FrancophonIA/ELRC3.0 huggingface dataset:
English: A course of OLYSIO lasts for either 12 or 24 weeks but you may need to take the other medicines for longer, according to your doctor's instructions.
Slovenian: Zdravilo OLYSIO morate med zdravljenjem jemati skupaj z drugimi zdravili za zdravljenje kronične okužbe z virusom hepatitisa C. Zdravljenje z zdravilom OLYSIO traja 12 ali 24 tednov, vendar boste morda morali jemati druga zdravila dlje, če vam tako naroči zdravnik.
English: There are no clinical data on the use of OLYSIO in re-treating patients who have failed an HCV NS3-4A protease inhibitor-based therapy (see sections 5.1 and 5.3).
Slovenian: Kliničnih podatkov o uporabi zdravila OLYSIO za ponovno zdravljenje bolnikov, pri katerih zdravljenje HCV z zaviralci proteaze HCV NS3-4A ni bilo uspešno, ni (glejte poglavji 5.1 in 5.3).
English: If you are not sure what to do, contact your doctor or pharmacist.
Slovenian: Če se ne morete odločiti kaj storiti, se posvetujte z zdravnikom ali farmacevtom.
English: OLYSIO in combination with peginterferon alfa and ribavirin Simeprevir efficacy in combination with peginterferon alfa and ribavirin is substantially reduced in patients infected with hepatitis C genotype 1a with the NS3 Q80K polymorphism at baseline compared to patients with hepatitis C genotype 1a without the Q80K polymorphism (see section 5.1).
Slovenian: Zdravilo OLYSIO v kombinaciji s peginterferonom alfa in ribavirinom Učinkovitost simeprevirja v kombinaciji s peginterferonom alfa in z ribavirinom je znatno zmanjšana pri bolnikih, okuženih s hepatitisom C genotipa 1a s polimorfizmom NS3 Q80K na začetku zdravljenja v primerjavi z bolniki, okuženimi s hepatitisom C genotipa 1a brez polimorfizmom NS3 Q80K (glejte poglavje 5.1).
English: Grade 2 ‘blood bilirubin increased' was reported in one patient (0.3%) receiving 12 weeks of treatment.
Slovenian: O 'zvečanju koncentracije bilirubina v krvi' stopnje 2 so poročali pri enem bolniku (0,3%; skupina, ki je zdravljenje prejemala 12 tednov).
English: Table 19: Treatment outcome in treatment-naïve HCV genotype 1 infected patients (pooled data studies C208 and C216)
Slovenian: Preglednica 19: Izid zdravljenja pri predhodno nezdravljenih bolnikih, okuženih s HCV genotipa 1 (združeni podatki iz študij C208 in C216)
English: Plasma exposure of simeprevir in HCV infected patients was about 2- to 3-fold higher compared to
Slovenian: Pri bolnikih z okužbo s HCV je bila izpostavljenost simeprevirju v plazmi približno 2- do 3-krat večja
English: nelfinavir, nevirapine, ritonavir, saquinavir or tipranavir to treat HIV infection - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin or simvastatin to lower cholesterol
Slovenian: nelfinavir, nevirapin, ritonavir, sakvinavir ali tipranavir za zdravljenje okužbe z virusom HIV - atorvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin ali simvastatin za zmanjševanje
English: In the pooled analysis of patients receiving 150 mg simeprevir in combination with peginterferon alfa and ribavirin in the controlled phase 2 and phase 3 studies, treatment-emergent simeprevir-resistance variants were no longer detectable in 90 out of 180 patients (50%) at the end of the studies after a median follow-up of 28 weeks (range 0-70 weeks).
