natgillin/translations-raw huggingface dataset:
Transporters In vitro studies demonstrated that telaprevir is an inhibitor of OATP1B1 and OATP2B1. 
In vitro študije so pokazale, da telaprevir zavira prenašalca OATP1B1 in OATP2B1.
Patients were required to have an HIV-1 RNA < 50 copies/ml 
Bolniki so morali imeti na presejalnem pregledu < 50 kopij RNK HIV-1/ml, število celic CD4 ≥ 300 celic/mm
Replicons with single substitutions at position 155 or 156 and double variants with substitutions at residues 36 and 155 showed cross-resistance to all protease inhibitors tested with a wide range of sensitivities. 
Pri variantah, rezistentnih na telaprevir, so testirali navzkrižno rezistenco proti reprezentativnim zaviralcem proteaze v sistemu replikonov HCV. Replikoni z eno samo substitucijo na mestu 155 ali 156 in dvojne variante s substitucijami na ostankih 36 in 155 so pokazale navzkrižno rezistenco za vse testirane zaviralce proteaze s širokim razponom občutljivosti.
(< 2.0 mEq/l) 
(< 2,0 mmol/l)
Table 15 shows the response rates for the T12/PR48 and the Pbo/PR48 arms. 
V preglednici 15 so prikazane stopnje odziva za kraka T12/PR48 in Pbo/PR48.
- Adequately controlled thyroid function (TSH) - Calculated creatinine clearance ≥ 50 ml/min 
- absolutno število nevtrofilcev ≥ 1.500/mm - zadosten nadzor delovanja ščitnice (TSH) - izračunan očistek kreatinina ≥ 50 ml/min
In placebo-controlled Phase 2 and 3 trials, 0.4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). 
V s placebom nadzorovanih preskušanjih faze II ali III je imelo 0,4% bolnikov sum na medikamentozni izpuščaj z eozinofilijo in sistemskimi simptomi (sindrom DRESS).
No specific antidote is available for overdose with INCIVO. 
Za preveliko odmerjanje zdravila INCIVO ni specifičnega antidota.
↑ alprazolam AUC 1.35 (1.23-1.49) Cmax 0.97 (0.92-1.03) 
↑ alprazolama AUC 1,35 (1,23-1,49) Cmax 0,97 (0,92-1,03)
In treatment-naïve patients in the Phase 3 studies, 4/16 (25%) patients with HCV RNA levels between 100 IU/ml and 1,000 IU/ml at week 4 achieved SVR. 
V študijah faze III pri bolnikih, ki še niso bili zdravljeni, so 4/16 (25%) bolniki s koncentracijami HCV RNK med 100 i.e./ml in 1.000 i.e./ml v 4. tednu dosegli SVR.
If you are taking any of the above, ask your doctor about switching to another medicine. 
Če jemljete katerokoli izmed naštetih zdravil, prosite zdravnika, da vam ga zamenja z drugim.
Janssen Cilag International NV 
Janssen Cilag International NV Turnhoutseweg 30
If improvement is not observed within 7 days of INCIVO discontinuation, sequential or simultaneous interruption or discontinuation of ribavirin and/or peginterferon alfa should be considered. 
Če se izpuščaj v 7 dneh po ukinitvi zdravila INCIVO ne izboljša bo lahko potrebna tudi postopna ali sočasna prekinitev zdravljenja s peginterferonom alfa in/ali ribavirinom.
When administered every 8 hours (q8h), in case a dose of INCIVO is missed within 4 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible. 
Jemanje zdravila na osem ur: v primeru, da bolnik pozabi vzeti odmerek zdravila INCIVO do 4 ure po času, ko ga običajno jemlje, mu naročite, naj čimprej vzame predpisani odmerek zdravila INCIVO s hrano.
Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin which are contraindicated in Child-Pugh score ≥ 6. 
Preberite tudi Povzetek glavnih značilnosti zdravil peginterferon alfa in ribavirin, ki sta pri bolnikih z oceno ≥ 6 po Child-Pughu kontraindicirana.
INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring (see section 4.4). 
Pri bolnikih, ki jemljejo antiaritmika razreda Ic propafenon in flekainid je potrebna previdnost, vključno z ustreznim kliničnim spremljanjem in spremljanjem EKG (glejte poglavje 4.4).
The frequency rate of the side effects associated with INCIVO is given below. 
Stopnje pogostnosti neželenih učinkov, povezanih z zdravilom INCIVO so navedene v nadaljevanju.
