FrancophonIA/ELRC3.0 huggingface dataset:
English: Velpatasvir was fully active against the sofosbuvir resistance-associated substitution S282T in NS5B while all velpatasvir resistance-associated substitutions in NS5A were fully susceptible to sofosbuvir.
Croatian: Velpatasvir je bio potpuno djelatan protiv supstitucije S282T u NS5B povezane s rezistencijom na sofosbuvir, dok su sve supstitucije u NS5A povezane s rezistencijom na velpatasvir bile potpuno osjetljive na sofosbuvir.
English: Potential for Epclusa to affect other medicinal products Velpatasvir is an inhibitor of drug transporter P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1 and OATP1B3.
Croatian: Mogućnost utjecaja lijeka Epclusa na druge lijekove Velpatasvir je inhibitor prijenosnika lijeka P-gp-a, proteina rezistencije raka dojke (engl. breast cancer resistance protein, BCRP), polipeptida za prijenos organskih aniona (engl. organic anion transporting polypeptide, OATP) 1B1 i OATP1B3.
English: HCV-Infected Subjects
Croatian: Ispitanici zaraženi HCV-om
English: Another patient had virus with Y93H at baseline and virologic failure and also developed low levels (< 5%) of NS5B NI RAVs N142T and E237G at failure.
Croatian: Drugi je bolesnik imao virus s Y93H na početku ispitivanja i virološki neuspjeh te je također razvio niske razine (< 5 %) varijante NS5B povezane s rezistencijom na nukleozidne inhibitore N142T i E237G pri neuspjehu.
English: Patients with genotype 5 HCV infection were enrolled to the Epclusa group.
Croatian: Bolesnici zaraženi HCV-om genotipa 5 bili su uključeni u skupinu s lijekom Epclusa.
English: In HCV-infected patients with severe renal impairment treated with sofosbuvir 200 mg with ribavirin (n=10) or sofosbuvir 400 mg with ribavirin (n=10) for 24 weeks or ledipasvir/sofosbuvir 90/400 mg (n=18) for 12 weeks, the pharmacokinetics of sofosbuvir and GS-331007 were consistent with that observed in HCV negative patients with severe renal impairment.
Croatian: U bolesnika zaraženih HCV-om i s teškim oštećenjem bubrega koji su liječeni dozom sofosbuvira od 200 mg i ribavirinom (n = 10) ili dozom sofosbuvira od 400 mg i ribavirinom (n = 10) tijekom 24 tjedna ili ledipasvirom/sofosbuvirom u dozi od 90/400 mg (n = 18) tijekom 12 tjedana, farmakokinetika sofosbuvira i GS-331007 bila je u skladu s onom opaženom u HCV-negativnih bolesnika s teškim oštećenjem bubrega.
English: Cases of severe bradycardia and heart block have been observed when sofosbuvir-containing regimens are used in combination with amiodarone and/or other medicinal products that lower heart rate (see sections 4.4 and 4.5).
Croatian: Slučajevi teške bradikardije i srčanog bloka uočeni su kada su se režimi koji sadrže sofosbuvir koristili u kombinaciji s amiodaronom i/ili lijekovima koji snižavaju srčanu frekvenciju (vidjeti dijelove 4.4 i
English: It is not known whether sofosbuvir or velpatasvir, the two active substances of Epclusa, pass into human breast milk.
Croatian: Nije poznato prelaze li sofosbuvir ili velpatasvir, dvije djelatne tvari u lijeku Epclusa, u majčino mlijeko kod ljudi.
English: SVR12 in patients with or without baseline NS5A RAVs in the Epclusa + RBV 12 week group for this study is shown in Table 8.
Croatian: SVR12 u bolesnika sa ili bez početnog NS5A RAV-a u skupini koja je primala lijek Epclusa + RBV tijekom 12 tjedana u ovom ispitivanju prikazan je u tablici 8.
English: Velpatasvir is also a substrate of OATP1B.
