natgillin/translations-raw huggingface dataset:
No relevant induction by telaprevir of CYP1A2, CYP2B6, CYP2C, and CYP3A isozymes was observed in vitro. 
Nije zabilježena značajna indukcija izoenzima CYP1A2, CYP2B6, CYP2C i CYP3A telaprevirom in vitro.
The use of INCIVO in combination with peginterferon alfa-2b The Phase 3 studies were all conducted with peginterferon alfa-2a in combination with INCIVO and ribavirin. 
Primjena INCIVA u kombinaciji s peginterferonom alfa-2b Faze III svih ispitivanja provedena su s peginterferonom alfa-2a u kombinaciji s INCIVOM i ribavirinom.
Contact your doctor or pharmacist immediately to ask for advice. 
Odmah potražite savjet liječnika ili ljekarnika.
Study 108 (ADVANCE) 
Ispitivanje 112 (EXTEND)
On-treatment-virologic failure includes patients who met a protocol-defined virologic stopping rule and/or had viral 
Virološki neuspjeh tijekom liječenja uključuje bolesnike koji su došli do protkolom definiranog virološkog pravila za zaustavljanje i/ili su imali virusni proboj.
Each film-coated tablet contains 375 mg of telaprevir. 
Jedna filmom obložena tableta sadrži 375 mg telaprevira.
During INCIVO treatment, rash events (all grades) were reported in 55% of patients who received INCIVO combination treatment and in 33% of patients who received peginterferon alfa and ribavirin. 
Za vrijeme liječenja INCIVOM osipi (svih stupnjeva) bili su prijavljeni u 55% bolesnika koji su primali kombiniranu terapiju INCIVOM i u 33% bolesnika koji su primali peginterferon alfa i ribavirin.
Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash 
Preporuke za praćenje kožnih reakcija i prekid primjene INCIVA, ribavirina i peginterferona alfa zbog teškog osipa
Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients. 
Ispitivanje 111 bilo je randomizirano ispitivanje, faze III, otvorenog tipa provedeno u bolesnika koji prethodno nisu bili liječeni.
Figure 2: Duration of treatment for previously treated patients with prior partial or prior 
Slika 2: Trajanje liječenja prethodno liječenih bolesnika s djelomičnim terapijskim odgovorom ili onih koji nisu odgovorili na ranije liječenje
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 informacije vezane uz primjenu INCIVA u kombinaciji s peginterferonom alfa i ribavirinom u bolesnika s HCV-1 infekcijom koji prethodno nisu bili liječeni i prethodno liječenih bolesnika koji su primatelji transplantirane jetre i na stabilnom režimu s imunosupresivima takrolimusom ili ciklosporinom A, vidjeti djelove 4.2,
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. 
Nazivnik je broj bolesnika s HCV RNK < 25 IU/ml na planiranom kraju liječenja ili nedostatak HCV RNK procjene na planiranom kraju liječenja i HCV RNK < 25 IU/ml tijekom praćenja od planiranog kraja liječenja nadalje.
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). 
Svi bolesnici su primili 12 tjedana liječenja INCIVOM s peginterferonom alfa-2a i ribavirinom nakon čega je slijedilo 36 tjedana liječenja s peginterferonom alfa-2a i ribavirinom (ukupno trajanje liječenja 48 tjedana).
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. 
Ispitivanje 107 bilo je prijelazno (engl. rollover) ispitivanje otvorenog tipa u bolesnika koji su bili liječeni kao kontrolna skupina (placebo, peginterferon alfa-2a i ribavirin) u fazi II ispitivanja telaprevira i koji nisu postigli SVR u fazi II ispitivanja.
Consultation with a specialist in dermatology is recommended. 
Preporučuje se potražiti savjet specijalista dermatologije.
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. 
Vrijednosti hemoglobina < 8,5 g/dl bile su zabilježene u 8% bolesnika koji su primali terapiju kombiniranu s INCIVOM u odnosu na 2% bolesnika koji su primali peginterferon alfa i ribavirin.
