FrancophonIA/ELRC3.0 huggingface dataset:
English: When compared to administration following a standard normal caloric meal, exposure (AUC) decreased by 73% when telaprevir was taken on an empty stomach, by 26% following a low-calorie high-protein meal (9 g fat, 260 kcal), and by 39% following a low-calorie low-fat meal (3.6 g fat, 249 kcal).
Slovenian: V primerjavi z zaužitjem zdravila po običajnem obroku z normalnim številom kalorij pa se je stopnja izpostavljenosti telaprevirju (AUC) zmanjšala za 73%, če so ga bolniki zaužili na prazen želodec, za 26%, če so ga zaužili po nizkokaloričnem in obroku z veliko beljakovin (9 g maščob, 260 kcal), in za 39%, če so ga zaužili po nizkokaloričnem, malo mastnem obroku (3,6 g maščob, 249 kcal), zato je treba telaprevir jemati s hrano.
English: No dose adjustment of INCIVO is required in stable liver transplant patients (see sections 4.8 and 5.1).
Slovenian: Pri stabilnih bolnikih po presaditvi jeter prilagajanje odmerka zdravila INCIVO ni potrebno (glejte poglavji 4.8 in 5.1).
English: INCIVO may increase concentrations of the co-administered medicinal product and this may result in an increased risk of their associated cardiac adverse reactions.
Slovenian: Zdravilo INCIVO lahko poveča koncentracije drugih sočasno uporabljenih zdravil, kar lahko vodi v zvečano tveganje za z njimi povezane srčne neželene učinke.
English: These changes should be based on frequent monitoring of tacrolimus or cyclosporine A plasma concentrations during INCIVO treatment.
Slovenian: Opisane spremembe odmerjanja je treba opraviti na osnovi pogostega spremljanja plazemskih koncentracij takrolimusa oziroma ciklosporina A med zdravljenjem z zdravilom INCIVO.
English: The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia (see section 4.4).
Slovenian: Kombiniranje teh dveh zdravil lahko vodi do povečanega tveganja za srčnožilne neželene učinke v zvezi s salmeterolom, vključno s podaljšanjem intervala QT, palpitacijami in sinusno tahikardijo (glejte poglavje 4.4).
English: Treatment with INCIVO should be initiated and monitored by a physician experienced in the
Slovenian: Zdravljenje z zdravilom INCIVO naj uvede in spremlja zdravnik z izkušnjami pri zdravljenju
English: AUC 1.30 (1.22-1.39) Cmax 1.30 (1.16-1.45) Cmin 1.41 (1.29-1.54) effect on P-gp transport in the gut
Slovenian: AUC 1,30 (1,22-1,39) Cmax 1,30 (1,16-1,45) Cmin 1,41 (1,29-1,54) učinek na transport s P-gp v črevesju
English: Sildenafil or tadalafil must not be used to treat a heart and lung disorder called pulmonary arterial hypertension.
Slovenian: Sildenafila ali tadalafila se ne sme uporabljati za zdravljenje srčne in pljučne bolezni, imenovane pljučna arterijska hipertenzija, lahko pa se uporabljata za druge namene.
English: Concomitant administration of INCIVO with active substances that strongly induce CYP3A e.g. rifampicin, St John's wort (Hypericum perforatum), carbamazepine, phenytoin and phenobarbital and thus may lead to lower exposure and loss of efficacy of INCIVO.
Slovenian: Sočasna uporaba zdravila INCIVO z učinkovinami, ki močno inducirajo CYP3A, npr. rifampicin, šentjanževka (Hypericum perforatum), karbamazepin, fenitoin in fenobarbital lahko povzroči manjšo izpostavljenost in izgubo učinka zdravila INCIVO.
English: Study 108 was a randomised, double-blind, parallel-group, placebo-controlled, Phase 3 study conducted in treatment-naïve patients.
Slovenian: Študija 108 je bila randomizirana, dvojno slepa in s placebom nadzorovana študija faze III pri vzporednih skupinah, ki je bila opravljena pri še nezdravljenih bolnikih.
English: In prior null responders, consideration should be given to conduct an additional HCV RNA test between weeks 4 and 12.
Slovenian: Pri bolnikih, ki se predhodno niso odzvali na zdravljenje, je treba pretehtati možnost opravljanja dodatnega testiranja HCV RNK med 4. in 12 tednom.
