natgillin/translations-raw huggingface dataset:
Erythropoisis-stimulating agents (ESAs) were generally not permitted and used in only 1% of patients in the Phase 2 and 3 clinical trials. 
U fazi II i III kliničkih ispitivanja tvari koje stimuliraju eritropoezu općenito nisu bile dopuštene i primijenile su se u samo 1% bolesnika.
Decisions related to your treatment may be made based on the results of these tests. 
Na temelju rezultata tih pretraga, liječnik može odlučiti o načinu liječenja.
It is not recommended to co-administer lopinavir/ritonavir and telaprevir (see section 4.4). 
Ne preporučuje se istodobno primjenjivati lopinavir/ritonavir s telaprevirom (vidjeti dio 4.4).
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. 
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.
• The Patient Information Leaflet 
• Sažetak opisa svojstava lijeka
Table 5 shows the response rates for the T12(b.i.d. 
Tablica 5 pokazuje stope odgovora za T12(b.i.d.)/PR skupinu i T12(q8h)/PR skupinu.
Therefore, herbal preparations containing St John's wort 
Stoga se biljni pripravci koji sadrže gospinu travu ne smiju
↑ midazolam (p.o.) AUC 8.96 (7.75-10.35) Cmax 2.86 (2.52-3.25) 
↑ atorvastatin AUC 7,88 (6,82-9,07) Cmax 10,6 (8,74-12,85)
QT interval prolongation and Torsade de Pointes have been reported with methadone (see section 4.4). 
Uz metadon su zabilježeni produljenje QT intervala i torsade de pointes (vidjeti dio 4.4).
- 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. 
- 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.
Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin which must be 
Vidjeti Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin, koji se moraju istodobno
Telaprevir exposure is comparable during co-administration with either peginterferon alfa-2a and ribavirin or peginterferon alfa-2b and ribavirin. 
Izloženost telapreviru tijekom istodobne primjene s peginterferonom alfa-2a i ribavirinom usporediva je s onom tijekom istodobne primjene s peginterferonom alfa-2b i ribavirinom.
Pbo/PR48: placebo for 16 weeks in combination with peginterferon alfa-2a and ribavirin for 48 weeks 
Pbo/PR48: placebo tijekom 16 tjedana u kombinaciji s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
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 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
Subgroup 
Distribucija
INCIVO treatment completed Permanently discontinue treatment with INCIVO, peginterferon alfa, and ribavirin. 
Trajno prekinuti liječenje liječenje INCIVOM, peginterferonom alfa i ribavirinom.
abacavir 
fenobarbital
Co-administration with phenytoin is contraindicated. 
Istodobna primjena s fenitoinom je kontraindicirana.
See also the package leaflets for peginterferon alfa and ribavirin. 
Također, pročitajte upute o lijeku za peginterferon alfa i ribavirin.
AUC 0.96 (0.84-1.10) Cmax 0.80 (0.69-0.93) Cmin 1.06 (0.87-1.30) 
↓ R-metadon AUC 0,71 (0,66-0,76) Cmax 0,71 (0,66-0,76) Cmin 0,69 (0,64-0,75)
• The Summary of Product Characteristics 
• Dodatne mjere minimizacije rizika
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. 
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.
itraconazole, ketoconazole, posaconazole, 
itrakonazol, ketokonazol, posakonazol, vorikonazol za liječenje gljivičnih infekcija (antimikotici)
If you notice the missed dose after 6 hours, then skip the intake and take the next doses as usual. 
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.
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. 
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.
ADRs to INCIVO are presented in table 3. 
Tablični sažeti prikaz nuspojava Nuspojave lijeka INCIVO prikazane su u Tablici 3.
It is recommended that the international normalised ratio (INR) be monitored when warfarin is co-administered with telaprevir. 
Kad se varfarin primjenjuje istodobno s telaprevirom preporučuje se praćenje međunarodnog normaliziranog omjera (INR).
)/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 
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
Table 10 shows SVR rates by extent of liver fibrosis at baseline. 
Tablica 10 pokazuje stope SVR prema opsegu fibroze jetre na početku ispitivanja.
