FrancophonIA/ELRC3.0 huggingface dataset:
English: If photosensitivity reactions occur, discontinuation of OLYSIO should be considered and patients should be monitored until the reaction has resolved.
Slovenian: Če se pojavijo fotosenzitivnostne reakcije, je treba razmisliti o prenehanju uporabe zdravila OLYSIO, bolnika pa spremljati do izboljšanja.
English: HPC3021 (PLUTO; Phase 3)
Slovenian: HPC3021 (PLUTO; faza 3)
English: Photosensitivity reactions
Slovenian: Fotosenzitivne reakcije
English: While no change in the pharmacokinetics of warfarin is expected, close monitoring of INR is recommended with all vitamin K antagonists.
Slovenian: Čeprav ni pričakovati nobenih sprememb farmakokinetike, se pri vseh antagonistih vitamina
English: 2 Following prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin (see section 5.1).
Slovenian: 2 Po predhodnem zdravljenju z interferonom (pegiliranim ali nepegiliranim), skupaj z ribavirinom ali brez ribavirina (glejte poglavje 5.1).
English: Respiratory, thoracic and mediastinal disorders: very common dyspnoea*
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora: zelo pogosti dispneja*
English: Discontinuation of simeprevir due to rash or pruritus occurred in 0.8% and 0.1% of simeprevir-treated patients, compared to 0.3% and 0% of placebo-treated patients, respectively.
Slovenian: Do prekinitve zdravljenja s simeprevirjem zaradi izpuščaja ali srbenja je prišlo pri 0,8% in 0,1% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 0,3% in 0% bolnikov, ki so prejemali placebo.
English: Mild increases in concentrations of triazolam may be expected.
Slovenian: Pričakovati je mogoče blago zvečanje koncentracije triazolama.
English: Other ritonavir-boosted or unboosted HIV PIs (Atazanavir, (Fos)amprenavir, Lopinavir, Indinavir, Nelfinavir, Saquinavir, Tipranavir)
Slovenian: drugi zaviralci proteaz, okrepljeni z ritonavirjem ali ne (atazanavir, amprenavir, fosamprenavir, lopinavir, indinavir, nelfinavir, sakvinavir, tipranavir)
English: 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.
Slovenian: Načrtovano skupno trajanje zdravljenja HCV je bilo 24 tednov, če so bili doseženi naslednji od odziva odvisni in v protokolu določeni kriteriji: zaznavna koncentracija HCV RNK < 25 i.e./ml ali nezaznavna po 4. tednu IN nezaznavna koncentracija HCV RNK po 12. tednu.
English: GLUCOCORTICOIDS Dexamethasone (systemic)
Slovenian: GLUKOKORTIKOIDI deksametazon (sistemski)
English: During the first 12 weeks of treatment, the most frequently reported adverse reactions (incidence ≥ 5%) were nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction (see section 4.4).
Slovenian: V prvih 12 tednih zdravljenja so najpogosteje (pri ≥ 5%) poročali o naslednjih neželenih učinkih: navzea, izpuščaj, srbenje, dispneja, zvečanje koncentracije bilirubina v krvi in fotosenzitivnostna reakcija (glejte poglavje 4.4).
English: 1 May include few patients with HCV non-genotype 1a/1b.
Slovenian: Lahko vključuje nekaj bolnikov z virusom hepatitisa C, ki niso genotipa 1a ali 1b.
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.
Slovenian: Simeprevir se v veliki meri veže na beljakovine v plazmi, zato ga z dializo po vsej verjetnosti ni mogoče v večji meri odstraniti iz telesa.
English: - Swallow the capsule whole.
Slovenian: - Kapsulo morate pogoltniti celo.
English: HERBAL PRODUCTS Milk thistle (Silybum marianum)
Slovenian: ZDRAVILA RASTLINSKEGA IZVORA pegasti badelj (Silybum marianum)
English: 1 Superior versus historical control rate (historical SVR rates of approved combination treatments of direct acting antivirals with peginterferon alfa and ribavirin).
Slovenian: 1 Superioren v primerjavi s predhodnimi kontrolami (predhodne stopnje SVR odobrene kombinacije zdravljenja z direktnim delovanjem na viruse s peginterferonom alfa in ribavirinom).
