FrancophonIA/ELRC3.0 huggingface dataset:
English: Due to the limited number of genotype 4-infected subjects with treatment emergent NS5A and NS3 resistance associated substitutions, trends in persistence of treatment emergent substitutions in this genotype could not be established.
Croatian: Zbog ograničenog broja ispitanika s infekcijom genotipom 4 u kojih su se tijekom liječenja razvile supstitucije povezane s rezistencijom u NS5A i NS3, za taj se genotip nisu mogli utvrditi trendovi postojanosti supstitucija nastalih tijekom liječenja.
English: Includes subjects with baseline sequencing data and who either achieved SVR12 or met criteria for virologic failure.
Croatian: Uključuje ispitanike za koje su postojali podaci prikupljeni sekvenciranjem na početku ispitivanja i koji su ili postigli SVR12 ili zadovoljili kriterije za izostanak uspješnog virološkog odgovora.
English: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Croatian: ZEPATIER je indiciran za liječenje kroničnog hepatitisa C u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
English: The geometric mean apparent terminal half-life (% geometric mean coefficient of variation) is approximately 24 (24 %) hours at 50 mg elbasvir and approximately 31 (34 %) hours at 100 mg grazoprevir in HCV-infected subjects.
Croatian: Geometrijska srednja vrijednost prividnog terminalnog poluvijeka (% geometrijske srednje vrijednosti koeficijenta varijacije) u ispitanika zaraženih HCV-om iznosi približno 24 (24%) sata za elbasvir u dozi od 50 mg te približno 31 (34%) sat za grazoprevir u dozi od 100 mg.
English: C-EDGE TN (double-blind)
Croatian: C-EDGE TN (dvostruko slijepo)
English: Treatment-emergent substitutions were detected in both HCV drug targets in 23/37 (62 %) genotype 1a, 1/8 (13 %) genotype 1b and 2/5 (40 %) genotype 4 subjects.
Croatian: Supstitucije nastale tijekom liječenja pronađene su u oba ciljna mjesta na koja djeluju lijekovi za HCV u 23/37 (62%) ispitanika s genotipom 1a, 1/8 (13%) ispitanika s genotipom 1b te 2/5 (40%) ispitanika s genotipom
English: Following administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir peak plasma concentrations occur at a median Tmax of 3 hours (range of 3 to 6 hours); grazoprevir peak plasma concentrations occur at a median Tmax of 2 hours (range of 30 minutes to 3 hours).
Croatian: Nakon primjene elbasvira/grazoprevira u ispitanika s infekcijom HCV-om, elbasvir postiže vršne koncentracije u plazmi nakon medijana Tmax od 3 sata (raspon od 3 do 6 sati), a grazoprevir nakon medijana Tmax od 2 sata (raspon od 30 minuta do 3 sata).
English: The EC50 values of elbasvir and grazoprevir against full-length or chimeric replicons encoding NS5A or NS3 sequences from reference sequences and clinical isolates are presented in Table 5.
Croatian: Vrijednosti EC50 elbasvira i grazoprevira protiv replikona pune duljine ili kimeričkih replikona koji kodiraju sekvence NS5A ili NS3 iz referentnih sekvenci i kliničkih izolata prikazane su u Tablici 5.
English: Co-administration with inducers of cytochrome P450 3A (CYP3A) or P-glycoprotein (P-gp), such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St. John's wort (Hypericum perforatum) (see sections 4.4 and 4.5).
Croatian: Istodobna primjena s induktorima izoenzima 3A citokroma P450 (CYP3A) ili P-glikoproteina (P-gp), poput efavirenza, fenitoina, karbamazepina, bosentana, etravirina, modafinila ili gospine trave (Hypericum perforatum) (vidjeti dijelove 4.4 i 4.5).
English: Effects on medicinal product levels.
Croatian: Učinci na koncentracije lijeka.
English: Elderly No dose adjustment of ZEPATIER is required for elderly patients (see sections 4.4 and 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka ZEPATIER u starijih bolesnika (vidjeti dijelove 4.4 i 5.2).
English: Other includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
Croatian: "Drugo" uključuje ispitanike koji su prekinuli liječenje zbog nuspojave, koji su izgubljeni u razdoblju praćenja ili one koji su prekinuli ispitivanje.
English: Sustained virologic response (SVR) was the primary endpoint in all studies and was defined as HCV RNA less than the lower limit of quantification (LLOQ: 15 HCV RNA IU/mL except in C-WORTHY and C-SCAPE [25 HCV RNA IU/mL]) at 12 weeks after the cessation of treatment (SVR12).
