FrancophonIA/ELRC3.0 huggingface dataset:
English: In subjects treated with boceprevir who did not achieve SVR and with post-baseline samples analysed for RAVs, interferon responsiveness was associated with detection of fewer RAVs, with 31% of these subjects having post-baseline RAVs compared to 69% of subjects with < 1-log10 decline in viral load at Treatment Week 4.
Croatian: U ispitanika liječenih boceprevirom koji nisu postigli trajan virološki odgovor, a čiji su uzorci, uzeti nakon početka ispitivanja, analizirani na prisutnost RAV-ova, odgovor na interferon povezan je s manjim brojem otkrivenih RAV-ova; RAV-ovi su ustanovljeni u 31% ovih ispitanika, u usporedbi sa 69% ispitanika u kojih je u 4. tjednu liječenja zabilježeno smanjenje virusnog opterećenja od < 1-log10.
English: There were 77 subjects who received ≥ 5 steps ribavirin dose reduction for the management of anaemia.
Croatian: U 77 ispitanika je radi liječenja anemije doza ribavirina snižavana u ≥ 5 koraka.
English: Dose modifications due to anaemia/haemolytic anaemia occurred twice as often in patients treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin (26%) compared to peginterferon alfa-2b and ribavirin alone (13%).
Croatian: Prilagodba doze zbog anemije/hemolitičke anemije bila je potrebna dvostruko češće u bolesnika liječenih kombinacijom lijeka Victrelis s peginterferonom alfa-2b i ribavirinom (26%), u usporedbi s liječenjem samo peginterferonom alfa-2b i ribavirinom (13%).
English: Use in patients who have previously failed treatment with an HCV protease inhibitor
Croatian: Primjena u bolesnika koji nisu odgovorili na prethodnu terapiju nekim inhibitorom HCV proteaze
English: Available pharmacodynamic/toxicological data in rats have shown effects of boceprevir/metabolites on fertility, which in females have been shown to
Croatian: Dostupni farmakodinamički/toksikološki podaci u štakora pokazali su djelovanje boceprevira i njegovih metabolita na plodnost, koje je u ženki bilo reverzibilno (vidjeti dio 5.3).
English: Maximum daily dose of Victrelis is 2,400 mg. Administration without food could be associated with a net loss of efficacy due to sub-optimal exposure.
Croatian: Primjena bez hrane mogla bi rezultirati neto gubitkom djelotvornosti zbog suboptimalne izloženosti.
English: Goitre, hypothyroidism Hyperthyroidism
Croatian: guša, hipotireoza
English: Victrelis, in combination with peginterferon alfa and ribavirin, is contraindicated when coadministered with medicines that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events such as orally administered midazolam and triazolam, bepridil, pimozide, lurasidone, lumefantrine, halofantrine, tyrosine kinase inhibitors, simvastatin, lovastatin, quetiapine, alfuzosin, silodosin, and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine) (see section 4.3).
Croatian: Victrelis u kombinaciji s peginterferonom alfa i ribavirinom kontraindiciran je ako se istodobno primjenjuju lijekovi čiji se klirens velikim dijelom odvija putem CYP3A4/5 i kod kojih su povišene koncentracije u plazmi povezane s ozbiljnim i/ili po život opasnim nuspojavama - kao što su peroralno primijenjeni midazolam i triazolam, bepridil, pimozid, lurasidon, lumefantrin, halofantrin, inhibitori tirozin kinaze, simvastatin, lovastatin, kvetiapin, alfuzozin, silodozin i derivati ergota (dihidroergotamin, ergonovin, ergotamin, metilergonovin) (vidjeti dio 4.3).
English: Sustained Virologic Response (SVR) in patients receiving similar therapy up to treatment week 36
Croatian: Trajan virološki odgovor (SVR) u bolesnika koji su primali sličnu terapiju do 36. tjedna liječenja
English: Please refer to the Summary of Product Characteristics for peginterferon alfa.
Croatian: Molimo pročitajte Sažetak opisa svojstava lijeka za peginterferon alfa.
