natgillin/translations-raw huggingface dataset:
The study was designed to compare SVR rates in patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 who were treated with INCIVO for 12 weeks in combination with peginterferon alfa-2a and ribavirin for either 24 weeks (T12/PR24 regimen) or 48 weeks (T12/PR48 regimen). 
Načrt študije je bil namenjen primerjavi stopnje trajnega virološkega odziva pri bolnikih z nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu, ki so bili zdravljeni z zdravilom INCIVO 12 tednov v kombinaciji s peginterferonom alfa-2a in ribavirinom za bodisi 24 tednov (shema T12/PR24) ali pa 48 tednov (shema T12/PR48).
All of these reactions resolved with treatment 
Vsi omenjeni učinki so izginili po ukinitvi zdravljenja.
Store in the original bottle. 
Shranjujte v originalni plastenki.
Co-administration of atorvastatin and telaprevir is contraindicated (see section 4.3). 
Sočasna uporaba atorvastatina in telaprevirja je kontraindicirana (glejte poglavje 4.3).
Plasma concentrations of telaprevir can be reduced by concomitant use of the herbal preparation St John's wort (Hypericum perforatum). 
Plazemska koncentracija telaprevirja je lahko zmanjšana pri sočasni uporabi zeliščnega pripravka šentjanževke (Hypericum perforatum), zato zeliščnih pripravkov, ki vsebujejo šentjanževko, ne smete
INCIVO must not be administered concurrently with Class Ia or III antiarrhythmics, except for 
Zdravila INCIVO ne smete predpisovati sočasno z antiaritmiki razreda Ia ali III (izjema je intravensko
There is no data using INCIVO in combination with peginterferon alfa-2b in treatment-experienced patients and limited data in treatment-naïve patients. 
O uporabi zdravila INCIVO v kombinaciji s peginterferonom alfa-2b pri bolnikih, ki so že bili zdravljeni, ni podatkov; pri bolnikih, ki še niso bili zdravljeni je podatkov malo.
Haemoglobin values of < 8.5 g/dl were observed in 8% of INCIVO combination treatment compared to 2% of patients receiving peginterferon alfa and ribavirin. 
Koncentracije hemoglobina < 85 g/l so ugotovili pri 8% kombiniranih zdravljenj z zdravilom INCIVO, v primerjavi z 2% bolnikov, ki so prejemali peginterferon alfa in ribavirin.
If you notice the missed dose after 6 hours, then skip the intake and take the next doses as usual. 
Če pa se na pozabljen odmerek spomnite po 6 urah, preskočite to jemanje zdravila in jemljite naslednje odmerke kot običajno.
Peginterferon alfa and ribavirin may be continued. 
Zdravljenje s peginterferonom alfa in ribavirinom se lahko nadaljuje.
INCIVO is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome, see section 4.4). 
Uporaba zdravila INCIVO pri bolnikih z zmerno do hudo okvaro jeter (razred B ali C po Child-Pughu, ocena ≥ 7) ali z dekompenzirano boleznijo jeter (ascites, krvavitev iz varic zaradi portalne hipertenzije, encefalopatija, in/ali zlatenica, ki ni povezana z Gilberovim sindromom) ni priporočljiva (glejte poglavje 4.4).
hypromellose acetate succinate, calcium hydrogen phosphate (anhydrous), microcrystalline cellulose, silica colloidal anhydrous, sodium lauryl sulphate, croscarmellose sodium, sodium polyvinyl alcohol, macrogol, talc, titanium dioxide (E171), iron oxide yellow (E172) 
hipromeloza acetat sukcinat, kalcijev hidrogenfosfat (brezvodni), mikrokristalna celuloza, koloidni brezvodni silicijev dioksid, natrijev lavrilsulfat, premreženi natrijev karmelozat,
- For all patients with cirrhosis irrespective of undetectable HCV RNA (target not detected) at weeks 4 or 12, an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks is recommended (see section 5.1). 
- Pri vseh bolnikih s cirozo, ne glede na nezaznavno koncentracijo HCV RNK (nezaznaven analit) v 4. ali v 12. tednu, je priporočljivo, da prejemajo samo peginterferon alfa in ribavirin še dodatnih 36 tednov, do skupnega trajanja zdravljenja 48 tednov (glejte poglavje 5.1).