Croatian: Velpatasvir je također supstrat OATP1B.
English: Velpatasvir median peak concentrations were observed at 3 hours post-dose.
Croatian: Medijan vršne koncentracije velpatasvira opažen je 3 sata nakon uzimanja doze.
English: Genotype 1, 2, 3, 4, 5 and 6
Croatian: Genotip 1, 2, 3, 4, 5 i 6
English: Medicinal products that inhibit OATP, CYP2B6, CYP2C8, or CYP3A4 may increase plasma concentration of velpatasvir.
Croatian: Lijekovi koji inhibiraju OATP, CYP2B6, CYP2C8 ili CYP3A4 mogu povisiti koncentraciju velpatasvira u plazmi.
English: Patients were on a stable HIV-1 antiretroviral therapy that included emtricitabine/tenofovir disoproxil fumarate or abacavir/lamivudine administered with a ritonavir boosted protease inhibitor (atazanavir, darunavir, or lopinavir), rilpivirine, raltegravir or emtricitabine/tenofovir disoproxil fumarate /elvitegravir/cobicistat.
Croatian: Bolesnici su bili na stabilnoj antiretrovirusnoj terapiji za HIV-1, koja je uključivala emtricitabin/ tenofovirdizoproksilfumarat ili abakavir/lamivudin primijenjen s ritonavirom pojačanim inhibitorom proteaze (atazanavir, darunavir ili lopinavir), rilpivirin, raltegravir ili emtricitabin/ tenofovirdizoproksilfumarat/elvitegravir/kobicistat.
English: Cirrhotic (n = 80)
Croatian: S cirozom (n = 80)
English: The pharmacokinetics of sofosbuvir was studied in HCV negative patients with mild (eGFR ≥ 50 and < 80 mL/min/1.73 m2), moderate (eGFR ≥ 30 and < 50 mL/min/1.73 m2), severe renal impairment (eGFR < 30 mL/min/1.73 m2) and patients with ESRD requiring haemodialysis following a single 400 mg dose of sofosbuvir, relative to patients with normal renal function (eGFR > 80 mL/min/1.73 m2).
Croatian: Farmakokinetika sofosbuvira bila je ispitana u HCV-negativnih bolesnika s blagim (eGFR ≥ 50 i < 80 ml/min/1,73 m2), umjerenim (eGFR ≥ 30 i < 50 ml/min/1,73 m2), teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i bolesnika sa završnim stadijem bolesti bubrega koji su zahtijevali hemodijalizu, nakon jedne doze od 400 mg sofosbuvira, u odnosu na bolesnike s normalnom funkcijom bubrega (eGFR > 80 ml/min/1,73 m2).
English: Effect on rifampicin exposure not studied.
Croatian: Učinak na izloženost rifampicinu nije ispitan.
English: Phenobarbital (Induction of P-gp and CYPs)
Croatian: Fenobarbital (Indukcija P-gp-a i CYP-ova)
English: Of the 1,035 patients treated with sofosbuvir/velpatasvir in the three Phase 3 clinical studies, 1,023 patients were included in the analysis of NS5A RAVs; 7 patients were excluded as they neither achieved sustained virologic response (SVR12) nor had virologic failure and 5 additional patients were excluded as NS5A gene sequencing failed.
Croatian: Od 1035 bolesnika liječenih sofosbuvirom/velpatasvirom u trima kliničkim ispitivanjima faze 3, 1023 bolesnika su bila uključena u analizu NS5A RAV-ova; sedam bolesnika je bilo isključeno jer nisu postigli održani virološki odgovor (SVR12) niti su imali virološki neuspjeh te je pet dodatnih bolesnika isključeno zbog neuspjeha sekvencioniranja NS5A gena.
English: Epclusa 12 weeks (59)
Croatian: Epclusa 12 tjedana (59)
English: Non-Cirrhotic (n = 197)
Croatian: Bez ciroze (n = 197)
English: Afterwards, close monitoring and potential dose adjustment of tacrolimus may be required.
