FrancophonIA/ELRC3.0 huggingface dataset:
English: • warfarin and other similar medicines called vitamin K antagonists used to thin the blood.
Croatian: • varfarin i druge slične lijekove pod nazivom antagonisti vitamina
English: Victrelis was associated with an additional decrease of approximately 1 g/dL in haemoglobin concentration (see section 4.4).
Croatian: Victrelis je povezan s dodatnim sniženjem koncentracije hemoglobina od približno 1 g/dl (vidjeti dio 4.4).
English: No dose adjustment of Victrelis is required for patients with mild, moderate or severe hepatic impairment.
Croatian: Nije potrebno prilagođavati dozu lijeka Victrelis u bolesnika s blagim, umjerenim ili teškim oštećenjem funkcije jetre.
English: The most frequently reported adverse reactions were fatigue, anaemia (see section 4.4), nausea,
Croatian: Najčešće prijavljene nuspojave bile su umor, anemija (vidjeti dio 4.4), mučnina, glavobolja i
English: The mean decreases in haemoglobin values from baseline were larger in previously treated patients compared to patients who had never received prior therapy.
Croatian: Srednje vrijednosti sniženja koncentracije hemoglobina u usporedbi s početnim vrijednostima bile su veće u bolesnika koji su prethodno bili liječeni u usporedbi s onima koji prethodno nisu bili liječeni.
English: For additional information on use of Victrelis in patients with advanced liver disease, see section 4.4.
Croatian: Za dodatne informacije o primjeni lijeka Victrelis u bolesnika s uznapredovalom bolešću jetre, vidjeti dio 4.4.
English: Treatment with Victrelis should be initiated and monitored by a physician experienced in the
Croatian: Liječenje lijekom Victrelis treba započeti i nadzirati liječnik s iskustvom u liječenju kroničnog
English: No human data on the effect of Victrelis on fertility are available.
Croatian: Nisu dostupni podaci o učinku lijeka Victrelis na plodnost u ljudi.
English: Table 10 Sustained Virologic Response (SVR) rates by IL28B rs12979860 genotype
Croatian: Tablica 10 Stope trajnog virološkog odgovora (SVR) prema genotipu IL28B rs12979860
English: There is no specific antidote for overdose with Victrelis.
Croatian: Nema specifičnog protulijeka za predoziranje lijekom Victrelis.
English: Studies in vitro indicate that boceprevir primarily undergoes metabolism through the aldoketoreductase (AKR)-mediated pathway to ketone-reduced metabolites that are inactive against HCV.
Croatian: Ispitivanja in vitro ukazuju da se boceprevir prvenstveno metabolizira putem posredovanim aldoketoreduktazom (AKR) u metabolite s reduciranim ketonima koji nisu aktivni protiv HCV-a.
English: • Store in a refrigerator (2C - 8C) until expiry.
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: Use in patients having HCV genotypes other than genotype 1
Croatian: Primjena u bolesnika s HCV infekcijom drugog genotipa osim genotipa 1
English: If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced.
Croatian: Ako bolesnik ima ozbiljnu nuspojavu koja može biti povezana s peginterferonom alfa i/ili ribavirinom, treba smanjiti dozu peginterferona alfa i/ili ribavirina.
English: The clinical significance of the reductions in etravirine pharmacokinetic parameters and boceprevir Cmin in the setting of combination therapy with HIV antiretroviral medicines, which also affect the pharmacokinetics of etravirine and/or boceprevir, has not been directly assessed.
Croatian: Nije izravno ispitan klinički značaj smanjenja farmakokinetičkih parametara etravirina i Cmin boceprevira u uvjetima kombinirane terapije antiretrovirusnim lijekovima za liječenje HIV-a koji također utječu na farmakokinetiku etravirina i/ili boceprevira.
English: Ketoconazole* (ketoconazole 400 mg two times daily +
Croatian: Ketokonazol* (ketokonazol 400 mg dvaput na dan +
English: C-boceprevir, the most abundant circulating metabolites were a diasteriomeric mixture of ketone-reduced metabolites with a mean exposure approximately 4 fold greater than that of boceprevir.
Croatian: C-boceprevira, u cirkulaciji je najzastupljenija bila dijastereoizomerska smjesa metabolita s reduciranim ketonima, s oko 4 puta većom srednjom izloženošću od boceprevira.
