FrancophonIA/ELRC3.0 huggingface dataset:
English: There is limited data on the use of simeprevir in patients older than 65 years.
Croatian: Podaci o primjeni simeprevira u bolesnika starijih od 65 godina su ograničeni.
English: Eighty-eight percent (459/521) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 88%.
Croatian: Osamdeset i osam posto (459/521) bolesnika liječenih simeprevirom bilo je pogodno za ukupno trajanje liječenja od 24 tjedna; u tih bolesnika stopa SVR12 bila je 88%.
English: No dose adjustment of OLYSIO is required in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze lijeka OLYSIO u bolesnika s blagim ili umjerenim oštećenjem bubrega.
English: Prior relapsers N = 15 % (n/N)
Croatian: Prethodni relaps N = 15 % (n/N)
English: Simeprevir is metabolised in the liver.
Croatian: Simeprevir se biotransformira u jetri.
English: Eighty percent (28/35), 90% (18/20), 40% (4/10) and 49% (19/39) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders, respectively, had undetectable HCV RNA at week 4.
Croatian: Osamdeset posto (28/35) bolesnika liječenih simeprevirom koji prethodno nisu bili liječeni, 90% (18/20) bolesnika s prethodnim relapsom, 40% (4/10) bolesnika s prethodnim djelomičnim odgovorom i 49% (19/39) bolesnika bez prethodnog odgovora imalo je nedetektabilnu HCV RNK u 4. tjednu.
English: It is not recommended to co-administer OLYSIO with systemic fluconazole or voriconazole.
Croatian: Ne preporučuje se istovremeno primjenjivati OLYSIO sa sistemskim flukonazolom ili vorikonazolom.
English: OLYSIO in combination with peginterferon alfa and ribavirin Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with hepatitis C genotype 1a with the NS3 Q80K polymorphism at baseline compared to patients with hepatitis C genotype 1a without the Q80K polymorphism (see section 5.1).
Croatian: OLYSIO u kombinaciji s peginterferonom alfa i ribavirinom Djelotvornost simeprevira u kombinaciji s peginterferonom alfa i ribavirinom značajno je snižena u bolesnika inficiranih hepatitisom C genotipa 1a s polimorfizmom NS3 Q80K na početku, u usporedbi s bolesnicima s hepatitisom C genotipom 1a bez polimorfizma Q80K (vidjeti dio 5.1).
English: - sildenafil or tadalafil to treat ‘pulmonary arterial hypertension' - midazolam or triazolam (when taken by mouth) to help you sleep or for anxiety
Croatian: - ciklosporin, sirolimus ili takrolimus za snižavanje imunološkog odgovora ili za sprječavanje neuspjeha kod transplantacije organa - sildenafil ili tadalafil za liječenje ‘plućne arterijske hipertenzije' - midazolam ili triazolam (kada se uzimaju kroz usta) za pomoć pri spavanju ili protiv tjeskobe
English: 24 weeks simeprevir + sofosbuvir N = 31 n (%)
Croatian: 24 tjedna simeprevir + sofosbuvir N = 31 n (%)
English: Mild increases in simeprevir concentrations may occur due to inhibition of CYP3A4 by amiodarone.
Croatian: Blaga povišenja koncentracija simeprevira mogu se pojaviti radi inhibicije CYP3A4 amiodaronom.
English: No dose adjustment is required for either drug when OLYSIO is co-administered with maraviroc.
Croatian: Nije potrebna prilagodba doze za bilo koji od lijekova kada se OLYSIO primjenjuje istovremeno s maravirokom.
English: Medicinal products that affect simeprevir exposure
Croatian: Lijekovi koji utječu na izloženost simepreviru
English: Combination treatment of OLYSIO with other medicinal products for the treatment of CHC may affect a patient's ability to drive and use machines.
Croatian: Kombinirano liječenje lijekom OLYSIO s drugim lijekovima za liječenje kroničnog hepatitisa C može utjecati na bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima.