English: OLYSIO contains lactose
Slovenian: Zdravilo OLYSIO vsebuje laktozo
English: PHOSPHODIESTERASE TYPE 5 INHIBITORS Sildenafil
Slovenian: ZAVIRALCI FOSFODIESTERAZE TIPA 5 sildenafil tadalafil vardenafil
English: Table 17: Studies conducted with simeprevir + peginterferon alfa + ribavirin: population and summary of study design
Slovenian: Preglednica 17: Študije, izvedene s kombinacijo simeprevir + peginterferon alfa + ribavirin: populacija in povzetek načrta študij
English: As exposure may be increased in HCV infected patients with severe renal impairment, caution is recommended when prescribing OLYSIO to these patients (see section 5.2).
Slovenian: Izpostavljenost se lahko poveča pri bolnikih, okuženih s HCV in s hudo okvaro jeter, zato je pri predpisovanju zdravila OLYSIO tem bolnikom priporočljiva previdnost (glejte poglavje 5.2).
English: Capsule content Sodium lauryl sulfate Magnesium stearate Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate
Slovenian: Vsebina kapsule natrijev lavrilsulfat magnezijev stearat koloidni brezvodni silicijev dioksid premreženi natrijev karmelozat laktoza monohidrat
English: Table 11: Studies conducted with simeprevir + sofosbuvir: population and summary of study design
Slovenian: Preglednica 11: Študije s simeprevirjem in sofosbuvirjem: populacija in povzetek načrta študij
English: R155Q3, D168A, D168F3, D168H, D168T, I170T5
Slovenian: Q80K3, S122A/G/I/T3, S122R, R155Q, D168A, D168F3, D168H, D168T, I170T5
English: Interim data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Slovenian: Vmesna analiza podatkov iz študije faze 2 pri 11 bolnikih s presaditvijo jeter, okuženih s HCV.
English: 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).
Slovenian: Pri bolnikih, starih > 45 let, so o dispneji poročali pri 16,4% bolnikov, ki so se zdravili s simeprevirjem, v primerjavi z 9,1% bolnikov, ki so prejemali placebo (vse stopnje, združeni podatki iz študij faze 3).
English: 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.
Slovenian: Če se bolnik na pozabljeni odmerek zdravila OLYSIO spomni po več kot 12 urah od običajnega časa odmerjanja, naj ne vzame pozabljenega odmerka zdravila OLYSIO, ampak naj nadaljuje z odmerjanjem zdravila OLYSIO skupaj s hrano po običajnem razporedu.
English: Table 9: Antiviral activity of simeprevir 200 mg monotherapy (studies C201 and C202) Genotype
Slovenian: Preglednica 9: Protivirusno delovanje 200 mg simeprevirja v monoterapiji (študiji C201 in C202)
English: How to take OLYSIO
Slovenian: Kako jemati zdravilo OLYSIO
English: 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) ↔
Slovenian: AUC R(-) metadona 0,99 (0,91-1,09) ↔ Cmax R(-) metadona 1,03 (0,97-1,09) ↔ Cmin R(-) metadona 1,02 (0,93-1,12) ↔
English: IL28B genotype
Slovenian: F4 genotip IL28B
English: Patients co-infected with HIV-1
Slovenian: Bolniki s sočasno okužbo s HIV-1
English: Carcinogenicity and mutagenicity
Slovenian: Karcinogenost in mutagenost
English: You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for information about side effects).
Slovenian: Med jemanjem zdravila OLYSIO lahko vaša koža postane bolj občutljiva na sončno svetlobo (kar imenujemo fotosenzitivnost) (za podatke o neželenih učinkih glejte poglavje 4).
English: 0.025 mg/kg
Slovenian: 0,25 mg
English: What OLYSIO is and what it is used for
Slovenian: Kaj je zdravilo OLYSIO in za kaj ga uporabljamo Kaj je zdravilo OLYSIO
English: Data from an ongoing, long-term follow-up study (study HPC3002) in patients who did not achieve SVR with a simeprevir-based regimen in a previous phase 2 study showed that in 70% (16/23) of these patients emerging mutations were no longer detected after a median follow-up of 88 weeks (range 47-147 weeks).
Slovenian: Podatki iz dolgotrajne študije spremljanja bolnikov, ki še poteka, (študije HPC3002), kažejo, da pri bolnikih, ki v predhodni študiji faze 2 niso dosegli trajnega virološkega odziva na shemo zdravljenja s simeprevirjem, v 70% (16/23) novih mutacij ni bilo več mogoče zaznati po medianem trajanju spremljanja 88 tednov (od 47 do 147 tednov).