Croatian: U svim je ispitivanjima primarna mjera ishoda bio održan virološki odgovor (engl. sustained virologic response, SVR), koji se definirao kao vrijednost HCV RNK ispod donje granice kvantifikacije (engl. lower limit of quantification, LLOQ: 15 HCV RNK IU/ml, osim u ispitivanjima C-WORTHY i CSCAPE [25 HCV RNK IU/ml]) 12 tjedana nakon prestanka liječenja (SVR12).
English: Table 5: Activities of elbasvir and grazoprevir in GT1a, GT1b and GT4 reference sequences and clinical isolates in replicon cells
Croatian: Tablica 5: Aktivnost elbasvira i grazoprevira u stanicama replikona s referentnim sekvencama GT 1a, GT1b i GT4 i stanicama replikona sa sekvencama iz kliničkih izolata
English: The frequency of late ALT elevations was higher in subjects with higher grazoprevir plasma concentration (see sections 4.4, 4.5 and 5.2).
Croatian: Učestalost kasnih povišenja vrijednosti ALT-a bila je veća među ispitanicima s višim koncentracijama grazoprevira u plazmi (vidjeti dijelove 4.4, 4.5 i 5.2).
English: The highest dose of elbasvir was 200 mg once daily for 10 days, and a single dose of 800 mg.
Croatian: Najviša doza elbasvira bila je 200 mg jedanput na dan tijekom 10 dana te jednokratna doza od 800 mg.
English: The safety and efficacy of ZEPATIER have not been established in liver transplant recipients.
Croatian: Sigurnost i djelotvornost lijeka ZEPATIER nisu ustanovljene u bolesnika s presatkom jetre.
English: HIV ANTIVIRAL AGENTS: PROTEASE INHIBITORS
Croatian: ANTIVIROTICI ZA LIJEČENJE INFEKCIJE HIV-om: INHIBITORI PROTEAZE
English: Both elbasvir and grazoprevir bind to human serum albumin and 1-acid glycoprotein.
Croatian: I elbasvir i grazoprevir vezuju se za albumin i 1-kiseli glikoprotein u serumu ljudi.
English: • oral ketoconazole for fungal infections
Croatian: • ketokonazol koji se uzima kroz usta, za liječenje gljivičnih infekcija
English: • The active substances are: elbasvir and grazoprevir.
Croatian: • Djelatne tvari su: elbasvir i grazoprevir.
English: C-WORTHY (open-label)
Croatian: C-WORTHY (otvoreno)
English: During clinical studies with ZEPATIER with or without ribavirin, < 1 % of subjects experienced elevations of ALT from normal levels to greater than 5 times the upper limit of normal (ULN), (see section 4.8).
Croatian: Tijekom kliničkih ispitivanja lijeka ZEPATIER s ribavirinom ili bez njega, u <1% ispitanika zabilježena su povišenja vrijednosti ALT-a iznad normalnih vrijednosti do više od 5 puta iznad gornje granice normale (GGN) (vidjeti dio 4.8).
English: It is not known whether the two medicines in ZEPATIER pass into human breast milk.
Croatian: Nije poznato izlučuju li se dva lijeka koja ZEPATIER sadrži u majčino mlijeko.
English: Genotype 4 N = 5 % (n)
Croatian: Genotip 4 N = 5 % (n)
English: Clinical Isolates
Croatian: Klinički izolati
English: In a pooled analysis of subjects treated with regimens containing elbasvir/grazoprevir or elbasvir + grazoprevir with or without ribavirin in Phase 2 and 3 clinical studies, resistance analyses were conducted for 50 subjects who experienced virologic failure and had sequence data available (6 with on-treatment virologic failure, 44 with post-treatment relapse).
Croatian: U analizi objedinjenih podataka prikupljenih u ispitanika liječenih režimima koji su sadržavali elbasvir/grazoprevir ili elbasvir + grazoprevir, s ribavirinom ili bez njega, u kliničkim ispitivanjima faze 2 i 3, analize rezistencije provedene su u 50 ispitanika u kojih je izostao uspješni virološki odgovor i za koje su bili dostupni podaci o sekvencama (6 u kojih je izostao virološki odgovor tijekom liječenja, 44 s relapsom nakon liječenja).
