FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Croatian: 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.
English: Table 8:
Croatian: 48. tjedan
English: Gastric lavage should only be performed if this can be done within one hour after ingestion.
Croatian: Lavažu želuca treba provoditi samo ako je od gutanja lijeka prošlo manje od jednog sata.
English: - 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,
Croatian: 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
English: 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.
Croatian: 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.
English: OUTER CARTON (4-bottle pack)
Croatian: KARTONSKA KUTIJA (pakiranje s 4 bočice)
English: 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).
Croatian: 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).
English: 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
Croatian: 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.
English: 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.
Croatian: 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
English: INCIVO must be taken in combination with peginterferon alfa and ribavirin.
Croatian: INCIVO se mora uzimati u kombinaciji s peginterferonom alfa i ribavirinom.
English: (e.g., CYP1A1, CYP1A2, BCRP, OATPs) regulated by the same nuclear receptors, the potential clinical impact is unknown.
Croatian: Potencijalan klinički utjecaj vezan uz druge enzime i transportere (npr., CYP1A1, CYP1A2, BCRP, OATPs) regulirane istim nuklearnim
English: 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.
Croatian: 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.
English: ↑ PDE-5 inhibitors inhibition of CYP3A
Croatian: Inhibicija CYP3A.
English: amlodipine, diltiazem, felodipine, nicardipine,
Croatian: amlodipin, diltiazem, felodipin, nikardipin, nifedipin, nizoldipin, verapamil za sniženje krvnog tlaka (blokatori kalcijevih kanala)
English: dihydroergotamine, ergonovine, ergotamine,
Croatian: dihidroergotamin, ergonovin, ergotamin, metilergonovin za liječenje migrene i glavobolja (ergot derivati)
English: 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
Croatian: 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.
English: Do not eat the desiccant.
Croatian: Nemojte progutati sredstvo za sušenje.
English: Figure 1: Duration of treatment for treatment-naïve patients and prior treatment
Croatian: Slika 1: Trajanje liječenja bolesnika koji prethodno nisu bili liječeni i bolesnika s relapsom nakon prethodnog liječenja
English: OUTER CARTON (1-bottle pack)
Croatian: KARTONSKA KUTIJA (pakiranje s 1 bočicom)
English: If medically indicated, earlier interruption or discontinuation of peginterferon alfa and ribavirin may be needed.
Croatian: Ako postoji medicinska indikacija, primjenu peginterferona alfa i ribavirina može biti potrebno prekinuti i prije, privremeno ili trajno.
English: Caution is warranted and clinical monitoring is recommended.
Croatian: Nalaže se oprez i preporučeno je kliničko praćenje.
English: 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.
Croatian: 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.
English: Eesti filiaal Lõõtsa 2
Croatian: Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa 2
English: Pregnancy and breast-feeding If you are pregnant, you must not take INCIVO.
Croatian: Ako ste trudni, ne smijete uzimati INCIVO.
English: Treatment with INCIVO should be initiated and monitored by a physician experienced in the
Croatian: Liječenje INCIVOM treba započeti i pratiti liječnik s iskustvom u liječenju kroničnog hepatitisa C.
English: All patients received 12 weeks of INCIVO in combination with the peginterferon alfa/ribavirin standard therapy.
Croatian: Svi su bolesnici primali INCIVO u kombinaciji sa standardnom terapijom peginterferonom alfa/ribavirinom tijekom 12 tjedana.
English: Check with your doctor
Croatian: • Uputa za liječnika
English: It is not recommended to co-administer fosamprenavir/ritonavir and telaprevir (see section 4.4).
Croatian: Ne preporučuje se istodobno primjenjivati fosamprenavir/ritonavir s telaprevirom (vidjeti dio 4.4).
English: Erythropoisis-stimulating agents (ESAs) were generally not permitted and used in only 1% of patients in the Phase 2 and 3 clinical trials.
Croatian: U fazi II i III kliničkih ispitivanja tvari koje stimuliraju eritropoezu općenito nisu bile dopuštene i primijenile su se u samo 1% bolesnika.
English: Decisions related to your treatment may be made based on the results of these tests.
Croatian: Na temelju rezultata tih pretraga, liječnik može odlučiti o načinu liječenja.
English: It is not recommended to co-administer lopinavir/ritonavir and telaprevir (see section 4.4).
Croatian: Ne preporučuje se istodobno primjenjivati lopinavir/ritonavir s telaprevirom (vidjeti dio 4.4).
English: Patients with undetectable HCV RNA ( target not detected) at weeks 4 and 12 were randomised at week 20 to receive either 24 weeks or 48 weeks of peginterferon alfa-2a and ribavirin treatment.
