FrancophonIA/ELRC3.0 huggingface dataset:
English: In the cirrhosis cohort, 4 patients with hepatocellular carcinoma underwent liver transplantation after 1-71 days of treatment; 3 of the 4 patients received 12 weeks of post-liver transplant treatment extension and 1 patient, treated for 23 days before transplantation, did not receive treatment extension.
Croatian: U kohorti s cirozom, 4 bolesnika s hepatocelularnim karcinomom bila su podvrgnuta presađivanju jetre nakon 1 - 71 dana liječenja; u 3 od ta 4 bolesnika liječenje se nakon presađivanja jetre produljilo za 12 tjedana, dok se u 1 bolesnika, koji je primao liječenje tijekom 23 dana prije presađivanja, liječenje nije produljilo.
English: Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4.2, 4.4 and 5.1).
Croatian: Daklinza je indicirana u kombinaciji s drugim lijekovima za liječenje kronične infekcije virusom hepatitisa C (HCV) u odraslih (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Elimination Following single-dose oral administration of 14C-daclatasvir in healthy subjects, 88% of total radioactivity was recovered in feces (53% as unchanged drug) and 6.6% was excreted in the urine (primarily as unchanged drug).
Croatian: Nakon peroralne primjene jednokratne doze 14C-daklatazvira u zdravih ispitanika, 88% ukupne radioaktivnosti otkriveno je u fecesu (53% u neizmijenjenu obliku), a 6,6% izlučeno je kroz mokraću
English: The duration of your treatment will depend on whether you have previously received treatment for your hepatitis C infection, the condition of your liver, and what other medicines you will take with Daklinza.
Croatian: Trajanje liječenja ovisit će o tome jeste li prethodno već primili liječenje za infekciju hepatitisom C, o stanju jetre i o lijekovima koje ćete uzimati istodobno s lijekom Daklinza.Možda ćete morati uzimati druge lijekove u različitim vremenskim periodima.
English: Daclatasvir was excreted into the milk of lactating rats with concentrations 1.7- to 2-fold maternal plasma levels.
Croatian: Daklatazvir se izlučivao u mlijeko ženki štakora u laktaciji u koncentracijama 1,7 do 2 puta većima od razina lijeka u plazmi majke.
English: Steady state was achieved after 4 days of once-daily administration.
Croatian: Stanje dinamičke ravnoteže postignuto je nakon 4 dana primjene jedanput na dan.
English: There are no clinical data in patients with genotype 5 (see section 5.1).
Croatian: Nema kliničkih podataka o primjeni u bolesnika s infekcijom genotipom 5 (vidjeti dio 5.1).
English: Data to support the treatment of genotype 2 infection with Daklinza and sofosbuvir are limited.
Croatian: Podaci koji podupiru liječenje infekcije genotipom 2 lijekom Daklinza i sofosbuvirom su ograničeni.
English: Patients demographics and main disease characteristics are summarised in Table 8.
Croatian: Demografske značajke bolesnika i glavne značajke bolesti sažeto su prikazane u Tablici 8.
English: Toxicology
Croatian: Toksikologija
English: All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Croatian: Niti jedan od 44 bolesnika s infekcijom HCV-om genotipa 2 (n=26) ili 3 (n=18) prethodno nije bio liječen.
English: No human data on the effect of daclatasvir on fertility are available.
Croatian: Nema dostupnih podataka o utjecaju daklatazvira na plodnost u ljudi.
English: Protease inhibitors (PIs) Boceprevir
Croatian: Inhibitori proteaze (PI) boceprevir
English: Sirolimus Mycophenolate mofetil
Croatian: sirolimus mikofenolat mofetil
English: In a study of pre- and postnatal development in rats, there was neither maternal nor developmental toxicity at doses up to 50 mg/kg/day, associated with AUC values 2-fold the clinical AUC exposure.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja u štakora, nisu primijećene ni toksičnost za majku ni razvojna toksičnost pri dozama do 50 mg/kg na dan, uz vrijednosti AUC-a 2 puta veće od AUC-a nakon kliničke izloženosti u ljudi.
English: Daclatasvir was not carcinogenic in mice or in rats at exposures 8-fold or 4-fold, respectively, the clinical AUC exposure.