English: Co-administration of ZEPATIER and OATP1B inhibitors is contraindicated because it may significantly increase grazoprevir plasma concentrations.
Croatian: Istodobna primjena lijeka ZEPATIER i inhibitora OATP1B je kontraindicirana jer može značajno povisiti koncentracije grazoprevira u plazmi.
English: Carcinogenicity studies for grazoprevir and elbasvir have not been conducted.
Croatian: Nisu provedena ispitivanja kancerogenosti grazoprevira i elbasvira.
English: Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Croatian: Elbasvir inhibira protein NS5A HCV-a, koji je neophodan za replikaciju virusne RNK i stvaranje viriona.
English: Lamivudine Abacavir Entecavir
Croatian: Lamivudin Abakavir Entekavir
English: Inner wallet
Croatian: Unutarnji kartonski ovitak
English: In non-HCV-infected subjects with dialysis-dependent, severe renal impairment, elbasvir and grazoprevir AUC values were unchanged compared to subjects with normal renal function.
Croatian: U ispitanika bez infekcije HCV-om koji su imali teško oštećenje funkcije bubrega ovisno o dijalizi, vrijednosti AUC elbasvira i grazoprevira nisu se promijenile u odnosu na ispitanike s normalnom funkcijom bubrega.
English: Adverse reactions Metabolism and nutrition disorders: Common decreased appetite
Croatian: Poremećaji metabolizma i prehrane: često smanjen tek
English: No human data on the effect of elbasvir and grazoprevir on fertility are available.
Croatian: Nema dostupnih podataka o učinku elbasvira i grazoprevira na plodnost u ljudi.
English: Grazoprevir has been shown to cross the placenta in rats and rabbits.
Croatian: Utvrđeno je da grazoprevir prolazi kroz placentu u štakora i kunića.
English: Frequent monitoring of tacrolimus whole blood concentrations, changes in renal function, and tacrolimus-associated adverse events upon the initiation of coadministration is recommended.
Croatian: Preporučuje se učestalo praćenje koncentracija takrolimusa u punoj krvi, promjena funkcije bubrega i nuspojava povezanih s primjenom takrolimusa nakon početka istodobne primjene.
English: No dose adjustment of ZEPATIER is required in patients with mild hepatic impairment (Child-Pugh A).
Croatian: Nije potrebno prilagođavati dozu lijeka ZEPATIER u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh stadij A).
English: Less than 1% of subjects treated with ZEPATIER with or without ribavirin experienced ALT elevations >2.5 - 5 times the ULN during treatment; there were no treatment discontinuations due to these ALT elevations.
Croatian: U manje od 1% ispitanika liječenih lijekom ZEPATIER s ribavirinom ili bez njega došlo je do povišenja vrijednosti ALT-a >2,5-5 puta iznad GGN-a tijekom liječenja; nijedan ispitanik nije prekinuo liječenje zbog tih povišenja ALT-a.
English: Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva: često artralgija, mialgija
English: In a biochemical assay, grazoprevir inhibited the proteolytic activity of the recombinant NS3/4A protease enzymes from HCV genotypes 1a, 1b, 3 and 4a with IC50 values ranging from 4 to 690 pM.
Croatian: U biokemijskom je testu grazoprevir inhibirao proteolitičku aktivnost rekombinantnih enzima proteaze NS3/4A HCV-a genotipa 1a, 1b, 3 i 4a, uz vrijednosti IC50 u rasponu od 4 do 690 pM.
English: Expected: ↑ Grazoprevir
Croatian: Očekivano: ↑ grazoprevir
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE and C-SCAPE.
Croatian: Uključuje ispitanike iz ispitivanja C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE i C-SCAPE *Uključuje ispitanike s virološkim probojem.
English: Elbasvir and grazoprevir are not OATP1B inhibitors in humans.
Croatian: Elbasvir i grazoprevir nisu inhibitori prijenosnika OATP1B u ljudi.
English: Following once daily administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir and grazoprevir reached steady state within approximately 6 days.
Croatian: Nakon primjene elbasvira/grazoprevira jedanput na dan u ispitanika s infekcijom HCV-om, elbasvir i grazoprevir postigli su stanje dinamičke ravnoteže nakon približno 6 dana.
English: Tell your doctor or pharmacist if you take any of the following medicines:
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od ovih lijekova:
English: ZEPATIER 50 mg/100 mg film-coated tablets elbasvir/grazoprevir
Croatian: ZEPATIER 50 mg/100 mg filmom obložene tablete elbasvir/grazoprevir
English: This is because ZEPATIER has not been tested in this age group.
