FrancophonIA/ELRC3.0 huggingface dataset:
English: Elvitegravir would also have potential to be a weak to modest inducer of CYP2B6 and CYP2C8 enzymes, as these enzymes are regulated in a similar manner to CYP2C9 and CYP3A.
Croatian: Elvitegravir također ima potencijal biti slab do umjeren induktor enzima CYP2B6 i CYP2C8, jer se ti enzimi reguliraju na sličan način kao i CYP2C9 i CYP3A.
English: Vitekta should not be used with a protease inhibitor boosted by another agent as dosing recommendations for such combinations have not been established.
Croatian: Vitekta se ne smije primjenjivati s inhibitorom proteaze koji je pojačan nekim drugim lijekom jer preporuke doziranja nisu ustanovljene za te kombinacije.
English: a Week 48 window is between day 309 and 364 (inclusive), week 96 window is between day 645 and 700 (inclusive).
Croatian: a Okvir 48. tjedna je između 309. i 364. dana (uključujući); okvir 96. tjedna je između 645. i 700. dana (uključujući).
English: Co-administration is not recommended (see section 4.4).
Croatian: Ne preporučuje se istovremena primjena (vidjeti dio 4.4).
English: b Includes subjects who had ≥ 50 copies/mL in the week 48 or week 96 window, subjects who discontinued early due to lack or loss of efficacy, subjects who had a viral load ≥ 50 copies/mL at time of change in background regimen, subjects who discontinued for reasons other than an adverse event (AE), death or lack or loss of efficacy and at the time of discontinuation had a viral load of ≥ 50 copies/mL.
Croatian: b Obuhvaća ispitanike koji su imali ≥ 50 kopija/ml u okviru 48. tjedna ili 96. tjedna, ispitanike s ranim prekidom zbog nedostatka ili gubitka djelotvornosti, ispitanike koji su imali virusno opterećenje ≥ 50 kopija/ml u vrijeme promjene pozadinskog režima, ispitanike koji su prekinuli iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti i koji su u vrijeme prekida imali virusno opterećenje ≥ 50 kopija/ml.
English: Elvitegravir plasma concentrations are lower with antacids due to local complexation in the gastrointestinal tract and not to changes in gastric pH.
Croatian: Koncentracije elvitegravira u plazmi niže su s antacidima zbog lokalne kompleksacije u gastrointestinalnom traktu, a ne zbog promjena želučanom pH.
English: Randomisation was stratified by screening HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) and the class of the second agent (NRTI or other classes).
Croatian: Randomizacija je stratificirana probirom razine HIV-1 RNK (≤ 100 000 kopija/ml ili > 100 000 kopija/ml) ili skupine drugog lijeka (NRTI ili druge skupine).
English: HIV-1 isolates with reduced susceptibility to elvitegravir have been selected in cell culture.
Croatian: Izolati HIV-1 sa smanjenom osjetljivošću na elvitegravir izabrani su u staničnoj kulturi.
English: Contains lactose, see leaflet for further information.
Croatian: Sadrži laktozu, za dodatne informacije vidjeti Uputu o lijeku.
English: Autoimmune disorders (such as Graves' disease) have also been reported; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment (see section 4.4).
Croatian: Autoimuni poremećaji (poput Gravesove bolesti) također su zabilježeni; međutim, prijavljeno vrijeme do nastupa poremećaja više varira i ti događaji mogu se pojaviti puno mjeseci nakon početka liječenja (vidjeti dio 4.4).
English: Elvitegravir is 98-99% bound to human plasma proteins and the binding is independent of drug concentration over the range of 1.0 ng/mL to 1.6 µg/mL.
Croatian: 98-99% elvitegravira je vezano za proteine ljudske plazme, te je vezivanje neovisno o koncentraciji lijeka u rasponu od 1,0 ng/ml do 1,6 µg/ml.
English: Of these 712 patients, 543 (269 elvitegravir and 274 raltegravir) and 439 (224 elvitegravir and 215 raltegravir) received at least 48 and 96 weeks of treatment, respectively.
