FrancophonIA/ELRC3.0 huggingface dataset:
English: When co-administration is required, starting with the lowest possible dose of atorvastatin should be considered with titration up to desired clinical effect while monitoring for safety, without exceeding a daily dose of 20 mg. For patients currently taking atorvastatin, the dose of atorvastatin should not exceed a daily dose of 20 mg during co-administration with Victrelis.
Croatian: U bolesnika koji trenutno uzimaju atorvastatin, doza atorvastatina ne smije premašiti dnevnu dozu od 20 mg pri istodobnoj primjeni s lijekom Victrelis.
English: Use of ribavirin dose reduction versus erythropoietin in the management of anaemia in previously
Croatian: Primjena snižene doze ribavirina naspram primjene eritropoetina u liječenju anemije u bolesnika koji
English: The SVR rates for those who received at least one dose of Victrelis (i.e. excluding patients who discontinued during PR lead-in) are 41% for null responders, 67% for partial responders and 96% for relapsers.
Croatian: Stope SVR-a u ispitanika koji su primili najmanje jednu dozu bilo kojeg studijskog lijeka (populacija koju se namjerava liječiti) prikazane su u Tablici 9. Stope SVR-a za ispitanike koji su primili barem jednu dozu lijeka Victrelis (tj. ne uključujući bolesnike koji su prekinuli liječenje tijekom faze uvođenja PR-a) iznosile su 41% za bolesnike koji uopće nisu odgovorili na liječenja, 67% za bolesnike koji su djelomično odgovorili i 96% za bolesnike koji su doživjeli relaps.
English: Victrelis must be administered in combination with peginterferon alfa and ribavirin.
Croatian: Victrelis se mora primjenjivati u kombinaciji s peginterferonom alfa i ribavirinom.
English: Anaemia*, neutropenia* Leukopenia*, thrombocytopenia*, pancytopenia,
Croatian: leukopenija*, trombocitopenija*, pancitopenija, agranulocitoza
English: %, (n/N) EOT %, (n/N) Relapse
Croatian: %, (n/N) EOT %, (n/N) Relaps
English: Victrelis in combination with ribavirin and peginterferon alfa is contraindicated in women who are
Croatian: Victrelis u kombinaciji s ribavirinom i peginterferonom alfa kontraindiciran je u trudnica (vidjeti
English: Concomitant administration of pravastatin with Victrelis increased exposure to pravastatin.
Croatian: Istodobna primjena pravastatina i lijeka Victrelis povećala je izloženost pravastatinu.
English: Refer to Summary of Product Characteristics for ribavirin and peginterferon alfa for additional information.
Croatian: Pročitajte Sažetke opisa svojstava lijeka za ribavirin i peginterferon alfa za dodatne informacije.
English: Victrelis inhibits the direct replication of the virus and contributes in this way to lowering the amount
Croatian: Victrelis sprječava izravno umnažanje virusa i na taj način pridonosi smanjenju količine virusa hepatitisa C u Vašem organizmu.
English: The most common reason for dose reduction was anaemia, which occurred more frequently in subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin than in subjects receiving peginterferon alfa-2b and ribavirin alone.
Croatian: Najčešći razlog za snižavanje doze bila je anemija, koja se javila s većom učestalošću u ispitanika koji su primali Victrelis u kombinaciji s peginterferonom alfa-2b i ribavirinom, nego u ispitanika koji su primali samo peginterferon alfa-2b i ribavirin.
English: FW 24.
Croatian: 24. tjedna praćenja.
English: 1 plasma HCV-RNA at Follow-up Week (FW) 24.
Croatian: 1 HCV-RNK u plazmi u 24. tjednu praćenja.
English: The onset of anaemia has been reported with peginterferon alfa and ribavirin therapy by Treatment Week 4.
Croatian: Kod liječenja peginterferonom alfa i ribavirinom nastup anemije prijavljen je do 4. tjedna liječenja.