English: Angioedema (see section 4.4), drug rash with eosinophilia and systemic symptoms (DRESS) syndrome, Stevens-Johnson syndrome Musculoskeletal and connective tissue disorders Arthralgia, myalgia
Croatian: reakcije fotoosjetljivosti, čir na koži, urtikarija (vidjeti angioedem (vidjeti dio 4.4), sindrom osipa izazvanog lijekom uz eozinofiliju i sustavne simptome (DRESS), Stevens-Johnsonov sindrom
English: The most frequently (> 25% of subjects) detected post-baseline RAVs in these subjects were amino acid substitutions V36M (61%) and R155K (68%) in subjects infected with genotype 1a viruses and T54A (42%), T54S (37%), A156S (26%) and V170A (32%) in subjects infected with genotype 1b
Croatian: Najčešći RAV-ovi otkriveni u tih ispitanika nakon početka ispitivanja (otkriveni u > 25% ispitanika) bili su V36M (61%) i R155K (68%) u ispitanika zaraženih virusom genotipa 1a, te T54A (42%), T54S (37%), A156S (26%) i V170A (32%) u ispitanika zaraženih virusom genotipa 1b.
English: If such reaction occurs, combination therapy should be discontinued and appropriate medical therapy immediately instituted
Croatian: Ako se pojave takve reakcije, treba prekinuti kombiniranu terapiju i odmah uvesti odgovarajuće liječenje (vidjeti dijelove 4.3 i 4.8).
English: • The Physician Educational Materials (PEM)
Croatian: • Materijale za edukaciju liječnika • Sažetak opisa svojstva lijeka (cjeloviti)
English: The distribution of subjects by gender was 60% men and 40% women.
Croatian: Raspodjela ispitanika prema spolu bila je 60% muškaraca i 40% žena.
English: • were a patient who has previously failed treatment with an HCV protease inhibitor
Croatian: • ako ste prethodno neuspješno liječeni nekim inhibitorom HCV proteaze
English: Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)
Croatian: Tél/Tel: 0800 38 693 (+32(0)27766211)
English: ACTION
Croatian: POSTUPAK
English: Table 3 Adverse reactions in combination with Victrelis with peginterferon alfa-2b and ribavirin reported during clinical trials
Croatian: Nuspojave kombinacije lijeka Victrelis s peginterferonom alfa-2b i ribavirinom prijavljene u kliničkim
English: Dose reduction of Victrelis is not recommended.
Croatian: Ne preporučuje se sniženje doze lijeka Victrelis.
English: In subjects who demonstrated interferon responsiveness by TW 4, treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 79-81%, compared to 51% in subjects treated with standard of care.
Croatian: U ispitanika koji su pokazali odgovor na interferon do 4. tjedna, liječenje kombinacijom lijeka Victrelis s peginterferonom-2b i ribavirinom rezultiralo je stopama SVR od 79-81%, u usporedbi s 51% u ispitanika liječenih standardnom terapijom.
English: ≥ 1-log10 decline
Croatian: Odgovor na uvodno liječenje (smanjenje smanjenje za < 1-log10
English: If permanent discontinuation of peginterferon alfa is required, then ribavirin and Victrelis must also be discontinued.
Croatian: Ako je nužno trajno obustaviti liječenje peginterferonom alfa, tada se također mora prekinuti primjena ribavirina i lijeka Victrelis.
English: What Victrelis looks like and contents of the pack The hard capsules have a yellowish-brown cap with the "MSD" logo printed in red ink and an offwhite body with "314" printed in red ink.
Croatian: Tvrde kapsule imaju žućkasto-smeđu kapicu s logotipom "MSD" otisnutim crvenom tintom i bjelkasto tijelo s oznakom "314" otisnutom crvenom tintom.
English: HCV protease monotherapy
Croatian: Monoterapija inhibitorom HCV proteaze
English: In a pooled analysis of subjects who were previously untreated and subjects who have failed previous therapy who received four weeks of peginterferon alfa-2b and ribavirin followed by boceprevir 800 mg three times daily in combination with peginterferon alfa-2b and ribavirin in two Phase III studies, post-baseline RAVs were detected in 15% of all subjects.
