FrancophonIA/ELRC3.0 huggingface dataset:
English: Contraindications of concomitant use (see section 4.3) INCIVO must not be administered concurrently with active substances that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as cardiac arrhythmia (i.e., amiodarone, astemizole, bepridil, cisapride, pimozide, quinidine, terfenadine), or peripheral vasospasm or ischemia (i.e., dihydroergotamine, ergonovine, ergotamine, methylergonovine), or myopathy, including rhabdomyolysis (i.e., lovastatin, simvastatin, atorvastatin), or prolonged or increased sedation or respiratory depression (i.e., quetiapine, orally administered midazolam or triazolam), or hypotension or cardiac arrhythmia (i.e., alfuzosin and sildenafil for pulmonary arterial hypertension).
Croatian: Kontraindikacije za istodobnu primjenu (vidjeti dio 4.3) INCIVO se ne smije primjenjivati istodobno s djelatnim tvarima čiji klirens uvelike ovisi o CYP3A i čije su povišene koncentracije u plazmi povezane s ozbiljnim i/ili životno opasnim događajima kao što su srčana aritmija (npr. amiodaron, astemizol, bepridil, cisaprid, pimozid, kinidin, terfenadin), periferni vazospazam ili ishemija (npr. dihidroergotamin, ergonovin, ergotamin, metilergonovin), miopatija, uključujući rabdomiolizu (npr. lovastatin, simvastatin, atorvastatin), produljena ili pojačana sedacija ili respiratorna depresija (npr. kvetiapin, peroralno primijenjeni midazolam ili triazolam) ili hipotenzija ili srčana aritmija (npr. alfuzosin i sildenafil za plućnu arterijsku hipertenziju).
English: INCIVO is not recommended in patients with moderate to severe hepatic impairment (Child-Pugh B or C, score ≥ 7) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome, see section 4.4).
Croatian: INCIVO se ne preporučuje u bolesnika s umjerenim do teškim oštećenjem funkcije jetre (Child-Pugh B ili C, indeks ≥ 7) ili dekompenziranom bolešću jetre (ascites, krvarenje uslijed portalne hipertenzije, encefalopatija i/ili žutica tipa različitog od Gilbertovog sindroma, vidjeti dio 4.4).
English: There is no data using INCIVO in combination with peginterferon alfa-2b in treatment-experienced patients and limited data in treatment-naïve patients.
Croatian: Ne postoje podaci o primjeni INCIVA u kombinaciji s peginterferonom alfa-2b u bolesnika koji su već prethodno bili liječeni, dok su podaci u bolesnika koji prethodno nisu bili liječeni ograničeni.
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring (see section 4.4).
Croatian: Potreban je oprez kod primjene INCIVA s antiaritmicima skupine Ic, propafenonom i flekainidom, što uključuje i odgovarajući klinički i EKG nadzor (vidjeti dio 4.4).
English: Consider consultation with a specialist in dermatology.
Croatian: Razmotrite savjetovanje s dermatologom.
English: Therefore, the use of INCIVO in patients with non-genotype-1 HCV is not recommended.
Croatian: Stoga se ne preporučuje primjena INCIVA u bolesnika s genotipom HCV-a koji nije genotip 1.
English: metformin to treat diabetes (antidiabetics)
Croatian: metformin za liječenje šećerne bolesti (antidijabetici)
English: If discontinued due to a skin reaction, INCIVO must not be restarted.
Croatian: Ukoliko je prekinuta njegova primjena zbog kožne reakcije, INCIVO se ne smije ponovno početi primjenjivati.
English: For patients receiving a total of 48 weeks of treatment, peginterferon alfa and ribavirin should be discontinued if HCV RNA is detectable at week 24 or week 36.
Croatian: U bolesnika čije liječenje ukupno traje 48 tjedana primjenu peginterferona alfa i ribavirina potrebno je prekinuti ako je HCV RNK mjerljiva u 24. ili 36. tjednu liječenja.
English: INCIVO is a strong, time-dependent inhibitor of CYP3A4 and also markedly inhibits P-gp.
Croatian: INCIVO je snažan, o vremenu ovisan inhibitor CYP3A4 i jednako tako primjetno inhibira P-gp.
