FrancophonIA/ELRC3.0 huggingface dataset:
English: • ZEPATIER should be discontinued if ALT elevation is accompanied by signs or symptoms of liver inflammation or increasing conjugated bilirubin, alkaline phosphatase, or international normalised ratio (INR).
Croatian: • Liječenje lijekom ZEPATIER treba prekinuti ako se uz povišene vrijednosti ALT-a pojave i znakovi ili simptomi upale jetre ili porast vrijednosti konjugiranog bilirubina, alkalne fosfataze ili međunarodnog normaliziranog omjera (engl. international normalised ratio, INR).
English: Saquinavir/ritonavir Tipranavir/ritonavir Atazanavir
Croatian: Sakvinavir/ritonavir Tipranavir/ritonavir Atazanavir
English: The medicinal product interactions described are based on results from studies conducted with either ZEPATIER or elbasvir (EBR) and grazoprevir (GZR) as individual agents, or are predicted medicinal product interactions that may occur with elbasvir or grazoprevir.
Croatian: Opisane interakcije između lijekova temelje se na rezultatima iz ispitivanja provedenih ili s lijekom ZEPATIER ili s elbasvirom (EBR) i grazoprevirom (GZR) kao zasebnim lijekovima ili predstavljaju predviđene interakcije između lijekova koje bi mogle nastupiti kod primjene elbasvira ili grazoprevira.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Croatian: U nekliničkim ispitivanjima zapaženi su učinci samo pri izloženosti dozama koje su znatno veće od maksimalne izloženosti u ljudi, što ukazuje na njihov mali značaj za kliničku primjenu.
English: If you are taking ZEPATIER with ribavirin, please make sure that you read the "Do not take" section of the ribavirin package leaflet.
Croatian: Ako uzimate ZEPATIER s ribavirinom, molimo Vas da obavezno pročitate dio "Nemojte uzimati" u uputi o lijeku za ribavirin.
English: The safety of ZEPATIER was assessed based on 3 placebo-controlled studies and 7 uncontrolled Phase 2 and 3 clinical studies in approximately 2,000 subjects with chronic hepatitis C infection with compensated liver disease (with or without cirrhosis).
Croatian: Sigurnost lijeka ZEPATIER ocjenjivala se na temelju 3 placebom kontrolirana ispitivanja i 7 nekontroliranih kliničkih ispitivanja faze 2 i 3 provedenih u približno 2000 ispitanika s kroničnom infekcijom virusom hepatitisa C i kompenziranom bolesti jetre (s cirozom ili bez nje).
English: Elbasvir and grazoprevir are not expected to be removed by peritoneal dialysis.
Croatian: Ne očekuje se da će se elbasvir i grazoprevir ukloniti peritonejskom dijalizom.
English: Some diabetic patients have experienced low sugar levels in the blood (hypoglycaemia) after starting treatment with medicines like
Croatian: U nekih bolesnika sa šećernom bolesti zabilježene su niske razine šećera u krvi (hipoglikemija) nakon početka liječenja lijekovima kao što je ZEPATIER.
English: Tell your doctor or pharmacist if you have problems swallowing tablets.
Croatian: Obavijestite svog liječnika ili ljekarnika ako imate poteškoća s gutanjem tableta.
English: C-SURFER (double-blind)
Croatian: C-SURFER (dvostruko slijepo)
English: • If it has been more than 16 hours since you should have taken your dose, do not take the missed dose.
Croatian: • Ako je prošlo više od 16 sati otkad ste trebali uzeti dozu, nemojte uzeti propuštenu dozu.
English: The safety and efficacy of elbasvir/grazoprevir (co-administered as a fixed-dose combination; EBR/GZR) or elbasvir + grazoprevir (co-administered as single agents; EBR + GZR) were evaluated in 8 clinical studies in approximately 2,000 subjects (see Table 8).
Croatian: Sigurnost i djelotvornost elbasvira/grazoprevira (istodobno primijenjeni kao kombinacija fiksnih doza; EBR/GZR) ili elbasvira + grazoprevira (istodobno primijenjeni kao zasebni lijekovi; EBR + GZR) ocjenjivale su se u 8 kliničkih ispitivanja provedenih u približno 2000 ispitanika (vidjeti Tablicu 8).