Croatian: Daklatazvir nije bio kancerogen u miševa niti u štakora pri izloženosti 8 puta, odnosno 4 puta većoj od kliničke AUC izloženosti.
English: Carcinogenesis and mutagenesis
Croatian: Kancerogenost i mutagenost
English: Resistance in cell culture
Croatian: Rezistencija u staničnoj kulturi
English: Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.6).
Croatian: Vrlo učinkovitu kontracepciju treba nastaviti koristiti još 5 tjedana nakon završetka terapije lijekom Daklinza (vidjeti dio 4.6).
English: The daclatasvir EC50 values in the replicon system were 0.003-1.25 nM for genotypes 3a, 4a, 5a and 6a, and 0.034-19 nM for genotype 2a as well as 0.020 nM for infectious genotype 2a (JFH-1) virus.
Croatian: EC50 vrijednosti daklatazvira iznosile su 0,003-1,25 nM protiv replikona genotipova 3a, 4a, 5a i 6a, 0,034-19 nM protiv replikona genotipa 2a te 0,020 nM protiv infektivnog virusnog genotipa 2a (JFH-1).
English: Daklinza must be administered in combination with other medicinal products for the treatment of chronic HCV infection (see sections 4.1 and 4.2).
Croatian: Daklinza se mora primjenjivati u kombinaciji s drugim lijekovima za liječenje kronične infekcije HCV-om (vidjeti dijelove 4.1 i 4.2).
English: SVR12 rates were lower among patients with cirrhosis (see Table 12).
Croatian: Stope SVR12 bile su niže kod bolesnika s cirozom (vidjeti Tablicu 12).
English: The recommended dose of Daklinza is 60 mg once a day.
Croatian: Preporučena doza lijeka Daklinza je 60 mg jedanput na dan.
English: Itraconazole Posaconazole Voriconazole
Croatian: itrakonazol posakonazol vorikonazol
English: SVR12 was achieved by 83% (50/60) of patients in the cirrhosis cohort, with a marked difference between patients with Child-Pugh A or B (92-94%) as compared to those with Child-Pugh C and 94% of patients in the post-liver transplant cohort (Table 9).
Croatian: SVR12 postiglo je 83% (50/60) bolesnika u kohorti s cirozom, uz značajnu razliku između bolesnika s bolešću Child-Pugh stadija A ili B (92 - 94%) u odnosu na one s bolešću Child-Pugh stadija C, te
English: Refer to section 4.5 for established and other potentially significant drug-drug interactions.
Croatian: Vidjeti dio 4.5 za potvrđene i druge moguće interakcije s drugim lijekovima.
English: Patients with genotype 3 infection were treated with daclatasvir + sofosbuvir +/- ribavirin for 12 or 24 weeks, where the longer treatment duration was associated with a lower risk for relapse (around 5%) in a preliminary analysis.
Croatian: Bolesnici s infekcijom genotipom 3, liječeni su kombinacijom daklatazvir + sofosbuvir +/- ribavirin tijekom 12 ili 24 tjedna, pri čemu je dulje liječenje bilo povezano s manjim rizikom od relapsa (oko 5%) u preliminarnim analizama.
English: Overall, SVR12 was achieved by 97% (149/153) of patients administered daclatasvir and sofosbuvir for 12 weeks in ALLY-2.
Croatian: Ukupno je SVR12 postiglo 97% (149/153) bolesnika koji su primali daklatazvir + sofosbuvir tijekom 12 tjedana u ispitivanju ALLY-2.
English: The sofosbuvir resistance-associated substitution S282T emerged in only 1 non-SVR12 patient infected with genotype 3.
Croatian: Supstitucija S282T, koja je povezana s rezistencijom na sofosbuvir, pojavila se u samo 1 bolesnika s infekcijom genotipom 3 koji nije postigao SVR12.
English: Daclatasvir unbound AUC was estimated to be 18%, 39% and 51% higher for subjects with creatinine clearance (CLcr) values of 60, 30 and 15 ml/min, respectively, relative to subjects with normal renal function.
Croatian: Procijenjeno je da je AUC nevezanog daklatazvira bio 18%, 39% odnosno 51% veći u ispitanika u kojih je klirens kreatinina (CLcr) bio 60, 30 odnosno 15 ml/min nego u ispitanika s normalnom bubrežnom funkcijom.
