natgillin/translations-raw huggingface dataset:
In the event of an overdose with OLYSIO, it is recommended to employ the usual supportive measures and observe the patient's clinical status.
U slučaju predoziranja lijekom OLYSIO, preporučuje se provesti uobičajene suportivne mjere i promatrati bolesnikov klinički status.
Opaque polyvinylchloride/polyethylene/polyvinylidenechloride (PVC/PE/PVDC) aluminium push-through blister strips of 7 capsules.
Neprozirni polivinilklorid/polietilen/polivinilideneklorid (PVC/PE/PVDC) aluminij blisteri kroz koje se može protisnuti kapsula, sa 7 kapsula.
The majority of the adverse reactions reported were grade 1 in severity.
Većina prijavljenih nuspojava bila je 1. stupnja težine.
The terminal elimination half-life of simeprevir was 10 to 13 hours in healthy subjects and 41 hours in HCV infected patients receiving 200 mg simeprevir.
Terminalno poluvrijeme eliminacije simeprevira bilo je 10 do 13 sati u zdravih ispitanika i 41 sat u HCV-om inficiranih bolesnika koji su primili 200 mg simeprevira.
Plasma Cmax and the area under the plasma concentration time curve (AUC) increased more than dose proportional after multiple doses between 75 mg and 200 mg once daily, with accumulation occurring following repeated dosing.
Cmax u plazmi i područje ispod krivulje koncentracija-vrijeme u plazmi (AUC) povisili su se više od proporcionalno dozi nakon višestrukih doza između 75 mg i 200 mg jedanput na dan, s kumulacijom koja se javila nakon ponovljenog doziranja.
The following side effects may happen with OLYSIO when used in combination with sofosbuvir: Common: may affect up to 1 in 10 people:
Sljedeće nuspojave mogu se javiti uz OLYSIO kada se uzima u kombinaciji sa sofosbuvirom: Često: mogu se javiti u do 1 na 10 osoba:
Cisapride has the potential to cause cardiac arrhythmias.
Cisaprid ima potencijal za izazivanje srčanih aritmija.
- If you are a woman, you must not become pregnant during treatment and for several
- Ako ste žena, ne smijete zatrudniti tijekom liječenja i nekoliko mjeseci nakon toga.
These increases in bilirubin levels were not associated with any adverse liver safety finding.
Ova povišenja razina bilirubina nisu bila povezana s bilo kojim od štetnih sigurnosnih nalaza za jetru.
Bilirubin elevations were generally not associated with elevations in liver transaminases and bilirubin levels normalised after end of treatment.
Povišenja bilirubina općenito nisu bila povezana s povišenjem transaminaza u jetri i razine bilirubina su se normalizirale nakon završetka liječenja.
This medicinal product may pose a risk to the environment (see section 5.3).
Ovaj lijek može predstavljati rizik za okoliš (vidjeti dio 5.3).
The safety and efficacy of OLYSIO in children aged below 18 years have not yet been established.
Sigurnost i djelotvornost lijeka OLYSIO u djece u dobi manjoj od 18 godina nisu još ustanovljene.
Table 21 shows the SVR rates for selected subgroups for study HPC3007.
Tablica 21 prikazuje stope SVR za odabrane podskupine za ispitivanje HPC3007.
Consider starting with the lowest dose of the PDE-5 inhibitor and increase as needed, with clinical monitoring as appropriate.
Razmotrite započinjanje s najnižom dozom PDE-5 inhibitora i povisite ju po potrebi, uz prikladno kliničko praćenje.
OLYSIO combination treatment with sofosbuvir may result in slowing of the heart rate (pulse) along with other symptoms when taken with amiodarone, a medicine used to treat irregular heart beat.
Kombinirano liječenje lijekom OLYSIO sa sofosbuvirom može rezultirati usporavanjem frekvencije srca (pulsa) zajedno s drugim simptomima kada se uzima s amiodaronom, lijekom koji se koristi za liječenje nepravilnih otkucaja srca.
Metabolites identified in faeces were formed via oxidation at the macrocyclic moiety or aromatic moiety or both and by O-demethylation followed by oxidation.
Metaboliti identificirani u fecesu bili su formirani putem oksidacije napola makrociklički, a napola aromatički ili oboje te O-demetilacijom nakon koje je slijedila oksidacija.