Croatian: Kasnije može biti potrebno pažljivo praćenje i prilagodba doze takrolimusa.
English: The 1 virologic failure patient with genotype 1 HCV had no NS5A or NS5B RAVs at failure.
Croatian: Jedan bolesnik s virološkim neuspjehom s HCV-om genotipa 1 nije imao NS5A ili NS5B RAV-ove pri neuspjehu.
English: Patients without cirrhosis and patients with compensated cirrhosis
Croatian: Bolesnici bez ciroze i bolesnici s kompenziranom cirozom
English: SOF+RBV 24 weeksa
Croatian: SOF+RBV 24 tjednaa
English: Population pharmacokinetic analysis in HCV-infected patients showed that within the age range (18 to 82 years) analysed, age did not have a clinically relevant effect on the exposure to sofosbuvir, GS-331007, or velpatasvir.
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da unutar analiziranog raspona dobi (18 do 82 godina), dob nije imala klinički značajan učinak na izloženost sofosbuviru, GS-331007 ili velpatasviru.
English: Replicons containing NS5A from clinical isolates
Croatian: Replikoni koji sadrže NS5A iz kliničkih izolata
English: When used in combination with ribavirin, refer also to the Summary of Product Characteristics of the medicinal product containing ribavirin.
Croatian: Kad se primjenjuje u kombinaciji s ribavirinom, pročitajte također sažetak opisa svojstava lijeka koji sadrži ribavirin.
English: EU/1/16/1116/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1116/001
English: Safety and efficacy of Epclusa have been assessed in patients with CPT Class B cirrhosis, but not in patients with CPT Class C cirrhosis (see sections 4.4, 4.8 and 5.1).
Croatian: Sigurnost i djelotvornost lijeka Epclusa procijenjeni su u pacijenata s cirozom jetre CPT stadija B, ali ne u pacijenata s cirozom CPT stadija C (vidjeti dijelove 4.4, 4.8 i 5.1).
English: Potential for other medicinal products to affect Epclusa Sofosbuvir and velpatasvir are substrates of drug transporters P-gp and BCRP.
Croatian: Mogućnost utjecaja drugih lijekova na lijek Epclusa Sofosbuvir i velpatasvir supstrati su prijenosnika lijekova P-gp-a i BCRP-a.
English: Study 4062 was an open-label clinical trial that evaluated 12 weeks of treatment with Epclusa in 59 HCV-infected patients with ESRD requiring dialysis.
Croatian: Ispitivanje 4062 bilo je otvoreno kliničko ispitivanje u kojem je procijenjeno 12-tjedno liječenje lijekom Epclusa u 59 bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu.
English: Co-administration with medicinal products that inhibit P-gp or BCRP may increase sofosbuvir or velpatasvir plasma concentrations.
Croatian: Istodobna primjena s lijekovima koji inhibiraju P-gp ili BCRP može povisiti koncentracije sofosbuvira ili velpatasvira u plazmi.
English: Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see sections 4.8, 5.1 and 5.2).
Croatian: Epclusa se u tih bolesnika može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.8, 5.1 i 5.2).
English: Randomisation was stratified by the presence or absence of cirrhosis and prior treatment experience (treatment-naïve versus treatment-experienced).
Croatian: Randomizacija je bila stratificirana prema prisutnosti ili odsutnosti ciroze i prethodnom liječenju (bolesnici koji prethodno nisu liječeni naspram prethodno liječenih bolesnika).
English: b Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
Croatian: b. Ostalo uključuje bolesnike koji nisu postigli SVR12 i nisu zadovoljili kriterije virološkog neuspjeha.
English: The safety assessment of Epclusa was based on pooled Phase 3 clinical study data from patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection (with or without compensated cirrhosis) including 1,035 patients who received Epclusa for 12 weeks.
