FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients taking REZOLSTA and raltegravir (for HIV infection), rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately.
Croatian: U bolesnika koji uzimaju lijek REZOLSTA i raltegravir (za HIV infekciju) u kombinaciji, osipi (obično blagi ili umjereni) se mogu javiti češće nego u bolesnika koji uzimaju samo jedan od ovih lijekova.
English: In the virologic failures of the GS-US-216-130 trial no cross-resistance with other HIV PIs was observed.
Croatian: Kod viroloških neuspjeha u ispitivanju GS-US-216-130 nije opažena križna rezistencija s drugim IP HIV-a.
English: Treatment with darunavir/cobicistat 800/150 mg during pregnancy results in low darunavir exposure (see section 5.2), which may be associated with an increased risk of treatment failure and an increased risk of HIV transmission to the child.
Croatian: Liječenje darunavirom/kobicistatom 800/150 mg tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dio 5.2), što može biti povezano s povećanim rizikom neuspjeha liječenja i povećanim rizikom prijenosa HIV-a na dijete.
English: Limited information is available in this population, and therefore, REZOLSTA should be used with caution in patients above 65 years of age (see sections 4.4 and 5.2).
Croatian: Za ovu populaciju dostupne su ograničene informacije, stoga se REZOLSTA u bolesnika starijih od 65 godina mora primjenjivati s oprezom (vidjeti dijelove 4.4 i 5.2).
English: PHOSPHODIESTERASE, TYPE 5 (PDE-5) INHIBITORS For the treatment of erectile dysfunction Sildenafil Tadalafil Vardenafil
Croatian: INHIBITORI FOSFODIESTERAZE TIPA 5 (PDE-5) Za liječenje erektilne disfunkcije Sildenafil
English: Based on the very limited renal elimination of cobicistat and darunavir, no special precautions or dose adjustments of REZOLSTA are required for patients with renal impairment.
Croatian: Temeljeno na vrlo ograničenoj bubrežnoj eliminaciji kobicistata i darunavira, za bolesnike s oštećenjima bubrega nisu potrebne posebne mjere opreza ili prilagodba doze lijeka REZOLSTA.
English: As REZOLSTA contains darunavir and cobicistat, interactions that have been identified with darunavir (in combination with cobicistat or with low dose ritonavir) or with cobicistat determine the interactions that may occur with REZOLSTA.
Croatian: Budući da REZOLSTA sadrži darunavir i kobicistat, interakcije koje su identificirane s darunavirom (u kombinaciji s kobicistatom ili s niskom dozom ritonavira) ili s kobicistatom predodređuju interakcije koje se mogu pojaviti s lijekom REZOLSTA.
English: If there is evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients using REZOLSTA, interruption or discontinuation of treatment should be considered promptly.
Croatian: Ako postoje dokazi o novoj ili pogoršanju disfunkcije jetre (uključujući klinički značajno povišenje jetrenih enzima i/ili simptome poput umora, anoreksije, mučnine, žutice, tamne mokraće, osjetljivosti jetre, hepatomegalije) kod bolesnika koji uzimaju lijek REZOLSTA, mora se odmah razmotriti privremeni ili trajni prekid liječenja.
English: What REZOLSTA contains - The active substances are darunavir and cobicistat.
Croatian: Što REZOLSTA sadrži - Djelatne tvari su darunavir i kobicistat.
English: Some clinical trials suggest raltegravir may cause a modest decrease in darunavir plasma concentrations.
Croatian: Neka klinička ispitivanja pokazuju da raltegravir može uzrokovati umjereno smanjenje koncentracija darunavira u plazmi.
English: Immune reconstitution inflammatory syndrome (IRIS)
Croatian: Upalni sindrom imunološke rekonstitucije (IRIS)
English: At the highest tested doses, the systemic exposures (based on AUC) to darunavir when co-administered with ritonavir were between 0.4- and 0.7-fold (mice) and 0.7- and 1-fold (rats), relative to those observed in humans at the recommended therapeutic doses.
Croatian: Pri najvišim ispitivanim dozama, sistemske izloženosti darunaviru (temeljene na AUC) kada je primijenjen istodobno s ritonavirom bile su između 0,4 i 0,7 puta (kod miševa) te 0,7 i 1 puta (kod štakora), u odnosu na opaženu izloženost kod ljudi pri preporučenim terapijskim dozama.
