FrancophonIA/ELRC3.0 huggingface dataset:
English: One patient in the Genvoya group (1 of 22 [4.5%]) and 2 patients in the E/C/F/TDF group (2 of 20 [10%]) had reduced susceptibility to tenofovir.
Croatian: Jedan bolesnik u skupini liječenoj lijekom Genvoya (1 od 22 [4,5%]) i 2 bolesnika u skupini koja je primala E/C/F/TDF (2 od 20 [10%]) imali su smanjenu osjetljivost na tenofovir.
English: Co-administration with CYP3A-metabolised corticosteroids is not recommended unless the potential benefit to the patient outweighs the risk, in which case patients should be monitored for systemic corticosteroid effects.
Croatian: Ne preporučuje se istodobna primjena s kortikosteroidima koji se metaboliziraju putem CYP3A, osim kada potencijalna korist za bolesnika nadmašuje rizik, a u tom slučaju je bolesnike potrebno pratiti radi eventualnih sistemskih učinaka kortikosteroida.
English: Following administration of tenofovir alafenamide, plasma [14C]-radioactivity showed a time-dependent profile with tenofovir alafenamide as the most abundant species in the initial few hours and uric acid in the remaining period.
Croatian: Nakon primjene tenofoviralafenamida, [14C]-radioaktivnost u plazmi pokazala je profil ovisan o vremenu s tenofoviralafenamidom kao najzastupljenijim u prvih nekoliko sati i mokraćnom kiselinom u preostalom razdoblju.
English: Cobicistat is also a weak CYP2D6 inhibitor and is metabolised, to a minor extent, by CYP2D6.
Croatian: Kobicistat je također slab inhibitor CYP2D6 i u manjoj ga mjeri metabolizira CYP2D6.
English: Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.
Croatian: Relevantni primjeri obuhvaćaju citomegalovirusni retinitis, generalizirane i/ili žarišne mikobakterijske infekcije, te upalu pluća uzrokovanu s Pneumocystis jirovecii.
English: For elvitegravir, Cmax and AUC increased 22% and 36% with a light meal, and 56% and 91% with a high-fat meal, relative to fasting conditions.
Croatian: Vrijednosti Cmax i AUC za elvitegravir povećale su se 22%, odnosno 36% s laganim obrokom, a s visokomasnim obrokom 56%, odnosno 91% u odnosu na stanje natašte.
English: Eighty-six percent of patients (62/72) were HBV suppressed (HBV DNA < 29 IU/mL) and 42% (30/72) were HBeAg positive at baseline.
Croatian: Osamdeset šest posto bolesnika (62/72) imalo je supresiju HBV-a (HBV DNA < 29 IU/ml) i 42% (30/72) bilo je HBeAg pozitivno pri ishodištu.
English: Viruses expressing the T66I/A mutations maintain susceptibility to raltegravir, while most other patterns showed reduced susceptibility to raltegravir.
Croatian: Virusi koji izražavaju mutacije T66I/A zadržavaju osjetljivost na raltegravir, dok većina drugih uzoraka pokazuje smanjenu osjetljivost na raltegravir.
English: Cobicistat exposures were unaffected by a light meal and although there was a modest decrease of 24% and 18% in Cmax and AUC respectively with a high-fat meal, no difference was observed in its pharmacoenhancing effect on elvitegravir.
Croatian: Lagani obrok nije utjecao na izloženost kobicistatu, a iako je došlo do umjerenog pada vrijednosti Cmax i AUC od 24%, odnosno 18% s visokomasnim obrokom, nikakva razlika nije zapažena u njegovom pojačavajućem farmakološkom učinku na elvitegravir.
English: • If you are intolerant to lactose (see Genvoya contains lactose later in this section).
Croatian: • Ako ne podnosite laktozu (u nastavku teksta potražite Genvoya sadrži laktozu).
English: No dose adjustment of clarithromycin is required.
Croatian: Nije potrebna prilagodba doze klaritromicina.
English: When administering with Genvoya, the maximum daily dose of ketoconazole should not exceed 200 mg per day.
Croatian: Prilikom primjene s lijekom Genvoya maksimalna dnevna doza ketokonazola ne smije biti veća od 200 mg na dan.
