FrancophonIA/ELRC3.0 huggingface dataset:
English: Subjects with significant liver function test abnormalities generally had abnormal baseline transaminases (AST or ALT), underlying chronic or acute hepatitis B or C co-infection, concomitant hepatotoxic medications (e.g., isoniazid), or a medical history of alcoholism or alcohol abuse.
Croatian: Ispitanici sa značajnim odstupanjima u nalazima testova jetrene funkcije u načelu su imali abnormalne početne razine transaminaza (AST-a ili ALT-a), podležeću kroničnu ili akutnu istodobnu infekciju hepatitisom B ili C, istodobno su uzimali hepatotoksične ljekove (npr. izoniazid) ili su u anamnezi imali alkoholizam ili prekomjerno uživanje alkohola.
English: The overall safety profile of EVOTAZ is based on available data from clinical trials conducted with atazanavir, atazanavir boosted with either cobicistat or ritonavir, and post-marketing data.
Croatian: Ukupan profil sigurnosti lijeka EVOTAZ temelji se na dostupnim podacima iz kliničkih ispitivanja provedenih s atazanavirom i atazanavirom pojačanim kobicistatom ili ritonavirom te podacima prikupljenima nakon stavljanja lijeka u promet.
English: Following a single 400 mg dose of [14C]atazanavir, 79% and 13% of the total radioactivity was recovered in the faeces and urine, respectively.
Croatian: Nakon jednokratne doze od 400 mg [14C]atazanavira, 79% ukupne radioaktivnosti pronađeno je u fecesu, a 13% u mokraći.
English: Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced exposures to atazanavir and ritonavir.
Croatian: Istodobna primjena boceprevira i atazanavira/ritonavira smanjila je izloženost atazanaviru i ritonaviru.
English: Itraconazole, like ketoconazole, is a potent inhibitor as well as a substrate of CYP3A4.
Croatian: Kao i ketokonazol, itrakonazol je snažan inhibitor, ali i supstrat za CYP3A4.
English: For medicinal products metabolised by CYP3A these higher plasma concentrations may potentially lead to severe, life-threatening or fatal events (see sections 4.3 and 4.5).
Croatian: Kod lijekova koji se metaboliziraju putem CYP3A te povišene plazmatske koncentracije mogu uzrokovati teške, po život opasne ili smrtonosne događaje (vidjeti dijelove 4.3 i 4.5).
English: Disopyramide Flecainide Mexiletine Propafenone
Croatian: Dizopiramid Flekainid Meksiletin Propafenon
English: For monitoring of blood lipids and glucose, reference is made to established HIV treatment guidelines.
Croatian: Za nadzor lipida i glukoze u krvi date su preporuke u su u utvrđenim smjernicama za liječenje HIV-a.
English: EVOTAZ should not be used in combination with ritonavir or medicinal products containing ritonavir due to similar pharmacological effects of cobicistat and ritonavir on CYP3A (see section 4.5).
Croatian: EVOTAZ se ne smije primjenjivati u kombinaciji s ritonavirom ni lijekovima koji sadrže ritonavir jer kobicistat i ritonavir imaju slične farmakološke učinke na CYP3A (vidjeti dio 4.5).
English: Maraviroc is not expected to have an impact on concentrations of atazanavir and cobicistat.
Croatian: Ne očekuje se da će maravirok utjecati na koncentracije atazanavira i kobicistata.
English: Effects of co-administration of EVOTAZ on progestin and estrogen are unknown.
Croatian: Učinci istodobne primjene lijeka EVOTAZ na progestin i estrogen nisu poznati.
English: However, a higher percentage of subjects in the atazanavir boosted with cobicistat group had increases in total bilirubin > 2 x ULN than those in the atazanavir boosted with ritonavir group (88.0% versus 80.9%).
Croatian: Međutim, povećanja ukupnog bilirubina > 2 x GGN imao je veći postotak ispitanika u skupini koja je primala atazanavir pojačan kobicistatom nego onih u skupini koja je primala atazanavir pojačan ritonavirom (88,0% naspram 80,9%).