English: In study HPC3007, 93% (241/260) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 83%.
Croatian: U ispitivanju HPC3007, 93% (241/260) bolesnika liječenih simeprevirom bilo je pogodno za ukupno trajanje liječenja od 24 tjedna; u tih bolesnika stopa SVR12 bila je 83%.
English: No dose adjustment of simeprevir is necessary in patients with mild hepatic impairment.
Croatian: Prilagodba doze simeprevira nije potrebna u bolesnika s blagim oštećenjem jetre.
English: It is not recommended to co-administer OLYSIO with cisapride.
Croatian: Ne preporučuje se istovremeno primjenjivati OLYSIO s cisapridom.
English: The interaction between simeprevir and the medicinal product was evaluated in a phase 2 pharmacokinetic study in 20 HCV-infected patients.
Croatian: Interakcija između simeprevira i lijeka bila je procijenjena u farmakokinetičkom ispitivanju faze 2 u 20 HCV-om zaraženih bolesnika.
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen in 30% of patients with HCV genotype 1a and in 0.5% of patients with HCV genotype 1b.
Croatian: Početni polimorfizmi na položajima NS3 proteaze 43, 80, 122, 155, 156, i/ili 168, koji su povezani sa smanjenom aktivnošću simeprevira in vitro općenito su bile manje česte (1,3%) u bolesnika s infekcijom HCV genotipom 1 (n = 2007; objedinjena ispitivanja faze 2 i faze 3 sa simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom), s iznimkom supstitucije Q80K u bolesnika s HCV genotipom 1a što je viđeno u 30% bolesnika s HCV genotipom 1a i u 0,5% bolesnika s HCV genotipom 1b.
English: Plasma protein binding is not meaningfully altered in patients with
Croatian: Vezanje na proteine plazme nije značajno promijenjeno u bolesnika s bubrežnim ili jetrenim oštećenjem.
English: Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Croatian: Simeprevir u kombinaciji sa sofosbuvirom: objedinjena ispitivanja HPC2002, HPC3017 i HPC3018 (12 tjedana) ili ispitivanje HPC2002 (24 tjedna); simeprevir u kombinaciji s peginterferonom alfa i ribavirinom: objedinjena ispitivanja C208, C216 i HPC3007 faze 3 (prvih 12 tjedana liječenja).
English: 12 weeks SMV + sofosbuvir
Croatian: 12 tjedana SMV + sofosbuvir
English: OLYSIO in combination with peginterferon alfa and ribavrin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR), therefore discontinuation of treatment is recommended in these patients.
Croatian: Postizanje održanog virološkog odgovora (od engl. sustained virologic response, SVR) nije vjerojatno u bolesnika s neadekvatnim virološkim odgovorom tijekom liječenja, stoga se u tih bolesnika preporučuje prekid liječenja.
English: 2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Croatian: 6,01 log10 IU/ml; 37% imalo je cirozu; 30% imalo je HCV genotip 4a, i 56% HCV genotip 4c ili 4d; 79% imalo je ne-CC IL28B alele (CT ili TT); 52% prethodno nisu bili liječeni, i 48% bili su prethodno
English: Treatment week 12: ≥ 25 IU/ml
Croatian: 12. tjedan liječenja: ≥ 25 IU/ml
English: HCV PRODUCTS Antiviral
Croatian: LIJEKOVI ZA LIJEČENJE INFEKCIJE HCV-om Antivirotici
English: In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated
Croatian: U bolesnika starijih > 45 godina, dispneja je bila prijavljena u 16,4% bolesnika liječenih simeprevirom u usporedbi s 9,1% bolesnika liječenih placebom (svi stupnjevi; objedinjeno za fazu 3).
English: The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic substudy within a phase 2 study in 22 HCV infected patients.
Croatian: Interakcija između simeprevira i lijeka bila je procijenjena u farmakokinetičkom podispitivanju u sklopu ispitivanja faze 2 u 22 HCV-om zaražena bolesnika.