Croatian: U zbirnoj analizi ispitanika koji prethodno nisu bili liječeni i ispitanika koji nisu odgovorili na prethodnu terapiju, koji su tijekom 4 tjedna primali peginterferon alfa-2b i ribavirin, a zatim boceprevir u dozi od 800 mg triput na dan u kombinaciji s peginterferonom alfa-2b i ribavirinom u dva klinička ispitivanja faze III, aminokiselinske varijante povezane s rezistencijom (RAV, engl. resistance-associated variants) su nakon početka liječenja otkrivene u 15% svih ispitanika.
English: - if you are a man who is taking ribavirin: do not have sex with a pregnant woman unless you use a condom.
Croatian: Nemojte stupati u spolne odnose s trudnicom bez uporabe kondoma.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist because
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku jer liječenje možda nije djelotvorno.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Thyroid neoplasm (nodules)
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe) Rijetko:
English: o Subjects with a detectable HCV-RNA at TW 8 but subsequently undetectable at TW 12 (late responders) were changed in a blinded fashion to placebo at the TW 36 visit and continued treatment with peginterferon alfa-2b + ribavirin for an additional 12 weeks, for a total treatment duration of 48 weeks.
Croatian: o Ispitanici s mjerljivom HCV-RNK u 8. tjednu liječenja, ali s nemjerljivom razinom u 12. tjednu (kasni odgovor), su na posjetu u 36. tjednu liječenja zaslijepljeno prebačeni na placebo i nastavili liječenje peginterferonom alfa-2b + ribavirinom još sljedećih 12 tjedana, što čini ukupno 48 tjedana liječenja.
English: ethinyl estradiol AUC ↓ 24% ethinyl estradiol Cmax ↔
Croatian: etinilestradiol AUC ↓ 24% etinilestradiol Cmax ↔
English: If permanent discontinuation of ribavirin is required, then peginterferon alfa and Victrelis must also be discontinued.
Croatian: Ako je nužno trajno obustaviti liječenje ribavirinom, tada se također mora prekinuti primjena peginterferona alfa i lijeka Victrelis.
English: As liver function may change during treatment with Victrelis, a close monitoring of International Normalised Ratio (INR) values is recommended in patients treated with vitamin K antagonists.
Croatian: Budući da tijekom liječenja lijekom Victrelis može doći do promjene u funkciji jetre, preporučuje se pomno praćenje vrijednosti međunarodnog normaliziranog omjera (engl.
English: The activity of boceprevir against the HCV genotype 1a replicon was reduced (2- to 6-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/L/M, Q41R, T54A/S, V55A, R155K and V158I.
Croatian: Aktivnost boceprevira protiv replikona HCV genotipa 1a bila je smanjena (2 do 6 puta) zbog sljedećih aminokiselinskih supstitucija u domeni NS3 proteaze: V36A/L/M, Q41R, T54A/S, V55A, R155K i V158I.
English: The activity of boceprevir against the HCV genotype 1b replicon was reduced (2- to 8-fold) by the following amino acid substitutions in the NS3 protease domain: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M and M175L.
Croatian: Aktivnost boceprevira protiv replikona HCV genotipa 1b bila je smanjena (2 do 8 puta) zbog sljedećih aminokiselinskih supstitucija u domeni NS3 proteaze: V36A/M, F43S, T54A/G/S, V55A, R155K/G, V158I, V170M i M175L.
English: Exposure to atorvastatin was increased when administered with Victrelis.
Croatian: Izloženost atorvastatinu povećala se kada se primjenjivao istodobno s lijekom Victrelis.
English: The median times for the most relevant boceprevir-resistant variants observed in genotype 1a patients (> 10%) to become undetectable were as follows: R155K+V36M, 0.69 years; V36M, 0.89 years; R155K+T54S, 1.05 years; R155K, 1.08 years; and T54S, 1.14 years.
Croatian: Medijani vremena potrebnog da najznačajnije varijante rezistentne na boceprevir primijećene u bolesnika s genotipom 1a (> 10%) postanu nemjerljive bili su sljedeći: 0,69 godina za R155K+V36M; 0,89 godina za V36M; 1,05 godina za R155K+T54S; 1,08 godina za R155K; 1,14 godina za T54S.
English: RAVs were detected in 8% of patients at baseline by population sequencing.