English: Data based on analyses at week 48
Croatian: Podaci dobiveni analizama u 48. tjednu
English: If concomitant use of REZOLSTA with sildenafil, vardenafil or tadalafil is indicated, sildenafil at a single dose not exceeding 25 mg in 48 hours, vardenafil at a single dose not exceeding 2.5 mg in 72 hours or tadalafil at a single dose not exceeding 10 mg in 72 hours is recommended.
Croatian: Ako je istodobna primjena lijeka REZOLSTA indicirana sa sildenafilom, vardenafilom ili tadalafilom, tada su preporučene sljedeće doze: jednokratna doza sildenafila ne prelazi 25 mg u 48 sati, jednokratna doza vardenafila ne prelazi 2,5 mg u 72 sata ili jednokratna doza tadalafila ne prelazi 10 mg u 72 sata.
English: REZOLSTA is not recommended for use in paediatric patients (3 to 17 years of age).
Croatian: Ne preporučuje se primjena lijeka REZOLSTA u pedijatrijskih bolesnika (u dobi od 3 do 17 godina).
English: As REZOLSTA contains darunavir and cobicistat, the adverse reactions associated with each of the individual compounds may be expected.
Croatian: Budući da REZOLSTA sadrži darunavir i kobicistat, mogu se očekivati nuspojave povezane sa svakom od pojedinih komponenti.
English: The overall safety profile of REZOLSTA is based on available clinical trial data from darunavir boosted with either cobicistat or ritonavir, from cobicistat and from post-marketing data from darunavir/ritonavir.
Croatian: Ukupni sigurnosni profil lijeka REZOLSTA temelji se na dostupnim podacima iz kliničkih ispitivanja darunavira pojačanog bilo kobicistatom bilo ritonavirom, iz kliničkih ispitivanja kobicistata i iz podataka nakon stavljanja lijeka u promet za darunavir/ritonavir.
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Croatian: - Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.
English: Systemic dexamethasone should be used with caution when combined with REZOLSTA.
Croatian: Sistemski deksametazon se mora primjenjivati s oprezom kada se kombinira s lijekom REZOLSTA.
English: Concomitant use of PDE-5 inhibitors for the treatment of erectile dysfunction with REZOLSTA should be done with caution.
Croatian: Mora se s oprezom istodobno primjenjivati inhibitore PDE-5 za liječenje erektilne disfunkcije s lijekom REZOLSTA.
English: For these neuroleptics, consider reducing the dose of the neuroleptic upon co-administration with REZOLSTA.
Croatian: Za te neuroleptike razmotrite smanjenje doze kod istodobne primjene s lijekom REZOLSTA.
English: Since darunavir and cobicistat are highly protein bound, dialysis is unlikely to be beneficial in significant removal of the active substances.
Croatian: S obzirom da darunavir i kobicistat imaju visoki afinitet vezanja na proteine, nije vjerojatno da bi dijaliza bila korisna za značajnije uklanjanje djelatnih tvari.
English: Change of estimated glomerular filtration rate calculated by Cockcroft-Gault method (eGFRCG) from baseline was observed within 7 days after start of treatment with cobicistat 150 mg among subjects with normal renal function (-9.9 ± 13.1 mL/min) and mild to moderate renal impairment (-11.9 ± 7.0 mL/min).
Croatian: Promjena procijenjene brzine glomerularne filtracije izračunata prema Cockcroft-Gaultovoj metodi (eGFRCG) u odnosu na početnu bila je uočena u roku od 7 dana nakon početka liječenja s kobicistatom od 150 mg među ispitanicima s normalnom funkcijom bubrega (-9,9 ± 13,1 ml/min), te s blagim do umjerenim oštećenjem bubrega (-11,9 ± 7,0 ml/min).
English: Low levels of metabolites are observed in urine and feces and do not contribute to the CYP3A inhibitory activity of cobicistat.
Croatian: Niske razine metabolita opažene su u mokraći i stolici i ne pridonose inhibitornoj aktivnosti kobicistata na CYP3A.
English: - The other ingredients are hypromellose, silicified microcrystalline cellulose, colloidal silicon dioxide, crospovidone and magnesium stearate.