English: Prompt evaluation and treatment of infections is recommended.
Croatian: Preporučuje se odmah procijeniti infekciju i započeti s liječenjem.
English: However, the combination therapy of Victrelis, peginterferon alfa and ribavirin may make you feel tired, faint, a sensation of your head spinning, changes in blood pressure, confused or difficulty seeing clearly.
Croatian: Međutim, kombinirano liječenje lijekom Victrelis, peginterferonom alfa i ribavirinom može izazvati umor, nesvjesticu, osjećaj vrtnje u glavi, promjene krvnog tlaka, zbunjenost i poteškoće s vidom.
English: In both treatment arms, patients with cirrhosis were at a higher risk to experience Grade 3-4 thrombocytopenia compared with non
Croatian: U obje su ispitivane skupine bolesnici s cirozom imali veći rizik da dobiju trombocitopeniju stupnja 3-4 u usporedbi s bolesnicima bez ciroze.
English: rilpivirine AUC ↑ 39% rilpivirine Cmax ↑ 15% rilpivirine Cmin ↑ 51%
Croatian: rilpivirin AUC ↑ 39% rilpivirin Cmax ↑ 15% rilpivirin Cmin ↑ 51%
English: In a genotype 1a replicon, the IC50 and IC90 values for boceprevir were 900 nM and 1,400 nM, respectively.
Croatian: U jednom replikonu genotipa 1a, vrijednost IC50 boceprevira iznosila je 900 nM, a vrijednost IC90 1400 nM.
English: Effects of food on oral absorption
Croatian: Učinci hrane na apsorpciju nakon peroralne primjene
English: Due to the combined treatment with peginterferon alfa and ribavirin, extreme care must be taken to avoid pregnancy in female patients or in female partners of male patients.
Croatian: Zbog kombiniranog liječenja peginterferonom alfa i ribavirinom neophodan je izniman oprez kako bi se izbjegla trudnoća u bolesnica ili partnerica bolesnika.
English: Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).
Croatian: Victrelis se u kombinaciji s peginterferonom alfa i ribavirinom koristi za liječenje kronične infekcije virusom hepatitisa C u odraslih osoba (naziva se i HCV infekcija).
English: Of 314 treatment-naïve and previously treated subjects who did not achieve SVR from Phase 2/3 studies (P03523, P03659, P05216, and P05101) in whom boceprevir-resistant variants had emerged during treatment, 73% (228/314) of subjects no longer had any RAVs detected at the boceprevir-resistance associated loci by population sequencing within 3 years post-therapy.
Croatian: Među 314 ispitanika (od kojih su neki prethodno primili liječenje, a neki ne) iz ispitivanja faze II/III (P03523, P03659, P05216 i P05101) koji nisu postigli SVR i u kojih su se tijekom liječenja pojavile varijante rezistentne na boceprevir, u njih 73% (228/314) sekvenciranjem populacije unutar 3 godine nakon liječenja više nisu otkriveni RAV-ovi na lokusima povezanima s rezistencijom na boceprevir.
English: Heart or circulation: heart attack; stopping breathing; blood clot in the leg or arm; decreased blood flow to parts of the brain (e.g., dizziness, double vision, or weakness on both sides of the
Croatian: Krv ili cirkulacija: srčani udar; prestanak disanja, krvni ugrušak u nozi ili ruci, smanjen dotok krvi u dijelove mozga (npr. omaglica, dvostruke slike ili slabost na obje strane tijela)
English: Shellac Red iron oxide (E172)
Croatian: šelak željezov oksid, crveni (E172)
English: Victrelis 400 mg single dose)
Croatian: Victrelis pojedinačna doza od 400 mg)
English: If there is no such value, the FW 12 value was carried forward.
Croatian: Ako takva vrijednost ne postoji, i dalje se uzima vrijednost iz 12. tjedna praćenja.
English: In repeat-dose toxicity studies boceprevir showed testicular degeneration in rats at systemic exposures lower than those in humans at the recommended human therapeutic dose.
Croatian: Istraživanja toksičnosti ponovljenih doza boceprevira pokazala su degeneraciju testisa u štakora pri sistemskoj izloženosti nižoj od izloženosti u ljudi pri preporučenim terapijskim dozama.
English: Each hard capsule contains 200 mg boceprevir.
Croatian: Jedna tvrda kapsula sadrži 200 mg boceprevira.