English: 12 weeks SMV + peg-IFN-alfa + RBV, followed by 12 or 36 weeks peg-IFN-alfa + RBV3; control group: 48 weeks placebo + peg-IFN-alfa + RBV
Slovenian: 12 tednov SMV + peg-IFN-alfa + RBV, nato 12 ali 36 tednov peg-IFN-alfa + RBV3; kontrolna skupina: 48 tednov placebo + peg-IFN-alfa + RBV
English: SVR12 without cirrhosis with cirrhosis
Slovenian: SVR12 brez ciroze s cirozo
English: HPC3018 (OPTIMIST-2; Phase 3)
Slovenian: HPC3018 (OPTIMIST-2; faza 3)
English: Steady-state was reached after 7 days of once daily dosing.
Slovenian: 7 dneh odmerjanja enkrat na dan.
English: What OLYSIO is used for OLYSIO is used with other medicines to treat chronic (long-term) hepatitis C infection in adults.
Slovenian: Zdravilo OLYSIO se jemlje skupaj z drugimi zdravili za zdravljenje kronične (dolgotrajne) okužbe z virusom hepatitisa C pri odraslih bolnikih.
English: HPC3017 (OPTIMIST-1; Phase 3)
Slovenian: HPC3017 (OPTIMIST-1; faza 3)
English: Antiretroviral - non-nucleoside reverse transcriptase inhibitors (NNRTIs) Efavirenz
Slovenian: Protiretrovirusna zdravila - nenukleozidni zaviralci reverzne transkriptaze (NNRTI) efavirenz
English: This effect was observed at higher systemic exposures (11-fold) than those in humans at the recommended dose of 150 mg once daily.
Slovenian: Ta učinek so opažali pri sistemski izpostavljenosti, ki je 11-krat presegala izpostavljenost pri ljudeh pri uporabi priporočenega odmerka 150 mg enkrat na dan.
English: 12 or 24 weeks SMV + sofosbuvir, with or without ribavirin4
Slovenian: 12 ali 24 tednov SMV + sofosbuvir, brez ribavirina ali z ribavirinom4
English: Table 23: Treatment outcome in HCV genotype 4 infected patients (study HPC3011) Treatment outcome
Slovenian: Preglednica 23: Izidi zdravljenja pri bolnikih, okuženih s HCV genotipa 4 (študija HPC3011) Izid zdravljenja1
English: > 5.0 x ULN
Slovenian: > 5,0 x ZMN
English: It is not recommended to co-administer OLYSIO with astemizole or terfenadine.
Slovenian: OLYSIO z astemizolom ali s terfenadinom ni priporočljiva.
English: All patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir achieved SVR12 (table 16).
Slovenian: Vsi bolniki s cirozo ali brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, so dosegli SVR12 (preglednica 16).
English: It is not recommended to co-administer OLYSIO with cisapride.
Slovenian: OLYSIO s cisapridom ni priporočljiva.
English: Antifungals (systemic administration) Itraconazole
Slovenian: Antimikotiki (sistemska uporaba) itrakonazol ketokonazol* posakonazol
English: It is not recommended to co-administer OLYSIO with any HIV PI, with or without ritonavir.
Slovenian: OLYSIO s katerimkoli zaviralcem proteaze virusa HIV, skupaj z ritonavirjem ali brez njega, ni priporočljiva.
English: Frequency Category simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin N = 781
Slovenian: Organski sistem Kategorija pogostnosti simeprevir + sofosbuvir simeprevir + peginterferon alfa + ribavirin n = 781
English: 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)
Slovenian: 24 tednov OLYSIO + sofosbuvir ali 12 tednov OLYSIO + sofosbuvir + ribavirin2 12 tednov OLYSIO + sofosbuvir (brez ribavirina) se lahko pretehta pri bolnikih z ocenjenim majhnim tveganjem za klinično napredovanje bolezni in možnostmi za kasnejše ponovno zdravljenje (glejte poglavji 4.4 in 5.1)
English: ANTICOAGULANTS Warfarin and other vitamin K antagonists warfarin 10 mg:
Slovenian: ANTIKOAGULANTI Varfarin in drugi antagonisti vitamina K
English: without cirrhosis, who are co-infected with HIV
Slovenian: brez ciroze, ki so okuženi tudi s HIV
English: Black printing ink Shellac (E904) Iron oxide black (E172)
Slovenian: črni železov oksid (E172) in šelak (E904).
