvoj fetusa, okot ili postnatalni razvoj.
English: Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Croatian: Tenofoviralafenamid nije ni inhibitor niti induktor CYP3A in vivo.
English: Bictegravir demonstrated equivalent antiviral activity against 5 nonnucleoside reverse transcriptase inhibitor (NNRTI)-resistant, 3 NRTI-resistant, and 4 protease inhibitor (PI)-resistant HIV-1 mutant clones compared with the wild-type strain.
Croatian: Biktegravir je pokazao jednaku antivirusnu aktivnost prema 5 mutiranih klonova virusa HIV-1 s rezistencijom na nenukleozidne inhibitore reverzne transkriptaze (NNRTI), 3 s rezistencijom na NRTI i 4 s rezistencijom na inhibitore proteaze (PI) u usporedbi s divljim sojem virusa.
English: Biktarvy should be administered at least 2 hours before iron supplements, or taken together with food (see section 4.5).
Croatian: Biktarvy treba davati najmanje 2 sata prije dodataka koji sadrže željezo ili ga treba uzimati s hranom (vidjeti dio 4.5).
English: The multiple dose pharmacokinetics of bictegravir are dose proportional over the dose range of 25 to 100 mg.
Croatian: Farmakokinetika višestruke doze biktegravira proporcionalna je dozi u rasponu doza od 25 to 100 mg.
English: Renal clearance of the unchanged parent was minimal.
Croatian: Bubrežni klirens nepromijenjenog izvornog lijeka bio je minimalan.
English: Bone toxicity was observed as reduced bone mineral density in rats and dogs at tenofovir exposures at least 43 times greater than those expected after administration of B/F/TAF.
Croatian: Toksičnost za kost uočena je kao smanjena mineralna gustoća kostiju u štakora i pasa pri izloženostima tenofoviru najmanje 43 puta većima od onih očekivanih nakon primjene B/F/TAF-a.
English: In vitro phenotyping studies showed that bictegravir is primarily metabolised by CYP3A and UGT1A1.
Croatian: In vitro ispitivanja fenotipa pokazala su da se biktegravir prvenstveno metabolizira putem CYP3A i UGT1A1.
English: White, high density polyethylene (HDPE) bottle with a polypropylene continuous-thread, child-resistant cap, lined with an induction activated aluminium foil liner containing 30 film-coated tablets.
Croatian: Bijela boca od polietilena visoke gustoće (HDPE) s polipropilenskim zatvaračem sigurnim za djecu s kontinuiranim navojem, otvora prekrivenog zaštitnom aluminijskom folijom, koja sadrži 30 filmom obloženih tableta.
English: • If you have hepatitis B infection.
Croatian: • ako ste zaraženi virusom hepatitisa B.
English: Patients had a mean age of 45 years (range 20-71), 89% were male, 73% were White, and 22% were Black.
Croatian: Srednja vrijednost za dob bolesnika bila je 45 godina (raspon 20-71), 89% bili su muškarci, 73% bili su bijelci, a 22% crnci.
English: (Inhibition of CYP3A)
Croatian: (inhibicija CYP3A)
English: Purplish-brown, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “9883” on the other side of the tablet.
Croatian: Ljubičastosmeđa, filmom obložena tableta u obliku kapsule s utisnutom oznakom „GSI“ na jednoj strani i „9883“ na drugoj strani tablete.
English: No dose adjustment of Biktarvy is required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Croatian: Nije potrebna prilagodba doze lijeka Biktarvy u bolesnika s blagim (Child-Pugh stadij A) ili umjerenim (Child-Pugh stadij B) oštećenjem funkcije jetre.
English: Table 2: Tabulated list of adverse reactions1
Croatian: Tablica 2: Tablični popis nuspojava1 Učestalost
English: 30 film-coated tablets 90 (3 bottles of 30) film-coated tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta 90 (3 boce od 30) filmom obloženih tableta
English: Population analyses using pooled pharmacokinetic data from adult studies did not identify any clinically relevant differences due to age, gender or race on the exposures of bictegravir, emtricitabine, or tenofovir alafenamide.