English: No dose adjustment of Victrelis is required in patients with any degree of renal impairment (see
Croatian: Nije potrebno prilagođavati dozu lijeka Victrelis u bolesnika s bilo kojim stupnjem oštećenja funkcije
English: Hepatobiliary disorders Uncommon:
Croatian: Poremećaji imunološkog sustava Rijetko:
English: omeprazole AUC ↑ 6%** omeprazole Cmax ↑ 3%
Croatian: omeprazol AUC ↑ 6%** omeprazol Cmax ↑ 3% omeprazol C8h ↑12%
English: Close clinical monitoring for respiratory depression and/or prolonged sedation should be exercised during co-administration of Victrelis with intravenous benzodiazepines (alprazolam, midazolam, triazolam).
Croatian: Potrebno je provoditi poman klinički nadzor tijekom istodobne primjene lijeka Victrelis i intravenski primijenjenih benzodiazepina (alprazolama, midazolama, triazolama) kako bi se uočili znakovi respiratorne depresije i/ili produljene sedacije.
English: Patients who have failed previous therapy: previous partial responders and relapsers to interferon and
Croatian: Bolesnici koji nisu odgovorili na prethodnu terapiju: bolesnici koji nisu uopće odgovorili, bolesnici koji su djelomično odgovorili i bolesnici koji su doživjeli relaps na prethodnu terapiju interferonom i
English: However, among poorly interferon-responsive patients to peginterferon alfa-2b/ribavirin during the 4-week lead-in period, the efficacy of boceprevir appeared to be reduced for those who had variants V36M, T54S, V55A or R155K detected at baseline.
Croatian: Međutim, čini se da je djelotvornost boceprevira umanjena u onih bolesnika sa slabim odgovorom na interferon tijekom 4-tjednog uvodnog liječenja peginterferonom alfa-2b/ribavirinom kojima su na početku liječenja ustanovljene varijante V36M, T54S, V55A ili R155K.
English: - if you are a woman of childbearing age who is taking ribavirin: you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped.
Croatian: Morate imati negativan test na trudnoću prije liječenja, svaki mjesec tijekom liječenja i tijekom 4 mjeseca nakon prestanka liječenja.
English: Each blister cavity is heat sealed closed with the peelable lidding in a configuration of 3 blister cavities per blister card and packaged.
Croatian: Jedna blisterska jažica zatvorena je pokrovnom folijom koja se odljepljuje.
English: No dose adjustment required for Victrelis or tenofovir.
Croatian: Nije potrebno prilagođavati dozu lijeka Victrelis niti tenofovira.
English: No dose adjustment of digoxin or Victrelis is recommended.
Croatian: Ne preporučuje se prilagođavati dozu digoksina niti lijeka Victrelis.
English: The race distribution of subjects was as follows: 82% White, 14% Black, 2% Asian, 1% multiracial, 1% American Indian or Alaskan Native.
Croatian: Raspodjela ispitanika po rasama bila je kako slijedi: 82% bijelaca, 14% crnaca, 2% Azijata, 1% miješane rase, 1% Indijanaca (iz Amerike i sa Aljaske).
English: † in previously untreated subjects with HIV co-infection
Croatian: Primjena u bolesnika s istodobnom HIV infekcijom
English: The race distribution of subjects was as follows: 84% white, 13% Black, 2% Asian, and 1% others.
Croatian: Raspodjela ispitanika po rasama bila je sljedeća: 84% bijelaca, 13% crnaca, 2% Azijata i 1% ostalih.
English: The distribution of subjects by gender was 67% men and 33% women.
Croatian: Raspodjela ispitanika prema spolu bila je 67% muškaraca i 33% žena.
English: • If you forget a dose and it is more than 2 hours before your next dose is due, take the missed dose with food.
Croatian: Ako ste zaboravili uzeti Victrelis - Ako zaboravite uzeti dozu, a do sljedeće doze je ostalo više od 2 sata, uzmite propuštenu dozu s hranom.