English: (OATP1B1/3, P-gp and CYP3A inhibition by ciclosporin)
Slovenian: (zaviranje OATP1B1/3, P-gp in CYP3A s ciklosporini)
English: When used together with other medicines to treat chronic hepatitis C infection, OLYSIO helps to clear HCV from your body.
Slovenian: Kadar se zdravilo OLYSIO jemlje z drugimi zdravili za zdravljenje kronične okužbe z virusom hepatitisa C pomaga telesu, da odstrani virus hepatitisa C iz telesa.
English: 24 weeks3
Slovenian: 24 tednov3
English: No emerging NS5B amino acid substitutions associated with sofosbuvir resistance were observed in patients who did not achieve SVR following treatment of simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks.
Slovenian: Substitucije aminokislin NS5B, povezane z odpornostjo na sofosbuvir, pri bolnikih, ki po 12 ali 24 tednih zdravljenja s simeprevirjem v kombinaciji s sofosbuvirjem (z ribavirinom ali brez ribavirina) niso dosegli SVR, niso opažali.
English: > 1.5 to ≤ 3.0 x ULN 22 (7.7%)
Slovenian: > 1,5 to ≤ 3,0 x ZMN 22 (7,7%)
English: The days of the week are printed on the blister strip.
Slovenian: Na pretisnem traku so natisnjene okrajšave imen dni v tednu.
English: R155K Q80X+D168X4
Slovenian: Q80X+D168X4 R155X+ D168X4
English: Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to that observed in healthy subjects.
Slovenian: Pri bolnikih z okužbo s HCV je bila izpostavljenost simeprevirju v plazmi približno 2- do 3-krat večja kot pri zdravih osebah.
English: Treatment-emergent laboratory abnormalities that were observed at a higher incidence in simeprevir-treated patients than in patients treated with placebo, peginterferon alfa and ribavirin are given in table 7.
Slovenian: Z zdravljenjem povzročene nenormalnosti laboratorijskih izvidov, ki so jih z večjo pogostnostjo opažali pri bolnikih, ki so prejemali simeprevir, kot pri bolnikih, ki so prejemali placebo, peginterferon alfa in ribavirin, so navedeni v preglednici 7.
English: 1 Simeprevir in combination with sofosbuvir: pooled studies HPC2002, HPC3017 and HPC3018 (12 weeks) or study HPC2002 (24 weeks); simeprevir in combination with peginterferon alfa and ribavirin: pooled phase 3 studies C208, C216 and HPC3007 (first 12 weeks of treatments).
Slovenian: 1 Simeprevir v kombinaciji s sofosbuvirjem: združene študije HPC2002, HPC3017 in HPC3018 (12 tednov) ali študija HPC2002 (24 tednov); simeprevir v kombinaciji s peginterferonom alfa and ribavirinom: združene študije faze 3 C208, C216 in HPC3007 (prvih 12 tednov zdravljenja).
English: The presence of Q80K at baseline was associated with lower SVR rates in HCV genotype 1a patients treated with simeprevir in combination with peginterferon alfa and ribavirin (tables 19, 21, 22).
Slovenian: Prisotnost polimorfizma Q80K ob izhodišču je bila povezana z manjšo pogostnostjo doseganja SVR pri bolnikih s HCV genotipa 1a, ki so prejemali simeprevir v kombinaciji s peginterferonom alfa in ribavirinom (preglednice 19, 21, 22).
English: All grades Grade 3
Slovenian: vse stopnje stopnja 3 stopnja 4 povezane prekinitve
English: The response rates for patients with cirrhosis (METAVIR score F4) receiving 12 or 24 weeks of simeprevir + sofosbuvir are shown in table 15.
Slovenian: Stopnje odzivov bolnikov s cirozo (ocena po klasifikaciji METAVIR F4), ki so 12 ali 24 tednov prejemali simeprevir + sofosbuvir, so prikazene v preglednici 15.
English: 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.
Slovenian: 1 V primeru izvida koncentracije HCV RNK ≥ 25 i.e./ml (po predhodni nezaznavni koncentraciji HCV RNK) je pred odločitvijo za ukinitev zdravljenja proti virusu hepatitisa C za potrditev izvida priporočljivo ponovno določiti koncentracijo HCV RNK.