Treatment regimen not containing sofosbuvir:
Režim liječenja koji ne sadrži sofosbuvir:
The efficacy of OLYSIO has not been studied in patients with HCV genotypes 2, 3, 5 or 6; therefore OLYSIO should not be used in these patients (see section 5.1).
Djelotvornost lijeka OLYSIO nije bila ispitana u bolesnika s HCV genotipovima 2, 3, 5 ili 6; stoga se OLYSIO ne smije primjenjivati u tih bolesnika (vidjeti dio 5.1).
Includes 4 simeprevir-treated patients who experienced relapse after SVR12.
Uključuje 4 bolesnika liječena simeprevirom koji su doživjeli relaps nakon SVR12.
Phase 3 study in Asian patients
Ispitivanje faze 3 u bolesnika azijatskog porijekla
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, 4d odnosno 4/drugo.
There were no grade 3 or 4 photosensitivity reactions reported and none of the patients discontinued treatment due to photosensitivity reactions.
Nisu bile prijavljene reakcije fotoosjetljivosti 3. ili 4. stupnja i niti jedan bolesnik nije prekinuo liječenje zbog reakcija fotoosjetljivosti.
Simeprevir must be taken with food (see section 4.2).
Simeprevir se mora uzeti s hranom (vidjeti dio 4.2).
What OLYSIO contains - The active substance is simeprevir.
Što OLYSIO sadrži - Djelatna tvar je simeprevir.
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.
Od 3 bolesnika s neuspjehom tijekom liječenja, 2 bolesnika su doživjela virološki proboj i jedan bolesnik je ranije prekinuo liječenje zbog štetnog događaja.
Simeprevir is a specific inhibitor of the HCV NS3/4A serine protease, which is essential for viral replication.
Simeprevir je specifični inhibitor NS3/4A serin proteaze HCV-a, koja je esencijalna za replikaciju virusa.
Overall treatment duration with peg-IFN-alfa and RBV was response-guided.
Cjelokupno trajanje liječenja s peg-IFN-alfa i RBV bilo je vođeno odgovorom.
Elevations in amylase and lipase were transient and mostly of mild or moderate severity.
Povišenja amilaze i lipaze bila su prolazna i većinom blage ili umjerene težine.
Therefore, in patients who are at high risk for hepatic decompensation or hepatic failure, liver function tests should be monitored before and as clinically indicated during OLYSIO combination therapy.
Stoga se u bolesnika koji imaju visok rizik od hepatičke dekompenzacije ili zatajenja jetre trebaju pratiti funkcionalni testovi jetre prije i, kao što je klinički indicirano, za vrijeme kombiniranog liječenja lijekom OLYSIO.
Read the package leaflets for these medicines for their dosage and directions on ‘how to take' them.
Pročitajte upute o lijeku za te lijekove vezano uz doziranje i uputstva o tome ‘kako uzimati' te lijekove.
Following a single oral administration of 200 mg
Nakon jedne peroralne primjene 200 mg
Relapsers after prior interferon-based therapy.
Bolesnici s relaspom nakon prethodne terapije temeljene na interferonu.
It is not known whether simeprevir or its metabolites are excreted in human milk.
Nije poznato izlučuju li se simeprevir ili njegovi metaboliti u majčino mlijeko.
If you are not sure what to do, contact your doctor or pharmacist.
Ako niste sigurni što treba učiniti, obratite se svom liječniku ili ljekarniku.
The type of food does not affect exposure to
Vrsta hrane ne utječe na izloženost simepreviru.
- If it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
- Ukoliko do slijedeće doze ima više od 12 sati, uzmite zaboravljenu dozu što je prije moguće s hranom.
The Q80K polymorphism was not observed in patients with genotype 4 infection.
Q80K polimorfizam nije zapažen u bolesnika s infekcijom genotipom 4.
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
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
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).
Table 4: Interactions and dose recommendation with other medicinal products Recommendation for co-administration
Tablica 4: Interakcije i preporuke za doziranje s drugim lijekovima
Johnson & Johnson d.o.o.
Johnson & Johnson S.E. d.o.o.
May include few patients with HCV non-genotype 1a/1b.
Može uključivati nekoliko bolesnika s HCV-om koji nije genotipa 1a/1b.
None of the patients discontinued treatment due to ‘blood bilirubin increased'.
Niti jedan bolesnik nije prekinuo liječenje zbog ‘povišenog bilirubina u krvi'.
Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Uključuje jednog bolesnika koji prethodno nije odgovorio koji je doživio relaps nakon SVR12, za kojeg se smatralo da je imao reinfekciju HCV-om (temeljeno na filogenetičkoj analizi).
SVR: SVR12 for study HPC3007 and SVR24 for study C206.
SVR: SVR12 za ispitivanje HPC3007 i SVR24 za ispitivanje C206.
Caution is warranted and clinical monitoring of patients is recommended when these calcium channel blockers are given orally.
Nalaže se oprez i preporučuje se kliničko praćenje bolesnika kada se ti blokatori kalcijevih kanala primjenjuju peroralno.
In these patients the SVR12 rates were 89%, 93%, 75% and 90%, respectively.
Kod tih bolesnika stope SVR12 bile su 89%, 93%, 75% odnosno 90%.
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, alkalne fosfataze i/ili bilirubina.
There are no data on the effect of simeprevir on human fertility.
Ne postoje podaci o učinku simeprevira na plodnost u ljudi.
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” kao “↔”).
Unchanged simeprevir in faeces accounted for on average 31% of the administered dose.
Nepromijenjeni simeprevir u fecesu ubrojan je kao prosjek 31% primijenjene doze.
Study HPC3021 N = 40 % (n/N)
Ispitivanje HPC3021 N = 40 % (n/N)
Simeprevir was not genotoxic in a series of in vitro and in vivo tests.
Simeprevir nije bio genotoksičan u serijama in vitro i in vivo ispitivanja.
HCV/HIV-1 co-infected patients.
HCV/HIV-1 koinficirani bolesnici.
Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Antiretrovirusni - ne-nukleozidni inhibitori reverzne transkriptaze (NNRTIs) Efavirenz
The one patient with on-treatment failure discontinued treatment early due to an adverse event.
Jedan bolesnik s neuspjehon tijekom liječenja prekinuo je liječenje ranije zbog štetnog događaja.
Patients had compensated liver disease (including cirrhosis), HCV RNA of at least 10,000 IU/ml, and liver histopathology consistent with CHC (if available).
Bolesnici su imali kompenziranu bolest jetre (uključujući cirozu), HCV RNK od najmanje 10 000 IU/ml i histopatologiju jetre u skladu s kroničnim hepatitisom C (ukoliko je dostupna).
Studies carried out in rats did not reveal significant findings on fertility, embryo-fetal development or pre- and post-natal development at any of the tested doses (corresponding to a systemic exposure in rats similar or lower than that observed in humans at the recommended dose of 150 mg once daily).
Ispitivanja provedena na štakorima nisu otkrila značajne nalaze vezano uz plodnost, embrio-fetalni razvoj ili pre- i post-natalni razvoj pri bilo kojoj ispitivanoj dozi (odgovara sistemskoj izloženosti u štakora sličnoj ili nižoj od one koja je uočena u ljudi pri preporučenoj dozi od 150 mg jedanput na dan).
- The recommended dose of OLYSIO is one capsule (150 milligrams) once a day.
- Preporučena doza lijeka OLYSIO je jedna kapsula (150 miligrama) jedanput na dan.
Read the package leaflets for these other medicines for information regarding driving and using machines.
Pročitajte upute o lijeku za te druge lijekove vezano uz informacije o upravljanju vozilima i strojevima.
Race No dose adjustment is necessary based on race (see section 5.2).
Rasa Prilagodba doze, na temelju rase, nije potrebna (vidjeti dio 5.2).
The doctor will advise you to stop breast-feeding or to stop taking OLYSIO while breast-feeding.
Liječnik će Vam savjetovati prekid dojenja ili prekid uzimanja lijeka OLYSIO tijekom dojenja.
Female patients of childbearing potential must use an effective form of contraception (see section 4.6).
Žene u reproduktivnoj dobi moraju koristiti učinkovitu kontracepciju (vidjeti dio 4.6).
OLYSIO capsules contain lactose monohydrate.
OLYSIO kapsule sadrže laktozu hidrat.
OLYSIO has not been studied in HCV infected patients with severe renal impairment (creatinine clearance below 30 ml/min) or end stage renal disease, including patients requiring haemodialysis.
OLYSIO nije ispitan u bolesnika zaraženih HCV-om s teškim oštećenjem bubrega (klirens kreatinina ispod 30 ml/min) ili završnim stadijem bubrežne bolesti, uključujući bolesnike kojima je potrebna hemodijaliza.
