FrancophonIA/ELRC3.0 huggingface dataset:
English: Cobicistat, does not directly treat your HIV, but boosts the levels of atazanavir in the blood.
Slovenian: Kobicistat okužbe z virusom HIV ne zdravi neposredno, temveč le poveča koncentracijo atazanavirja v krvi.
English: Treatment difference -2.2% (95% CI = -7.4%, 3.0%) -2.1% (95% CI = -8.7%, 4.5%) Virologic failurec
Slovenian: 2,2 % (95 % IZ = 7,4 %, 3,0 %) 2,1 % (95 % IZ = 8,7 %, 4,5 %)
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).
Slovenian: Splošne težave in spremembe na mestu aplikacije pogosti utrujenost občasni zvišana telesna temperatura, astenija, bolečina v prsnem košu, splošno slabo počutje redki motnje hoje a Te neželene učinke so odkrili med spremljanjem zdravil po prihodu na trg, njihova pogostnost pa je ocenjena s pomočjo statističnega izračuna na podlagi celotnega števila bolnikov, ki so bili izpostavljeni atazanavirju (z ritonavirjem ali brez njega) v randomiziranih nadzorovanih ali drugih razpoložljivih kliničnih preskušanjih (n = 2.321).
English: ANTIDEPRESSANTS Other antidepressants:
Slovenian: ANTIDEPRESIVI Drugi antidepresivi:
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).
Slovenian: Ker se atazanavir in kobicistat močno vežeta na plazemske proteine je malo verjetno, da bi se v večji meri odstranila s hemodializo ali peritonealno dializo (glejte poglavji 4.2 in 5.2).
English: Patients with chronic hepatitis B or hepatitis C virus co-infection:
Slovenian: Bolniki s sočasno kronično okužbo z virusom hepatitisa B ali hepatitisa C:
English: Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Slovenian: Nukleozidni/nukleotidni zaviralci reverzne transkriptaze (NRTI-ji)
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of cobicistat has not been studied.
Slovenian: Vpliva hude okvare jeter (Child-Pugh C) na farmakokinetiko kobicistata niso raziskovali.
English: There are other medicines that may not be taken together or may require a change in their mode of administration when taken with EVOTAZ.
Slovenian: So pa še nekatera druga zdravila, ki jih ne smete jemati skupaj z zdravilom EVOTAZ ali pa je v primeru sočasnega jemanja treba njihov način uporabe spremeniti.
English: Atazanavir with cobicistat and emtricitabine and tenofovir DF fixed-dose combination was non-inferior in achieving HIV-1 RNA <50 copies/ml when compared to atazanavir with ritonavir and emtricitabine and tenofovir DF fixed-dose combination.
Slovenian: Kombinacija atazanavirja s kobicistatom ter emtricitabina in tenofovirja DF v fiksni kombinaciji je bila pri doseganju vrednosti HIV-1 RNA < 50 kopij/ml enakovredna (ni bila inferiorna) kombinaciji atazanavirja z ritonavirjem ter emtricitabina in tenofovirja DF v fiksni kombinaciji.
English: 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.
Slovenian: Kobicistat z zaviranjem presnove s CYP3A okrepi sistemsko izpostavljenost substratom za CYP3A, kot je atazanavir, ki imajo omejeno biološko uporabnost in kratek razpolovni čas zaradi presnove s CYP3A.
English: These antiepileptics are expected to decrease atazanavir and/or cobicistat plasma concentrations.
Slovenian: Za te antiepileptike pričakujemo, da bodo zmanjšali koncentracije atazanavirja in/ali kobicistata v plazmi.
English: If you notice any of these symptoms please inform your doctor.
Slovenian: Če opazite katerega koli od teh simptomov, o tem obvestite zdravnika.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT AND BOTTLE LABEL 1.
Slovenian: BESEDILO NA ŠKATLI IN NALEPKI PLASTENKE 1.
English: 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.
Slovenian: Od 1.151 bolnikov, ki so prejemali atazanavir v odmerku 400 mg enkrat na dan, je 177 bolnikov sočasno imelo kronični hepatitis B ali C. Od 655 bolnikov, ki so prejemali atazanavir v odmerku 300 mg enkrat na dan skupaj z ritonavirjem v odmerku 100 mg enkrat na dan, je 97 bolnikov sočasno imelo kronični hepatitis B ali C. Pri sočasno okuženih bolnikih je verjetnost za izhodiščno zvišane vrednosti jetrnih aminotransferaz večja kot pri bolnikih brez kroničnega virusnega hepatitisa.