Croatian: Naime, ZEPATIER se nije ispitivao u toj dobnoj skupini.
English: • have any other medical conditions.
Croatian: • ako imate bilo koju drugu bolest.
English: If you are taking ZEPATIER with ribavirin, make sure that you also read the Pregnancy and Breast-feeding sections of the package leaflet for this other medicine.
Croatian: Ako uzimate ZEPATIER s ribavirinom, obavezno pročitajte i dio "Trudnoća i dojenje" u uputi o lijeku za taj lijek.
English: ZEPATIER contains lactose and sodium
Croatian: ZEPATIER sadrži laktozu i natrij
English: Relative to fasting conditions, the administration of a single dose of elbasvir/grazoprevir with a highfat (900 kcal, 500 kcal from fat) meal to healthy subjects resulted in decreases in elbasvir AUC0-inf and Cmax of approximately 11 % and 15 %, respectively, and increases in grazoprevir AUC0-inf and Cmax of approximately 1.5-fold and 2.8-fold, respectively.
Croatian: U odnosu na primjenu natašte, primjena jednokratne doze elbasvira/grazoprevira uz obrok s visokim udjelom masti (900 kcal, 500 kcal iz masti) u zdravih ispitanika snizila je AUC0-inf i Cmax elbasvira za približno 11% odnosno 15% te povisila AUC0-inf i Cmax grazoprevira za približno 1,5 puta odnosno 2,8 puta.
English: Elbasvir was excreted into the milk of lactating rats with concentrations 4-fold that of the maternal plasma concentrations.
Croatian: Elbasvir se izlučivao u mlijeko ženki štakora u laktaciji u koncentracijama 4 puta višima od koncentracija u majčinoj plazmi.
English: Effect of baseline HCV polymorphisms on treatment response
Croatian: Učinak polimorfizama HCV-a prisutnih na početku ispitivanja na odgovor na liječenje
English: In non-HCV-infected subjects with severe renal impairment (eGFR < 30 mL/min/1.73 m2) who were not on dialysis, elbasvir and grazoprevir AUC values were increased by 86 % and 65 %, respectively, compared to non-HCV-infected subjects with normal renal function (eGFR > 80 mL/min/1.73 m2).
Croatian: U ispitanika bez infekcije HCV-om koji su imali teško oštećenje funkcije bubrega (eGFR < 30 ml/min/1,73 m2) i nisu bili na dijalizi, vrijednosti AUC elbasvira i grazoprevira povećale su se za 86% odnosno 65% u odnosu na ispitanike bez infekcije HCV-om s normalnom funkcijom bubrega (eGFR > 80 ml/min/1,73 m2).
English: Expected: ↑ sunitinib
Croatian: Očekivano: ↑ sunitinib
English: If you are lactose intolerant, or if you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Croatian: Ako ne podnosite laktozu ili Vam je liječnik rekao da ne podnosite neke vrste šećera, posavjetujte se sa svojim liječnikom prije nego uzmete ovaj lijek.
English: Grazoprevir is a substrate of OATP1B drug transporters.
Croatian: Grazoprevir je supstrat prijenosnika lijekova OATP1B.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: O tome treba voditi računa u bolesnika na prehrani s kontroliranim unosom natrija.
English: The following adverse reactions were identified in patients taking ZEPATIER without ribavirin for 12 weeks.
Croatian: Sljedeće nuspojave utvrđene su u bolesnika koji su uzimali ZEPATIER bez ribavirina tijekom 12 tjedana.
English: How to take ZEPATIER
Croatian: Kako uzimati ZEPATIER
English: NS5A substitutions conferring resistance to elbasvir may reduce the antiviral activity of other NS5A inhibitors.
Croatian: Supstitucije u proteinu NS5A koje uzrokuju rezistenciju na elbasvir mogu smanjiti antivirusnu aktivnost drugih inhibitora NS5A.
English: During clinical studies with ZEPATIER with or without ribavirin, regardless of treatment duration, < 1 % (13/1,690) of subjects experienced elevations of ALT from normal levels to greater than 5 times the ULN, generally at or after treatment week 8 (mean onset time 10 weeks, range 6-12 weeks).