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.
Croatian: Autoimuni poremećaji (poput Gravesove bolesti i autoimunog hepatitisa) također su zabilježeni u stanju imunološke reaktivacije; međutim, prijavljeno vrijeme do nastupa poremećaja više varira i ti događaji mogu se pojaviti puno mjeseci nakon početka liječenja.
English: Both elvitegravir and cobicistat are primarily metabolised and eliminated by the liver.
Croatian: Elvitegravir i kobicistat prvenstveno se metaboliziraju i eliminiraju kroz jetru.
English: Start with the lowest possible dose of atorvastatin with careful monitoring upon co-administration with Genvoya.
Croatian: Potrebno je započeti s najnižom mogućom dozom atorvastatina uz pažljivo praćenje nakon istodobne primjene lijeka Genvoya.
English: The safety profile of Genvoya in patients with mild to moderate renal impairment was similar to that in patients with normal renal function (see section 5.1).
Croatian: Sigurnosni profil lijeka Genvoya u bolesnika s blagim do umjerenim oštećenjem funkcije bubrega bio je sličan onome u bolesnika s normalnom funkcijom bubrega (vidjeti dio 5.1).
English: diarrhoea, vomiting, abdominal pain, flatulence
Croatian: proljev, povraćanje, bol u abdomenu, flatulencija
English: Co-administration is contraindicated with medicinal products that are strong inducers of CYP3A due to the potential for loss of virologic response and possible resistance to Genvoya.
Croatian: Kontraindicirana je istodobna primjena s lijekovima koji su snažni induktori CYP3A zbog mogućeg gubitka virološkog odgovora i moguće rezistencije na lijek Genvoya.
English: Following oral administration with food in HIV-1 infected patients, peak plasma concentrations were observed approximately 4 hours post-dose for elvitegravir, 3 hours post-dose for cobicistat, 3 hours post-dose for emtricitabine, and 1 hour post-dose for tenofovir alafenamide.
Croatian: Nakon peroralne primjene s hranom u bolesnika zaraženih virusom HIV-1, vršne koncentracije u plazmi zapažene su otprilike 4 sata nakon doziranja elvitegravira, 3 sata nakon doziranja kobicistata, 3 sata nakon doziranja emtricitabina i 1 sat nakon doziranja tenofoviralafenamida.
English: Medicinal products that are highly dependent on CYP3A metabolism and have high first pass metabolism are the most susceptible to large increases in exposure when co-administered with cobicistat (see “Concomitant use contraindicated” and section 4.3).
Croatian: Lijekovi koji su jako ovisni o metabolizmu putem CYP3A i imaju izražen metabolizam prvog prolaska najpodložniji su velikim povećanjima izloženosti kada se primjenjuju istodobno s kobicistatom (vidjeti „Kontraindicirana istodobna primjena“ i dio 4.3).
English: 5 This study was conducted using Genvoya.
Croatian: 5 To je ispitivanje provedeno pomoću lijeka Genvoya.
English: What you need to know before you take Genvoya Do not take Genvoya:
Croatian: Što morate znati prije nego počnete uzimati lijek Genvoya Nemojte uzimati lijek Genvoya:
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 pretrazi bakterijske mutagenosti (Amesov test) i negativan u in vivo analizi mikronukleusa štakora u dozama do 2000 mg/kg.
English: suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness), depression2
Croatian: suicidalne ideacije i pokušaj suicida (u bolesnika s depresijom ili psihijatrijskom bolešću u anamnezi), depresija2
English:  If you notice the side effects described above, tell your doctor immediately.
Croatian:  Ako primijetite gore opisane nuspojave, odmah o tome obavijestite liječnika.
English: Following oral administration of [14C]-elvitegravir/ritonavir, 94.8% of the dose was recovered in faeces, consistent with the hepatobiliary excretion of elvitegravir; 6.7% of the administered dose was recovered in urine.
Croatian: Nakon peroralne primjene [14C]elvitegravira/ritonavira, 94,8% doze izolirano je u stolici, što je u skladu s hepatobilijarnom ekskrecijom elvitegravira; 6,7% primijenjene doze izolirano je u urinu.