Croatian: Sekvenciranjem populacije virusa RAV-ovi su na početku ispitivanja ustanovljeni u 8% bolesnika.
English: Haemorrhagic diathesis, lymphadenopathy, lymphopenia
Croatian: hemoragijska dijateza, limfadenopatija, limfopenija
English: In subjects with < 1-log10 decline in viral load at TW 4 (poor interferon-responsiveness), treatment with the combination of Victrelis with peginterferon alfa-2b and ribavirin resulted in SVR rates of 28 38%, respectively, compared to 4% in subjects treated with standard of care.
Croatian: Među ispitanicima koji su u 4. tjednu liječenja imali smanjenje virusnog opterećenja za < 1-log10 (slab odgovor na interferon), liječenjem kombinacijom lijeka Victrelis s peginterferonom alfa-2b i ribavirinom postignute su stope SVR od 28 38%, u usporedbi s 4% ispitanika koji su primali standardnu terapiju.
English: Decreased appetite* Dehydration*, hyperglycaemia*, hypertriglyceridaemia,
Croatian: Poremećaji metabolizma i prehrane dehidracija*, hiperglikemija*, hipertrigliceridemija,
English: Anaemia was observed in 49% of subjects treated with the combination of Victrelis with peginterferon alfa-2b and ribavirin compared with 29% of subjects treated with peginterferon alfa-2b and ribavirin alone.
Croatian: Anemija je zabilježena u 49% ispitanika liječenih kombinacijom lijeka Victrelis s peginterferonom alfa-2b i ribavirinom, u usporedbi s 29% ispitanika liječenih samo peginterferonom alfa-2b i ribavirinom.
English: SVR rates with "missing=failure" approach were nearly identical to those in the table: 37% for Control, 62% for
Croatian: Stope SVR uz pristup "nedostaje = nije odgovorio" bile su gotovo identične onima iz tablice: 37% za kontrolnu skupinu; 62% za Victrelis-RGT, 65% za Victrelis-PR48.
English: In poorly interferon responsive patients (defined as < 1-log10 decline in HCV-RNA at TW 4) the use of triple therapy should be considered on a case by case basis, as the likelihood of achieving sustained virologic response (SVR) with triple therapy is lower in these patients (see section 5.1).
Croatian: U bolesnika sa slabim odgovorom na interferon (definiranim kao smanjenje HCV-RNK od < 1-log10 u 4. tjednu liječenja) primjenu trojne terapije treba razmotriti za svaki pojedinačni slučaj, obzirom da je vjerojatnost postizanja trajnog virološkog odgovora (engl.
English: In the limited number of co-infected subjects who did not achieve SVR and for whom population sequencing was performed, the prevalence of post-baseline RAVs was higher than that in mono
Croatian: U malog broja ispitanika s istodobnom infekcijom HIV-om koji nisu postigli SVR i za koje je provedeno sekvenciranje populacije, prevalencija RAV-ova nakon početka ispitivanja bila je veća nego u ispitanika zaraženih samo HCV-om u ispitivanju SPRINT-2.
English: All cirrhotic patients and null responders - Recommended treatment duration is 48 weeks: 4 weeks of bitherapy with peginterferon alfa+ ribavirin + 44 weeks of tritherapy with peginterferon alfa + ribavirin + Victrelis.
Croatian: - Preporučeno trajanje liječenja je 48 tjedana: 4 tjedna dvojne terapije peginterferon alfa + ribavirin + 44 tjedna trojne terapije peginterferon alfa + ribavirin + Victrelis.
English: The addition of Victrelis to peginterferon alfa-2b and ribavirin was associated to higher incidences of increase in uric acid, triglycerides and cholesterol total compared to peginterferon alfa-2b and
Croatian: Dodavanje lijeka Victrelis peginterferonu alfa-2b i ribavirinu bilo je povezano s većom incidencijom povišenih vrijednosti mokraćne kiseline, triglicerida i ukupnog kolesterola u usporedbi s primjenom samo peginterferona alfa-2b i ribavirina.