English: † (Grade 3) >10.0 × ULN (Grade 4) Total Bilirubin (mg/dL) 2.6-5.0 × ULN (Grade 3) >5.0 × ULN (Grade 4)
Croatian: † (stupanj 3) >10,0 × GGN (stupanj 4) Ukupni blirubin (mg/dl) 2,6-5,0 × GGN (stupanj 3) >5,0 × GGN (stupanj 4)
English: St. John's wort (Hypericum perforatum)
Croatian: BILJNI PRIPRAVCI Gospina trava (Hypericum perforatum)
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin had serious adverse reactions (abdominal pain, transient ischaemic attack and anaemia).
Croatian: Manje od 1% ispitanika liječenih lijekom ZEPATIER u kombinaciji s ribavirinom ili bez njega imalo je ozbiljne nuspojave (bol u abdomenu, tranzitorna ishemijska ataka i anemija).
English: Potential for ZEPATIER to affect other medicinal products
Croatian: Potencijal lijeka ZEPATIER da utječe na druge lijekove
English: Potential for other medicinal products to affect ZEPATIER
Croatian: Potencijal drugih lijekova da utječu na ZEPATIER
English: Cirrhosis was not a risk factor for late ALT elevations.
Croatian: Ciroza nije bila faktor rizika za kasno povišenje vrijednosti ALT-a.
English: Concentrations of dabigatran may increase when co-administered with elbasvir, with possible increased bleeding risk.
Croatian: Koncentracije dabigatrana mogu se povisiti pri istodobnoj primjeni s elbasvirom, pri čemu se može povećati rizik od krvarenja.
English: C-EDGE COINFECTION (open-label)
Croatian: C-EDGE COINFECTION (otvoreno)
English: Talk to your doctor or pharmacist before taking ZEPATIER if you:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete ZEPATIER:
English: • dabigatran to prevent blood clots
Croatian: • dabigatran, za sprječavanje nastanka krvnih ugrušaka
English: If you are on a low sodium diet, talk to your doctor before taking this medicine.
Croatian: Ako ste na prehrani s ograničenim unosom natrija, obratite se svom liječniku prije nego što uzmete ovaj lijek.
English: Grazoprevir is an inhibitor of the HCV NS3/4A protease which is necessary for the proteolytic cleavage of the HCV encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication.
Croatian: Grazoprevir je inhibitor proteaze NS3/4A HCV-a, koja je potrebna za proteolitičko cijepanje poliproteina kojeg kodira HCV (u zrele oblike proteina NS3, NS4A, NS4B, NS5A i NS5B) i neophodna za virusnu replikaciju.
English: • warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Croatian: • varfarin i drugi slični lijekovi pod nazivom antagonisti vitamina
English: Elbasvir and grazoprevir are substrates of CYP3A and P-gp.
Croatian: Elbasvir i grazoprevir su supstrati za CYP3A i P-gp.
English: The safety and efficacy of ZEPATIER in children and adolescents aged less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka ZEPATIER u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: Most late ALT elevations resolved with ongoing therapy with ZEPATIER or after completion of therapy (see section 4.4).
Croatian: Većina kasnih povišenja vrijednosti ALT-a povukla se s nastavkom terapije lijekom ZEPATIER ili nakon završetka terapije (vidjeti dio 4.4).
English: Co-administration with grazoprevir did not result in clinically relevant increases in exposures of CYP3A substrates.
Croatian: Istodobna primjena s grazoprevirom nije klinički značajno povećala izloženost supstratima CYP3A.
English: For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Croatian: Za aktivnost protiv pojedinih genotipova virusa hepatitisa C (HCV) vidjeti dijelove 4.4 i 5.1.
English: Grazoprevir oral exposures are approximately 2-fold greater in HCV-infected subjects as compared to healthy subjects.
Croatian: Izloženost grazopreviru nakon peroralne primjene približno je 2 puta veća u ispitanika zaraženih HCV-om nego u zdravih ispitanika.
English: Patients should be informed that fatigue has been reported during treatment with ZEPATIER (see section 4.8).