English: Co-administration of EVOTAZ in patients receiving medicinal products that are substrates of the transporters P-gp, BCRP, MATE1, OATP1B1 and OATP1B3 may result in increased plasma concentrations of the co-administered medicinal products (see section 4.4).
Croatian: Istodobna primjena lijeka EVOTAZ u bolesnika koji primaju lijekove koji su supstrati za prijenosnike P-gp, BCRP, MATE1, OATP1B1 i OATP1B3 može povisiti plazmatske koncentracije tih istodobno primijenjenih lijekova (vidjeti dio 4.4.)
English: General disorders and administration site conditions common fatigue uncommon pyrexia, asthenia, chest pain, malaise rare gait disturbance a These adverse reactions were identified through post-marketing surveillance; however, the frequencies were estimated from a statistical calculation based on the total number of patients exposed to atazanavir (with and without ritonavir) in randomised controlled and other available clinical trials (n = 2321).
Croatian: manje često pireksija, astenija, bolovi u prsištu, malaksalost rijeko poremećaj hoda a Ove su nuspojave identificirane tijekom praćenja nakon stavljanja lijeka u promet; međutim, učestalost je procijenjena statističkim izračunom na temelju ukupnog broja bolesnika izloženih atazanaviru (u kombinaciji s ritonavirom ili bez njega) u randomiziranim kontroliranim i drugim dostupnim kliničkim ispitivanjima (n = 2321).
English: Atazanavir demonstrates nonlinear pharmacokinetics with greater than dose-proportional increases in AUC and Cmax values over the dose range of 200 mg to 800 mg once daily.
Croatian: Atazanavir pokazuje nelineanu farmakokinetiku s povećanjima vrijednosti AUC-a i Cmax koja su veća od onih proporcionalnih dozi u rasponu doza od 200 mg do 800 mg jedanput na dan.
English: The rates of study drug discontinuation due to bilirubin-related adverse events were low and similar in both groups (4.9% in the cobicistat-boosted group and 4.0% in the ritonavir-boosted group).
Croatian: Stope prekida primjene ispitivanog lijeka zbog nuspojava povezanih s bilirubinom bile su niske i slične u obje skupine (4,9% u skupini koja je primala atazanavir pojačan kobicistatom i 4,0% u skupini koja je primal atazanavir pojačan ritonavirom).
English: As atazanavir and cobicistat are highly bound to plasma proteins, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis (see sections 4.2 and 5.2).
Croatian: Budući da se atazanavir i kobicistat u velikoj mjeri vežu za proteine u plazmi, malo je vjerojatno da će se značajno ukloniti iz tijela hemodijalizom ili peritonejskom dijalizom (vidjeti dijelove 4.2 i 5.2).
English: Steady-state cobicistat Cmax, AUCtau and Ctau (mean ± SD) values were 1.5 ± 0.5 μg/ml, 11.1 ± 4.5 μg•hr/ml and 0.05 ± 0.07 μg/ml, respectively (n=22).
Croatian: Vrijednost Cmax, AUCtau i Ctau (srednja vrijednost ± SD) kobicistata u stanju dinamičke ravnoteže iznosila je 1,5 ± 0,5 μg/ml, 11,1 ± 4,5 μg•hr/ml odnosno 0,05 ± 0,07 μg/ml (n=22).
English: Table 3: Virologic outcome of randomised treatment of study GS-US-216-0114 at weeks 48a and 144b
Croatian: Tablica 3: Virološki ishod randomiziranog liječenja u u 48.a i 144.b tjednu ispitivanja
English: Caution is also required during the first time of treatment if switching the pharmacoenhancer from ritonavir to cobicistat (see section 4.4).
Croatian: Oprez se preporučuje i tijekom prve primjene ako se prelazi s ritonavira kao farmakokinetičkog pojačivača na kobicistat (vidjeti dio 4.4).
