FrancophonIA/ELRC3.0 huggingface dataset:
English: Evaluation of varying combinations of boceprevir and interferon alfa-2b that produced 90% suppression of replicon RNA showed additivity of effect; no evidence of synergy or antagonism was
Croatian: Ispitivanja različitih kombinacija boceprevira i interferona alfa-2b koje su dovele do 90%-tne supresije RNK replikona pokazala su aditivnost učinka; nisu pronađeni dokazi sinergije niti antagonizma.
English: Patients without cirrhosis who are previously untreated or who have failed previous therapy The following dosing recommendations differ for some subgroups from the dosing studied in the Phase 3 trials (see section 5.1).
Croatian: Bolesnici bez ciroze koji prethodno nisu bili liječeni ili koji nisu odgovorili na prethodnu terapiju Sljedeće preporuke za doziranje se za neke podskupine razlikuju u odnosu na doze ispitivane u ispitivanjima faze III (vidjeti dio 5.1).
English: It is unknown what effect therapy with Victrelis will have on the activity of subsequently administered HCV protease inhibitors, including re-treatment with Victrelis.
Croatian: Nije poznato koji će učinak terapija lijekom Victrelis imati na djelovanje naknadno primijenjenih inhibitora HCV proteaze, uključujući i ponovno liječenje lijekom Victrelis.
English: ANTI-INFECTIVES Antifungals
Croatian: ANTIINFEKTIVI Antimikotici
English: Subjects were on an antiretroviral regimen with stable HIV disease (HIV-1 viral load < 50 copies/mL and CD4 count ≥ 200 cells/µL).
Croatian: Ispitanici su bili na antiretrovirusnoj terapiji i imali stabilnu HIV bolest (virusno opterećenje HIV-1 < 50 kopija/ml i broj CD4 stanica ≥ 200 stanica/µl).
English: Boceprevir was not genotoxic in a battery of in vitro or in vivo assays, including bacterial mutagenicity, human peripheral blood lymphocyte and mouse micronucleus assays.
Croatian: Boceprevir nije bio genotoksičan u nizu testova in vitro ili in vivo, uključujući testove mutagenosti bakterija, humanih limfocita u perifernoj krvi i mišjih mikronukleusa.
English: The concomitant use of Victrelis with rifampicin or anticonvulsants (such as phenytoin, phenobarbital or carbamazepine) may significantly reduce the plasma exposure of boceprevir.
Croatian: Istodobna primjena lijeka Victrelis s rifampicinom ili antikonvulzivima (kao što su fenitoin, fenobarbital ili karbamazepin) može značajno smanjiti izloženost bocepreviru u plazmi.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: • quetiapine - used to treat schizophrenia, bipolar disorder and major depressive disorder
Croatian: • kvetiapin - za liječenje shizofrenije, bipolarnog poremećaja te velikog depresivnog poremećaja
English: Table 2 provides dosing recommendations as a result of drug interactions with Victrelis.
Croatian: U Tablici 2 navedene su preporuke za doziranje s obzirom na interakcije s lijekom Victrelis.
English: The most common HIV PI taken was atazanavir followed by lopinavir and darunavir.
Croatian: Najčešće korišten inhibitor HIV proteaze bio je atazanavir, a zatim lopinavir i darunavir.
English: This regimen has only been tested in subjects who have failed previous therapy who were late responders (see section 5.1).
Croatian: Ovaj režim liječenja ispitivan je samo u bolesnika koji nisu odgovorili na prethodnu terapiju, a koji su imali kasni odgovor (vidjeti dio 5.1).
English: Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being
Croatian: Psihičke bolesti: promjene raspoloženja; osjećaj da Vam se život raspada; halucinacije (kada vidite, osjećate ili čujete stvari koje nisu stvarne); razmišljanje o samoubojstvu, pokušaj samoubojstva; osjećaj velike sreće (manija), a nakon toga osjećaj duboke tuge ili bezvrijednosti
English: The safety profile of Victrelis in HCV/HIV-1 co-infected patients (n=64) was overall similar to the safety profile in mono-infected HCV patients.