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.
U usporedbi s uzimanjem bez hrane, primjena simeprevira s hranom zdravim je ispitanicima povisila 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.
No clinically relevant drug-drug interaction is expected.
Ne očekuje se klinički značajna interakcija lijek-lijek.
In the pooled phase 3 safety data, the majority of the adverse reactions reported during 12 weeks treatment with simeprevir were grade 1 to 2 in severity.
U objedinjenim sigurnosnim podacima faze 3, većina nuspojava koje su prijavljene tijekom 12 tjedana liječenja sa simeprevirom bile su težine stupnja 1 do 2.
Co-administration with other direct acting antivirals against HCV OLYSIO should only be co-administered with other direct acting antiviral medicinal products if the benefits are considered to outweigh the risks based upon available data.
Istodobna primjena s ostalim antiviroticima koji djeluju direktno na HCV OLYSIO se smije primijeniti istodobno s ostalim antivirusnim lijekovima direktnog učinka samo ako se na temelju dostupnih podataka procijeni da korist nadvladava rizik.
6 cells/ml).
6 stanica/ml
Age (18-73 years) had no clinically meaningful effect on the pharmacokinetics of simeprevir based on a population pharmacokinetic analysis (n = 21, age above 65 years) of HCV infected patients treated with simeprevir.
Dob (18-73 godina) nije klinički značajno utjecala na farmakokinetiku simeprevira, temeljeno na populacijskoj farmakokinetičkoj analizi (n = 21, dob iznad 65 godina) bolesnika inficiranih HCV-om koji su liječeni simeprevirom.
If you are not sure, talk to your doctor or pharmacist before taking OLYSIO.
Ako niste sigurni, obratite se svom liječniku ili ljekarniku prije nego što uzmete OLYSIO.
Substitutions D168V and R155K alone or in combinations with other mutations at these positions emerged most frequently (table 10).
Najčešće su nastale supstitucije D168V i R155K same ili u kombinacijama s drugim mutacijama na tim položajima (tablica 10).
If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the
Ako se pojave reakcije fotoosjetljivosti, u obzir se mora uzeti prekid primjene lijeka OLYSIO, a bolesnike treba pratiti dok ne
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 supstitucijom, dotične nastale varijante nisu više bile detektabilne na kraju ispitivanja.
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.
There is no specific antidote for overdose with OLYSIO.
Ne postoji specifični antidot za predoziranje lijekom OLYSIO.
- OLYSIO contains the active substance ‘simeprevir'.
- OLYSIO sadrži djelatnu tvar “simeprevir“.
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.
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.
- being sensitive to sunlight (photosensitivity) - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver).
- osjetljivost na sunčevu svjetlost (fotoosjetljivost) - povišene razine “bilirubina“ u Vašoj krvi (bilirubin je pigment kojeg stvara jetra).
In these patients the SVR12 rates were 96%, 94%, 100% and 68%,
Kod tih bolesnika stope SVR12 bile su 96%, 94%, 100%
12 weeks OLYSIO + sofosbuvir (without ribavirin) may be considered for patients deemed at low risk for clinical disease progression and who have subsequent retreatment options (see sections 4.4 and 5.1)
+ sofosbuvir (bez ribavirina) može se uzeti u obzir u bolesnika za koje je procijenjeno da imaju nizak rizik za kliničku progresiju bolesti i koji imaju naknadne mogućnosti ponovnog liječenja (vidjeti dijelove 4.4 i 5.1)
Mild increases in concentrations of these antiarrhythmics may be expected when these medicinal products are administered orally.
Mogu se očekivati blagi porasti koncentracija ovih antiaritmika kada se ovi lijekovi primjenjuju peroralno.
Common: may affect up to 1 in 10 people: - increased ‘bilirubin' levels in your blood (bilirubin is a pigment made by the liver)* - being sensitive to sunlight (photosensitivity)
Često: mogu se javiti u do 1 na 10 osoba: - povišene razine “bilirubina“ u Vašoj krvi (bilirubin je pigment kojeg stvara jetra)* - osjetljivost na sunčevu svjetlost (fotoosjetljivost)
Maximum plasma concentrations (Cmax) are typically achieved between 4 to
Maksimalne koncentracije u plazmi (Cmax) obično se postižu unutar 4 do 6 sati nakon doze.
OLYSIO should only be used during pregnancy or in women of childbearing potential if the benefit justifies the risk.