English: A randomized, parallel-arm, open-label study (P06086) was conducted to compare two strategies for the management of anaemia (use of erythropoietin versus ribavirin dose reduction) in 687 subjects including 60 cirrhotic patients with previously untreated CHC genotype 1 infection who became anaemic during therapy with Victrelis 800 mg orally three times daily in combination with PR [peginterferon alfa-2b 1.5 µg/kg/week subcutaneously and weight-based ribavirin (600 1,400 mg
Croatian: Randomizirano otvoreno ispitivanje s paralelnim skupinama (P06086) provedeno je kako bi se usporedile dvije strategije liječenja anemije (primjena eritropoetina naspram snižavanja doze ribavirina) u 687 ispitanika, uključujući 60 cirotičnih bolesnika s prethodno neliječenom CHC infekcijom genotipa 1 u kojih se anemija razvila tijekom liječenja lijekom Victrelis u dozi od 800 mg peroralno triput na dan u kombinaciji s PR-om [peginterferonom alfa-2b supkutano u dozi od 1,5 µg/kg/tjedno i ribavirinom u dozi prilagođenoj tjelesnoj težini bolesnika (600 -1400 mg/dan peroralno, podijeljeno u dvije doze)].
English: To obtain the hard capsules the foil of the blister should be peeled off. Victrelis is to be taken orally with food (a meal or light snack).
Croatian: Victrelis se mora uzimati peroralno, s hranom (uz obrok ili lagani međuobrok).
English: No dose adjustment is necessary when coadministered with Victrelis.
Croatian: Nije potrebno prilagođavati dozu pri istodobnoj primjeni s lijekom Victrelis.
English: No dose adjustment required for Victrelis or raltegravir.
Croatian: Nije potrebno prilagođavati dozu lijeka Victrelis niti raltegravira.
English: It is not recommended to co-administer darunavir/ritonavir and Victrelis.
Croatian: Ne preporučuje se istodobna primjena darunavira/ritonavira s lijekom Victrelis.
English: • Co-administration 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,
Croatian: • 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 poput peroralno primijenjenog midazolama i triazolama, bepridila, pimozida, lurasidona, lumefantrina, halofantrina, inhibitora tirozin kinaze, simvastatina, lovastatina, kvetiapina, alfuzozina, silodozina i derivata ergota (dihidroergotamina, ergonovina, ergotamina, metilergonovina) (vidjeti dio 4.5).
English: Stomach and gut: diarrhoea; being sick (vomiting) Mental illness: feeling anxious; feeling of deep sadness or of being worthless (depression);
Croatian: Psihičke bolesti: osjećaj tjeskobe; osjećaj duboke tuge ili bezvrijednosti (depresija); osjećaj razdražljivosti, napetosti i nemira
English: A greater than 10-fold reduction in boceprevir susceptibility was conferred by the amino acid substitutions A156S/T/V, V170A, R155W+A156G and V36M+R155K.
Croatian: Aminokiselinske supstitucije A156S/T/V, V170A, R155W+A156G i V36M+R155K smanjile su osjetljivost na boceprevir više od 10 puta.
English: Among the 314 subjects, 230 were infected with genotype 1a HCV and 84 were infected with genotype 1b HCV. Seventy percent (70%) (162/230) of genotype 1a subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Croatian: Od 314 ispitanika, njih 230 bilo je zaraženo HCV genotipom 1a, a njih 84 HCV genotipom 1b.