English: In patients with normal renal and hepatic function, an interruption of colchicine treatment is recommended, or only a limited colchicine treatment course at a reduced colchicine dose should be used.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic in jeter je priporočljivo prekiniti zdravljenje s kolhicinom ali skrajšano zdravljenje z zmanjšanim odmerkom kolhicina.
English: After the end of INCIVO treatment, uric acid values typically decrease over the following 8 weeks and are comparable to those observed in patients receiving peginterferon alfa and ribavirin alone.
Slovenian: Po koncu zdravljenja z zdravilom INCIVO koncentracije sečne kisline običajno postopoma upadejo v naslednjih 8 tednih in so podobne koncentracijam, opaženim pri bolnikih, ki so prejemali samo peginterferon alfa in ribavirin.
English: In that study, the following common adverse events were reported more frequently with the 1,875 mg every 8 hours regimen compared to the 750 mg every 8 hours regimen: nausea, headache, diarrhoea, decreased appetite, dysgeusia and vomiting.
Slovenian: V tej študiji so pogosteje poročali o pogostih neželenih učinkih pri shemi odmerjanja 1.875 mg na vsakih 8 ur v primerjavi s shemo odmerjanja 750 mg na 8 ur: navzea, glavobol, driska, zmanjšan tek, disgevzija in bruhanje.
English: You must carefully read the information under Rash in section 4 Possible Side Effects.
Slovenian: Natančno preberite podatke o izpuščajih v poglavju 4.
English: Available data suggest that peginterferon alfa, and perhaps also ribavirin, may contribute to the frequency and severity of rash associated with INCIVO combination treatment.
Slovenian: Razpoložljivi podatki nakazujejo, da peginteron alfa in verjetno tudi ribavirin prispevata k pogostnosti in jakosti izpuščaja (povezanega s kombiniranim zdravljenju z
English: Rifampicin reduces the telaprevir plasma AUC by approximately 92%.
Slovenian: Rifampicin zmanjša plazemsko vrednost AUC za telaprevir za približno 92%, zato zdravila INCIVO ne smete uporabljati sočasno z rifampicinom.
English: Table 6 shows SVR rates by IL28B genotype and the stage of liver fibrosis at baseline.
Slovenian: V preglednici 6 so prikazane stopnje SVR po genotipu IL28B in stopnja jetrne fibroze ob začetku
English: The primary assessment was an evaluation of non-inferiority, using a margin of -10.5% of the 24-week regimen compared to the 48-week regimen in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12.
Slovenian: Primarna ocena, ki je bila opravljena, je bilo ovrednotenje neinferiornosti zdravila, pri čemer so uporabili mejo -10,5% pri 24-tedenski shemi, v primerjavi z 48-tedensko shemo pri bolnikih z nezaznavno HCV RNK (nezaznaven analit) v
English: SVR rates were higher (absolute difference of at least 28%) for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA (< 800,000, ≥ 800,000 IU/ml), and extent of liver fibrosis.
Slovenian: Stopnje SVR pri skupini T12/PR so bile višje (absolutna razlika najmanj 28%) kot pri skupini Pbo/PR48 za vse podskupine po spolu, starosti, rasi, etnični pripadnosti, indeksu telesne mase, podtipu genotipa HCV, začetni vrednosti HCV RNK (< 800.000, ≥ 800.000 i.e./ml) in obsegu jetrne fibroze.
English: There are no clinical data on the use of INCIVO in HCV patients with moderate or severe renal impairment (CrCl ≤ 50 ml/min) (see section 4.4).
Slovenian: Kliničnih podatkov o uporabi zdravila INCIVO pri bolnikih, okuženih z virusom HCV z zmerno do hudo okvaro ledvic (CrCl (očistek kreatinina) ≤ 50 ml/min) ni (glejte poglavje 4.4).
English: Monitor for progression or systemic symptoms until the rash is resolved.
Slovenian: Spremljajte napredovanje ali sistemske simptome, dokler izpuščaj ne izgine.
English: If ribavirin is permanently discontinued for the management of anaemia, INCIVO must also be permanently discontinued.
Slovenian: Če ste dokončno ukinili ribavirin zaradi zdravljenja anemije, je treba ukiniti tudi zdravilo INCIVO.