Croatian: Od tih 712 pacijenata, 543 pacijenta (269 iz skupine na elvitegraviru i 274 iz skupine na raltegraviru) i 439 pacijenata (224 iz skupine na elvitegraviru i 215 iz skupine na raltegraviru) primalo je liječenje najmanje 48 tjedana, odnosno 96 tjedana.
English: Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency (see section 4.5).
Croatian: Pacijentice koje primjenjuju estrogene kao hormonsku nadomjesnu terapiju potrebno je klinički pratiti radi znakova deficijencije estrogena (vidjeti dio 4.5).
English: The BR was selected by the investigator based on genotypic/phenotypic resistance testing and prior antiretroviral treatment history.
Croatian: Ispitivač je odabrao BR na osnovi ispitivanja genotipske/fenotipske rezistencije i ranijih liječenja antiretrovirusnim lijekovima u anamnezi.
English: Similar rates of raltegravir resistance development occurred in the HIV-1 from subjects treated with raltegravir (26/351 raltegravir-treated subjects, 7.4%).
Croatian: Slične stope razvoja rezistencije na raltegravir bile su u HIV-1 ispitanika liječenih raltegravirom (26/351 ispitanika liječenih raltegravirom, 7,4%).
English: The mean plasma to blood drug concentration ratio is 1.37.
Croatian: Omjer srednje vrijednosti koncentracije lijeka u plazmi i koncentracije lijeka u krvi je 1,37.
English: Where interactions were studied, the effect on Vitekta was determined by comparing the pharmacokinetics of boosted elvitegravir (using either ritonavir or cobicistat as a pharmacokinetic enhancer) in the absence and presence of the co-administered medicinal product.
Croatian: U ispitivanjima interakcija, učinak na Vitektu određen je usporedbom farmakokinetike pojačanog elvitegravira (primjenjujući ili ritonavir ili kobicistat kao farmakokinetički pojačivač) u odsutnosti i prisutnosti istovremeno primijenjenog lijeka.
English: This enzyme helps the virus to multiply in the cells in your body.
Croatian: Taj enzim pomaže umnožavanju virusa u stanicama u tijelu.
English: Elvitegravir was negative in an in vitro bacterial mutagenicity test (Ames test) and negative in an in vivo rat micronucleus assay at doses up to 2,000 mg/kg.
Croatian: Elvitegravir je bio negativan u in vitro testu bakterijske mutagenosti (Amesov test) i negativan u in vivo analizi mikronukleusa štakora u dozama do 2000 mg/kg.
English: Elvitegravir is a modest inducer and may have the potential to induce CYP2C9 and/or inducible UGT enzymes.
Croatian: Elvitegravir je umjereni induktor i može imati potencijal indukcije CYP2C9 i/ili inducibilnih UGT enzima.
English: Magnesium/aluminum-containing antacid suspension (20 mL single dose)
Croatian: Anatacidna suspenzija koja sadrži magnezij/aluminij (jednokratna doza od 20 ml)
English: However, clinical data have shown there are no clinically relevant changes in the exposure of methadone (which is primarily metabolised by CYP2B6 and CYP2C19) following co-administration with boosted elvitegravir versus administration of methadone alone (see Table 2).
Croatian: No, klinički su podaci pokazali da ne postoje klinički značajne promjene izloženosti metadona (koji se prvenstveno metabolizira putem CYP2B6 i CYP2C19) nakon istovremene primjene s pojačanim elvitegravirom naspram primjene samog metadona (vidjeti
English: HMG-CoA REDUCTASE INHIBITORS
Croatian: INHIBITORI REDUKTAZE HMG Co-A
English: Additional integrase substitutions observed in cell culture selection included H51Y, F121Y, S147G, S153Y, E157Q, and R263K.
Croatian: Dodatne supstitucije integraze zapažene u izdvojenoj staničnoj kulturi bile su H51Y, F121Y, S147G, S153Y, E157Q i R263K.
English: What you need to know before you take Vitekta Do not take Vitekta
Croatian: Što morate znati prije nego počnete uzimati lijek Vitekta Nemojte uzimati lijek Vitekta
English: If you vomit less than 1 hour after taking Vitekta, take another tablet with food.