English: Ten percent of subjects (17/168) were cirrhotic, including 3 (6%) prior null responders, 2 (7%) prior relapsers, and
Croatian: Deset posto ispitanika (17/168) je imalo cirozu, uključujući 3 (6%) ispitanika koja nisu odgovorila na prethodno liječenje, 2 (7%) ispitanika koja su doživjela relaps kod prethodnog liječenja i 12 (14%) ispitanika koji su ostvarili djelomičan odgovor na prethodno liječenje.
English: Administer peginterferon alfa and ribavirin for 4 weeks, and then
Croatian: Primijenite peginterferon alfa i ribavirin tijekom 4 tjedna, a zatim2.
English: Co-administration of Victrelis with alfuzosin and silodosin is contraindicated (see section 4.3).
Croatian: Istodobna primjena lijeka Victrelis s alfuzozinom i silodozinom je kontraindicirana (vidjeti dio 4.3).
English: The median times for the most relevant boceprevir-resistant variants observed in genotype 1b patients (> 10%) to become undetectable were as follows: I/V170A, 0.46 years; T54A, 0.47 years; V55A, 0.83 years; A156S, 0.89 years; and T54S, 1.11 years.
Croatian: Medijani vremena potrebnog da najznačajnije varijante rezistentne na boceprevir primijećene u bolesnika s genotipom 1b (> 10%) postanu nemjerljive bili su sljedeći: 0,46 godina za I/V170A; 0,47 godina za T54A; 0,83 godina za V55A; 0,89 godina za A156S; 1,11 godina za T54S.
English: Co-administration of oral midazolam and oral triazolam with Victrelis is contraindicated (see section 4.3).
Croatian: Istodobna primjena oralnog midazolama i oralnog triazolama s lijekom Victrelis je kontraindicirana (vidjeti dio 4.3).
English: The distribution of subjects by genders was 37% men and 63% women.
Croatian: Raspodjela ispitanika prema spolu bila je 37% muškaraca i 63% žena.
English: Dysuria, nocturia Renal impairment
Croatian: dizurija, nokturija
English: Refer to the Summary of Product Characteristics for ribavirin for information regarding dose reduction and/or discontinuation of ribavirin.
Croatian: Pročitajte Sažetak opisa svojstava lijeka za ribavirin za podatke o snižavanju doze i/ili prekidu terapije ribavirinom.
English: General: difficult breathing and swallowing; tumour of the thyroid; infection of the blood; swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain - signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light
Croatian: Rijetke (mogu se javiti se u do 1 na 1000 osoba) Općenito: otežano disanje i gutanje; tumor štitnjače; infekcija krvi; oticanje ili kvržice u organima tijela; bolest koja dovodi do sve jače paralize mišića; bolest mozga - znakovi mogu obuhvaćati glavobolju i vrućicu, paralizu dijela tijela, ukočen vrat ili osjetljivost na svjetlost
English: (CYP3A inhibition - effect on
Croatian: (CYP3A inhibicija - utjecaj na
English: Subjects with these baseline variants and reduced response to peginterferon alfa-2b/ribavirin represented approximately 1% of the total number of
Croatian: Ispitanici kojima su na početku liječenja ustanovljene te varijante i koji su slabije odgovorili na peginterferon alfa-2b/ribavirin čine približno 1% ukupnog broja ispitanika koji su primali boceprevir.
English: Skin and subcutaneous tissue disorders Very common:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Vrlo često:
English: Concomitant administration of Victrelis with sirolimus requires significant dose reduction and prolongation of the dosing interval for sirolimus, with close monitoring of sirolimus blood concentrations and frequent assessments of renal function and sirolimus-related side effects.
Croatian: Istodobna primjena lijeka Victrelis i sirolimusa iziskuje značajno smanjenje doze i produljenje intervala doziranja sirolimusa, uz pažljivo praćenje koncentracija sirolimusa u krvi te česte procjene funkcije bubrega i nuspojava povezanih s primjenom sirolimusa.
English: If the patient has HCV-RNA results greater than or equal to 100 IU/mL at TW 12; then discontinue
Croatian: Ako bolesnik ima nalaz HCV-RNK veći ili jednak 100 IU/ml u TL 12; tada prekinite trojnu terapiju.