English: Stomach and gut: lower stomach pain; pancreatitis Urinary: painful when urinating; burning feeling or difficulty urinating; get up several times during the night to urinate
Croatian: Mokraćni sustav: bol pri mokrenju; žarenje pri mokrenju ili otežano mokrenje; ustajanje više puta noću radi mokrenja
English: Heart or circulation: fast or uneven heart-beat; high or low blood pressure Blood: drop in the number of blood platelets - the signs may include bleeding or bruising more easily than usual; high sugar (glucose) levels in the blood; high triglycerides levels in the blood; high uric acid levels in the blood; a combination of low platelet, red and white blood cell counts (pancytopenia); a severe drop of neutrophil count (agranulocytosis)
Croatian: Prsni koš: otežano disanje; nelagoda u prsnom košu, bol u prsnom košu; osjećaj težine u prsnom košu uz otežano disanje ili piskanje pri disanju Srce ili cirkulacija: brzo ili nepravilno kucanje srca; visok ili nizak krvni tlak Krv: smanjenje broja krvnih pločica - znakovi mogu obuhvaćati krvarenje ili neuobičajenu pojavu modrica; visoka razina šećera (glukoze) u krvi; visoka razina triglicerida u krvi; visoka razina mokraćne kiseline u krvi; kombinacija premalog broja krvnih pločica, crvenih krvnih stanica i bijelih krvnih stanica (pancitopenija); znatan pad broja neutrofila (agranulocitoza)
English: Increased clinical and laboratory monitoring for HIV suppression is warranted.
Croatian: Potreban je pojačan klinički i laboratorijski nadzor radi praćenja supresije HIV-a.
English: The proportion of subjects who received a transfusion for the management of anaemia was 3% of subjects in the Victrelis-containing arms compared to < 1% of subjects receiving peginterferon alfa-2b and ribavirin alone.
Croatian: Udio bolesnika koji su primili transfuziju za liječenje anemije bio je 3% u skupinama ispitanika koji su primali Victrelis te < 1% u skupinama koje su primale samo peginterferon alfa-2b i ribavirin.
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four-week lead-in with peginterferon alfa-2b and ribavirin (ModifiedIntent-to-Treat population) demonstrated SVR rates in the combined cohort of 67% to 68% Victreliscontaining arms vs. 40% PR48 control.
Croatian: Sekundarna analiza ispitanika koji su primili barem jednu dozu lijeka Victrelis ili placeba nakon četverotjednog uvodnog liječenja peginterferonom alfa-2b i ribavirinom (modificirana populacija koju se namjerava liječiti), pokazala je da stope SVR u kombiniranoj kohorti skupina koje su primale Victrelis iznosi 67% do 68% naspram 40% u PR48 kontrolnoj skupini.
English: A secondary analysis of subjects who received at least one dose of Victrelis or placebo after the four week lead-in with peginterferon alfa-2b and ribavirin (Modified-Intent-to-Treat population) demonstrated SVR rates of 61% to 67% in the Victreliscontaining arms compared to 22% PR48 control.
Croatian: Sekundarna analiza ispitanika koji su primili barem jednu dozu lijeka Victrelis ili placeba nakon četverotjednog uvodnog liječenja peginterferonom alfa-2b i ribavirinom (modificirana populacija koju se namjerava liječiti), pokazala je stope SVR u skupinama koje su primale Victrelis od 61% do 67%, dok je u kontrolnoj skupini PR48 iznosio 22%.
English: (CYP3A induction - effect on
Croatian: (inhibicija CYP3A - učinak na
English: The number of subjects with cirrhosis is limited (where 40 subjects were treated with Victrelis of the
Croatian: Broj ispitanika s cirozom je ograničen (40 od ukupno 53 ispitanika liječeno je lijekom Victrelis).
English: The race distribution of subjects was as follows: 85% White, 12% Black, 1% Asian, < 1% multiracial, < 1% Native Hawaiian or Other Pacific Islander.
Croatian: Raspodjela ispitanika po rasama bila je kako slijedi: 85% bijelaca, 12% crnaca, 1% Azijata, < 1% miješane rase, < 1% Polinežana.
English: Concomitant administration of Victrelis with tacrolimus requires significant dose reduction and prolongation of the dosing interval of tacrolimus, with close monitoring of tacrolimus blood concentrations and frequent assessments of renal function and tacrolimus-related side effects.
