natgillin/translations-raw huggingface dataset:
Co-administration with EVOTAZ has the potential to produce serious and/or life-threatening bleeding due to increased exposure to warfarin and has not been studied.
Istodobna primjena s lijekom EVOTAZ može uzrokovati ozbiljno i/ili po život opasno krvarenje zbog povećane izloženosti varfarinu pa nije ispitivana.
EVOTAZ should not be used in combination with products containing the same active components including atazanavir, cobicistat or with fixed-dose products that contain cobicistat.
EVOTAZ se ne smije primjenjivati u kombinaciji s lijekovima koji sadrže iste djelatne tvari, uključujući atazanavir, kobicistat te lijekove s fiksnom kombinacijom doza koji sadrže kobicistat.
Concomitant use of EVOTAZ and fluticasone or other glucocorticoids that are metabolized by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Ne preporučuje se istodobna primjena lijeka EVOTAZ i flutikazona ili drugih glukokortikoida koji se metaboliziraju putem CYP3A4, osim u slučajevima kada moguća korist od liječenja nadmašuje rizik od sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i supresiju nadbubrežne žlijezde (vidjeti dio 4.5).
Glecaprevir AUC : ↑553% Glecaprevir Cmax : ↑306% (↑215% Glecaprevir Cmin : ↑1330% (↑885% Pibrentasvir AUC : ↑64% (↑48% Pibrentasvir Cmax : ↑29% (↑15% Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC : ↑11% (↑3% Atazanavir Cmax : ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% * Effect of atazanavir and ritonavir on the first dose of glecaprevir and pibrentasvir is reported.
Glekaprevir AUC: ↑553% (↑424% Glekaprevir Cmax: ↑306% (↑215% Glekaprevir Cmin: ↑1330% (↑885% Pibrentasvir AUC: ↑64% (↑48% Pibrentasvir Cmax: ↑29% (↑15% ↑45%) Pibrentasvir Cmin: ↑129% (↑95% Atazanavir AUC: ↑11% (↑3% ↑19%) Atazanavir Cmax: ↔ 0% (↓ Atazanavir Cmin: ↑16% (↑7% ↑25%) * Prijavljen je učinak atazanavira i ritonavira na prvu dozu glekaprevira i pibrentasvira.
In clinical study GS-US-216-0114, a phase 3 randomised, active-controlled clinical study, in which 692 treatment-naïve patients received at least one dose of atazanavir boosted with cobicistat (n = 344) or atazanavir boosted with ritonavir (n = 348) administered with other antiretroviral medicinal products, the most frequently reported adverse reactions in the atazanavir boosted with cobicistat group during 144 weeks were associated with elevated bilirubin levels (see Table 2).
U randomiziranom, aktivnim lijekom kontroliranom kliničkom ispitivanju faze 3 (GS-US-216-0114), u kojem su 692 prethodno neliječena bolesnika primila najmanje jednu dozu atazanavira pojačanog kobicistatom (n = 344) ili atazanavira pojačanog ritonavirom (n = 348) u kombinaciji s drugim antiretrovirusnim lijekovima, najčešće prijavljene nuspojave u skupini liječenoj atazanavirom pojačanim kobicistatom tijekom 144 tjedana bile su povezane s povišenim razinama bilirubina (vidjeti Tablicu 2).
Administration of a single dose of EVOTAZ with a high fat meal (1,038 kcal, 59 g fat, 37 g protein) resulted in a 14% reduction in atazanavir Cmax with no change in atazanavir AUC or cobicistat exposures (Cmax, AUC) relative to the fasting state.
Primjena jedne doze lijeka EVOTAZ uz obrok s visokim udjelom masnoća (1038 kcal, 59 g masnoća, 37 g proteina) smanjila je Cmax atazanavira za 14%, ali nije utjecala na AUC atazanavira niti na izloženost kobicistatu (Cmax, AUC) u odnosu na primjenu natašte.
In a fertility and early embryonic development study in rats, atazanavir altered oestrus cycling with no effects on mating or fertility.
U ispitivanju učinaka na plodnost i rani embrionalni razvoj, atazanavir je promijenio estrusni ciklus bez učinaka na parenje ili plodnost.