English: Efficacy in patients with HCV genotype 1
Croatian: Djelotvornost u bolesnika s HCV genotipom 1
English: Increased simeprevir concentrations may occur due to inhibition of OATP1B1 by atorvastatin.
Croatian: Povišene koncentracije simeprevira mogu se javiti radi inhibicije OATP1B1 atorvastatinom.
English: OLYSIO in combination with peginterferon alfa and ribavirin: HCV/HIV-1 co-infected patients should be treated for the same duration as HCV mono-infected patients, except for co-infected patients with cirrhosis who should receive 36 weeks of treatment with peginterferon alfa and ribavirin after completing 12 weeks of treatment with OLYSIO, peginterferon alfa and ribavirin (total treatment
Croatian: OLYSIO u kombinaciji s peginterferonom alfa i ribavirinom: Bolesnike s koinfekcijom HCV-om i HIV-om-1 potrebno je liječiti jednako dugo kao i bolesnike samo s HCV infekcijom, osim koinficiranih bolesnika s cirozom, koji trebaju primiti liječenje peginterferonom alfa i ribavirinom tijekom 36 tjedana, nakon završetka liječenja lijekom OLYSIO, peginterferonom alfa i ribavirinom u trajanju od 12 tjedana (ukupno trajanje liječenja od 48 tjedana).
English: Table 6: Treatment-emergent laboratory abnormalities in amylase and lipase in patients receiving 12 or 24 weeks of simeprevir in combination with sofosbuvir (12 weeks: pooled studies HPC2002, HPC3017 and HPC3018; 24 weeks: study HPC2002)
Croatian: Tablica 6: Poremećaji laboratorijskih nalaza amilaze i lipaze koji su proizašli iz liječenja u bolesnika koji su primali 12 ili 24 tjedna simeprevir u kombinaciji sa sofosbuvirom (12 tjedana: objedinjena ispitivanja HPC2002, HPC3017 i HPC3018; 24 tjedna: ispitivanje HPC2002)
English: The majority of HCV genotype 1 infected patients treated with simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks who did not achieve SVR due to virologic reasons and with sequencing data available had emerging NS3 amino acid substitutions at position 168 and/or emerging R155K: 5 out of 6 patients in study HPC2002, 1 out of 3 patients in study HPC3017 and 11 out of 13 patients in study HPC3018.
Croatian: Većina bolesnika inficiranih HCV genotipom 1 koji su liječeni simeprevirom u kombinaciji sa sofosbuvirom (s ili bez ribavirina) tijekom 12 ili 24 tjedna i koji nisu postigli SVR zbog viroloških razloga i s dostupnim podacima sekvenciranja imali su nastale NS3 supstitucije aminokiselina na mjestu 168 i/ili nastalu R155K: 5 od 6 bolesnika u ispitivanju HPC2002, 1 od 3 bolesnika u ispitivanju HPC3017 i 11 od 13 bolesnika u ispitivanju HPC3018.
English: The 167 enrolled patients had a median age of 57 years (range 27 to 70 years; with 5% above 65 years); 64% were male; 81% were White, 19% Black or African American, and 21% Hispanic; 37% had a BMI ≥ 30 kg/m2; the median baseline HCV RNA level was 6.7 log10 IU/ml;
Croatian: 167 uključenih bolesnika imalo je medijan dobi 57 godina (raspon 27 do 70 godina; s 5% iznad 65 godina); 64% su bili muškarci; 81% su bili bijele rase, 19% crne rase ili Afroamerikanci, i 21% Hispanci; 37% imalo je BMI ≥ 30 kg/m2; medijan početne razine HCV RNA bio je 6,7 log10 IU/ml; 75% nije imalo cirozu (METAVIR skor za fibrozu F0-3) i 25% je imalo cirozu (METAVIR skor za fibrozu
English: Treatment week 24: ≥ 25 IU/ml
Croatian: 24. tjedan liječenja: ≥ 25 IU/ml
English: There are no clinical data on the efficacy of simeprevir in patients with a history of exposure to the NS3/4A PIs telaprevir or boceprevir.