In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued INCIVO alone due to anaemia, and 0.9% of patients discontinued INCIVO combination treatment due to anaemia compared to 0.5% receiving peginterferon alfa and ribavirin (see section 4.4). 
V s placebom nadzorovanih preskušanjih faze II in III so zaradi anemije pri 2,7% bolnikov ukinili samo zdravilo INCIVO, pri 0,9% bolnikov so ukinili kombinirano zdravljenje z zdravilom INCIVO, za razliko od 0,5% bolnikov, ki so prejemali peginterferon alfa in ribavirin (glejte poglavje 4.4).
(e.g., CYP1A1, CYP1A2, BCRP, OATPs) regulated by the same nuclear receptors, the potential clinical impact is unknown. 
Morebitni klinični vpliv na druge encime in prenašalce (npr. CYP1A1, CYP1A2, BCRP, OATP), ki jih regulirajo isti jedrni receptorji, ni znan.
The resistance profile observed in Study HPC3006 in treatment-naïve and treatment-experienced HCV-1 infected liver transplant recipients who were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A was similar to the resistance profile in HCV-infected patients without a liver transplant. 
Profil odpornosti v študiji HPC3006 pri še ne zdravljenih in že zdravljenih s HCV-1 okuženih bolnikih po presaditvi jeter, ki so prejemali stabilen odmerek imunosupresiva (takrolimus ali ciklosporin A) je bil podoben profilu pri s HCV-1 okuženih bolnikih brez presaditve jeter.
In Study HPC3008 (see sections 4.8 and 5.1), transient grade 3 (2.5 to ≤5 X ULN) and grade 4 (>5 X ULN) bilirubin increases during INCIVO treatment were seen in 39% and in 22% of the 59 patients on atazanavir/ritonavir, respectively. 
V skupini 59 bolnikov, ki so prejemali atazanavir/ritonavir pri kombiniranem zdravljenju z zdravilom INCIVO v študiji HPC3008 (glejte poglavji 4.8 in 5.1) so pri 39% bolnikov opazili prehodno zvišanje koncentracije bilirubina stopnje 3 (2,5 do ≤5 X ULN) in pri 22% bolnikov zvišanje koncentracije
Study 106 was a randomised, double-blind, placebo-controlled, Phase 2 study that enrolled patients who had failed prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin. 
Študija 106 je bila randomizirana, dvojno slepa in s placebom nadzorovana študija faze II, v katero so vključili bolnike z neuspešnim predhodnim zdravljenjem s peginterferonom alfa-2a in ribavirinom oziroma peginterferonom alfa-2b in ribavirinom.
Because INCIVO must be used in combination with peginterferon alfa and ribavirin, the contraindications and warnings applicable to those medicinal products are applicable to combination therapy. 
Ker moramo zdravilo INCIVO uporabljati v kombinaciji s peginterferonom alfa in ribavirinom, se kontraindikacije in opozorila za ti dve zdravili nanašajo tudi na kombinirano terapijo.
Selected laboratory abnormalities of at least moderate intensity (≥ Grade 2) that represent a worsening from baseline and are considered ADRs observed in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled Phase 2 and Phase 3 trials 
Izbrani nenormalni laboratorijski izvidi najmanj zmerne jakosti (≥ 2. stopnje), ki predstavljajo poslabšanje začetnih vrednosti ter štejejo za neželene učinke, opažene pri bolnikih, okuženih s HCV in zdravljenih z zdravilom INCIVO pri kombiniranem zdravljenju, na podlagi združenih podatkov, dobljenih v s placebom nadzorovanih preskušanjih faze II in III, so navedeni v spodnji preglednici.
5.3 Preclinical safety data 
6.6 Posebni varnostni ukrepi za odstranjevanje
If you notice the missed dose after 4 hours, then skip the intake and take the next doses as usual. 
Če pa se na pozabljen odmerek spomnite po 4 urah, preskočite to jemanje zdravila in jemljite naslednje odmerke kot običajno.
Haemoglobin values of < 10 g/dl were observed in 34% of patients who received INCIVO combination treatment and in 14% of patients who received peginterferon alfa and ribavirin. 
Koncentracije hemoglobina < 100 g/l so opazili pri 34% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO, in pri 14% bolnikov, ki so prejemali peginterferon alfa in ribavirin.