English: In the description of Phase 3 study outcomes for Studies 108, 111, and C216, SVR, considered virologic cure, was defined based on the HCV RNA assessment in the study week 72 visit window, using the last measurement in the window.
Slovenian: V opisu izidov študije faze III za študije 108, 111 in C216 je bil SVR (ocenjena virološka ozdravljenost) določen na osnovi ocene HCV RNK ob obisku v 72. tednu študije, z uporabo zadnje meritve v tem obdobju.
English: Follow-up analysis of INCIVO-treated patients who did not achieve an SVR showed that the population of wild-type virus increased and the population of telaprevir-resistant variants became undetectable over time after the end of telaprevir treatment.
Slovenian: Analiza spremljanja z zdravilom INCIVO zdravljenih bolnikov, ki niso dosegli trajnega virološkega odziva, je pokazala, da se je po koncu zdravljenja s telaprevirjem sčasoma povečala populacija z divjim tipom virusa in je postopoma izginila populacija za telaprevir rezistentnih variant.
English: Half the rashes started during the first 4 weeks, but rash can occur at any time during INCIVO combination treatment.
Slovenian: Polovica primerov izpuščaja se je pojavila v prvih 4 tednih, čeprav se lahko tak izpuščaj pojavi kadarkoli med kombiniranim zdravljenjem z zdravilom INCIVO.
English: It is not known whether telaprevir is dialyzable by peritoneal or haemodialysis.
Slovenian: Ni znano, ali lahko telaprevir odstranjujemo iz telesa s peritonealno dializo ali s hemodializo.
English: Co-administration of oral midazolam or triazolam with telaprevir is contraindicated.
Slovenian: Sočasna peroralna uporaba midazolama ali triazolama s telaprevirjem je kontraindicirana.
English: No relevant inhibition by telaprevir of the organic cation transporter (OCT) OCT2 was observed in vitro.
Slovenian: In vitro študije niso pokazale pomembnega zaviranja organskega kationskega prenašalca OCT2 (OCT - organic cation transporter) s telaprevirjem.
English: Table 13: SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction) in the T12(DS)/PR48
Slovenian: Preglednica 13: stopnje SVR ob odgovoru v 4. tednu (zmanjšanje za < 1 log10 ali ≥ 1 log10) v skupini T12(DS)/PR48: študija C216
English: Ribavirin may be restarted per the dosing modification guidelines for ribavirin.
Slovenian: Ribavirin lahko tudi ponovno uvedete, skladno z navodili za prilagajanje njegovega odmerka.
English: In a follow-up study of 98 treatment-naïve and prior treatment-failure patients who were treated with a INCIVO regimen in a Phase 2 or Phase 3study and did not achieve SVR, telaprevir-resistant variants were no longer detected in 85% (83/98) of patients (median follow-up of 27.5 months).
Slovenian: V študiji spremljanja 98 predhodno nezdravljenih bolnikov in bolnikov, pri katerih je bilo predhodno zdravljenje neuspešno in so bili zdravljeni s shemo zdravila INCIVO v študiji faze II ali III ter niso dosegli trajnega virološkega odziva, na telaprevir rezistentnih variant niso več našli pri 85% (83/98) bolnikov (mediani čas spremljanja 27,5 mesecev).
English: Gastric lavage should only be performed if this can be done within one hour after ingestion.
Slovenian: Izpiranje želodca lahko uporabite samo kadar ga lahko opravite v času ene ure po zaužitju.
English: Tell your health care provider if you have problems swallowing whole tablets.
Slovenian: Zdravniku morate povedati, če težko pogoltnete celo tableto.
English: 168 film-coated tablets (4 bottles containing 42 tablets each) The bottles are not to be distributed individually.
Slovenian: 168 filmsko obloženih tablet (4 plastenke, ena plastenka vsebuje 42 filmsko obloženih tablet)
English: After repeated oral administration, R-diastereomer of telaprevir (30-fold less active), pyrazinoic acid, and a metabolite that underwent reduction at the α-ketoamide bond of telaprevir (not active) were found to be the predominant
Slovenian: Po večkratnih peroralnih odmerkih so ugotovili, da sta glavna presnovka telaprevirja njegov R-diastereoizomer (ki je 30-krat manj aktiven), pirazinoična kislina in presnovek, ki je reduciran na α-ketoamidni vezi telaprevirja (in ni aktiven).
