natgillin/translations-raw huggingface dataset:
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. 
Ispitivanje C216 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje, faze III, provedeno u bolesnika koji nisu postigli SVR uz prethodno liječenje peginterferonom alfa-2a i ribavirinom ili peginterferonom alfa-2b i ribavirinom.
On-treatment virologic failure was defined as meeting a virologic stopping rule and/or having viral breakthrough. 
Virološki neuspjeh tijekom liječenja bio je definiran kao dostizanje viroloških pravila za prekid i/ili doživljavanje virološkog proboja.
In placebo-controlled Phase 2 and 3 trials, the overall incidence and severity of rash increased when INCIVO was co-administered with peginterferon alfa and ribavirin. 
U fazi II i III placebom kontroliranih ispitivanja ukupna incidencija i težina osipa povećale su se kad se INCIVO primjenjivao istodobno s peginterferonom alfa i ribavirinom.
Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks with an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks. 
Liječenje INCIVOM se mora započeti u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana uz dodatnih 36 tjedana liječenja samo peginterferonom alfa i ribavirinom do ukupnog trajanja liječenja od 48 tjedana.
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. 
U ispitivanju otvorenog tipa, bolesnici koji prethodno nisu bili liječeni a primali su ili peginterferon alfa-2a/ribavirin (n = 80) ili peginterferon alfa-2b/ribavirin (n = 81) u kombinaciji s lijekom INCIVO, imali su usporedive stope SVR.
It is not recommended to co-administer darunavir/ritonavir and telaprevir (see section 4.4). 
Ne preporučuje se istodobno primjenjivati darunavir/ritonavir s telaprevirom (vidjeti dio 4.4).
On-treatment virologic failure was defined as meeting a virologic stopping rule or having viral breakthrough. 
Virološki neuspjeh tijekom liječenja bio je definiran kao dostizanje virološkog pravila za prekid ili doživljavanje virološkog proboja.
versus 750 mg every 8 hours (q8h) were 1.08 (1.02; 1.13) for AUC24,ss, 0.878 (0.827; 0.930) for Ctrough,ss, and 1.18 (1.12;1.24) for Cmax,ss. 
Na temelju populacijskog farmakokinetičkog modela izloženosti telapreviru u stanju dinamičke ravnoteže, geometrijska srednja vrijednost omjera najmanjih kvadrata (90% CI) za 1125 mg dva puta na dan (b.i.d.) naspram 750 mg svakih 8 sati bila je 1,08 (1,02; 1,13) za AUC24,ss, 0,878 (0,827; 0,930) za Cnajniža,ss, i 1,18 (1,12;1,24) za Cmax,ss.
Female patients of childbearing age and their male partners A hormonal contraceptive (‘the pill') may not be reliable during the treatment with INCIVO. 
Hormonska kontracepcija (”pilula”) ne mora biti pouzdana metoda za vrijeme liječenja INCIVOM.
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. 
Ispitivanje 106 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje, faze II, koje je uključilo bolesnike u kojih je prethodno liječenje peginterferonom alfa-2a i ribavirinom ili peginterferonom alfa-2b i ribavirinom bilo neuspješno.
The safety and efficacy of INCIVO in children aged < 18 years have not yet been established. 
< 18 godina nisu još ustanovljene.
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. 
Ne postoji dovoljno kliničkih podataka koji bi podržali liječenje bolesnika s HCV infekcijom izazvanom drugim genotipovima HCV-a osim genotipa
Following the end of the INCIVO treatment, please see the ribavirin package leaflet regarding continued contraception 
Kada završite liječenje INCIVOM, molimo vas pročitajte što piše u uputi o lijeku za ribavirin o potrebama daljnjeg sprječavanja trudnoće.
Electrolyte disturbances (e.g., hypokalaemia, hypomagnesaemia and hypocalcaemia) should be monitored and corrected, if necessary, prior to initiation and during INCIVO therapy. 