English: The activity of cobicistat as a pharmacokinetic enhancer to atazanavir has been demonstrated in pharmacokinetic trials.
Slovenian: Delovanje kobicistata kot stopnjevalca farmakokinetike atazanavirja je bilo dokazano v farmakokinetičnih preskušanjih.
English: 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).
Slovenian: Sočasna uporaba zdravila EVOTAZ in flutikazona ali drugih glukokortikoidov, ki se presnavljajo s CYP3A4, ni priporočljiva, razen če možne koristi zdravljenja prevladajo nad tveganjem za pojav sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvične žleze (glejte poglavje 4.5).
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.
Slovenian: Pri z virusom HIV okuženih bolnikih s hudo imunsko pomanjkljivostjo lahko ob uvedbi kombiniranega protiretrovirusnega zdravljenja nastane vnetna reakcija na asimptomatične ali rezidualne oportunistične patogene in povzroči resno klinično stanje ali poslabšanje simptomov.
English: In treatment-naïve HIV-1 infected patients
Slovenian: Predhodno nezdravljeni bolniki, okuženi z virusom HIV-1
English: If you accidentally take more EVOTAZ than your doctor recommended, contact your doctor at once or contact the nearest hospital for advice.
Slovenian: Če ste vzeli večji odmerek zdravila EVOTAZ, kot bi smeli Če ste po nesreči vzeli prevelik odmerek zdravila EVOTAZ, se takoj posvetujte z zdravnikom ali poiščite pomoč v najbližji bolnišnici.
English: Recommended dosage of colchicine when administered with EVOTAZ in patients without renal or hepatic impairment: a dose reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with EVOTAZ is required.
Slovenian: Priporočeno odmerjanje kolhicina pri sočasni uporabi z zdravilom EVOTAZ pri bolnikih brez okvare ledvic ali jeter: če je pri bolnikih z normalnim delovanjem ledvic ali jeter potrebno zdravljenje z zdravilom EVOTAZ, je treba odmerek kolhicina zmanjšati ali zdravljenje s kolhicinom prekiniti.
English: Do not double the next dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Slovenian: Pri nekaterih bolnikih se med kombiniranim protiretrovirusnim zdravljenjem lahko pojavi bolezen kosti, imenovana osteonekroza (odmiranje kostnega tkiva zaradi nezadostne prekrvitve kosti).
English: Talk to your doctor or pharmacist before taking EVOTAZ.
Slovenian: Pred začetkom jemanja zdravila EVOTAZ se posvetujte z zdravnikom ali farmacevtom.
English: The frequency of treatment emergent hepatitis or transaminase elevations in co-infected patients was comparable between atazanavir and comparator regimens (see section 4.4).
Slovenian: Pogostnost med zdravljenjem nastalega hepatitisa ali zvišanja vrednosti aminotransferaz pri sočasno okuženih bolnikih je bila primerljiva med atazanavirjem in primerjalnimi shemami zdravljenja (glejte poglavje 4.4).
English: Ethinyloestradiol AUC: ↔ Ethinyloestradiol Cmax: ↔ Ethinyloestradiol Cmin: Not calculated
Slovenian: Etinilestradiol AUC: ↔ Etinilestradiol Cmax: ↔ Etinilestradiol Cmin: ni izračunano
English: Clarithromycin may increase concentrations of atazanavir and cobicistat.
Slovenian: Klaritromicin lahko poveča koncentracije atazanavirja in kobicistata.
English: Low levels of metabolites are observed in urine and faeces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Slovenian: V urinu in blatu so opazili nizke ravni presnovkov, ki ne prispevajo k zaviralnemu učinki kobicistata na CYP3A.
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.
Slovenian: Pri vrednotenju prednatalnega in postnatalnega razvoja pri podganah je atazanavir pri odmerkih, ki so bili toksični za matere, povzročil prehodno zmanjšanje telesne mase mladičev.
English: 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
Slovenian: Bolezni kože in podkožja pogosti izpuščaj občasni srbenje, multiformni eritema,b, toksične kožne erupcijea,b, sindrom medikamentoznega izpuščaja z eozinofilijo in sistemskimi simptomi (sindrom DRESS)a,b, angioedema, urtikarija, alopecija redki
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.
Slovenian: Sistemska izpostavljenost atazanavirju pri odmerkih, ki so povzročili toksične učinke pri materah, je bila vsaj tolikšna ali nekoliko večja kot izpostavljenost človeka pri uporabi odmerka 400 mg enkrat na dan.