English: Chest: being short of breath when lying flat; serious lung infection like pneumonia; sharp chest pains which are worse when breathing; pain behind breast bone which can spread to neck and
Croatian: Prsni koš: nedostatak zraka pri ležanju na ravnom; teška infekcija pluća poput upale pluća; oštra bol u prsnom košu koja se pogoršava pri disanju; bol iza prsne kosti koja se može širiti u
English: Caution should be exercised in patients taking drospirenone-containing medicines with conditions that predispose them to hyperkalaemia or patients taking potassium-sparing diuretics.
Croatian: Potreban je oprez u bolesnika koji uzimaju lijekove koji sadrže drospirenon i imaju tegobe zbog kojih postoji predispozicija za razvoj hiperkalijemije kao i u bolesnika koji uzimaju diuretike koji štede kalij.
English: Victrelis contains lactose
Croatian: Victrelis sadrži laktozu
English: Combination therapy of Victrelis, peginterferon alfa and ribavirin may influence some patients' ability to drive and use machines.
Croatian: Liječenje kombinacijom lijeka Victrelis, peginterferona alfa i ribavirina može u nekih bolesnika utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: • have low blood potassium (hypokalaemia)
Croatian: • ako imate nisku razinu kalija u krvi (hipokalijemiju).
English: Victrelis 200 mg hard capsules boceprevir
Croatian: Victrelis 200 mg tvrde kapsule boceprevir
English: Merck Sharp & Dohme Ireland (Human Health) Limited
Croatian: Merck Sharp & Dohme Ireland (Human Health)
English: • CYP3A4 inducer medicines (such as antibiotic medicine - rifampicin, and anticonvulsant medicines - carbamazepine, phenobarbital, phenytoin)
Croatian: • lijekove koji su induktori enzima CYP3A4 (kao što su antibiotici - rifampicin i lijekovi protiv napadaja - karbamazepin, fenobarbital, fenitoin)
English: All patients in this treatment arm were limited to 32 weeks of Victrelis.
Croatian: Svim bolesnicima u ovoj terapijskoj skupini liječenje lijekom Victrelis bilo je ograničeno na 32 tjedna.
English: † Rates for patients who are previously untreated
Croatian: Bolesnici koji prethodno nisu bili liječeni
English: HBV/HCV co-infected patients are at risk of HBV reactivation, and should therefore be monitored and managed according to current
Croatian: Bolesnici istodobno zaraženi HBV-om/HCV-om izloženi su riziku od reaktivacije HBV-a te ih stoga treba pratiti i liječiti sukladno važećim kliničkim smjernicama.
English: The TW 4 response was a stronger predictor of SVR compared to response to previous treatment and allowed the determination of the subject's on-treatment interferon
Croatian: Odgovor u 4. tjednu liječenja bio je jači pretkazatelj SVR nego odgovor na prethodno liječenje i omogućavao je određivanje odgovora ispitanika na interferon tijekom liječenja.
English: drospirenone AUC ↑ 99% drospirenone Cmax ↑ 57%
Croatian: drospirenon AUC ↑ 99% drospirenon Cmax ↑ 57%
English: Population pharmacokinetic analysis of Victrelis indicated that age had no apparent effect on exposure.
Croatian: Populacijska farmakokinetička analiza lijeka Victrelis ukazala je da dob nema vidljivog učinka na izloženost lijeku.
English: The race distribution of subjects was as follows: 77% White, 19% Black, and 4% others.
Croatian: Raspodjela ispitanika po rasama bila je kako slijedi: 77% bijelaca, 19% crnaca i 4% ostalih.
English: The ovulation suppression activity of oral contraceptives containing lower doses of norethindrone/ethinyl estradiol and of other forms of hormonal contraception during coadministration with Victrelis has not been established.
Croatian: Nije utvrđeno djelovanje oralnih kontraceptiva koji sadrže niže doze noretindrona/etinilestradiola i drugih oblika hormonske kontracepcije na supresiju ovulacije tijekom istodobne primjene s lijekom Victrelis.
English: Patients receiving prednisone and Victrelis should be monitored appropriately.
Croatian: Bolesnike koji primaju prednizon i Victrelis treba nadzirati na odgovarajući način.
English: • Peginterferon alfa-2b + ribavirin for 48 weeks (PR48).