All patients received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 36 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 48 weeks). 
Vsi bolniki so 12 tednov prejemali zdravilo INCIVO v kombinaciji s peginterferonom alfa-2a in ribavirinom, čemur je sledilo 36 tednov zdravljenja s peginterferonom alfa-2a in ribavirinom (celotno zdravljenje je trajalo 48 tednov).
INCIVO has not been studied in patients with severe hepatic impairment (Child-Pugh C, score ≥ 10) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome) and is not recommended in these populations. 
Uporabe zdravila INCIVO pri bolnikih s hudo okvaro jeter (razred C po Child-Pughu, ocena ≥ 10) ali dekompenzirano jetrno boleznijo (ascites, krvavitev iz varic zaradi portalne hipertenziije, encefalopatija, in/ali zlatenica, ki ni povezana z Gilberovim sindromom) niso preučevali.
Table 17 shows the overall response rates in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected liver transplant recipients and by subgroup (patients receiving tacrolimus or cyclosporine A). 
V preglednici 17 so prikazane celokupne stopnje odziva v skupini še nezdravljenih in skupini že zdravljenih kroničnih s HCV genotipa 1 okuženih bolnikov s presajenimi jetri in stopnje odziva v podskupinah (bolniki, ki so prejemali takrolimus oziroma ciklosporin A).
In placebo-controlled Phase 2 and 3 clinical trials, the overall incidence and severity of anaemia increased with INCIVO combination treatment compared to peginterferon alfa and ribavirin alone. 
V s placebom nadzorovanih kliničnih preskušanjih faze II ali III sta se povečali skupna incidenca in jakost anemije pri kombiniranem zdravljenju z zdravilom INCIVO v primerjavi z zdravljenjem samo s peginterferonom alfa in ribavirinom.
HCV RNA < 25 IU/ml at End of Treatment 
Nezaznavna HCV RNK < 25 i.e./ml ob koncu zdravljenja
If INCIVO treatment is discontinued due to adverse drug reactions or because of insufficient virologic response, INCIVO treatment should not be reinitiated. 
Če zdravljenje z zdravilom INCIVO ukinete zaradi neželenih učinkov ali nezadostnega virološkega
Study 110 was a phase II randomised, double-blind, placebo-controlled study conducted in patients with chronic genotype 1 HCV/HIV co-infection who were treatment-naïve for hepatitis C. Patients were either not on antiretroviral therapy (CD4 count ≥ 500 cells/mm 
Randomizirana, dvojno slepa in s placebom nadzorovana študija faze II pri bolnikih s kroničnim HCV genotipa 1, sočasno okuženih s HIV, ki še niso prejemali zdravil proti hepatitisu C. Bolniki niso prejemali protiretrovirusnega zdravljenja (število celic CD4 ≥ 500 celic/mm
INCIVO co-administration with domperidone should be avoided (see section 4.5). 
Sočasni uporabi zdravila INCIVO z domperidonom se je treba izogibati (glejte poglavje 4.5).
All patients received peginterferon alfa-2a and ribavirin for 48 weeks. 
Vsi bolniki so 48 tednov prejemali peginterferon alfa-2a in ribavirin.
The 162 enrolled patients had a median age of 46 years (range: 20 to 67 years); 78.4% of the patients were male; 6.8% had a body mass index ≥ 30 kg/m2; 4.3% were Black; 1.9% were Asian; 87.0% had baseline HCV RNA levels ≥ 800,000 IU/ml; 17.3% had bridging fibrosis; 13.0% had cirrhosis; 65.6% had HCV genotype 1a; 33.8% had HCV genotype 1b; 39.5% (n = 64) were HCV treatment-naïve; 17.9% (n = 29) were prior relapsers; 11.1% (n = 18) were prior partial responders; 31.5% (n = 51) were prior null responders. 