Tijekom trudnoće i u žena reproduktivne dobi OLYSIO se smije uzimati jedino ako korist primjene opravdava rizik.
Asian patients
Bolesnici azijatskog porijekla
As liver function may change during treatment with OLYSIO, close monitoring of International Normalised Ratio (INR) values is recommended.
Budući da tijekom liječenja lijekom OLYSIO može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (INR).
Table 12: Demographics and baseline characteristics (studies HPC3017 and HPC3018) HPC3017 N = 310
Tablica 12: Demografske i početne karakteristike (ispitivanja HPC3017 i HPC3018) HPC3017 N = 310
One patient in the 12-week treatment group (0.3%) and none of the patients in the 24-week treatment group discontinued treatment due to adverse reactions.
Jedan bolesnik u skupini s 12-tjednim liječenjem (0,3%) i niti jedan bolesnik u skupini s 24-tjednim liječenjem nije prekinuo liječenje zbog nuspojava.
In vitro experiments with human Caco-2 cells indicated that simeprevir is a substrate of P-gp.
In vitro eksperimenti s humanim Caco-2 stanicama ukazuju na to da je simeprevir supstrat P-gp-a.
Treatment stopping rules for HCV therapy were used to ensure that patients with inadequate on-treatment virologic response discontinued treatment in a timely manner.
Pravila za kraj liječenja za HCV terapiju su se koristila kako bi se osiguralo da bolesnici s neodgovarajućim virološkim odgovorom tijekom liječenja prekinu liječenje u zadanom vremenskom okviru.
- 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.
The effect of simeprevir 150 mg once daily and 350 mg once daily for 7 days on the QT interval was evaluated in a randomised, double-blind, placebo- and positive-controlled (moxifloxacin 400 mg once daily), 4-way cross-over study in 60 healthy subjects.
Učinak simeprevira od 150 mg jedanput na dan i 350 mg jedanput na dan tijekom 7 dana na QT interval bilo je procijenjeno u randomiziranom, dvostruko slijepom, s placebom i pozitivnom kontrolom kontroliranom (moksifloksacin 400 mg jedanput na dan), 4- smjernom ukriženom ispitivanju u 60 zdravih ispitanika.
Most photosensitivity reactions in simeprevir-treated patients were of mild or moderate severity (grade 1 or 2); 0.3% of the simeprevir-treated patients experienced serious reactions leading to hospitalisation (see section 4.4).
Većina reakcija fotoosjetljivosti kod bolesnika liječenih simeprevirom bile su blage ili umjerene težine (stupanj 1 ili 2); 0,3% bolesnika liječenih simeprevirom doživjelo je ozbiljne reakcije koje su dovele do hospitalizacije (vidjeti dio 4.4).
Two patients had HIV virologic failure defined as confirmed HIV-1 RNA ≥ 200 copies/ml after previous < 50 copies/ml; these failures occurred 36 and 48 weeks after end of simeprevir treatment.
Dva bolesnika imala su HIV virološki neuspjeh definiran kao potvrđena HIV-1 RNK ≥ 200 kopija/ml nakon prethodne < 50 kopija/ml; ovaj neuspjeh se pojavio 36 i 48 tjedana nakon kraja liječenja simeprevirom.
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.
The mean absolute bioavailability of simeprevir following a single oral 150 mg dose of simeprevir in fed conditions is 62%.
Srednja vrijednost apsolutne bioraspoloživosti simeprevira nakon jedne peroralne doze od 150 mg simeprevira u stanju sitosti je 62%.
If a dose of OLYSIO is missed, and the patient notices within 12 hours of the usual dosing time, the patient should take the missed dose of OLYSIO with food as soon as possible and then take the next dose of OLYSIO at the regularly scheduled time.
Ako se propusti doza lijeka OLYSIO, a bolesnik to primijeti unutar 12 sati od uobičajenog vremena doziranja, bolesnik propuštenu dozu lijeka OLYSIO mora uzeti što je prije moguće s hranom, a sljedeću dozu lijeka OLYSIO uzeti prema uobičajenom rasporedu.
Inhibitors of OATP1B1/3 such as eltrombopag or gemfibrozil may result in increases in simeprevir plasma concentrations.
Inhibitori OATP1B1/3 poput eltrombopaga ili gemfibrozila mogu dovesti do povišenja koncentracija simeprevira u plazmi.