Slovenian: Rezultati analize združenih podatkov bolnikov, ki so prejemali 150 mg odmerek simeprevirja v kombinaciji s peginterferonom alfa in z ribavirinom v nadzorovanih študijah faze 2 in faze 3, kažejo, da variant virusa z odpornostjo na simeprevir, do katere je prišlo med zdravljenjem, ni bilo več mogoče zaznati pri 90 od 180 bolnikov (pri 50%) ob koncu študije po mediano 28 tednih spremljanja bolnikov (od 0 do 70 tednov).
English: As simeprevir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by
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: Combination treatment of OLYSIO with other medicines used for treating your chronic hepatitis C infection may affect your ability to drive and use machines.
Slovenian: Zdravljenje z zdravilom OLYSIO, skupaj z drugimi zdravili za zdravljenje kronične okužbe z virusom hepatitisa C, lahko zmanjša sposobnost za upravljanje vozil in strojev.
English: If you are not sure, talk to your doctor or pharmacist before taking OLYSIO.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila OLYSIO posvetujte z zdravnikom ali farmacevtom.
English: Cases of bradycardia have been observed when OLYSIO is used in combination with sofosbuvir and concomitant amiodarone (see sections 4.4 and 4.5).
Slovenian: Pri uporabi zdravila OLYSIO v kombinaciji s sofosbuvirjem in amiodaronom so opazili primere bradikardije (glejte poglavje 4.4 in 4.5).
English: Grade 3 rash or pruritus occurred in 0.5% and 0.1% of simeprevir-treated patients, respectively.
Slovenian: Izpuščaj ali srbenje stopnje 3 sta se pojavila pri 0,5% oziroma 0,1% bolnikov, ki so prejemali simeprevir.
English: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss Tel: +49 2137 955-955
Slovenian: Janssen-Cilag GmbH Johnson & Johnson Platz 1 D-41470 Neuss
English: Grade 3 rash was reported in one patient (0.3%; 12-week treatment group) which led to treatment discontinuation; none of the patients experienced grade 4 rash.
Slovenian: O izpuščaju stopnje 3, ki je vodil v prekinitev zdravljenja, so poročali pri enem bolniku (0,3%; skupina, ki je zdravljenje prejemala 12 tednov); pri nobenem bolniku se ni pojavil izpuščaj stopnje 4.
English: Discontinuation of simeprevir due to adverse reactions occurred in 0.9% of patients receiving simeprevir with peginterferon alfa and ribavirin.
Slovenian: Do prekinitve uporabe simeprevirja zaradi neželenih učinkov je prišlo pri 0,9% bolnikov, ki so prejemali simeprevir skupaj s peginterferonom alfa in z ribavirinom.
English: The majority of HCV genotype 1 infected patients treated with simeprevir in combination with sofosbuvir (with or without ribavirin) for 12 or 24 weeks who did not achieve SVR due to virologic reasons and with sequencing data available had emerging NS3 amino acid substitutions at position 168 and/or emerging R155K: 5 out of 6 patients in study HPC2002, 1 out of 3 patients in study HPC3017 and 11 out of 13 patients in study HPC3018.
Slovenian: Pri večini bolnikov, okuženih s HCV genotipa 1, zdravljenih s simeprevirjem v kombinaciji s sofosbuvirjem (z ribavirinom ali brez ribavirina) 12 ali 24 tednov, ki niso dosegli SVR zaradi viroloških razlogov in so bili za njih na voljo podatki iz sekvenciranja, je prišlo do substitucije aminokislin NS3 na mestu 168 in/ali R155K: 5 od 6 bolnikov v študiji HPC2002, 1 od 3 bolnikov v študiji HPC3017 in 11 od 13 bolnikov v študiji HPC3018.
English: Human experience of overdose with simeprevir is limited.
Slovenian: Izkušenj s prevelikim odmerjanje zdravila simeprevirja pri ljudeh je zelo malo.
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 in 30% of patients with HCV genotype 1a and in 0.5% of 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: 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: 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: Efficacy in adults with HCV genotype 4
Slovenian: Učinkovitost pri odraslih, okuženih s HCV genotipa 4
English: It is not recommended to co-administer OLYSIO with systemic itraconazole, ketoconazole or posaconazole.