English: Tabulated summary of interactions
Croatian: Tablični sažetak interakcija
English: The overall safety profile of daclatasvir is based on data from 2215 patients with chronic HCV infection who received Daklinza once daily either in combination with sofosbuvir with or without ribavirin (n=679, pooled data) or in combination with peginterferon alfa and ribavirin (n=1536, pooled data) from a total of 14 clinical studies.
Croatian: Ukupan profil sigurnosti daklatazvira temelji se na podacima prikupljenima u 2215 bolesnika s kroničnom infekcijom HCV-om koji su primali lijek Daklinza jedanput na dan u kombinaciji sa sofosbuvirom, uz ribavirin ili bez njega (n=679, objedinjeni podaci) ili u kombinaciji s peginterferonom alfa i ribavirinom (n=1536, objedinjeni podaci) u ukupno 14 kliničkih ispitivanja.
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Croatian: Nema pravila o prekidu virološkog liječenja koja bi se mogla primijeniti na kombinaciju lijeka Daklinza sa sofosbuvirom.
English: Population pharmacokinetic analysis identified gender as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) with female subjects having slightly lower CL/F, but the magnitude of the effect on daclatasvir exposure is not clinically important.
Croatian: U populacijskoj farmakokinetičkoj analizi utvrđeno je da spol predstavlja statistički značajnu kovarijantu za prividni klirens daklatazvira (CL/F) nakon peroralne primjene jer je CL/F bio nešto niži u žena, ali opseg tog učinka na izloženost daklatazviru nije klinički značajan.
English: It is not known whether daclatasvir is excreted in human milk.
Croatian: Nije poznato izlučuje li se daklatazvir u humano mlijeko.
English: At steady state, protein binding of daclatasvir in HCV-infected patients was approximately 99% and independent of dose at the dose range studied (1 mg to 100 mg).
Croatian: U stanju dinamičke ravnoteže je vezivanje daklatazvira za proteine u bolesnika s infekcijom HCV-om iznosilo približno 99% te nije ovisilo o dozi u ispitivanom rasponu doza (1 mg do 100 mg).
English: These medicines lower the effect of Daklinza so your treatment will not work.
Croatian: Navedeni lijekovi smanjuju učinak lijeka Daklinza pa Vaše liječenje neće biti djelotvorno.
English: Study conducted in patients with chronic HCV infection
Croatian: Ispitivanje je provedeno u bolesnika s kroničnom infekcijom HCV-om
English: In study AI444040, 211 adults with HCV genotype 1, 2, or 3 infection and without cirrhosis received daclatasvir and sofosbuvir, with or without ribavirin.
Croatian: U ispitivanju AI444040, 211 odraslih osoba s infekcijom HCV-om genotipa 1, 2 ili 3 i bez ciroze je primilo daklatazvir i sofosbuvir, sa ili bez ribavirina.
English: No dose adjustment of Daklinza is required for patients aged ≥65 years (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
English: ↔ Daclatasvir*
Croatian: ↔ daklatazvir*
English: Lamivudine Zidovudine Emtricitabine Abacavir Didanosine Stavudine
Croatian: lamivudin zidovudin emtricitabin abakavir didanozin stavudin
English: The concomitant use of amiodarone was limited through the clinical development of sofosbuvir plus direct-acting antivirals (DAAs).
Croatian: Istovremena primjena amiodarona bila je ograničena tijekom kliničkog razvoja sofosbuvira uz izravno djelujuće antivirotike.
English: Rifabutin Rifapentine
Croatian: rifabutin rifapentin
English: Warfarin
Croatian: varfarin
English: Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Croatian: Toksičnost za majku koja je uključivala smrtnost, pobačaje, štetne kliničke znakove, smanjenje tjelesne težine i smanjen unos hrane, primijećena je u obje vrste životinja, pri izloženosti 25 puta (štakor) i 72 puta (kunić) većoj od AUC-a nakon kliničke izloženosti u ljudi.
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who were post-liver transplant).
Croatian: Povećanja vrijednosti ukupnog bilirubina 3./4. stupnja primijećena su u 5% bolesnika (sva u bolesnika s istodobnom infekcijom HIV-om koji su istodobno primali i atazanavir, bolesnika s cirozom Child-Pugh stadija A, B ili C te bolesnika kojima je presađena jetra).