Croatian: Procjena sigurnosti primjene lijeka Epclusa temeljila se na objedinjenim podacima iz kliničkog ispitivanja faze 3 bolesnika s infekcijom HCV-a genotipa 1, 2, 3, 4, 5 ili 6 (sa ili bez kompenzirane ciroze) uključujući 1035 bolesnika koji su primali lijek Epclusa tijekom 12 tjedana.
English: Liver transplant patients
Croatian: Bolesnici s transplantiranom jetrom
English: Based on the population pharmacokinetic analysis in HCV-infected patients, mean steady-state AUC0-24 for sofosbuvir (n = 982), GS-331007 (n = 1,428) and velpatasvir (n = 1,425) were 1,260, 13,970 and 2,970 ng•h/mL, respectively.
Croatian: Na temelju analize populacijske farmakokinetike u HCV-om zaraženih bolesnika, srednji AUC0-24 u stanju dinamičke ravnoteže za sofosbuvir (n = 982), GS-331007 (n = 1428) i velpatasvir (n = 1425) bili su 1260, 13 970 odnosno 2970 ng•h/ml.
English: No teratogenic effects were observed in the mouse and rat developmental toxicity studies with velpatasvir at AUC exposures approximately 31- and 6-fold higher, respectively, than the human exposure at the recommended clinical dose.
Croatian: Nisu opaženi teratogeni učinci u ispitivanjima razvojne toksičnosti s velpatasvirom na miševima i štakorima pri izloženostima AUC približno za 31 odnosno 6 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: Renal impairment No dose adjustment of Epclusa is required for patients with mild or moderate renal impairment.
Croatian: Ne preporučuje se prilagodba doze lijeka Epclusa u pacijenata s blagim ili umjerenim oštećenjem bubrega.
English: What you need to know before you take Epclusa Do not take Epclusa
Croatian: Što morate znati prije nego počnete uzimati lijek Epclusa
English: Do not stop taking Epclusa
Croatian: Nemojte prestati uzimati lijek Epclusa
English: Population pharmacokinetics analysis in HCV-infected patients indicated that cirrhosis (including decompensated cirrhosis) had no clinically relevant effect on the exposure to velpatasvir (see section 4.2).
Croatian: Analiza populacijske farmakokinetike u bolesnika zaraženih HCV-om pokazala je da ciroza (uključujući dekompenzirani cirozu) nije imala klinički relevantni učinak na izloženost velpatasviru (vidjeti dio 4.2).
English: Table 5: Activity of sofosbuvir and velpatasvir against transient replicons containing NS5A or NS5B from clinical isolates
Croatian: Tablica 5: Djelotvornost sofosbuvira i velpatasvira protiv prolaznih replikona koji sadrže NS5A i NS5B iz kliničkih izolata Genotip replikona
English: Effect on ketoconazole exposure not studied.
Croatian: Učinak na izloženost ketokonazolu nije ispitan.
English: Tablet core: Copovidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
Croatian: Jezgra tablete: kopovidon, mikrokristalična celuloza, umrežena karmelozanatrij, magnezijev stearat
English: The pharmacokinetics of sofosbuvir, GS-331007, and velpatasvir were studied in HCV-infected patients with ESRD requiring dialysis treated with Epclusa (n=59) for 12 weeks, and compared to patients without renal impairment in the sofosbuvir/velpatasvir Phase 2/3 trials.
Croatian: Farmakokinetika sofosbuvira, GS-331007 i velpatasvira ispitana je u bolesnika zaraženih HCV-om s ESRD-om koji je zahtijevao dijalizu liječenih lijekom Epclusa (n = 59) tijekom 12 tjedana, koji su uspoređeni s bolesnicima bez oštećenja bubrega u ispitivanjima sofosbuvira/velpatasvira faze 2/3.
English: Sofosbuvir and GS-331007 are not inhibitors of drug transporters P-gp, BCRP, MRP2, BSEP, OATP1B1, OATP1B3 and OCT1.
