natgillin/translations-raw huggingface dataset:
Antifungals (systemic administration) Itraconazole 
Antimikotici (sistemska primjena) Itrakonazol
In study HPC3017, patients without cirrhosis were enrolled; in study HPC3018, patients with cirrhosis were enrolled (table 12). 
U ispitivanju HPC3017 bili su uključeni bolesnici bez ciroze; u ispitivanje HPC3018 bili su uključeni bolesnici s cirozom (tablica 12).
No effects on fertility were observed in animal studies (see section 5.3). 
Nisu uočeni učinci na plodnost u ispitivanjima na životinjama (vidjeti dio 5.3).
Treatment discontinuation in patients with inadequate on-treatment virologic response OLYSIO in combination with sofosbuvir 
Prekid liječenja u bolesnika s neadekvatnim virološkim odgovorom OLYSIO u kombinaciji sa sofosbuvirom
Pregnancy, contraception and breast-feeding 
Trudnoća, kontracepcija i dojenje Trudnoća
ANTIHISTAMINES Astemizole Terfenadine 
ANTIHISTAMINICI Astemizol
12, 24 or 48 weeks SMV in combination with 48 weeks peg-IFN-alfa + RBV; control group: 48 weeks placebo + peg-IFN-alfa + RBV 
12, 24 ili 48 tjedana SMV u kombinaciji s 48 tjedana peg-IFN-alfa + RBV; kontrolna skupina: 48 tjedana placebo + peg-IFN-alfa + RBV
What OLYSIO is used for OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults. 
Za što se OLYSIO koristi - OLYSIO se koristi s drugim lijekovima za liječenje kronične (dugotrajne) infekcije hepatitisom C u odraslih.
HPC3007 (PROMISE; Phase 3) 
HPC3007 (PROMISE; Faza 3)
Antiretroviral - protease inhibitors (PIs) Darunavir/ritonavir3 
Antiretrovirusni - inhibitori proteaze (PI-jevi) Darunavir/ritonavir3
HERBAL PRODUCTS Milk thistle (Silybum marianum) 
BILJNI PRIPRAVCI sikavica (Silybum marianum)
R(-) methadone AUC 0.99 (0.91-1.09) ↔ R(-) methadone Cmax 1.03 (0.97-1.09) ↔ R(-) methadone Cmin 1.02 (0.93-1.12) ↔ 
R(-) metadon AUC 0,99 (0,91-1,09) ↔ R(-)metadon Cmax 1,03 (0,97-1,09) ↔ R(-)metadon Cmin 1,02 (0,93-1,12) ↔
Patients with cirrhosis1 
Bolesnici s cirozom1
Tell your doctor if any of the following applies: - you currently take, or have taken in the last few months, the medicine amiodarone (your doctor may consider alternative treatments if you have taken this medicine) - you take other medicines to treat irregular heart beat or high blood pressure. 
trenutno uzimate, ili ste u zadnjih nekoliko mjeseci uzimali, lijek amiodaron (Vaš liječnik može razmotriti alternativno liječenje ukoliko ste uzimali ovaj lijek)
1 Open-label, randomised, except for studies HPC3018 and HPC3021 which were single arm, and study HPC2014 which was partly randomised. 
1 Otvorena, randomizirana, osim za ispitivanja HPC3018 i HPC3021 koja su bila s jednom skupinom bolesnika, i ispitivanje HPC2014 koje je bilo djelomično randomizirano.
Posology The recommended dosage of OLYSIO is one capsule of 150 mg once daily, taken with food. 
Preporučeno doziranje lijeka OLYSIO je jedna kapsula od 150 mg jedanput na dan, uzeta s hranom.
R155Q3, D168A, D168F3, D168H, D168T, I170T5 
D168A, D168F D168H, D168T, I170T5
Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design 
Tablica 11: Ispitivanja provedena sa simeprevirom + sofosbuvirom: populacija i sažetak dizajna ispitivanja
Genotype 1a1 N = 116 % (n) 
Genotip 1a1 N = 116 % (n)
Genotype 1, treatment-experienced4 
Genotip 1, prethodno liječeni4
4 simeprevir-treated patients who experienced relapse after SVR12. 
Uključuje 4 bolesnika liječena simeprevirom koji su doživjeli relaps nakon SVR12.
METAVIR fibrosis score 
METAVIR skor za fibrozu
In case of severe rash, OLYSIO and other co-administered medicinal products for the treatment of CHC should be discontinued and the patients should be monitored until the symptoms have resolved. 
U slučaju teškog osipa, OLYSIO i druge istovremeno primijenjene lijekove za liječenje kroničnog hepatitisa C treba prestati uzimati i bolesnike treba pratiti dok se simptomi ne povuku.
Dexlansoprazole Esomeprazole Lansoprazole Pantoprazole Rabeprazole 
Dekslanzoprazol Esomeprazol Lanzoprazol Pantoprazol Rabeprazol
The contraindications and warnings regarding pregnancy and contraception requirements applicable to the co-administered medicinal products also apply to their use in OLYSIO combination treatment. 
Kontraindikacije i upozorenja vezana uz trudnoću i zahtjevi za kontracepciju primjenjivi na istodobno primijenjene lijekove također su primjenjivi na njihovu primjenu u kombiniranom liječenju s lijekom OLYSIO.
2 Comparison based on historic controls. 
2 Usporedba temeljena na povijesnoj kontroli.
- you have ever taken any medicines to treat hepatitis C; - you have any other liver problems in addition to hepatitis C; - you have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely; - you have had or are going to have an organ transplant. 
- imate ili ste prethodno imali infekciju virusom hepatitisa B, jer će Vas liječnik možda htjeti pobliže pratiti; - ste bili podvrgnuti ili idete na transplantaciju (presađivanje) organa.
The efficacy of simeprevir (150 mg once daily) as part of an interferon-free regimen (sofosbuvir, 400 mg once daily) was evaluated in patients with HCV genotype 1 or 4 infection, who were treatment-naïve or treatment-experienced patients (following prior interferon-based therapy) (table 11). 
Djelotvornost simeprevira (150 mg jedanput dnevno) kao dio režima bez interferona (sofosbuvir, 400 mg jedanput dnevno) bio je procijenjen u bolesnika inficiranih HCV genotipom 1 ili 4, koji prethodno nisu bili liječeni i prethodno liječenih bolesnika (nakon prethodne terapije temeljene na interferonu) (tablica 11).
You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for information about side effects). 
Tijekom uzimanja lijeka OLYSIO možete biti više osjetljivi na sunce (fotoosjetljivost) (za informacije o nuspojavama pogledajte dio 4).
In vitro combination of simeprevir with interferon, ribavirin, NS5A or NS5B inhibitors resulted in additive or synergistic effects. 
ribavirinom, NS5A ili NS5B inhibitorima rezultirala je aditivnim ili sinergističkim učincima.
Co-administration of OLYSIO with ciclosporin is not recommended as this leads to significantly higher exposure of simeprevir based on interim data from an ongoing phase 2 study in HCV infected post-liver transplant patients (see section 4.5). 
Bolesnici s presađenim organima Istodobna primjena lijeka OLYSIO s ciklosporinom ne preporučuje se jer dovodi do značajno višoj izloženosti simepreviru, temeljeno na privremenim podacima iz ispitivanja faze 2 koje traje, u bolesnika nakon transplantacije jetre koji su inficirani HCV-om (vidjeti dio 4.5).
HCV genotype 4a - 4d 
HCV genotip 1b HCV genotip 4a - 4d
Photosensitivity reactions 
Reakcije fotoosjetljivosti
Disopyramide Flecainide Mexiletine Propafenone Quinidine 
Dizopiramid Flekainid Meksiletin Propafenon Kinidin
All patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir achieved SVR12 (table 16). 
Svi bolesnici s ili bez ciroze koji su primali 12 tjedana simeprevir + sofosbuvir postigli su SVR12 (tablica 16).
Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2). 
U bolesnika liječenih simeprevirom većina slučajeva pojave osipa i pruritusa bilo je blage ili umjerene težine (stupanj 1 ili 2).
HPC3021 (PLUTO; Phase 3) 
HPC3021 (PLUTO; faza 3)
In patients aged > 45 years, dyspnoea was reported in 16.4% of simeprevir-treated patients compared to 9.1% in placebo-treated patients (all grades; pooled phase 3). 
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).
Lipase Grade 1 
Lipaza 1. stupanj
If a dose of OLYSIO is missed by more than 12 hours after the usual dosing time, the patient should not take the missed dose of OLYSIO and should resume dosing of OLYSIO with food at the regularly scheduled time. 
Ako se propusti doza lijeka OLYSIO više od 12 sati od uobičajenog vremena doziranja, bolesnik ne smije uzeti propuštenu dozu lijeka OLYSIO, a s doziranjem lijeka OLYSIO mora nastaviti s hranom,
The following side effects may happen with OLYSIO when used in combination with peginterferon alfa and ribavirin: 
Sljedeće nuspojave mogu se javiti uz OLYSIO kada se uzima u kombinaciji s peginterferonom alfa i ribavirinom:
photosensitivity reaction* 
reakcije fotoosjetljivosti*
Paediatric population The pharmacokinetics of simeprevir in children aged below 18 years have not been investigated. 
Farmakokinetika simeprevira u djece starosti ispod 18 godina nije bila ispitana.
treatment was 24 weeks if the following on-treatment protocol-defined response-guided therapy criteria were met: HCV RNA < 25 IU/ml detectable or undetectable at week 4 AND undetectable HCV RNA at week 12. 
HCV liječenja bilo je 24 tjedna ako su tijekom liječenja zadovoljeni sljedeći odgovorom vođeni kriteriji terapije koji su definirani protokolom: HCV RNA < 25 IU/ml detektabilna ili nedetektabilna u 4. tjednu
Table 18: Studies conducted with simeprevir + peginterferon alfa + ribavirin: demographics and baseline characteristics Pooled C208 and C216 N = 785 
Table 18: Ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: demografske i početne karakteristike Objedinjena C208 i C216 N = 785
If adverse reactions, potentially related to the medicinal products that are used in combination with OLYSIO for the treatment of CHC, require dosage adjustment or interruption of the medicinal product(s), refer to the instructions outlined in the respective Summary of Product Characteristics for these medicinal products. 
Ukoliko je zbog nuspojava, koje su potencijalno povezane s lijekovima koji se uzimaju u kombinaciji s lijekom OLYSIO za liječenje kroničnog hepatitisa C, potrebno prilagoditi doziranje ili prekinuti uzimanje lijeka/lijekova, pogledajte upute navedene u u pripadajućem sažetku opisa svojstava za pojedini lijek.
Effect on drug levels Least Squares Mean Ratio (90%CI) 
Omjer srednjih vrijednosti dobivenih metodom najmanjeg kvadrata (90%CI)
Tell your doctor immediately if you are taking OLYSIO with sofosbuvir and any medicines for heart problems, and during treatment you experience: - shortness of breath - light-headedness - palpitations - fainting. 
- Odmah recite svom liječniku ukoliko uzimate lijek OLYSIO sa sofosbuvirom i bilo kojim lijekom za probleme sa srcem, te ukoliko tijekom liječenja osjetite:
Co-administration of OLYSIO with substances that moderately or strongly induce or inhibit cytochrome P450 3A (CYP3A4) is not recommended as this may lead to significantly lower or higher exposure of simeprevir, respectively. 
Interakcije s lijekovima Istovremena primjena lijeka OLYSIO s tvarima koje umjereno ili jako induciraju ili inhibiraju citokrom P450 3A (CYP3A4) se ne preporučuje jer može dovesti do značajno niže odnosno više izloženosti simepreviru.
These HCV protease inhibitors are anticipated to be cross-resistant, and co-administration is not recommended (see also section 4.5). 
HCV-a očekuje se da će biti križno rezistentni, te se istovremena primjena ne preporučuje (također vidjeti dio 4.5).
One patient (3.2%) receiving 24 weeks of treatment experienced a grade 4 ‘blood bilirubin increased' event. 
(3,2%) koji je liječen tijekom 24 tjedna imao je događaj ‘povišen bilirubin u krvi' 4. stupnja.
Compared to intake without food, administration of simeprevir with food to healthy subjects increased the AUC by 61% after a high-fat, high-caloric (928 kcal) and 69% after a normal caloric (533 kcal) breakfast, and delayed the absorption by 1 hour and 1.5 hours, respectively. 
AUC za 61% nakon doručka s visokim udjelom masti i kalorija (928 kcal) i za 69% nakon doručka s normalom količinom kalorija (533 kcal), te je odgodila apsorpciju za 1 sat odnosno za 1,5 sati.
Concentrations of ledipasvir and simeprevir are increased when simeprevir is co-administered with ledipasvir. 
Koncentracije ledipasvira i simeprevira su povišene kada se simeprevir primjenjuje istovremeno s ledipasvirom.
or amiodarone to treat irregular heart beat - clarithromycin, erythromycin (when taken by mouth or given by injection) or telithromycin to treat bacterial infections - warfarin and other similar medicines called vitamin K antagonists used to thin the blood. 
- klaritromicin, eritromicin (kada se uzima kroz usta ili primjenjuje injekcijom) ili telitromicin za liječenje bakterijskih infekcija - varfarin i drugi slični lijekovi pod nazivom antagonisti vitamina
The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure. 
Ustrajnost supstitucija povezanih s rezistencijom Ustrajnost supstitucija aminokiselina NS3 proteaze koje uzrokuju rezistenciju na simeprevir bila je procijenjena nakon neuspjeha liječenja.
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 after end of treatment. 
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.
Increased simeprevir concentrations may occur due to mild inhibition of CYP3A4 by amlodipine and moderate inhibition of CYP3A4 by diltiazem and verapamil. 
Mogu se javiti povišene koncentracije simeprevira radi blage inhibicije CYP3A4 amlodipinom i umjerene inhibicije CYP3A4 diltiazemom i verapamilom.
Compared to healthy subjects with normal hepatic function, the mean steady-state AUC of simeprevir was 2.4-fold higher in non-HCV infected subjects with moderate hepatic impairment (Child-Pugh class B) and 5.2-fold higher in non-HCV infected subjects with severe hepatic impairment (Child-Pugh class C). 
U usporedbi sa zdravim ispitanicima s normalnom funkcijom jetre, srednja vrijednost AUC-a simeprevira u stanju dinamičke ravnoteže bila je 2,4-puta viša u bolesnika koji nisu inficirani HCVom s umjerenim oštećenjem jetre (Child-Pugh stadij B) i 5,2-puta viša u bolesnika koji nisu inficirani
4 Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin. 
4 Doziranje ribavirina dvaput dnevno na temelju tjelesne težine, prema sažetku opisa svojstava lijeka za ribavirin.
OLYSIO at the usual scheduled time. 
prema uobičajenom rasporedu.
In 2% and 0.3% of the simeprevir-treated patients grade 3 or 4 ‘blood bilirubin increased' was reported, respectively (pooled phase 3 studies). 
0,3% bolesnika liječenih simeprevirom bio je prijavljen ‘povišen bilirubin u krvi' stupnja 3 ili 4 (objedinjena ispitivanja faze 3).
MARKETING AUTHORISATION NUMBER(S) EU/1/14/924/001 (7 capsules) 
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/924/001 (7 kapsula)
How to take OLYSIO 
Kako uzimati OLYSIO
Proton pump inhibitors Omeprazole 
Inhibitori protonske pumpe Omeprazol
Posaconazole 
Posakonazol
ANTICONVULSANTS Carbamazepine Oxcarbazepine Phenobarbital Phenytoin 
Karbamazepin Okskarbazepin Fenobarbital Fenitoin
> 5.0 x ULN 
> 5,0 x GGN
Gastrointestinal disorders: very common nausea common constipation constipation constipation 
Poremećaji probavnog sustava: vrlo često mučnina često konstipacija konstipacija konstipacija
Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design 
Tablica 17: Ispitivanja provedena sa simeprevirom + peginterferonom alfa + ribavirinom: populacija i sažetak dizajna ispitivanja
Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects. 
Izloženost simepreviru u plazmi HCV-om inficiranih bolesnika bila je oko 2- do 3-puta viša u usporedbi s onom uočenom u zdravih ispitanika.
common rash*, pruritus*, photosensitivity reaction* 
često osip*, pruritus*, reakcije fotoosjetljivosti*
HPC3018 (OPTIMIST-2; Phase 3) 
HPC3018 (OPTIMIST-2; faza 3)
Refer also to the Summary of Product Characteristics of the medicinal products that are used in combination with OLYSIO. 
Također pogledajte sažetak opisa svojstava lijeka za lijekove koji se koriste u kombinaciji s lijekom OLYSIO.
Study1 
Ispitivanje1
Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin1 
Tablica 5: Nuspojave identificirane kod primjene simeprevira u kombinaciji sa sofosbuvirom ili simeprevira u kombinaciji s peginterferonom alfa i ribavirinom1
Read the package leaflets for the other medicines used for treating your hepatitis C infection for side effects reported with these medicines. 
U uputama o lijeku za druge lijekove koje koristite za liječenje infekcije hepatitisom C pročitajte o nuspojavama prijavljenim s tim lijekovima.
10 mg rosuvastatin AUC 2.81 (2.34-3.37) ↑ rosuvastatin Cmax 3.17 (2.57-3.91) ↑ rosuvastatin Cmin not studied 
10 mg rosuvastatin AUC 2,81 (2,34-3,37) ↑ rosuvastatin Cmax 3,17 (2,57-3,91) ↑ rosuvastatin Cmin nije ispitano
No dose adjustment of OLYSIO is required in patients with mild hepatic impairment (Child-Pugh class A). 
Prilagodba doze za lijek OLYSIO u bolesnika s blagim oštećenjem jetre (Child-Pugh stadij A) nije potrebna.
HPC3017 (OPTIMIST-1; Phase 3) 
HPC3017 (OPTIMIST-1; faza 3)
without cirrhosis, who are co-infected with HIV 
bez ciroze, koji su koinficirani HIV-om s cirozom, koji su koinficirani HIV-om
OLYSIO has no or negligible influence on the ability to drive and use machines. 
4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima OLYSIO ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype 
Tablica 9: Antivirusna aktivnost simeprevira od 200 mg u monoterapiji (ispitivanja C201 i C202)
Dosage adjustment or interruption of medicinal products used in combination with OLYSIO for the treatment of CHC 
Prilagodbe doziranja ili prekid uzimanja lijekova koji se uzimaju u kombinaciji s lijekom OLYSIO za liječenje kroničnog hepatitisa C
The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 14% (70/509); 67% achieved SVR12. 
Udio bolesnika liječenih simeprevirom s HCV RNK < 25 IU/ml koja je bila detektabilna u 4. tjednu bio je 14% (70/509); 67% postiglo je SVR12.
There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions. 
4. stupnja i niti jedan bolesnik nije prekinuo liječenje zbog reakcija fotoosjetljivosti.
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 duration of 48 weeks). 
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).
Antiretroviral - nucleoside or nucleotide reverse transcriptase inhibitors (N(t)RTIs) Tenofovir disoproxil fumarate 
Antiretrovirusni - nukleozidni ili nukleotidni inhibitori reverzne transkriptaze (N(t)RTI-jevi)
Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients. 
Privremeni podaci iz ispitivanja faze 2 u 11 bolesnika nakon transplantacije jetre inficiranih HCV-om.
Seventy-one percent (37/52), 93% (14/15), 80% (8/10) and 36% (10/28) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4. 