English: Paseo de las Doce Estrellas, 5-7 E-28042 Madrid
Croatian: Paseo de las Doce Estrellas, 5-7 E-28042 Madrid Tel: +34 91 722 81 00
English: In the Phase 3 studies, none of the patients with HCV RNA > 1,000 IU/ml at either week 4 or week 12 achieved SVR with continued peginterferon alfa and ribavirin treatment.
Croatian: U fazi III ispitivanja niti jedan od bolesnika s HCV RNK > 1000 IU/ml u 4. ili 12. tjednu nije postigao SVR uz nastavak liječenja peginterferonom alfa i ribavirinom.
English: If INCIVO is discontinued for anaemia, patients may continue treatment with peginterferon alfa and ribavirin.
Croatian: Ako se INCIVO prestane primjenjivati zbog anemije, bolesnici mogu nastaviti liječenje peginterferonom alfa i ribavirinom.
English: HCV RNA< 25 IU/ml in the week 12 follow-up window
Croatian: HCV RNK< 25 IU/ml u 12. tjednu praćenja
English: The overall safety profile of INCIVO in treatment- naïve and treatment-experienced HCV-1 infected patients who were liver transplant recipients on a stable regimen of the immunosuppressants tacrolimus or cyclosporine A was generally similar to the safety profile of INCIVO in patients without a history of liver transplantation, although anaemia was reported more frequently (55.4% versus 32.1% in the Phase 2-3 safety pooling) during the INCIVO treatment phase.
Croatian: Ukupni sigurnosni profil INCIVA u liječenju bolesnika s HCV-1 infekcijom koji prethodno nisu bili liječeni ili u prethodno liječenih bolesnika kojima je transplantirana jetra na stabilnom režimu s imunosupresivima takrolimusom ili ciklosporinom A, bio je općenito sličan sigurnosnom profilu INCIVA kod bolesnika bez transplantacije jetre u povijesti bolesti, premda je anemija bila češće prijavljivana (55,4% naspram 32,1% na temelju podataka o sigurnosti objedinjenih iz faze 2-3) tijekom liječenja INCIVOM.
English: INCIVO has not been studied in patients with severe hepatic impairment (Child-Pugh C, score ≥ 10) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert's Syndrome) and is not recommended in these populations.
Croatian: INCIVO nije ispitivan u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh C, indeks ≥ 10) ili s dekompenziranom bolešću (ascites, krvarenje uslijed portalne hipertenzije, encefalopatija, i/ili žutica tipa različitog od Gilbertovog sindroma) jetre te se ne preporučuje u ovoj populaciji bolesnika.
English: Telaprevir exposure was similar regardless of whether the total daily dose of 2,250 mg was administered as 750 mg every 8 hours (q8h) or 1,125 mg twice daily (b.i.d.).
Croatian: Izloženost telapreviru bila je slična neovisno o tome je li ukupna dnavna doza od 2250 mg bila primijenjena kao 750 mg svakih 8 sati ili kao 1125 mg dva puta na dan (b.i.d.).
English: After repeated oral administration, R-diastereomer of telaprevir (30-fold less active), pyrazinoic acid, and a metabolite that underwent reduction at the α-ketoamide bond of telaprevir (not active) were found to be the predominant
Croatian: Nakon ponovne peroralne primjene pronađeni su glavni metaboliti telaprevira, R-diastereomer telaprevira (30 puta slabijeg djelovanja), pirazinoična kiselina i metabolit koji je prošao redukciju na α-ketoamidnoj vezi telaprevira (bez djelovanja).
English: Some patients may require higher doses of tacrolimus or cyclosporine A than at the initiation of treatment.
Croatian: Neki bolesnici mogu zahtijevati više doze takrolimusa ili ciklosporina
English: The overall safety profile of INCIVO in HCV/HIV-1 co-infected patients (either not on antiretroviral therapy or on antiretroviral therapy) was similar to the safety profile in mono-infected HCV patients, except for patients receiving atazanavir/ritonavir who frequently experienced a transient increase in indirect bilirubin levels (including grades 3 to 4) through week 2, returning to near baseline by week 12 (see section 4.4).