Croatian: Sigurnosni profil lijeka Victrelis u bolesnika s istodobnom HCV/HIV-1 infekcijom (n=64) sveukupno je bio sličan sigurnosnom profilu u bolesnika zaraženih samo HCV-om.
English: If you are not sure, talk to your doctor or pharmacist before taking Victrelis.
Croatian: Ako niste sigurni, porazgovarajte s liječnikom ili ljekarnikom prije nego uzmete Victrelis.
English: Alternative contraceptives should be considered (see section 4.5).
Croatian: Treba razmotriti primjenu nekog drugog kontraceptiva (vidjeti dio 4.5).
English: Co-administration of Victrelis with an oral contraceptive containing ethinyl estradiol and at least 1 mg of norethindrone is unlikely to alter the contraceptive effectiveness.
Croatian: Nije vjerojatno da bi istodobna primjena lijeka Victrelis i oralnog kontraceptiva koji sadrži etinilestradiol i najmanje 1 mg noretindrona mogla izmijeniti djelotvornost kontraceptiva.
English: Multipack: 336 (4 packs of 84) hard capsules
Croatian: Višestruko pakiranje: 336 tvrdih kapsula (4 kutije sa 84 tvrde kapsule)
English: After this period, the medicinal product should be disposed.
Croatian: Nakon tog razdoblja lijek se treba zbrinuti.
English: Adverse reactions are listed by System Organ Class (see Table 3).
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava (vidjeti Tablicu 3).
English: • have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body)
Croatian: • ako ste nekad imali probleme s krvlju, kao što je anemija (premali broj zdravih crvenih krvnih stanica koje prenose kisik po organizmu)
English: At steady-state, the exposure ratio for the two diastereomers is approximately 2:1, with the predominant diastereomer being pharmacologically active.
Croatian: U stanju dinamičke ravnoteže, omjer izloženosti za dva dijastereoizomera iznosi oko 2:1, s tim da je farmakološki aktivan onaj dijastereoizomer koji
English: Do not take Victrelis if any of the above apply to you.
Croatian: Nemojte uzimati Victrelis ako se nešto od navedenog odnosi na Vas.
English: Boceprevir/metabolites are excreted in rat milk (see section 5.3).
Croatian: Boceprevir/metaboliti izlučuju se u mlijeko štakorica (vidjeti dio 5.3).
English: No clinically significant differences in pharmacokinetic parameters were observed between patients with end-stage renal disease (ESRD) and healthy subjects.
Croatian: Nisu opažene klinički značajne razlike u farmakokinetičkim parametrima između bolesnika s krajnjim stadijem bubrežne bolesti i zdravih ispitanika.
English: If serum haemoglobin concentrations continued to decrease to ≤ 8.5 g/dL, subjects could be treated with additional anaemia interventions, including the use of erythropoietin or ribavirin dose reduction.
Croatian: Ako su ispitanicima koncentracije hemoglobina u serumu nastavile padati do ≤ 8,5 g/dl, moglo ih se liječiti dodatnim interventnim terapijama za anemiju, uključujući primjenu eritropoetina ili snižavanje
English: • immunosuppressants - tacrolimus, sirolimus, cyclosporine
Croatian: • imunosupresive - takrolimus, sirolimus, ciklosporin
English: • hormonal replacement therapy - oestrogen-based medicines
Croatian: • hormonsku nadomjesnu terapiju - lijekove na bazi estrogena
English: Ribavirin dose reduction is the preferred strategy for managing treatment-emergent anaemia (see section 5.1).
Croatian: Snižavanje doze ribavirina je strategija kojoj se daje prednost u liječenju anemije koja se javlja pri liječenju (vidjeti dio 5.1).
English: Potent CYP3A4 inducers
Croatian: Snažni induktori CYP3A4
English: Combined use with peginterferon alfa-2a as compared to alfa-2b:
Croatian: Kombinacija s peginterferonom alfa-2a u usporedbi s alfa-2b:
English: ORAL CONTRACEPTIVES Drospirenone/Ethinyl estradiol*: (drospirenone
Croatian: Drospirenon/etinilestradiol*: (drospirenon
English: Victrelis contains the active ingredient boceprevir which helps to fight against hepatitis C infection by stopping the virus multiplying.