Croatian: • Peginterferon alfa-2b + ribavirin tijekom 48 tjedana (PR48).
English: If the patient has confirmed, detectable HCV-RNA at TW 24; then discontinue three-medicine
Croatian: Ako bolesnik ima potvrđenu mjerljivu HCV-RNK u TL 24; tada prekinite trojnu terapiju.
English: Pack sizes: carton of 84 hard capsules and multipack containing 336 (4 packs of 84) hard capsules.
Croatian: Veličine pakiranja: kutija s 84 tvrde kapsule i višestruko pakiranje koje sadrži 336 tvrdih kapsula
English: Seven percent of subjects receiving the combination of Victrelis with peginterferon alfa-2b and ribavirin had neutrophil counts of < 0.5 x 10
Croatian: Sedam posto ispitanika koji su primali kombinaciju lijeka Victrelis s peginterferonom alfa-2b i ribavirinom imalo je < 0,5 x 10
English: The antiviral activity of boceprevir was evaluated in a biochemical assay for slow binding inhibitors of NS3 protease and in the genotype 1a and 1b HCV replicon system.
Croatian: Protuvirusno djelovanje boceprevira ocijenjeno je biokemijskim testom za sporovezujuće inhibitore NS3 proteaze kao i sustavom replikona HCV-a genotipa 1a i 1b.
English: Neuropathy peripheral*, cognitive disorder, hyperaesthesia, lethargy, loss of consciousness, mental impairment, neuralgia, presyncope
Croatian: periferna neuropatija*, kognitivni poremećaj, hiperestezija, letargija, gubitak svijesti, mentalni poremećaj, neuralgija,
English: Subjects randomized to receive erythropoietin (N=251)
Croatian: Ispitanici randomizirani da primaju eritropoetin (N=251)
English: SVR rates with “missing=failure” approach were 17/80 [21.3%] for PR48, 94/162 [58.0%] for Victrelis-RGT,
Croatian: Stope SVR-a uz pristup "nedostaje = nije odgovorio" bile su 17/80 [21,3%] za PR48, 94/162 [58,0%] za Victrelis-RGT, 106/161 [65,8%] za
English: Boceprevir is an inhibitor of the HCV NS3 protease.
Croatian: Boceprevir je inhibitor NS3 proteaze virusa hepatitisa C (HCV).
English: If the patient has hepatitis C virus ribonucleic acid (HCV-RNA) results greater than or equal to 1,000 IU/mL at TW 8; then discontinue three-medicine regimen.
Croatian: Ako bolesnik ima nalaz ribonukleinske kiseline virusa hepatitisa C (HCV-RNK) veći ili jednak 1000 IU/ml u TL 8; tada prekinite trojnu terapiju.
English: If other HCV-RNA values were available after FW 24, the last available value in the period after FW 24 was used.
Croatian: Ako su nakon 24. tjedna praćenja bile dostupne i druge vrijednosti HCV-RNK, korištena je posljednja dostupna vrijednost nakon 24. tjedna praćenja.
English: Boceprevir has been shown to be a p-glycoprotein (P-gp) and breast cancer resistant protein (BCRP) substrate in vitro.
Croatian: Pokazalo se da je boceprevir in vitro supstrat za p-glikoprotein (P-gp) i protein koji uzrokuje rezistenciju raka dojke na lijekove (engl.
English: Victrelis 800 mg three times daily)
Croatian: Victrelis 800 mg triput na dan)
English: Whether on treatment early viral response and/or IL28B genotype could reliably identify those patients who are unlikely to retrieve significant benefit of boceprevir (higher SVR rates or short course treatment duration) on top of the bitherapy is currently under investigation.
Croatian: Još se ispituje mogu li se na temelju ranog virološkog odgovora i/ili genotipa IL28B pouzdano otkriti oni bolesnici koji vjerojatno neće imati značajne koristi od dodavanja boceprevira dvojnoj terapiji (više stope SVR ili kraće trajanje liječenja).
English: Boceprevir, in combination with peginterferon alfa and ribavirin, was evaluated in a total of 98 patients (64 in the boceprevir arm) co-infected with Human Immunodeficiency Virus (HIV) and HCV genotype 1 who were previously untreated for chronic HCV infection (see section 4.8 and 5.1).