In a trial where HIV-infected subjects (n=22) were instructed to take atazanavir 300 mg with cobicistat 150 mg once daily with food, the steady-state atazanavir Cmax, AUCtau and Ctau (mean ± SD) values were 3.9 ± 1.9 μg/ml, 46.1 ± 26.2 μg•hr/ml and 0.80 ± 0.72 μg/ml, respectively.
U ispitivanju u kojem su ispitanici s HIV infekcijom (n=22) uzimali atazanavir u dozi od 300 mg s kobicistatom u dozi od 150 mg jedanput na dan s hranom, vrijednost Cmax, AUCtau i Ctau (srednja vrijednost ± SD) atazanavira u stanju dinamičke ravnoteže iznosila je 3,9 ± 1,9 μg/ml, 46,1 ± 26,2 μg•hr/ml odnosno 0,80 ± 0,72 μg/ml.
Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Nije računato
Indinavir is also associated with indirect (unconjugated) hyperbilirubinaemia due to inhibition of UGT.
Indinavir se povezuje i s indirektnom (nekonjugiranom) hiperbilirubinemijom uzrokovanom inhibicijom UGT-a.
Co-administration of simvastatin or lovastatin with EVOTAZ is contraindicated due to an increased risk of myopathy including rhabdomyolysis (see section 4.3).
Istodobna primjena simvastatina ili lovastatina s lijekom EVOTAZ je kontraindicirana zbog povećanog rizika od miopatije, uključujući rabdomiolizu (vidjeti dio 4.3).
Caution is warranted and therapeutic concentration monitoring of these medicinal products is recommended if they are used concomitantly with EVOTAZ.
Potreban je oprez te se preporučuje kontrolirati terapijske koncentracije navedenih lijekova pri njihovoj istodobnoj primjeni s lijekom EVOTAZ.
Concomitant administration of EVOTAZ with ticagrelor is contraindicated.
Istodobna primjena lijeka EVOTAZ i tikagrelora je kontraindicirana.
As EVOTAZ contains atazanavir and cobicistat, the adverse reactions associated with each of the individual components may be expected.
Budući da EVOTAZ sadrži atazanavir i kobicistat, mogu se očekivati nuspojave koje se povezuju s primjenom svake od tih dviju sastavnica pojedinačno.
In 2 controlled clinical studies for combination therapy with other antiretroviral medicinal products 1,806 adult patients receiving atazanavir 400 mg once daily (1,151 patients, 52 weeks median duration and 152 weeks maximum duration) or atazanavir 300 mg boosted with ritonavir 100 mg once daily (655 patients, 96 weeks median duration and 108 weeks maximum duration), the most frequently reported adverse reactions were nausea, diarrhoea and jaundice.
U 2 kontrolirana klinička ispitivanja kombinirane terapije s drugim antiretroviroticima, 1806 odraslih bolesnika primalo je atazanavir u dozi od 400 mg jedanput na dan (1151 bolesnik, medijan trajanja 52 tjedna, najdulje trajanje 152 tjedna) ili atazanavir u dozi od 300 mg pojačan ritonavirom u dozi od 100 mg jedanput na dan (655 bolesnika, medijan trajanja 96 tjedana, najdulje trajanje 108 tjedana), najčešće prijavljene nuspojave bile su mučnina, proljev i žutica.
Co- administration of EVOTAZ and ticagrelor may increase concentrations of the anticoagulant.
Istodobna primjena lijeka EVOTAZ i tikagrelora može povisiti koncentracije antikoagulansa.
Tenofovir alafenamide AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
Tenofoviralafenamid AUC ↑75% (↑55% ↑98%) Cmax ↑80% (↑48% ↑118%)
In HIV-infected patients with severe immune deficiency at the time of initiation of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.
U bolesnika s HIV infekcijom i teškom imunodeficijencijom u trenutku započinjanja kombinirane antiretrovirusne terapije može nastupiti upalna reakcija na asimptomatske ili rezidualne oportunističke infekcije.
Patients should not breast-feed while taking EVOTAZ.
Bolesnice ne bi smjele dojiti tijekom uzimanja lijeka EVOTAZ.
Do not take EVOTAZ: if you are allergic to atazanavir, cobicistat or any of the other ingredients of this medicine (listed in section 6) if you have moderate to severe liver problems if you are taking any of these medicines: see also Other medicines and EVOTAZ
Nemojte uzimati EVOTAZ: ako ste alergični na atazanavir, kobicistat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.) ako imate umjerene do teške jetrene tegobe ako uzimate neki od ovih lijekova: pogledajte i dio 'Drugi lijekovi i EVOTAZ' rifampicin (antibiotik za liječenje tuberkuloze) karbamazepin, fenobarbital i fenitoin (antiepileptici koji se koriste za sprječavanje napadaja)
The mechanism of interaction is CYP3A inhibition.