English: 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.
Slovenian: Zdravila EVOTAZ se ne sme uporabljati v kombinaciji z zdravili, ki vsebujejo iste učinkovine, vključno z atazanavirjem in kobicistatom, ali v kombinaciji z zdravili, ki vsebujejo kobicistat v fiksni kombinaciji.
English: ANTIHISTAMINE AGENTS Astemizole
Slovenian: ANTIHISTAMINIKI Astemizol
English: Concomitant administration of EVOTAZ with ticagrelor is contraindicated.
Slovenian: Sočasna uporaba zdravila EVOTAZ in ticagrelorja je kontraindicirana.
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).
Slovenian: Vrednosti Cmax, AUCtau in Ctau (povprečna vrednost ± SD) kobicistata v stanju dinamičnega ravnovesja pa so bile naslednje: Cmax 1,5 ± 0,5 μg/ml, AUCtau 11,1 ± 4,5 μg•uro/ml in Ctau 0,05 ± 0,07 μg/ml (n=22).
English: No significant effect on didanosine and stavudine concentrations was observed.
Slovenian: Pomembnega vpliva na koncentracije didanozina in stavudina niso opazili.
English: Concomitant use of EVOTAZ and corticosteroids that are metabolised by CYP3A (e.g. fluticasone propionate or other inhaled or nasal corticosteroids) may increase the risk of development of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression.
Slovenian: Sočasna uporaba zdravila EVOTAZ in kortikosteroidov, ki se presnavljajo s pomočjo encimov CYP3A (npr. flutikazonpropionata in drugih inhaliranih ali nazalnih kortikosteroidov) lahko poveča tveganje za razvoj sistemskih kortikosteroidnih učinkov, vključno s Cushingovim sindromom in supresijo nadledvičnih žlez.
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).
Slovenian: Pri bolnikih, ki se zdravijo z zdravili, ki so substrati za prenašalce P-gp, BCRP, MATE1, OATP1B1 ali OATP1B3, se pri sočasni uporabi zdravila EVOTAZ lahko povečajo plazemske koncentracije sočasno uporabljenih zdravil (glejte poglavje 4.4).
English: Buprenorphine/naloxone in combination with cobicistat
Slovenian: Buprenorfin/nalokson v kombinaciji s kobicistatom
English: Etravirine
Slovenian: Etravirin
English: Since atazanavir and cobicistat are extensively metabolised by the liver and highly protein bound, dialysis is unlikely to be beneficial in significant removal of this medicinal product.
Slovenian: Ker se atazanavir in kobicistat obsežno presnavljata v jetrih in močno vežeta na proteine, je malo verjetno, da bi se ju z dializo lahko odstranilo v pomembnejšem obsegu.
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir.
Slovenian: Izpuščaji so običajno blagi do zmerni makulopapulozni izbruhi na koži, ki se lahko pojavijo v prvih 3 tednih po uvedbi zdravljenja z atazanavirjem.
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.
Slovenian: Po enkratnem 400-mg odmerku [14C]atazanavirja se je 79 % celotne radioaktivnosti izločilo z blatom,
English: Cmax and AUCs after a high fat meal decreased 36% and 25% in comparison to a light meal, respectively; however, the 24-hour atazanavir concentration was similar when EVOTAZ was given with a light meal and a high fat meal.
Slovenian: V primerjavi z uporabo po lahkem obroku se je pri uporabi po obroku z visoko vsebnostjo maščob vrednost Cmax zmanjšala za 36 %, vrednost AUC pa za 25 %, vendar pa je bila 24-urna koncentracija atazanavirja pri uporabi zdravila EVOTAZ skupaj z lahkim obrokom ali z obrokom z visoko vsebnostjo maščob podobna.
English: For more information consult the REYATAZ Summary of Product Characteristics.
Slovenian: Za več informacij glejte povzetek glavnih značilnosti zdravila REYATAZ.
English: Do not take sildenafil with EVOTAZ when sildenafil is used for the treatment of pulmonary arterial hypertension.
Slovenian: Med zdravljenjem z zdravilom EVOTAZ ne smete uporabljati sildenafila za zdravljenje pljučne arterijske hipertenzije.
English: In healthy subjects, the renal elimination of unchanged atazanavir was approximately 7% of the administered dose.
Slovenian: Pri zdravih osebah se je preko ledvic v nespremenjeni obliki izločilo približno 7 % uporabljenega odmerka atazanavirja.