Croatian: Sofosbuvir i GS-331007 nisu inhibitori prijenosnika lijekova P-gp-a, BCRP-a, MRP2, BSEP-a, OATP1B1, OATP1B3, i OCT1.
English: Studies in patients with decompensated cirrhosis (CPT Class B) Analyses were conducted to explore the association between pre-existing baseline NS5A RAVs and treatment outcome for patients with decompensated cirrhosis in one Phase 3 study (ASTRAL-4).
Croatian: Ispitivanja u bolesnika s dekompenziranom cirozom (CPT stadij B) Provedene su analize kako bi se ispitala povezanost između postojećih početnih NS5A RAV-ova i ishoda liječenja u bolesnika s kompenziranom cirozom u jednom ispitivanju faze 3 (ASTRAL-4).
English: If a dose of Epclusa is missed and it is within 18 hours of the normal time, patients should be instructed to take the tablet as soon as possible and then patients should take the next dose at the usual time.
Croatian: Ako se propusti uzeti doza lijeka Epclusa, a još nije proteklo 18 sati od uobičajenog vremena uzimanja, bolesnike treba uputiti da uzmu tabletu čim prije i zatim uzmu sljedeću dozu u uobičajeno vrijeme.
English: c n = 4 for genotype 2, n = 2 for genotype 4 and n = 1 for genotype 6.
Croatian: c. n = 4 za genotip 2, n = 2 za genotip 4 i n = 1 za genotip 6.
English: The median terminal half-life of velpatasvir following administration of Epclusa was approximately 15 hours.
Croatian: Nakon primjene lijeka Epclusa, medijan terminalnog poluvijeka velpatasvira iznosio je približno 15 sati.
English: In vitro selection of HCV replicons with reduced susceptibility to velpatasvir was performed in cell culture for multiple genotypes including 1a, 1b, 2a, 3a, 4a, 5a and 6a.
Croatian: In vitro odabir replikona HCV-a sa smanjenom osjetljivošću na velpatasvir proveden je u staničnoj kulturi za više genotipova uključujući 1a, 1b, 2a, 3a, 4a, 5a i 6a.
English: Epclusa 400 mg/100 mg film-coated tablets.
Croatian: NAZIV LIJEKA Epclusa 400 mg/100 mg filmom obložene tablete.
English: Ribavirin Dose
Croatian: Doza ribavirina
English: Velpatasvir had no adverse effects on behaviour, reproduction, or development of the offspring in the rat pre- and post-natal development study at AUC exposures approximately 5-fold higher than the human exposure at the recommended clinical dose.
Croatian: Nije bilo štetnih učinaka velpatasvira na ponašanje, reprodukciju ili razvoj potomstva u ispitivanjima prenatalnog i postnatalnog razvoja u štakora pri AUC izloženostima približno za 5 puta većim od ljudske izloženosti pri preporučenoj kliničkoj dozi.
English: Among the patients who received treatment with Epclusa + RBV for 12 weeks, 29% (25/85) of patients had baseline virus with NS5A RAVs: 29% (19/66), 75% (3/4), 15% (2/13), and 50% (1/2) for patients with genotype 1, 2, 3 and 4 HCV, respectively.
Croatian: Među bolesnicima koji su liječeni lijekom Epclusa + RBV tijekom 12 tjedana, 29 % (25/85) bolesnika imalo je početni virus s NS5A RAV-om: 29 % (19/66), 75 % (3/4), 15 % (2/13) i 50 % (1/2) za bolesnike s HCV-om genotipa 1, 2, 3 odnosno 4.
English: In one Phase 3 study in patients with decompensated cirrhosis who received Epclusa + RBV for 12 weeks, 3 patients (1 with genotype 1 and 2 with genotype 3) qualified for resistance analysis due to virologic failure.
Croatian: U jednom ispitivanju faze 3 u pacijenata s dekompenziranom cirozom koji su primali lijek Epclusa + RBV tijekom 12 tjedana, tri bolesnika (jedan s genotipom 1 i dva s genotipom 3) kvalificirala su se za analizu rezistencije zbog virološkog neuspjeha.