Croatian: Ukupni sigurnosni profil INCIVA u bolesnika s istodobnom HCV/HIV-1 infekcijom (koji ili nisu ili jesu na antiretrovirusnom liječenju) bio je sličan sigurnosnom profilu bolesnika koji imaju samo HCV infekciju, osim za bolesnike u skupini koja se liječi atazanavirom/ritonavirom koji su često doživjeli prolazno povećanje razine indirektnog bilirubina (uključujući stupnjeve 3 do 4) tijekom 2. tjedna, s povratom na približnu osnovnu vrijednost do 12. tjedna (vidjeti dio 4.4).
English: INCIVO was given for the first 8 weeks of treatment (T8/PR regimen) or the first 12 weeks of treatment (T12/PR regimen) in combination with peginterferon alfa-2a and ribavirin for either 24 or 48 weeks.
Croatian: INCIVO se davao tijekom prvih 8 tjedana liječenja (režim T8/PR) ili prvih 12 tjedana liječenja (režim T12/PR) u kombinaciji s peginterferonom alfa-2a i ribavirinom koji su se davali 24 ili 48 tjedana.
English: If you notice the missed dose within 4 hours, you must take two tablets immediately.
Croatian: Ako primijetite da ste propustili uzeti dozu lijeka, a prošlo je manje od 4 sata, morate odmah uzeti dvije tablete.
English: Take INCIVO with peginterferon alfa and ribavirin for 12 weeks.
Croatian: Uzimajte INCIVO s peginterferonom alfa i ribavirinom tijekom 12 tjedana.
English: Exposure at this dose was comparable to the exposure in HCV-infected patients receiving a dose of 750 mg INCIVO every 8 hours plus peginterferon alfa and ribavirin.
Croatian: Izloženost pri ovoj dozi bila je usporediva izloženosti bolesnika s HCV infekcijom koji su primali dozu od 750 mg INCIVA svakih 8 sati uz peginterferon alfa i ribavirin.
English: - itching around or near the anus, bleeding around or near the anus or rectum, a small tear in the skin that lines the anus that may cause pain and/or bleeding during bowel movements; - red, cracked, dry, scaly skin (eczema), rash with red, cracked, dry, scaly skin (exfoliative rash); - swelling of the face, swelling of the arms and/or legs (oedema);
Croatian: - svrbež oko ili u blizini anusa, krvarenje oko ili u blizini anusa ili rektuma, sitne pukotine u koži anusa koje mogu prouzročiti bol i/ili krvarenje kod pražnjenja crijeva; - crvena, popucala, suha, ljuskava koža (ekcem), osip s crvenom, ispucalom, suhom i ljuskavom kožom (eksfolijativni osip); - oticanje lica, oticanje ruku i/ili nogu (edem); - nenormalni okus lijeka.
English: No relevant inhibition by telaprevir of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP2E1 isozymes was observed in vitro.
Croatian: Nije bila primijećena znatna inhibicija izoenzima CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 i CYP2E1 telaprevirom in vitro.
English: There may be itching with the rash.
Croatian: Osip može biti praćen svrbežom.
English: (> 3.4 x ULN)
Croatian: (> 3,4 x GGN)
English: Clinical relevance unknown.
Croatian: Klinička važnost nije poznata.
English: The overall safety profile of INCIVO is based on Phase 2 and 3 clinical trial data (both controlled and uncontrolled) containing 3,441 patients who received INCIVO combination treatment and on
Croatian: Opći sigurnosni profil INCIVA temelji se na podacima iz faza II i III ispitivanja (kontroliranih i nekontroliranih) provedenih na 3441 bolesnika koji su primali kombinirano liječenje INCIVOM, te na spontanim postmarketinškim prijavama.
English: SVR rates for patient subgroups: Study 108
Croatian: Tablica 8: Stope SVR-a prema podskupinama bolesnika: Ispitivanje 108 Podskupina
English: The in vitro replication capacity of telaprevir-resistant variants was lower than that of wild-type virus.
Croatian: Varijante rezistentne na telaprevir imale su niži kapacitet replikacije od virusa divljeg tipa in vitro.
English: INCIVO 375 mg film-coated tablets telaprevir
Croatian: INCIVO 375 mg filmom obložene tablete telaprevir
English: Peginterferon alfa-2a/peginterferon alfa-2b and ribavirin were used according to their relevant Summary of Product Characteristics.
Croatian: Peginterferon alfa-2a/peginterferon alfa-2b i ribavirin primjenjivali su se u skladu s njihovim odgovarajućim Sažetkom opisa svojstava lijeka.