English: Cobicistat is not expected to induce CYP3A4 or P-gp.
Slovenian: Ne pričakujemo, da bi kobicistat induciral CYP3A4 ali P-gp.
English: If you notice any symptoms of infection, please inform your doctor immediately.
Slovenian: Če opazite kakršne koli znake okužbe, o tem nemudoma obvestite zdravnika.
English: rifampicin (an antibiotic used to treat tuberculosis)
Slovenian: rifampicin (zdravilo za zdravljenje okužb z mikobakterijami).
English: Clarithromycin AUC ↑94% (↑75%
Slovenian: Klaritromicin AUC ↑94% (↑75%
English: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: Not calculated
Slovenian: Atorvastatin AUC: ↑ 822% Atorvastatin Cmax: ↑ 1785% Atorvastatin Cmin: ni izračunano
English: Drospirenone AUC: ↑ 130% Drospirenone Cmax: ↔ Drospirenone Cmin: Not calculated
Slovenian: Drospirenon AUC: ↑ 130% Drospirenon Cmax: ↔ Drospirenon Cmin: ni izračunano
English: What EVOTAZ looks like and contents of the pack EVOTAZ tablets are pink, oval, biconvex, film coated tablet of approximate dimensions of 19 mm x 10.4 mm, debossed on one side with "3641" and plain-faced on the other side of the tablet.
Slovenian: Izgled zdravila EVOTAZ in vsebina pakiranja EVOTAZ tablete so rožnate, ovalne, obojestransko izbočene, filmsko obložene tablete, velike približno 19 mm x 10,4 mm, z oznako “3641” na eni in brez oznak na drugi strani.
English: Atazanavir, dosed 1 hr after ddI+d4T (fasted) Atazanavir AUC ↔3% (↓36%
Slovenian: Atazanavir, uporaba 1 uro po ddI+d4T (na tešče) Atazanavir AUC ↔3% (↓36%
English: Trazodone
Slovenian: Trazodon
English: If you develop signs or symptoms of kidney stones (pain in your side, blood in your urine, pain when you urinate), please inform your doctor immediately if you are taking oral contraceptives ("the Pill") to prevent pregnancy.
Slovenian: Če se pojavijo znaki ali simptomi ledvičnih kamnov (bolečina v ledvenem predelu, kri v urinu, bolečina pri uriniranju), o tem nemudoma obvestite zdravnika.
English: People who already have type A or B haemophilia may notice increased bleeding.
Slovenian: Bolniki, ki imajo hemofilijo tipa A ali B, lahko pogosteje krvavijo.
English: Concomitant administration of boceprevir and atazanavir/ritonavir resulted in reduced exposures to atazanavir and ritonavir.
Slovenian: Pri sočasni uporabi boceprevirja in atazanavirja/ritonavirja se je izpostavljenost atazanavirju in ritonavirju zmanjšala.
English: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: Not calculated
Slovenian: Rosuvastatin AUC: ↑ 242% Rosuvastatin Cmax: ↑ 958% Rosuvastatin Cmin: ni izračunano
English: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: Not determined
Slovenian: AUC: ↔7% (↓11% ↓3%) Cmax: ↓13% (↓20% ↓6%) Cmin: ni bilo določeno
English: Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) 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.
Slovenian: Poročajo, da se med imunsko reaktivacijo lahko pojavijo tudi avtoimunske bolezni (kot sta Gravesova bolezen in avtoimunski hepatitis), čas do njihovega nastanka pa je bolj spremenljiv, zato se lahko pojavijo tudi več mesecev po začetku zdravljenja.
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.
Slovenian: Povprečna (± SD) sprememba ocene glomerulne filtracije (eGFR) po Cockcroft-Gaultovi metodi je po 144 tednih zdravljenja v skupini z atazanavirjem, okrepljenim s kobicistatom, ter fiksno kombinacijo emtricitabina in tenofovirja DF znašala -15,1 ± 16,5 ml/min, v skupini z atazanavirjem, okrepljenim z ritonavirjem, ter fiksno kombinacijo emtricitabina in tenofovirja DF pa -8,0 ± 16,8 ml/min.
English: 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).
Slovenian: Pri analizi bolnikov, pri katerih je bilo zdravljenje z atazanavirjem v odmerku 300 mg skupaj s kobicistatom v odmerku 150 mg v študiji GS-US-216-0114 do 144. tedna neuspešno, so bili na voljo ovrednoteni genotipski podatki o izhodiščnih in pri zdravljenju neuspešnih izolatih za vseh 21 viroloških neuspehov v tej skupini zdravljenja (6 %, 21/344).