HORMONAL CONTRACEPTIVES/OESTROGEN ethinylestradiol* norethindrone* 
HORMONSKI KONTRACEPTIVI/ESTROGEN
If you notice the missed dose after 4 hours, then skip the intake and take the next doses as usual. 
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.
T12/PR48: INCIVO for 12 weeks followed by placebo for 4 weeks, in combination with peginterferon alfa-2a and ribavirin for 48 weeks; 
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;
Renal impairment 
Linearnost/nelinearnost
PDE-5 INHIBITORS sildenafil tadalafil vardenafil 
INHIBITORI FOSFODIESTERAZE, TIP 5 (PDE-5)
Bridging fibrosis Cirrhosis 
Premoštavajuća fibroza
45 to ≤ 65 years of age Black 
45 do ≤ 65 godina starosti Ispitanici crne rase Hispano-latino porijeklo Indeks tjelesne mase ≥ 30 kg/m
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 
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
The frequency rate of the side effects associated with INCIVO is given below. 
Učestalost nuspojava povezanih s INCIVOM navedena je u daljnjem tekstu.
HCV RNA levels should be monitored at weeks 4 and 12 to determine treatment duration. 
Da bi se odredilo trajanje liječenja potrebno je u 4. i 12. tjednu odrediti koncentraciju HCV RNK.
INCIVO must be administered with peginterferon alfa and ribavirin. 
INCIVO se mora primjenjivati s peginterferonom alfa i ribavirinom.
Caution is warranted and clinical monitoring of patients is recommended. 
Nalaže se oprez i preporučuje kliničko praćenje bolesnika.
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). 
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).
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. 
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
QT interval prolongation and Torsade de Pointes have been reported with voriconazole and posaconazole. 
Uz vorikonazol i posakonazol zabilježeni su produljenje QT intervala i torsade de pointes.
amiodarone, bepridil, quinidine, other Class Ia or III antiarrhythmics to treat certain heart disorders such as irregular heart beat (antiarrhythmics) 
amiodaron, bepridil, kinidin, ostali antiaritmici skupine Ia ili III
to treat some stomach conditions (gastrointestinal motility agents) 
cisaprid za liječenje nekih želučanih tegoba (sredstva koja djeluju na pokretljivost probavnog sustava)
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. 
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
Prior relapsers Prior partial responders Prior null responders 
Bolesnici s prethodno djelomičnim odgovorom Bolesnici s prethodnim potpunim izostankom odgovora
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. 
Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je manje od 6 sati, morate odmah uzeti tri tablete.
Do not 
I DOHVATA
Telaprevir had no effects on fertility or fecundity when evaluated in rats. 
U ispitivanjima na štakorima telaprevir nije imao učinke na plodnost.
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. 
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
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. 
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
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 
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
oral midazolam* 
OPIJATNI ANALGETICI metadon*
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). 
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).
ul. 
SVR
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. 
INCIVO je bio procijenjen u kombinaciji s peginterferonom alfa i ribavirinom u 74 bolesnika s HCV-1 infekcijom nakon transplantacije jetre bez ciroze koji su dobivali ili takrolimus ili ciklosporin A.
It is important to stay hydrated with fluids during INCIVO combination treatment. 
INCIVO važno je održavanje hidracije organizma tekućinom.
SVR in patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 
SVR u bolesnika s nemjerljivom HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu SVR u bolesnika koji nisu imali nemjerljivu HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu
Prior relapsers 
Relaps
T12/PR48: INCIVO for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks; Pbo/PR: placebo for 12 weeks with peginterferon alfa-2a and ribavirin for 48 weeks 
T12/PR48: INCIVO tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana; Pbo/PR: placebo tijekom 12 tjedana s peginterferonom alfa-2a i ribavirinom tijekom 48 tjedana
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 
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
A total of 352 (65%) patients had undetectable HCV RNA (target not detected) at weeks 4 and 12. 
Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu imalo je ukupno 352 (65%) bolesnika.