English: Peginterferon alfa and ribavirin may be continued.
Croatian: Peginterferon alfa i ribavirin mogu se nastaviti primjenjivati.
English: HCV RNA < 25 IU/ml at End of Treatment
Croatian: HCV RNK < 25 IU/ml na kraju liječenja
English: Consult with a specialist in dermatology.
Croatian: Potražite savjet specijalista dermatologije.
English: Refer also to the Summary of Product Characteristics for peginterferon alfa and ribavirin which are contraindicated in Child-Pugh score ≥ 6.
Croatian: Vidjeti također Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin koji su kontraindicirani kad je Child-Pugh indeks ≥ 6.
English: In the event that treatment with INCIVO in such patients is judged strictly necessary, patients should be closely monitored, including ECG assessments.
Croatian: U slučaju da se liječenje INCIVOM smatra neophodnim, bolesnike treba pažljivo pratiti, uključujući praćenje EKG-a.
English: Steady-state exposure to telaprevir was 46% lower in subjects with moderate hepatic impairment (Child-Pugh Class B, score 7-9) compared to healthy subjects.
Croatian: Izloženost telapreviru u stanju dinamičke ravnoteže bila je 46% niža u ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadij B, rezultat 7-9) u usporedbi sa zdravim ispitanicima.
English: • Pictures of rash according to different grades
Croatian: • Slike različitih stupnjeva osipa.
English: Co-administration of INCIVO and medicinal products that induce CYP3A and/or P-gp may markedly decrease telaprevir plasma concentrations.
Croatian: Istodobna primjena INCIVA i lijekova koji induciraju CYP3A i/ili P-gp može primjetno sniziti koncentracije telaprevira u plazmi.
English: - to check for changes in some values of your blood cells or chemistry.
Croatian: - kako bi provjerio imate li anemiju (smanjenje broja crvenih krvnih stanica) - kako bi provjerio ima li promjene nekih vrijednosti krvnih stanica ili kemijskih vrijednosti u Vašoj krvi, što se može vidjeti iz krvnih pretraga.
English: In Phase 2 and 3 clinical trials of telaprevir, treatment-naïve and prior treatment-failure patients with predominant telaprevir-resistant variants at baseline (pre-treatment) were rare (V36M, T54A and R155K < 1% and T54S 2.7%).
Croatian: U fazi II i III kliničkih ispitivanja s telaprevirom rijetki su bili bolesnici koji prethodno nisu bili liječeni ili je liječenje u njih bilo neuspješno, a koji su na početku (prije liječenja) imali pretežno varijante rezistentne na telaprevir (V36M, T54A i R155K < 1% i T54S 2,7%).
English: Table 6: SVR rates for patient subgroups: Study C211 T12(b.i.d.
Croatian: Tablica 6: SVR stope za podskupine bolesnika: Ispitivanje C211 Podskupina
English: Prior partial responders
Croatian: Bolesnici s prethodnim djelomičnim odgovorom
English: The study enrolled prior relapsers (patients with HCV RNA undetectable at end of treatment with a pegylated interferon-based regimen, but HCV RNA detectable within 24 weeks of treatment follow-up) and prior non-responders (patients who did not have undetectable HCV RNA levels during or at the end of a prior course of at least 12 weeks of treatment).
Croatian: Ispitivanje je uključilo bolesnike s prethodnim relapsom (bolesnici s nemjerljivim HCV RNK na kraju liječenja režimom temeljenim na pegiliranom interferonu, ali mjerljivim HCV RNK u 24-tjednom praćenju nakon liječenja) i bolesnike u kojih je prethodno izostao odgovor (bolesnici u kojih se HCV RNK mogao otkriti tijekom ili na kraju prethodnog liječenja u trajanju od najmanje 12 tjedana).
English: Co-administration of rifampicin with telaprevir is contraindicated.
Croatian: Istodobna primjena rifampicina s telaprevirom je kontraindicirana.
English: Study 108 was a randomised, double-blind, parallel-group, placebo-controlled, Phase 3 study conducted in treatment-naïve patients.
Croatian: Ispitivanje 108 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje, faze III, na usporednim skupinama provedeno u bolesnika koji prethodno nisu bili liječeni.
English: In addition, the limit of quantification of 25 IU/ml was used to determine SVR.
Croatian: Osim toga, da bi se odredio SVR, koristila se granica kvantifikacije od 25 IU/ml.