Croatian: Istodobna primjena lijeka Victrelis i takrolimusa iziskuje značajno smanjenje doze i produljenje intervala doziranja takrolimusa, uz pažljivo praćenje koncentracija takrolimusa u krvi te česte procjene funkcije bubrega i nuspojava povezanih s primjenom takrolimusa.
English: • Store outside of the refrigerator at or below 30C for a period of not more than 3 months until
Croatian: • Čuvati izvan hladnjaka na temperaturi do 30C najdulje 3 mjeseca, ali ne dulje od isteka roka
English: Gastroenteritis*, pneumonia*, staphylococcal infection*, candidiasis, ear infection, fungal skin infection, nasopharyngitis, onychomycosis, pharyngitis, respiratory tract infection, rhinitis, skin infection, urinary tract
Croatian: Nuspojave bronhitis*, celulitis*, herpes simplex, gripa, gljivična infekcija usne šupljine, sinusitis gastroenteritis*, upala pluća*, stafilokokna infekcija*, kandidijaza, infekcija uha, gljivična infekcija kože, nazofaringitis, onihomikoza, faringitis, infekcija dišnih puteva, rinitis, infekcija kože, infekcija mokraćnih puteva
English: In comparison, 79% (66/84) of genotype 1b subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing.
Croatian: U 70% (162/230) ispitanika s genotipom 1a sekvenciranjem populacije nisu otkriveni RAV-ovi na lokusima povezanima s rezistencijom na boceprevir.
English: Abdominal pain lower*, gastritis*, pancreatitis*, anal pruritus, colitis, dysphagia, faeces discoloured, frequent bowl movements, gingival bleeding, gingival pain, gingivitis, glossitis, lip dry, odynophagia, proctalgia, rectal haemorrhage, salivary hypersecretion, sensitivity of teeth, tongue discolouration, tongue ulceration Pancreatic insufficiency
Croatian: bol u donjem dijelu abdomena*, gastritis*, pankreatitis*, svrbež anusa, kolitis, disfagija, promjena boje stolice, učestale stolice, krvarenje iz gingive, bol u gingivi, gingivitis, glositis, suhe usne, odinofagija, proktalgija, krvarenje iz rektuma, hipersekrecija sline, osjetljivost zuba, promjena boje jezika, ulceracija jezika insuficijencija gušterače
English: Coadministration of quetiapine with Victrelis is contraindicated (see section 4.3).
Croatian: Istodobna primjena kvetiapina s lijekom Victrelis je kontraindicirana (vidjeti dio 4.3).
English: • Store outside of the refrigerator at or below 30°C for a period of not more than 3 months until expiry.
Croatian: • Čuvati izvan hladnjaka na temperaturi do 30°C najdulje 3 mjeseca, ali ne dulje od isteka roka valjanosti.
English: Neutropenia
Croatian: palpitacije
English: Tacrolimus* (tacrolimus 0.5 mg single dose + Victrelis 800 mg single dose)
Croatian: Ciklosporin* (ciklosporin pojedinačna doza od 100 mg + Victrelis pojedinačna doza od 800 mg)
English: Treatment with pravastatin can be initiated at the recommended dose when co-administered with Victrelis.
Croatian: Kod istodobne primjene s lijekom Victrelis, liječenje pravastatinom može se započeti preporučenom dozom.
English: Refer to the Summary of Product Characteristics for peginterferon alfa and ribavirin for additional
Croatian: Pročitajte Sažetke opisa svojstava lijeka za peginterferon alfa i ribavirin za dodatne informacije.
English: The proportion of subjects with decreased neutrophils was higher in the Victrelis-containing arms compared to subjects receiving only peginterferon alfa-2b and ribavirin.
Croatian: Udio ispitanika sa smanjenim brojem neutrofila bio je veći u skupinama koje su primale Victrelis u usporedbi s ispitanicima koji su primali samo peginterferon alfa-2b i ribavirin.