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 
↔telaprevir AUC 1,07 (1,00-1,15) Cmax 1,07 (0,98-1,16) Cmin 1,14 (1,04-1,26) ↑ raltegravir AUC 1,31 (1,03-1,67) Cmax 1,26 (0,97-1,62) Cmin 1,78 (1,26-2,53)
Table 3: Adverse drug reactions to INCIVO (taken in combination with peginterferon alfa and ribavirin) in HCV-infected patients in clinical trials a and post-marketing Adverse Drug Reactions INCIVO, peginterferon alfa, and ribavirin combination therapy oral candidiasis anaemia thrombocytopenia b, lymphopenia hypothyroidism hyperuricaemia b, hypokalaemia gout dysgeusia, syncope 
Tablica 3: Nuspojave INCIVA (koji se uzima u kombinaciji s peginterferonom alfa i ribavirinom) u bolesnika zaraženih HCV-om u kliničkim ispitivanjima a i postmarketinški
Your doctor should check your rash to determine how to manage it. 
Kako bi mogao odrediti kako liječiti osip, liječnik Vas treba pregledati.
T12(DS)/PR % (n/N) ≥ 1 log10 reduction in HCV RNA at week 4 
Sniženje HCV RNK ≥ 1 log10 u 4. tjednu
Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child-Pugh A, score 5-6). 
Kad se INCIVO primjenjuje u bolesnika s hepatitisom C i blagim oštećenjem funkcije jetre (Child-Pugh A, rezultat 5-6), prilagodba doze nije potrebna.
See also section 4.3 for medicinal products which are contraindicated with INCIVO. 
Za lijekove koji su kontraindicirani s INCIVOM, vidjeti također dio 4.3.
regimen results in the same daily dose with similar drug exposures of telaprevir, the relative drug interactions are expected to be similar. 
Očekuje se da će relativne interakcije lijekova biti slične, ako se uzme u obzir da shema uzimanja 1125 mg b.i.d. dovodi do istih dnevnih doza sa sličnim izloženostima telapreviru.
Cmin 1.10 (0.97-1.24) induction of CYP3A by carbamazepine, and inhibition of CYP3A by telaprevir 
↓ telaprevir ↑ rifabutin rifabutin inducira CYP3A, a telaprevir inhibira
Patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 
Nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i
SVR in patients who did not have undetectable HCV RNA (target not detected) at weeks 4 
Nazivnik je bio broj bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) na kraju liječenja
↓ ethinylestradiol AUC 0.72 (0.69-0.75) Cmax 0.74 (0.68-0.80) Cmin 0.67 (0.63-0.71) ↔ norethindrone AUC 0.89 (0.86-0.93) Cmax 0.85 (0.81-0.89) Cmin 0.94 (0.87-1.00) mechanism unknown 
 telaprevir AUC 0,46 (0,41-0,52) Cmax 0,47 (0,41-0,52) Cmin 0,48 (0,40-0,56) ↔ lopinavir AUC 1,06 (0,96-1,17) Cmax 0,96 (0,87-1,05) Cmin 1,14 (0,96-1,36) mehanizam nije poznat
Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin. 
Za informacije o smanjenju doze i/ili prekidu primjene ribavirina pogledajte Sažetak opisa svojstava lijeka za ribavirin.
to treat fungal infections (antifungals) 
za liječenje upalnog artritisa (sredstva protiv uloga) za liječenje određenih infekcija (antimikobakterijski lijekovi)
Serious skin reactions including rash with systemic symptoms, progressive severe rash, 
Ozbiljne kožne reakcije uključujući osip sa sistemskim simptomima, progresivni teški osip, sumnja ili dijagnoza generalizirane bulozne erupcije, DRESS, SJS/TEN, akutna generalizirana egzantematozna pustuloza,
See the package leaflets for peginterferon alfa and ribavirin for a list of their contraindications (e.g. pregnancy precautions for men and women) since INCIVO must be used in combination with peginterferon alfa and ribavirin. 
S obzirom da se INCIVO mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom, kontraindikacije za peginterferon alfa i ribavirina pogledajte u pripadajućoj uputi o lijeku (npr. mjere zaštite od trudnoće za muškarce i žene).
Treatment-Experienced Patients by Subgroup 
Bolesnice reproduktivne dobi i njihovi partneri
Increases in serum uric acid occur very commonly during treatment with INCIVO in combination with peginterferon alfa and ribavirin. 
Tijekom liječenja INCIVOM u kombinaciji s peginterferonom alfa i ribavirinom vrlo često dolazi do povišenja mokraćne kiseline u serumu.