Prije početka i za vrijeme terapije INCIVOM treba pratiti i po potrebi korigirati poremećaje elektrolita (npr. hipokalijemiju, hipomagnezijemiju i hipokalcijemiju).
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) 
Opći poremećaji i reakcije na periferni edem, abnormalan okus proizvoda faze II i faze III placebom kontroliranih ispitivanja (objedinjeni podaci) uključile su 1346 bolesnika zaraženih HCV
- 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. 
- Bolesnici u kojih ribonukleinska kiselina virusa hepatitisa C (HCV RNK) nije mjerljiva (cilj nije izmjeren) u 4. i 12. tjednu liječenja nastavit će primati samo peginterferon alfa i ribavirin još 12 tjedana, tako da liječenje traje ukupno 24 tjedna.
BOTTLE LABEL (4-bottle pack) 
NALJEPNICA NA BOČICI (pakiranje od 4 bočice)
to treat inflammatory arthritis (anti-gout agents) to treat certain infections (antimycobacterials) to help you sleep and/or relieve anxiety (benzodiazepines) to help you sleep and/or relieve anxiety (non-benzodiazepine sedatives) 
alprazolam, midazolam u obliku injekcije za spavanje i/ili ublažavanje tjeskobe (benzodiazepini) za spavanje i/ili ublažavanje tjeskobe (nebenzodiazepinski sedativi)
Additional methods of non-hormonal contraception should be used when hormonal contraceptives are co-administered with telaprevir. 
Kad se hormonska kontracepcija primjenjuje istodobno s telaprevirom, potrebne su dodatne nehormonske metode kontracepcije.
Relapse was defined as having HCV RNA ≥ 25 IU/ml during the follow-up period after previous HCV RNA < 25 IU/ml at planned end of treatment and not achieving SVR12. 
Relaps je bio definiran kao HCV RNK ≥ 25 IU/ml tijekom razdoblja praćenja nakon prethodne HCV RNK < 25 IU/ml na planiranom kraju liječenja i nepostizanje SVR12.
Improvement of rash occurs after INCIVO dosing completion or discontinuation; however, rashes may take several weeks to 
Nakon završetka doziranja INCIVA ili prekida njegove primjene dolazi do poboljšanja osipa, međutim, povlačenje osipa može trajati i
No clinical data are available regarding the treatment of pre- or peri-liver or other transplant patients with INCIVO in combination with peginterferon alfa and ribavirin. 
Ne postoje dostupni klinički podaci o liječenju bolesnika INCIVOM u kombinaciji s peginterferonom alfa i ribavirinom prije ili za vrijeme transplantacije jetre ili drugih organa.
Relapse was defined as having detectable plasma HCV RNA from planned end of treatment onwards after previous HCV RNA < 25 IU/ml at planned end of HCV treatment, and not achieving SVR12. 
Relaps je bio definiran kao prisutnost mjerljivog HCV RNK u plazmi od planiranog kraja liječenja nadalje nakon prethodnog HCV RNK < 25 IU/ml na planiranom kraju HCV liječenja, te nepostizanje SVR12.
Manufacturer Janssen-Cilag SpA, Via C. Janssen, 
Proizvođač Janssen-Cilag SpA,
The total dose is 6 tablets or - 2 tablets of INCIVO every 8 hours with food. 
- 2 tablete INCIVA svakih 8 sati uz hranu.
Table 11 shows the response rates for the recommended simultaneous start (T12/PR48) and the Pbo/PR48 arms. 
Tablica 11 pokazuje stope odgovora u skupini s preporučenim istodobnim početkom liječenja (T12/PR48) i u skupini Pbo/PR48.
The impact of predominant telaprevir-resistant variants at baseline is likely greatest in patients with a poor interferon response, 
Vjerojatno je utjecaj varijanti pretežno rezistentnih na telaprevir na početku liječenja najveći u bolesnika sa slabim odgovorom na interferon, kao što su bolesnici u kojih je prethodno potpuno izostao terapijski odgovor.