For all populations in the study (prior relapsers, prior partial responders, and prior null responders), SVR rates were higher 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 level, and extent of liver fibrosis. 
Pri vseh populacijah v tej študiji (pri bolnikih, ki so imeli predhodno ponovitev bolezni, bolnikih, ki so se prej delno odzvali na zdravljenje, in bolnikih, ki se prej niso odzvali nanj), so bile stopnje trajnega virološkega odziva večje v skupini T12/PR kot v skupini Pbo/PR48 po podskupinah glede na spol, starost, raso, etnično pripadnost, indeks telesne mase, podtip genotipa HCV, začetne vrednosti HCV RNK in obseg jetrne fibroze.
These can be seen in the results from blood tests. 
Vse to bo izvedel iz izvidov preiskav krvi in vam pojasnil.
The use of INCIVO in combination with peginterferon alfa-2b The Phase 3 studies were all conducted with peginterferon alfa-2a in combination with INCIVO and ribavirin. 
Uporaba zdravila INCIVO skupaj s peginterferonom alfa-2b Vse študije faze III so bile izvedene z uporabo peginterferona alfa-2a v kombinaciji z zdravilom INCIVO in ribavirinom.
Decisions related to your treatment may be made based on the results of these tests. 
Na osnovi izvidov teh preiskav se bo zdravnik lahko odločil o načinu vašega zdravljenja.
The mean telaprevir Cmax and AUC were 10% and 21% greater, respectively, compared to healthy subjects (see section 4.2). 
Srednja vrednost Cmax za telaprevir je bila za 10% večja in srednja vrednost AUC za 21% večja kot pri zdravih preiskovancih
The difference in SVR rates (95% confidence interval) between the T12/PR and Pbo/PR groups was 33 (26, 39). 
Med skupinama T12/PR in Pbo/PR je bila razlika v stopnjah SVR (95% interval zaupanja) 33 (26, 39).
In the event that co-administration of such medicinal products with INCIVO is judged strictly necessary, clinical monitoring including ECG assessments is recommended. 
Če ocenite, da je sočasna uporaba takšnih zdravil z zdravilom INCIVO potrebna, je priporočljivo klinično spremljanje, vključno s snemanjem EKG.
↑ ketoconazole (400 mg) AUC 1.46 (1.35-1.58) Cmax 1.23 (1.14-1.33) 
↑ ketokonazola (400 mg) AUC 1,46 (1,35-1,58) Cmax 1,23 (1,14-1,33)
General disorders and administration site conditions common oedema peripheral, product taste abnormal the placebo-controlled Phase 2 and Phase 3 Studies (pooled data) included 1,346 HCV-infected patients incidence rates are based on adverse event reporting rates (additionally, see Laboratory abnormalities below) 
na mestu aplikacije periferni edem, nenormalen okus zdravila s placebom nadzorovane študije faze II in faze III (združeni podatki) so vključevale 1.346 s HCV okuženih bolnikov stopnje pogostnosti temeljijo na stopnjah poročil o neželenih učinkih (dodatno glejte Nenormalni laboratorijski izvidi v nadaljevanju)
If INCIVO is discontinued for anaemia, patients may continue treatment with peginterferon alfa and ribavirin. 
Če ste ukinili zdravilo INCIVO zaradi anemije, bolnik lahko nadaljuje zdravljenje s peginterferonom alfa in ribavirinom.
Permanently discontinue INCIVO immediately. 
Takoj ukinite zdravilo INCIVO.
Co-administration with carbamazepine is contraindicated. 
Sočasna uporaba s karbamazepinom je kontraindicirana.
The impact of predominant telaprevir-resistant variants at baseline is likely greatest in patients with a poor interferon response, 
Pomen prevladujočih na telaprevir odpornih variant pred začetkom zdravljenja je verjetno največji pri bolnikih s slabim odzivom na interferon, kot so na primer bolniki, ki se niso odzvali na zdravljenje.
The study enrolled prior relapsers (patients with HCV RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow-up) and prior non-responders (patients who did not have undetectable HCV RNA levels during or at the end of a prior course of at least 12 weeks of treatment). 
V to študijo so vključili bolnike, ki so imeli predhodno ponovitev bolezni (bolnike z nezaznavno HCV RNK ob koncu zdravljenja pri uporabi sheme zdravljenja na osnovi pegiliranega interferona, ki pa so imeli zaznavno HCV RNK 24 tednov po spremljanju bolnikov) in bolnike, ki se predhodno niso odzvali na zdravljenje (bolnike, ki niso imeli nemerljive HCV RNK med ali ob koncu predhodnega ciklusa, ki je zajemal najmanj 12 tednov zdravljenja).