English: HCV replicons expressing daclatasvir-associated resistance substitutions remained fully sensitive to interferon alfa and other anti-HCV agents with different mechanisms of action, such as NS3 protease and NS5B polymerase (nucleoside and non-nucleoside) inhibitors.
Croatian: Replikoni HCV-a s ekspresijom supstitucija koje uzrokuju rezistenciju na daklatazvir i dalje su bili potpuno osjetljivi na interferon alfa i druge lijekove protiv HCV-a s drugačijim mehanizmima djelovanja, poput (nukleozidnih i nenukleozidnih) inhibitora NS3 proteaze i NS5B polimeraze.
English: daclatasvir + pegIFN/RBV
Croatian: daklatazvir + pegIFN/RBV
English: SVR12 was achieved in 90% of treatment-naïve patients and 86% of treatment-experienced patients.
Croatian: SVR12 je postignut kod 90% prethodno neliječenih bolesnika te kod 86% onih koji su već bili liječeni.
English: Among the 167 patients with HCV genotype 1 infection, 126 were treatment-naïve and 41 had failed prior therapy with a PI regimen (boceprevir or telaprevir).
Croatian: Od 167 bolesnika s infekcijom HCV-om genotipa 1, njih 126 prethodno nije bilo liječeno, a 41 bolesnik nije odgovorio na prethodno liječenje režimom koji je uključivao inhibitor proteaze (boceprevir ili telaprevir).
English: Use of highly effective contraception should be continued for 5 weeks after completion of Daklinza therapy (see section 4.5).
Croatian: Vrlo učinkovitu kontracepciju treba nastaviti koristiti još 5 tjedana nakon završetka terapije lijekom Daklinza (vidjeti dio 4.5).
English: - If undetectable HCV RNA is achieved, but not at both treatment weeks 4 and 12, Daklinza should be discontinued at 24 weeks and peginterferon alfa and ribavirin continued for a total duration of 48 weeks.
Croatian: - ako se postigne nemjerljiva razina HCV RNK, ali ne i u 4. i u 12. tjednu, primjenu lijeka Daklinza treba prekinuti nakon 24 tjedna, a primjenu peginterferona alfa i ribavirina nastaviti tijekom ukupno 48 tjedana.
English: Modest increases in concentrations of daclatasvir are expected, but no dose adjustment of Daklinza or fluconazole is required.
Croatian: Očekuju se skromna povećanja koncentracija daklatazvira, ali nije potrebno prilagođavati dozu lijeka Daklinza ni flukonazola.
English: HCV/HIV co-infection (ALLY-2)
Croatian: Istodobna infekcija HCV-om i HIV-om (ALLY-2)
English: pegIFN/RB V N=42
Croatian: pegIFN/RBV N=42
English: Since Daklinza must always be used in combination with other medicines against hepatitis C infection, please make sure that you read the "Do not take" section of the package leaflets for these medicines.
Croatian: Budući da se Daklinza uvijek mora uzimati u kombinaciji s drugim lijekovima protiv infekcije hepatitisom C, obavezno pročitajte dio "Nemojte uzimati" u Uputama o tim lijekovima.
English: Nervous system disorders very common headache headache common dizziness, migraine dizziness, migraine
Croatian: Poremećaji živčanog sustava vrlo često glavobolja glavobolja često omaglica, migrena omaglica, migrena
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see section 5.1) Recurrent HCV infection post-liver transplant (GT 1, 3 or 4) Patients without cirrhosis
Croatian: Daklinza + sofosbuvir +/- ribavirin tijekom 24 tjedna (vidjeti dio 5.1) Povrat infekcije HCV-om nakon presađivanja jetre (GT 1, 3 ili 4) Bolesnici bez ciroze
English: In vitro daclatasvir is an inhibitor of renal uptake transporters, OAT1 and 3, and OCT2, but is not expected to have a clinical effect on the pharmacokinetics of substrates of these transporters.
Croatian: In vitro je daklatazvir inhibitor bubrežnih transportnih proteina, OAT 1 i 3 te organskog kationskog prijenosnika (engl. organic cation transporter, OCT2) ali ne očekuje se da će imati kliničkog učinka na farmakokinetiku supstrata za te prijenosnike.
English: Daklinza 30 mg, 60 mg and 90 mg film-coated tablets are available in packs of 28 tablets in nonperforated calendar blisters and perforated unit dose blisters.