Sedamdeset i jedan posto (37/52), 93% (14/15), 80% (8/10) i 36% (10/28) bolesnika liječenih simeprevirom koji prethodno nisu bili liječeni, prethodno su doživjeli relaps,
(OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin) 
(OATP1B1/3, P-gp i CYP3A inhibicija ciklosporinom)
In 32 out of 48 patients (67%) with emerging single D168V and in 34 out of 66 (52%) patients with emerging single R155K, the respective emerging variants were no longer detected at end of the studies. 
U 32 od 48 bolesnika (67%) s nastalom samom D168V supstitucijom i u 34 od 66 (52%) bolesnika s nastalom samom R155K
QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains simeprevir sodium equivalent to 150 mg of simeprevir. 
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna tvrda kapsula sadrži simeprevirnatrij što odgovara 150 mg simeprevira.
S-warfarin AUC 1.04 (1.00-1.07) ↔ S-warfarin Cmax 1.00 (0.94-1.06) ↔ S-warfarin Cmin not studied 
S-varfarin AUC 1,04 (1,00-1,07) ↔ S-varfarin Cmax 1,00 (0,94-1,06) ↔ S-varfarin Cmin nije ispitano
In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin. 
U pasa, simeprevir je bio povezan s reverzibilnom multifokalnom hepatocelularnom nekrozom s povezanim povišenjima ALT, AST,
Compared to healthy subjects with normal renal function (classified using the Modification of Diet in Renal Disease [MDRD] eGFR formula; eGFR ≥ 80 ml/min), the mean steady-state AUC of simeprevir was 1.62-fold higher (90% confidence interval: 0.73-3.6) in subjects with severe renal impairment (eGFR below 30 ml/min). 
Modification of Diet in Renal Disease [MDRD]); eGFR ≥ 80 ml/min), srednja vrijednost AUC-a u stanju dinamičke ravnoteže simeprevira bila je za 1,62 puta viša (interval pouzdanosti 90%: 0,73-3,6) u ispitanika s teškim oštećenjem bubrega
The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir + sofosbuvir are shown in table 15. 
Stope odgovora za bolesnike s cirozom (METAVIR skor F4) koji su primali 12 ili 24 tjedna simeprevir + sofosbuvir su prikazani u tablici 15.
Treatment week 24: ≥ 25 IU/ml1 
24. tjedan liječenja: ≥ 25 IU/ml1
Elevations in direct and indirect bilirubin have been reported in patients treated with simeprevir and were mostly of mild or moderate severity. 
Povišen bilirubin u krvi U bolesnika liječenih simeprevirom prijavljena su povišenja direktnog i indirektnog bilirubina i bila su većinom blage ili umjerene težine.
SVR12 without cirrhosis with cirrhosis 
SVR12 bez ciroze s cirozom
Interim data from a phase 2 study in 9 HCV infected post-liver transplant patients. 
Privremeni podaci iz ispitivanja faze 2 u 9 bolesnika nakon transplantacije jetre inficiranih HCV-om.
Intravenous: midazolam AUC 1.10 (0.95-1.26) ↑ midazolam Cmax 0.78 (0.52-1.17) ↓ midazolam Cmin not studied 
Intravenski: midazolam AUC 1,10 (0,95-1,26) ↑ midazolam Cmax 0,78 (0,52-1,17) ↓ midazolam Cmin nije ispitano
Treatment week 12: ≥ 25 IU/ml1 
12. tjedan liječenja: ≥ 25 IU/ml1
40 mg omeprazole AUC 1.21 (1.00-1.46) ↑ omeprazole Cmax 1.14 (0.93-1.39) ↑ omeprazole Cmin not studied 
40 mg omeprazol AUC 1,21 (1,00-1,46) ↑ omeprazol Cmax 1,14 (0,93-1,39) ↑ omeprazol Cmin nije ispitano
Patients without cirrhosis N = 155 % (n/N) 
Bolesnici bez ciroze N = 155 % (n/N)
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 given in table 7. 
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 prikazani su u tablici 7.
Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781 
Učestalost simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781