Croatian: Bolesnici s nemjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu bili su randomizirani u 20. tjednu u skupine koje su liječene peginterferonom alfa-2a i ribavirinom ili 24 ili 48 tjedana.
English: • The Patient Information Leaflet
Croatian: • Sažetak opisa svojstava lijeka
English: Table 5 shows the response rates for the T12(b.i.d.
Croatian: Tablica 5 pokazuje stope odgovora za T12(b.i.d.)/PR skupinu i T12(q8h)/PR skupinu.
English: Therefore, herbal preparations containing St John's wort
Croatian: Stoga se biljni pripravci koji sadrže gospinu travu ne smiju
English: ↑ midazolam (p.o.) AUC 8.96 (7.75-10.35) Cmax 2.86 (2.52-3.25)
Croatian: ↑ atorvastatin AUC 7,88 (6,82-9,07) Cmax 10,6 (8,74-12,85)
English: QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4).
Croatian: Uz metadon su zabilježeni produljenje QT intervala i torsade de pointes (vidjeti dio 4.4).
English: - Patients with detectable HCV RNA at either weeks 4 or 12 receive an additional 36 weeks of peginterferon alfa and ribavirin alone for a total treatment duration of 48 weeks.
Croatian: - Bolesnici u kojih je mjerljiva HCV RNK u 4. ili 12. tjednu liječenja nastavit će primati samo peginterferon alfa i ribavirin još 36 tjedana, tako da liječenje traje ukupno 48 tjedana.
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be
Croatian: Vidjeti Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin, koji se moraju istodobno
English: Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin.
Croatian: Izloženost telapreviru tijekom istodobne primjene s peginterferonom alfa-2a i ribavirinom usporediva je s onom tijekom istodobne primjene s peginterferonom alfa-2b i ribavirinom.
English: Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks
Croatian: Pbo/PR48: placebo tijekom 16 tjedana u kombinaciji s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
English: 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.
Croatian: Profil rezistencije zabilježen u Ispitivanju HPC3006 kod HCV-1 zaraženih prethodno neliječenih i liječenih bolesnika s transplantiranom jetrom koji su bili na stabilnom režimu s imunosupresivima takrolimusom ili ciklosporinom
English: Subgroup
Croatian: Distribucija
English: INCIVO treatment completed Permanently discontinue treatment with INCIVO, peginterferon alfa, and ribavirin.
Croatian: Trajno prekinuti liječenje liječenje INCIVOM, peginterferonom alfa i ribavirinom.
English: abacavir
Croatian: fenobarbital
English: Co-administration with phenytoin is contraindicated.
Croatian: Istodobna primjena s fenitoinom je kontraindicirana.
English: See also the package leaflets for peginterferon alfa and ribavirin.
Croatian: Također, pročitajte upute o lijeku za peginterferon alfa i ribavirin.
English: AUC 0.96 (0.84-1.10) Cmax 0.80 (0.69-0.93) Cmin 1.06 (0.87-1.30)
Croatian: ↓ R-metadon AUC 0,71 (0,66-0,76) Cmax 0,71 (0,66-0,76) Cmin 0,69 (0,64-0,75)
English: • The Summary of Product Characteristics
Croatian: • Dodatne mjere minimizacije rizika
English: T12/PR: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks P < 0.0001; T12/PR compared to Pbo/PR48.
Croatian: T12/PR: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 24 ili 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana P < 0,0001; T12/PR u usporedbi s Pbo/PR48.
English: itraconazole, ketoconazole, posaconazole,
Croatian: itrakonazol, ketokonazol, posakonazol, vorikonazol za liječenje gljivičnih infekcija (antimikotici)
English: If you notice the missed dose after 6 hours, then skip the intake and take the next doses as usual.
Croatian: Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je više od 6 sati, preskočite uzimanje te doze i sljedeće doze uzmite prema uobičajenom rasporedu.
English: 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.
Croatian: Na probiru, zahtjev za bolesnike je bio HIV-1 RNK < 50 kopija/ml i broj CD4 > 300 stanica/mm Bolesnici su primili dozu od 750 mg INCIVA svakih 8 sati, osim bolesnika na režimu temeljenom na efavirenzu koji su primili dozu od 1125 mg INCIVA svakih 8 sati.
English: ADRs to INCIVO are presented in table 3.
Croatian: Tablični sažeti prikaz nuspojava Nuspojave lijeka INCIVO prikazane su u Tablici 3.
English: It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir.
Croatian: Kad se varfarin primjenjuje istodobno s telaprevirom preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
English: )/PR: INCIVO 1,125 mg twice daily for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks; T12(q8h)/PR: INCIVO 750 mg every 8 hours for 12 weeks with peginterferon alfa-2a and ribavirin for 24 or 48 weeks
Croatian: T12(b.i.d.)/PR: INCIVO 1125 mg dva puta na dan tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 24 ili 48 tjedana; T12(q8h)/PR: INCIVO 750 mg svakih 8 sati tijekom 12 tjedna s peginterferonom alfa-2a i ribavirinomtijekom 24 ili 48 tjedana
English: Table 10 shows SVR rates by extent of liver fibrosis at baseline.