Vključenih je bilo 162 bolnikov, mediana vrednost starosti je bila 46 let (razpon od 20 do 67), od tega je bilo 78,4% moških, 6,8% je imelo indeks telesne mase ≥ 30 kg/m2, 4,3% je bilo črncev, 1,9% azijcev, 87,0% je imelo začetno koncentracijo HCV RNK ≥ 800.000 i.e./ml, 17,3% je imelo mostno fibrozo, 13,0% je imelo cirozo, 65,6% je imelo HCV genotipa 1a, 33,8% je imelo HCV genotipa 1b, 39,5% (n = 64) jih še ni prejemalo zdravil proti HCV, pri 17,9% (n = 29) se je bolezen ponovila, 11,1% (n = 18) se je le delno odzvalo na zdravljenje in 31,5% (n = 51) bolnikov se prej na zdravljenje ni odzvalo.
Other includes patients with detectable HCV RNA at the planned end of treatment but who did not have viral breakthrough, and patients with a missing SVR assessment during planned follow-up. 
Ostalo vključuje bolnike z zaznavno koncentracijo HCV RNK ob načrtovanem koncu zdravljenja, ki pa niso imeli virusnega preboja, in bolnike, pri katerih manjka ocena SVR pri načrtovanem spremljanju.
Co-administration with phenobarbital is contraindicated. 
Sočasna uporaba s fenobarbitalom je kontraindicirana.
Figure 1: Duration of treatment for treatment-naïve patients and prior treatment 
Slika 1: trajanje zdravljenja pri še nezdravljenih bolnikih in pri tistih, ki se jim je bolezen
HCV RNA > 1,000 IU/ml at week 4 of treatment 
HCV RNK > 1.000 i.e./ml v 4. tednu zdravljenja
In placebo-controlled Phase 2 and 3 trials, severe rash (primarily eczematous, pruritic and involving more than 50% body surface area) was reported in 4.8% of patients who received INCIVO combination treatment compared to 0.4% receiving peginterferon alfa and ribavirin. 
V s placebom nadzorovanih preskušanjih faze II in III so o hudem izpuščaju (predvsem ekcemu s pruritusom, ki zajema več kot 50% telesne površine) poročali pri 4,8% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO, v primerjavi z 0,4% tistih, ki so prejemali samo peginterferon alfa in ribavirin.
The total daily dose is 6 tablets (2,250 mg). 
Skupni dnevni odmerek je 6 tablet (t.j.
AUC 1.00 (0.94-1.07) Cmax 1.01 (0.96-1.05) Cmin 1.03 (0.93-1.14) ↑ tenofovir 
Cmax 1,01 (0,96-1,05) Cmin 1,03 (0,93-1,14) ↑ tenofovirja
- Patients with undetectable hepatitis C virus ribonucleic acid (HCV RNA) (target not detected) at weeks 4 and 12 receive an additional 12 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 24 weeks. 
- Bolniki z nezaznavno koncentracijo ribonukleinske kisline virusa hepatitisa C (HCV RNK) (nezaznaven analit) v 4. in 12. tednu naj prejemajo samo peginterferon alfa in ribavirin še dodatnih 12 tednov, do skupnega trajanja zdravljenja 24 tednov.
The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin). 
Populacija bolnikov, ki se niso odzvali na predhodno zdravljenje, je zajemala 2 podskupini: bolnike, ki so se prej delno odzvali na zdravljenje (imeli so zmanjšanje vrednosti HCV RNK v 12. tednu za ≥ 2 log10, niso pa dosegli nemerljive HCV RNK ob koncu zdravljenja s peginterferonom in ribavirinom) in tiste bolnike, ki se prej niso odzvali na zdravljenje (ti so imeli zmanjšanje vrednosti HCV RNK v 12. tednu za < 2 log10 pri predhodnem zdravljenju s
The denominator is the number of patients with HCV RNA < 25 IU/ml at planned end of treatment or a missing HCV RNA assessment at planned end of treatment and HCV RNA < 25 IU/ml during follow-up from planned end of treatment onwards. 
Imenovalec je število bolnikov s HCV RNK < 25 i.e./ml ali pri katerih ni podatka o koncentraciji HCV RNK ob načrtovanem zaključku zdravljenja in, ki so imeli koncentracijo HCV RNK < 25 i.e./ml v obdobju spremljanja po zaključku zdravljenja.
Study C216 was a randomised, double-blind, placebo-controlled, Phase 3 study conducted in patients who did not achieve SVR with prior treatment with peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin. 