Croatian: Ako povraćate kad je prošlo manje od 1 sata od uzimanja lijeka Vitekta, uzmite drugu tabletu s hranom.
English: Vitekta should be administered once daily as follows: - Either at the same time as a once daily ritonavir-boosted protease inhibitor - Or with the first dose of a twice daily ritonavir-boosted protease inhibitor.
Croatian: Lijek Vitekta potrebno je primjenjivati jedanput na dan, kako slijedi: - ili u isto vrijeme kao ritonavirom pojačani inhibitor proteaze jedanput na dan - ili s prvom dozom ritonavirom pojačanog inhibitora proteaze dvaput na dan.
English: Phenotypic resistance to elvitegravir was most commonly associated with the primary integrase substitutions T66I, E92Q and Q148R.
Croatian: Fenotipska rezistencija na elvitegravir najčešće je bila povezana s primarnim supstitucijama integraze T66I, E92Q i Q148R.
English: There is no specific antidote for overdose with elvitegravir.
Croatian: Ne postoji specifični antidot za predoziranje elvitegravirom.
English: Elvitegravir versus raltegravir
Croatian: Elvitegravir naspram raltegravira
English: 4.7 Effects on ability to drive and use machines No studies on the effects of elvitegravir on the ability to drive and use machines have been performed.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Nisu provedena ispitivanja utjecaja elvitegravira na sposobnost upravljanja vozilima i rada sa
English:  If any of these applies to you, do not take Vitekta and tell your doctor immediately.
Croatian: Ako se ovo odnosi na Vas, nemojte uzimati lijek Vitekta i odmah o tome obavijestite liječnika.
English: Do not use this medicine after the expiry date which is stated on the bottle and carton after {EXP}.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na boci i kutiji iza „Rok valjanosti“.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/883/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/883/002
English: With the exception of Y143C/R/H, HIV-1 with the primary raltegravir-associated substitutions T66K, Q148H/K/R, or N155H in integrase is associated with reduced susceptibility to elvitegravir.
Croatian: Uz iznimku Y143/C/R/H, HIV-1 s primarnim supstitucijama povezanih s raltegravirom, T66K, Q148H/K/R ili N155H u integrazi povezan je sa smanjenom osjetljivošću na elvitegravir.
English: While taking Vitekta you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate lijek Vitekta, i dalje možete razvijati infekcije ili druge bolesti koje su povezane s HIV infekcijom.
English: Viruses expressing the T66I/A substitutions maintain susceptibility to raltegravir, while most other patterns of elvitegravir-associated substitutions are associated with reduced susceptibility to raltegravir.
Croatian: Virusi koji izražavaju supstitucije T66I/A zadržavaju osjetljivost na raltegravir, dok je većina drugih uzoraka supstitucija povezanih s elvitegravirom povezana sa smanjenom osjetljivošću na raltegravir.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: When your supply of Vitekta starts to run low, get more from your doctor or pharmacist.
Croatian: Kad Vam se smanji zaliha lijeka Vitekta, nabavite još lijeka od liječnika ili ljekarnika.
English: Metabolic parameters
Croatian: Tjelesna težina i metabolički parametri
English: Indigo carmine aluminium lake (E132), macrogol 3350 (E1521), polyvinyl alcohol (partially hydrolysed) (E1203), talc (E553B), titanium dioxide (E171), iron oxide yellow (E172).
Croatian: Film ovojnica: boja indigo carmine aluminium lake (E132), makrogol 3350 (E1521), poli(vinilni alkohol) (djelomično hidroliziran) (E1203), talk (E553B), titanijev dioksid (E171), željezov oksid, žuti (E172).
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of elvitegravir has not been studied.
Croatian: Učinak teškog oštećenja funkcije jetre (Child-Pugh stadij C) na farmakokinetiku elvitegravira nije ispitan.
English: If you are also taking didanosine, take it at least 1 hour before or at least 2 hours after Vitekta.