Other includes patients with detectable HCV RNA at their actual end of treatment but who did not meet the definition of on-treatment virologic failure, and patients with a missing HCV RNA assessment during planned follow-up. 
Ostalo uključuje bolesnike s mjerljivom HCV RNK na njihovom stvarnom kraju liječenja, ali koji nisu zadovoljili definiciju virološkog neuspjeha tijekom liječenja, te bolesnike bez procijenjene HCV RNK tijekom planiranog praćenja.
Treatment-naive patients or prior relapsers who were non-cirrhotic and achieved extended rapid virologic response (eRVR) received 12 weeks of treatment with INCIVO plus peginterferon alfa-2a and ribavirin followed by 12 weeks of treatment with peginterferon alfa-2a and ribavirin (total treatment duration of 24 weeks). 
Bolesnici koji prethodno nisu bili liječeni ili oni koji su prethodno doživjeli relaps te su bez ciroze jetre i postigli su produženi brzi virološki odgovor (eRVR, engl. extended rapid virologic response), liječeni su INCIVOM plus peginterferon alfa-2a i ribavirin tijekom12 tjedana, nakon čega je uslijedilo liječenje u trajanju od 12 tjedana s peginterferonom alfa-2a i ribavirinom (ukupno trajanje liječenja od 24 tjedna).
Table 1: Guidelines for discontinuation of INCIVO, Peginterferon Alfa, and Ribavirin treatment 
Tablica 1: Smjernice za prestanak liječenja INCIVOM, peginterferonom alfa i ribavirinom Lijekovi
In the C211 Phase 3 clinical trial, there was no difference in the type of emerging variants between patients receiving telaprevir 1,125 mg twice daily (b.i.d.) 
U fazi III C211 kliničkog ispitivanja nije bilo razlike u tipu varijanti u nastajnju između bolesnika koji su primali 1125 mg telaprevira dva puta na dan (b.i.d.) i bolesnika koji su primali 750 mg telaprevira svakih 8 sati.
Ribavirin can damage your unborn baby. 
Ribavirin može naškoditi vašem nerođenom djetetu, stoga je neophodno poduzeti sve mjere opreza kako ne biste zatrudnjeli za vrijeme trajanja liječenja.
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. 
Budući da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom, kontraindikacije i upozorenja koja vrijede za navedene lijekove, vrijede i za kombiniranu terapiju.
HIV-ANTIVIRAL AGENTS: HIV-PROTEASE INHIBITORS (PIs) atazanavir/ritonavir* 
ANTIVIRUSNI LIJEKOVI PROTIV HIV-a: INHIBITORI REVERZNE TRANSKRIPTAZE efavirenz*
HCV RNA > 1,000 IU/ml at week 12 of treatment 
HCV RNK > 1000 IU/ml nakon 12 tjedana liječenja
QT interval prolongation and Torsade de Pointes have been reported with clarithromycin and erythromycin. 
Uz klaritromicin i eritromicin zabilježeni su produljenje QT intervala i torsade de pointes.
QT interval prolongation has been reported with telithromycin (see section 4.4). 
Produljenje QT intervala prijavljeno je s telitromicinom (vidjeti dio 4.4).
Co-administration of atorvastatin and telaprevir is contraindicated (see section 4.3). 
Istodobna primjena atorvastatina s telaprevirom je kontraindicirana (vidjeti dio 4.3).
Hepatobiliary disorders common hyperbilirubinaemia 
Poremećaji jetre i žuči često hiperbilirubinemija
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for a list of their contraindications since INCIVO must be used in combination with peginterferon alfa and ribavirin. 
Za popis kontraindikacija za peginterferon alfa i ribavirin, vidjeti odgovarajuće Sažetke opisa svojstava lijeka, budući da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom.
Uncommon side effects (affects less than 1 in 100 people): - increase in creatinine in your blood; - painful inflammation of the joints most commonly in the foot (gout); - damage to back of the eye (retina); - inflammation of the anus and rectum; - inflamed pancreas 
Manje česte nuspojave (javljaju se u manje od 1 na 100 osoba): - povišenje kreatinina u krvi; - bolna upala zglobova, najčešće zglobova stopala (giht);
Plasma concentrations of telaprevir can be reduced by concomitant use of the herbal preparation St John's wort (Hypericum perforatum). 