Croatian: Boceprevir u kombinaciji s peginterferonom alfa i ribavirinom procijenjen je u ukupno 98 bolesnika (64 ih je primalo boceprevir) koji su istodobno bili zaraženi virusom humane imunodeficijencije (HIV) i HCV-om genotipa 1 i koji prethodno nisu bili liječeni zbog kronične HCV infekcije (vidjeti dijelove 4.8 i 5.1).
English: In clinical trials, HCV-RNA in plasma was measured with the Roche COBAS Taqman 2.0 assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
Croatian: U kliničkim ispitivanjima, HCV-RNK u plazmi određivala se testom Roche COBAS Taqman 2.0, s granicom detekcije od 9,3 IU/ml i granicom kvantifikacije od 25 IU/ml.
English: Caution should be exercised in patients with conditions that predispose them to hyperkalaemia or patients taking potassiumsparing diuretics (see section 4.4).
Croatian: Potreban je oprez u bolesnika koji imaju tegobe zbog kojih postoji predispozicija za razvoj hiperkalijemije ili u bolesnika koji uzimaju diuretike koji štede kalij (vidjeti dio 4.4).
English: Treatment of overdose with Victrelis should consist of general supportive measures, including monitoring of vital signs, and observation of the patient's clinical status.
Croatian: Liječenje predoziranja lijekom Victrelis treba obuhvatiti opće suportivne mjere, uključujući nadzor vitalnih znakova i praćenje
English: If you are breast-feeding, your doctor will advise you to discontinue breast-feeding or to discontinue Victrelis while breast-feeding.
Croatian: Ako dojite, liječnik će Vam savjetovati da prestanete dojiti ili da prekinete uzimati Victrelis dok dojite.
English: • have another liver problem in addition to hepatitis C infection • have HIV (human immunodeficiency virus) or have ever had any other problems with your
Croatian: • ako ste zaraženi virusom HIV-a (virusom humane imunodeficijencije) ili ste nekad imali drugih problema s imunološkim sustavom
English: If therapy is initiated, a very close monitoring for signs of infections and worsening liver function is warranted.
Croatian: Ako se terapija uvede, neophodan je vrlo poman nadzor kako bi se uočili eventualni znakovi infekcija ili
English: Victrelis must not be used by itself.
Croatian: Victrelis se ne smije koristiti kao jedini lijek.
English: Each capsule has a yellowish-brown, opaque cap with an "MSD" logo imprinted in red ink and offwhite, opaque body with the code "314" imprinted in red ink.
Croatian: Kapsula ima žućkasto-smeđu neprozirnu kapicu s logotipom "MSD" otisnutim crvenom tintom i bjelkasto neprozirno tijelo s oznakom "314" otisnutom crvenom tintom.
English: If a patient misses a dose and it is less than 2 hours before the next dose is due, the missed dose
Croatian: Ako bolesnik propusti dozu, a do sljedeće je doze ostalo manje od 2 sata, propuštenu dozu treba
English: Mean age of subjects randomized was 43.6 years.
Croatian: Srednja dob randomiziranih ispitanika bila je 43,6 godina.
English: No data are available; therefore, the combination of boceprevir with these medicines is not-recommended (see section 4.4).
Croatian: Podaci nisu dostupni te se ne preporučuje kombinacija boceprevira s tim lijekovima (vidjeti dio 4.4).
English: Mean age of subjects randomized was 49.1 years.
Croatian: Srednja dob randomiziranih ispitanika bila je 49,1 godina.
English: In a study comparing the use of ribavirin dose reduction and erythropoesis stimulating agents in the management of treatment-emergent anaemia, the use of erythropoesis stimulating agents was associated with an increased risk of thromboembolic events (see section 5.1).
Croatian: U ispitivanju u kojem se uspoređivalo sniženje doze ribavirina u odnosu na primjenu lijekova koji stimuliraju eritropoezu za liječenje anemije koja se javlja pri liječenju, primjena lijekova koji stimuliraju eritropoezu bila je povezana s povećanim rizikom od tromboembolijskih događaja (vidjeti
English: Plasma trough concentrations of Victrelis were decreased when administered with efavirenz.
Croatian: Najniže koncentracije lijeka Victrelis u plazmi snižene su kad se primjenjuje istodobno s efavirenzom.
English: The addition of boceprevir to peginterferon alfa and ribavirin is associated with an additional decrease in haemoglobin concentrations of approximately 1 g/dL by Treatment Week 8 compared to standard of care (see section 4.8).