English: Patients should be informed that dizziness has been reported during treatment with Genvoya.
Croatian: Bolesnike treba obavijestiti da je zabilježena omaglica tijekom liječenja lijekom Genvoya.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo izvješće o ocjeni periodičkog(ih) izvješća o neškodljivosti lijeka (PSUR) za kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid, znanstveni zaključci CHMP-a su sljedeći:
English: It is important not to miss a dose of Genvoya.
Croatian: Važno je da ne propustite uzeti dozu lijeka Genvoya.
English: Tenofovir alafenamide is active against hepatitis B virus (HBV).
Croatian: Tenofoviralafenamid djeluje protiv virusa hepatitisa B (HBV).
English: The interactions described are based on studies conducted with Genvoya, or the components of Genvoya (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide), as individual agents and/or in combination, or are potential drug-drug interactions that may occur with Genvoya.
Croatian: Opisane interakcije temelje se na ispitivanjima koja su provedena s lijekom Genvoya ili komponentama lijeka Genvoya (elvitegravirom, kobicistatom, emtricitabinom i tenofoviralafenamidom) kao pojedinačnim tvarima i/ili u kombinaciji, ili su potencijalne interakcije lijekova koje se mogu pojaviti s lijekom Genvoya.
English: When administering with Genvoya, the maximum daily dose of itraconazole should not exceed 200 mg per day.
Croatian: Kod primjene s lijekom Genvoya maksimalna dnevna doza itrakonazola ne smije biti veća od 200 mg na dan.
English: Do not stop taking Genvoya without talking to your doctor.
Croatian: Nemojte prestati uzimati lijek Genvoya bez prethodnog razgovora sa svojim liječnikom.
English: • antibiotics, used to treat bacterial infections including tuberculosis, containing: rifabutin, clarithromycin and telithromycin
Croatian: • antibiotike, primjenjuju se za liječenje bakterijskih infekcija, uključujući i tuberkulozu, a koji sadržavaju: rifabutin, klaritromicin i telitromicin
English: Five subjects had virologic failure through the end of the study; no phenotypic or genotypic resistance to Genvoya was detected.
Croatian: Pet bolesnika imalo je virološki neuspjeh do kraja ispitivanja; nije bila otkrivena fenotipska ili genotipska rezistencija na lijek
English: digoxin, disopyramide, flecainide, lidocaine, mexiletine, propafenone, metoprolol, timolol, amlodipine, diltiazem, felodipine, nicardipine, nifedipine and verapamil
Croatian: • lijekove za srce, kao što su: digoksin, dizopiramid, flekainid, lidokain, meksiletin, propafenon, metoprolol, timolol, amlodipin, diltiazem, felodipin, nicardipin, nifedipin i verapamil
English: These findings should be considered for any child exposed in utero to nucleos(t)ide analogues, who present with severe clinical findings of unknown aetiology, particularly neurologic findings.
Croatian: Te nalaze treba uzeti u obzir u svakog djeteta koje je in utero bilo izloženo analozima nukleozida i nukleotida, a koje je imalo tešku kliničku sliku nepoznate etiologije, osobito neurološke nalaze.
English: The mean age was 58 years (range 24-82), with 63 patients (26%) who were ≥ 65 years of age.
Croatian: Srednja vrijednost dobi bila je 58 godina (raspon 24-82), sa 63 bolesnika (26%) u dobi ≥ 65 godina.
English: Do not stop taking Genvoya
Croatian: Nemojte prestati uzimati lijek Genvoya
English: No dose adjustment of Genvoya is required in adults or adolescents (aged at least 12 years and of at least 35 kg body weight) with estimated creatinine clearance (CrCl) ≥ 30 mL/min.
Croatian: Nije potrebna prilagodba doze lijeka Genvoya u odraslih ili adolescenata (u dobi od najmanje 12 godina i s tjelesnom težinom od najmanje 35 kg) s procijenjenim klirensom kreatinina (CrCl) ≥ 30 ml/min.
English: The effect of severe hepatic impairment (Child-Pugh Class C) on the pharmacokinetics of elvitegravir or cobicistat has not been studied.
