FrancophonIA/ELRC3.0 huggingface dataset:
English: During the INCIVO/placebo treatment phase, the most frequently reported ADRs of at least Grade 2 in severity in the INCIVO group (incidence ≥ 5.0%) were anaemia, rash, pruritus, nausea, and
Croatian: Tijekom faze liječenja INCIVOM/placebom, najčešće zabilježene nuspojave najmanje 2. stupnja težine u skupini koja je primala INCIVO (incidencija ≥ 5,0%) bile su anemija, osip, svrbež, mučnina i
English: For all populations in the study (prior relapsers, prior partial responders, and prior null responders), SVR rates were higher for the T12/PR group than for the Pbo/PR48 group across subgroups by sex, age, race, ethnicity, body mass index, HCV genotype subtype, baseline HCV RNA level, and extent of liver fibrosis.
Croatian: Za sve populacije u ispitivanju (bolesnici s prethodnim relapsom, bolesnici s prethodno djelomičnim odgovorom i bolesnici s prethodnim potpunim izostankom odgovora), stope SVR bile su više u skupini T12/PR nego u skupini Pbo/PR48 u svim podskupinama prema spolu, dobi, rasi, etničkoj pripadnosti, indeksu tjelesne mase, podtipu HCV genotipa, početnoj koncentraciji HCV RNK i opsegu fibroze jetre.
English: QT interval prolongation has been reported with ketoconazole (see section 4.4).
Croatian: Produljenje QT intervala zabilježeno je s ketokonazolom (vidjeti dio 4.4).
English: The non-responder-population was comprised of 2 subgroups: prior partial responders (greater than or equal to 2 log10 reduction in HCV RNA at week 12, but not achieving HCV RNA undetectable at end of treatment with a peginterferon and ribavirin) and prior null responders (less than 2 log10 reduction in HCV RNA at week 12 of prior treatment with peginterferon and ribavirin).
Croatian: Populacija bolesnika u kojih je izostao odgovor sastojala se od dvije podskupine: bolesnici s prethodnim djelomičnim odgovorom (sniženje HCV RNK veće ili jednako 2 log10 u 12. tjednu, ali nije se postigla nemjerljivost HCV RNK na kraju liječenja peginterferonom i ribavirinom) i bolesnici s potpunim izostankom odgovora (sniženje HCV RNK manje od 2 log10 u 12. tjednu prethodnog liječenja peginterferonom i ribavirinom).
English: INCIVO should be administered in conjunction with ribavirin and either peginterferon alfa-2a or -2b.
Croatian: INCIVO treba primijeniti zajedno s ribavirinom i peginterferonom alfa-2a ili -2b.
English: Steady-state exposure to telaprevir was 15% lower in subjects with mild hepatic impairment (Child-Pugh Class A, score 5-6) compared to healthy subjects.
Croatian: Izloženost telapreviru u stanju dinamičke ravnoteže bila je 15% niža u ispitanika s blagim oštećenjem funkcije jetre (Child-Pugh stadij A, indeks 5-6) u usporedbi sa zdravim ispitanicima.
English: The difference in SVR rates (95% confidence interval) between the T12/PR and Pbo/PR groups were 63 (51, 74) for prior relapsers, 46 (27, 66) for prior partial responders, and 26 (13,
Croatian: Razlika u postotcima trajnog virološkog odgovora (95%-tni interval pouzdanosti) između skupina T12/PR i Pbo/PR iznosila je 63 (51, 74) za bolesnike s prethodnim relapsom, 46 (27, 66) za bolesnika s prethodno djelomičnim odgovorom i 26 (13, 39) za bolesnike bez prethodnog odgovora.
English: Most drug-drug interaction studies have been performed with a telaprevir dose of 750 mg every 8 hours (q8h).
Croatian: Većina ispitivanja interakcija lijekova provedena su s dozom telaprevira od 750 mg svakih 8 sati.
English: In placebo-controlled Phase 2 and 3 trials, 1.9% of patients discontinued INCIVO alone due to anaemia, and 0.9% of patients discontinued INCIVO combination treatment due to anaemia compared to 0.5% receiving peginterferon alfa and ribavirin (see section 4.4).
Croatian: U fazi II i III placebom kontroliranih ispitivanja 1,9% bolesnika prekinulo je uzimati samo INCIVO zbog anemije, dok je 0,9% bolesnika prekinulo kombinirano liječenje INCIVOM zbog anemije u odnosu na 0,5% onih koji su primali peginterferon alfa i ribavirin (vidjeti dio 4.4).