Croatian: Ako također uzimate i didanozin, uzmite ga najmanje 1 sat prije ili najmanje 2 sata nakon uzimanja
English: This will improve your immune system and reduce the risk of developing illnesses linked to
Croatian: Vaš imunološki sustav i smanjiti rizik od razvoja bolesti povezanih s HIV infekcijom.
English: • problems with digestion resulting in discomfort after meals (dyspepsia)
Croatian: • poteškoće sa spavanjem (nesanica) • tegobe s probavom koji dovode do nelagode nakon obroka (dispepsija)
English: Following oral administration of ritonavir-boosted [
Croatian: Nakon peroralne primjene ritonavirom pojačanog [
English: Available pharmacodynamic/toxicological data in rats have shown excretion of elvitegravir in milk.
Croatian: Dostupni farmakodinamički/toksikološki podaci u štakora pokazuju da se elvitegravir izlučuje u mlijeko.
English: HCV protease inhibitors Telaprevir (750 mg three times daily)/
Croatian: Inhibitori proteaze HCV-a Telaprevir (750 mg tri puta na dan)/
English: If Vitekta is stopped for any reason, speak to your doctor before you restart taking Vitekta tablets.
Croatian: Ako zbog bilo kojeg razloga prestanete uzimati lijek Vitekta, porazgovarajte s liječnikom prije nego što ponovno počnete uzimati tablete Vitekta.
English: Although there may be no actual or predicted interactions between a medicinal product and elvitegravir, there may be interactions between a medicinal product and ritonavir and/or the protease inhibitor co-administered with elvitegravir.
Croatian: Iako možda ne postoje stvarne ili predviđene interakcije između nekog lijeka i elvitegravira, ipak mogu postojati interakcije između tog lijeka i ritonavira i/ili inhibitora proteaze istovremeno primijenjenog s elvitegravirom.
English: It is unknown whether elvitegravir/metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se elvitegravir/metaboliti u majčino mlijeko u ljudi.
English: Pack size: 1 bottle of 30 film-coated tablets.
Croatian: Veličina pakiranja: 1 boca od 30 filmom obloženih tableta.
English: If you are lactose-intolerant, or if you have been told that you have an intolerance to other sugars, talk to your doctor before taking this medicine.
Croatian: Ako ne podnosite laktozu ili su Vam rekli da ne podnosite neke druge šećere, posavjetujte se s liječnikom prije nego što počnete uzimati ovaj lijek.
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed
Croatian: U in vitro testu kromosomske aberacije elvitegravir je bio negativan s metaboličkom aktivacijom; no, neodređeni odgovor zapažen je
English: Elvitegravir (antacid suspension given ± 4 hours from elvitegravir administration): AUC: ↔
Croatian: Elvitegravir (antacidna suspenzija dana ± 4 sata od primjene elvitegravira): AUC: ↔
English: Medicinal products that are strong (causing a > 5-fold increase in substrate clearance) or moderate (causing a 2-5 fold increase in substrate clearance) inducers of CYP3A are expected to decrease plasma concentrations of elvitegravir.
Croatian: Lijekovi koji su jaki (uzrokuju > 5-struko povećanje klirensa supstrata) ili umjereni induktori CYP3A (uzrokuju 2-5-struko povećanje klirensa supstrata) očekivano smanjuju koncentracije elvitegravira u plazmi.
English: The choice of dose of Vitekta depends on the co-administered protease inhibitor (see Table 1 and sections 4.4 and 4.5).
Croatian: Izbor doze lijeka Vitekta ovisi o istovremeno primijenjenom inhibitoru proteaze (vidjeti tablicu 1 i dijelove 4.4 i 4.5).
English: The Cmax and AUCtau of elvitegravir increased 22% and 36% with a light meal, while increasing 56% and 91% with a high-fat meal, respectively.
Croatian: Cmax i AUCtau za elvitegravir povećali su se 22%, odnosno 36% s laganim obrokom, a s punomasnim obrokom 56%, odnosno 91%.
English: Excipient with known effect: Each tablet contains 6.2 mg lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 6,2 mg laktoze (u obliku hidrata).