Relapse was defined as having less than 25 IU/ml at the planned end of treatment followed by HCV RNA ≥ 25 IU/ml at the last observation within the SVR follow-up visit window. 
Relaps je definiran kao postojanje manje od 25 IU/ml na planiranom kraju liječenja nakon čega slijedi HCV RNK ≥ 25 IU/ml pri zadnjem opažanju unutar vremenskog prozora posjete praćenja SVR.
Undetectable HCV RNA (target not detected) at 
Nemjerljiva HCV RNK (cilj nije izmjeren) u
The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV-infected liver transplant recipients as measured by SVR12. 
Primarni cilj ispitivanja bio je procijeniti antivirusnu djelotvornost INCIVA, peginterferona alfa-2a, i ribavirina kod primatelja transplantirane jetre s HCV infekcijom, mjerenu putem SVR12.
The recommendations for monitoring of cutaneous reactions, and for discontinuation of INCIVO, ribavirin and peginterferon alfa are summarised in the table below: 
Preporuke za praćenje kožnih reakcija i prekid primjene INCIVA, ribavirina i peginterferona alfa sažeto su prikazane u sljedećoj tablici:
Study HPC3008 was an open-label, Phase 3b study conducted in patients with chronic genotype 1 HCV/HIV-1 co-infection who were treatment-naïve for hepatitis C or who did not achieve SVR with prior treatment with peginterferon alfa (2a or 2b) and ribavirin (including prior relapsers, prior partial responders and prior null responders). 
Ispitivanje HPC3008 bilo je otvoreno ispitivanje Faze 3b provedeno u HCV genotipa 1/HIV-1 koinficiranih bolesnika, kojima hepatitis C prethodno nije bio liječen ili koji nisu dostigli SVR u prethodnom liječenju uz peginterferon alfa (2a ili 2b) i ribavirin (uključujući one s prethodnim relapsom, one koji su prethodno djelomično odgovorili i one koji prethodno nisu odgovorili).
In placebo-controlled Phase 2 and 3 trials, 0.4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS). 
U fazi II i III placebom kontroliranih ispitivanja 0,4% bolesnika imalo je osip za koji se sumnjalo da je uzrokovan lijekom, s eozinofilijom i sustavnim simptomima (engl.
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 
Promjene vrijednosti odabranih laboratorijskih nalaza barem umjerenog intenziteta (≥ 2. stupnja) koje predstavljaju pogoršanje u odnosu na početno stanje i smatraju se nuspojavama na lijek, a opažene su u bolesnika s HCV infekcijom liječenih terapijom kombiniranom s INCIVOM na temelju objedinjenih podataka iz faze II i III placebom kontroliranih ispitivanja prikazane su u sljedećoj tablici.
Since INCIVO treatment always needs to be used together with peginterferon alfa and ribavirin, please also check the package leaflets for the dosage instructions of these medicines. 
Budući da se INCIVO uvijek treba uzimati zajedno s peginterferonom alfa i ribavirinom, molimo također provjerite upute o svakom pojedinom lijeku za upute o doziranju navedenih lijekova.
73.8% (59/80) of patients in the pooled peginterferon alfa-2a group met the criteria (undetectable HCV RNA (target not detected) at week 4 through week 20) for the shortened 24 week peginterferon/ribavirin treatment duration versus 61.7% (50/81) of patients in the pooled 
U skupini koja se sastojala od svih bolesnika koji su primali peginterferon alfa-2a, 73,8% (59/80) bolesnika zadovoljilo je kriterije (nemjerljiv HCV RNK (cilj nije izmjeren) u 4. tjednu, pa do 20. tjedna) za skraćeno trajanje liječenja peginterferonom/ribavirinom od 24 tjedna nasuprot 61,7% (50/81) bolesnika u skupini koja se sastojala od svih bolesnika koji su primali peginterferon alfa-2b.