English: 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.
Slovenian: Med 144 tedenskim zdravljenjem v študiji GS-US-216-0114 je bila hiperbilirubinemija (> 1 x ZMN; zgornja meja normalne vrednosti) pogosta: 97,7 % v skupini z atazanavirjem, okrepljenim s kobicistatom, ter fiksno kombinacijo emtricitabina in tenofovirja DF, in 97,4 % v skupini z atazanavirjem, okrepljenim z ritonavirjem, ter fiksno kombinacijo emtricitabina in tenofovirja DF.
English: Cobicistat exposures are non-linear and greater than dose-proportional over the range of 50 mg to 400 mg, consistent with a mechanism-based CYP3A inhibitor.
Slovenian: V razponu odmerkov od 50 mg do 400 mg se povečajo bolj kot proporcionalno z odmerkom, kar je v skladu z zaviranjem mehanizma CYP3A.
English: Didanosine Cmin ↑13% (↓9%
Slovenian: Didanozin Cmin ↑13% (↓9%
English: Rashes are usually mild-to-moderate maculopapular skin eruptions that occur within the first 3 weeks of starting therapy with atazanavir, a component of EVOTAZ.
Slovenian: Izpuščaji so običajno blagi do zmerni makulopapulozni izbruhi na koži, ki se lahko pojavijo v prvih 3 tednih po uvedbi zdravljenja z atazanavirjem, sestavino zdravila EVOTAZ.
English: Systemic exposures of atazanavir in mice (males), rats, and dogs at doses associated with hepatic changes were at least equal to that observed in humans given 400 mg once daily.
Slovenian: Sistemska izpostavljenost miši (samci), podgan in psov atazanavirju pri odmerkih, ki so bili povezani s spremembami na jetrih, je bila vsaj tolikšna kot izpostavljenost človeka pri uporabi odmerka 400 mg enkrat na dan.
English: Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Slovenian: Nenukleozidni zaviralci reverzne transkriptaze (NNRTI-ji)
English: Didanosine Cmax ↓36% (↓45%
Slovenian: Didanozin Cmax ↓36% (↓45%
English: ANTIDIABETICS Metformin
Slovenian: ANTIDIABETIKI Metformin
English: Co-administration with EVOTAZ can increase plasma concentrations of medicinal products that are metabolised by CYP2D6 (see sections 4.3 and 4.5).
Slovenian: Pri sočasni uporabi zdravila EVOTAZ se lahko povečajo plazemske koncentracije zdravil, ki se presnavljajo s CYP2D6 (glejte poglavji 4.3 in 4.5).
English: If drospirenone/ethinyloestradiol is coadministered with atazanavir/cobicistat, clinical monitoring is recommended due to the potential for hyperkalemia.
Slovenian: Pri sočasni uporabi drospirenona/etinilestradiola in atazanavirja/kobicistata se priporoča klinično nadziranje zaradi možnosti pojava hiperkaliemije.
English: 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.
Slovenian: V preskušanju, v katerem so bolniki, okuženi z virusom HIV (n=22) jemali atazanavir v odmerku 300 mg s kobicistatom v odmerku 150 mg enkrat na dan skupaj s hrano so bile vrednosti Cmax, AUCtau in Ctau (povprečna vrednost ± SD) atazanavirja v stanju dinamičnega ravnovesja naslednje: Cmax 3,9 ± 1,9 μg/ml, AUCtau 46,1 ± 26,2 μg•uro/ml in Ctau 0,80 ± 0,72 μg/ml.
English: Specific dosing recommendations are not
Slovenian: posebnih priporočil za odmerjanje ne moremo navesti.
English: Efavirenz decreases atazanavir concentrations and is expected to decrease cobicistat plasma concentrations.
Slovenian: Efavirenz zmanjša koncentracije atazanavirja, pričakujemo pa tudi zmanjšanje koncentracij kobicistata v plazmi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains atazanavir sulphate corresponding to 300 mg atazanavir and 150 mg of cobicistat.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje atazanavirjev sulfat v količini, ki ustreza 300 mg atazanavirja, in 150 mg kobicistata.
English: Cobicistat has not been studied in patients with severe hepatic impairment and is not recommended in these patients.
Slovenian: Pri bolnikih s hudo okvaro jeter uporabe kobicistata niso raziskovali, zato njegova uporaba pri teh bolnikih ni priporočljiva.