INCIVO in combination with peginterferon alfa and ribavirin was evaluated in 74 HCV-1 infected, post-liver transplant patients without cirrhosis receiving either tacrolimus or cyclosporine A. At the initiation of INCIVO treatment, doses of co-administered tacrolimus or cyclosporine A need to be markedly reduced, including a prolongation in the dosing interval for tacrolimus, in order to maintain therapeutic plasma concentrations of the immunosuppressant. 
Zdravilo INCIVO v kombinaciji s peginterferonom alfa in ribavirinom so ocenjevali pri 74 s HCV-1 okuženih bolnikih s presajenimi jetri brez ciroze, ki so prejemali takrolimus ali ciklosporin A. Ob uvedbi zdravljenja z zdravilom INCIVO je bilo za vzdrževanje terapevtskih plazemskih koncentracij imunosupresiva potrebno zelo zmanjšati odmerek sočasno uporabljenega takrolimusa (vključno s podaljšanjem intervala odmerjanja takrolimusa) ali ciklosporina A. Po zaključku zdravljenja z zdravilom INCIVO je bilo potrebno odmerek takrolimusa ali ciklosporina A zvečati in skrajšati interval odmerjanja takrolimusa.
Multiple metabolites were detected in faeces, plasma, and urine. 
V blatu, plazmi in seču so odkrili več presnovkov.
Predominant baseline resistance to telaprevir does not preclude successful treatment with telaprevir, peginterferon alfa, and ribavirin. 
Prevladujoča začetna rezistenca za telaprevir pa ne izključuje možnosti uspešnega zdravljenja s telaprevirjem, peginterferonom alfa in ribavirinom.
Telaprevir is a weak in vitro inhibitor of the transporters multidrug and toxin extrusion (MATE) MATE1 and MATE2-K with an IC50 of 28.3 μM and 32.5 μM, respectively. 
In vitro je telaprevir šibek zaviralec prenašalcev MATE-1 (IC50 28,3 μmol/l) in MATE2-K (IC50 32,5 μmol/l).
In the event that treatment with INCIVO in such patients is judged strictly necessary, patients should be closely monitored, including ECG assessments. 
Če menite, da je zdravljenje z zdravilom INCIVO pri takšnih bolnikih res nujno, jih morate skrbno nadzirati, vključno s snemanjem EKG.
If you need help, ask your doctor or pharmacist. 
Če potrebujete pomoč, se posvetujte s svojim zdravnikom ali s farmacevtom.
Use of INCIVO in treatment of other HCV genotypes There are not sufficient clinical data to support the treatment of patients with HCV genotypes other than genotype 1. 
Uporaba zdravila INCIVO pri zdravljenju okužbe z drugimi genotipi HCV Ni zadostnih kliničnih podatkov, ki bi govorili v prid zdravljenju bolnikov z drugimi genotipi HCV (razen genotipa 1), zato uporaba zdravila INCIVO pri bolnikih, ki so okuženi s HCV drugih genotipov
Patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 
Bolniki z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu
The difference in SVR rates (95% confidence interval) between the T12/PR and Pbo/PR groups were 63 (51, 74) for prior relapsers, 46 (27, 66) for prior partial responders, and 26 (13, 
Razlika v stopnji trajnega virološkega odziva (95% interval zaupanja) med skupinama T12/PR in Pbo/PR je bila 63 (51, 74) za bolnike, ki so imeli predhodno ponovitev bolezni, 46 (27, 66) za tiste, ki so se prej delno odzvali na zdravljenje, in 26 (13, 39) za tiste, ki se prej niso odzvali na zdravljenje.
Caution is warranted and clinical monitoring of patients is recommended. 
Potrebna je previdnost in priporočljivo je klinično spremljanje bolnika.
Co-administration of INCIVO and medicinal products that induce CYP3A and/or P-gp may markedly decrease telaprevir plasma concentrations. 
Sočasna uporaba zdravila INCIVO in zdravil, ki inducirajo izoencim CYP3A in/ali P-gp, lahko izrazito zmanjša plazemske koncentracije telaprevirja.
Table 16 shows the response rates in treatment-naïve patients and in treatment-experienced patients by subgroup (treatment-naïve, prior relapsers and prior non-responders). 