Croatian: Nema kliničkih podataka o djelotvornosti simeprevira u bolesnika koji su u prošlosti bili izloženi NS3/4A inhibitorima proteaze, telapreviru ili bocepreviru.
English: It is not recommended to co-administer OLYSIO with darunavir/ritonavir.
Croatian: Ne preporučuje se istovremeno primjenjivati OLYSIO s darunavirom/ritonavirom.
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised
Croatian: Tijekom primjene simeprevira s peginterferonom alfa i ribavirinom, povišenja razina konjugiranog i nekonjugiranog bilirubina općenito nisu bila povezana s povišenjem razine transaminaza u jetri i vratila su se na normalnu razinu nakon završetka liječenja.
English: OLYSIO 150 mg hard capsules simeprevir
Croatian: OLYSIO 150 mg tvrde kapsule simeprevir
English: Medicinal products that are affected by the use of simeprevir Simeprevir mildly inhibits the CYP1A2 activity and intestinal CYP3A4 activity, while it does not affect hepatic CYP3A4 activity.
Croatian: Simeprevir blago inhibira aktivnost CYP1A2 i intestinalnog CYP3A4, dok ne utječe na aktivnost jetrenog CYP3A4.
English: Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are
Croatian: Poremećaji laboratorijskih nalaza koji su proizašli tijekom liječenja te su uočeni s većom incidencijom u bolesnika liječenih simeprevirom nego u bolesnika liječenih placebom, peginterferonom alfa i ribavirinom
English: Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Croatian: Klasifikacija organskih sustava Učestalost simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
English: Simeprevir in combination with peginterferon alfa and ribavirin The efficacy of simeprevir in combination with peginterferon alfa and ribavirin was evaluated in patients with HCV genotype 1 or 4 infection, with or without HIV-1 co-infection, who were treatment-naïve or treatment-experienced (following prior interferon-based therapy) (tables 17 and
Croatian: Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom Djelotvornost simeprevira u kombinaciji s peginterferonom alfa i ribavirinom bila je procijenjena u bolesnika s infekcijom HCV genotipom 1 ili 4, s ili bez koinfekcije HIVom-1, koji prethodno nisu bili liječeni ili prethodno liječenih (nakon prethodne terapije temeljene na interferonu) (tablica 17 i 18).
English: No dose adjustment is necessary based on gender.
Croatian: Nije potrebna prilagodba doze temeljena na spolu.
English: The 63 enrolled patients had a median age of 51 years (range 24 to 68 years; with 2% above 65 years); 54% were male; 43% had a
Croatian: 63 uključena bolesnika imalo je medijan dobi od 51 godine (raspon 24 do 68 godina; s 2% iznad 65 godina); 54% bili su muškarci; 43% imalo je BMI ≥ 30 kg/m2; medijan početne razine HCV RNA bila je
English: If you have any further questions about any of these medicines, ask your doctor or pharmacist.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s bilo kojim od navedenih lijekova, obratite se svom liječniku ili ljekarniku.
English: Treatment week 4: ≥ 25 IU/ml
Croatian: 4. tjedan liječenja: ≥ 25 IU/ml
English: Pre-treatment testing for NS3 Q80K polymorphism in patients infected with HCV genotype 1a
Croatian: Ispitivanje na NS3 Q80K polimorfizam koje prethodi liječenju u bolesnika inficiranih HCV-om
English: - The other ingredients are sodium lauryl sulfate, magnesium stearate, colloidal anhydrous silica, croscarmellose sodium, lactose monohydrate, gelatin, titanium dioxide (E171), iron oxide black (E172) and shellac (E904).