Croatian: Bolesnike treba upozoriti da je tijekom liječenja lijekom ZEPATIER prijavljen umor (vidjeti dio 4.8).
English: Table 1: Recommended ZEPATIER therapy for treatment of chronic hepatitis C infection in patients with or without compensated cirrhosis (Child-Pugh A only) HCV genotype
Croatian: Tablica 1: Preporučena terapija lijekom ZEPATIER za liječenje kronične infekcije virusom hepatitisa C u bolesnika s kompenziranom cirozom ili bez nje (samo Child-Pugh stadij A) Genotip HCV-a
English: Co-administration of ZEPATIER with sunitinib may increase sunitinib concentrations leading to an increased risk of sunitinib-associated adverse events.
Croatian: Istodobna primjena lijeka ZEPATIER sa sunitinibom može povisiti koncentracije sunitiniba, što može dovesti do povećanog rizika od nuspojava povezanih sa sunitinibom.
English: This will give the medicine the best chance to treat your hepatitis C infection.
Croatian: Tada postoji najveća vjerojatnost da će lijek izliječiti infekciju virusom hepatitisa C.
English: Embryo fetal and post natal development
Croatian: Embriofetalni i postnatalni razvoj
English: Hepatic laboratory testing should be performed prior to therapy, at treatment week 8, and as clinically indicated.
Croatian: Potrebno je provoditi laboratorijske pretrage funkcije jetre prije liječenja, u 8. tjednu liječenja i sukladno kliničkoj indikaciji.
English: • If you or your partner becomes pregnant while taking ZEPATIER with ribavirin or in the months that follow, tell your doctor straight away.
Croatian: • Ako Vi ili Vaša partnerica tijekom liječenja lijekom ZEPATIER s ribavirinom ili unutar nekoliko mjeseci po njegovu završetku ipak zatrudnite, odmah o tome obavijestite svog liječnika.
English: For grazoprevir, the absolute bioavailability after a 200 mg single dose ranged from 15 - 27% and after multiple 200 mg doses ranged from 20 - 40%.
Croatian: Apsolutna bioraspoloživost grazoprevira nakon pojedinačne doze od 200 mg je u rasponu 15-27%, a nakon višekratnih doza od 200 mg u rasponu 20-40%.
English: Additional Study Details
Croatian: Dodatne informacije o ispitivanju
English: Interaction not studied.
Croatian: K Interakcija nije ispitana.
English: Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Croatian: Jedna filmom obložena tableta sadrži 50 mg elbasvira i 100 mg grazoprevira.
English: If more than 16 hours have passed since ZEPATIER is usually taken, then the patient should be instructed that the missed dose should NOT be taken and to take the next dose per the usual dosing schedule.
Croatian: Ako je od vremena kada se ZEPATIER obično uzima prošlo više od 16 sati, bolesniku treba reći da NE SMIJE uzeti propuštenu dozu i da sljedeću dozu uzme prema uobičajenom rasporedu.
English: In population pharmacokinetic analyses, there was no effect of weight on elbasvir pharmacokinetics.
Croatian: Prema populacijskim farmakokinetičkim analizama, tjelesna težina nije utjecala na farmakokinetiku elbasvira.
English: ZEPATIER is not for use in children and adolescents under 18 years of age.
Croatian: ZEPATIER nije namijenjen za primjenu u djece i adolescenata mlađih od 18 godina.
English: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 3.04 mmol (or 69.85 mg) of sodium.
Croatian: Jedna filmom obložena tableta sadrži 87,02 mg laktoze (u obliku hidrata) i 3,04 mmol (ili 69,85 mg) natrija.
English: • have had a liver transplant
Croatian: • ako Vam je presađena jetra
English: ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Croatian: Liječenje lijekom ZEPATIER mora započeti i nadzirati liječnik s iskustvom u liječenju bolesnika s kroničnim hepatitisom C.
English: Interaction studied with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (fixed-dose combination)
Croatian: Interakcija se ispitivala s elvitegravirom/kobicistatom/ emtricitabinom/tenofovir dizoproksilfumaratom (fiksna kombinacija doza)
English: Expected: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudine ↔ Abacavir ↔ Entecavir
Croatian: Očekivano: ↔ elbasvir ↔ grazoprevir ↔ lamivudin ↔ abakavir ↔ entekavir
English: Grazoprevir pharmacokinetics increased in a greater than dose-proportional manner over the range of 10-800 mg once daily in HCV-infected subjects.