Croatian: Tijekom kliničkih ispitivanja lijeka ZEPATIER s ribavirinom ili bez njega, neovisno o trajanju liječenja, kod < 1% (13/1690) ispitanika vrijednosti ALT-a porasle su iznad normalnih vrijednosti do više od 5 puta iznad GGN-a, u pravilu u 8. tjednu liječenja ili nakon toga (srednja vrijednost vremena nastupa: 10 tjedana; raspon: 6-12 tjedana).
English: In general, other NS5A substitutions conferring resistance to NS5A inhibitors may also confer resistance to elbasvir.
Croatian: Općenito, ostale supstitucije u proteinu NS5A koje uzrokuju rezistenciju na inhibitore NS5A mogu uzrokovati rezistenciju i na elbasvir.
English: Table 7: SVR in GT1a-, GT1b- or treatment-experienced GT4-infected subjects bearing baseline NS5A or NS3 polymorphisms SVR12 by Treatment Regimen ZEPATIER, 12 Weeks
Croatian: Tablica 7: SVR u ispitanika s infekcijom GT 1a, ispitanika s infekcijom GT 1b ili prethodno liječenih ispitanika s infekcijom GT 4 koji su imali polimorfizme NS5A ili NS3 na početku ispitivanja SVR12 prema režimu liječenja ZEPATIER, 12 tjedana
English: Some NS3 substitutions at A156 and at D168 confer reduced antiviral activity to grazoprevir as well as to other NS3/4A protease inhibitors.
Croatian: Neke supstitucije u proteinu NS3 na mjestima A156 i D168 smanjuju antivirusnu aktivnost grazoprevira, kao i drugih inhibitora proteaze NS3/4A.
English: Co-administration with ZEPATIER is contraindicated.
Croatian: Istodobna primjena s lijekom ZEPATIER je kontraindicirana.
English: C-SCAPE (open-label)
Croatian: C-SCAPE (otvoreno)
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin permanently discontinued treatment due to adverse reactions.
Croatian: Manje od 1% ispitanika liječenih lijekom ZEPATIER u kombinaciji s ribavirinom ili bez njega trajno je prekinulo liječenje zbog nuspojava.
English: Subjects who had failed prior treatment with boceprevir, simeprevir, or telaprevir in combination with peg-IFN + RBV received EBR + GZR with RBV for 12 weeks.
Croatian: Ispitanici koji nisu uspješno odgovorili na prethodno liječenje boceprevirom, simeprevirom ili telaprevirom u kombinaciji s peg-IFN+RBV primali su EBR+GZR s RBV-om tijekom 12 tjedana.
English: Serum Late ALT elevations
Croatian: Kasna povišenja vrijednosti ALT-a u serumu
English: Treatment-emergent substitutions observed in the viral populations of these subjects based on genotypes are shown in Table 6.
Croatian: Tablica 6 prikazuje supstitucije nastale tijekom liječenja zapažene u virusnim populacijama kod tih ispitanika, prema genotipovima.
English: Lactose monohydrate, hypromellose, titanium dioxide, triacetin, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172), carnauba wax
Croatian: Film ovojnica: laktoza hidrat, hipromeloza, titanijev dioksid, triacetin, žuti željezov oksid (E172), crveni željezov oksid (E172), crni željezov oksid (E172), karnauba vosak.
English: Patients with moderate or severe hepatic impairment (Child-Pugh B or C) (see sections 4.2 and 5.2).
Croatian: Bolesnici s umjerenim ili teškim oštećenjem funkcije jetre (Child-Pugh stadij B ili C) (vidjeti dijelove 4.2 i 5.2).
English: In addition, 11 subjects received open-label EBR + GZR for 12 weeks (intensive PK arm).
Croatian: Osim toga, 11 ispitanika primalo je otvoreno liječenje kombinacijom EBR+GZR tijekom 12 tjedana (skupina s intenzivnim farmakokinetičkim testiranjem).
English: Population PK analyses of HCV-infected patients in Phase 2 and 3 studies demonstrated that grazoprevir steady-state AUC0-24 increased by approximately 65 % in HCV-infected patients with compensated cirrhosis (all with CP-A) compared to HCV-infected non-cirrhotic patients, while elbasvir steady-state AUC was similar (see section 4.2).
Croatian: Populacijske farmakokinetičke analize bolesnika s HCV infekcijom iz ispitivanja faze 2 i 3 pokazale su da se AUC0-24 grazoprevira u stanju dinamičke ravnoteže povećao za približno 65% u bolesnika s HCV infekcijom s kompenziranom cirozom (svi su bili stadija CP-A) u usporedbi s onima bez ciroze, dok je AUC elbasvira u stanju dinamičke ravnoteže bio sličan (vidjeti dio 4.2).