Croatian: Victrelis sadrži djelatnu tvar boceprevir koja pomaže u liječenju hepatitisa C tako što zaustavlja umnožavanje virusa.
English: Boceprevir was absorbed following oral administration with a median Tmax of 2 hours.
Croatian: Boceprevir se apsorbira nakon peroralne primjene uz medijan Tmax od 2 sata.
English: Caution should be exercised with medicines known to prolong QT interval such as amiodarone, quinidine, methadone, pentamidine and some neuroleptics.
Croatian: Potreban je oprez kod primjene lijekova koji produljuju QT-interval, kao što su amiodaron, kinidin, metadon, pentamidin i neki neuroleptici
English: In medicine interaction trials conducted with AKR inhibitors diflunisal and ibuprofen, boceprevir exposure did not increase to a clinically significant extent.
Croatian: U ispitivanjima interakcija lijekova provedenima s inhibitorima AKR-a diflunisalom i ibuprofenom, izloženost bocepreviru nije se povećala do klinički značajne razine.
English: Do not take Victrelis if you are taking any of the medicines above.
Croatian: Nemojte uzimati Victrelis ako uzimate neki od navedenih lijekova.
English: This is not observed in mice
Croatian: Ovo nije opaženo u miševa niti majmuna.
English: A study with peginterferon alfa-2a in treatment experienced patients gave consistent results as compared to the study P05101 (see section 4.4).
Croatian: Rezultati ispitivanja s peginterferonom alfa-2a u bolesnika koji su prethodno bili liječeni bili su konzistentni u usporedbi s ispitivanjem P05101 (vidjeti dio 4.4).
English: Close clinical monitoring is warranted.
Croatian: Neophodan je poman klinički nadzor.
English: Peelable blisters containing 12 hard capsules (3x4 capsule blister strip).
Croatian: Blisteri koji se odljepljuju sadrže 12 tvrdih kapsula (blister kartice sa 3x4 kapsule).
English: Mean age of subjects randomized was 52.7 years.
Croatian: Srednja dob randomiziranih ispitanika bila je 52,7 godina.
English: Injection-site reactions have not been included since Victrelis is administered orally.
Croatian: Reakcije na mjestu injekcije nisu uključene jer se Victrelis primjenjuje peroralno.
English: The V55I and D168N single substitutions did not reduce sensitivity to boceprevir.
Croatian: Pojedinačne supstitucije V55I i D168N nisu smanjile osjetljivost na boceprevir.
English: For data regarding drug-drug interactions with antiretroviral agents, see section 4.5.
Croatian: Za podatke o interakcijama s antiretrovirusnim lijekovima vidjeti dio 4.5.
English: A clinical drug interaction study with digoxin demonstrated that boceprevir is a mild P-gp inhibitor in vivo, increasing digoxin exposure by 19%.
Croatian: Kliničko ispitivanje interakcija lijekova s digoksinom pokazalo je da je boceprevir blag inhibitor P-gp-a in vivo te da povećava izloženost digoksinu za 19%.
English: • The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pre-gelatinized starch, magnesium stearate, yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin, and shellac.
Croatian: • Drugi sastojci su: natrijev laurilsulfat, mikrokristalična celuloza, laktoza hidrat, umrežena karmelozanatrij, prethodno geliran škrob, magnezijev stearat, željezov oksid, žuti (E172), željezov oksid, crveni (E172), titanijev dioksid (E171), želatina i šelak.
English: In rats, boceprevir induced reversible effects on fertility and early embryonic development in female rats at exposures 1.2-fold the human exposure at the recommended therapeutic dose.
Croatian: U štakora je boceprevir uzrokovao reverzibilne učinke na plodnost i rani embrionalni razvoj pri izloženosti ženki 1,2 puta većoj od izloženosti u ljudi pri preporučenim terapijskim dozama.
English: Boceprevir has not been studied in patients with decompensated cirrhosis (see section 5.2).
Croatian: Boceprevir nije ispitivan u bolesnika s dekompenziranom cirozom (vidjeti dio 5.2).