English: Also see PULMONARY ATERIAL HYPERTENSION in this table for further information regarding co-administration of EVOTAZ with sildenafil.
Croatian: Vidjeti i dio 'PLUĆNA ARTERIJSKA HIPERTENZIJA' u ovoj tablici za dodatne informacije o istodobnoj primjeni lijeka EVOTAZ i sildenafila.
English: Atazanavir and fluconazole concentrations were not significantly modified when atazanavir/ritonavir was co-administered with fluconazole.
Croatian: Koncentracije atazanavira i flukonazola nisu se značajno promijenile kada se atazanavir/ritonavir primjenjivao istodobno s flukonazolom.
English: Eye disorders very common ocular icterus
Croatian: Poremećaji oka vrlo često očni ikterus
English: The studies presented in Table 1 were conducted in healthy subjects unless otherwise noted.
Croatian: Ako nije drugačije naznačeno, ispitivanja prikazana u Tablici 1 provedena su u zdravih ispitanika.
English: Clinical and laboratory monitoring for hyperbilirubinaemia is recommended.
Croatian: Preporučuje se kliničko i laboratorijsko praćenje na pojavu hiperbilirubinemije.
English: Maraviroc is a substrate of CYP3A and its plasma concentration increases when co-administered with potent CYP3A inhibitors.
Croatian: Maravirok je supstrat za CYP3A i njegove se plazmatske koncentracije povisuju pri istodobnoj primjeni sa snažnim inhibitorima CYP3A.
English: Particular caution should be used when prescribing EVOTAZ in association with medicinal products which have the potential to increase the QT interval and/or in patients with pre-existing risk factors (bradycardia, long congenital QT, electrolyte imbalances (see sections 4.8 and 5.3).
Croatian: Osobit je oprez potreban kad se EVOTAZ propisuje zajedno s drugim lijekovima koji mogu produljiti QT-interval i/ili bolesnicima s već prisutnim čimbenicima rizika (bradikardija, kongenitalno produljen QT-interval, poremećaji elektrolita (vidjeti dijelove 4.8 i 5.3).
English: Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.8).
Croatian: Redovito praćenje bubrežne funkcije u bolesnika treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.8).
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: na zahtjev Europske agencije za lijekove; prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjenarezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: There is no specific antidote for overdose with EVOTAZ.
Croatian: Ne postoji specifičan protulijek za predoziranje lijekom EVOTAZ.
English: Reduced plasma concentrations of atazanavir may be the consequence of increased gastric pH if antacids, including buffered medicinal products, are administered with EVOTAZ.
Croatian: Snižene plazmatske koncentracije atazanavira mogu biti posljedica povišenog želučanog pH ako se antacidi, uključujući puferirane lijekove, primjenjuju s lijekom EVOTAZ.
English: In a nonclinical fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility (see section 5.3).
Croatian: U nekliničkom ispitivanju plodnosti i ranog embrionalnog razvoja u štakora, atazanavir je promijenio estrusne cikluse, ali nije utjecao na parenje ni plodnost (vidjeti dio 5.3).
English: In an ex vivo rabbit pharmacology study, isolated hearts were exposed to atazanavir, cobicistat, or atazanavir and cobicistat in combination.
Croatian: U ex vivo farmakološkom ispitivanju na kunićima, izolirana su se srca izlagala atazanaviru, kobicistatu ili kombinaciji atazanavira i kobicistata.
English: If overdose occurs with EVOTAZ, the patient must be monitored for evidence of toxicity.
Croatian: U slučaju predoziranja lijekom EVOTAZ, bolesnika se mora nadzirati zbog moguće pojave znakova toksičnosti.
English: Cobicistat reversibly inhibits MATE1, and concentrations of metformin may be increased when co-administered with EVOTAZ.
Croatian: Kobicistat reverzibilno inhibira MATE1, pa koncentracije metformina mogu porasti kod istodobne primjene lijeka EVOTAZ.
English: Among the 19 patients, 1 developed the emtricitabine-associated resistance substitution M184V with no tenofovir or protease inhibitor associated resistance substitutions.