Croatian: Tablica 10 pokazuje stope SVR prema opsegu fibroze jetre na početku ispitivanja.
English: HORMONAL CONTRACEPTIVES/OESTROGEN ethinylestradiol* norethindrone*
Croatian: HORMONSKI KONTRACEPTIVI/ESTROGEN
English: If you notice the missed dose after 4 hours, then skip the intake and take the next doses as usual.
Croatian: Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je više od 4 sata, preskočite uzimanje te doze i sljedeće doze uzmite prema uobičajenom rasporedu.
English: T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and ribavirin for 48 weeks;
Croatian: T12/PR48: INCIVO tijekom 12 tjedana nakon čega je slijedio placebo tijekom 4 tjedna, u kombinaciji s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana;
English: Renal impairment
Croatian: Linearnost/nelinearnost
English: PDE-5 INHIBITORS sildenafil tadalafil vardenafil
Croatian: INHIBITORI FOSFODIESTERAZE, TIP 5 (PDE-5)
English: Bridging fibrosis Cirrhosis
Croatian: Premoštavajuća fibroza
English: 45 to ≤ 65 years of age Black
Croatian: 45 do ≤ 65 godina starosti Ispitanici crne rase Hispano-latino porijeklo Indeks tjelesne mase ≥ 30 kg/m
English: T12/PR24: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 24 weeks; T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks
Croatian: T12/PR24: INCIVO tijekom 12 tjedana uz peginterferon alfa-2a i ribavirin tijekom 24 tjedna; T12/PR48: INCIVO tijekom 12 tjedana uz peginterferon alfa-2a i ribavirin tijekom 48 tjedana
English: The frequency rate of the side effects associated with INCIVO is given below.
Croatian: Učestalost nuspojava povezanih s INCIVOM navedena je u daljnjem tekstu.
English: HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration.
Croatian: Da bi se odredilo trajanje liječenja potrebno je u 4. i 12. tjednu odrediti koncentraciju HCV RNK.
English: INCIVO must be administered with peginterferon alfa and ribavirin.
Croatian: INCIVO se mora primjenjivati s peginterferonom alfa i ribavirinom.
English: Caution is warranted and clinical monitoring of patients is recommended.
Croatian: Nalaže se oprez i preporučuje kliničko praćenje bolesnika.
English: Patients in these studies, 108, 111 and C216, had compensated liver disease, detectable HCV RNA, and liver histopathology consistent with chronic hepatitis C. Unless otherwise indicated, INCIVO was administered at a dosage of 750 mg every 8 hours (q8h); the peginterferon alfa-2a dose was 180 µg/week, and the ribavirin dose was 1,000 mg/day (patients weighing < 75 kg) or 1,200 mg/day (patients weighing ≥ 75 kg).
Croatian: Ako nije bilo indicirano drugačije, INCIVO se primjenjivao u dozi od 750 mg svakih 8 sati (q8h); doza peginterferona alfa-2a bila je 180 µg/tjednu, a doza ribavirina bila je 1000 mg/danu (bolesnici s tjelesnom težinom < 75 kg) ili 1200 mg na dan (bolesnici s tjelesnom težinom ≥ 75 kg).
English: The 1,088 enrolled patients had a median age of 49 years (range: 18 to 69); 58% of the patients were male; 23% had a body mass index ≥ 30 kg/m2; 9% were Black; 11% were Hispanic or Latino; 77% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 6% had cirrhosis; 59% had HCV genotype 1a; and 40% had HCV genotype 1b.
Croatian: Medijan dobi 1088 uključena bolesnika bio je 49 godina (raspon: 18 do 69 godina); 58% bolesnika bili su muškarci; 23% imalo je indeks tjelesne mase ≥ 30 kg/m2; 9% bili su crne rase; 11% bili su hispano ili latino porijekla; 77% imalo je početnu koncentraciju HCV RNK ≥ 800 000 IU/ml; 15% imalo je premoštavajuću fibrozu; 6% imalo je cirozu; 59% imalo je HCV genotip 1a; a 40% imalo je
English: QT interval prolongation and Torsade de Pointes have been reported with voriconazole and posaconazole.
Croatian: Uz vorikonazol i posakonazol zabilježeni su produljenje QT intervala i torsade de pointes.