Croatian: karmelozanatrij, umrežena; laktoza hidrat, želatina, titanijev dioksid (E171), željezov oksid, crni
English: Table 10: Treatment-emergent amino-acid substitutions in pooled phase 2 and phase 3 studies: patients who did not achieve SVR with 150 mg simeprevir in combination
Croatian: Tablica 10: Supstitucije amninokiselina proizašle iz liječenja u objedinjenim ispitivanjima faze 2 i faze 3: bolesnici koji nisu postigli SVR sa 150 mg simeprevira u kombinaciji s peginterferonom alfa i ribavirinom
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12.
Croatian: Udio bolesnika liječenih simeprevirom s HCV RNK < 25 IU/ml koja je bila detektabilna u 4. tjednu bio je 14% (70/509); 67%
English: Seventy-nine percent (404/509) of simeprevir-treated patients had undetectable HCV RNA at week 4; in these patients the SVR12 rate was 90%.
Croatian: Sedamdeset i devet posto (404/509) bolesnika liječenih simeprevirom imalo je nedetektabilnu HCV RNK u 4. tjednu; u tih bolesnika stopa SVR12 bila je 90%.
English: These characteristics have no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Croatian: Ove karakteristike nisu imale klinički značajan učinak na farmakokinetiku simeprevira temeljeno na populacijskoj farmakokinetičkoj analizi HCV-om inficiranih bolesnika liječenih simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
English: Data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Croatian: Podaci iz ispitivanja faze 2 u 11 bolesnika nakon transplantacije jetre
English: Treatment-experienced to prior treatment with peginterferon and ribavirin.
Croatian: Prethodno iskustvo liječenja s peginterferonom i ribavirinom.
English: Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and
Croatian: Simeprevir u kombinaciji s peginterferonom alfa i ribavirinom Sigurnosni profil simeprevira u kombinaciji s peginterferonom alfa i ribavirinom u bolesnika s infekcijom HCV genotipa 1 temelji se na objedinjenim podacima iz ispitivanja faze 2 i ispitivanja faze 3 C205, C206, C208, C216 i HPC3007 koja su uključivala 924 bolesnika koji su primali simeprevir od 150 mg jedanput na dan tijekom 12 tjedana i 540 bolesnika koji su primali placebo s peginterferonom alfa i ribavirinom.
English: Simeprevir in combination with sofosbuvir: Photosensitivity reactions were reported in 3.1% of simeprevir-treated patients receiving 12 weeks of treatment compared to 6.5% in patients receiving 24 weeks of treatment (all grades).
Croatian: Simeprevir u kombinaciji sa sofosbuvirom: Reakcije fotoosjetljivosti bile su prijavljene u 3,1% bolesnika liječenih simeprevirom koji su liječeni tijekom 12 tjedana u usporedbi s 6,5% u bolesnika koji su liječeni tijekom 24 tjedna (svi stupnjevi).
English: The overall safety profile of simeprevir is based on data from 580 HCV genotype 1 infected patients who received simeprevir in combination with sofosbuvir with or without ribavirin (pooled data from the clinical phase 2 study HPC2002 and the clinical phase 3 studies HPC3017 and HPC3018) and 1,486 HCV genotype 1 infected patients who received simeprevir (or placebo) in combination with peginterferon alfa and ribavirin (pooled data from the clinical phase 2 studies C205 and C206 and the clinical phase 3 studies C208, C216 and HPC3007).
Croatian: Cjelokupni sigurnosni profil simeprevira temelji se na podacima za 580 bolesnika s infekcijom HCV genotipa 1 koji su primali simeprevir u kombinaciji sa sofosbuvirom s ili bez ribavirina (objedinjeni podaci iz kliničkog ispitivanja HPC2002 faze 2 i kliničkih ispitivanja HPC3017 i HPC3018 faze 3) i 1,486 bolesnika s infekcijom HCV genotipa 1 koji su primali simeprevir (ili placebo) u kombinaciji s peginterferonom alfa i ribavirinom (objedinjeni podaci iz kliničkih ispitivanja C205 i C206 faze 2 i kliničkih ispitivanja C208, C216 i HPC3007 faze 3).
English: Data from a phase 2 study in 9 HCV infected post-liver transplant patients.