Slovenian: Sočasna uporaba zdravila OLYSIO s sistemsko obliko itrakonazola, ketokonazola ali posakonazola ni priporočljiva.
English: 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: 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
English: Grade 2 and 3 adverse reactions were reported in 3.5% (n = 10) and 0.3% (n = 1) of patients, respectively, receiving 12 weeks simeprevir with sofosbuvir; no grade 4 adverse reactions were reported.
Slovenian: O stopnji 2 in 3 so poročali pri 3,5% (n = 10) oziroma pri 0,3% (n = 1) bolnikov, ki so 12 tednov prejemali simeprevir in sofosbuvir.
English: The safety profile of simeprevir is comparable in patients with HCV genotype 4 infection and HCV genotype 1 infection, when given either in combination with sofosbuvir or in combination with peginterferon alfa and ribavirin.
Slovenian: Varnostni profil simeprevirja pri bolnikih, okuženih s HCV genotipa 4 in HCV genotipa 1, ki so prejemali simeprevir v kombinaciji s sofosbuvirjem ali v kombinaciji s peginterferonom alfa in
English: Photosensitivity reactions have been observed with OLYSIO combination treatment (see section 4.8).
Slovenian: Pri kombiniranem zdravljenju z zdravilom OLYSIO so opažali fotosenzitivnostne reakcije (glejte poglavje 4.8).
English: Some of the treatment-emergent NS3 amino acid substitutions detected in simeprevir-treated patients who did not achieve SVR in clinical studies (e.g., R155K) have been shown to reduce anti-HCV activity of telaprevir, boceprevir, and other NS3/4A PIs.
Slovenian: Za nekatere substitucije aminokislin NS3, do katerih je prišlo v času zdravljenja in so jih odkrili pri bolnikih, ki so v kliničnih študijah (npr. v študiji R155K) prejemali simeprevir, niso pa dosegli trajnega virološkega odziva, so dokazali, da zmanjšujejo protivirusno aktivnost telaprevirja, boceprevirja in drugih zaviralcev proteaze NS3/4A.
English: simvastatin acid AUC 1.88 (1.63-2.17) ↑ simvastatin acid Cmax 3.03 (2.49-3.69) ↑
Slovenian: AUC simvastatinske kisline 1,88 (1,63-2,17)  Cmax simvastatinske kisline 3,03 (2,49-3,69)  Cmin simvastatinske kisline niso preučevali
English: It is not recommended to co-administer OLYSIO with any HIV PI, with or without ritonavir.
Slovenian: Sočasna uporaba zdravila OLYSIO s katerimkoli zaviralcem proteaze virusa HIV, skupaj z ritonavirjem ali brez njega, ni priporočljiva.
English: Caution is warranted and therapeutic drug monitoring for amiodarone and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Slovenian: Pri peroralni uporabi je priporočljivo terapevtsko spremljanje uporabe amiodarona in/ali klinično spremljanje bolnikov (npr. z EKG).
English: Plasma Cmax and AUC of simeprevir were similar during co-administration of simeprevir with peginterferon alfa and ribavirin compared with administration of simeprevir alone.
Slovenian: Vrednosti Cmax in AUC simeprevirja v plazmi so bile pri sočasnem jemanju simeprevirja s peginterferonom alfa in ribavirinom približno enake kot pri jemanju samega simeprevirja.
English: Discontinue peginterferon alfa and ribavirin (treatment with OLYSIO is complete at week 12)
Slovenian: 1 ukinite zdravljenje s peginterferonom alfa in ribavirinom (zdravljenje z zdravilom OLYSIO je po 12 tednih že
English: It is not recommended to co-administer OLYSIO with systemic fluconazole or voriconazole.