English: The concomitant use of rifabutin and telaprevir is not recommended.
Slovenian: Sočasna uporaba rifabutina in telaprevirja ni priporočljiva.
English: Common side effects (affects less than 1 in 10 people):
Slovenian: Pogosti neželeni učinki (pojavijo se pri manj kot 1 od 10 bolnikov)
English: Table 8 shows SVR rates for patient subgroups.
Slovenian: V preglednici 8 so podane stopnje virološkega odziva za podskupine bolnikov.
English: INCIVO 375 mg film-coated tablets
Slovenian: INCIVO 375 mg filmsko obložene tablete
English: (2.0-2.4 mEq/l)
Slovenian: (2,0-2,4 mmol/l)
English: HCV/Human immunodeficiency virus type (HIV)-1 co-infection HCV/HIV-1 co-infected patients should be treated in the same way as HCV mono-infected patients.
Slovenian: Sočasna okužba s HCV/virusom humane imunske pomanjkljivosti-1 (HIV-1) Bolnike s sočasno okužbo s HCV in HIV-1 je treba zdraviti enako kot bolnike, ki so okuženi samo s HCV.
English: )/PR] in combination with peginterferon alfa-2a and ribavirin.
Slovenian: )/PR] v kombinaciji s peginterferonom alfa-2a in ribavirinom.
English: The efficacy and safety of INCIVO in patients with genotype 1 chronic hepatitis C were evaluated in four Phase 3 studies: 3 in treatment-naïve patients and 1 in previously treated patients (relapsers, partial responders, and null responders).
Slovenian: Učinkovitost in varnost zdravila INCIVO pri bolnikih z genotipom 1 kroničnega hepatitisa C sta bili ovrednoteni v štirih študijah faze III - tri so bile opravljene pri nezdravljenih bolnikih, ena pa pri predhodno zdravljenih bolnikih (tistih, pri katerih se je bolezen ponovila, tistih, ki so se le delno odzvali na zdravljenje, in tistih, ki se sploh niso odzvali nanj).
English: HCV/HBV (hepatitis B virus) co-infection There are no data on the use of INCIVO in patients with HCV/HBV co-infection.
Slovenian: Sočasna okužba z virusoma HCV in HBV (virus hepatitisa B) Ni podatkov o uporabi zdravila INCIVO pri bolnikih, ki imajo sočasno okužbo s HCV in HBV.
English: - swollen veins in the rectum or anus (haemorrhoids), pain in the anus or rectum;
Slovenian: - otekle vene v danki ali zadnjiku (hemoroidi), bolečine v danki ali zadnjiku,
English: (12.1-15.0 mg/dl)
Slovenian: (121-150 mg/l)
English: oral triazolam
Slovenian: peroralno uporabljen triazolam
English: Based on population sequencing analyses of HCV in these 215 patients, the emergence of telaprevir-resistant HCV variants was detected in 105 (84%) virologic failures and in 55 (61%) relapsers, and wild-type virus was detected in 15 (12%) virologic failures and in 24 (27%) relapsers.
Slovenian: Na podlagi populacijskih sekvencijskih analiz HCV pri teh 215 bolnikih so ugotovili pojav za telaprevir rezistentnih variant HCV pri 105 (84%) primerih virološke neuspešnosti in pri 55 (61%) preiskovancih, pri katerih se je bolezen ponovila, divji tip virusa so ugotovili pri 15 (12%) primerih virološke neuspešnosti in pri 24 (27%) preiskovancih, pri katerih se je bolezen ponovila, medtem ko podatki o sekvencioniranju HCV niso bili na voljo za 16 (7%) bolnikov.
English: Telaprevir may be less effective due to decreased concentrations.
Slovenian: Zaradi zmanjšane koncentracije je lahko telaprevir manj učinkovit.
English: If the rash does not improve within 7 days following INCIVO discontinuation, ribavirin should be interrupted.
Slovenian: Če se izpuščaj v 7 dneh po ukinitvi zdravila INCIVO ne izboljša je treba prekiniti zdravljenje z ribavirinom.
English: Consultation with a specialist in dermatology is recommended.
Slovenian: Posvet z dermatologom je priporočen.
English: All rashes should be monitored for progression and until the rash is resolved.