Croatian: Analize populacije pomoću objedinjenih farmakokinetičkih podataka prikupljenih u ispitivanjima na odraslim bolesnicima nisu identificirale klinički značajne razlike vezane uz dob, spol ili rasnu pripadnost u izloženosti biktegraviru, emtricitabinu ili tenofoviralafenamidu.
English: The in vitro human blood to plasma bictegravir concentration ratio was 0.64.
Croatian: In vitro omjer koncentracije biktegravira u ljudskoj krvi i plazmi bio je 0,64.
English: What you need to know before you take Biktarvy Do not take Biktarvy:
Croatian: Što morate znati prije nego počnete uzimati Biktarvy Nemojte uzimati Biktarvy:
English: (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba)
English: b Includes patients who had ≥ 50 copies/mL in the Week 48 window; patients who discontinued early due to lack or loss of efficacy; patients who discontinued for reasons other than lack or loss of efficacy and at the time of discontinuation had a viral value of ≥ 50 copies/mL.
Croatian: b Obuhvaća bolesnike koji su imali ≥ 50 kopija/ml u okviru 48. tjedna; bolesnike koji su rano prestali primati ispitivani lijek zbog nedostatka ili gubitka djelotvornosti; bolesnike koji su prekinuli liječenje iz razloga koji nisu nedostatak ili gubitak djelotvornosti i koji su u vrijeme prekida liječenja imali virusnu vrijednost ≥ 50 kopija/ml.
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.
Croatian: U bolesnika je HIV-1 morao biti stabilno suprimiran (HIV-1 RNK < 50 kopija/ml) početnim režimom najmanje 3 mjeseca prije ulaska u ispitivanje.
English: HIV-1 RNA < 20 copies/mL
Croatian: HIV-1 RNK < 20 kopija/ml
English: Bictegravir is not an inhibitor or inducer of CYP in vivo.
Croatian: Biktegravir nije ni inhibitor niti induktor CYP-a in vivo.
English: Bictegravir is an integrase strand transfer inhibitor (INSTI) that binds to the integrase active site and blocks the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.
Croatian: Biktegravir je inhibitor integraze - integrase strand transfer inhibitor, INSTI koji se veže za aktivno mjesto integraze i blokira korak prijenosa lanca u okviru integracije retrovirusne deoksiribonukleinske kiseline (DNK), što je ključno za replikacijski ciklus HIV-a.
English: Do not use this medicine after the expiry date which is stated on the carton and bottle after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
English: (-5.9% to
Croatian: (-5,9% do
English: In addition, 6 patients had the pre-existing INSTI resistance-associated mutation T97A; all had HIV-1 RNA < 50 copies/mL at Week 96 or the last visit.
Croatian: Pored toga, 6 bolesnika imalo je već postojeću mutaciju povezanu s rezistencijom na INSTI, tj. T97A; u svih je bio HIV-1 RNK < 50 kopija/ml u 96. tjednu ili prilikom zadnjeg pregleda.
English: Biktarvy should not be taken simultaneously with supplements containing magnesium and/or aluminium due to the expected substantial decrease of bictegravir exposure (see section 4.4).
Croatian: Lijek Biktarvy ne smije se uzimati istodobno s dodacima koji sadrže magnezij i/ili aluminij zbog očekivanog znatnog smanjenja izloženosti biktegraviru (vidjeti dio
English: The safety and efficacy of Biktarvy in patients with significant underlying liver disorders have not been established.
Croatian: Bolest jetre Sigurnost i djelotvornost primjene lijeka Biktarvy u bolesnika s prisutnim značajnim bolestima jetre nisu ustanovljene.
English: In HIV infected patients with severe immune deficiency at the time of institution of CART, an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Croatian: U bolesnika zaraženih HIV-om s teškom imunodeficijencijom u vrijeme uvođenja CART-a može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, koja može uzrokovati ozbiljna klinička stanja ili pogoršanje simptoma.
English: During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose.
