natgillin/translations-raw huggingface dataset:
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)
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.