English: INCIVO co-administration with domperidone should be avoided (see section 4.5).
Croatian: Istodobnu primjenu INCIVA s domperidonom treba izbjegavati (vidjeti dio 4.5).
English: Refer also to the Summary of Product Characteristics for ribavirin for patients with CrCL < 50 ml/min
Croatian: Vidjeti također Sažetak opisa svojstava lijeka za ribavirin kod bolesnika s CrCl < 50 ml/min (vidjeti
English: Predominant baseline resistance to telaprevir does not preclude successful treatment with telaprevir, peginterferon alfa, and ribavirin.
Croatian: Početna pretežna rezistencija na telaprevir ne isključuje uspjeh liječenja telaprevirom, peginterferonom alfa i ribavirinom.
English: Skin and subcutaneous tissue disorders very common pruritus, rash common eczema, swelling face, exfoliative rash uncommon drug rash with eosinophilia and systemic symptoms (DRESS), urticaria rare
Croatian: Poremećaji kože i potkožnog tkiva vrlo često svrbež, osip često ekcem, oticanje lica, eksfolijativni osip manje često osip uzrokovan lijekom uz eozinofiliju i sustavne simptome (DRESS), urtikarija rijetko
English: Please check with your doctor and follow
Croatian: Provjerite s liječnikom i pridržavajte se preporučenog trajanja
English: Table 16 shows the response rates in treatment-naïve patients and in treatment-experienced patients by subgroup (treatment-naïve, prior relapsers and prior non-responders).
Croatian: Tablica 16 prikazuje stope odgovora u bolesnika koji prethodno nisu bili liječeni i u prethodno liječenih bolesnika prema podskupinama (prethodno neliječeni, s prethodnim relapsom i bez
English: Among prior relapsers in the T12/PR24 treatment group who had undetectable HCV RNA (target not detected) at week 4 and 12 of treatment, the SVR rate was 100%
Croatian: Među bolesnicima 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 100% (24/24).
English: alprazolam*
Croatian: buprenorfin*
English: Medicinal products
Croatian: FARMAKOLOŠKA SVOJSTVA
English: No relevant induction by telaprevir of CYP1A2, CYP2B6, CYP2C, and CYP3A isozymes was observed in vitro.
Croatian: Nije zabilježena značajna indukcija izoenzima CYP1A2, CYP2B6, CYP2C i CYP3A telaprevirom in vitro.
English: 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.
Croatian: Primjena INCIVA u kombinaciji s peginterferonom alfa-2b Faze III svih ispitivanja provedena su s peginterferonom alfa-2a u kombinaciji s INCIVOM i ribavirinom.
English: Contact your doctor or pharmacist immediately to ask for advice.
Croatian: Odmah potražite savjet liječnika ili ljekarnika.
English: Study 108 (ADVANCE)
Croatian: Ispitivanje 112 (EXTEND)
English: On-treatment-virologic failure includes patients who met a protocol-defined virologic stopping rule and/or had viral
Croatian: Virološki neuspjeh tijekom liječenja uključuje bolesnike koji su došli do protkolom definiranog virološkog pravila za zaustavljanje i/ili su imali virusni proboj.
English: Each film-coated tablet contains 375 mg of telaprevir.
Croatian: Jedna filmom obložena tableta sadrži 375 mg telaprevira.
English: 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.
Croatian: 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.
English: Recommendations for Monitoring of Cutaneous Reactions and Discontinuation of INCIVO, Ribavirin and Peginterferon alfa for Severe Rash
Croatian: Preporuke za praćenje kožnih reakcija i prekid primjene INCIVA, ribavirina i peginterferona alfa zbog teškog osipa
English: Study 111 was a Phase 3, randomised, open label study conducted in treatment-naïve patients.
Croatian: Ispitivanje 111 bilo je randomizirano ispitivanje, faze III, otvorenog tipa provedeno u bolesnika koji prethodno nisu bili liječeni.
English: Figure 2: Duration of treatment for previously treated patients with prior partial or prior
Croatian: Slika 2: Trajanje liječenja prethodno liječenih bolesnika s djelomičnim terapijskim odgovorom ili onih koji nisu odgovorili na ranije liječenje
English: 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,
Croatian: 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,
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: Consultation with a specialist in dermatology is recommended.