Croatian: Utjecaj teškog oštećenja funkcije jetre (Child Pugh, stadij C) na farmakokinetiku elvitegravira ili kobicistata nije ispitan.
English: In a human clinical study of 35 healthy subjects, echocardiograms performed at baseline and after receiving 150 mg cobicistat once daily for at least 15 days indicated no clinically significant change in left ventricular function.
Croatian: U kliničkim ispitivanjima kod ljudi, na 35 zdravih ispitanika ehokardiogrami obavljeni na početku i nakon primanja 150 mg kobicistata jedanput dnevno u trajanju od najmanje 15 dana nisu ukazali na klinički važnu promjenu u funkciji lijeve klijetke.
English: If a patient misses a dose of Genvoya by more than 18 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako bolesnik propusti uzeti dozu lijeka Genvoya u roku duljem od 18 sati, bolesnik ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati doze prema uobičajenom rasporedu.
English: Similar patterns of psychiatric disorders were observed in comparative studies of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), which lists these events in its product information (studies GS-US-292-0104 or GS-US-292-0111).
Croatian: Slični uzorci psihijatrijskih poremećaja primijećeni su u usporednim ispitivanjima elvitegravira/kobicistata/emtricitabina/tenofoviralafenamida (E/C/F/TAF) naspram elvitegravira/kobicistata/emtricitabina/tenofovirdizoproksilfumarata (E/C/F/TDF), što je dovelo do uvrštavanja ovih događaja u informacije o lijeku (ispitivanje GS-US-292-0104 ili GS-US-292-0111).
English: Elvitegravir, cobicistat, and emtricitabine have all demonstrated low carcinogenic potential in mice and rats.
Croatian: Elvitegravir, kobicistat i emtricitabin pokazali su nisku razinu kancerogenosti u miševa i štakora.
English: The results reported from a prospective study (IMPAACT P1026s) showed that treatment with cobicistat and elvitegravir-containing regimens during pregnancy results in lower elvitegravir and cobicistat exposures (Table 7).
Croatian: Prijavljeni rezultati prospektivnog ispitivanja (IMPAACT P1026s) pokazali su da liječenje režimima koji sadrže kobicistat i elvitegravir tijekom trudnoće rezultira nižom izloženošću elvitegraviru i kobicistatu (Tablica 7).
English: There are no or limited data (less than 300 pregnancy outcomes) from the use of Genvoya in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Genvoya u trudnica ograničeni (manje od 300 trudnoća).
English: Elvitegravir, emtricitabine, and tenofovir alafenamide demonstrated synergistic antiviral activity in cell culture.
Croatian: Elvitegravir, emtricitabin i tenofoviralafenamid pokazuju sinergističko antivirusno djelovanje u staničnoj kulturi.
English: Tenofovir alafenamide is not an inhibitor or inducer of CYP3A in vivo.
Croatian: Tenofoviralafenamid nije inhibitor ni induktor CYP3A in vivo.
English:  If any of these applies to you, talk to your doctor before taking Genvoya.
Croatian: Ako se bilo što od ovog odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete lijek Genvoya.
English: HIV-1 with the raltegravir-selected substitutions T66A/K, Q148H/K, and N155H showed cross-resistance to elvitegravir.
Croatian: HIV-1 sa supstitucijama izdvojenim raltegravirom T66A/K, Q148H/K i N155H pokazao je križnu rezistenciju na elvitegravir.
English: Table 3: Pooled virologic outcomes of studies GS-US-292-0104 and GS-US-292-0111 at Weeks 48 and 144a,b
Croatian: Tablica 3: Objedinjeni virološki ishodi u ispitivanjima GS-US-292-0104 i GS-US-292-0111 u 48. i 144. tjednua,b
English: Following oral administration of [14C]-cobicistat, 99% of circulating radioactivity in plasma was unchanged cobicistat.
Croatian: Nakon peroralne primjene [14C]-kobicistata, 99% cirkulirajuće radioaktivnosti u plazmi predstavljao je nepromijenjeni kobicistat.
English: Of the patients who were HBsAg positive at baseline, 3/70 (4.3%) achieved seroconversion to anti-HBs at Week 48.