V preglednic 16 so prikazane stopnje odziva pri nezdravljenih in zdravljenih bolnikih po podskupinah (nezdravljeni bolniki, bolniki s ponovitvijo bolezni in bolniki, ki se na zdravljenje niso odzvali).
Improvement of rash occurs after INCIVO dosing completion or discontinuation; however, rashes may take several weeks to 
Po zaključku zdravljenja z zdravilom INCIVO ali po njegovi ukinitvi običajno pride do izboljšanja izpuščaja, vendar lahko traja tudi nekaj tednov, da izpuščaj izgine.
(> 15.0 mg/dl) 
(> 150 mg/l)
In HCV negative patients with moderate hepatic impairment, reduced exposure to telaprevir was observed. 
Pri bolnikih, z zmerno okvaro jeter, ki niso bili okuženi s HCV, so opazili zmanjšano izpostavljenost telaprevirju.
Telaprevir had no effects on fertility or fecundity when evaluated in rats. 
Plodnost Telaprevir ni vplival na plodnost pri podganah.
Table 2 provides dosing recommendations as a result of drug interactions with INCIVO. 
V preglednici 2 so podana priporočila za odmerjanje glede na medsebojna delovanja zdravila INCIVO z drugimi zdravili.
In patients who have an inadequate viral response, treatment should be discontinued (see sections 4.2 and 4.4, Laboratory tests). 
Nezadosten virološki odziv Pri bolnikih z nezadostnim virološkim odzivom je treba zdravljenje ukiniti (glejte poglavji 4.2 in 4.4,
Histopathological findings in the liver were similar in both rat and dog studies, of which not all were fully resolved after recovery. 
Histopatološke ugotovitve so bile pri študijah na podganah in psih podobne, pri čemer se vse spremembe po odtegnitvi zdravila niso normalizirale.
Dosage adjustment of fentanyl or alfentanil may be necessary. 
Morda bo potrebno prilagoditi odmerek fentanila oz. alfentanila.
Caution is warranted and clinical monitoring is recommended for itraconazole, posaconazole, and voriconazole. 
Potrebna je previdnost in priporočljivo je klinično spremljanje bolnikov pri uporabi itrakonazola, posakonazola in vorikonazola.
INCIVO must always be taken together with food. 
Zdravilo INCIVO morate vedno jemati s hrano.
Peginterferon alfa-2a/peginterferon alfa-2b and ribavirin were used according to their relevant Summary of Product Characteristics. 
Peginterferon alfa-2a oz. peginterferon alfa-2b in ribavirin so uporabljali v skladu z njunimi Povzetki
Each tablet of INCIVO contains 375 mg of telaprevir. 
Ena tableta zdravila INCIVO vsebuje 375 mg telaprevirja.
Erythropoisis-stimulating agents (ESAs) were generally not permitted and used in only 1% of patients in the Phase 2 and 3 clinical trials. 
Uporabljali so jih samo pri 1% bolnikov v kliničnih preskušanjih faze II in III.
Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon-based therapies (e.g., hepatic decompensation, serious bacterial infections). 
Uporaba pri bolnikih z napredovalo jetrno boleznijo Ugotovili so, da sta hipoalbuminemija in majhno število trombocitov napovednika hudih zapletov (npr. dekompenzirane bolezni jeter in hudih bakterijskih okužb) tako pri jetrni bolezni, kot tudi pri zdravljenju, ki vsebuje interferon.
During INCIVO treatment, rash events (all grades) were reported in 55% of patients who received INCIVO combination treatment and in 33% of patients who received peginterferon alfa and ribavirin. 
Med zdravljenjem z zdravilom INCIVO so o izpuščajih (vseh stopenj) poročali pri 55% bolnikov, ki so prejemali zdravilo INCIVO pri kombiniranem zdravljenju, in pri 33% bolnikov, ki so prejemali peginterferon alfa in ribavirin.
metformin to treat diabetes (antidiabetics) 
metformin za zdravljenje sladkorne bolezni tipa II (antidiabetiki)
No fibrosis, minimal fibrosis, or portal fibrosis 
Ni fibroze, minimalna fibroza ali portalna fibroza
Based on the results of drug-drug clinical interaction studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded. 
Na osnovi rezultatov študij medsebojnega delovanja z drugimi učinkovinami (npr. escitalopram, zolpidem, etinilestradiol), ne moremo izključiti indukcije presnovnih encimov s
No relevant induction by telaprevir of CYP1A2, CYP2B6, CYP2C, and CYP3A isozymes was observed in vitro. 
