FrancophonIA/ELRC3.0 huggingface dataset:
English: When ZEPATIER is used in combination with ribavirin, women of childbearing potential or their male partners must use an effective form of contraception during treatment and for a period of time after the treatment has concluded.
Slovenian: Kadar se zdravilo ZEPATIER uporablja skupaj z ribavirinom, morajo ženske v rodni dobi ali njihovi spolni partnerji med zdravljenjem in še določeno obdobje po koncu zdravljenja uporabljati učinkovito kontracepcijo.
English: • dabigatran to prevent blood clots
Slovenian: • dabigatran za preprečitev krvnih strdkov,
English: HCV/HBV (hepatitis B virus) co-infection
Slovenian: Sočasna okužba s HCV/HBV (virusom hepatitisa B)
English: If you forget to take ZEPATIER
Slovenian: Če ste pozabili vzeti zdravilo ZEPATIER
English: Elbasvir and grazoprevir are substrates of CYP3A and P-gp.
Slovenian: Elbasvir in grazoprevir sta substrata CYP3A in P-gp.
English: ZEPATIER is not recommended for use in children and adolescents under 18 years of age because the safety and efficacy have not been established in this population.
Slovenian: Zdravila ZEPATIER ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker varnost in učinkovitost v tej populaciji nista bili dokazani.
English: Elbasvir and grazoprevir are extensively bound (> 99.9 % and 98.8 %, respectively) to human plasma proteins.
Slovenian: Elbasvir in grazoprevir sta v veliki meri vezana na beljakovine v humani plazmi (elbasvir > 99,9 %, grazoprevir 98,8 %).
English: Uncommon: may affect up to 1 in 100 people • abnormalities in laboratory tests of liver function
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov • nenormalni izvidi laboratorijskih testov za oceno delovanja jeter
English: Co-administration with grazoprevir did not result in clinically relevant increases in exposures of CYP3A substrates.
Slovenian: Sočasna uporaba z grazoprevirjem ni klinično pomembno povečala izpostavljenosti substratom CYP3A.
English: • tacrolimus to prevent organ transplant rejection
Slovenian: • takrolimus za preprečitev zavrnitve darovanega organa,
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.
Slovenian: Grazoprevir je zaviralec proteaze NS3/4A HCV, ki je potrebna za proteolitično cepitev HCV kodiranega poliproteina (v zrele oblike proteinov NS3, NS4A, NS4B, NS5A in NS5B) in je bistvena za replikacijo virusov.
English: • have any liver problems other than hepatitis C
Slovenian: • imate razen hepatitisa C še kakšne druge težave z jetri,
English: Carcinogenicity studies for grazoprevir and elbasvir have not been conducted.
Slovenian: Študij kancerogenosti z grazoprevirjem in elbasvirjem niso izvedli.
English: The safety and efficacy of ZEPATIER in children and adolescents aged less than 18 years have not been established.
Slovenian: Varnost in učinkovitost zdravila ZEPATIER pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
English: Includes subjects from C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE and C-SCAPE.
Slovenian: Vključuje preiskovance iz C-EDGE TN, C-EDGE COINFECTION, C-EDGE TE in C-SCAPE.
English: Saquinavir/ritonavir Tipranavir/ritonavir Atazanavir
Slovenian: Sakvinavir/ritonavir Tipranavir/ritonavir Atazanavir
English: • The active substances are: elbasvir and grazoprevir.
Slovenian: • Učinkovini sta: elbasvir in grazoprevir.
English: If ZEPATIER is co-administered with ribavirin, the information for ribavirin with regard to contraception, pregnancy testing, pregnancy, breast-feeding, and fertility also applies to this combination regimen (refer to the Summary of Product Characteristics for the co-administered medicinal product for additional information).
Slovenian: Če je zdravilo ZEPATIER uporabljeno sočasno z ribavirinom, veljajo glede kontracepcije, testov nosečnosti, nosečnosti, dojenja in plodnosti za to kombinirano shemo enake informacije kot za ribavirin (za dodatne informacije glejte povzetek glavnih značilnosti sočasno uporabljenega zdravila).
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).
Slovenian: Študije na živalih niso pokazale škodljivih učinkov elbasvirja ali grazoprevirja na plodnost ob izpostavljenostih elbasvirju in grazoprevirju, ki so bile večje od izpostavljenosti pri človeku med uporabo priporočenega kliničnega odmerka (glejte poglavje 5.3).