English: If haemoglobin is < 10 g/dL (or < 6.2 mmol/L) management of anaemia may be warranted (see
Croatian: Ako je koncentracija hemoglobina < 10 g/dl (ili < 6,2 mmol/l), možda će biti potrebno liječiti anemiju (vidjeti dio 4.8).
English: The data available (see section 5.3) warrant caution in patients at risk of QT prolongation (long
Croatian: Dostupni podaci (vidjeti dio 5.3) upućuju na oprez u bolesnika s rizikom od produljenja QT-intervala (urođeni dugi QT, hipokalijemija).
English: Boceprevir was shown to be devoid of embryonic or teratogenic potential in both rats and rabbits at maternotoxic dose levels.
Croatian: Pokazalo se da boceprevir nema embriogeni ili teratogeni potencijal ni u štakora ni u zečeva pri dozama toksičnim za majku.
English: Indeed, serum progesterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels indicated that ovulation was suppressed during coadministration of norethindrone 1 mg/ethinyl estradiol 0.035 mg with Victrelis (see section 4.6).
Croatian: Štoviše, razine progesterona, luteinizirajućeg hormona (LH) i folikulostimulirajućeg hormona (FSH) u serumu ukazivale su na supresiju ovulacije kod istodobne primjene noretindrona 1 mg/etinilestradiola 0,035 mg i lijeka Victrelis (vidjeti dio 4.6).
English: • ‘ergot' type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or methylergonovine - used for migraine and cluster headaches
Croatian: • lijekove iz skupine derivata ergota, kao što su dihidroergotamin, ergonovin, ergotamin ili metilergonovin - za liječenje migrene i "cluster" glavobolja
English: • difficulty breathing or swallowing, wheezing, hives, itching, swelling of your face, eyes, lips,
Croatian: • otežano disanje ili gutanje, piskanje pri disanju, koprivnjaču, svrbež, oticanje lica, očiju, usana,
English: Heart or circulation: abnormal or rapid heart rate; heart disease caused by poor blood flow in
Croatian: Srce i cirkulacija: neuobičajeno ili vrlo brzo kucanje srca; srčana bolest uzrokovana slabim
English: The SVR rate was 62.5% (40/64) in subjects treated with Victrelis in combination with PR and 29.4% (10/34) in subjects treated with PR alone (see Table 6).
Croatian: Stopa SVR-a iznosila je 62,5% (40/64) u ispitanika liječenih lijekom Victrelis u kombinaciji s PR-om te 29,4% (10/34) u ispitanika liječenih samo PR-om (vidjeti Tablicu 6).
English: The IC50 and IC90 values for boceprevir against different genotype 1b replicons ranged from 200 to 600 nM and 400 to 900 nM, respectively, in a 72-hour cell culture assay.
Croatian: Vrijednosti IC50 boceprevira protiv različitih replikona genotipa 1b kretale su se u rasponu od 200 do 600 nM, a vrijednosti IC90 od 400 do 900 nM, u 72-satnom testu na kulturi stanica.
English: Caution should be exercised when boceprevir is combined with ketoconazole or azole antifungals (itraconazole, posaconazole, voriconazole).
Croatian: Potreban je oprez kad se boceprevir kombinira s ketokonazolom ili azolnim antimikoticima (itrakonazolom, posakonazolom, vorikonazolom).
English: Patients receiving digoxin should be monitored appropriately.
Croatian: Bolesnike koji primaju digoksin treba nadzirati na odgovarajući način.
English: Tachycardia*, arrhythmia, cardiovascular disorder
Croatian: tahikardija*, aritmija, kardiovaskularni poremećaj
English: No gender-related pharmacokinetic differences in the phase III studies have been observed in adult patients.
Croatian: Spol U ispitivanjima faze III nisu opažene farmakokinetičke razlike s obzirom na spol u odraslih bolesnika.
English: The subjects included 62% (104/168) genotype 1a and 38% (63/168) genotype 1b.
Croatian: Među ispitanicima je njih 62% (104/168) bilo zaraženo virusom genotipa 1a, a njih 38% (63/168) virusom genotipa 1b.
English: The median time for all RAVs to become undetectable was 1.17 years for genotype 1a.