Croatian: - Drugi sastojci su hipromeloza, silicirana mikrokristalična celuloza, koloidni silicijev dioksid, krospovidon i magnezijev stearat.
English: ANTIFUNGALS Clotrimazole Fluconazole Itraconazole Isavuconazole Posaconazole
Croatian: ANTIFUNGICI Klotrimazol Flukonazol Itrakonazol Izavukonazol Posakonazol
English: These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs.
Croatian: Oni mogu uključiti žutu boju kože ili bjeloočnica, tamnu mokraću (boje čaja), blijede stolice, mučninu, povraćanje, gubitak apetita, ili bol, probadanje ili bol i nelagodu na desnoj strani u predjelu ispod rebara.
English: In all other ART-experienced patients or if HIV-1 genotype testing is not available, the use of REZOLSTA is not appropriate and another antiretroviral regimen should be used.
Croatian: Primjena lijeka REZOLSTA nije prikladna za sve druge bolesnike prethodno liječene ART-om ili ako pretrage genotipa HIV-1 nisu dostupne, te se mora primijeniti drugi antiretrovirusni režim.
English: In the rat, the combination of darunavir with ritonavir lead to a small increase in effect on RBC parameters, liver and thyroid and increased incidence of islet fibrosis in the pancreas (in male rats only) compared to treatment with darunavir alone.
Croatian: Kod štakora, kombinacija darunavira s ritonavirom dovela je do malog povećanja učinka na parametre eritrocita, jetru i štitnjaču, te povećane incidencije fibroze otočića u pankreasu (samo kod mužjaka štakora) u usporedbi s liječenjem sa samim darunavirom.
English: HIV-1 RNA < 50 copies/mL Virologic failure No virologic data in 48-week window
Croatian: HIV-1 RNK < 50 kopija/ml Virološki neuspjeh Bez podataka o virološkom odgovoru tijekom 48 tjedana
English: Darunavir exhibits activity against laboratory strains and clinical isolates of HIV-1 and laboratory strains of HIV-2 in acutely infected T-cell lines, human peripheral blood mononuclear cells and human monocytes/macrophages with median EC50 values ranging from 1.2 to 8.5 nM (0.7 to 5.0 ng/mL).
Croatian: Darunavir pokazuje aktivnost protiv laboratorijskih sojeva i kliničkih izolata HIV-1, te laboratorijskih sojeva HIV-2 u akutno inficiranim linijama T-stanica, humanim mononuklearnim stanicama iz periferne krvi i humanim monocitima/makrofagima s medijanom vrijednosti EC50 u rasponu od 1,2 do 8,5 nM (0,7 do 5,0 ng/ml).
English: Treatment with REZOLSTA during pregnancy results in low darunavir exposure (see sections 4.4 and 5.2).
Croatian: Liječenje lijekom REZOLSTA tijekom trudnoće rezultira niskom izloženošću darunaviru (vidjeti dijelove 4.4 i 5.2).
English: ART-naïve patients The recommended dose regimen is one film-coated tablet of REZOLSTA once daily taken with food.
Croatian: Bolesnici koji nisu prethodno liječeni antiretrovirusnom terapijom (ART-om) Preporučeni režim doziranja je jedna filmom obložena tableta lijeka REZOLSTA jedanput na dan, uzeta s hranom.
English: Inhibition of CYP3A-mediated metabolism by cobicistat enhances the systemic exposure of CYP3A substrates, such as darunavir, where bioavailability is limited and half-life is shortened due to CYP3A-dependent metabolism.
Croatian: Inhibicija metabolizma posredovanog s CYP3A kobicistatom, povećava sistemsku izloženost supstratima CYP3A, poput darunavira, čija je bioraspoloživost ograničena i poluvijek skraćen radi metabolizma ovisnog o CYP3A.
English: Expected interactions between REZOLSTA and antiretroviral and non-antiretroviral medicinal products are listed in the table below and are based on the identified interactions with darunavir/ritonavir, darunavir/cobicistat and with cobicistat.
Croatian: Očekivane interakcije između lijeka REZOLSTA i antiretrovirusnih i ne-antiretrovirusnih lijekova su navedene u tablici niže i temelje se na identificiranim interakcijama s darunavirom/ritonavirom, darunavirom/kobicistatom i s kobicistatom.
English: Limited data is available in patients with HIV-1 clades other than B (see section 5.1).