The control regimen (Pbo/PR) had a fixed treatment duration of 48 weeks, with telaprevir-matching placebo for the first 12 weeks and peginterferon alfa-2a and ribavirin for 48 weeks. 
Kontrolni režim (Pbo/PR) liječenja imao je fiksno trajanje od 48 tjedana, uz placebo koji je odgovarao telapreviru tijekom prvih 12 tjedana i peginterferon alfa-2a i ribavirin tijekom 48 tjedana.
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. 
U fazi II i III placebom kontroliranih ispitivanja težak osip (prvenstveno ekcematozan, pruritičan i koji zahvaća više od 50% površine tijela) prijavljen je u 4,8% bolesnika koji su primali kombinirano liječenje INCIVOM u usporedbi s 0,4% bolesnika koji su primali peginterferon alfa i ribavirin.
Plasma concentrations with the telaprevir 1,875 mg every 8 hours dose used in this trial were comparable to those observed in studies in HCV-infected patients who received telaprevir 750 mg every 8 hours in combination with peginterferon alfa-2a and ribavirin. 
U tom su kliničkom ispitivanju koncentracije u plazmi nakon primjene doze telaprevira od 1875 mg svakih 8 sati bile usporedive s onima primijećenima u bolesnika s HCV infekcijom koji su u ispitivanjima primali telaprevir u dozi od 750 mg svakih 8 sati u kombinaciji s peginterferonom alfa-2a i ribavirinom.
The primary objective of the study was to assess the antiviral efficacy of INCIVO, peginterferon alfa-2a, and ribavirin in HCV/HIV-1 co-infected patients as measured by SVR12. 
Primarni cilj ispitivanja bila je procjena antivirusne djelotvornosti INCIVA, peginterferona alfa-2a i ribavirina u bolesnika koinficiranih HCV/HIV-1 infekcijom, mjereno prema SVR12.
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. 
Vrijednosti hemoglobina < 10 g/dl bile su zabilježene u 34% bolesnika koji su primali terapiju kombiniranu s INCIVOM i 14% bolesnika koji su primali peginterferon alfa i ribavirin.
Table 7 shows the response rates for the recommended T12/PR and the Pbo/PR48 groups. 
Tablica 7 pokazuje stope odgovora u preporučenim skupinama T12/PR i Pbo/PR48.
Caution is warranted and clinical monitoring is recommended when co-administered with INCIVO. 
Nalaže se oprez i preporučuje klinički nadzor kad se primjenjuju istodobno s INCIVOM.
Table 13 shows the SVR rates by week 4 response (< 1 log10 or ≥ 1 log10 reduction in HCV RNA) for prior partial responders and for prior null responders in the T12(DS)/PR group. 
Tablica 13 pokazuje stope SVR prema odgovoru nakon 4 tjedna (smanjenje HCV RNK < 1 log10 ili ≥ 1 log10) u bolesnika s prethodno djelomičnim odgovorom i bolesnika s prethodnim potpunim izostankom odgovora u skupini T12(DS)/PR.
All patients includes the 322 patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 and the 218 other patients treated in the study (118 who did not have undetectable HCV RNA (target not detected) at weeks 4 and 12 and 100 who discontinued the study before week 20, when randomisation occurred) 
Svi bolesnici uključuje 322 bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu i 218 drugih bolesnika liječenih u ispitivanju (118 koji nisu imali nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu i 100 koji su prekinuli ispitivanje prije 20. tjedna, kad se provodila randomizacija)
- 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). 
- Svim bolesnicima s cirozom, bez obzira na to je li u njih mjerljiva HCV RNK (cilj nije izmjeren) u 4. ili 12. tjednu liječenja, preporučuje se davati samo peginterferon alfa i ribavirin tijekom dodatnih 36 tjedana, tako da liječenje traje ukupno 48 tjedana (vidjeti dio 5.1).