English: Antacids e.g. Aluminium or magnesium hydroxide; calcium carbonate
Croatian: Antacidi npr. aluminijev ili magnezijev hidroksid, kalcijev karbonat
English: Epclusa 24 weeks (n = 90)
Croatian: Epclusa 24 tjedna (n = 90)
English: Treatmentexperienced (n = 71)
Croatian: Prethodno liječeni bolesnici (n = 71)
English: Safety data are limited in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2) and ESRD requiring haemodialysis.
Croatian: Podaci o sigurnosti primjene ograničeni su u bolesnika s teškim oštećenjem bubrega (eGFR < 30 ml/min/1,73 m2) i ESRD-om koji zahtijeva hemodijalizu.
English: Sofosbuvir and GS-331007 AUC0-24 and Cmax were similar in healthy adult subjects and patients with HCV infection.
Croatian: AUC0-24 i Cmax sofosbuvira i GS-331007 bili su slični u zdravih odraslih ispitanika i bolesnika zaraženih HCV-om.
English: The single genotype 3 patient who had baseline NS5A RAVs and failed to achieve SVR12 had NS5A substitution Y93H at baseline; pharmacokinetic data from this patient was consistent with non-adherence to treatment.
Croatian: Jedan bolesnika zaražen HCV-om genotipa 3 koji je imao početne NS5A RAV-ove i nije postigao SVR12 imao je NS5A supstituciju Y93H na početku; farmakokinetički podaci ovog bolesnika bili su konzistentni s nepridržavanjem liječenja.
English: d Other includes patients who did not achieve SVR12 and did not meet virologic failure criteria.
Croatian: d. Ostalo uključuje bolesnike koji nisu postigli SVR12 i nisu zadovoljili kriterije virološkog neuspjeha.
English: Epclusa can be used in these patients with no dose adjustment when no other relevant treatment options are available (see section 4.4, 4.8, 5.1 and 5.2).
Croatian: U tih se bolesnika Epclusa može primjenjivati bez prilagodbe doze kada nisu dostupne nikakve druge odgovarajuće mogućnosti liječenja (vidjeti dijelove 4.4, 4.8, 5.1 i 5.2).
English: Variants were selected at NS5A resistance associated positions 24, 28, 30, 31, 32, 58, 92 and 93.
Croatian: Odabrane su varijante na mjestima povezanim s rezistencijom NS5A 24, 28, 30, 31, 32, 58, 92 i 93. Varijante povezane s rezistencijom (engl. resistance associated variants, RAVs) odabrane u dva ili više genotipa bile su F28S, L31I/V i Y93H.
English: Treatmentexperienced (n = 69)
Croatian: Prethodno liječeni bolesnici (n = 69)
English: The efficacy of Epclusa was evaluated in three Phase 3 studies in patients with genotype 1 to 6 HCV infection with or without compensated cirrhosis, one Phase 3 study in patients with genotype 1 to 6 HCV infection with decompensated cirrhosis, one Phase 3 study in HCV/HIV-1 co-infected patients with genotype 1 to 6 HCV infection and one Phase 2 trial in patients with HCV infection and ESRD requiring dialysis, as summarised in Table 9.
Croatian: Djelotvornost lijeka Epclusa procijenjena je u trima ispitivanjima faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 sa ili bez kompenzirane ciroze, u jednom ispitivanju faze 3 u bolesnika s infekcijom HCV-om genotipa 1 do 6 s dekompenziranom cirozom, jednom ispitivanju faze 3 u bolesnika s koinfekcijom virusima HCV/HIV-1 s HCV-om genotipa 1 do 6 i u jednom ispitivanju faze 2 u bolesnika s infekcijom HCV-om i s ESRD-om koji je zahtijevao dijalizu, što je sažeto prikazano u tablici 9.