English: How ZEPATIER works
Croatian: Kako djeluje ZEPATIER
English: C-SALVAGE (open-label)
Croatian: C-SALVAGE (otvoreno)
English: The frequency of serious adverse reactions and discontinuations due to adverse reactions in subjects with compensated cirrhosis were comparable to those seen in subjects without cirrhosis.
Croatian: Učestalost ozbiljnih nuspojava i prekida liječenja zbog nuspojava u ispitanika s kompenziranom cirozom bila je usporediva s onom opaženom u ispitanika bez ciroze.
English: The persistence of elbasvir and grazoprevir treatment-emergent amino acid substitutions in NS5A, and NS3, respectively, was assessed in genotype 1-infected subjects in Phase 2 and 3 studies whose virus had treatment-emergent resistance-associated substitution in the drug target, and with available data through at least 24 weeks post-treatment using population (or Sanger) sequencing.
Croatian: Postojanost supstitucija aminokiselina u proteinima NS5A i NS3 koje nastaju tijekom liječenja elbasvirom odnosno grazoprevirom ocjenjivala se u ispitivanjima faze 2 i 3 sekvenciranjem populacije (ili Sangerovim sekvenciranjem) u ispitanika s infekcijom genotipa 1 u kojih je virus na ciljnom mjestu imao supstituciju povezanu s rezistencijom nastalu tijekom liječenja i za koje su bili dostupni podaci za razdoblje od najmanje 24 tjedna nakon liječenja.
English: Table 6: Treatment-emergent amino acid substitutions in the pooled analysis of ZEPATIER with and without ribavirin regimens in Phase 2 and Phase 3 clinical studies
Croatian: Tablica 6: Supstitucije aminokiselina nastale tijekom liječenja prema analizi objedinjenih podataka za režime liječenja lijekom ZEPATIER s ribavirinom ili bez njega u kliničkim ispitivanjima faze 2 i faze 3
English: Emtricitabine (200 mg once daily)
Croatian: Emtricitabin (200 mg jedanput na dan)
English: Schering-Plough Labo N.V. Industriepark 30 - Zone A 2220 Heist-op-den-Berg BELGIUM
Croatian: Industriepark 30 - Zone A 2220 Heist-op-den-Berg Belgija
English: Outcome for subjects without SVR On-treatment virologic failure Relapse
Croatian: Ishod u ispitanika bez SVR-a Bez uspješnog virološkog odgovora tijekom liječenja* Relaps
English: TN subjects with GT 1 infection with or without cirrhosis (with or without HCV/HIV1 co-infection) or who were peg-IFN + RBV null responders, were randomised to EBR + GZR with or without RBV for 8, 12 or 18 weeks.
Croatian: Ispitanici koji prethodno nisu liječeni s infekcijom genotipom 1, s cirozom ili bez nje (s istodobnom HCV/HIV-1 infekcijom ili bez nje) ili koji nisu ostvarili nikakav odgovor na peg-IFN+RBV, bili su randomizirani za EBR+GZR, s RBV-om ili bez njega, tijekom 8, 12 ili 18 tjedana.
English: When elbasvir/grazoprevir was studied with ribavirin, the most frequent adverse reactions to elbasvir/grazoprevir + ribavirin combination therapy were consistent with the known safety profile of ribavirin.
Croatian: Kada se elbasvir/grazoprevir ispitivao u kombinaciji s ribavirinom, najčešće nuspojave kod primjene kombinirane terapije elbasvirom/grazoprevirom
English: Genotype 1b N = 8 % (n)
Croatian: Genotip 1b N = 8 % (n)
English: ↑ Simvastatin (primarily due to intestinal BCRP inhibition and CYP3A inhibition)
Croatian: ↑ simvastatin (prvenstveno zbog inhibicije BCRP-a u crijevima i inhibicije CYP3A)
English: In general, in HCV genotype 1a, 1b or 4replicons, combinations of grazoprevir resistance-associated substitutions further reduced grazoprevir antiviral activity.
Croatian: Općenito, kod replikona HCV-a genotipa 1a, 1b ili 4, kombinacije supstitucija koje se povezuju s rezistencijom na grazoprevir dodatno su smanjile antivirusnu aktivnost grazoprevira.
English: Tell your doctor or pharmacist if you notice any of the following side effects.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primijetite bilo koju od sljedećih nuspojava: