natgillin/translations-raw huggingface dataset:
Elderly (over 65 years of age) 
Starije osobe (u dobi iznad 65 godina)
In addition, tell your doctor if you take any medicines used to treat irregular heart beat or high blood pressure. 
Dodatno, obavijestite svog liječnika ako uzimate bilo koji lijek za liječenje nepravilnih otkucaja srca ili visokog krvnog tlaka.
4 Patient individualised dose at the discretion of the physician, according to local clinical practice. 
4 Doza određena individualno za bolesnika kako je odredio liječnik, prema lokalnoj kliničkoj praksi.
What OLYSIO is and what it is used for What you need to know before you take OLYSIO How to take OLYSIO 
Što je OLYSIO i za što se koristi Što morate znati prije nego počnete uzimati OLYSIO
C208 - C216 (QUEST-1 and QUEST-2; 
C208 - C216 (QUEST-1 i QUEST-2; Faza 3)
Patients who are identified as being at high risk of bradyarrhythmia should be continuously monitored for 48 hours in an appropriate clinical setting. 
Bolesnici u kojih je prepoznat visok rizik za bradiaritmije trebaju biti kontinuirano praćeni tijekom 48 sati u prikladnom kliničkom okruženju.
These blood tests help your doctor to - check if the treatment is working for you - check your liver function. 
Krvne pretrage pomažu Vašem liječniku - provjeriti je li liječenje za Vas učinkovito
The adverse reactions are listed by system organ class (SOC) and frequency: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000). 
Nuspojave su navedene prema klasifikaciji organskih sustava (SOC) i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko
5 Two patients had emerging single substitution I170T. 
Dva bolesnika imala su nastalu pojedinačnu supstituciju I170T.
- If you are a woman, you must not become pregnant during treatment and for several months afterwards. 
- Ako ste žena, ne smijete zatrudniti tijekom liječenja i nekoliko mjeseci nakon toga.
If the capsule shell is indented or bent - without being broken or opened - the capsule can still be used. 
Ako je ovojnica kapsule udubljena ili savijena - bez da se razlomila ili otvorila- kapsula se još može uzeti.
Simeprevir was not irritating to rabbit skin, and is not likely to cause skin sensitisation. 
Simeprevir nije bio iritans za kožu zeca i nije vjerojatno da će uzrokovati preosjetljivost kože.
In Europe, the prevalence was lower, 19% (73/377) in patients with HCV genotype 1a and 0.3% (3/877) in genotype 1b. 
U Europi, prevalencija je bila niža, 19% (73/377) u bolesnika s HCV genotipom 1a i 0,3% (3/877) u genotipu 1b.
The type of food does not affect exposure to simeprevir. 
Vrsta hrane ne utječe na izloženost simepreviru.
Carcinogenicity studies with simeprevir have not been conducted. 
Ispitivanja kancerogenosti sa simeprevirom nisu bila provedena.
Environmental Risk Assessment (ERA) Simeprevir is classified as a PBT (persistent, bioaccumulative and toxic) substance (see section 6.6). 
Procjena rizika za okoliš (ERA) Simeprevir je klasificiran kao PBT (postojana, bioakumulativna i toksična) tvar (vidjeti dio 6.6).
1 This interaction study has been performed with a dose higher than the recommended dose for simeprevir assessing the maximal effect on the co-administered drug. 
1 Ovo ispitivanje interakcije bilo je provedeno s dozom koja je viša od preporučene doze za simeprevir procjenjujući maksimalni učinak na istovremeno primijenjeni lijek.
122, 155 and/or 168. 
155 i/ili 168.
Table 4: Interactions and dose recommendation with other medicinal products Medicinal products by therapeutic areas 
Tablica 4: Interakcije i preporuke za doziranje s drugim lijekovima Lijekovi prema terapijskim skupinama
Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, the majority of the radioactivity in plasma (up to 98%) was accounted for by unchanged drug and a small part of the radioactivity in plasma was related to metabolites (none being major metabolites). 
Nakon jedne peroralne primjene 200 mg 14C-simeprevira zdravim ispitanicima, većina radioaktivnosti u plazmi (do 98%) brojala se kao nepromijenjen lijek, a mali dio radioaktivnosti u plazmi bio je povezan s metabolitima (nijedan nije bio metabolit u većini).
Resistance in cell culture 
Rezistencija u kulturi stanica
3 Substitutions only observed in combinations with other emerging substitutions at one or more of the NS3 positions 80, 
Supstitucije uočene samo u kombinacijama s drugim nastalim supstitucijama na jednom ili više NS3 položaja 80, 122,
SEDATIVES/ANXIOLYTICS Midazolam 
SEDATIVI/ANKSIOLITICI Midazolam
C206 (ASPIRE; Phase 2) 
C206 (ASPIRE; Faza 2)
- Swallow the capsule whole. 
- Kapsulu progutajte cijelu.
Simeprevir is extensively bound to plasma proteins (> 99.9%), primarily to albumin and, to a lesser extent, alfa-1-acid glycoprotein. 
Distribucija Simeprevir se opsežno veže na proteine plazme (> 99,9%), primarno na albumin te u manjoj mjeri na alfa-1-kiseli glikoprotein.
- If you are a man, your female partner must not become pregnant during your treatment and for several months afterwards. 
- Ako ste muškarac, Vaša partnerica ne smije zatrudniti tijekom Vašeg liječenja i nekoliko mjeseci nakon toga.
Study HPC3007 
Ispitivanje HPC3007
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
This is due to potential liver function changes during treatment with OLYSIO. 
zbog mogućih promjena u funkciji jetre tijekom liječenja lijekom OLYSIO.
Antiviral activity in vivo 
Antivirusna aktivnost in vivo
HIV PRODUCTS Antiretroviral - CCR5 antagonist Maraviroc 
Antiretrovirusni - CCR5 antagonisti Maravirok
1 HCV/HIV-1 co-infected patients. 
1 HCV/HIV-1 koinficirani bolesnici.
Co-administration is not recommended. 
Istovremena primjena se ne preporučuje.
This is particularly significant if these are accompanied by either of the following symptoms: - feel sick (nauseous), are sick (vomit) or lose your appetite - confusion. 
Navedeno je od posebnog značaja ako je praćeno bilo kojim od sljedećih simptoma: - ako osjećate mučninu, povraćanje ili gubitak apetita
Study HPC3007: includes 5 simeprevir-treated patients who experienced relapse after SVR12. 
Ispitivanje HPC3007: uključuje 5 bolesnika liječenih simeprevirom koji su doživjeli relaps nakon SVR12.
Simeprevir does not inhibit OCT2 in vitro. 
Simeprevir ne inhibira OCT2 in vitro.
2 Out of the 3 patients with on-treatment failure, 2 patients experienced viral breakthrough and one patient discontinued treatment early due to an adverse event. 
2 Od 3 bolesnika s neuspjehom tijekom liječenja, 2 bolesnika su doživjela virološki proboj i jedan bolesnik je ranije prekinuo liječenje zbog štetnog događaja.
Hyperbilirubinemia Grade 1 
Hiperbilirubinemija Stupanj 1
SVR12 rates for selected subgroups METAVIR fibrosis score F0-2 
Stope SVR12 za odabrane podskupine METAVIR skor za fibrozu F0-2
X represents multiple amino acids. 
predstavlja višestruke aminokiseline.
The days of the week are printed on the blister strip. 
Dani u tjednu otisnuti su na blisteru.
How to take - The recommended dose of OLYSIO is one capsule (150 milligrams) once a day. 
Kako uzimati lijek - Preporučena doza lijeka OLYSIO je jedna kapsula (150 miligrama) jedanput na dan.
In these patients the SVR12 rates were 96%, 94%, 100% and 68%, respectively. 
Kod tih bolesnika stope SVR12 bile su 96%, 94%, 100% odnosno 68%.
Simeprevir is highly protein bound, therefore dialysis is unlikely to result in significant removal of simeprevir (see section 5.2). 
Simeprevir se u visokoj mjeri veže na proteine, stoga nije vjerojatno da će dijaliza dovesti do značajnog uklanjanja simeprevira (vidjeti dio 5.2).
Black printing ink Shellac (E904) Iron oxide black (E172) 
Crna tinta za označivanje šelak (E904) željezov oksid, crni (E172)
All patients receiving OLYSIO combination treatment with sofosbuvir in combination with amiodarone with or without other drugs that lower heart rate should also be warned of the symptoms of bradycardia and heart block and should be advised to seek medical advice urgently should they experience them. 
Svi bolesnici koji primaju kombinirano liječenje lijekom OLYSIO sa sofosbuvirom u kombinaciji s amiodaronom s ili bez drugih lijekova koji snižavaju frekvenciju srca trebaju također biti upozoreni na simptome bradikardije i srčanog zastoja, te im se treba savjetovati da hitno potraže medicinski savjet ukoliko ih osjete.
Cases are potentially life threatening, therefore amiodarone should only be used in patients on OLYSIO combination treatment with sofosbuvir when other alternative antiarrhythmic treatments are not tolerated or are contraindicated. 
Slučajevi su potencijalno opasni po život, stoga se amiodaron treba primijeniti u bolesnika koji se liječe kombinacijom lijekova OLYSIO sa sofosbuvirom, samo kada se druga, alternativna liječenja antiaritmicima ne podnose ili su kontraindicirana.
Established and theoretical interactions between simeprevir and selected medicinal products are listed in table 4 (least square mean ratios with 90% confidence intervals (90% CI) are presented, increase is indicated as “↑”, decrease as “↓”, no change as “↔”). 
Ustanovljene i teoretske interakcije između simeprevira i odabranih lijekova navedene su u tablici 4 (prikazani su omjeri srednjih vrijednosti dobivenih metodom najmanjih kvadrata s intervalom pouzdanosti od 90% (90% CI), povišenje je navedeno kao “↑”, sniženje kao “↓”, “nije bilo promjene”
1 WHO worst toxicity grades 1 to 4. 
1 Najteža toksičnost 1. do 4. stupnja prema SZO-u.
While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists. 
Iako se ne očekuje promjena farmakokinetike varfarina, preporučuje se pomno praćenje međunarodnog normaliziranog omjera (INR) sa svim antagonistima vitamina
Genotype 1b 
Genotip 1b
As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis. 
Budući da se simeprevir u visokoj mjeri veže na proteine plazme, nije vjerojatno da će se značajno uklanjati dijalizom.
CALCIUM CHANNEL BLOCKERS (oral administration) Amlodipine 
BLOKATORI KALCIJEVIH KANALA (peroralna primjena) Amlodipin
Hepatitis B virus (HBV) co-infection 
Koinfekcija virusom hepatitisa B (HBV)
Clarithromycin Telithromycin 
Klaritromicin Telitromicin
Talk to your doctor or pharmacist about all your medical conditions before taking OLYSIO in particular if: - you have hepatitis C that is not ‘genotype 1' or ‘genotype 4'; 
Razgovarajte s liječnikom ili ljekarnikom o Vašem cjelokupnom medicinskom stanju prije nego što uzmete OLYSIO, naročito ako: - imate hepatitis C koji nije “genotipa 1“ ili “genotipa 4“; - ste ste ikada uzimali bilo kakve lijekove za liječenje hepatitisa C; - dodatno uz hepatitis C imate bilo koji drugi problem s jetrom;
2 SVR: SVR12 for study HPC3007 and SVR24 for study C206. 
2 SVR: SVR12 za ispitivanje HPC3007 i SVR24 za ispitivanje C206.
Genotype 1 (N = 9) Genotype 2 (N = 6) Genotype 3 (N = 8) Genotype 4 (N = 8) Genotype 5 (N = 7) Genotype 6 (N = 8) 
Genotip 1 (N = 9) Genotip 2 (N = 6) Genotip 3 (N = 8) Genotip 4 (N = 8) Genotip 5 (N = 7) Genotip 6 (N = 8)
How to remove capsule Press either edge of the pocket to push the capsule through the foil, as shown. 
Kako biste istisnuli kapsulu kroz foliju, pritisnite jedan ili drugi rub džepića, kao što je prikazano.
St John's wort (Hypericum perforatum) 
gospina trava (Hypericum perforatum)
IL28B genotype 
IL28B genotip
Discontinuation of simeprevir due to ‘blood bilirubin increased' was rare (0.1%; n = 1). 
Prekidi uzimanja simeprevira radi ‘povišenog bilirubina u krvi' bili su rijetki (0,1%; n = 1).
Viral breakthrough rates were 24% (11/45), 20% (5/25) and 11% (4/36) in patients with genotype 4a, 4d and 4/other, respectively. 
Stope virološkog proboja bile su 24% (11/45), 20% (5/25) i 11% (4/36) u bolesnika s genotipom 4a,
1 The one patient with on-treatment failure discontinued treatment early due to an adverse event. 
1 Jedan bolesnik s neuspjehon tijekom liječenja prekinuo je liječenje ranije zbog štetnog događaja.
Other NNRTIs (Delavirdine, Etravirine, Nevirapine) 
Ostali NNRTI-jevi (delavirdin, etravirin, nevirapin)
None of the patients experienced grade 3 or 4 pruritus; none of the patients discontinued treatment due to pruritus. 
Niti jedan bolesnik nije doživio pruritus 3. ili 4 stupnja; niti jedan bolesnik nije prekinuo liječenje zbog pruritusa.
Antiretroviral - integrase inhibitor Raltegravir 
Antiretrovirusni - inhibitori integraze Raltegravir
If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the reaction has resolved. 
Ako se pojave reakcije fotoosjetljivosti, u obzir se mora uzeti prekid primjene lijeka OLYSIO, a bolesnike treba pratiti dok ne dođe do njihovog povlačenja.
- digoxin, disopyramide, flecainide, mexiletine, propafenone or quinidine (when taken by mouth) 
- digoksin, dizopiramid, flekainid, meksiletin, propafenon ili kinidin (kada se uzimaju kroz usta)
2 Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1). 
2 Nakon prethodnog liječenja s interferonom (pregiliranim ili nepegiliranim), sa ili bez ribavirina (vidjeti dio 5.1)
In healthy adult subjects receiving single doses up to 600 mg or once daily doses up to 400 mg for 5 days, and in HCV infected adult patients receiving 200 mg once daily for 4 weeks, adverse reactions were consistent with those observed in clinical studies at the recommended dose (see section 4.8). 
U zdravih odraslih ispitanika koji su primali jednu dozu do 600 mg ili doze do 400 mg jedanput na dan tijekom 5 dana, i u odraslih bolesnika inficiranih HCV-om koji su primali 200 mg jedanput na dan tijekom 4 tjedna, nuspojave su bile konzistentne s onima koje su uočene u kliničkim ispitivanjima pri preporučenoj dozi (vidjeti dio 4.8).
When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from your body. 
Kada se uzima zajedno s drugim lijekovima za liječenje kronične infekcije virusom hepatitisa C, OLYSIO pomaže odstranjenju HCV-a iz Vašeg tijela.
INFORMATION IN BRAILLE olysio 150 mg 
16. PODACI NA BRAILLEOVOM PISMU olysio 150 mg
No meaningful changes in QTc interval were observed with either the recommended dose of 150 mg once daily or the supratherapeutic dose of 350 mg once daily. 
Nisu uočene značajne promjene QTc intervala bilo s preporučenom dozom od 150 mg jedanput na dan ili u supraterapijskoj dozi od 350 mg jedanput na dan.
3 Overall treatment duration with peg-IFN-alfa and RBV was response-guided. 
3 Cjelokupno trajanje liječenja s peg-IFN-alfa i RBV bilo je vođeno odgovorom.
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Hispanic 
Dob (godine) medijan (raspon) % iznad 65 godina Muški spol Rasa bijela crna/Afroamerikanci Hispanci
Table 21: SVR12 rates for selected subgroups (study HPC3007) Subgroup simeprevir + peginterferon + ribavirin % (n/N) 
Tablica 21: Stope SVR12 za odabrane podskupine (ispitivanje HPC3007) Podskupina simeprevir + peginterferon + ribavirin % (n/N)
1 May include few patients with HCV non-genotype 1a/1b. 
1 Može uključivati nekoliko bolesnika s HCV-om koji nije genotipa 1a/1b.
Age (years) median (range) % above 65 yrs Male gender Race White Black/African American Asian Hispanic 
Dob (godine) medijan (raspon) % iznad 65 godina Muški spol Rasa bijela crna/Afroamerikanci azijati Hispanci
All HCV genotypes N = 197 % (n) 
Svi HCV genotipovi N = 197 % (n)
1 Re-evaluation of HCV RNA is recommended in case of HCV RNA ≥ 25 IU/ml after previous undetectable HCV RNA to confirm HCV RNA levels prior to discontinuing HCV treatment. 
1 Ponovna procjena HCV RNK preporučena je u slučaju HCV RNK ≥ 25 IU/ml nakon prethodno nedetektabilne HCV RNK kako bi se potvrdile razine HCV RNK prije prekida liječenja HCV-a.
HPC2014 (OSIRIS; Phase 2) 
HPC2014 (OSIRIS; faza 2)
NAME OF THE MARKETING AUTHORISATION HOLDER Janssen-Cilag International NV 
NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Janssen-Cilag International NV
No clinically relevant drug-drug interaction is expected. 
Ne očekuje se klinički značajna interakcija lijekova.
12 or 24 weeks SMV + sofosbuvir, with or without ribavirin4 
12 ili 24 tjedna SMV + sofosbuvir, s ili bez ribavirina4
ANTITUSSIVE Dextromethorphan (DXM) 
Dekstrometorfan (DXM)
This effect was observed at higher systemic exposures (11-fold) than those in humans at the recommended dose of 150 mg once daily. 
Ovaj učinak bio je uočen pri višim sistemskim izloženostima (11-puta) nego u onih kod ljudi pri preporučenoj dozi od 150 mg jedanput na dan.
HPC2002 (COSMOS; Phase 2) 
HPC2002 (COSMOS; faza 2)
5 Comparison based on historic controls. 
5 Usporedba temeljena na povijesnim kontrolama.
(inhibition of P-gp transporter) 
(inhibicija P-gp prijenosnika)
2 Relapsers after prior interferon-based therapy. 
2 Bolesnici s relaspom nakon prethodne terapije temeljene na interferonu.
2 The daily dose of ribavirin is weight based (< 75 kg = 1,000 mg and ≥ 75 kg = 1,200 mg) and administered orally in two divided doses with food; also refer to the Summary of Product Characteristics of ribavirin. 
2 Dnevna doza ribavirina temelji se na tjelesnoj težini (< 75 kg = 1,000 mg i ≥ 75 kg = 1,200 mg) i primjenjuje se peroralno u dvije podijeljene doze uz obrok; također vidjeti sažetak opisa svojstava lijeka za ribavirin.
* darunavir/ritonavir + 50 mg simeprevir compared to 150 mg simeprevir alone. 
* darunavir/ritonavir + 50 mg simeprevira u usporedbi s monoterapijom simeprevirom od 150 mg.
pruritus*, photosensitivity reaction* 
pruritus*, reakcije fotoosjetljivosti*
Other NRTIs (Abacavir, Didanosine, Emtricitabine, Lamivudine, Stavudine, Zidovudine) 
Ostali NRTI-jevi (abakavir, didanozin, emtricitabin, lamivudin, stavudin, zidovudin)
levels were reported in more than 1 in 10 people (very common). 
Vrlo često: mogu se javiti u više od 1 na 10 osoba:
When ribavirin is added to the combination of OLYSIO and sofosbuvir, and ribavirin needs to be discontinued, treatment of OLYSIO with sofosbuvir without ribavirin can be continued (see section 5.1). 
Kada je ribavirin dodan uz kombinaciju lijeka OLYSIO i sofosbuvira, te ribavirin treba prekinuti uzimati, liječenje lijekom OLYSIO i sofosbuvirom bez ribavirina može se nastaviti (vidjeti dio 5.1).
The median baseline CD4+ cell count in patients on highly active antiretroviral therapy (HAART) was 561 x 106 cells/ml (range: 275-1,407 x 106 cells/ml). 
Medijan početnog broja CD4+ stanica u bolesnika na visoko aktivnom antiretrovirusnom liječenju (HAART-u) bio je 561 x 106 stanica/ml (raspon: 275-1407 x 106 stanica/ml).
Note, substitutions at NS3 position 43 and 156 associated with reduced simeprevir activity in vitro were not observed at time of failure. 
Napomena, supstitucije na NS3 položajima 43 i 156 povezane sa smanjenom aktivnošću simeprevira in vitro nisu bile uočene u vrijeme neuspjeha liječenja.
Viral relapse2 
Virološki relaps2
7 The interaction between simeprevir and the medicinal product was evaluated in a pharmacokinetic study in opioid-dependent adults on stable methadone maintenance therapy. 
7 Interakcija između simeprevira i lijeka bila je procijenjena u farmakokinetičkom ispitivanju u odraslih ovisnih o opioidima koji su na stabilnoj metadonskoj terapiji održavanja.
Fluconazole Voriconazole 
Flukonazol Vorikonazol
Following a single oral administration of 200 mg 14C-simeprevir to healthy subjects, on average 91% of the total radioactivity was recovered in faeces. 