Mehanizam interakcije je inhibicija CYP3A.
How to take EVOTAZ
Kako uzimati EVOTAZ
Regular monitoring of the renal function of patients should be maintained throughout the treatment duration (see section 4.4)
Redovito praćenje bubrežne funkcije u bolesnika treba se održavati tijekom cijelog trajanja liječenja (vidjeti dio 4.4).
EVOTAZ is a fixed-dose combination of the antiviral drug atazanavir boosted by the pharmacokinetic enhancer cobicistat.
EVOTAZ je fiksna kombinacija antivirusnog lijeka atazanavira pojačanog farmakokinetičkim pojačivačem kobicistatom.
However, atazanavir must not be used in patients with moderate (Child-Pugh Class B) to severe (Child-Pugh Class C) hepatic impairment.
Međutim, atazanavir se ne smije primjenjivati u bolesnika s umjerenim (Child-Pugh stadij B) do teškim (Child-Pugh stadij C) oštećenjem jetrene funkcije.
What you need to know before you take EVOTAZ 3.
Što morate znati prije nego počnete uzimati EVOTAZ 3. Kako uzimati EVOTAZ 4. Moguće nuspojave
As EVOTAZ contains atazanavir and cobicistat, any interactions that have been identified with these active substances individually may occur with EVOTAZ.
Budući da EVOTAZ sadrži atazanavir i kobicistat, sve interakcije identificirane kod primjene tih dviju djelatnih tvari zasebno mogu se javiti i kod primjene lijeka EVOTAZ.
Increase monitoring for adverse reactions.
Potreban je pojačan nadzor zbog mogućih nuspojava.
Clarithromycin may increase concentrations of atazanavir and cobicistat.
Klaritromicin može povisiti koncentracije atazanavira i kobicistata.
In some cases, nephrolithiasis has been associated with acute renal failure or renal insufficiency.
U nekim je slučajevima nefrolitijaza bila povezana s akutnim zatajenjem bubrega ili bubrežnom insuficijencijom.
Patients receiving tenofovir disoproxil should be monitored for tenofovir-associated adverse reactions.
Bolesnike koji primaju tenofovirdizoproksil potrebno je nadzirati zbog mogućih nuspojava povezanih s tenofovirom.
When administered in combination, no clear additive or synergistic cardiovascular effects were observed at atazanavir and cobicistat concentrations at least 2-fold higher than the free atazanavir and cobicistat concentrations at the RHD Cmax.
Kada su se primjenjivali u kombinaciji, nisu primijećeni nikakvi očiti aditivni ni sinergistički učinci na kardiovaskularni sustav pri koncentracijama atazanavira i kobicistata koje su bile najmanje 2 puta više od koncentracija slobodnog atazanavira i kobicistata pri vrijednosti Cmax koja se postiže nakon primjene preporučene doze za ljude.
Skin and subcutaneous tissue disorders common rash uncommon pruritus, erythema multiformea,b, toxic skin eruptionsa,b, drug rash with eosinophilia and systemic symptoms (DRESS) syndromea,b, angioedemaa, urticaria, alopecia rare
Poremećaji kože i potkožnog tkiva često osip manje često svrbež, multiformni eritema,b, toksične kožne erupcijea,b, medikamentozni osip praćen eozinofilijom i sistemskim simptomima (DRESS)a,b, angioedema, urtikarija, alopecija rijeko
Based on the very limited renal elimination of cobicistat and atazanavir, no special precautions or dose adjustments of EVOTAZ are required for patients with renal impairment.
S obzirom na vrlo ograničenu eliminaciju kobicistata i atazanavira putem bubrega, u bolesnika s oštećenjem bubrežne funkcije nisu potrebne posebne mjere opreza ni prilagodbe doze lijeka EVOTAZ.
Cobicistat is primarily metabolised and eliminated by the liver.
Kobicistat se metabolizira i eliminira prvenstveno putem jetre.