Croatian: Od 19 bolesnika, 1 je razvio supstituciju M184V, povezanu s rezistencijom na emtricitabin bez supstitucija povezanih s rezistencijom na tenofovir ili inhibitore proteaze.
English: Concentrations of these medicinal products may be increased when co-administered with EVOTAZ resulting in the potential for increased adverse events usually associated with these anticancer medicinal products.
Croatian: Istodobna primjena s lijekom EVOTAZ može povisiti koncentracije navedenih lijekova, što može pojačati nuspojave koje se obično povezuju s tim lijekovima za liječenje raka.
English: Of these 692 patients, 613 (300 atazanavir with cobicistat and 313 atazanavir with ritonavir) and 496 (250 atazanavir with cobicistat and 246 atazanavir with ritonavir) received at least 48 and 144 weeks of treatment, respectively.
Croatian: Među ta 692 bolesnika, njih 613 (300 liječenih atazanavirom s kobicistatom i 313 liječenih atazanavirom s ritonavirom) primalo je liječenje tijekom najmanje 48 tjedana, a njih 496 (250 liječenih atazanavirom s kobicistatom i 246 liječenih atazanavirom s ritonavirom) tijekom najmanje 144 tjedna.
English: The safety and efficacy of atazanavir with cobicistat in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Croatian: Sigurnost i djelotvornost atazanavira u kombinaciji s kobicistatom u bolesnika s HIV-1 infekcijom ocijenjene su u randomiziranom, dvostruko slijepom, aktivnim lijekom kontroliranom ispitivanju faze 3 (GS-US-216-0114) u prethodno neliječenih bolesnika s HIV-1 infekcijom i procijenjenom početnom vrijednošću klirensa kreatinina iznad 70 ml/min (n = 692).
English: Limited data are available on the development of resistance to atazanavir boosted with cobicistat.
Croatian: Dostupni su ograničeni podaci o razvoju rezistencije na atanazavir pojačan kobicistatom.
English: Teл.
Croatian: LOC.
English: Both asymptomatic first-degree (23%) and second-degree (1%) atrioventricular block were reported in paediatric patients.
Croatian: U pedijatrijskih je bolesnika bio prijavljen i asimptomatski atrioventrikularni blok prvog stupnja (23%) i drugog stupnja (1%).
English: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Croatian: Drospirenon AUC: ↑ 130% Drospirenon Cmax: ↔ Drospirenon Cmin: Nije računato
English: If signs or symptoms of nephrolithiasis occurs, temporary interruption or discontinuation of treatment may be considered.
Croatian: Ako se pojave znakovi ili simptomi nefrolitijaze, može se razmotriti privremen ili trajan prekid liječenja.
English: Systemic exposure to atazanavir at doses that resulted in maternal toxicity was at least equal to or slightly greater than that observed in humans given 400 mg once daily.
Croatian: Sistemska izloženost atazanaviru u dozama koje koje su bile toksične za majku bila je barem jednaka ili nešto veća od one opažene u ljudi koji su primali dozu od 400 mg jedanput na dan.
English: Low levels of metabolites are observed in urine and faeces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Croatian: Male količine metabolita pronađene su u mokraći i fecesu, ali one ne pridonose inhibicijskom djelovanju kobicistata na CYP3A.
English: The co-administration of EVOTAZ with stavudine is not expected to significantly alter the exposure of stavudine.
Croatian: Ne očekuje se da će istodobna primjena lijeka EVOTAZ i stavudina značajno promijeniti izloženost stavudinu.
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
Croatian: Osipi su obično blage do umjereno teške makulopapularne kožne erupcije koje nastaju unutar prva 3 tjedna nakon početka terapije atazanavirom.
English: In treatment-naïve HIV-1 infected patients
Croatian: Prethodno neliječeni bolesnici s HIV-1 infekcijom
English: Moderate to severe hepatic impairment.
Croatian: Umjereno do teško oštećenje jetrene funkcije.