Croatian: Od bolesnika koji su pri ishodištu bili HBsAg pozitivni, 3/70 (4,3%) postiglo je serokonverziju u anti-HBs u 48. tjednu.
English: Tenofovir alafenamide is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Croatian: Tenofoviralafenamid nije inhibitor CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6.
English: Therefore, Genvoya should not be used during breast-feeding.
Croatian: Stoga se Genvoya ne smije primjenjivati tijekom dojenja.
English: In vitro, tenofovir alafenamide is not metabolised by CYP1A2, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Croatian: In vitro se tenofoviralafenamid ne metabolizira pomoću CYP1A2, CYP2C8, CYP2C9, CYP2C19 ili CYP2D6.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as elvitegravir, where bioavailability is limited and half-life is shortened by CYP3A-dependent metabolism.
Croatian: Inhibicija CYP3A posredovanog metabolizma s kobicistatom pojačava sistemsku izloženost supstratima CYP3A, kao što je elvitegravir, čija je bioraspoloživost ograničena, a poluvrijeme skraćeno metabolizmom koji ovisi o CYP3A.
English: If you forget to take Genvoya
Croatian: Ako ste zaboravili uzeti lijek Genvoya
English: In human clinical studies, a 10 mg oral dose of tenofovir alafenamide in Genvoya resulted in tenofovir diphosphate concentrations > 4-fold higher in PBMCs and > 90% lower concentrations of tenofovir in plasma as compared to a 245 mg oral dose of tenofovir disoproxil (as fumarate) in E/C/F/TDF.
Croatian: U kliničkim ispitivanjima u ljudi, peroralna doza od 10 mg tenofoviralafenamida u lijeku Genvoya rezultira koncentracijama tenofovirdifosfata > 4 puta većima u PBMC-ovima i > 90% manjim koncentracijama tenofovira u plazmi u usporedbi s peroralnom dozom tenofovirdizoproksila (u obliku fumarata) od 245 mg u E/C/F/TDF.
English: • sedatives and hypnotics, used to treat anxiety: buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem and lorazepam
Croatian: • sedative i hipnotike, primjenjuju se za liječenje tjeskobe: buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem i lorazepam
English: Table 4: Virologic outcomes of Study GS-US-292-0109 at Weeks 48a and 96b
Croatian: Tablica 4. Virološki ishodi ispitivanja GS-US-292-0109 u 48.a i 96.b tjednu
English: Of the 10 patients who were not HBV suppressed at baseline (HBV DNA ≥ 29 IU/mL), 7 became suppressed, 2 remained detectable, and 1 had missing data.
Croatian: Od 10 bolesnika koji nisu imali supresiju HBV-a pri ishodištu (HBV DNA ≥ 29 IU/ml), u 7 je došlo do supresije, 2 su zadržala detektibilnost, a za 1 bolesnika podaci nisu poznati.
English: 2 These studies were performed with ritonavir boosted elvitegravir.
Croatian: Ta su ispitivanja provedena s ritonavirom pojačanim elvitegravirom.
English: Overall, 22% had baseline plasma HIV-1 RNA > 100,000 copies/mL.
Croatian: Sveukupno, 22% bolesnika imalo je početnu razinu HIV-1 RNK u plazmi > 100 000 kopija/ml.
English: Based on this, section 4.8 of the SmPC of medicinal products containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC has been updated to add suicidal ideation and suicide attempt (in patients with a pre-existing history of depression or psychiatric illness) as new adverse drug reactions.
Croatian: Na temelju toga je dio 4.8 sažetka opisa svojstava lijekova koji sadrže elvitegravir/kobicistat/emtricitabin/tenofoviralafenamid u fiksnoj kombinaciji ažuriran kako bi se dodale suicidalne ideacije i pokušaj suicida (u bolesnika s otprije postojećom depresijom ili psihijatrijskom bolešću u anamnezi) kao nove nuspojave na lijek.
English: Co-administration of Genvoya and sildenafil for the treatment of pulmonary arterial hypertension is contraindicated.
Croatian: Istodobna primjena lijeka Genvoya i sildenafila za liječenje plućne arterijske hipertenzije je kontraindicirana.