Croatian: Farmakokinetika grazoprevira rasla je više nego proporcionalno primijenjenoj dozi u rasponu doza od 10 do 800 mg primijenjenih jedanput na dan u ispitanika zaraženih HCV-om.
English: Beige, oval tablet of dimensions 21 mm x 10 mm debossed with “770” on one side and plain on the other.
Croatian: Bež, ovalna tableta, dimenzija 21 mm x 10 mm, s utisnutom oznakom "770" na jednoj strani i bez oznake na drugoj strani.
English: The potential for grazoprevir to be a breast cancer resistance protein (BCRP) substrate cannot be excluded.
Croatian: Ne može se isključiti mogućnost da je grazoprevir supstrat za protein koji uzrokuje rezistenciju raka dojke na liječenje (engl. breast cancer resistance protein, BCRP).
English: The efficacy of ZEPATIER in patients previously exposed to ZEPATIER, or to medicinal products of the same classes as those of ZEPATIER (NS5A inhibitors or NS3/4A inhibitors other than telaprevir, simeprevir, boceprevir), has not been demonstrated (see section 5.1).
Croatian: Nije dokazana djelotvornost lijeka ZEPATIER u bolesnika prethodno izloženih lijeku ZEPATIER ili lijekovima iz istih skupina kojima pripadaju i djelatne tvari lijeka ZEPATIER (inhibitori NS5A ili inhibitori NS3/4A, osim telaprevira, simeprevira, boceprevira) (vidjeti dio 5.1).
English: ZEPATIER 50 mg/100 mg film-coated tablets
Croatian: ZEPATIER 50 mg/100 mg filmom obložene tablete
English: It is unknown whether elbasvir or grazoprevir and their metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se elbasvir ili grazoprevir i njihovi metaboliti u majčino mlijeko.
English: Concentrations of elbasvir were not quantifiable in the dialysate samples.
Croatian: Koncentracije elbasvira u uzorcima dijalizata nisu bile mjerljive.
English: The tablets are packaged into a carton containing two (2) cardboard cards, each cardboard card containing (2) 7-count aluminium blisters sealed in a cardboard card for a total of 28 tablets.
Croatian: Tablete su pakirane u kutiju koja sadrži dva (2) kartonska ovitka, od kojih svaki sadrži 2 aluminijska blistera sa 7 tableta zatvorena u kartonski ovitak (ukupno 28 tableta).
English: • Patients should be instructed to consult their healthcare professional without delay if they have onset of fatigue, weakness, lack of appetite, nausea and vomiting, jaundice or discoloured faeces.
Croatian: • Bolesnike treba uputiti da se bez odlaganja obrate svom zdravstvenom radniku ako primijete umor, slabost, gubitak teka, mučninu i povraćanje, žuticu ili promjenu boje stolice.
English: In the clinical studies, the dose of ribavirin was weight-based (< 66 kg = 800 mg/day, 66 to 80 kg = 1,000 mg/day, 81 to 105 kg = 1,200 mg/day, > 105 kg = 1,400 mg/day) administered in two divided doses with food.
Croatian: U kliničkim se ispitivanjima doza ribavirina određivala prema tjelesnoj težini (<66 kg=800 mg/dan, 66 do 80 kg=1000 mg/dan, 81 do 105 kg=1200 mg/dan, >105 kg=1400 mg/dan), a primjenjivala se podijeljena u dvije doze, zajedno s hranom.
English: Elbasvir pharmacokinetics were approximately dose-proportional over the range of 5-100 mg once daily.
Croatian: Farmakokinetika elbasvira bila je približno proporcionalna primijenjenoj dozi u rasponu doza od 5 do 100 mg jedanput na dan.
English: Elbasvir and grazoprevir are inhibitors of the drug transporter BCRP at the intestinal level in humans and may increase plasma concentrations of co-administered BCRP substrates.