In vitro niso opazili pomembne, s telaprevirjem povzročene, indukcije izoencimov CYP1A2, CYP2B6, CYP2C, in CYP3A.
Administration of activated charcoal may also be used to aid in the removal of 
Kot pomoč pri odstranjevanju neabsorbirane zdravilne učinkovine lahko uporabite tudi aktivno oglje.
Your doctor should check your rash to determine how to manage it. 
Zdravnik vas bo pregledal, da ugotovi, kako pozdraviti izpuščaj.
Exposure at this dose was comparable to the exposure in HCV-infected patients receiving a dose of 750 mg INCIVO every 8 hours plus peginterferon alfa and ribavirin. 
Pri tem odmerku je bila izpostavljenost zdravilu podobna izpostavljenosti pri bolnikih, okuženih s HCV, ki so prejemali 750 mg odmerek zdravila INCIVO na 8 ur, skupaj s peginterferonom alfa in ribavirinom.
• The Patient Information Leaflet 
• Navodilo za uporabo za bolnike
Refer to section 4.3 for a listing of medicinal products that are contraindicated for use with INCIVO due to potentially life-threatening adverse events or potential loss of therapeutic effect to INCIVO. 
Seznam učinkovin, ki so, zaradi možnosti pojava življenju nevarnih neželenih učinkov ali možnosti izgube terapevtskega učinka, kontraindicirane pri uporabi zdravila INCIVO, je v poglavju 4.3.
(< 7.0 g/dl) 
(< 70 g/l)
Patients received INCIVO at a dosage of 750 mg every 8 hours, except for patients on an efavirenz-based regimen who received INCIVO at a dosage of 1,125 mg every 8 hours. 
Bolniki so prejemali 750 mg zdravila INCIVO na 8 ur, bolniki na osnovni shemi z efavirenzom pa so prejemali 1.125 mg zdravila INCIVO na 8 ur.
A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12. 
Skupaj 352 (65%) bolnikov je imelo nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu, v preglednici 9 pa so podane stopnje odziva.
- who have previously been treated with interferon alfa (pegylated or non-pegylated) alone or in combination with ribavirin, including relapsers, partial responders and null responders (see 
- pri bolnikih, ki so bili že zdravljeni z interferonom alfa (pegiliranim ali nepegiliranim) v monoterapiji ali v kombinaciji z ribavirinom, vključno z bolniki, pri katerih se je bolezen ponovila, oziroma pri bolnikih, ki so se na zdravljenje odzvali delno ali se na zdravljenje niso
See section 4.4 for recommendations for monitoring of rash and discontinuation of INCIVO, ribavirin, and peginterferon alfa. 
Glejte poglavje 4.4 za priporočila o spremljanju izpuščaja in prekinitvi zdravljena z zdravilom INCIVO, ribavirinom in interferonom alfa.
Doses may need to be increased when combined with telaprevir. 
Pri sočasni uporabi s telaprevirjem bo morda potrebno zvišati odmerke.
At baseline, 3 (8%) patients had bridging fibrosis and 2 (5%) patients had cirrhosis in the T12/PR48 arm. 
Na začetku zdravljenja so imeli v kraku T12/PR48 mostno fibrozo 3 bolniki (8%) in cirozo 2 bolnika (5%).
Based on the results of drug-drug interaction clinical studies (e.g., escitalopram, zolpidem, ethinylestradiol), induction of metabolic enzymes by telaprevir cannot be excluded. 
Na osnovi rezultatov kliničnih preskušanj medsebojnih delovanj z drugimi učinkovinami (npr. escitalopram, zolpidem, etinilestradiol) ne moremo izključiti verjetnosti, da telaprevir inducira presnovne encime.
These are recommended baseline values for initiation of INCIVO combination treatment: - Haemoglobin: ≥ 12 g/dl (females); ≥ 13 g/dl (males) 
- hemoglobin: ≥ 120 g/l (ženske); ≥ 130 g/l (moški)
Alternatively, telaprevir can be administered orally with food as 375 mg tablets, 750 mg every 8 hours (q8h) for 12 weeks, in combination with peginterferon alfa and ribavirin. 