Slovenian: Sočasna uporaba zdravila OLYSIO s sistemskim flukonazolom ali vorikonazolom ni priporočljiva.
English: The response rates for patients with or without cirrhosis receiving 12 weeks of simeprevir + sofosbuvir are shown in
Slovenian: Stopnje odziva bolnikov s cirozo ali brez ciroze, ki so 12 tednov prejemali simeprevir + sofosbuvir, so
English: You may be more sensitive to sunlight (photosensitivity) when taking OLYSIO (see section 4 for
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: In study HPC3007, 93% (241/260) of the simeprevir-treated patients were eligible for a total treatment duration of 24 weeks; in these patients the SVR12 rate was 83%.
Slovenian: V študiji HPC3007 je bilo 93% (241/260) bolnikov, ki so prejemali simeprevir, primernih za skupno trajanje zdravljenja 24 tednov.
English: Data from a 3-year follow-up study in patients who did not achieve SVR with simeprevir in combination with peginterferon alfa and ribavirin in a previous phase 2 or phase 3 study showed that in 86% (37/43) of these patients the emerging mutations at time of failure in the previous study were no longer detected after a median follow-up of 180 weeks (range 47-230 weeks) (study HPC3002).
Slovenian: Podatki 3-letne študije spremljanja bolnikov kažejo, da pri bolnikih, ki v predhodnih študijah faze 2 ali faze 3 niso dosegli trajnega virološkega odziva na shemo zdravljenja s simeprevirjem v kombinaciji s peginterferonom alfa in ribavirinom, v 86% (37/43) novih mutacij v času neuspeha zdravljenja v prejšnji študiji ni bilo več mogoče zaznati po medianem trajanju spremljanja 180 tednov (od 47 do 230 tednov) (študija HPC3002).
English: Most of the rash and pruritus events in simeprevir-treated patients were of mild or moderate severity
Slovenian: Večina primerov izpuščaja in srbenja pri bolnikih, ki so prejemali simeprevir, je bila blagih ali zmernih (stopnje 1 ali 2).
English: There are no clinical data on the efficacy of simeprevir in patients with a history of exposure to the NS3/4A PIs telaprevir or boceprevir.
Slovenian: Kliničnih podatkov o učinkovitosti simeprevirja pri bolnikih, ki so bili že izpostavljeni zaviralcema proteaze HCV NS3/4A telaprevirju ali boceprevirju, ni.
English: Includes relapsers, partial and null reponders to prior treatment with interferon (pegylated or non-pegylated), with or without ribavirin, and interferon-intolerant patients.
Slovenian: Vključuje bolnike s ponovitvijo bolezni, bolnike z delnim odzivom ali brez odziva na predhodno zdravljenje z interferonom (pegiliranim ali nepegiliranim), z ribavirinom ali brez ribavirina, in bolnike, ki ne prenešajo interferona.
English: If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking
Slovenian: Če karkoli od zgoraj navedenega velja za vas (ali če o tem niste prepričani), se pred začetkom uporabe zdravila OLYSIO posvetujte z zdravnikom ali farmacevtom.
English: Laboratory parameter WHO toxicity range
Slovenian: Laboratorijski parameter
English: Increased simeprevir exposures have been observed in individuals with severe renal impairment.
Slovenian: Pri posameznikih s hudo okvaro ledvic so opažali povečano izpostavljenost simeprevirju.
English: Caution is warranted and therapeutic drug monitoring for these antiarrhythmics and/or clinical monitoring (ECG etc.) when orally administered are recommended.
Slovenian: Pri peroralni uporabi je priporočljivo terapevtsko spremljanje uporabe teh antiaritmikov in/ali klinično spremljanje bolnikov (npr. z EKG).
English: Chimeric replicons carrying NS3 sequences derived from HCV PI treatment-naïve genotype 1a and genotype 1b patients displayed median fold change (FC) in simeprevir EC50 values of 1.4 (N = 78) and 0.4 (N = 59) compared to reference genotype 1b replicon, respectively.