Croatian: Tijekom terapije protiv HIV-a moguće je povećanje tjelesne težine i povišenje razina lipida i glukoze u krvi.
English: Discontinued study drug due to AE or death and last available HIV-1 RNA < 50 copies/mL Discontinued study drug due to other reasons and last available HIV-1 RNA < 50 copies/mLc
Croatian: Prekid primanja ispitivanog lijeka zbog štetnih događaja ili smrti i posljednje dostupne vrijednosti HIV-1 RNK < 50 kopija/ml Prekid primanja ispitivanog lijeka iz drugih razloga i posljednje dostupne vrijednosti HIV-1 RNK
English: Biktarvy is a single tablet for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults.
Croatian: Biktarvy je jedna tableta za liječenje odraslih osoba zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1).
English: Patients co-infected with HIV and HBV
Croatian: Bolesnici istodobno zaraženi HIV-om i HBV-om
English: There are no pharmacokinetic data on bictegravir or tenofovir alafenamide in patients with creatinine clearance less than 15 mL/min.
Croatian: Nema farmakokinetičkih podataka o biktegraviru ili tenofoviralafenamidu u bolesnika s klirensom kreatinina manjim od 15 ml/min.
English: Biktarvy has not been studied in patients with severe hepatic impairment (Child-Pugh Class C), therefore Biktarvy is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Lijek Biktarvy nije ispitan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) te se stoga primjena lijeka Biktarvy ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: Co-administration of ciclosporin (IV or oral use) is not recommended.
Croatian: Ne preporučuje se istodobna primjena ciklosporina (i.v. ili peroralno).
English: For monitoring of blood lipids and glucose reference is made to established HIV treatment guidelines.
Croatian: Za nadzor lipida i glukoze u krvi dane su preporuke u utvrđenim smjernicama za liječenje HIV-a.
English: Film-coating Polyvinyl alcohol Titanium dioxide (E171) Macrogol
Croatian: Poli(vinilni alkohol) titanijev dioksid (E171)
English: Patients co-infected with HIV and hepatitis B or C virus
Croatian: Bolesnici s istodobnom infekcijom HIV-om i virusom hepatitisa B ili C
English: Gilead Sciences Ireland UC IDA Business & Technology Park Carrigtohill
Croatian: IDA Business & Technology Park Carrigtohill
English: When your supply of Biktarvy starts to run low, get more from your doctor or pharmacist.
Croatian: Kad Vam se smanji zaliha lijeka Biktarvy, nabavite još lijeka od liječnika ili ljekarnika.
English: At Week 96, 4 patients were HBV suppressed and had HIV-1 RNA < 50 copies/mL.
Croatian: U 96. tjednu, 4 bolesnika imalo je suprimiran HBV i imali su HIV-1 RNK < 50 kopija/ml.
English: No dose adjustment is required upon co-administration in patients with normal renal function.
Croatian: Nije potrebna prilagodba doze nakon istodobne primjene u bolesnika s normalnom funkcijom bubrega.
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.
Croatian: Biktarvy se ne smije primjenjivati istodobno s lijekovima koji sadrže tenofoviralafenamid, tenofovirdizoproksil, lamivudin ili adefovirdipivoksil koji se primjenjuju u liječenju infekcije HBV-om.
English: DTG = dolutegravir 3TC = lamivudine a Week 48 window was between Day 295 and 378 (inclusive).
Croatian: DTG = dolutegravir 3TC = lamivudin a Okvir 48. tjedna bio je između 295. i (uključivo) 378. dana.
English: Because there is a lower tenofovir exposure in rats and mice after the administration of tenofovir alafenamide compared to tenofovir disoproxil fumarate, carcinogenicity studies and a rat peri-postnatal study were conducted only with tenofovir disoproxil fumarate.
Croatian: Budući da je izloženost tenofoviru u štakora i miševa nakon primjene tenofoviralafenamida manja nego pri primjeni tenofovirdizoproksilfumarata, ispitivanja kancerogenosti te perinatalno i postnatalno ispitivanje u štakora provedena su samo s tenofovirdizoproksilfumaratom.