Croatian: Preporučuje se potražiti savjet specijalista dermatologije.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Undetectable HCV RNA (target not detected) at
Croatian: Nemjerljiva HCV RNK (cilj nije izmjeren) u
English: 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.
Croatian: Primarni cilj ispitivanja bio je procijeniti antivirusnu djelotvornost INCIVA, peginterferona alfa-2a, i ribavirina kod primatelja transplantirane jetre s HCV infekcijom, mjerenu putem SVR12.
English: The recommendations for monitoring of cutaneous reactions, and for discontinuation of INCIVO, ribavirin and peginterferon alfa are summarised in the table below:
Croatian: Preporuke za praćenje kožnih reakcija i prekid primjene INCIVA, ribavirina i peginterferona alfa sažeto su prikazane u sljedećoj tablici:
English: 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).
Croatian: 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).
English: In placebo-controlled Phase 2 and 3 trials, 0.4% of patients had suspected Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Croatian: 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.
English: 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
Croatian: 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.
English: 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.
Croatian: 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.
English: 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
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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.
Croatian: Primarni cilj ispitivanja bila je procjena antivirusne djelotvornosti INCIVA, peginterferona alfa-2a i ribavirina u bolesnika koinficiranih HCV/HIV-1 infekcijom, mjereno prema SVR12.
English: 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.
Croatian: 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.
English: Table 7 shows the response rates for the recommended T12/PR and the Pbo/PR48 groups.
Croatian: Tablica 7 pokazuje stope odgovora u preporučenim skupinama T12/PR i Pbo/PR48.
English: Caution is warranted and clinical monitoring is recommended when co-administered with INCIVO.
Croatian: Nalaže se oprez i preporučuje klinički nadzor kad se primjenjuju istodobno s INCIVOM.
English: 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.
Croatian: 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.
English: 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)
Croatian: 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)
English: - 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).
Croatian: - 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).
English: Caution is warranted, laboratory and clinical monitoring is recommended.
Croatian: Nalaže se oprez i preporučuje laboratorijsko i kliničko praćenje.
English: Haematology evaluations (including white cell differential count) are recommended at weeks 2, 4, 8
Croatian: Hematološke pretrage (uključujući diferencijalnu krvnu sliku) preporučuje se napraviti u 2., 4., 8. i 12. tjednu, te ako je klinički potrebno.
English: 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.
Croatian: 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.
English: HCV RNA > 1,000 IU/ml at week 4 of treatment
Croatian: HCV RNK > 1000 IU/ml nakon 4 tjedna liječenja
English: Hepatic impairment
Croatian: Težak osip
English: 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.
Croatian: 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.
English: INCIVO should be used with caution with Class Ic antiarrhythmics propafenone and flecainide, including appropriate clinical and ECG monitoring.
Croatian: U primjeni INCIVA s antiaritmicima skupine Ic, tj. propafenonom i flekainidom, potreban je oprez kao i odgovarajuće kliničko i EKG praćenje.
English: 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.
Croatian: 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.
English: INCIVO, 1,125 mg (three 375 mg film-coated tablets) should be taken orally twice daily (b.i.d.)
Croatian: 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.
English: Co-administration of domperidone with INCIVO should be avoided (see section 4.4).
Croatian: Istodobnu primjenu domperidona s INCIVOM treba izbjegavati (vidjeti dio 4.4).
English: 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
Croatian: 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.
English: Co-administration of INCIVO and medicinal products that inhibit CYP3A and/or P-gp may increase telaprevir plasma concentrations.
Croatian: Istodobna primjena INCIVA i lijekova koji inhibiraju CYP3A i/ili P-gp može povisiti koncentracije
English: 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).
Croatian: "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).
English: Following completion of INCIVO therapy contraceptive recommendations should be followed as in the Summary of Product Characteristics for ribavirin, and as described below.
Croatian: Nakon završetka liječenja INCIVOM treba se pridržavati preporuka za kontracepciju koje su navedene u Sažetku opisa svojstava lijeka za ribavirin i
English: Concurrent administration of salmeterol and telaprevir is not recommended.
Croatian: Ne preporučuje se istodobna primjena salmeterola i telaprevira.
English: 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.
Croatian: 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.
English: (HIV RNA < 50 copies/ml, CD4 count ≥ 300 cells/mm
Croatian: 3), ili su HIV imali pod kontrolom (HIV RNK < 50 kopija/ml, CD4 broj