Slovenian: Himerni replikoni, ki so vsebovali sekvence za NS3, pridobljene pri bolnikih s HCV genotipa 1a in genotipa 1b, ki pred tem še niso prejemali zaviralcev proteaz, so pokazali mediano 1,4-kratno (N = 78) oziroma 0,4-kratno (N = 59) spremembo vrednosti EC50 simeprevirja v primerjavi z referenčnim replikonom genotipa 1b.
English: Includes one prior null responder who experienced relapse after SVR12, who was considered to have an HCV re-infection (based on phylogenetic analyses).
Slovenian: Vključno s podatki enega bolnika, pri katerem ni bilo odziva na predhodnje zdravljenje; po dosegu SVR12 v študiji je prišlo do ponovitve bolezni, in za katerega (na podlagi filogenetske analize) menijo, da je se je ponovno okužil s HCV.
English: See section 4.
Slovenian: stopnja 4
English: The clinical relevance of this difference in viral breakthrough rates is
Slovenian: Klinični pomen razlik v stopnjah virusnega preboja med različnimi podskupinami ni znan.
English: 2; the median baseline HCV RNA level was 6.01 log10 IU/ml; 37% had cirrhosis; 30% had HCV genotype 4a, and 56% HCV genotype 4c or 4d; 79% had non-CC IL28B alleles (CT or TT); 52% were treatment-naïve, and 48% were treatment-experienced.
Slovenian: je imelo ITM ≥ 30 kg/m2; mediana izhodiščne koncentracije HCV RNK je bila 6,01 log10 i.e./ml; 37% jih je imelo cirozo; 30% je bilo okuženih s HCV genotipa 4a, in 56% okužbo s HCV genotipa 4c ali 4d; 79% jih je imelo ne-CC IL28B alele (CT ali TT); 52% bolnikov še ni bilo zdravljenih, in 48% bolnikov je že bilo zdravljenih.
English: The dosing recommendation is applicable to the recommended dose of simeprevir 150 mg once daily.
Slovenian: Priporočilo za odmerjanje se nanaša na priporočeni odmerek 150 mg
English: Simeprevir in combination with sofosbuvir: Photosensitivity reactions were reported in 3.1% of simeprevir-treated patients receiving 12 weeks of treatment compared to 6.5% in patients receiving 24 weeks of treatment (all grades).
Slovenian: Simeprevir v kombinaciji s sofosbuvirjem: o fotosenzitivnih reakcijah so poročali pri 3,1% bolnikov, ki so zdravljenje s simeprevirjem prejemali 12 tednov, v primerjavi s 6,5% bolnikov, ki so zdravljenje prejemali 24 tednov (vse stopnje).
English: Mild increases in concentrations of amiodarone may be expected when amiodarone
Slovenian: Pri peroralni uporabi je mogoče pričakovati blago zvečanje koncentracije amiodarona.
English: What OLYSIO looks like and contents of the pack The hard capsules are white, with ‘TMC435 150' printed in black ink.
Slovenian: Trde kapsule so bele barve in imajo s črnim barvilom natisnjeno oznako "TMC435 150".
English: Seventy-one percent (37/52), 93% (14/15), 80% (8/10) and 36% (10/28) of simeprevir-treated treatment-naïve patients, prior relapsers, prior partial responders and prior null responders had undetectable HCV RNA at week 4.
Slovenian: Enainsedemdeset odstotkov (37/52) bolnikov brez predhodnega zdravljenja, 93% (14/15) bolnikov s ponovitvijo bolezni po predhodnem zdravljenju, 80% (8/10) bolnikov z delnim odzivom na predhodno zdravljenje in 36% (10/28) bolnikov brez odziva na predhodno zdravljenje (vsi navedeni bolniki so prejemali simeprevir) je imelo po 4 tednih nezaznavno koncentracijo HCV RNK.