English: • decide if you should take ZEPATIER and for how long
Slovenian: • da se odloči, ali morate jemati zdravilo ZEPATIER in koliko časa,
English: Tell your doctor or pharmacist if you take any of the following medicines:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete katero od naslednjih zdravil:
English: Effect of baseline HCV polymorphisms on treatment response
Slovenian: Vpliv izhodiščnih polimorfizmov HCV na odziv na zdravljenje
English: Elbasvir is an inhibitor of HCV NS5A, which is essential for viral RNA replication and virion assembly.
Slovenian: Elbasvir je zaviralec NS5A HCV, ki je bistvena za replikacijo virusne RNA in sestavljanje viriona.
English: It is unknown whether elbasvir or grazoprevir and their metabolites are excreted in human milk.
Slovenian: Ni znano, ali se elbasvir ali grazoprevir in njuni presnovki izločajo v materino mleko.
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.
Slovenian: Primarna pot izločanja elbasvirja in grazoprevirja je izločanje v blatu: v blatu se je pojavil skoraj ves (> 90 %) radioaktivno označeni odmerek, v urinu pa < 1 %.
English: Both elbasvir and grazoprevir bind to human serum albumin and 1-acid glycoprotein.
Slovenian: Elbasvir in grazoprevir se vežeta na humani serumski albumin in 1-kisli glikoprotein.
English: • unusual hair loss or thinning
Slovenian: • neobičajno izpadanje ali redčenje las
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).
Slovenian: Varnost zdravila ZEPATIER so ocenili na podlagi 3 s placebom nadzorovanih študij in 7 nenadzorovanih kliničnih študij 2. in 3. faze pri približno 2.000 preiskovancih s kronično okužbo s hepatitisom C in kompenzirano boleznijo jeter (s cirozo ali brez nje).
English: Serum Late ALT elevations
Slovenian: Zakasnela zvišanja ALT v serumu
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
Slovenian: • če jemljete katero od naslednjih zdravil: o rifampicin, ki se običajno uporablja za tuberkulozo, o zaviralce HIV proteaze, na primer atazanavir, darunavir, lopinavir, sakvinavir ali tipranavir, o efavirenz ali etravirin za HIV, o elvitegravir/kobicistat/emtricitabin/dizoproksiltenofovirijev fumarat ali elvitegravir/kobicistat/emtricitabin/tenofovir alafenamid za HIV, o ciklosporin za preprečitev zavrnitve darovanega organa ali za zdravljenje resnih vnetnih bolezni oči, ledvic, sklepov ali kože, o bosentan za pljučno arterijsko hipertenzijo, o karbamazepin ali fenitoin, ki se uporabljata predvsem za epilepsijo in napade krčev, o modafinil, ki pomaga ljudem, ki ne morejo ostati budni, o šentjanževko (Hypericum perforatum), zdravilo rastlinskega izvora za depresijo ali druge težave.
English: What ZEPATIER is ZEPATIER is an antiviral medicine that contains the active substances elbasvir and grazoprevir.
Slovenian: Kaj je zdravilo ZEPATIER Zdravilo ZEPATIER je protivirusno zdravilo, ki vsebuje zdravilni učinkovini elbasvir in grazoprevir.
English: Expected: ↑ Fluvastatin (primarily due to intestinal BCRP inhibition)
Slovenian: Pričakovano: ↑ fluvastatin (predvsem zaradi zaviranja črevesne BCRP)
English: Each film-coated tablet contains 50 mg elbasvir and 100 mg grazoprevir.
Slovenian: Ena filmsko obložena tableta vsebuje 50 mg elbasvirja in 100 mg grazoprevirja.
English: Most late ALT elevations resolved with ongoing therapy with ZEPATIER or after completion of therapy (see section 4.4).
Slovenian: Večina zakasnelih zvišanj ALT se je normalizirala med nadaljevanjem zdravljenja z zdravilom ZEPATIER ali po koncu zdravljenja (glejte poglavje 4.4).
English: Effects on medicinal product levels.
Slovenian: Vplivi na koncentracijo zdravil.
English: C-SURFER (double-blind)
Slovenian: C-SURFER (dvojno slepa)
English: Concentrations of elbasvir were not quantifiable in the dialysate samples.
Slovenian: Koncentracije elbasvirja v vzorcih dializata ni bilo mogoče količinsko določiti.
English: Grazoprevir is a substrate of OATP1B drug transporters.
Slovenian: Grazoprevir je substrat prenašalcev zdravil OATP1B.
English: Based on pooled data from patients treated with ZEPATIER for 12 weeks without ribavirin ULN: Upper limit of normal according to testing laboratory.