Caution is warranted, laboratory and clinical monitoring is recommended. 
Nalaže se oprez i preporučuje laboratorijsko i kliničko praćenje.
Haematology evaluations (including white cell differential count) are recommended at weeks 2, 4, 8 
Hematološke pretrage (uključujući diferencijalnu krvnu sliku) preporučuje se napraviti u 2., 4., 8. i 12. tjednu, te ako je klinički potrebno.
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. 
U fazi II i III placebom kontroliranih kliničkih ispitivanja ukupna incidencija i težina anemije bila je povećana uz kombinirano liječenje INCIVOM u usporedbi s liječenjem samo peginterferonom alfa i ribavirinom.
HCV RNA > 1,000 IU/ml at week 4 of treatment 
HCV RNK > 1000 IU/ml nakon 4 tjedna liječenja
Hepatic impairment 
Težak osip
In the placebo-controlled Phase 2 and 3 trials, transfusions were reported during the INCIVO/placebo treatment phase in 2.5% of patients receiving INCIVO combination treatment and 0.7% in patients receiving peginterferon alfa and ribavirin alone. 
U fazi II i III placebom kontroliranih ispitivanja zabilježene su transfuzije za vrijeme faze liječenja INCIVOM/placebom u 2,5% bolesnika liječenih kombiniranom terapijom INCIVOM i u 0,7% bolesnika koji su primali samo peginterferon alfa i ribavirin.
INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring. 
U primjeni INCIVA s antiaritmicima skupine Ic, tj. propafenonom i flekainidom, potreban je oprez kao i odgovarajuće kliničko i EKG praćenje.
In treatment-naïve patients in the Phase 3 studies, 4/16 (25%) patients with HCV RNA levels between 100 IU/ml and 1,000 IU/ml at week 4 achieved SVR. 
Od bolesnika u fazi III ispitivanja koji prethodno nisu bili liječeni SVR postiglo je 4/16 (25%) bolesnika s HCV RNK između 100 IU/ml i 1000 IU/ml u 4. tjednu.
INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.) 
INCIVO treba uzimati u dozi od 1125 mg (tri filmom obložene tablete od 375 mg) peroralno dva puta na dan (b.i.d.) uz obrok.
Co-administration of domperidone with INCIVO should be avoided (see section 4.4). 
Istodobnu primjenu domperidona s INCIVOM treba izbjegavati (vidjeti dio 4.4).
The exposure (AUC) to telaprevir increased slightly greater than proportionally to the dose after single-dose administration of 375 up to 1,875 mg with food, possibly due to saturation of metabolic 
Nakon primjene jednokratne doze od 375 do 1875 mg uz obrok izloženost (AUC) telapreviru povećala se malo više nego proporcionalno u odnosu na dozu, vjerojatno zbog saturacije metaboličkih puteva ili transportnih proteina.
Co-administration of INCIVO and medicinal products that inhibit CYP3A and/or P-gp may increase telaprevir plasma concentrations. 
Istodobna primjena INCIVA i lijekova koji inhibiraju CYP3A i/ili P-gp može povisiti koncentracije
All patients includes the 322 patients with undetectable HCV RNA (target not detected) at weeks 4 and 12 and the 218 other patients treated in the study (118 who did not have undetectable HCV RNA (target not detected) at week 4 and 12 and 100 who discontinued the study before week 20, when randomisation occurred). 
"Svi bolesnici" uključuje 322 bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu i 218 drugih bolesnika liječenih u ispitivanju (118 koji nisu imali nemjerljiv HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu i 100 koji su prekinuli ispitivanje prije 20. tjedna, kad se provodila randomizacija).
Following completion of INCIVO therapy contraceptive recommendations should be followed as in the Summary of Product Characteristics for ribavirin, and as described below. 