English: 8 or 12 weeks SMV + sofosbuvir
Slovenian: 8 ali 12 tednov SMV + sofosbuvir
English: Table 15: Treatment outcome in HCV genotype 1 infected patients with cirrhosis receiving 12 or 24 weeks simeprevir + sofosbuvir, with or without ribavirin
Slovenian: Preglednica 15: Izidi zdravljenja bolnikov, okuženih s HCV genotipa 1, s cirozo, ki so 12 ali 24 tednov prejemali simeprevir + sofosbuvir, z ribavirinom ali brez ribavirina
English: The days of the week are printed on
Slovenian: Na pretisnem traku so natisnjene okrajšave imen dni v tednu.
English: 12 weeks OLYSIO + sofosbuvir
Slovenian: 12 tednov OLYSIO + sofosbuvir
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)
English: Body-weight based twice daily ribavirin dosing, according to the Summary of Product Characteristics of ribavirin.
Slovenian: Odmerjanje ribavirina glede na telesno maso, dvakrat na dan, v skladu s povzetkom glavnih značilnosti zdravila za
English: Plasma concentrations of midazolam were not affected when administered intravenously as simeprevir does not inhibit hepatic CYP3A4.
Slovenian: Pri intravenskem vnosu midazolama ni prišlo do spremembe njegove koncentracije v plazmi, ker simeprevir ne zavira encima CYP3A4 v jetrih.
English: The persistence of simeprevir-resistant NS3 amino acid substitutions was assessed following treatment failure.
Slovenian: Po neuspehu zdravljenja so ocenjevali trajnost substitucij aminokislin NS3, ki povzročajo odpornost na simeprevir.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product
Slovenian: Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih
English: In study HPC2002, increased bilirubin was reported in 0% of patients receiving 12 weeks of simeprevir and sofosbuvir without ribavirin versus 9.3% of patients receiving 12 weeks of simeprevir and sofosbuvir with ribavirin.
Slovenian: V študiji HPC2002 so o zvečanju koncentracije bilirubina poročali pri 0% bolnikov, ki so12 tednov prejemali simeprevir in sofosbuvir brez ribavirina, v primerjavi z 9,3% bolnikov, ki so 12 tednov prejemali simeprevir s sofosbuvirjem in ribavirinom
English: Refer to table 3 for treatment stopping rules based on HCV RNA levels at weeks 4, 12 and 24 for patients receiving treatment with OLYSIO, peginterferon alfa and ribavirin.
Slovenian: Smernice za ukinitev zdravljenja glede na koncentracije RNK virusa hepatitisa C (HCV RNA) po 4, 12 in 24 tednih zdravljenja bolnikov, ki so prejemali zdravilo OLYSIO, peginterferon alfa in ribavirin, so navedene v preglednici 3.
English: These increases in bilirubin levels were not associated with any adverse liver safety finding.
Slovenian: Zvečanje koncentracije bilirubina ni bilo povezano s pojavom neželenih učinkov na jetrih.
English: Amylase and lipase elevations were not
Slovenian: Zvečanje koncentracij amilaze in lipaze ni bilo povezano s pankreatitisom.
English: Use of a sensitive quantitative HCV RNA assay for monitoring HCV RNA levels during treatment is recommended.
Slovenian: Za spremljanje koncentracije HCV RNK med zdravljenjem je priporočljiva uporaba občutljive kvantitativne metode
English: Data from a phase 2 study in 11 HCV infected post-liver transplant patients.
Slovenian: Podatki iz študije faze 2 pri 11 bolnikih s presaditvijo jeter, okuženih
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: 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: 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
Slovenian: Sočasna okužba s HCV/virusom humane imunske pomanjkljivosti-1 (HIV-1) Pri bolnikih s sočasno okužbo s HCV/HIV-1 prilagajanje odmerkov zdravila OLYSIO ni potrebno