Croatian: Podaci iz ispitivanja faze 2 u 9 bolesnika nakon transplantacije jetre
English: OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Croatian: - OLYSIO se koristi s drugim lijekovima za liječenje kronične (dugotrajne) infekcije
English: You may experience a rash during treatment with OLYSIO.
Croatian: Tijekom liječenja lijekom OLYSIO može Vam se pojaviti osip.
English: Gender had no clinically relevant effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis of HCV infected patients treated with simeprevir in combination with peginterferon alfa and ribavirin.
Croatian: Spol nije imao klinički značajan učinak na farmakokinetiku simeprevira temeljeno na populacijskoj farmakokinetičkoj analizi HCV-om inficiranih bolesnika liječenih simeprevirom u kombinaciji s peginterferonom alfa i ribavirinom.
English: Simeprevir in combination with sofosbuvir: Rash and pruritus were reported in 8.0% and 8.4%, respectively, of patients receiving 12 weeks of treatment compared to 12.9% and 3.2%, respectively, of patients receiving 24 weeks of treatment (all grades).
Croatian: Simeprevir u kombinaciji sa sofosbuvirom: Osip i pruritus prijavljeni su u 8,0% odnosno 8,4% bolesnika koji su liječeni tijekom 12 tjedana, u usporedbi s 12,9% odnosno 3,2% bolesnika koji su liječeni 24 tjedna (svi stupnjevi).
English: The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in
Croatian: Stope odgovora za bolesnike s ili bez ciroze koji su primali 12 tjedana simeprevir + sofosbuvir
English: Refer to the Summary of Product Characteristics for these co-administered medicinal products regarding their potential effect on the ability to drive and use
Croatian: Molimo pogledajte sažetak opisa svojstava lijeka za istodobno primijenjene lijekove vezano uz njihov potencijalni učinak na sposobnost upravljanja vozilima i rada sa strojevima.
English: Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity
Croatian: U bolesnika liječenih simeprevirom većina slučajeva pojave osipa i pruritusa bilo je blage ili umjerene
English: 24 weeks simeprevir + sofosbuvir
Croatian: simeprevir + sofosbuvir
English: The safety profile of simeprevir in combination with peginterferon alfa and ribavirin is comparable between HCV genotype 1 infected patients with and without HIV-1 co-infection.
Croatian: Sigurnosni profil simeprevira u kombinaciji s peginterferonom alfa i ribavirinom usporediv je između bolesnika inficiranih HCV genotipom 1 sa ili bez koinfekcije HIVom-1.
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15
Croatian: Johnson & Johnson România SRL Str.
English: In study HPC2002, increased bilirubin was reported in 0% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 9.3% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Croatian: U ispitivanju HPC2002, povišen bilirubin bio je prijavljen u 0% bolesnika koji su 12 tjedana primali simeprevir i sofosbuvir bez ribavirina naspram 9,3% bolesnika koji su 12 tjedana primali simeprevir i sofosbuvir s ribavirinom.
English: HCV genotype 1 subtype-specific patterns of simeprevir treatment-emergent amino acid substitutions were observed in patients not achieving SVR.
Croatian: Obrasci supstitucija aminokiselina, specifični za podtip HCV genotipa 1, koji su proizašli iz liječenja simeprevirom bili su uočeni u bolesnika koji nisu postigli SVR.
English: Table 7: Treatment-emergent laboratory abnormalities observed at a higher incidence in patients receiving simeprevir in combination with peginterferon alfa and ribavirin (pooled phase 3 studies C208, C216 and HPC3007; first 12 weeks of treatments)
Croatian: Tablica 7: Poremećaji laboratorijskih nalaza koji su nastali tijekom liječenja uočeni u većoj incidenciji kod bolesnika koji su primali simeprevir u kombinaciji s peginterferonom alfa i ribavirinom (objedinjena ispitivanja faze 3 C208, C216 i HPC3007; tijekom prvih 12 tjedana liječenja)