English: In patients who had undetectable HCV RNA (target not detected) at weeks 4 and 12, there was no additional benefit to extending peginterferon alfa-2a and ribavirin treatment to 48 weeks (difference in SVR rates of 2%; 95% confidence interval: -4%, 8%).
Croatian: U bolesnika u kojih se HCV RNK (cilj nije izmjeren) nije mogao otkriti u 4. i 12. tjednu nije bilo dodatne koristi od produljenja liječenja peginterferonom alfa-2a i ribavirinom do 48 tjedana (razlika u stopama SVR od 2%; 95%-tni interval pouzdanosti: -4%, 8%).
English: Each tablet of INCIVO contains 375 mg of telaprevir.
Croatian: Jedna tableta INCIVA sadrži 375 mg telaprevira.
English: In HCV negative patients with moderate hepatic impairment, reduced exposure to telaprevir was observed.
Croatian: U bolesnika negativnih na HCV s umjerenim oštećenjem funkcije jetre primijećena je smanjena izloženost telapreviru.
English: Alternatively, telaprevir can be administered orally with food as 375 mg tablets, 750 mg every 8 hours (q8h) for 12 weeks, in combination with peginterferon alfa and ribavirin.
Croatian: Alternativno, telaprevir se može primijeniti peroralno uz obrok u obliku tableta od 375 mg, 750 mg svakih 8 sati tijekom 12 tjedana, u kombinaciji s peginterferonom alfa i ribavirinom.
English: Table 17 shows the overall response rates in treatment- naïve and treatment-experienced chronic genotype 1 HCV- infected liver transplant recipients and by subgroup (patients receiving tacrolimus or cyclosporine A).
Croatian: Tablica 17 pokazuje stopu ukupnog odgovora bolesnika koji prethodno nisu bili liječeni i prethodno liječenih bolesnika s kroničnom infekcijom HCV-om genotipa 1 s transplantiranom jetrom i prema podskupinama (bolesnici koji primaju takrolimus ili ciklosporin A).
English: In one of those studies, a telaprevir 1,875 mg every 8 hours regimen was evaluated and the placebo-adjusted maximum mean increase in QTcF was 8.0 msec (90% CI: 5.1-10.9).
Croatian: U jednom od tih ispitivanja u kojem se procjenjivao telaprevir u dozi od 1875 mg svakih 8 sati, maksimalno prosječno povećanje QTcF uz korekciju u odnosu na placebo, iznosilo je 8,0 ms (90% CI: 5,1-10,9).
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE
English: No adjustment of the buprenorphine dose is required when co-administered with telaprevir.
Croatian: Nije potrebna prilagodba doze buprenorfina kad se primjenjuje istodobno s telaprevirom.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU
English: Furthermore, high rates of anaemia have been seen when using INCIVO with peginterferon and ribavirin in patients with these characteristics.
Croatian: Nadalje, uočene su više stope anemije kada se INCIVO uzimao s peginterferonom i ribavirinom u bolesnika s tim obilježjima.
English: Important information about some of the ingredients of INCIVO This medicinal product contains 2.3 mg sodium per tablet, which should be taken into consideration by patients on a controlled sodium diet.
Croatian: Ovaj lijek sadrži 2,3 mg natrija po tableti, što se mora uzeti u obzir kod bolesnika na dijeti s
English: Tacrolimus may prolong the QT interval (see section 4.4).
Croatian: Takrolimus može produljiti QT interval (vidjeti dio 4.4).
English: abacavir, efavirenz, tenofovir disoproxil to treat HIV infections (reverse transcriptase inhibitors) to lower cholesterol levels (HMG CoA reductase inhibitors) all types of hormonal contraceptives (‘the pill') hormonal contraceptives hormone replacement therapy to lower your immune system (immunosuppressants), medicines used in some rheumatic diseases or to avoid problems with organ transplants to improve breathing for asthma (inhaled beta agonists) to treat type II diabetes (blood glucose lowering medicine) for the treatment of opioid (narcotic) dependence to treat erectile dysfunction or to treat a heart and lung disorder called pulmonary arterial hypertension (PDE-5 inhibitors)
Croatian: hormonska kontracepcija nadomjesna hormonska terapija ciklosporin, sirolimus, takrolimus za potiskivanje imunološkog sustava (imunosupresivi), lijekovi koji se primjenjuju u liječenju nekih reumatskih bolesti ili za sprječavanje problema s presađenim organima za poboljšanje disanja kod astme (inhalacijski beta agonisti) za liječenje šećerne bolesti tipa II (lijek za snižavanje glukoze u krvi) za liječenje ovisnosti o opijatima (narkoticima)
English: The appropriate dose of INCIVO in hepatitis C-infected patients with moderate hepatic impairment has not been determined.