English: 30 film-coated tablets 30 tablets
Croatian: OBLIK I SADRŽAJ 30 filmom obloženih tableta 30 tableta
English: Following administration of [14C]-emtricitabine, complete recovery of the emtricitabine dose was achieved in urine (~86%) and faeces (~14%).
Croatian: Nakon primjene [14C]emtricitabina, potpuna izolacija doze emtricitabina ostvarena je u urinu (~86%) i stolici (~14%).
English: Discontinuation of Genvoya therapy in patients co-infected with HIV and HBV may be associated with severe acute exacerbations of hepatitis.
Croatian: Prekid terapije lijekom Genvoya u bolesnika istodobno zaraženih HIV-om i HBV-om može biti povezan s teškim akutnim egzacerbacijama hepatitisa.
English: The safety of elvitegravir, cobicistat, emtricitabine or tenofovir alafenamide has not been established in these patients.
Croatian: Sigurnost elvitegravira, kobicistata, emtricitabina ili tenofoviralafenamida u tih bolesnika nije ustanovljena.
English: b In both studies, patients were stratified by baseline HIV-1 RNA (≤ 100,000 copies/mL, > 100,000 copies/mL to ≤ 400,000 copies/mL, or > 400,000 copies/mL), by CD4+ cell count (< 50 cells/µL, 50-199 cells/µL, or ≥ 200 cells/µL), and by region (US or ex-US).
Croatian: b U oba ispitivanja bolesnici su stratificirani prema početnoj HIV-1 RNK (≤ 100 000 kopija/ml, > 100 000 kopija/ml do ≤ 400 000 kopija/ml, ili > 400 000 kopija/ml), prema broju CD4+ stanica (< 50 stanica/µl, 50-199 stanica/µl ili ≥ 200 stanica/µl) te po regiji (SAD ili izvan SAD-a).
English: At Week 48, the virologic response rate to Genvoya in treatment-naïve HIV-1 infected adolescents was similar to response rates in studies of treatment-naïve HIV-1 infected adults.
Croatian: U 48. tjednu stopa virološkog odgovora na lijek Genvoya u adolescenata zaraženih virusom HIV-1 koji prethodno nisu bili liječeni bila je slična stopama odgovora u ispitivanjima odraslih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni.
English: Based on these limited data, the safety profile of Genvoya in patients with HIV/HBV co-infection was similar to that in patients with HIV-1 monoinfection.
Croatian: Na temelju ovih ograničenih podataka, sigurnosni profil lijeka Genvoya u bolesnika koji su istodobno bili zaraženi HIV-om i HBV-om bio je sličan onome u bolesnika zaraženih samo virusom HIV-1.
English: On the basis of the scientific conclusions for cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing cobicistat / elvitegravir / emtricitabine / tenofovir alafenamide is unchanged subject to the proposed changes to the product information
Croatian: Na temelju znanstvenih zaključaka za kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid, CHMP smatra da je omjer koristi i rizika lijeka(ova) koji sadrži(e) kobicistat/elvitegravir/emtricitabin/tenofoviralafenamid nepromijenjen, uz predložene izmjene informacija o lijeku.
English: Genvoya has not been studied in patients with severe hepatic impairment (Child-Pugh Class C); therefore, Genvoya is not recommended for use in patients with severe hepatic impairment (see sections 4.4 and 5.2).
Croatian: Genvoya nije ispitana u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C) te se stoga primjena lijeka Genvoya ne preporučuje u bolesnika s teškim oštećenjem funkcije jetre (vidjeti dijelove 4.4 i 5.2).
English: Mean % change of cobicistat pharmacokinetic parametersa
Croatian: Srednja vrijednost % promjene farmakokinetičkih parametara kobicistataa
English: Increased monitoring for rifabutin-associated adverse reactions including neutropenia and uveitis is warranted due to an expected increase in exposure to desacetyl-rifabutin.
Croatian: Potreban je stroži nadzor nuspojava povezanih s rifabutinom, uključujući i neutropeniju i uveitis zbog očekivanog povećanja izloženosti dezacetilrifabutinu.
English: Tenofovir alafenamide is mainly eliminated following metabolism to tenofovir.
Croatian: Tenofoviralafenamid se uglavnom eliminira nakon metabolizma u tenofovir.