Nakon završetka liječenja INCIVOM treba se pridržavati preporuka za kontracepciju koje su navedene u Sažetku opisa svojstava lijeka za ribavirin i
Concurrent administration of salmeterol and telaprevir is not recommended. 
Ne preporučuje se istodobna primjena salmeterola i telaprevira.
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. 
U fazi II i III placebom kontroliranih ispitivanja anemija je (svi stupnjevi) bila zabilježena u 32,1% bolesnika liječenih kombiniranom terapijom INCIVOM i u 14,8% bolesnika koji su primali peginterferon alfa i ribavirin.
(HIV RNA < 50 copies/ml, CD4 count ≥ 300 cells/mm 
3), ili su HIV imali pod kontrolom (HIV RNK < 50 kopija/ml, CD4 broj
The primary objective was to demonstrate the noninferiority of T12(b.i.d. 
Primarni cilj bio je pokazati neinferiornosti T12(b.i.d.)/PR u odnosu na T12(q8h)/PR.
Co-administration with phenobarbital is contraindicated. 
Istodobna primjena s fenobarbitalom je kontraindicirana.
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). 
Ispitivanje je bilo ustrojeno tako da su se uspoređivale stope SVR u bolesnika s nemjerljivim HCV RNK (cilj nije izmjeren) u 4. i 12. tjednu liječenih INCIVOM tijekom 12 tjedana, u kombinaciji s peginterferonom alfa-2a i ribavirinom koji su se davali 24 tjedana (režim T12/PR24) ili 48 tjedana (režim T12/PR48).
HCV/Human immunodeficiency virus type (HIV)-1 co-infection HCV/HIV-1 co-infected patients should be treated in the same way as HCV mono-infected patients. 
Bolesnici koji su istodobno inficirani s HCV-om i HIV-om-1 moraju se liječiti na isti način kao i bolesnici s HCV monoinfekcijom.
Table 15 shows the response rates for the T12/PR48 and the Pbo/PR48 arms. 
Tablica 15 prikazuje stope odgovora za skupine T12/PR48 i Pbo/PR48.
Potent CYP3A inducers, such as carbamazepine, phenytoin and phenobarbital, are contraindicated 
Kontraindicirani su jaki induktori CYP3A, kao što su karbamazepin, fenitoin i fenobarbital (vidjeti dio 4.3).
No fibrosis, minimal fibrosis, or portal fibrosis 
Bez fibroze, minimalna fibroza ili
All patients received 12 weeks of treatment with INCIVO in combination with peginterferon alfa-2a and ribavirin. 
Svi bolesnici su bili liječeni 12 tjedana INCIVOM u kombinaciji s peginterferonom alfa-2a i ribavirinom.
21.6% of patients receiving INCIVO combination treatment required ribavirin dose reduction for anaemia compared to 9.4% of patients receiving peginterferon alfa and ribavirin alone. 
Smanjenje doze ribavirina zbog anemije bilo je potrebno u 21,6% bolesnika liječenih kombiniranom terapijom INCIVOM, u odnosu na 9,4% bolesnika koji su primali samo peginterferon alfa i ribavirin.
INCIVO must not be restarted if discontinued by your doctor. 
Ne smijete ponovno početi uzimati INCIVO ako Vam je liječnik prekinuo primjenu
During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 3 in the INCIVO group (incidence ≥ 1.0%) were anaemia, rash, thrombocytopenia, lymphopenia, 
Tijekom faze liječenja INCIVOM/placebom, najčešće zabilježene nuspojave najmanje 3. stupnja u skupini koja je primala INCIVO (incidencija ≥ 1,0%) bile su anemija, osip, trombocitopenija, limfopenija, svrbež i mučnina.