Croatian: Medijan vremena potrebnog da svi RAV-ovi postanu nemjerljivi iznosio je 1,17 godina za genotip 1a.
English: Population pharmacokinetic analysis of Victrelis indicated that race had no apparent effect on exposure.
Croatian: Populacijska farmakokinetička analiza lijeka Victrelis ukazala je da rasa nema vidljivog učinka na izloženost lijeku.
English: Sustained Virologic Response (SVR) to treatment was defined as undetectable
Croatian: Trajan virološki odgovor (SVR) na liječenje definiran je kao nemjerljiva razina
English: Victrelis 200 mg hard capsules
Croatian: Victrelis 200 mg tvrde kapsule
English: At Treatment Week 24
Croatian: U 24. tjednu liječenja
English: Decreases in neutrophil counts may require dose reduction of peginterferon alfa or discontinuation of therapy.
Croatian: Smanjenje broja neutrofila može zahtijevati smanjenje doze peginterferona alfa ili prekid liječenja.
English: Concomitant administration of Victrelis and quetiapine may increase plasma concentrations of quetiapine leading to quetiapine-related toxicity, including coma.
Croatian: Istodobna primjena lijeka Victrelis i kvetiapina može povisiti koncentracije kvetiapina u plazmi što može dovesti do toksičnosti povezane s kvetiapinom, uključujući komu.
English: It is not known whether boceprevir is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se boceprevir u majčino mlijeko u ljudi.
English: This co-administration might be considered on a case by case basis if deemed necessary, in patients with suppressed HIV viral loads and with HIV viral strain without any suspected resistance to the HIV regimen.
Croatian: Istodobna primjena ovih lijekova može se razmotriti u pojedinačnim slučajevima ako se smatra neophodnom, i to u bolesnika koji imaju smanjeno virusno opterećenje HIV-om i zaraženi su sojem HIV-a koji bez ikakve sumnje nije rezistentan na režim liječenja HIV-a.
English: • intravenous sedatives - benzodiazepines (e.g., alprazolam, midazolam, triazolam)
Croatian: • intravenski primijenjene sedative - benzodiazepine (npr. alprazolam, midazolam, triazolam)
English: Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded.
Croatian: Bolesnici muškog spola ili njihove partnerice moraju primjenjivati djelotvornu kontracepciju tijekom liječenja i 7 mjeseci po njegovu završetku.
English: IL28B rs12979860 was genotyped in 653 of 1,048 (62%) subjects in SPRINT-2 (previously untreated) and 259 of 394 (66%) subjects in RESPOND-2 (previous treatment failure) [see section 5.1 for the clinical trial descriptions].
Croatian: Genotip varijante IL28B rs12979860 određen je u 653 od 1048 ispitanika (62%) u ispitivanju SPRINT-2 (prethodno nisu bili liječeni) te u 259 od 394 ispitanika (66%) u ispitivanju RESPOND-2 (prethodno liječenje bez odgovora) [vidjeti dio 5.1 za opise kliničkih ispitivanja].
English: The concomitant use of Victrelis with doxazosin or tamsulosin may increase plasma concentrations of these medicines.
Croatian: Istodobna primjena lijeka Victrelis s doksazozinom i tamsulozinom može povećati koncentracije tih lijekova u plazmi.
English: The median time for all RAVs to become undetectable was 1.04 years for genotype 1b.
Croatian: Medijan vremena potrebnog da svi RAV-ovi postanu nemjerljivi iznosio je 1,04 godine za genotip 1b.
English: The use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events including pulmonary embolism, acute myocardial infarction, cerebrovascular accident, and
Croatian: Primjena lijekova koji stimuliraju eritropoezu bila je povezana s povećanim rizikom od tromboembolijskih događaja, uključujući plućnu emboliju, akutni infarkt miokarda, cerebrovaskularni incident i duboku vensku trombozu.
English: Croscarmellose sodium Pre-gelatinized starch Magnesium stearate
Croatian: škrob, prethodno geliran magnezijev stearat
English: Subjects were randomized in a 2:1 ratio and stratified based on cirrhosis/fibrosis and baseline HCV-RNA (< 800,000 IU/mL vs. ≥ 800,000 IU/mL).