Študija C216 je bila randomizirana, dvojno slepa in s placebom nadzorovana študija faze III, pri bolnikih, ki niso dosegli trajnega virološkega odziva pri predhodnem zdravljenju s peginterferonom alfa-2a in ribavirinom oziroma s peginterferonom alfa-2b in ribavirinom.
If discontinued due to a skin reaction, INCIVO must not be restarted. 
Če ste zdravilo INCIVO enkrat ukinili zaradi kožne reakcije, ne smete ponovno začeti zdravljenja z njim.
Patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12 received 24 weeks of peginterferon alfa-2a and ribavirin treatment, and patients who did not have undetectable HCV RNA (target not detected) at week 4 and week 12 received 48 weeks of peginterferon alfa-2a and ribavirin treatment. 
Bolniki, ki so imeli nezaznavno HCV RNK (nezaznaven analit) v 4. in 12. tednu, so 24 tednov prejemali zdravljenje s peginterferonom alfa-2a in ribavirinom, tisti, ki pa niso imeli nemerljive HCV RNK (nezaznaven analit) v 4. tednu in v 12. tednu, so prejemali zdravljenje s peginterferonom alfa-2a in ribavirinom v času 48 tednov.
Therefore, no dose adjustment is recommended for INCIVO in HCV patients with renal impairment. 
Zato prilagajanje odmerka zdravila INCIVO pri bolnikih z ledvično okvaro ni priporočeno.
Take INCIVO with peginterferon alfa and ribavirin for 12 weeks. 
Zdravilo INCIVO jemljite s peginterferonom alfa in ribavirinom 12 tednov.
Caution is recommended when prescribing INCIVO concurrently with medicinal products known to induce QT prolongation and which are CYP3A substrates such as erythromycin, clarithromycin, telithromycin, posaconazole, voriconazole, ketoconazole, tacrolimus, salmeterol (see section 4.5). 
Pri predpisovanju zdravila INCIVO sočasno z drugimi zdravili, ki podaljšajo interval QT in so tudi substrati izoencima CYP3A, na primer z eritromicinom, klaritromicinom, telitromicinom, posakonazolom, vorikonazolom, ketokonazolom, takrolimusom ali salmeterolom, svetujemo previdnost (glejte poglavje 4.5).
The response rate in the Pbo/PR arm was higher than that seen in other clinical studies of peginterferon bitherapy (historical SVR rates < 36%). 
Stopnja odziva v kraku Pbo/PR je bila, v primerjavi z drugimi kliničnimi študijami dvojnega zdravljenja s peginterferonom
AUC 0.80 (0.76-0.85) Cmax 0.79 (0.74-0.84) Cmin 0.85 (0.75-0.98) ↑ atazanavir AUC 1.17 (0.97-1.43) Cmax 0.85 (0.73-0.98) Cmin 1.85 (1.40-2.44) inhibition of CYP3A by telaprevir 
↓ telaprevirja AUC 0,80 (0,76-0,85) Cmax 0,79 (0,74-0,84) Cmin 0,85 (0,75-0,98) ↑ atazanavirja AUC 1,17 (0,97-1,43) Cmax 0,85 (0,73-0,98) Cmin 1,85 (1,40-2,44) zaviranje CYP3A s telaprevirjem
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and 
V fazi zdravljenja z zdravilom INCIVO oz. s placebom so, v skupini, ki je prejemala zdravilo INCIVO, najpogosteje poročali o naslednjih neželenih učinkih jakosti najmanj 2. stopnje (pogostnost ≥ 5,0%): anemija, izpuščaj, pruritus, navzea in driska.
Some patients may experience fainting or problems with vision during INCIVO treatment. 
Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih bolnikih se med zdravljenjem z zdravilom INCIVO lahko pojavi omedlevica ali motnje vida.
Telaprevir is a strong inhibitor of the important drug metabolising enzyme CYP3A4. 
Telaprevir je močan zaviralec encima CYP3A4, ki je pomemben pri presnovi učinkovin.
If you have any questions about your medicines, please ask your doctor or pharmacist. 
Če imate kakršnakoli vprašanja o vaših zdravilih, se posvetujte z zdravnikom ali s farmacevtom.
Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash 
Priporočila za spremljanje kožnih reakcij in ukinitev zdravil INCIVO, ribavirin in peginterferon alfa v primeru hudega izpuščaja
Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h). 