Croatian: Za bolesnike s drugim podtipovima HIV-1 osim B dostupni su ograničeni podaci (vidjeti dio 5.1).
English: The recommended dose of emtricitabine/tenofovir alafenamide is 200/10 mg once daily when used with REZOLSTA.
Croatian: Preporučena doza emtricitabin/ tenofoviralafenamida kada se uzima s lijekom REZOLSTA je 200/10 mg jedanput na dan.
English: Darunavir is an inhibitor of CYP3A, a weak inhibitor of CYP2D6 and an inhibitor of P-gp.
Croatian: Darunavir je inhibitor CYP3A, slabi inhibitor CYP2D6 i inhibitor P-gp-a.
English: Based on theoretical considerations dolutegravir is not expected to affect the pharmacokinetics of REZOLSTA.
Croatian: Temeljeno na teorijskim postavkama, ne očekuje se da će dolutegravir utjecati na farmakokinetiku lijeka REZOLSTA.
English: Plasma concentrations of these medicinal products may be increased when co-administered with REZOLSTA, resulting in reduced serum cortisol concentrations.
Croatian: Mogu biti povećane koncentracije tih lijekova u plazmi kada se primjenjuju istodobno s lijekom REZOLSTA, što dovodi do smanjenih koncentracija kortizola u serumu.
English: Non completer is failure imputation: patients who discontinued prematurely are imputed with a change equal to 0
Croatian: Bolesnik koji nije završio ispitivanje zabilježen je kao neuspjeh: bolesnicima koji su prijevremeno prekinuli ispitivanje pripisana je promjena jednaka 0.
English: Drug-induced hepatitis (e.g. acute hepatitis, cytolytic hepatitis) has been reported with darunavir/ritonavir.
Croatian: Lijekom izazvan hepatitis (npr. akutni hepatitis, citolitički hepatitis) bio je prijavljen kod liječenja darunavirom/ritonavirom.
English: A common side effect of REZOLSTA is skin rash (more often when used in combination with raltegravir), itching.
Croatian: Česta nuspojava lijeka REZOLSTA je kožni osip (češće se javlja u kombinaciji s raltegravirom), svrbež.
English: Pharmacokinetic results of total darunavir after administration of darunavir/cobicistat 800/150 mg once daily as part of an antiretroviral regimen, during the second trimester of pregnancy, the third trimester of pregnancy, and postpartum Pharmacokinetics of total darunavir (mean ± SD)
Croatian: Farmakokinetički rezultati ukupnog darunavira nakon primjene darunavira/kobicistata 800/150 mg jedanput na dan kao dijela antiretrovirusnog režima, tijekom drugog tromjesečja trudnoće, trećeg tromjesečja trudnoće i u postpartalnom razdoblju Farmakokinetika ukupnog darunavira (srednja vrijednost ± SD)
English: Voriconazole should not be combined with REZOLSTA unless an assessment of the benefit/risk ratio justifies the use of voriconazole.
Croatian: Vorikonazol se ne smije kombinirati s lijekom REZOLSTA osim ako se procijeni da omjer koristi i rizika opravdava primjenu vorikonazola.
English: Alternative or additional contraceptive measures are recommended when oestrogen based contraceptives are co administered with REZOLSTA.
Croatian: Preporučuju se druge ili zamjenske kontracepcijske mjere kada se kontraceptivi na bazi estrogena primjenjuju istodobno s lijekom REZOLSTA.
English: These can include, but are not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
Croatian: Oni mogu uključivati, ali nisu ograničeni na, teški osip ili osip praćen vrućicom, općom malaksalosti, umorom, tupim bolovima u mišićima i zglobovima, stvaranjem mjehurića, oralnim lezijama, konjunktivitisom, hepatitisom i/ili eozinofilijom.
English: Although darunavir has not been studied in patients with renal impairment, population pharmacokinetic analysis showed that the pharmacokinetics of darunavir were not significantly affected in HIV infected patients with moderate renal impairment (CrCl between 30-60 mL/min, n = 20) (see sections 4.2 and 4.4).
Croatian: Iako darunavir nije ispitivan kod bolesnika s oštećenjem bubrega, analiza populacijske farmakokinetike pokazala je da kod bolesnika inficiranih HIV-om s umjerenim oštećenjem bubrega nije bilo značajnog utjecaja na farmakokinetiku darunavira (CrCl između 30-60 ml/min, n = 20) (vidjeti dijelove 4.2 i 4.4).