English: Increased plasma concentrations of orally administered calcium channel blockers may be expeced.
Slovenian: Pričakovati je mogoče zvečanje koncentracije peroralnih zaviralcev kalcijevih kanalčkov.
English: Other NNRTIs (Delavirdine, Etravirine, Nevirapine)
Slovenian: drugi nenukleozidni zaviralci reverzne transkriptaze (delavirdin, etravirin, nevirapin)
English: The proportion of simeprevir-treated patients with HCV RNA < 25 IU/ml detectable at week 4 was 18% (47/259); 60% achieved SVR12.
Slovenian: Delež bolnikov, zdravljenih s simeprevirjem, s koncentracijo HCV RNK < 25 i.e./ml, zaznavno po 4 tednih, je bil 18% (47/259), 60% jih je doseglo SVR12.
English: H2-receptor antagonists Cimetidine
Slovenian: Antagonisti histaminskih receptorjev H2 cimetidin nizatidin ranitidin
English: Baseline polymorphisms at NS3 positions 43, 80, 122, 155, 156, and/or 168, associated with reduced simeprevir activity in vitro were generally uncommon (1.3%) in patients with HCV genotype 1 infection (n = 2,007; pooled phase 2 and phase 3 studies with simeprevir in combination with peginterferon alfa and ribavirin), with exception of the substitution Q80K in HCV genotype 1a patients which was seen 30% in patients with HCV genotype 1a and 0.5% in patients with HCV genotype 1b.
Slovenian: Izhodiščni polimorfizem NS3 na položajih 43, 80, 122, 155, 156, in/ali 168, ki je povezan z zmanjšano aktivnostjo simeprevirja in vitro, pri bolnikih z okužbo s HCV genotipa 1 (n = 2.007; združene študije faze 2 in 3 s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom) večinoma ni bil pogost (v 1,3%), z izjemo substitucije Q80K pri bolnikih s HCV genotipa 1a, ki so jo opazili pri 30% bolnikov s HCV genotipa 1a in 0,5% bolnikov s HCV genotipa 1b.
English: Median simeprevir FC values against baseline isolates of genotype 4a, genotype 4d and genotype 4other were 0.5 (N = 38), 0.4 (N = 24), and 0.8 (N = 29), respectively.
Slovenian: Mediane vrednosti količnika spremembe aktivnosti simeprevirja proti izhodiščnim izolatom genotipa 4a, genotipa 4 in drugih genotipov 4, so bile 0,5 (N = 38), 0,4
English: Table 5: Adverse reactions identified with simeprevir in combination with sofosbuvir or simeprevir in combination with peginterferon alfa and ribavirin1
Slovenian: Preglednica 5: Neželeni učinki, ugotovljeni s simeprevirjem v kombinaciji s sofosbuvirjem ali s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom1
English: Like all medicines, OLYSIO can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: * In a clinical study in Asian patients from China and South-Korea, increased blood ‘bilirubin'
Slovenian: * V klinični študiji pri bolnikih azijskega porekla s Kitajske in Južne Koreje so poročali o zvečani koncentraciji bilirubina v krvi pri več kot 1 od 10 bolnikov (zelo pogosto).
English: Patients with HCV genotype 1a predominantly had emerging R155K alone or in combination with amino acid substitutions at NS3 positions 80, 122 and/or 168, while patients with HCV genotype 1b had most often an emerging D168V substitution (table 10).
Slovenian: genotipa 1a je večinoma prišlo do substitucije R155K samostojno ali v kombinaciji s substitucijami aminokislin NS3 na položajih 80, 122 in/ali 168, medtem ko je pri bolnikih s HCV genotipa 1b najpogosteje prišlo do substitucije D168V (preglednica 10).
English: 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.
Slovenian: Linearnost/nelinearnost Po večkratnih odmerkih od 75 mg do 200mg enkrat na dan sta se Cmax v plazmi in površina pod krivuljo časovnega poteka koncentracije v plazmi (AUC) povečali bolj kot sorazmerno z odmerkom, ker je pri ponavljanju odmerjanja prišlo do kopičenja.