English: 9.0% (-9.5% to 27.5%)
Croatian: 9,0% (-9,5% do 27,5%)
English: Following oral administration of ritonavir-boosted elvitegravir with food in HIV-1 infected subjects, elvitegravir peak plasma concentrations were observed 4 hours post-dose.
Croatian: Nakon peroralne primjene ritonavirom pojačanog elvitegravira s hranom u pacijenata zaraženih HIV-1-om, vršne koncentracije elvitegravira u plazmi zapažene su 4 sata nakon doziranja.
English: Mean steady-state exposure (AUCtau) of unboosted elvitegravir is ~ 20% lower after multiple dosing versus a single dose, indicating modest autoinduction of its metabolism.
Croatian: Srednja vrijednost izloženosti pojačanog elvitegravira u stanju dinamičke ravnoteže (AUCtau) je ~ 20% niža nakon višestrukog doziranja naspram jednokratne doze, ukazujući na umjerenu autoindukciju njegova metabolizma.
English: Autoimmune disorders (such as Graves' disease) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.
Croatian: Autoimuni poremećaji (poput Gravesove bolesti) također su zabilježeni u okruženju imunološke reaktivacije; međutim, prijavljeno vrijeme do nastupa poremećaja više varira i ti događaji mogu se pojaviti puno mjeseci nakon početka liječenja.
English: The most common substitutions that emerged in HIV-1 isolates from elvitegravir-treated subjects were T66I/A (n = 8), E92Q/G (n = 7), T97A (n = 4), S147G (n = 4), Q148R (n = 4), and N155H (n = 5) in integrase.
Croatian: Najčešće supstitucije koje su nastale u izolatima HIV-1 u ispitanika liječenih elvitegravirom bile su T66I/A (n = 4), E92Q/G (n = 7), T97A (n = 4), S147G (n = 4), Q148R (n = 4) i N155H (n = 5) u integrazi.
English: Elvitegravir was non-inferior in achieving HIV-1 RNA < 50 copies/mL when compared to raltegravir.
Croatian: Elvitegravir je bio neinferioran u postizanju HIV-1 RNK < 50 kopija/ml u usporedbi s raltegravirom.
English: • if you are taking one of these medicines: carbamazepine, phenobarbital, phenytoin, used to treat epilepsy and prevent seizures rifampicin, used to prevent and treat tuberculosis and other infections St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety, or products that contain it
Croatian: • ako uzimate jedan od sljedećih lijekova: karbamazepin, fenobarbital, fenitoin, koji se primjenjuju za liječenje epilepsije i sprječavanje napadaja rifampicin, koji se primjenjuje za sprječavanje i liječenje tuberkuloze i drugih infekcija gospina trava (Hypericum perforatum), biljni pripravak koji se primjenjuje za depresiju i tjeskobu, ili proizvodi koji sadrže gospinu travu
English: Excipient with known effect: Each tablet contains 10.9 mg lactose (as monohydrate).
Croatian: Pomoćna tvar s poznatim učinkom: jedna tableta sadrži 10,9 mg laktoze (u obliku hidrata).
English: 0.8% (-17.7% to 19.3%)
Croatian: 0,8% (-17,7% do 19,3%)
English: • If you notice 18 hours or more after the time you usually take Vitekta, then do not take the missed dose.
Croatian: • Ako to primijetite a prošlo je 18 sati ili više od vremena kada obično uzimate lijek Vitekta, tada propuštenu dozu nemojte uzeti.
English: In phenotypic analyses of HIV-1 isolates with resistance substitutions from elvitegravir-treated subjects, 14/20 (70%) had reduced susceptibility to elvitegravir and 12/20 (60%) had reduced susceptibility to raltegravir.
Croatian: U fenotipskim analizama izolata HIV-1 sa supstitucijama rezistencije u ispitanika liječenih elvitegravirom, 14/20 (70%) imalo je smanjenu osjetljivost na elvitegravir i 12/20 (60%) imalo je smanjenu osjetljivost na raltegravir.