(target not detected) at weeks 4 and 12 of treatment, the SVR rate was 89% (25/28) and the relapse rate was 7%. 
U bolesnika s prethodnim relapsom u terapijskoj skupini T12/PR24 u kojih je HCV RNK bio nemjerljiv (cilj nije izmjeren) u 4. i 12. tjednu liječenja, stopa SVR iznosila je 89% (25/28), a stopa relapsa 7%.
In patients with HCV RNA between 100 IU/ml and 1,000 IU/ml at week 12, 
Od bolesnika s koncentracijom HCV RNK između 100 IU/ml i 1000 IU/ml u 12. tjednu trajni virološki odgovor postiglo je 2/8 (25%) bolesnika.
Use of peginterferon alfa 2a or 2b Two types of peginterferon alfa (2a and 2b) were studied in the Phase 2a open label, randomised 
U fazi II randomiziranog ispitivanja otvorenog tipa C208 ispitivale su se dvije vrste peginterferona alfa (2a i 2b) u bolesnika koji prethodno nisu bili liječeni.
and patients receiving telaprevir 750 mg every 8 hours (q8h). 
↓ telaprevir 1 125 mg svakih 8 sati (u odnosu na 750 mg svakih 8 sati)
)/PR N = 369 % (n/N) 
T12(b.i.d.)/PR N = 369 % (n/N)
Duration of treatment - Treatment-naïve adults and prior treatment relapsers Treatment with INCIVO must be initiated in combination with peginterferon alfa and ribavirin and administered for 12 weeks (see figure 1). 
INCIVO se mora početi uzimati u kombinaciji s peginterferonom alfa i ribavirinom i primjenjivati tijekom 12 tjedana (vidjeti Sliku 1).
Contact your doctor immediately if you get a skin rash. 
Ako dobijete kožni osip, odmah se javite liječniku.
↑ alprazolam AUC 1.35 (1.23-1.49) Cmax 0.97 (0.92-1.03) 
Cmin 1,93 (1,55-2,41)
You must read the package leaflets for peginterferon alfa and ribavirin for additional information. 
Za dodatne informacije, morate pročitati upute o lijeku za peginterferon alfa i ribavirin.
After weaning, rat pup body weight gain silica colloidal anhydrous sodium lauryl sulphate croscarmellose sodium sodium stearyl fumarate 
Po prestanku sisanja, porast tjelesne težine mladunčadi štakora vratio se na kalcijev hidrogenfosfat, bezvodni silicijev dioksid, koloidni, bezvodni
All treatment regimens had a 48-week duration of peginterferon alfa-2a and ribavirin treatment. 
U svim terapijskim skupinama liječenje peginterferonom alfa-2a i ribavirinom trajalo je 48 tjedana.
- 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 
INCIVO je indiciran u kombinaciji s peginterferonom alfa i ribavirinom za liječenje odraslih bolesnika s kroničnim hepatitisom C genotipa 1 i kompenziranom bolešću jetre (uključujući cirozu): - koji prethodno nisu bili liječeni, - koji su prethodno bili liječeni samo interferonom alfa (pegiliranim ili nepegiliranim) ili u kombinaciji s ribavirinom, uključujući bolesnike s relapsom, s djelomičnim terapijskim odgovorom i one koji nisu odgovorili na ranije liječenje (vidjeti dijelove 4.4 i 5.1).
Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia. 
Za zbrinjavanje anemije nastale liječenjem, prednost se daje smanjenju doze ribavirina.
When administered twice daily (b.i.d. 
Ako uzimate INCIVO dva puta na dan (ujutro i navečer)
Treatment Outcome Treatment-Naïve Patients N = 64 % (n/N) 
Bolesnici s iskustvom u liječenju prema podskupini S prethodnim relapsom N = 29 % (n/N)
Treatment is started at a low dose, which the doctor may then increase slowly until an appropriate dose is reached. 
Liječenje započinje s malom dozom, koju liječnik potom može polako povećavati dok ne dosegne odgovarajuću dozu.
Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units). 
Lijek Enzepi je dostupan u obliku kapsula (5 000, 10 000, 25 000 i 40 000 jedinica).
The full EPAR for Enzepi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR za lijek Enzepi nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.