Croatian: Nije utvrđena odgovarajuća doza INCIVA za bolesnike s hepatitisom C i umjerenim oštećenjem funkcije jetre.
English: SVR rates for the T12(DS)/PR group were 88% (124/141) for prior relapsers, 56% (27/48) for prior partial responders, and 33% (25/75) for prior null responders.
Croatian: U skupini T12(DS)/PR, stope SVR iznosile su 88% (124/141) u bolesnika s prethodnim relapsom, 56% (27/48) u bolesnika s prethodno djelomičnim odgovorom i 33% (25/75) u bolesnika s prethodno potpunim izostankom odgovora.
English: If your doctor stops INCIVO, it should not be restarted.
Croatian: Ako liječnik prekine primjenu INCIVA, ne smijete ga ponovno početi uzimati.
English: Table 12 shows SVR rates by extent of liver fibrosis.
Croatian: Tablica 12 pokazuje stope SVR prema opsegu fibroze jetre.
English: All patients received peginterferon alfa-2a and ribavirin for 48 weeks.
Croatian: Svi su bolesnici primili peginterferon alfa-2a i ribavirin 48 tjedana.
English: AUC 0.53 (0.47-0.60) Cmax 0.68 (0.60-0.77) Cmin 0.32 (0.25-0.42) ↑ phenytoin
Croatian: ↓ telaprevir AUC 0,53 (0,47-0,60) Cmax 0,68 (0,60-0,77) Cmin 0,32 (0,25-0,42) ↑ fenitoin
English: Examples are: blood count levels, thyroid (a gland in your neck that controls your metabolism) levels, liver and kidney
Croatian: Primjeri takvih pretraga jesu: broj krvnih stanica, razina hormona štitne žlijezde (žlijezda na prednjoj strani vrata koja kontrolira metabolizam) i pretrage jetre i bubrega.
English: INCIVO must not be administered concurrently with Class Ia or III antiarrhythmics, except for
Croatian: INCIVO se ne smije primjenjivati istodobno s antiaritmicima skupine Ia ili III, osim s intravenskim
English: When administered every 8 hours (q8h), in case a dose of INCIVO is missed within 4 hours of the time it is usually taken, patients should be instructed to take the prescribed dose of INCIVO with food as soon as possible.
Croatian: Kada se primjenjuje svakih 8 sati, u slučaju da se s primjenom INCIVA zakasni manje od 4 sata od vremena kad se lijek obično uzima, bolesnicima treba savjetovati da čim prije uzmu propisanu dozu INCIVA uz obrok.
English: Mild and moderate CYP3A inducers should be avoided, particularly in patients who are prior non-responders (partial or null responders for peginterferon alfa/ribavirin), unless specific dose recommendations are given (refer to table 2).
Croatian: Slabe i umjereno jake induktore enzima CYP3A treba izbjegavati, osobito u bolesnika koji prethodno nisu imali terapijski odgovor (bolesnici s djelomičnim odgovorom ili s potpunim izostankom odgovora na peginterferon alfa/ribavirin), osim kad su navedene specifične preporuke za dozu (vidjeti
English: In prior null responders, consideration should be given to conduct an additional HCV RNA test between weeks 4 and 12.
Croatian: U bolesnika bez prethodnog terapijskog odgovora potrebno je razmotriti dodatno mjerenje HCV RNK između 4. i 12. tjedna.
English: At week 12, INCIVO dosing ended and patients continued on peginterferon alfa-2a and ribavirin treatment.
Croatian: U 12. tjednu, završilo je doziranje INCIVA, a bolesnici su nastavili liječenje peginterferonom alfa-2a i ribavirinom.
English: Monitor for progression or systemic symptoms until the rash is resolved.
Croatian: Pratiti zbog napredovanja osipa ili sustavnih simptoma do povlačenja osipa.