Croatian: Elbasvir i grazoprevir su inhibitori transportnog proteina lijekova BCRP-a u crijevima ljudi te mogu povisiti koncentracije istodobno primijenjenih supstrata BCRP-a u plazmi.
English: Grazoprevir AUC is estimated to be 15 % higher in a 53 kg subject compared to a 77 kg subject.
Croatian: Procjenjuje se da je AUC grazoprevira 15% veći u ispitanika tjelesne težine 53 kg nego u ispitanika tjelesne težine 77 kg.
English: • joint pain or painful, swollen joints
Croatian: • bol u zglobovima ili bolni, otečeni zglobovi
English: Elbasvir has been shown to cross the placenta in rats and rabbits.
Croatian: Utvrđeno je da elbasvir prolazi kroz placentu u štakora i kunića.
English: The observed treatment response differences by treatment regimen in specific patient populations in the presence or absence of baseline NS5A or NS3 polymorphisms are summarised in Table 7.
Croatian: Primijećene razlike u odgovoru na liječenje prema režimu liječenja u specifičnim populacijama bolesnika u prisutnosti ili odsutnosti polimorfizama NS5A ili NS3 na početku ispitivanja sažeto su navedene u Tablici 7.
English: The highest dose of grazoprevir was 1,000 mg once daily for 10 days, and a single dose of 1,600 mg.
Croatian: Najviša doza grazoprevira bila je 1000 mg jedanput na dan tijekom 10 dana i jednokratna doza od 1600 mg.
English: The primary route of elimination of elbasvir and grazoprevir is through faeces with almost all (> 90 %) of the radiolabeled dose recovered in faeces compared to < 1 % in urine.
Croatian: Primarni put eliminacije elbasvira i grazoprevira je putem fecesa; gotovo je sva (> 90%) radioaktivno označena doza pronađena u fecesu, dok je u mokraći pronađeno < 1% doze.
English: Elbasvir is not a CYP3A inhibitor in vitro and grazoprevir is a weak CYP3A inhibitor in humans.
Croatian: Elbasvir ne inhibira CYP3A in vitro, a grazoprevir je slab inhibitor CYP3A u ljudi.
English: Animal studies do not indicate harmful effects of elbasvir or grazoprevir on fertility at elbasvir and grazoprevir exposures higher than the exposure in humans at the recommended clinical dose (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na štetne učinke elbasvira ili grazoprevira na plodnost pri razinama izloženosti elbasviru i grazopreviru većima od one koja se postiže u ljudi nakon primjene preporučene kliničke doze (vidjeti dio 5.3).
English: Grazoprevir was excreted into the milk of lactating rats with concentrations < 1-fold of the maternal plasma concentrations.
Croatian: Grazoprevir se izlučivao u mlijeko ženki štakora u laktaciji u koncentracijama < 1 puta od koncentracija u majčinoj plazmi.
English: Expected: ↑ Fluvastatin (primarily due to intestinal BCRP inhibition)
Croatian: Očekivano: ↑ fluvastatin (prvenstveno zbog inhibicije BCRP-a u crijevima)
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY and C-SURFER.
Croatian: Uključuje ispitanike iz ispitivanja C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE, C-WORTHY i C-SURFER *Uključuje ispitanike s virološkim probojem.
English: • you are taking any of the following medicines: o rifampicin, usually given for tuberculosis o HIV protease inhibitors such as atazanavir, darunavir, lopinavir, saquinavir, or tipranavir o efavirenz or etravirine for HIV o elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate or elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide for HIV o ciclosporin to stop organ transplant rejection or to treat serious inflammatory illnesses of eyes, kidney, joints or skin o bosentan for pulmonary arterial hypertension o carbamazepine or phenytoin, mainly used for epilepsy and seizures o modafinil to help people who cannot stay awake o St. John's wort (Hypericum perforatum, a herbal medicine) for depression or other problems
Croatian: o rifampicin, obično se daje za liječenje tuberkuloze o inhibitore HIV proteaze, poput atazanavira, darunavira, lopinavira, sakvinavira ili tipranavira o efavirenz ili etravirin, za liječenje infekcije HIV-om o elvitegravir/kobicistat/emtricitabin/tenofovir dizoproksilfumarat ili elvitegravir/kobicistat/emtricitabin/tenofovir alafenamid, za liječenje infekcije HIV-om o ciklosporin, za sprječavanje odbacivanja presađenog organa ili liječenje ozbiljnih upalnih bolesti očiju, bubrega, zglobova ili kože o bosentan, za liječenje plućne arterijske hipertenzije o karbamazepin ili fenitoin, uglavnom se koriste za liječenje epilepsije i napadaja o modafinil, za pomoć osobama koje ne mogu ostati budne o gospinu travu (Hypericum perforatum, biljni lijek), za liječenje depresije ili drugih tegoba.