Film-coating hypromellose (hydroxypropyl methyl cellulose, E464) titanium dioxide (E171) talc (E553b) triacetin (E1518) red iron oxide (E172)
Film ovojnica hipromeloza (hidroksipropilmetilceluloza, E464) titanijev dioksid (E171) talk (E553b) triacetin (E1518) željezov oksid, crveni (E172)
No teratogenic effects were observed in rats or rabbits at maternally toxic doses.
Nisu opaženi teratogeni učinci u štakora ni kunića pri dozama koje su bile toksične za majku.
The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Učestalost hepatitisa ili povišenja razine transaminaza koji su se u bolesnika s istodobnim infekcijama javljali tijekom liječenja bila je usporediva kod primjene atazanavira i usporednih režima (vidjeti dio 4.4).
Co-administration with EVOTAZ may result in increased concentrations of the PDE5 inhibitor and an increase in PDE5 inhibitor-associated adverse events.
Istodobna primjena s lijekom EVOTAZ može povisiti koncentracije inhibitora PDE5 i pojačati nuspojave povezane s djelovanjem inhibitora PDE5.
In an analysis of treatment-failure subjects who received atazanavir 300 mg co-administered with cobicistat 150 mg in study GS-US-216-0114 through Week 144, evaluable genotypic data from paired baseline and treatment-failure isolates were available for all 21 virologic failures in this group (6%, 21/344).
U analizi ispitanika koji nisu odgovorili na liječenje, a primali su atazanavir u dozi od 300 mg istodobno s kobicistatom u dozi od 150 mg tijekom 144 tjedana u ispitivanju GS-US-216-0114, ocjenjivi genotipski podaci iz uparenih izolata prikupljenih na početku ispitivanja i nakon neuspjeha liječenja bili su dostupni za svih 21 slučajeva virološkog neuspjeha u toj skupini bolesnika (6%, 21/344).
Patients with chronic hepatitis B or hepatitis C virus co-infection:
Bolesnici s istodobnom kroničnom infekcijom virusom hepatitisa B ili hepatitisa C
There have been reports of unusual heart beat in patients taking atazanavir-containing regimen.
Prijavljeni su i slučajevi nepravilnog srčanog ritma u bolesnika liječenih režimom koje je sadržavao atazanavir.
Cobicistat: AUC: ↔ Cmax: ↔ Cmin: ↓66%
Kobicistat: AUC: ↔ Cmax: ↔ Cmin: ↓66%
EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if one or more co-administered agent requires dose adjustment based on creatinine clearance (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir; see sections 4.2, 4.8 and 5.2).
Liječenje lijekom EVOTAZ ne smije se započeti u bolesnika s klirensom kreatinina manjim od 70 ml/min ako bilo koji od istodobno primijenjenih lijekova zahtijeva prilagodbu doze na temelju klirensa kreatinina (npr. emtricitabin, lamivudin, tenofovirdizoproksil ili adefovir; vidjeti dijelove 4.2, 4.8 i 5.2).
Indinavir is associated with indirect unconjugated hyperbilirubinaemia due to inhibition of UGT.
Indinavir se povezuje s indirektnom (nekonjugiranom) hiperbilirubinemijom zbog inhibicije UGT-a.
Co-administration of EVOTAZ with proton pump inhibitors is not recommended.
Ne preporučuje se istodobna primjena lijeka EVOTAZ s inhibitorima protonske pumpe.
Voxilaprevir Cmax : ↑342% (↑265%
Voksilaprevir Cmax: ↑342% (↑265%
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection.
Nakon što započnete liječenje HIV infekcije, osim oportunističkih infekcija mogu se pojaviti i autoimune bolesti (stanja koja nastaju kada imunosni sustav napada zdrava tjelesna tkiva).
Rifampicin substantially decreases plasma concentrations of atazanavir, which may result in loss of therapeutic effect of EVOTAZ and development of resistance to atazanavir.
Rifampicin značajno snizuje plazmatske koncentracije atazanavira, što za posljedicu može imati gubitak terapijskog učinka lijeka EVOTAZ i razvoj rezistencije na atazanavir.
A study of the pharmacokinetics of cobicistat was performed in non-HIV-1 infected subjects with moderate hepatic impairment (Child-Pugh Class B).
Ispitivanje farmakokinetike kobicistata provedeno je u ispitanika bez HIV-1 infekcije koji su imali umjereno oštećenje jetrene funkcije (Child-Pugh stadij B).
Co-administration with EVOTAZ may result in increased concentrations of salmeterol and an increase in salmeterol-associated adverse events.
Istodobna primjena s lijekom EVOTAZ može povisiti koncentracije salmeterola i pojačati nuspojave povezane sa salmeterolom.
Among 1,151 patients receiving atazanavir 400 mg once daily, 177 patients were co-infected with chronic hepatitis B or C, and among 655 patients receiving atazanavir 300 mg once daily with ritonavir 100 mg once daily, 97 patients were co-infected with chronic hepatitis B or C. Co-infected patients were more likely to have baseline hepatic transaminase elevations than those without chronic viral hepatitis.
Od 1151 bolesnika koji su primali atazanavir u dozi od 400 mg jedanput na dan, njih 177 imalo je istodobnu kroničnu infekciju virusom hepatitisa B ili C, dok je među 655 bolesnika koji su primali atazanavir u dozi od 300 mg jedanput na dan s ritonavirom u dozi od 100 mg jedanput na dan, njih 97 imalo istodobnu kroničnu infekciju virusom hepatitisa B ili C.
Ethinyloestradiol AUC: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Not calculated
Etinilestradiol AUC: ↔ Etinilestradiol Cmax: ↔ Etinilestradiol Cmin: Nije računato
Patients were randomised in a 1:1 ratio to receive either atazanavir 300 mg with cobicistat 150 mg once daily or atazanavir 300 mg with ritonavir 100 mg once daily, each administered with a fixed background regimen containing tenofovir DF 300 mg and emtricitabine 200 mg administered as a fixed-dose combination tablet.
Bolesnici su bili randomizirani u omjeru 1:1 za primanje atazanavira u dozi od 300 mg u kombinaciji s kobicistatom u dozi od 150 mg jedanput na dan ili atazanavira u dozi od 300 mg u kombinaciji s ritonavirom u dozi od 100 mg jedanput na dan, oba uz fiksni osnovni režim koji je sadržavao tenofovir DF u dozi od 300 mg i emtricitabin u dozi od 200 mg, primijenjen u obliku tablete s fiksnom kombinacijom doza.
In study GS-US-216-0114, through 144 weeks of treatment hyperbilirubinaemia (> 1 x ULN) was common: 97.7% in the atazanavir boosted with cobicistat plus emtricitabine and tenofovir DF fixed-dose combination group, and 97.4% in the atazanavir boosted with ritonavir plus emtricitabine and tenofovir DF fixed-dose combination group.
U ispitivanju GS-US-216-0114 je hiperbilirubinemija (> 1 x gornja granica normale [GGN]) tijekom 144 tjedna liječenja bila česta: javila se u 97,7% bolesnika u skupini koja je primala atazanavir pojačan kobicistatom plus fiksnu kombinaciju emtricitabina i tenofovira DF i u 97,4% bolesnika u skupini koja je primala atazanavir pojačan ritonavirom plus fiksnu kombinaciju emtricitabina i tenofovira DF.
Gastrointestinal disorders very common nausea common vomiting, diarrhoea, dyspepsia, abdominal pain, abdominal distension, flatulence, dry mouth uncommon pancreatitis, gastritis, stomatitis aphthous
Poremećaji probavnog sustava vrlo često mučnina često povraćanje, proljev, dispepsija, bol u abdomenu, distenzija abdomena, flatulencija, suha usta manje često pankreatitis, gastritis, aftozni stomatitis
Carbamazepine Phenobarbital Phenytoin
ANTIEPILEPTICI Karbamazepin Fenobarbital Fenitoin
These antiepileptics are expected to decrease atazanavir and/or cobicistat plasma concentrations.
Očekuje se da će ovi antiepileptici sniziti plazmatske koncentracije atazanavira i/ili kobicistata.
No significant effect on lamivudine and zidovudine concentrations was observed when co-administered with atazanavir.
Nije opažen značajan učinak na koncentracije lamivudina i zidovudina pri istodobnoj primjeni s atazanavirom.
Table 2: Tabulated summary of adverse reactions
Tablica 2: Tablični prikaz nuspojava
Co-administration of EVOTAZ with other protease inhibitors is not recommended.
Ne preporučuje se istodobna primjena lijeka EVOTAZ s drugim inhibitorima proteaze.
The active substances are atazanavir and cobicistat.
Djelatne tvari su atazanavir i kobicistat.
Unchanged drug accounted for approximately 20% and 7% of the administered dose in the faeces and urine, respectively.
Lijek u neizmijenjenom obliku činio je približno 20% primijenjene doze u fecesu i 7% u mokraći.
Atazanavir should be used with caution in patients with mild (Child-Pugh Class A) hepatic impairment.
Atazanavir treba primjenjivati uz oprez u bolesnika s blagim (Child-Pugh stadij A) oštećenjem jetrene funkcije.
An increase of > 3 x ULN in alanine aminotransferase or aspartate aminotransferase was recorded in 12.8% of subjects in the cobicistat-boosted group and 9.0% in the ritonavir-boosted group.
Porast razine alanin aminotransferaze ili aspartat aminotransferaze > 3 x GGN zabilježen je u 12,8% ispitanika u skupini koja je primala atazanavir pojačan kobicistatom i 9,0% ispitanika u skupini koja je primala atazanavir pojačan ritonavirom.
EVOTAZ should not be initiated in patients with creatinine clearance less than 70 ml/min if any co-administered agent (e.g. emtricitabine, lamivudine, tenofovir disoproxil or adefovir) requires dose adjustment based on creatinine clearance (see sections 4.4, 4.8 and 5.2).
Liječenje lijekom EVOTAZ ne smije se započeti u bolesnika s klirensom kreatinina manjim od 70 ml/min ako bilo koji od istodobno primijenjenih lijekova (npr. emtricitabin, lamivudin, tenofovirdizoproksilili adefovir) zahtijeva prilagodbu doze na temelju klirensa kreatinina (vidjeti dijelove 4.4, 4.8 i 5.2).
There are limited clinical data with cobicistat in pregnant women.
Klinički podaci o primjeni kobicistata u trudnica su ograničeni.
Avoid concomitant use of EVOTAZ and rivaroxaban.
Treba izbjegavati istodobnu primjenu lijeka EVOTAZ i rivaroksabana.
Among experienced patients treated with atazanavir 300 mg once daily with 100 mg ritonavir once daily for a median duration of 95 weeks, 53% had Grade 3-4 total bilirubin elevations.
Među prethodno liječenim bolesnicima koji su primali atazanavir u dozi od 300 mg jedanput na dan sa 100 mg ritonavira jedanput na dan tijekom medijana od 95 tjedana, njih 53% imalo je povišenje ukupnog bilirubina 3.-4. stupnja.
Tablet core microcrystalline cellulose (E460(i)) croscarmellose sodium (E468) sodium starch glycolate crospovidone (E1202) stearic acid (E570) magnesium stearate (E470b) hydroxypropyl cellulose (E463) silicon dioxide (E551)
Jezgra tablete celuloza, mikrokristalična (E460(i)) karmelozanatrij, umrežena (E468) natrijev škroboglikolat krospovidon (E1202) stearatna kiselina (E570) magnezijev stearat (E470b) hidroksipropilceluloza (E463) silicijev dioksid (E551)
Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as atazanavir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Inhibicijom metabolizma u kojem posreduje CYP3A, kobicistat povećava sistemsku izloženost supstratima za CYP3A (poput atazanavira), koji zbog metabolizma ovisnog o CYP3A imaju ograničenu bioraspoloživost i kratak poluvijek.
Co-administration of neuroleptics with EVOTAZ may result in increased plasma concentrations of neuroleptics.
Istodobna primjena neuroleptika s lijekom EVOTAZ može povisiti plazmatske koncentracije neuroleptika.
Following oral administration of [14C]cobicistat, 86% and 8.2% of the dose were recovered in faeces and urine, respectively.
Nakon peroralne primjene [14C]kobicistata, 86% doze pronađeno je u fecesu, a 8,2% u mokraći.
Because atazanavir is a component of EVOTAZ, co-administration of EVOTAZ with nevirapine or efavirenz is not recommended (see section 4.5).
Budući da je atazanavir sastavnica lijeka EVOTAZ, ne preporučuje se istodobna primjena lijeka EVOTAZ s nevirapinom ili efavirenzom (vidjeti dio 4.5).
Telaprevir 750 mg three times daily (cobicistat 150 mg once daily in combination with elvitegravir)
Telaprevir 750 mg triput na dan (kobicistat 150 mg jedanput na dan u kombinaciji s elvitegravirom)