Croatian: Dodavanje boceprevira peginterferonu alfa i ribavirinu povezano je s dodatnim sniženjem koncentracije hemoglobina od približno 1 g/dl do 8. tjedna liječenja u usporedbi sa standardnim liječenjem (vidjeti dio 4.8).
English: 9/L) was higher in boceprevir-treated patients (29%) than in placebo-treated patients (17%), in combination with peginterferon alfa-2b and ribavirin.
Croatian: 9/l) bio je veći u skupinama liječenima boceprevirom (29%) nego u bolesnika koji su primali placebo (17%) u kombinaciji s peginterferonom alfa-2b i ribavirinom.
English: (CYP3A inhibition and/or P-gp
Croatian: (inhibicija CYP3A i/ili inhibicija P-gp-a)
English: In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.
Croatian: U kliničkim ispitivanjima HCV-RNK u plazmi određivala se testom Roche COBAS Taqman, s granicom detekcije od 9,3 IU/ml i granicom kvantifikacije od 25 IU/ml.
English: HIV Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Croatian: Nukleozidni inhibitor HIV reverzne transkriptaze (NRTI)
English: The concomitant use of Victrelis with potent CYP3A4 inducers (rifampicin, carbamazepine, phenobarbital, phenytoin) is not recommended (see section 4.5).
Croatian: Ne preporučuje se istodobna primjena lijeka Victrelis sa snažnim induktorima CYP3A4 (rifampicinom, karbamazepinom, fenobarbitalom, fenitoinom) (vidjeti dio 4.5).
English: All subjects with detectable HCV-RNA in plasma at TW 12 were discontinued from treatment.
Croatian: Svi ispitanici s mjerljivom HCV-RNK u plazmi u 12. tjednu isključeni su iz liječenja.
English: Fifty-seven percent (208/368) of subjects in the Victrelis-RGT arm and 56% (204/366) of subjects in the Victrelis-PR48 arm had undetectable HCV-RNA at TW 8 compared with 17% (60/363) of
Croatian: U 57% ispitanika (208/368) u skupini Victrelis-RGT i 56% ispitanika (204/366) u skupini Victrelis-PR48 razine HCV-RNK u 8. tjednu liječenja nisu bile mjerljive, u usporedbi sa 17% ispitanika (60/363) u skupini PR.
English: Skin and hair: reddening of the skin; bacterial skin infection Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain
Croatian: Koža i kosa: crvenilo kože; bakterijska infekcija kože Želudac i crijeva: poteškoće pri probavljanju hrane; povraćanje krvi; povraćanje; proljev i jaka bol u gornjem desnom dijelu trbuha (abdomena)
English: Acute myocardial infarction*, atrial fibrillation*, coronary artery disease*, pericarditis*, pericardial
Croatian: akutni infarkt miokarda*, fibrilacija atrija*, bolest koronarnih arterija*, perikarditis*, perikardijalna efuzija
English: No dose adjustment is required in these patients and in patients with any degree of renal impairment.
Croatian: Nije potrebno prilagođavati dozu u tih bolesnika kao ni u bolesnika s bilo kojim stupnjem oštećenja funkcije bubrega.
English: 3 and/or serum albumin < 35 g/L and/or signs of coagulopathy (International Normalized Ratio (INR) > 1.7) at baseline.
Croatian: 3 i/ili vrijednost albumina u serumu < 35 g/l i/ili znakove koagulopatije (INR (engl.
English: * The Full Analysis Set (FAS) consisted of all subjects who became anaemic (serum haemoglobin of approximately ≤10 g/dL within the treatment period) and were randomized to using either ribavirin dose reduction or erythropoietin (N=500).
Croatian: * Cijeli set analiza (FAS) obuhvaćao je sve ispitanike koji su postali anemični (hemoglobin u serumu približno ≤ 10 g/dl tijekom razdoblja liječenja) te su randomizirani da primaju ili sniženu dozu ribavirina ili eritropoetin (N=500).
English: The concomitant use of Victrelis with doxazosin and tamsulosin is not recommended (see section 4.5).
Croatian: Istodobna primjena lijeka Victrelis s doksazozinom i tamsulozinom se ne preporučuje (vidjeti dio 4.5).
English: Victrelis contains lactose.
Croatian: Victrelis sadrži laktozu.