Croatian: Daklinza 30 mg, 60 mg i 90 mg filmom obložene tablete dostupne su u pakiranjima s 28 tableta u neperforiranim kalendarski označenim blisterima i perforiranim blisterima djeljivima na jedinične doze.
English: Conversion of the FibroTest score to the corresponding METAVIR score suggests that 35% of all patients (49% of patients with prior PI failure, 30% of patients with genotype 2 or 3) had ≥F3 liver fibrosis.
Croatian: FibroTesta u odgovarajući METAVIR rezultat pokazuje da je 35% svih bolesnika (49% bolesnika koji nisu odgovorili na prethodno liječenje inhibitorom proteaze, 30% bolesnika s genotipom 2 ili 3) imalo fibrozu jetre stupnja ≥ F3.
English: and you notice 20 hours or more after the time you usually take Daklinza, wait and take the next dose at your usual time.
Croatian: Sljedeću dozu uzmite u uobičajeno vrijeme. i primijetite to 20 ili više sati nakon što obično uzimate lijek Daklinza, pričekajte i uzmite sljedeću dozu u uobičajeno vrijeme.
English: Due to the lack of data, coadministration of Daklinza and etravirine or nevirapine is not recommended.
Croatian: Zbog nedostatka podataka ne preporučuje se istodobna primjena lijeka Daklinza s etravirinom ili nevirapinom.
English: pegIFN/RB V N=6
Croatian: pegIFN/RBV N=6
English: Effect of food on oral absorption
Croatian: Utjecaj hrane na apsorpciju nakon peroralne primjene
English: Data from compassionate use programmes which included patients with genotype 3 infection and cirrhosis, support the use of Daklinza + sofosbuvir for 24 weeks in these patients.
Croatian: Podaci iz programa milosrdnog davanja lijeka koji su još u tijeku a uključivali su bolesnike s infekcijom genotipom 3 i cirozom, podržavaju primjenu lijeka Daklinza + sofosbuvira kroz 24 tjedna u tih bolesnika.
English: In addition some medicines may affect the way Daklinza works.
Croatian: neki lijekovi mogu utjecati na način kako djeluje Daklinza.
English: Administration of daclatasvir 60 mg tablet after a light meal resulted in no reduction in daclatasvir exposure.
Croatian: Primjena tablete daklatazvira od 60 mg nakon laganog obroka nije smanjila izloženost daklatazviru.
English: mean median
Croatian: srednja vrijednost medijan
English: No data are available on the persistence of daclatasvir resistance-associated substitutions beyond 6 months post-treatment in patients treated with daclatasvir and sofosbuvir with/without ribavirin.
Croatian: Nema podataka o postojanosti supstitucija koja rezistenciju na daklatazvir nakon više od 6 mjeseci po završetku liječenja u bolesnika liječenih daklatazvirom i sofosbuvirom (s ribavirinom ili bez njega).
English: Daclatasvir had no effects on fertility in female rats at any dose tested.
Croatian: Daklatazvir nije utjecao na plodnost ženki štakora ni pri jednoj ispitivanoj dozi.
English: Close monitoring is recommended if this medicinal product is administered with Daklinza in combination with sofosbuvir (see sections 4.4 and
Croatian: Preporučuje se pažljivo praćenje, ako se ovaj lijek primjenjuje s lijekom Daklinza u kombinaciji sa sofosbuvirom (vidjeti dijelove 4.4. i 4.8.)
English: HERBAL SUPPLEMENTS St. John's wort (Hypericum perforatum)
Croatian: BILJNI PRIPRAVCI gospina trava (Hypericum perforatum)
English: Treatment with Daklinza should be initiated and monitored by a physician experienced in the management of chronic hepatitis C.
Croatian: 4.2 Doziranje i način primjene Liječenje lijekom Daklinza mora započeti i nadzirati liječnik s iskustvom u liječenju kroničnog hepatitisa C.
English: In one cohort the majority of patients were treated with daclatasvir + sofosbuvir + ribavirin for 12 weeks.
Croatian: U jednoj kohorti većina bolesnika liječena je kombinacijom daklatazvir + sofosbuvir + ribavirin tijekom 12 tjedana.