Telaprevir lahko bolniki jemljejo tudi peroralno s hrano v obliki 375 mg tablet, in sicer 750 mg na osem ur 12 tednov, v kombinaciji s peginterferonom alfa in ribavirinom.
oral midazolam* 
peroralno uporabljen midazolam*
Undetectable HCV RNA (target not detected) at 
koncentracijo HCV RNK (nezaznaven analit) v
INCIVO acts against the virus that causes hepatitis C infection and is used to treat chronic hepatitis C infection in adult patients (aged 18-65 years) in combination with peginterferon alfa and ribavirin. 
Zdravilo INCIVO deluje proti okužbi z virusom hepatitisa C in se v kombinaciji s peginterferonom alfa in ribavirinom uporablja za zdravljenje kronične okužbe z virusom hepatitisa C pri odraslih (starih 18-65 let).
alprazolam* 
etravirin*
Clinical and laboratory monitoring for hyperbilirubinaemia is recommended (see section 4.4 and 4.8). 
Zaradi pogoste hiperbilirubinemije je priporočeno klinično in laboratorijsko spremljanje bolnika (glejte poglavji 4.4 in 4.8).
INCIVO should be administered in conjunction with ribavirin and either peginterferon alfa-2a or -2b. 
Zdravilo je treba uporabljati skupaj z ribavirinom in peginterferonom alfa-2a ali -2b.
An increase in dose from 750 mg every 8 hours to 1,875 mg every 8 hours in a multiple-dose study resulted in a less than proportional increase (i.e., about 40%) in telaprevir exposure. 
Zvečanje odmerka v študiji uporabe večkratnih odmerkov s 750 mg na 8 ur na 1.875 mg na 8 ur je vodilo do zvečanja izpostavljenosti telaprevirju, ki je bilo za približno 40% manjše od
It is not recommended to co-administer sildenafil or vardenafil and telaprevir. 
Sočasna uporaba sildenafila ali vardenafila in telaprevirja ni priporočena.
Neither telaprevir nor its major metabolite caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation. 
Tako telaprevir kot tudi njegov glavni presnovek v običajni skupini testov mutagenosti (ob presnovni aktivaciji ali brez nje) nista povzročila poškodb DNA.
In patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12, there was no additional benefit to extending peginterferon alfa-2a and ribavirin treatment to 48 weeks (difference in SVR rates of 2%; 95% confidence interval: -4%, 8%). 
Pri bolnikih, ki so imeli nezaznavno HCV RNK v 4. in 12. tednu, ni bilo dodatne koristi od podaljšanja zdravljenja s peginterferonom alfa-2a in ribavirinom na 48 tednov (razlika v stopnji trajnega virološkega odziva je bila 2%; 95% interval
↑ ketoconazole (200 mg) AUC 2.25 (1.93-2.61) Cmax 1.75 (1.51-2.03) 
↑ ketokonazola (200 mg) AUC 2,25 (1,93-2,61) Cmax 1,75 (1,51-2,03)
Co-administration of INCIVO and medicinal products that inhibit CYP3A and/or P-gp may increase telaprevir plasma concentrations. 
Sočasna uporaba zdravila INCIVO in drugih zdravil, ki zavirajo izoencim CYP3A in/ali P-gp, lahko zveča plazemske koncentracije telaprevirja.
The total dose is 6 tablets or - 2 tablets of INCIVO every 8 hours with food. 
- 2 tableti zdravila INCIVO na vsakih 8 ur s hrano.
If medically indicated, earlier interruption or discontinuation of peginterferon alfa and ribavirin may be needed. 
Če je indicirano, bo lahko potrebno prej prekiniti ali ukiniti zdravljenje s peginterferonom alfa in ribavirinom.
Bridging fibrosis Cirrhosis 
Mostna fibroza
Permanent and immediate discontinuation of INCIVO, peginterferon alfa, and ribavirin. 
Stalna in takojšnja prekinitev zdravljenja z zdravili INCIVO, peginterferon alfa, in ribavirin.
Within each frequency grouping, ADRs are presented in order of decreasing seriousness. 
V kategorijah pogostnosti so neželeni učinki navedeni po padajoči resnosti.
In Phase 3 studies, a sensitive real-time PCR assay with a limit of quantification of 25 IU/ml and a limit of detection of 10-15 IU/ml was used to determine whether HCV RNA levels were undetectable (target not detected) (see section 5.1). 
V študijah faze III so za določanje, ali so koncentracije HCV RNK nezaznavne (nezaznaven analit), uporabljali metodo PCR (Polymerase Chain Reaction) z mejo kvantifikacije 25 i.e./ml in mejo detekcije 10-15 i.e./ml (glejte poglavje 5.1).