Istodobna primjena biljnih pripravaka gospine trave (Hypericum perforatum) može smanjiti koncentracije telaprevira u plazmi.
5.8% of patients discontinued INCIVO alone due to rash events and 2.6% of patients discontinued INCIVO combination treatment for rash events compared to none of those receiving peginterferon 
Zbog pojave osipa 5,8% bolesnika prekinulo je liječenje INCIVOM, a 2,6% bolesnika prekinulo je kombinirano liječenje INCIVOM, dok prekida zbog pojave osipa nije bilo ubolesnika koji su primali peginterferon alfa i ribavirin.
Upon completion of INCIVO, doses of tacrolimus or cyclosporine A need to be increased, and the dosing interval for tacrolimus will need to be reduced. 
Nakon završetka liječenja INCIVOM, potrebno je doze takrolimusa ili ciklosporina
For specific dosage instructions for peginterferon alfa and ribavirin, the Summary of Product Characteristics for these medicinal products should be consulted. 
Za posebne upute vezane uz doziranje peginterferona alfa i ribavirina potrebno je pogledati Sažetak opisa svojstava lijeka za te lijekove.
At baseline, 3 (8%) patients had bridging fibrosis and 2 (5%) patients had cirrhosis in the T12/PR48 arm. 
U skupini T12/PR48, 3 (8%) bolesnika na početku ispitivanja je imalo premoštavajuću fibrozu, a 2 (5%) bolesnika imalo je cirozu.
Study HPC3006 was an open-label, Phase 3b study in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected patients who were first time liver transplant recipients and were on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A. No patients had cirrhosis of the liver graft. 
Ispitivanje HPC3006 bilo je otvoreno ispitivanje faze 3b, u bolesnika s kroničnom infekcijom HCV genotipa 1 koji prethodno nisu bili liječeni i u prethodno liječenih bolesnika kojima je prvi put transplantirana jetra, te su bili na stabilnom režimu liječenja s imunosupresivima takrolimusom ili ciklosporinom A.
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. 
Bolesnici s nemjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu primali su peginterferon alfa-2a i ribavirin 24 tjedna, a bolesnici s mjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu liječeni su peginterferonom alfa-2a i ribavirinom 48 tjedana.
an herbal product to relieve anxiety to lower cholesterol levels (HMG CoA reductase inhibitors) 
biljni pripravak za ublažavanje tjeskobe atorvastatin, lovastatin, simvastatin za sniženje vrijednosti kolesterola (inhibitori HMG CoA reduktaze)
Table 17: Treatment outcome in genotype 1 HCV-infected liver transplant recipients (Study HPC3006) 
Tablica 17: Ishod liječenja kod bolesnika s infekcijom HCV-om genotipa 1 s transplantiranom
Baseline liver fibrosis No fibrosis or minimal fibrosis 
Fibroza jetre na početku ispitivanja Bez fibroze, minimalna fibroza ili
BOTTLE LABEL (1-bottle pack) 
NALJEPNICA NA BOČICI (pakiranje s 1 bočicom)
Use in patients with advanced liver disease 
Bolesnici s transplantiranim organima
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. 
Medijan dobi za 162 uključena bolesnika bio je 46 godina (raspon: 20 do 67 godina); 78,4% bolesnika bili su muškarci; 6,8% imalo je indeks tjelesna mase ≥ 30 kg/m2; 4,3% bili su crne rase; 1,9% je bilo azijatskog porijekla; 87,0% imalo je početne razine HCV RNK ≥ 800 000 IU/ml; 17,3% imalo je premoštavajuću fibrozu; 13,0% imalo je cirozu; 65,6% imalo je HCV genotip 1a; 33,8% imalo je HCV genotip 1b; 39,5% (n = 64) prethodno nije primilo liječenje za HCV; 17,9% (n = 29) imalo je prethodno relaps; 11,1% (n = 18) je prethodno djelomično odgovorilo; 31,5% (n = 51) prethodno nije odgovorilo.