English: Very common (may affect more than 1 in 10 people): headache, nausea (feeling sick), fatigue reduction in red blood cells (anaemia)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 osoba): glavobolja, mučnina, umor smanjenje broja crvenih krvnih stanica (anemija)
English: Cirrhotic cohort N = 60
Croatian: Kohorta s cirozom N=60
English: The impact of baseline NS5A RAVs on cure rates of genotype 4 infection is not apparent.
Croatian: Utjecaj početnih varijanti NS5A koje su povezane s rezistencijom na stopu izlječenja infekcije genotipom 4 nije vidljiv.
English: SVR rates were comparable regardless of age, race, gender, IL28B allele status, or baseline HCV RNA level.
Croatian: Stope SVR-a bile su usporedive neovisno o dobi, rasi, spolu, statusu alela IL28B ili početnoj razini HCV RNK.
English: Paediatric population The pharmacokinetics of daclatasvir in paediatric patients have not been evaluated.
Croatian: Pedijatrijska populacija Nije ocijenjena farmakokinetika dakvatazvira u pedijatrijskih bolesnika.
English: Daclatasvir is an inhibitor of HCV genotypes 1a and 1b replication in cell-based replicon assays with effective concentration (50% reduction, EC50) values of 0.003-0.050 and 0.001-0.009 nM, respectively, depending on the assay method.
Croatian: Daklatazvir je inhibitor replikacije HCV-a genotipova 1a i 1b u testovima replikona u staničnoj kulturi, s vrijednostima efektivne koncentracije (smanjenje za 50%, EC50) od 0,003-0,050 odnosno
English: No dose adjustment of Daklinza 60 mg once daily or lopinavir/ritonavir is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza 60 mg jedanput na dan ni lopinavira/ritonavira.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS CALENDAR BLISTER (NON-PERFORATED) TEXT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP TEKST KALENDARSKI OZNAČENOG BLISTERA (NEPERFORIRANOG)
English: Seven percent of patients had compensated cirrhosis; 92% had HCV genotype 1 (72% 1a and 20% 1b) and 8% had HCV genotype 4; 65% of patients had IL-28B rs12979860 non-CC genotypes.
Croatian: Sedam posto bolesnika imalo je kompenziranu cirozu; 92% imalo je HCV genotipa 1 (72% 1a i 20% 1b), a 8% imalo je HCV genotipa 4; 65% bolesnika imalo je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
English: Patients received daclatasvir 60 mg once daily, sofosbuvir 400 mg once daily, and ribavirin (600 mg starting dose) for 12 weeks and were monitored for 24 weeks post treatment.
Croatian: 60 mg jedanput na dan, sofosbuvir u dozi od 400 mg jedanput na dan i ribavirin (početna doza od 600 mg) tijekom 12 tjedana te su bili praćeni tijekom 24 tjedna nakon liječenja.
English: Safety monitoring is advised when initiating treatment with Daklinza in patients receiving dabigatran etexilate or other intestinal P-gp substrates that have a narrow therapeutic range.
Croatian: Preporučuje se praćenje sigurnosti kada se lijek Daklinza uvodi u bolesnika koji primaju dabigatran eteksilat ili druge supstrate za crijevni P-gp uskog terapijskog raspona.
English: Virologic breakthrough**
Croatian: Virološki neuspjeh Virološki proboj** Relaps**
English: Treatment-naïve patients with HCV genotype 1 who received 12 weeks of treatment had a similar response as those treated for 24 weeks (Table 6).
Croatian: Prethodno neliječeni bolesnici s HCV-om genotipa 1 liječeni tijekom 12 tjedana imali su sličan odgovor kao i oni liječeni tijekom 24 tjedna (Tablica 6).
English: Patients achieving virologic response [HCV RNA undetectable at weeks 4 and 12] completed therapy after 24 weeks while those who did not achieve virologic response received an additional 24 weeks of treatment with pegIFN/RBV, to complete a total of 48 weeks of study therapy.
Croatian: Bolesnici koji su postigli virološki odgovor [nemjerljive razine HCV RNK u 4. i 12.tjednu] završili su terapiju nakon 24 tjedna, dok su oni koji nisu postigli virološki odgovor primili dodatno liječenje od 24 tjedna s pegIFN/RBV, kako bi završili terapiju u ukupnom trajanju od 48 tjedana.
English: > 10 to ≤12 g/dL
Croatian: > 10 i ≤12 g/dl