Slovenian: na podlagi združenih podatkov pri bolnikih, ki so se 12 tednov zdravili z zdravilom ZEPATIER brez ribavirina ZNM: zgornja normalna meja glede na laboratorijske preiskave
English: C-EDGE COINFECTION (open-label)
Slovenian: C-EDGE COINFECTION (odprta)
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).
Slovenian: Varnost in učinkovitost elbasvirja/grazoprevirja (sočasno uporabljena v fiksni kombinaciji odmerkov: EBR/GZR) ali elbasvirja + grazoprevirja (sočasno uporabljena vsak posamezno; EBR + GZR) so ocenili v 8 kliničnih študijah pri približno 2.000 preiskovancih (glejte preglednico 8).
English: ZEPATIER contains lactose monohydrate.
Slovenian: Zdravilo ZEPATIER vsebuje laktozo monohidrat.
English: For hepatitis C virus (HCV) genotype-specific activity see sections 4.4 and 5.1.
Slovenian: Za specifično aktivnost glede na genotip virusa hepatitisa C (HCV) glejte poglavji 4.4 in 5.1.
English: The substitutions associated with resistance to NS5B inhibitors do not affect the activity of elbasvir or grazoprevir.
Slovenian: Substitucije, povezane z odpornostjo na zaviralce NS5B, ne vplivajo na aktivnost elbasvirja ali grazoprevirja.
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.
Slovenian: Pri preučevanju elbasvirja/grazoprevirja skupaj z ribavirinom, je bil najpogostejši neželeni učinek kombinacije elbasvirja/grazoprevirja z ribavirinom skladen z znanim varnostnim profilom ribavirina.
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.
Slovenian: V kliničnih študijah je odmerek ribavirina temeljil na telesni masi (< 66 kg = 800 mg/dan, 66 do 80 kg = 1.000 mg/dan, 81 do 105 kg = 1.200 mg/dan, > 105 kg = 1.400 mg/dan) in je bil uporabljen v dveh deljenih odmerkih s hrano.
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.
Slovenian: Ugotovljene razlike v odzivu na zdravljenje glede na režim zdravljenja pri posebnih populacijah bolnikov in glede na prisotnost ali odsotnost izhodiščnih polimorfizmov NS5A ali NS3 so navedene v preglednici 7.
English: Outcome for subjects without SVR On-treatment virologic failure Relapse
Slovenian: Izid pri preiskovancih brez SVR Virološki neuspeh med zdravljenjem Recidiv
English: What ZEPATIER is and what it is used for What you need to know before you take ZEPATIER How to take ZEPATIER
Slovenian: Kaj je zdravilo ZEPATIER in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo ZEPATIER Kako jemati zdravilo ZEPATIER Možni neželeni učinki
English: Musculoskeletal and connective tissue disorders: Common arthralgia, myalgia
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva: Pogosti artralgija, mialgija
English: What ZEPATIER looks like and contents of the pack The film-coated tablets are beige, oval, debossed with “770” on one side and plain on the other.
Slovenian: Izgled zdravila ZEPATIER in vsebina pakiranja Filmsko obložene tablete so ovalne oblike, bež barve, ki imajo na eni strani vtisnjeno oznako "770", na drugi strani pa so brez oznake.
English: • If it has been less than 16 hours since you should have taken your dose, take the missed dose as soon as possible.
Slovenian: • če je od takrat, ko bi morali vzeti odmerek, minilo manj kot 16 ur, vzemite izpuščeni odmerek čim prej.
English: † (Grade 3) >10.0 × ULN (Grade 4) Total Bilirubin (mg/dL) 2.6-5.0 × ULN (Grade 3) >5.0 × ULN (Grade 4)
Slovenian: † (3. stopnja) > 10,0 × ZNM (4. stopnja) Celokupni bilirubin (mg/dl) 2,6-5,0 × ZNM (3. stopnja) > 5,0 × ZNM (4. stopnja)
English: For specific dosage instructions for ribavirin, including dose modification, refer to the ribavirin Summary of Product Characteristics.
Slovenian: Za podrobna navodila glede odmerjanja ribavirina, vključno s prilagoditvijo odmerka, prosimo, glejte Povzetek glavnih značilnosti zdravila za ribavirin.
English: Elbasvir and grazoprevir are partially eliminated by oxidative metabolism, primarily by CYP3A.
Slovenian: Elbasvir in grazoprevir se delno odstranjujeta z oksidativno presnovo, predvsem preko CYP3A.