Croatian: Ispitanici su randomizirani u omjeru 2:1 i stratificirani na temelju ciroze/fibroze i početne vrijednosti HCV-RNK (< 800 000 IU/ml naspram ≥ 800 000 IU/ml).
English: SVR rates with “missing=failure” approach were similar to those in the table: 69.9% (174/249) for subjects randomized to receive ribavirin dose reduction; 68.5% (172/251) for subjects randomized to receive
Croatian: Stope SVR-a uz pristup "nedostaje = nije odgovorio" bile su slične onima u tablici: 69,9% (174/249) za ispitanike randomizirane za snižavanje doze ribavirina: 68,5% (172/251) za ispitanike randomizirane za primanje
English: The combination of boceprevir with these medicines is not recommended (see section 4.4).
Croatian: Kombinacija boceprevira s tim lijekovima se ne preporučuje (vidjeti dio 4.4).
English: In both studies, the addition of Victrelis to the current standard of care (peginterferon alfa and ribavirin) significantly increased sustained virologic response (SVR) rates compared to the current standard of care alone.
Croatian: U oba je ispitivanja dodavanje lijeka Victrelis današnjoj standardnoj terapiji (peginterferonu alfa i ribavirinu) značajno povećalo stope trajnog virološkog odgovora (SVR) u usporedbi s primjenom samo standardne terapije.
English: No clinical paediatric exposure data is available (see section 4.2).
Croatian: Nisu dostupni klinički podaci o izloženosti pedijatrijskih bolesnika (vidjeti dio 4.2).
English: Co-administration of Victrelis with medicines that induce or inhibit CYP3A4/5 could increase or decrease exposure to Victrelis (see section 4.4).
Croatian: Primjena lijeka Victrelis istodobno s lijekovima koji induciraju ili inhibiraju CYP3A4/5 može povećati, odnosno smanjiti izloženost lijeku Victrelis (vidjeti dio 4.4).
English: • antiarrhythmic medicines- amiodarone, quinidine
Croatian: • lijekove protiv aritmije - amiodaron, kinidin
English: Please refer to the Summary of Product Characteristics for peginterferon alfa for the contraindication in patients with decompensated liver disease.
Croatian: Molimo pročitajte Sažetak opisa svojstava lijeka za peginterferon alfa za kontraindikaciju u bolesnika s dekompenziranom bolešću jetre.
English: Follow-up analysis of boceprevir-treated subjects who did not achieve SVR showed that the population of wild-type virus increased and the majority of boceprevir-resistant variants became undetectable over time after the end of boceprevir treatment.
Croatian: Naknadna analiza ispitanika liječenih boceprevirom koji nisu postigli trajan virološki odgovor (SVR) pokazala je da se po završetku liječenja boceprevirom populacija virusa divljega tipa povećala i da je većina varijanti rezistentnih na boceprevir s vremenom postala nemjerljiva.
English: Administer peginterferon alfa and ribavirin and finish through TW 48.
Croatian: Primijenite peginterferon alfa i ribavirin i završite tijekom TL 48.
English: This should be discussed
Croatian: Razgovarajte o tome sa svojim
English: Plasma concentrations of calcium channel blockers may increase when administered with Victrelis.
Croatian: Koncentracije blokatora kalcijevih kanala u plazmi mogu se povisiti kad se primjenjuju s lijekom Victrelis.
English: Combined use with peginterferon alfa-2a see specific section in section 4.4.
Croatian: Za primjenu s peginterferonom alfa-2a vidjeti odgovarajući odjeljak u dijelu 4.4.
English: The absolute bioavailability of Victrelis has not been studied.
Croatian: Nije ispitivana apsolutna bioraspoloživost lijeka Victrelis.
English: Boceprevir has a mean total body clearance (CL/F) of approximately 161 l/hr.
Croatian: Srednji ukupni klirens iz organizma (CL/F) boceprevira iznosi približno 161 l/hr.
English: The frequency of severe or life threatening infections tends to be higher in boceprevir-containing arms than the control arm.
Croatian: Učestalost teških ili po život opasnih infekcija veća je u skupinama koje su primale boceprevir nego u kontrolnoj skupini.