Table 8: 
48. tjedan
Gastric lavage should only be performed if this can be done within one hour after ingestion. 
Lavažu želuca treba provoditi samo ako je od gutanja lijeka prošlo manje od jednog sata.
- low blood platelet count, decrease in lymphocytes (a type of white blood cell), decrease in thyroid gland activity, increase in uric acid in your blood, decrease in potassium in your blood, 
Česte nuspojave (javljaju se u manje od 1 na 10 osoba): - gljivična infekcija u ustima; - nizak broj trombocita, smanjenje broja limfocita (vrsta bijelih krvnih stanica), smanjena aktivnost štitne žlijezde, povišenje mokraćne kiseline u krvi, sniženje kalija u krvi, povišenje
RNA levels ≥ 800,000 IU/ml; 10.8% had bridging fibrosis; none had cirrhosis; 38.9% had HCV genotype 1a; 58.3% had HCV genotype 1b; 2.8% had HCV genotype 1d; 21.6% had IL28B genotype CC; 54.1% had IL28B genotype CT; 24.3% had IL28B genotype TT; 28.4% (n = 21) were HCV treatment- naïve; 71.6% (n = 53) were treatment-experienced [14.9% (n = 11) were prior relapsers; 40.5% (n = 30) were prior non-responders; 16.2% (n = 12) could not be classified]; median time since liver transplantation was 2.5 years (range: 0.6 to 9.5 years); 67.6% (n = 50) received tacrolimus; 32.4% (n = 24) received cyclosporine A. 
74 bolesnika uključenih u ispitivanje imalo je medijan dobi 56 godina (raspon: 43 do 68 godina); 91,9% bolesnika bili su muškarci; 24,3% imalo je indeks tjelesne mase ≥ 30 kg/m2; 1,4% bili su crne rase; 95,9% imalo je početne vrijednosti HCV RNK ≥ 800 000 IU/ml; 10,8% imalo je premoštavajuću fibrozu; nitko nije imao cirozu; 38,9% imalo je HCV genotip 1a; 58,3% imalo je HCV genotip 1b; 2,8% imalo je HCV genotip 1d; 21,6% imalo je IL28B genotip CC; 54,1% imalo je IL28B genotip CT; 24,3% imalo je IL28B genotip TT; 28,4% (n = 21) nije bilo prethodno liječeno za HCV infekciju; 71,6% (n = 53) bilo je prethodno liječeno [14,9% (n = 11) bili su bolesnici s prethodnim relapsom; 40,5% (n = 30) nisu prethodno odgovarali na liječenje; 16,2% (n = 12) nisu mogli biti klasificirani]; medijan vremena od transplantacije jetre bio je 2,5 godine (raspon: 0,6 do 9,5 godina); 67,6% (n = 50) primalo je takrolimus; 32,4% (n = 24) primalo je ciklosporin A.
OUTER CARTON (4-bottle pack) 
KARTONSKA KUTIJA (pakiranje s 4 bočice)
Treatment-naive patients and prior relapsers who did not achieve eRVR, prior partial responders, prior null responders, and all cirrhotic 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). 
Bolesnici koji prethodno nisu bili liječeni i oni s prethodnim relapsom koji nisu postigli eRVR, oni koji su prethodno djelomično odgovorili, oni koji prethodno uopće nisu odgovorili i svi bolesnicu s cirozom, liječeni su INCIVOM plus peginterferon alfa-2a i ribavirin tijekom 12 tjedana, nakon čega je uslijedilo liječenje u trajanju od 36 tjedana s peginterferonom alfa-2a i ribavirinom (ukupno trajanje liječenja od 48 tjedana).
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 
Budući da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom, kontraindikacije i upozorenja koja vrijede za navedene lijekove vrijede i za kombinirano liječenje.