English: Tacrolimus 2 mg patient individualised dose4
Slovenian: takrolimus 2 mg odmerek, prilagojen posameznemu bolniku4
English: In dogs, simeprevir was associated with a reversible multifocal hepatocellular necrosis with associated increases in ALT, AST, alkaline phosphatase and/or bilirubin.
Slovenian: Pri psih je bil simeprevir povezan z reverzibilno multifokalno hepatocelularno nekrozo in s pridruženimi zvečanji koncentracij alanin-aminotransferaze (ALT), aspartat-aminotransferaze (AST),
English: It is not recommended to co-administer OLYSIO with systemic itraconazole, ketoconazole or posaconazole.
Slovenian: OLYSIO s sistemsko obliko itrakonazola, ketokonazola ali posakonazola ni priporočljiva.
English: It is not recommended to co-administer OLYSIO with systemic fluconazole or voriconazole.
Slovenian: OLYSIO s sistemskim flukonazolom ali vorikonazolom ni priporočljiva.
English: (CYP3A4 enzyme induction [etravirine or nevirapine] or inhibition [delavirdine])
Slovenian: (indukcija [etravirin in nevirapin] CYP3A4 ali zaviranje [delavirdin] CYP3A4)
English: During administration of simeprevir with peginterferon alfa and ribavirin, the elevations in direct and indirect bilirubin were generally not associated with elevations in liver transaminases and normalised after end of treatment.
Slovenian: Med jemanjem simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom zvečanje direktnega in indirektnega bilirubina na splošno ni bilo povezano z zvečanjem koncentracije jetrnih transaminaz.
English: For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.
Slovenian: Za aktivnost, specifično za genotip virusa hepatitisa C (HCV), glejte poglavji 4.4 in 4.5. 4.2 Odmerjanje in način uporabe
English: Grade 2
Slovenian: stopnja 2
English: Read the package leaflets for these other medicines for information regarding driving and using machines.
Slovenian: Za podatke glede vožnje in upravljanja s stroji preberite tudi navodila za uporabo drugih zdravil.
English: The safety profile of simeprevir in combination with sofosbuvir in patients with HCV genotype 1 infection with or without cirrhosis is based on pooled data from the phase 2 study HPC2002 and the phase 3 studies HPC3017 and HPC3018 which included 472 patients who received simeprevir with sofosbuvir without ribavirin (155, 286 and 31 patients received 8, 12 or 24 weeks of treatment, respectively) and 108 patients who received simeprevir with sofosbuvir and ribavirin (54 patients each received 12 or 24 weeks of treatment).
Slovenian: Varnostni profil simeprevirja v kombinaciji s sofosbuvirjem pri bolnikih, okuženih s HCV genotipa 1, s cirozo ali brez ciroze, temelji na na združenih podatkih iz študije faze 2 (študija HPC2002) in študij faze 3 (študiji HPC3017 in HPC3018), v katere so vključili 472 bolnikov, ki so prejemali simeprevir s sofosbuvirjem brez ribavirina (155, 286 in 31 bolnikov je prejelo 8, 12 oziroma 24 tednov zdravljenja) in 108 bolnikov, ki so prejemali simeprevir s sofosbuvirjem in ribavirinom (po 54 bolnikov je prejelo 12 oziroma 24 tednov zdravljenja).
English: Simeprevir in combination with peginterferon alfa and ribavirin The safety profile of simeprevir in combination with peginterferon alfa and ribavirin in patients with HCV genotype 1 infection is based on the pooled data from the phase 2 studies and phase 3 studies C205, C206, C208, C216 and HPC3007 which included 924 patients who received simeprevir 150 mg once daily for 12 weeks and 540 patients who received placebo with peginterferon alfa and ribavirin.
Slovenian: Simeprevir v kombinaciji s peginterferonom alfa in ribavirinom Varnostni profil simeprevirja v kombinaciji s peginterferonom alfa in ribavirinom pri bolnikih, okuženih s HCV genotipa 1, temelji na združenih podatkih iz študij faze 2 in študij faze 3 (študije C205, C206, C208, C216 in HPC3007), v katerih je sodelovalo 924 bolnikov, ki so prejemali 150 mg simeprevirja enkrat na dan 12 tednov in 540 bolnikov, ki so prejemali placebo s peginterferonom alfa in z ribavirinom.
English: ≥ 1.1 to ≤ 1.5 x ULN 34 (11.9%)
Slovenian: ≥ 1,1 do ≤ 1,5 x ZMN 34 (11,9%)