English: Pharmacotherapeutic group: antivirals for systemic use, protease inhibitors, ATC code: J05AE12
Croatian: Farmakoterapijska skupina: Lijekovi za sistemsko liječenje virusnih infekcija, inhibitori proteaze,
English: Partial responders**** in parent study
Croatian: Bolesnici koji su djelomično odgovorili**** u izvornom ispitivanju
English: The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection has not been studied in patients who have failed previous therapy with Victrelis or other HCV protease inhibitors.
Croatian: Nisu ispitivane sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C genotipa 1 u bolesnika koji nisu odgovorili na prethodnu terapiju lijekom Victrelis ili drugim inhibitorom HCV proteaze.
English: Overall, the presence of baseline RAVs did not appear to have a notable association with treatment response in subjects receiving the combination of boceprevir with peginterferon alfa-2b and ribavirin.
Croatian: Sveukupno, čini se da prisutnost RAV-ova na početku ispitivanja nije bila značajno povezana s odgovorom na liječenje u ispitanika koji su primali kombinaciju boceprevira s peginterferonom
English: Relapser: subject who failed to achieve SVR after at least 12 weeks of previous treatment with peginterferon alfa-2b and ribavirin, but had undetectable HCV-RNA at the end of treatment.
Croatian: Ispitanik s relapsom: ispitanik koji nije uspio postići SVR nakon najmanje 12 tjedana prethodnog liječenja peginterferonom alfa-2b i ribavirinom, ali je imao nemjerljive razine HCV-RNK na kraju
English: o Subjects with undetectable HCV-RNA at TW 8 (early responders) and who also had undetectable HCV-RNA through TW 24 discontinued therapy and entered o Subjects with detectable HCV-RNA at TW 8 or any subsequent treatment week but subsequently undetectable at TW 24 (late responders) were changed in a blinded fashion to placebo at the TW 28 visit and continued therapy with peginterferon alfa-2b + ribavirin for an additional 20 weeks, for a total treatment
Croatian: o Ispitanici s mjerljivom HCV-RNK u 8. tjednu liječenja ili kasnije, ali s nemjerljivom razinom u 24. tjednu liječenja (kasni odgovor), su na posjetu u 28. tjednu liječenja zaslijepljeno prebačeni na placebo i nastavili liječenje peginterferonom alfa-2b + ribavirinom sljedećih 20 tjedana, do ukupno 48 tjedana
English: tacrolimus AUC ↑ 1610% tacrolimus Cmax ↑ 890%
Croatian: ciklosporin AUC ↑ 168% ciklosporin Cmax ↑ 101%
English: (tacrolimus 0.5 mg single dose + Victrelis 800 mg three times daily multiple doses)
Croatian: (ciklosporin pojedinačna doza od 100 mg + Victrelis 800 mg triput na dan u višestrukim dozama)
English: Aggression*, homicidal ideation*, panic attack*, paranoia*, substance abuse*, suicidal ideation*, abnormal behaviour, anger, apathy, confusional state, mental status changes, restlessness Bipolar disorder*, completed suicide*, suicide attempt*, hallucination auditory, hallucination visual, psychiatric
Croatian: anksioznost*, depresija*, insomnija, razdražljivost emocionalna labilnost, agitiranost, poremećaj libida, promjene raspoloženja, poremećaj spavanja agresivnost*, razmišljanja o ubojstvu*, napadaj panike*, paranoja*, zlouporaba lijeka/sredstva ovisnosti*, suicidalne ideje*, poremećeno ponašanje, ljutnja, apatija, konfuzno stanje, promjene mentalnog statusa, nemir bipolarni poremećaj*, izvršeno samoubojstvo*, pokušaj samoubojstva*, auditorne halucinacije, vizualne halucinacije, psihička dekompenzacija omaglica*, glavobolja* hipoestezija*, parestezija*, sinkopa*, amnezija, poremećaj pažnje, poremećaj pamćenja, migrena, parosmija, tremor,