English: • carbamazepine, phenobarbital, phenytoin, used to treat epilepsy and prevent seizures
Croatian: • karbamazepin, fenobarbital, fenitoin, koji se primjenjuju za liječenje epilepsije i sprečavanje napadaja
English: Upon boosting with ritonavir (100 mg), net inhibition of elvitegravir metabolism is observed with significantly increased systemic exposures (20-fold higher AUC), high trough concentrations, and longer median elimination half-life (9.5 versus 3.5 hours).
Croatian: Nakon pojačavanja ritonavirom (100 mg), opažena je neto inhibicija metabolizma elvitegravira uz značajno povećanu sistemsku izloženost (20-puta veći AUC); visoke najniže koncentracije i dulji medijan poluvijeka eliminacije (9,5 naspram 3,5 sata).
English: Due to insufficient clinical data, the combination of elvitegravir with tipranavir is not recommended (see section 4.2).
Croatian: Zbog nedostatnih kliničkih podataka ne preporučuje se kombinacija elvitegravira i tipranavira (vidjeti dio 4.2).
English: The most frequently reported adverse reactions to elvitegravir were diarrhoea (7.1%) and nausea
Croatian: Najčešće prijavljene nuspojave na elvitegravir bile su proljev (7,1%) i mučnina (4,0%) (vidjeti
English: If a patient misses a dose of Vitekta by more than 18 hours, and it is almost time for their next dose, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako pacijent propusti uzeti dozu lijeka Vitekta u roku duljem od 18 sati, i uskoro je vrijeme za sljedeću dozu, pacijent ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati doze prema uobičajenom rasporedu.
English: The recommended dose of Vitekta is one 85 mg tablet or one 150 mg tablet taken orally once daily with food.
Croatian: Preporučena doza lijeka Vitekta je jedna tableta od 85 mg ili jedna tableta od 150 mg uzeta peroralno jedanput na dan, s hranom.
English: Elvitegravir-resistant viruses show varying degrees of cross-resistance to the integrase strand transfer inhibitor raltegravir depending on the type and number of substitutions.
Croatian: Virusi rezistentni na elvitegravir pokazuju razne stupnjeve križne rezistencije na raltegravir inhibitora prijenosa lanca integraze, ovisno o vrsti i broju supstitucija.
English: Co-administration of elvitegravir and rilpivirine is not expected to change elvitegravir plasma concentrations, therefore no dose adjustment of Vitekta is required.
Croatian: Istovremena primjena elvitegravira i rilpivirina očekivano ne mijenja koncentracije elvitegravira u plazmi, stoga nije potrebna prilagodba doze lijeka Vitekta.
English: • herbal products: St. John's wort (Hypericum perforatum)
Croatian: • biljni lijekovi: gospina trava (Hypericum perforatum)
English: The following pack size is available: outer cartons containing 1 bottle of 30 film-coated tablets.
Croatian: Dostupna je sljedeća veličina pakiranja: vanjske kutije koje sadrže 1 bocu s 30 filmom obloženih tableta.
English: Your treatment with Vitekta should only be started by a doctor who is experienced in treating
Croatian: Vaše liječenje lijekom Vitekta smije započeti samo liječnik s iskustvom u liječenju HIV infekcije.
English: If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.
Croatian: Ako u tih pacijenata nastupe znakovi pogoršanja bolesti jetre, mora se razmotriti privremeni ili trajni
English: Croscarmellose sodium, hydroxypropyl cellulose, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate.
Croatian: Jezgra tablete: umrežena karmelozanatrij, hidroksipropilceluloza, laktoza (u obliku hidrata), magnezijev stearat, mikrokristalična celuloza, natrijev laurilsulfat.
English: Caution should be exercised when co-administering Vitekta and a hormonal contraceptive.
Croatian: Nužan je oprez pri istovremenoj primjeni lijeka Vitekta i hormonskog kontraceptiva.
English: The maximum doses of elvitegravir tested in the development toxicity studies in rats and rabbits corresponded to exposures that are approximately 29-fold and 0.2-fold the human therapeutic exposure, respectively.
Croatian: Maksimalne doze elvitegravira testirane u ispitivanjima razvojne toksičnosti u štakora i kunića odgovaraju izloženostima koje su približno 29-puta, odnosno 0,2-puta veće od terapijske izloženosti u ljudi.