English: NARCOTIC ANALGESICS/TREATMENT OF OPIOID DEPENDENCE Buprenorphine/naloxone
Croatian: NARKOTIČKI ANALGETICI / LIJEČENJE OVISNOSTI O OPIOIDNIM LIJEKOVIMA
English: Ranitidine
Croatian: Ranitidin
English: HMG CO-A REDUCTASE INHIBITORS Atorvastatin
Croatian: INHIBITORI HMG-CoA REDUKTAZE Atorvastatin
English: Up to same dose levels, there was no teratogenicity with darunavir in rats and rabbits when treated alone nor in mice when treated in combination with ritonavir.
Croatian: Do istih razina doza, nije bilo teratogenosti s liječenjem samo darunavirom kod štakora i kunića, a niti kod miševa uz liječenje kombinacijom s ritonavirom.
English: A safe and effective dose of sildenafil for the treatment of pulmonary arterial hypertension co-administered with REZOLSTA has not been established.
Croatian: Nije ustanovljena sigurna i učinkovita doza sildenafila za liječenje pulmonalne arterijske hipertenzije s istodobnom primjenom lijeka REZOLSTA.
English: Virologic failures selected for resistance testing were defined as: never suppressed: HIV-1 RNA < 1 log10 reduction from baseline and ≥ 50 copies/mL at week 8, confirmed at the following visit; rebound: HIV-1 RNA < 50 copies/mL followed by confirmed HIV-1 RNA to ≥ 400 copies/mL or confirmed > 1 log10 HIV-1 RNA increase from the nadir; discontinuations with HIV-1 RNA ≥ 400 copies/mL at last visit Virologic failures based on TLOVR non-VF censored algorithm (HIV-1 RNA > 50 copies/mL) IAS-USA lists
Croatian: Virološki neuspjesi odabrani za ispitivanje rezistencije bili su definirani kao: nikada nije došlo do supresije: HIV-1 RNK < 1 log10 smanjenje u odnosu na početnu vrijednost i ≥ 50 kopija/ml u 8. tjednu, potvrđeno pri slijedećoj posjeti; povratak: HIV-1 RNK < 50 kopija/ml nakon čega je potvrđena HIV-1 RNK ≥ 400 kopija/ml ili potvrđen porast > 1 log10 HIV-1 RNK u odnosu na nadir; prekidi s HIV-1 RNK ≥ 400 kopija/ml na zadnjoj posjeti
English: Concomitant use of a HMG CoA reductase inhibitor and REZOLSTA may increase plasma concentrations of the lipid lowering agent, which may lead to adverse events such as myopathy.
Croatian: Istodobna primjena inhibitora HMG CoA reduktaze i lijeka REZOLSTA može povećati koncentracije lijeka za snižavanje lipida u plazmi, što može dovesti do štetnih događaja poput miopatije.
English: Co-administration of darunavir/cobicistat and medicinal products primarily metabolised by CYP3A may result in increased systemic exposure to such medicinal products, which could increase or prolong their therapeutic effect and adverse reactions.
Croatian: Istodobna primjena darunavira/kobicistata i lijekova koji se primarno metaboliziraju putem CYP3A može rezultirati povećanom sistematskom izloženošću takvim lijekovima, što može povećati ili produžiti njihov terapijski učinak i nuspojave.
English: * These adverse drug reactions have not been reported in clinical trial experience with darunavir/cobicistat but have been noted with darunavir/ritonavir treatment and could be expected with darunavir/cobicistat too.
Croatian: * ove nuspojave nisu bile prijavljene tijekom iskustva iz kliničkog ispitivanja s darunavirom/kobicistatom ali su zabilježene pri liječenju s darunavirom/ritonavirom te se također mogu očekivati s darunavirom/kobicistatom.
English: Caution is warranted and therapeutic concentration monitoring, if available, is recommended for these antiarrhythmics when co-administered with REZOLSTA.
Croatian: Nužan je oprez, a praćenje terapijskih koncentracija se preporučuje za ove antiaritmike ako je dostupno kada se primjenjuje istodobno s lijekom REZOLSTA.