English: C-EDGE COSTAR (double-blind)
Croatian: C-EDGE COSTAR (dvostruko slijepo)
English: The table is not all-inclusive.
Croatian: Tablica ne uključuje sve interakcije.
English: Co-administration of ZEPATIER with P-gp inhibitors is expected to have a minimal effect on the plasma concentrations of ZEPATIER.
Croatian: Očekuje se da će istodobna primjena lijeka ZEPATIER s inhibitorima P-gp-a minimalno utjecati na koncentracije lijeka ZEPATIER u plazmi.
English: Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment.
Croatian: Vezanje za proteine u plazmi nije značajno izmijenjeno u bolesnika s oštećenjem funkcije bubrega ili funkcije jetre.
English: For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Croatian: Za specifične upute za doziranje ribavirina, uključujući prilagođavanje doze, pročitajte sažetak opisa svojstava lijeka za ribavirin.
English: Carbamazepine Phenytoin
Croatian: Karbamazepin Fenitoin
English: Glucose levels of diabetic patients initiating DAA therapy should be closely monitored, particularly within the first 3 months, and their diabetic medication modified when necessary.
Croatian: Razine glukoze u bolesnika s dijabetesom koji započinju liječenje direktno djelujućim antivirotikom treba pažljivo nadzirati, posebno unutar prva tri mjeseca, te prema potrebi prilagoditi lijek protiv dijabetesa.
English: • check how your liver is working - tell your doctor straight away if you have any of the following signs of liver problems: loss of appetite; feeling or being sick; feeling tired or weak;
Croatian: • provjeriti kako Vam radi jetra-odmah obavijestite svog liječnika ako imate bilo koji od sljedećih znakova jetrenih tegoba: gubitak teka; mučninu ili povraćanje; osjećaj umora ili slabosti; žutu boju kože ili bjeloočnica; promjene boje stolice.
English: Therefore, no dose adjustment is required for CYP3A substrates when co-administered with ZEPATIER.
Croatian: Stoga nije potrebno prilagođavati dozu supstrata CYP3A pri njihovoj istodobnoj primjeni s lijekom ZEPATIER.
English: The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters.
Croatian: Tablete su pakirane u kutiju koja sadrži dva kartonska ovitka, od kojih svaki sadrži dva aluminijska blistera sa 7 tableta.
English: The substitutions associated with resistance to NS5B inhibitors do not affect the activity of elbasvir or grazoprevir.
Croatian: Supstitucije povezane s rezistencijom na inhibitore NS5B ne utječu na aktivnost elbasvira ni grazoprevira.
English: Co-administration with inhibitors of organic anion transporting polypeptide 1B (OATP1B), such as rifampicin, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin (see sections 4.4 and 4.5).
Croatian: Istodobna primjena s inhibitorima polipeptidnog prijenosnika organskih aniona 1B (engl. organic anion transporting polypeptide 1B, OATP1B), poput rifampicina, atazanavira, darunavira, lopinavira, sakvinavira, tipranavira, kobicistata ili ciklosporina (vidjeti dijelove 4.4 i 4.5).
English: A should be considered in patients with baseline HCV RNA level >800,000 IU/ml and/or the presence of specific NS5A polymorphisms causing at least a 5-fold reduction in activity of elbasvir to minimise the risk of treatment failure (see section 5.1).
Croatian: A, u bolesnika s početnom razinom HCV RNK >800 000 IU/ml i/ili prisutnošću specifičnih polimorfizama u NS5A koji uzrokuju najmanje peterostruko smanjenje aktivnosti elbasvira (vidjeti dio 5.1).