English: Co-administration of EVOTAZ and medicinal products that induce CYP3A4 is contraindicated or not recommended (see sections 4.3 and 4.5) because, in addition to decreased plasma concentrations of atazanavir due to induction of CYP3A4, decreased plasma concentrations of cobicistat could result in cobicistat plasma levels that are insufficient to achieve adequate pharmacoenhancement of atazanavir.
Croatian: Istodobna primjena lijeka EVOTAZ i lijekova koji induciraju CYP3A4 je kontraindicirana ili se ne preporučuje (vidjeti dijelove 4.3 i 4.5); naime, osim što indukcija CYP3A4 smanjuje plazmatske koncentracije atazanavira, smanjene plazmatske koncentracije kobicistata mogle bi dovesti do razina kobicistata u plazmi koje nisu dostatne za postizanje odgovarajućeg farmakokinetičkog pojačanja atazanavira.
English: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: Not determined
Croatian: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: nije određen
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama nisu dostatna s obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: The following statements reflect the pharmacokinetic properties of atazanavir in combination with cobicistat or the individual components of EVOTAZ.
Croatian: Sljedeći odlomci opisuju farmakokinetička svojstva atazanavira u kombinaciji s kobicistatom ili farmakokinetička svojstva pojedinačnih sastavnica lijeka EVOTAZ.
English: Viruses were known to be susceptible to atazanavir, emtricitabine and tenofovir DF at baseline.
Croatian: Za viruse je na početku ispitivanja utvrđeno da su osjetljivi na atazanavir, emtricitabin i tenofovir DF.
English: Co-administration of EVOTAZ and tenofovir alafenamide 25 mg for treatment of HBV infection is not recommended
Croatian: Ne preporučuje se istodobna primjena lijeka EVOTAZ s 25 mg tenofoviralafenamida za liječenje HBV infekcije.
English: If you miss a dose of EVOTAZ by 12 hours or less, take it right away with food and then take your next scheduled dose at the usual time.
Croatian: Ako primijetite da ste propustili uzeti dozu lijeka EVOTAZ unutar 12 sati od kada ste je trebali uzeti, uzmite je odmah s hranom, a zatim uzmite sljedeću dozu prema uobičajenom rasporedu.
English: c Includes subjects who had ≥50 copies/ml in the week 48 or 144 windows, subjects who discontinued early due to lack or loss of efficacy, subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy and at the time of discontinuation had a viral value of ≥50 copies/ml.
Croatian: bOkvir 144. tjedna obuhvaća razdoblje između 967. i 1050. dana (uključujući i te dane) c Uključuje ispitanike koji su imali ≥50 kopija/ml u okviru 48. ili 144. tjedna, ispitanike koji su rano prekinuli liječenje zbog nedostatka ili gubitka djelotvornosti, ispitanike koji su prekinuli liječenje zbog razloga koji nisu bili nuspojava, smrt ili nedostatak ili gubitak djelotvornosti i koji su u trenutku prekida liječenja imali virusnu vrijednost ≥50 kopija/ml.
English: Co-administration of EVOTAZ with warfarin has the potential to produce serious and/or life-threatening bleeding due to increased warfarin plasma concentrations, and it is recommended that the INR (International Normalized Ratio) be monitored (see section 4.5).
Croatian: Istodobna primjena lijeka EVOTAZ s varfarinom može uzrokovati ozbiljno i/ili po život opasno krvarenje zbog povišenih plazmatskih koncentracija varfarina i stoga se preporučuje kontrolirati INR (internacionalni normalizirani omjer) (vidjeti dio 4.5).
English: Buprenorphine/naloxone in combination with cobicistat
Croatian: Buprenorfin/nalokson u kombinaciji s kobicistatom
English: Two percent of patients treated with atazanavir experienced concurrent Grade 3-4 ALT/AST and Grade 3-4 total bilirubin elevations.