English: Table 8 presents sustained virologic response per treatment arm in patients who had failed previous therapy that were early responders and late responders and that received similar therapy up to
Croatian: Tablici 8 prikazan je trajan virološki odgovor po terapijskim skupinama u bolesnika koji nisu odgovorili na prethodnu terapiju, a sada su imali rani ili kasni odgovor i primali sličnu terapiju do
English: The addition of Victrelis to the peginterferon alfa-2b and ribavirin therapy significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin therapy alone (59% to 66% Victreliscontaining arms vs. 21% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 36 weeks for many previous treatment failures (see Table 7).
Croatian: Dodavanje lijeka Victrelis peginterferonu alfa-2b i ribavirinu značajno je povećalo stope SVR u usporedbi s primjenom samo peginterferona alfa-2b i ribavirina (59% do 66% u terapijskim skupinama koje su primale Victrelis u usporedbi s 21% u kontrolnoj skupini PR48) u randomiziranih ispitanika koji su primili barem jednu dozu bilo kojeg studijskog lijeka (populacija iz cijelog seta analiza) te smanjilo trajanje liječenja na 36 tjedana za mnoge bolesnike koji nisu uspješno odgovorili na prethodno liječenje (vidjeti Tablicu 7).
English: Table 8 Sustained Virologic Response (SVR), End of Treatment (EOT) and Relapse in patients who had failed previous therapy (early and late responders)
Croatian: Tablica 8 Trajan virološki odgovor (SVR), odgovor na kraju liječenja (EOT) i relaps u bolesnika koji nisu odgovorili na prethodnu terapiju (rani i kasni odgovor)
English: 3 mg daily + ethinyl estradiol 0.02 mg daily + Victrelis 800 mg three times daily)
Croatian: 3 mg na dan + etinilestradiol 0,02 mg na dan + Victrelis 800 mg triput na dan)
English: The study included 5 subjects with cirrhosis and 4 were in the
Croatian: U ispitivanje je uključeno 5 ispitanika s cirozom, od kojih su 4 liječena lijekom Victrelis).
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: The addition of Victrelis to peginterferon alfa-2b and ribavirin significantly increased the SVR rates compared to peginterferon alfa-2b and ribavirin alone in the combined cohort (63% to 66% Victreliscontaining arms vs. 38% PR48 control) for randomized subjects who received at least one dose of any study medicine (Full-Analysis-Set population) and decreased the length of therapy to 28 weeks for early responders (see Table 4).
Croatian: Dodavanje lijeka Victrelis peginterferonu alfa-2b i ribavirinu značajno je povećalo stope SVR u usporedbi s primjenom samo peginterferona alfa-2b i ribavirina u kombiniranoj kohorti (63% do 66% u terapijskim skupinama koje su primale Victrelis naspram 38% u kontrolnoj skupini PR48) randomiziranih ispitanika koji su primili barem jednu dozu bilo kojeg studijskog lijeka (populacija iz cijelog seta analiza) te smanjilo trajanje liječenja na 28 tjedana za bolesnike s ranim odgovorom (vidjeti Tablicu 4).
English: Dose adjustments of cyclosporine should be anticipated when administered with Victrelis and should be guided by close monitoring of cyclosporine blood concentrations, and frequent assessments of renal function and cyclosporine-related side effects.
Croatian: Kod istodobne primjene s lijekom Victrelis mora se predvidjeti prilagođavanje doze ciklosporina, pri čemu se treba rukovoditi pažljivim praćenjem koncentracija ciklosporina u krvi i čestim procjenama funkcije bubrega te nuspojava povezanih s primjenom ciklosporina.
English: Table 5 Sustained Virologic Response (SVR), End of Treatment (EOT), and Relapse in previously untreated patients (early and late responders)
Croatian: Tablica 5 Trajan virološki odgovor (SVR), odgovor na kraju liječenja (EOT) i relaps u bolesnika koji prethodno nisu bili liječeni (s ranim i kasnim odgovorom)
English: Platelet counts were decreased for subjects in the Victrelis containing-arms (3%) compared to subjects receiving peginterferon alfa-2b and ribavirin alone (1%).
Croatian: Broj trombocita bio je smanjen u skupinama ispitanika koje su primale Victrelis (3%) u usporedbi s ispitanicima koji su primali samo peginterferon alfa-2b i ribavirin (1%).