If the missed dose is noticed more than 4 hours after the time INCIVO should be taken, the missed dose should be skipped and the patient should resume the normal dosing schedule. 
Ako se propuštena doza primjeti nakon više od 4 sata od vremena kad je bolesnik trebao uzeti INCIVO, propuštenu dozu treba preskočiti te nastaviti uzimati lijek prema uobičajenom
INCIVO must be taken in combination with peginterferon alfa and ribavirin. 
INCIVO se mora uzimati u kombinaciji s peginterferonom alfa i ribavirinom.
(e.g., CYP1A1, CYP1A2, BCRP, OATPs) regulated by the same nuclear receptors, the potential clinical impact is unknown. 
Potencijalan klinički utjecaj vezan uz druge enzime i transportere (npr., CYP1A1, CYP1A2, BCRP, OATPs) regulirane istim nuklearnim
Other includes patients with detectable HCV RNA at their actual end of treatment but who did not have viral breakthrough, and patients with a missing HCV RNA assessment during planned follow-up. 
Ostalo uključuje bolesnike s detektabilnom HCV RNK na njihovom stvarnom kraju liječenja, ali koji nisu imali virusni proboj, te bolesnike bez procijenjene HCV RNK tijekom planiranog praćenja.
↑ PDE-5 inhibitors inhibition of CYP3A 
Inhibicija CYP3A.
amlodipine, diltiazem, felodipine, nicardipine, 
amlodipin, diltiazem, felodipin, nikardipin, nifedipin, nizoldipin, verapamil za sniženje krvnog tlaka (blokatori kalcijevih kanala)
dihydroergotamine, ergonovine, ergotamine, 
dihidroergotamin, ergonovin, ergotamin, metilergonovin za liječenje migrene i glavobolja (ergot derivati)
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 
Ispitivanje 110 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano, faze II, a provedeno je u bolesnika s kroničnom istodobnom infekcijom HCV/HIV genotipa 1, kojima hepatitis C prethodno nije bio liječen.
Do not eat the desiccant. 
Nemojte progutati sredstvo za sušenje.
Figure 1: Duration of treatment for treatment-naïve patients and prior treatment 
Slika 1: Trajanje liječenja bolesnika koji prethodno nisu bili liječeni i bolesnika s relapsom nakon prethodnog liječenja
OUTER CARTON (1-bottle pack) 
KARTONSKA KUTIJA (pakiranje s 1 bočicom)
If medically indicated, earlier interruption or discontinuation of peginterferon alfa and ribavirin may be needed. 
Ako postoji medicinska indikacija, primjenu peginterferona alfa i ribavirina može biti potrebno prekinuti i prije, privremeno ili trajno.
Caution is warranted and clinical monitoring is recommended. 
Nalaže se oprez i preporučeno je kliničko praćenje.
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 uključuje bolesnike s mjerljivom HCV RNK na planiranom kraju liječenja bez virusnog proboja, a bolesnici su kojima je nedostajala SVR procjena tijekom planiranog praćenja.
Eesti filiaal Lõõtsa 2 
Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa 2
Pregnancy and breast-feeding If you are pregnant, you must not take INCIVO. 
Ako ste trudni, ne smijete uzimati INCIVO.
Treatment with INCIVO should be initiated and monitored by a physician experienced in the 
Liječenje INCIVOM treba započeti i pratiti liječnik s iskustvom u liječenju kroničnog hepatitisa C.
All patients received 12 weeks of INCIVO in combination with the peginterferon alfa/ribavirin standard therapy. 
Svi su bolesnici primali INCIVO u kombinaciji sa standardnom terapijom peginterferonom alfa/ribavirinom tijekom 12 tjedana.
Check with your doctor 
• Uputa za liječnika
It is not recommended to co-administer fosamprenavir/ritonavir and telaprevir (see section 4.4). 
Ne preporučuje se istodobno primjenjivati fosamprenavir/ritonavir s telaprevirom (vidjeti dio 4.4).