English: The table below shows the 48-week efficacy data of the darunavir/cobicistat arm of the TMC114FD2HTX3001 trial:
Croatian: U sljedećoj su tablici prikazani podaci o djelotvornosti nakon 48 tjedana u skupini koja je primala darunavir/kobicistat u ispitivanju TMC114FD2HTX3001:
English: As limited information is available on the use of REZOLSTA in patients aged 65 and over, caution should be exercised, reflecting the greater frequency of decreased hepatic function and of concomitant disease or other therapy (see sections 4.2 and 5.2).
Croatian: S obzirom da su dostupni ograničeni podaci o primjeni lijeka REZOLSTA kod bolesnika u dobi od 65 godina i više, nužan je oprez, zbog povećane učestalosti smanjene funkcije jetre, te konkomitantnih bolesti ili druge terapije (vidjeti dijelove 4.2 i 5.2).
English: CORTICOSTEROIDS Corticosteroids primarily metabolised by CYP3A (including betamethasone, budesonide, fluticasone, mometasone, prednisone, triamcinolone).
Croatian: Kortikosteroidi koji se prvenstveno metaboliziraju putem CYP3A (uključujući betametazon, budezonid, flutikazon, mometazon, prednizon, triamcinolon).
English: If switching from ritonavir as a pharmacoenhancer to cobicistat, caution is required during the first two weeks of treatment with REZOLSTA, particularly if doses of any concomitantly administered medicinal products have been titrated or adjusted during use of ritonavir as a pharmacoenhancer.
Croatian: Potreban je oprez tijekom prva dva tjedna liječenja lijekom REZOLSTA u slučaju prijelaza s ritonavira kao farmakokinetičkog pojačivača na kobicistat, naročito ako su doze bilo kojeg od istodobno primijenjenih lijekova titrirane ili prilagođene tijekom primjene ritonavira kao farmakokinetičkog pojačivača.
English: The effect of cobicistat on serum creatinine was investigated in a Phase I trial in subjects with normal renal function (eGFR ≥ 80 mL/min, n = 12) and mild to moderate renal impairment (eGFR:50-79 mL/min, n = 18).
Croatian: Učinak kobicistata na kreatinin u serumu ispitivan je u ispitivanju faze I u ispitanika s normalnom funkcijom bubrega (eGFR ≥ 80 ml/min, n = 12), te kod blagog do umjerenog oštećenja bubrega (eGFR:50-79 ml/min, n = 18).
English: What REZOLSTA looks like and contents of the pack Film-coated, pink, oval shaped tablet, mentioning TG on one side, 800 on the other side.
Croatian: Ružičasta filmom obložena tableta, ovalnog oblika, s navedenim TG na jednoj strani, 800 na drugoj strani.
English: Increased CPK, myalgia, myositis and, rarely, rhabdomyolysis have been reported with the use of HIV protease inhibitors, particularly in combination with NRTIs.
Croatian: Povišena kreatin fosfokinaza (CPK), mialgija, miozitis i rijetko rabdomioliza bili su prijavljeni uz primjenu inhibitora proteaze HIV-a, osobito u kombinaciji s NRTI.
English: Concomitant use of REZOLSTA 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.
Croatian: Istodobnom primjenom lijeka REZOLSTA i kortikosteroida koji se metaboliziraju putem CYP3A (npr flutikazonpropionata ili drugih inhalacijskih ili nazalnih kortikosteroida) može se povećati rizik od razvoja sistemskih učinaka kortikosteroida, uključujući Cushingov sindrom i adrenalnu supresiju.
English: Use of other antiplatelets not affected by CYP inhibition or induction (e.g. prasugrel) is recommended (see section 4.3).
Croatian: Preporučuje se uzimanje drugih inhibitora agregacije trombocita na koje ne utječe CYP inhibicija ili indukcija (npr. prasugrel) (vidjeti dio 4.3).
English: Number of subjects with virologic failure and genotype data that develop mutations c at endpoint, n/N
Croatian: Broj ispitanika s virološkim neuspjehom i spareni genotip koji su razvili mutacije c na ishodu, n/N
English: ART-experienced patients
Croatian: ART-om prethodno liječeni bolesnici
English: HIV-1 RNA < 50 copies/mL All patients
Croatian: HIV-1 RNK < 50 kopija/ml Svi bolesnici