Slovenian: Napredovanje vseh izpuščajev je treba spremljati, dokler izpuščaji ne izginejo.
English: These active substances include alfuzosin, amiodarone, bepridil, quinidine, astemizole, terfenadine, cisapride, pimozide, ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), lovastatin, simvastatin, atorvastatin, sildenafil or tadalafil (only when used for treatment of pulmonary arterial hypertension), quetiapine and orally administered midazolam or triazolam (see section 4.5).
Slovenian: Med te zdravilne učinkovine sodijo na primer alfuzosin, amiodaron, bepridil, kinidin, astemizol, terfenadin, cisaprid, pimozid, ergot alkaloidi (dihidroergotamin, ergonovin, ergotamin, metilergonovin), lovastatin, simvastatin, atorvastatin, sildenafil ali tadalafil (samo pri uporabi za zdravljenje pljučne arterijske hipertenzije), kvetiapin ter peroralno uporabljen midazolam ali triazolam (glejte poglavje 4.5).
English: A lower ribavirin dose (600 mg/day) at initiation of INCIVO treatment is recommended (see section 5.1).
Slovenian: Ob uvedbi zdravljenja z zdravilom INCIVO je priporočljiva uporaba manjšega odmerka ribavirina (600 mg/dan) (glejte poglavje 5.1).
English: The incidence of adverse drug reactions (ADRs) of at least moderate intensity (≥ Grade 2) was higher in the INCIVO group than in the placebo group.
Slovenian: Pogostnost neželenih učinkov zdravila najmanj zmerne jakosti (≥ 2. stopnje) je bila višja v skupini, ki je prejemala zdravilo INCIVO, kot v skupini, ki je prejemala placebo.
English: 21.6% of patients receiving INCIVO combination treatment required ribavirin dose reduction for anaemia compared to 9.4% of patients receiving peginterferon alfa and ribavirin alone.
Slovenian: Pri 21,6% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO, je bilo potrebno zmanjšanje odmerka ribavirina zaradi anemije za razliko od 9,4% bolnikov, ki so prejemali samo peginterferon alfa in ribavirin.
English: Patients receiving cyclosporine A N = 24 % (n/N)
Slovenian: Bolniki, ki so prejemali ciklosporin A N = 24 % (n/N)
English: Each bottle contains one pouch or two pouches of desiccant to keep the tablets dry.
Slovenian: Vsaka plastenka vsebuje eno ali dve vrečki s sušilnim sredstvom, ki zagotavlja, da so tablete suhe.
English: Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d.
Slovenian: Študija C211 je bila randomizirana, odprta študija faze III pri še nezdravljenih bolnikih, ki so bili naključno razdeljeni v eno izmed dveh skupin: INCIVO 750 mg na 8 ur [T12(q8h)/PR] ali INCIVO 1.125 mg dvakrat na dan [T12(b.i.d.
English: There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years.
Slovenian: Na voljo je le malo farnakokinetičnih podatkov o uporabi zdravila INCIVO pri bolnikih s HCV, starih ≥ 65 let.
English: The exposure (AUC) to telaprevir increased slightly greater than proportionally to the dose after single-dose administration of 375 up to 1,875 mg with food, possibly due to saturation of metabolic
Slovenian: Stopnja izpostavljenosti (AUC) telaprevirju po jemanju enkratnega odmerka od 375 do 1.875 mg s hrano je naraščala nekoliko več kot premosorazmerno odmerku, morda zaradi nasičenja presnovnih
English: Mild rash: localised skin eruption and/or a skin eruption with a limited distribution (up to several isolated sites on the body)
Slovenian: Blag izpuščaj: lokaliziran izpuščaj in/ali omejen izpuščaj (nekaj izoliranih mest na telesu)
English: Your doctor will do blood tests before starting treatment and regularly during your treatment: - to see how much virus is in your blood and to determine if you have the type of virus (genotype 1) that can be treated with INCIVO.
Slovenian: - spremljal, koliko virusa je v vaši krvi in ugotovil, ali ste okuženi s tipom virusa (genotipom 1), ki ga lahko zdravimo z zdravilom INCIVO.
English: - painful inflammation of the joints most commonly in the foot (gout);
Slovenian: - boleče vnetje sklepov (največkrat na nogi) (protin)
English: Figure 2: Duration of treatment for previously treated patients with prior partial or prior
Slovenian: Slika 2: trajanje zdravljenja pri predhodno zdravljenih bolnikih z delnim odzivom na
English: You must not reduce your dose of INCIVO.