Eye disorders uncommon retinopathy 
Poremećaji oka manje često retinopatija
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, bezvodni kalcijev hidrogenfosfat, mikrokristalična celuloza, bezvodni silicijev dioksid koloidni, natrijev laurilsulfat, umrežena karmelozanatrij, natrijev
Gastrointestinal disorders very common nausea, diarrhoea, vomiting, haemorrhoids, proctalgia common anal pruritus, rectal haemorrhage, anal fissure uncommon proctitis, pancreatitis 
Poremećaji probavnog sustava vrlo često mučnina, proljev, povraćanje, hemoroidi, proktalgija često analni svrbež, rektalno krvarenje, analna fisura manje često proktitis, pankreatitis
INCIVO must not be administered as monotherapy and must only be prescribed in combination with both peginterferon alfa and ribavirin. 
INCIVO se ne smije primjenjivati kao monoterapija i mora se propisivati samo u kombinaciji s peginterferonom alfa i ribavirinom.
Permanent and immediate discontinuation of INCIVO, peginterferon alfa, and ribavirin. 
Trajni i neodložni prestanak primjene INCIVA, peginterferona alfa i ribavirina.
In Phase 3 studies, a sensitive real-time PCR assay with a limit of quantification of 25 IU/ml and a limit of detection of 10-15 IU/ml was used to determine whether HCV RNA levels were undetectable (target not detected) (see section 5.1). 
Za provjeru jesu li koncentracije HCV RNK nemjerljive (cilj nije izmjeren), u fazi III ispitivanja, koristio se osjetljivi test lančane reakcije polimerazom (PCR) u stvarnom vremenu s granicom kvantifikacije od 25 IU/ml i granicom mjerljivosti od 10-15 IU/ml (vidjeti dio 5.1).
dexamethasone if taken by mouth or through to treat asthma or to treat inflammatory and autoimmune conditions (corticosteroids) 
budezonid, inhalacijski flutikazon ili flutikazon za primjenu u nos, deksametazon ako se uzima kroz usta ili prima injekcijom za liječenje astme ili za liječenje upalnih i autoimunih stanja (kortikosterodi)
If you have any questions about your medicines, please ask your doctor or pharmacist. 
Ako imate pitanja o lijekovima koje uzimate, molimo obratite se liječniku ili ljekarniku.
Use INCIVO with caution in patients with: - a history of acquired QT prolongation; - clinically relevant bradycardia (persistent heart rate < 50 bpm); - a history of heart failure with reduced left-ventricular ejection fraction; - a requirement for medicinal products known to prolong the QT interval but the metabolism of which is not mainly CYP3A4 dependent (e.g. methadone, see section 4.5). 
INCIVO treba primjenjivati s oprezom u bolesnika: - koji u povijesti bolesti imaju stečeno produljenje QT intervala; - s klinički značajnom bradikardijom (frekvencija srca trajno < 50 otkucaja u minuti); - koji u povijesti bolesti imaju srčano zatajenje sa smanjenom ejekcijskom frakcijom lijevog ventrikula;
There are limited clinical data on the use of INCIVO in HCV patients aged ≥ 65 years. 
Postoje samo ograničeni klinički podaci o primjeni INCIVA u bolesnika s HCV-om starosti
If the missed dose is noticed more than 6 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 6 sati od vremena kad je bolesnik trebao uzeti INCIVO, propuštenu dozu treba preskočiti te nastaviti uzimati lijek prema uobičajenom rasporedu doziranja.
Study C211 was a randomised, open-label, Phase 3 study conducted in treatment-naïve patients who were randomised to one of two treatment groups: INCIVO 750 mg every 8 hours [T12(q8h)/PR] or INCIVO 1,125 mg twice daily [T12(b.i.d. 
Ispitivanje C211 bilo je randomizirano, otvoreno, faze III, provedeno u bolesnika koji prethodno nisu bili liječeni i koji su bili randomizirani u jednu od dviju skupina liječenja: INCIVO 750 mg svakih 8 sati [T12(q8h)/PR] ili INCIVO 1125 mg dva puta na dan [T12(b.i.d.)/PR] u kombinaciji s peginterferonom alfa-2a i ribavirinom.