English: It is not known whether the two medicines in ZEPATIER pass into human breast milk.
Slovenian: Ni znano, ali učinkovini zdravila ZEPATIER prehajata v materino mleko.
English: ZEPATIER 50 mg/100 mg film-coated tablets
Slovenian: ZEPATIER 50 mg/100 mg filmsko obložene tablete
English: Swallow the tablet whole with or without food.
Slovenian: Tablete pogoltnite cele, s hrano ali brez nje.
English: ZEPATIER contains 3.04 mmol (or 69.85 mg) sodium per dose.
Slovenian: Zdravilo ZEPATIER vsebuje 3,04 mmol (ali 69,85 mg) natrija na odmerek.
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.
Slovenian: Vrednosti EC50 za elbasvir in grazoprevir proti replikonom polne dolžine ali himeričnim replikonom, ki kodirajo zaporedje NS5A ali NS3 iz referenčnih zaporedij in kliničnih izolatov, so prikazane v preglednici 5.
English: ZEPATIER treatment should be initiated and monitored by a physician experienced in the management of patients with CHC.
Slovenian: Zdravljenje z zdravilom ZEPATIER mora uvesti in spremljati zdravnik z izkušnjami pri zdravljenju bolnikov s kroničnim hepatitisom C.
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.
Slovenian: Tablete so pakirane v škatli, ki vsebuje dva (2) kartonska ovitka; vsak kartonski ovitek vsebuje dva (2) aluminijasta pretisna omota s 7 tabletami, zapečatena v kartonskem ovitku, tako da škatla vsebuje skupaj 28 tablet.
English: Each film-coated tablet contains 87.02 mg of lactose (as monohydrate) and 3.04 mmol (or 69.85 mg) of sodium.
Slovenian: Ena filmsko obložena tableta vsebuje 87,02 mg laktoze (v obliki monohidrata) in 3,04 mmol (ali 69,85 mg) natrija.
English: Driving and using machines Do not drive or operate machines if you feel tired after taking your medicine.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Če ste po jemanju zdravila utrujeni, ne vozite in ne upravljajte strojev.
English: TN = Treatment-Naïve
Slovenian: TN (Treatment-Naïve) = še nezdravljeni
English: In addition, 11 subjects received open-label EBR + GZR for 12 weeks (intensive PK arm).
Slovenian: Poleg tega je 11 preiskovancev 12 tednov odprto prejemalo EBR + GZR (skupina z intenzivno FK).
English: Emergent Amino Acid Substitutions
Slovenian: Nastale aminokislinske substitucije
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).
Slovenian: Učinkovitost zdravila ZEPATIER ni bila dokazana pri bolnikih, predhodno izpostavljenih zdravilu ZEPATIER ali zdravilom iz istih skupin, kot zdravilo ZEPATIER (zaviralci NS5A ali NS3/4A, razen telaprevirja, simeprevirja, boceprevirja) (glejte poglavje 5.1).
English: Use with caution; dose adjustment of sunitinib may be required.
Slovenian: Morda bo potrebna prilagoditev odmerka sunitiniba.
English: EBR with GZR
Slovenian: EBR z GZR
English: Less than 1 % of subjects treated with ZEPATIER with or without ribavirin permanently discontinued treatment due to adverse reactions.
Slovenian: Pri manj kot 1 % preiskovancev, zdravljenih z zdravilom ZEPATIER z ribavirinom ali brez njega, so zdravljenje zaradi pojava neželenih učinkov trajno ukinili.
English: Expected: ↑ sunitinib
Slovenian: Pričakovano: ↑ sunitinib
English: Co-administration of ZEPATIER with sunitinib may increase sunitinib concentrations leading to an increased risk of sunitinib-associated adverse events.
Slovenian: Sočasna uporaba zdravila ZEPATIER s sunitinibom lahko zviša koncentracije sunitiniba, kar lahko poveča tveganje za pojav neželenih učinkov povezanih s sunitinibom.
English: Human experience of overdose with ZEPATIER is limited.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila ZEPATIER pri človeku je malo.
English: Then take your next dose at your usual time.
Slovenian: Naslednji odmerek nato vzemite ob običajnem času jemanja.
English: NS3 polymorphisms considered were any amino acid substitution at positions 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170, and 175.
Slovenian: Za polimorfizme NS3 so upoštevali katero koli aminokislinsko substitucijo na položajih 36, 54, 55, 56, 80, 107, 122, 132, 155, 156, 158, 168, 170 in 175.