Slovenian: Odmerka zdravila INCIVO ne smete zmanjšati.
English: In the description of the Phase 3 study outcomes for Study C211, HPC3008 and HPC3006, SVR12, considered virologic cure, was defined based on HCV RNA below the limit of quantification (25 IU/ml) using the last measurement in the visit window 12 weeks after the planned end of
Slovenian: V opisu izidov študij faze III za študiji C211, HPC3008 in HPC3006 je bil SVR12 (virološka ozdravljenost) določen na osnovi ocene HCV RNK pod mejo kvantifikacije (25 i.e./ml) 12. tednov po načrtovanem zaključku zdravljenja, z uporabo zadnje meritve v tem obdobju.
English: On-treatment-virologic failure includes patients who met a protocol-defined virologic stopping rule and/or had viral
Slovenian: Virološki neuspeh med zdravljenjem vključuje bolnike, ki so ustrezali v protokolu določenim kriterijem za prekinitev zdravljenja in/ali so imeli virusni preboj.
English: INCIVO has not been studied in HCV-infected patients with moderate hepatic impairment (Child-Pugh B, score 7-9).
Slovenian: Zdravila INCIVO niso preučevali pri s HCV okuženih bolnikih z zmerno okvaro jeter (razred B po Child-Pughu, ocena 7-9).
English: Do not drive or operate machines if you feel faint or have problems with your vision while taking INCIVO.
Slovenian: Med jemanjem zdravila INCIVO ne vozite in ne upravljajte s stroji, če čutite, da boste omedleli
English: Signs might be yellowing of the skin or eyes (jaundice), swelling of the stomach (ascites) or legs due to fluid, and bleeding from swollen veins (varices) in the gullet (oesophagus).
Slovenian: Med njihove znake lahko sodijo porumenelost kože ali oči (zlatenica), otekanje trebuha (ascites) ali nog zaradi kopičenja tekočin in krvavitev iz oteklih ven (varic) požiralnika.
English: See also the Summary of Product
Slovenian: Preberite si tudi Povzetek glavnih značilnosti zdravila
English: Following administration of a single oral dose of 750 mg
Slovenian: Izločanje Po jemanju enkratnega peroralnega 750 mg odmerka s C
English: DRESS presents as a rash with eosinophilia associated with one or more of the following features: fever, lymphadenopathy, facial oedema, and internal organ involvement (hepatic, renal, pulmonary).
Slovenian: Sindrom DRESS vključuje izpuščaj z eozinofilijo, povezan z enim ali več izmed naslednjih simptomov: zvišana telesna temperatura, limfadenopatija, edem obraza in prizadetost notranjih organov (jetra, ledvica, pljuča).
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Slovenian: Priporočljivo je, da med sočasno uporabo varfarina s telaprevirjem spremljate vrednost mednarodnega normaliziranega količnika (INR).
English: The recommended total duration of treatment for patients who have received a liver transplant is 48 weeks.
Slovenian: Pri bolnikih s presajenimi jetri je priporočeno celotno trajanje zdravljenja 48 tednov.
English: For patients receiving a total of 48 weeks of treatment, peginterferon alfa and ribavirin should be discontinued if HCV RNA is detectable at week 24 or week 36.
Slovenian: Pri bolnikih, ki so se zdravili vseh 48 tednov, je treba zdravljenje s peginterferonom alfa, in ribavirinom ukiniti, če je koncentracija HCV RNK zaznavna v 24. ali 36. tednu.
English: Plasma concentrations with the telaprevir 1,875 mg every 8 hours dose used in this trial were comparable to those observed in studies in HCV-infected patients who received telaprevir 750 mg every 8 hours in combination with peginterferon alfa-2a and ribavirin.
Slovenian: Plazemske koncentracije pri odmerku telaprevirja 1.875 mg na vsakih 8 ur, ki je bil uporabljen v tem preskušanju, so bile podobne kot pri tistih, ki so jih opažali v študijah pri s HCV okuženih bolnikih, ki so prejemali telaprevir v odmerku 750 mg na vsakih 8 ur, v kombinaciji s peginterferonom alfa-2a in