Croatian: Dva posto bolesnika liječenih atazanavirom istodobno je imalo povišenje razine ALT-a/AST-a 3.-4. stupnja i povišenje razine ukupnog bilirubina 3.-4. stupnja.
English: Plasma concentrations of these medicinal products may be increased when co-administered with EVOTAZ, resulting in reduced serum cortisol concentrations.
Croatian: Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s EVOTAZOM, što dovodi do smanjenih koncentracija kortizola u serumu.
English: Exposure to clarithromycin is expected to increase if co-administered with EVOTAZ.
Croatian: Očekuje se povećana izloženost klaritromicinu pri istodobnoj primjeni s lijekom EVOTAZ.
English: This effect may be due to an induction of CYP3A4.
Croatian: Taj bi učinak mogao biti posljedica indukcije CYP3A4.
English: Co-administration with antiretroviral medicinal products EVOTAZ is indicated for use with other antiretrovirals for the treatment of HIV-1 infection.
Croatian: EVOTAZ je indiciran u kombinaciji s drugim antiretroviroticima za liječenje HIV-1 infekcije.
English: However, patients should be informed that dizziness has been reported during treatment with regimens containing atazanavir or cobicistat (see section 4.8).
Croatian: Međutim, bolesnike treba upozoriti da je tijekom liječenja režimima koji su sadržavali atazanavir ili kobicistat prijavljena omaglica (vidjeti dio 4.8)
English: The resistance profile of EVOTAZ is driven by atazanavir.
Croatian: Profil rezistencije lijeka EVOTAZ temelji se na atazanaviru.
English: In the pre- and postnatal development assessment in rats, atazanavir produced a transient reduction in body weight in the offspring at a maternally toxic dose.
Croatian: Procjena prenatalnog i postnatalnog razvoja u štakora pokazala je da je atazanavir izazvao prolazno smanjenje tjelesne težine potomstva pri dozama koje su bile toksične za majku.
English: In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (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 koji u trenutku uvođenja kombinirane antiretrovirusne terapije (CART) imaju tešku imunodeficijenciju, može doći do upalne reakcije na asimptomatske ili rezidualne oportunističke patogene, što može prouzročiti ozbiljna klinička stanja ili pogoršanje simptoma.
English: Effect of cobicistat on atazanavir pharmacokinetics
Croatian: Učinak kobicistata na farmakokinetiku atazanavira
English: In a 3-month combination oral toxicity study of atazanavir and cobicistat in rats, there were no toxicologic interactions apparent as no additive or synergistic toxicities were observed.
Croatian: U 3-mjesečnom ispitivanju toksičnosti peroralne primjene kombinacije atazanavira i kobicistata provedenom na štakorima nisu opažene aditivne ni sinergističke toksičnosti te nije bilo primjetnih toksikoloških interakcija.
English: The mean (± SD) change in estimated glomerular filtration rate (eGFR) by Cockcroft-Gault method after 144 weeks of treatment was -15.1 ± 16.5 ml/min in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group and -8.0 ± 16.8 ml/min in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
Croatian: Srednja vrijednost (± SD) promjene procijenjene brzine glomerularne filtracije (engl. estimated glomerular filtration rate, eGFR) izračunate Cockcroft-Gaultovom metodom nakon 144 tjedana liječenja iznosila je -15,1 ± 16,5 ml/min u skupini koja je primala atazanavir pojačan kobicistatom plus kombinaciju fiksne doze emtricitabina i tenofovira DF te -8,0 ± 16,8 ml/min u skupini koja je primala atazanavir pojačan ritonavirom plus kombinaciju fiksne doze emtricitabina i tenofovira DF.
English: Co-administration of nevirapine and EVOTAZ is expected to increase nevirapine plasma concentrations which may increase the risk of nevirapine-associated toxicity (see section 4.4).
Croatian: Očekuje se da će istodobna primjena nevirapina i lijeka EVOTAZ povisiti plazmatske koncentracije nevirapina, što bi moglo povećati rizik od toksičnosti povezane s primjenom nevirapina (vidjeti dio 4.4).