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
Slovenian: Preglednica 1: Priporočeno zdravljenje kroničnega hepatitisa C z zdravilom ZEPATIER pri bolnikih s kompenzirano cirozo ali brez nje (samo Child-Pugh A) genotip HCV
English: Your doctor will test your blood before, during and after your treatment with ZEPATIER.
Slovenian: Zdravnik vas bo pred zdravljenjem, med zdravljenjem in po zdravljenju z zdravilom ZEPATIER napotil na preiskave krvi.
English: The tablets are packaged into a carton containing two cardboard cards, each cardboard card containing two 7-count aluminium blisters.
Slovenian: Tablete so pakirane v škatli, ki vsebuje dva kartonska ovitka; vsak kartonski ovitek vsebuje 2 aluminijasta pretisna omota s 7 tabletami.
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.
Slovenian: Elbasvir in grazoprevir pri človeku zavirata prenašalni BCRP v črevesu in lahko zvišata koncentracijo sočasno uporabljenih substratov BCRP v plazmi.
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.
Slovenian: V biokemičnem preizkusu je grazoprevir zavrl proteolitično aktivnost rekombinantnih proteaznih encimov NS3/4A HCV genotipov 1a, 1b, 3 in 4a z vrednostmi IC50 od 4 do 690 pM.
English: Other medicines and ZEPATIER
Slovenian: Druga zdravila in zdravilo ZEPATIER
English: General disorders and administration site conditions: Very common fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije: Zelo pogosti utrujenost
English: Expected: ↔ Elbasvir ↔ Grazoprevir ↔ Lamivudine ↔ Abacavir ↔ Entecavir
Slovenian: Pričakovano: ↔ elbasvir ↔ grazoprevir ↔ lamivudin ↔ abakavir ↔ entekavir
English: Interactions between ZEPATIER and other medicinal products
Slovenian: Medsebojno delovanje med zdravilom ZEPATIER in drugimi zdravili
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).
Slovenian: Sočasna uporaba z zaviralci transportnega polipeptida organskih anionov 1B (OATP1B), kot so rifampicin, atazanavir, darunavir, lopinavir, sakvinavir, tipranavir, kobicistat ali ciklosporin (glejte poglavji 4.4 in 4.5).
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%.
Slovenian: Absolutna biološka uporabnost grazoprevirja po enkratnem odmerku 200 mg je bila v razponu od 15 - 27 %, po večratnih odmerkih 200 mg pa od
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.
Slovenian: Če ne prenašate laktoze, ali če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom.
English: GT 1 TE with HCV protease inhibitor regimen
Slovenian: GT 1 TE s shemo HCV zaviralca proteaz,
English: The highest dose of elbasvir was 200 mg once daily for 10 days, and a single dose of 800 mg.
Slovenian: Največji odmerek elbasvirja je bil 200 mg enkrat na dan 10 dni in največji enkratni odmerek je bil 800 mg.
English: Elbasvir pharmacokinetics were approximately dose-proportional over the range of 5-100 mg once daily.
Slovenian: Farmakokinetika elbasvirja je v razponu od 5 do 100 mg enkrat na dan približno sorazmerna odmerku.
English: ZEPATIER is indicated for the treatment of chronic hepatitis C (CHC) in adults (see sections 4.2, 4.4 and 5.1).
Slovenian: Zdravilo ZEPATIER je indicirano za zdravljenje kroničnega hepatitisa C pri odraslih (glejte poglavja 4.2, 4.4 in 5.1).
English: Co-administration of ZEPATIER with P-gp inhibitors is expected to have a minimal effect on the plasma concentrations of ZEPATIER.
Slovenian: Sočasna uporaba zdravila ZEPATIER z zaviralci P-gp predvidoma minimalno vpliva na koncentracije zdravila ZEPATIER v plazmi.
English: Includes 1 subject with cirrhosis status of “unknown” in C-SCAPE.
Slovenian: Vključuje 1 preiskovanca, pri katerem je bila v C-SCAPE prisotnost ciroze neznana.
English: C-EDGE COSTAR (double-blind)
Slovenian: C-EDGE COSTAR (dvojno slepa)
English: Following once daily administration of elbasvir/grazoprevir to HCV-infected subjects, elbasvir and grazoprevir reached steady state within approximately 6 days.
Slovenian: Pri uporabi elbasvirja/grazoprevirja enkrat na dan pri preiskovancih, okuženih s HCV, sta elbasvir in grazoprevir dosegla stanje dinamičnega ravnovesja v približno 6 dneh.