English: Itraconazolee Voriconazolee Posaconazolee Isavuconazolee
Croatian: Itrakonazole Vorikonazole Posakonazole Isavukonazole
English: Patients should be instructed that if vomiting occurs within 3 hours of dosing an additional tablet of Epclusa should be taken.
Croatian: Bolesnike treba uputiti da uzmu dodatnu tabletu lijeka Epclusa ako povraćanje nastupi u roku od tri sata nakon uzimanja doze.
English: This may make Epclusa work less well.
Croatian: To može oslabiti djelovanje lijeka Epclusa.
English: Each film-coated tablet contains 400 mg sofosbuvir and 100 mg velpatasvir.
Croatian: Jedna filmom obložena tableta sadrži 400 mg sofosbuvira i 100 mg velpatasvira.
English: Epclusa 12 weeks (106)
Croatian: Epclusa 12 tjedana (106)
English: At baseline, 29% of patients had cirrhosis, 22% were treatment experienced, 32% had received a kidney transplant, 92% were on haemodialysis, and 8% were on peritoneal dialysis; mean duration on dialysis was 7.3 years (range: 0 to 40 years).
Croatian: Na početku ispitivanja, 29% bolesnika imalo je cirozu, 22% bilo je prethodno liječeno, 32% imalo je transplantiran bubreg, 92% bilo je na hemodijalizi, a 8% na peritonejskoj dijalizi; srednja vrijednost trajanja liječenja dijalizom iznosila je 7,3 godine (raspon: od 0 do 40 godina).
English: (Inhibition of P-gp)
Croatian: (Inhibicija P-gp-a)
English: Table 9: Studies conducted with Epclusa in patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection
Croatian: Tablica 9: Ispitivanja provedena s lijekom Epclusa u bolesnika s infekcijom HCV-om genotipa 1, 2, 3, 4, 5 i 6
English: Total (all GTs) (n = 624)
Croatian: Ukupno (svi GT-i) (n = 624)
English: • a wide spread severe rash with peeling skin which may be accompanied by fever, flu like symptoms, blisters in the mouth, eyes, and/or genitals (Stevens Johnson syndrome).
Croatian: simptomima nalik gripi, mjehurićima u ustima, na očima i/ili na genitalijama (Stevens
English: The pharmacokinetics of sofosbuvir was studied following 7-day dosing of 400 mg sofosbuvir in HCV-infected patients with moderate and severe hepatic impairment (CPT Class B and C).
Croatian: Farmakokinetika sofosbuvira bila je ispitana nakon 7 dana doziranja 400 mg sofosbuvira u bolesnika zaraženih HCV-om s umjerenim i teškim oštećenjem jetre (CPT stadij B i C).
English: Epclusa 12 weeks (134) SOF+RBV 12 weeks (132)
Croatian: Epclusa 12 tjedana (134) SOF+RBV 12 tjedana (132)
English: Genotype 2, 4, and 6 HCV-infected patients had a higher prevalence of NS5A RAVs (70%, 63% and 52%, respectively) compared to genotype 1 (23%), genotype 3 (16%), and genotype 5 (18%) HCV-infected patients.
Croatian: Bolesnici s infekcijom HCV-om genotipa 2, 4 i 6 imali su veću prevalenciju NS5A RAV-ova (70 %, 63 % odnosno 52 %) u usporedbi s bolesnicima s infekcijom HCV-om genotipa 1 (23 %), genotipa 3 (16 %) i genotipa 5 (18 %).
English: • oxcarbazepine (medicine used to treat epilepsy and prevent seizures);
Croatian: • okskarbazepin (lijek koji se primjenjuje za liječenje epilepsije i sprječavanje napadaja);
English: Table 7: SVR12 in patients with and without baseline Y93H, 1% Cut-off (Resistance Analysis Population Set) ASTRAL 3
Croatian: Tablica 7: SVR12 u bolesnika sa ili bez početnog Y93H, 1 % granične vrijednosti (populacijski niz za analizu rezistencije) ASTRAL 3