Večina študij medsebojnih delovanj z drugimi učinkovinami je bila izvedena z odmerkom 750 mg telaprevirja na 8 ur.
Naïve patients treated with either peginterferon alfa-2a/ribavirin (n = 80) or peginterferon alfa-2b/ribavirin (n = 81) in combination with INCIVO, in an open label study, had comparable SVR rates. 
V odprti študiji so imeli bolniki, ki predhodno niso bili zdravljeni, ki so prejemali peginterferon alfa-2a/ribavirin (n = 80) ali peginterferon alfa-2b/ribavirin (n = 81) v kombinaciji z zdravilom INCIVO primerljive stopnje SVR.
In placebo-controlled Phase 2 and 3 trials, anaemia (all grades) was reported in 32.1% of patients who received INCIVO combination treatment and in 14.8% of patients who received peginterferon alfa and ribavirin. 
V s placebom nadzorovanih preskušanjih faze II in III so pri 32,1% bolnikov, ki so prejemali kombinirano zdravljenje z zdravilom INCIVO in pri 14,8% bolnikov, ki so prejemali peginterferon alfa in ribavirin poročali o anemiji (vseh stopenj).
Toxic epidermal necrolysis (TEN) including fatal outcome has been observed in post-marketing experience (see section 4.8). 
Pri uporabi v obdobju trženja zdravila so opazili pojav toksične epidermalne nekrolize (TEN), vključno z enim smrtnim izidom (glejte poglavje 4.8).
No relevant inhibition by telaprevir of alcohol dehydrogenase was observed in vitro. 
V in vitro pogojih telaprevir ni pomembno zaviral alkoholdehidrogenaz.
Close monitoring of metformin efficacy and safety is recommended when starting or stopping INCIVO in patients receiving metformin. 
Pri uvajanju in prekinjanju zdravljenja z zdravilom INCIVO je priporočljivo skrbno spremljanje učinkovitosti in varnosti metformina.
The following laboratory evaluations (complete blood count with white blood cell differential counts, electrolytes, serum creatinine, liver function tests, TSH, uric acid) must be conducted in all patients prior to initiating INCIVO combination treatment. 
Pred uvedbo kombiniranega zdravljenja z zdravilom INCIVO je treba pri vseh bolnikih opraviti laboratorijske preiskave celotne krvne slike z diferencialno belo krvno sliko, določiti koncentracije elektrolitov, koncentracijo kreatinina v serumu, opraviti preiskave delovanja jeter, določiti koncentracijo TSH, določiti koncentracijo sečne kisline.
Study 107 was an open label, rollover study for patients who were treated in the control group (placebo, peginterferon alfa-2a, and ribavirin) of a Phase 2 study of telaprevir and who did not achieve SVR in the Phase 2 study. 
Študija 107 je bila odprta obnovljena študija faze II uporabe telaprevirja pri bolnikih, ki so bili pred tem v kontrolni skupini (in so prejemali placebo, peginterferon alfa-2a in ribavirin) ter niso dosegli trajnega virološkega odziva v študiji druge faze.
For specific dosage instructions for peginterferon alfa and ribavirin, the Summary of Product Characteristics for these medicinal products should be consulted. 
Za natančna navodila o odmerjanju peginterferona alfa in ribavirina preberite Povzetek glavnih značilnosti zdravila za obe zdravili.
Liver transplant patients without cirrhosis 
Bolniki po preseditvi jeter brez ciroze
For information on the use of INCIVO in combination with peginterferon alfa and ribavirin in treatment-naïve and treatment-experienced HCV-1 infected patients who were liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A, see sections 4.2, 
Za podatke o uporabi zdravila INCIVO v kombinaciji s peginterferonom alfa in ribavirinom pri še nezdravljenih in že zdravljenih s HCV-1 okuženih bolnikih s presajenimi jetri, ki so prejemali stabilen odmerek imunosupresiva (takrolimus ali ciklosporin A), glejte poglavja 4.2 , 4.5, Imunosupresivi, 4.8 in 5.1.
All patients received 12 weeks of treatment with INCIVO in combination with peginterferon alfa-2a and ribavirin. 
Vsi bolniki so se 12 tednov zdravili z zdravilom INCIVO v kombinaciji s peginterferonom alfa-2a in ribavirinom.