English: amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics)
Croatian: amiodaron, bepridil, kinidin, ostali antiaritmici skupine Ia ili III
English: to treat some stomach conditions (gastrointestinal motility agents)
Croatian: cisaprid za liječenje nekih želučanih tegoba (sredstva koja djeluju na pokretljivost probavnog sustava)
English: The 740 enrolled patients had a median age of 51 years (range: 18 to 70); 60% of the patients were male; 21% had a body mass index ≥ 30 kg/m2; 5% were Black; 2% were Asian; 85% had baseline HCV RNA levels ≥ 800,000 IU/ml; 15% had bridging fibrosis; 14% had cirrhosis; 57% had HCV genotype 1a; and 43% had HCV genotype 1b.
Croatian: 740 uključenih bolesnika imalo je medijan dobi 51 godinu (raspon: 18 do 70); 60% bolesnika bili su muškarci; 21% je imalo indeks tjelesne mase ≥ 30 kg/m2; 5% je bilo crne rase; 2% je bilo azijatskog porijekla; 85% je imalo početne vrijednosti HCV RNK ≥ 800 000 IU/ml; 15% imalo je premoštavajuću fibrozu; 14% imalo je cirozu; 57% imalo je HCV genotip 1a i 43% imalo je HCV
English: Prior relapsers Prior partial responders Prior null responders
Croatian: Bolesnici s prethodno djelomičnim odgovorom Bolesnici s prethodnim potpunim izostankom odgovora
English: If you are taking INCIVO twice daily (morning and evening) If you notice the missed dose within 6 hours, you must take three tablets immediately.
Croatian: Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je manje od 6 sati, morate odmah uzeti tri tablete.
English: Do not
Croatian: I DOHVATA
English: Telaprevir had no effects on fertility or fecundity when evaluated in rats.
Croatian: U ispitivanjima na štakorima telaprevir nije imao učinke na plodnost.
English: The 540 enrolled patients had a median age of 51 years (range: 19 to 70); 60% of the patients were male; 32% had a body mass index ≥ 30 kg/m2; 14% were Black; 10% were Hispanic or Latino; 82% had baseline HCV RNA levels > 800,000 IU/ml; 16% had bridging fibrosis; 11% had cirrhosis; 72% had HCV genotype 1a; and 27% had HCV genotype 1b.
Croatian: Medijan dobi 540 uključenih bolesnika bio je 51 godina (raspon: 19 do 70 godina); 60% bolesnika bili su muškarci; 32% je imalo indeks tjelesne mase ≥ 30 kg/m2; 14% bili su crnci; 10% bili su hispano ili latino porijekla; 82% imalo je početnu koncentraciju HCV RNK > 800 000 IU/ml; 16% je imalo premoštavajuću fibrozu; 11% imalo je cirozu; 72% imalo je HCV genotip 1a; a 27% je imalo
English: The 662 enrolled patients had a median age of 51 years (range: 21 to 70); 70% of the patients were male; 26% had a body mass index ≥ 30 kg/m2; 5% were Black; 11% were Hispanic or Latino; 89% had baseline HCV RNA levels > 800,000 IU/ml; 22% had bridging fibrosis; 26% had cirrhosis; 54% had HCV genotype 1a; and 46% had HCV genotype 1b.
Croatian: Medijan dobi 662 uključena bolesnika bila je 51 godina (raspon: 21 do 70 godina); 70% bolesnika bili su muškarci; 26% imalo je indeks tjelesne mase ≥ 30 kg/m2; 5% bili su crne rase; 11% bili su hispano ili latino porijekla; 89% imalo je početnu koncentraciju HCV RNK > 800 000 IU/ml; 22% imalo je premoštavajuću fibrozu; 26% imalo je cirozu; 54% imalo je HCV genotip 1a; a 46% imalo je
English: a Grade ≥ 2) that represent a worsening from baseline and are considered adverse drug reactions in HCV-infected patients treated with INCIVO combination treatment from the pooled data from the placebo-controlled
Croatian: Tablica 4: Promjene vrijednosti odabranih laboratorijskih nalaza (DAIDS predstavljaju pogoršanje u odnosu na početno stanje i smatraju se nuspojavama, u bolesnika s HCV infekcijom liječenih kombiniranom terapijom s INCIVOM na temelju objedinjenih podataka iz faze II i III placebom kontroliranih ispitivanja
English: oral midazolam*
Croatian: OPIJATNI ANALGETICI metadon*
English: Duration of treatment - Previously treated adults with prior partial or prior null response Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks, followed by peginterferon alfa and ribavirin therapy alone (without INCIVO) for a total treatment duration of 48 weeks (see figure 2).
Croatian: INCIVO se mora početi uzimati u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana, a nakon toga se liječenje nastavlja samo peginterferonom alfa i ribavirinom (bez INCIVA) do ukupnog trajanja liječenja od 48 tjedana (vidjeti sliku 2).
English: ul.
Croatian: SVR