Nakon peroralne primjene jedne doze 200 mg 14C-simeprevira zdravim ispitanicima, prosječno je 91% od ukupne radioaktivnosti otkriveno u fecesu.
- Do not use this medicine after the expiry date which is stated on the carton and blister packaging after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blister pakiranju iza oznake Rok valjanosti odnosno EXP.
OLYSIO contains lactose 
OLYSIO sadrži laktozu
STIMULANTS Methylphenidate 
STIMULANSI Metilfenidat
6 Comparison based on historic controls. 
6 Usporedba temeljena na povijesnim kontrolama.
Any substitution at NS3 position 43, 80, 122, 155, 156, or 1682 
NS3 položajima 43, 80, 122, 155, 156 ili 1682
Plasma protein binding is not meaningfully altered in patients with renal or hepatic impairment. 
Vezanje na proteine plazme nije značajno promijenjeno u bolesnika s bubrežnim ili jetrenim oštećenjem.
1 p < 0.001 compared to historical control of peginterferon alfa and ribavirin. 
1 p < 0,001 u usporedbi s povijesnom kontrolom s peginterferonom alfa i ribavirinom.
- 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). 
- Drugi sastojci su natrijev laurilsulfat, magnezijev stearat, silicijev dioksid, koloidni bezvodni; karmelozanatrij, umrežena; laktoza hidrat, želatina, titanijev dioksid (E171), željezov oksid, crni (E172) i šelak (E904).
HCV/Human immunodeficiency virus type 1 (HIV-1) co-infection No dose adjustment of OLYSIO is required in HCV/HIV-1 co-infected patients (see sections 4.8, 5.1 and 5.2). 
Istodobna infekcija HCV-om/virusom humane imunodeficijencije tipa 1 (HIV-1) Nije potrebna prilagodba doze za lijek OLYSIO u bolesnika s koinfekcijom HCV-om i HIV-om-1 (vidjeti dijelove 4.8, 5.1 i 5.2).
HMG CO-A REDUCTASE INHIBITORS Rosuvastatin 
INHIBITORI HMG CO-A REDUKTAZE Rosuvastatin
Increased plasma concentrations of orally administered calcium channel blockers may be expeced. 
Mogu se očekivati povišene koncentracije peroralno primijenjenih blokatora kalcijevih kanala.
3 The dose of simeprevir in this interaction study was 50 mg when co-administered in combination with darunavir/ritonavir, compared to 150 mg in the simeprevir alone treatment group. 
3 Doza simeprevira u ovom ispitivanju interakcije bila je 50 mg kada se istovremeno primjenjivao u kombinaciji s darunavirom/ritonavirom, u usporedbi sa 150 mg u skupini koja je liječena samo simeprevirom.
The safety and efficacy of simeprevir have not been established in HCV infected patients with moderate or severe hepatic impairment (Child-Pugh class B or C). 
Sigurnost i djelotvornost simeprevira nisu bile ustanovljene u bolesnika inficiranih HCV-om s umjerenim ili teškim oštećenjem jetre (Child-Pugh stadij B ili C).
1 Double-blind, randomised, placebo-controlled, except for studies C212 and HPC3011 which were open-label, single arm. 
1 Dvostruko slijepo, randomizirano, placebom kontrolirano, osim za ispitivanja C212 i HPC3011 koja su bila otvorena ispitivanja u jednoj skupini bolesnika.
HPC3011 (RESTORE; Phase 3) 
HPC3011 (RESTORE; Faza 3)
Study HPC2014 N = 43 % (n/N) 
Ispitivanje HPC2014 N = 43 % (n/N)
1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin). 
1 Superiorna naspram povijesne kontrolne stope (povijesne SVR stope odobrene kombinacije liječenja antivirusnim lijekovima direktnog djelovanja s peginterferonom alfa i ribavirinom).
The long-term clinical impact of the emergence or persistence of simeprevir-resistance-associated substitutions is unknown. 
Nije poznat dugotrajni klinički utjecaj nastanka ili trajanja supstitucija povezanih s rezistencijom na simeprevir.
Other ritonavir-boosted or unboosted HIV PIs (Atazanavir, (Fos)amprenavir, Lopinavir, Indinavir, Nelfinavir, Saquinavir, Tipranavir) 
Ostali ritonavirom pojačani ili nepojačani inhibitori proteaze HIV-a (atazanavir, (fos)amprenavir, lopinavir, indinavir, nelfinavir, sakvinavir, tipranavir)