natgillin/translations-raw huggingface dataset:
Patient demographics and baseline disease characteristics are summarised in Table 10. 
Demografske značajke bolesnika i početne značajke bolesti sažeto su prikazane u Tablici 10.
No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2). 
Nije potrebno prilagođavati dozu lijeka Daklinza u bolesnika s bilo kojim stupnjem oštećenja bubrežne funkcije (vidjeti dio 5.2).
Most patients (61%) had IL-28B rs12979860 non-CC genotypes. 
Većina bolesnika (61%) imala je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain 
Poremećaji probavnog sustava vrlo često mučnina često proljev, povraćanje, bol u abdomenu, gastroezofagealna refluksna bolest, konstipacija, suha usta, flatulencija mučnina, proljev, bol u abdomenu
AI444043 was an open-label, single-arm study of daclatasvir with pegIFN/RBV in treatment-naïve adults with chronic HCV genotype 1 infection who were co-infected with HIV. 
Ispitivanje AI444043 bilo je otvoreno, ispitivanje daklatazvira s pegIFN/RBV u jednoj skupini prethodno neliječenih odraslih bolesnika s kroničnom infekcijom HCV-om genotipa 1, koji su istodobno imali infekciju HIV-om.
ANTICOAGULANTS Dabigatran etexilate 
ANTIKOAGULANSI dabigatran eteksilat
In study ALLY-3, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 152 adults infected with HCV genotype 3; 101 patients were treatment-naïve and 51 patients had failed prior antiviral therapy. 
U ispitivanju ALLY-3, kombinacija daklatazvira i sofosbuvira primijenjena tijekom 12 tjedana bila je procijenjena kod 152 odrasle osobe zaražene HCV-om genotipa 3; 101 bolesnik je bio prethodno neliječen a u 51 bolesnika prijašnja antivirusna terapija nije uspjela.
Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040 
Tablica 6: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom, HCV genotipa 1 u ispitivanju AI444040
Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2. 
Ciroza se utvrđivala biopsijom jetre, vrijednošću > 14,6 kPa izmjerenom uređajem FibroScan ili rezultatom ≥ 0,75 prema FibroTestu i indeksom omjera aspartat aminotransferaze (AST) i trombocita (engl. aspartate aminotransferase: platelet ratio index, APRI) > 2. U 5 se bolesnika status ciroze nije mogao odrediti.
Patients without cirrhosis 
Bolesnici bez ciroze
Daclatasvir in combination with sofosbuvir 
Daklatazvir u kombinaciji sa sofosbuvirom
BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O. 
SQUIBB POLSKA SP. Z O.O.
In clinical studies of Daklinza in combination with sofosbuvir with or without ribavirin, 2% of patients had Grade 3 haemoglobin decreases; all of these patients received Daklinza + sofosbuvir + ribavirin. 
U kliničkim ispitivanjima lijeka Daklinza u kombinaciji sa sofosbuvirom s ribavirinom ili bez njega, 2% bolesnika imalo je smanjenje razine hemoglobina 3. stupnja; svi su ti bolesnici primali lijek
Table 10: Demographics and baseline characteristics in Study ALLY-2 
Tablica 10: Demografske značajke bolesnika i početne značajke bolesti u ispitivanju ALLY-2
For HCV genotype 1, SVR12 rates were 64% (54% for 1a; 84% for 1b) for patients treated with daclatasvir + pegIFN/RBV and 36% for patients treated with placebo + pegIFN/RBV. 
Ishodi liječenja u ispitivanju AI444010 za bolesnike s HCV-om genotipa 4 prikazani su u Tablici 13. Stope SVR12 za HCV genotipa 1 iznosile su 64% (54% za 1a; 84% za 1b) za bolesnike liječene daklatazvirom + pegIFN/RBV te 36% za bolesnike koji su primali placebo + pegIFN/RBV.
↔ Daclatasvir ↔ Azithromycin or Ciprofloxacin 
↔ azitromicin ili ciprofloksacin
Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily) 
Drugi antivirotici za liječenje HCV-a peginterferon alfa 180 µg jedanput na tjedan i ribavirin 1000 mg ili 1200 mg na dan u dvije odvojene doze (daklatazvir 60 mg jedanput na dan)
Pack size of 28 film-coated tablets in non-perforated calendar blisters. 
Veličina pakiranja: 28 filmom obloženih tableta u neperforiranim kalendarski označenim blisterima.
The pharmacokinetics of daclatasvir following a single 60 mg oral dose were studied in non-HCV infected subjects with renal impairment. 
Farmakokinetika daklatazvira nakon primjene jednokratne peroralne doze od 60 mg ocijenjena je u ispitanika s oštećenjem bubrežne funkcije koji nisu imali infekciju HCV-om.
↔ Daclatasvir AUC: ↔∗ Cmax: ↔∗ Cmin: ↔∗ 
↔ daklatazvir AUC: ↔∗ Cmax: ↔∗
The most common of these side effects are listed below. 
U nastavku se navode najčešće od tih nuspojava.
SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies. 
Stope SVR-a bile su > 94% uz sve režime kombinirane antiretrovirusne terapije, uključujući terapije utemeljene na pojačanom inhibitoru proteaze,
Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1) 
Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana (vidjeti dio 5.1)
Treatment duration was 12 weeks for 82 treatment-naïve HCV genotype 1 patients, and 24 weeks for all other patients in the study. 
Liječenje 82 prethodno neliječena bolesnika s HCV-om genotipa 1 trajalo je 12 tjedana, a liječenje svih preostalih bolesnika koji su sudjelovali u ispitivanju 24 tjedna.
Daklinza contains the active ingredient daclatasvir. 
Daklinza sadrži djelatnu tvar daklatazvir.
Post-Liver Transplant N = 53 
Bolesnici kojima je presađena jetra N=53
Daklinza + sofosbuvir (without ribavirin) for 24 weeks 
Daklinza + sofosbuvir (bez ribavirina) tijekom 24 tjedna
For daclatasvirtreated patients with HCV RNA results at both follow-up Weeks 12 and 24, concordance of SVR12 and SVR24 was 97% for HCV genotype 1 and 100% for HCV genotype 4. 
U bolesnika liječenih daklatazvirom koji su postigli željene razine HCV RNK i u 12. i u 24. tjednu praćenja, podudarnost između SVR12 i SVR24 iznosila je 97% za HCV genotipa 1 te 100% za
In repeat-dose toxicology studies in animals, hepatic effects (Kupffer-cell hypertrophy/ hyperplasia, mononuclear cell infiltrates and bile duct hyperplasia) and adrenal gland effects (changes in cytoplasmic vacuolation and adrenal cortical hypertrophy/hyperplasia) were observed at exposures similar or slightly higher than the clinical AUC exposure. 
(hipertrofija/hiperplazija Kupfferovih stanica, mononuklearni stanični infiltrati i hiperplazija žučnih vodova) te učinci na nadbubrežnu žlijezdu (promjene u citoplazmatskoj vakuolizaciji te hipertrofija/hiperplazija kore nadbubrežne žlijezde) s izloženošću koja je nešto veća od kliničke AUC
No dose adjustment of Daklinza, peginterferon alfa, or ribavirin is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza, peginterferona alfa ni ribavirina.
Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily individualized dose* (daclatasvir 60 mg once daily) 
buprenorfin/nalokson, individualizirana doza od 8/2 mg do 24/6 mg jedanput na dan* (daklatazvir 60 mg jedanput na dan)
Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir 
Daklinza 30 mg filmom obložene tablete Daklinza 60 mg filmom obložene tablete Daklinza 90 mg filmom obložene tablete
Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir. 
Primjena lijeka Daklinza s verapamilom može dovesti do povećane koncentracije daklatazvira
How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it. 
Lijek Daklinza morate uzimati onoliko dugo koliko Vam je rekao Vaš liječnik.
Patients in the daclatasvir treatment group who did not have HCV RNA undetectable at both Weeks 4 and 12 and all placebo-treated patients continued pegIFN/RBV for another 24 weeks. 
Bolesnici u skupini liječenoj daklatazvirom koji nisu imali nemjerljivu razinu HCV RNK i u 4. i u 12. tjednu te svi bolesnici koji su primali placebo nastavili su liječenje kombinacijom pegIFN/RBV još 24 tjedna.
Daclatasvir showed additive to synergistic interactions with interferon alfa, HCV nonstructural protein 3 (NS3) PIs, HCV nonstructural protein 5B (NS5B) non-nucleoside inhibitors, and HCV NS5B nucleoside analogues in combination studies using the cell-based HCV replicon system. 
U kombiniranim ispitivanjima, u kojima se koristio sustav replikona HCV-a razvijen na staničnoj kulturi, daklatazvir je pokazao aditivne do sinergističke interakcije s interferonom alfa, inhibitorima proteaze nestrukturnog proteina 3 (NS3) HCV-a, nenukleozidnim inhibitorima nestrukturnog proteina 5B (NS5B) HCV-a i nukleozidnim analozima NS5B HCV-a.
Daclatasvir in combination with peginterferon alfa and ribavirin AI444042 and AI444010 were randomised, double-blind studies that evaluated the efficacy and safety of daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV) in the treatment of chronic HCV infection in treatment-naïve adults with compensated liver disease (including cirrhosis). 
Ispitivanja AI444042 i AI444010 bila su randomizirana, dvostruko slijepa ispitivanja u kojima su se ocjenjivale djelotvornost i sigurnost daklatazvira u kombinaciji s peginterferonom alfa i ribavirinom
INFORMATION IN BRAILLE Daklinza 90 mg 
16. PODACI NA BRAILLEOVOM PISMU Daklinza 90 mg
Posology The recommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals. 
Preporučena doza lijeka Daklinza je 60 mg jedanput na dan, a uzima se peroralno neovisno o obrocima.
Daklinza + sofosbuvir + ribavirin for 12 weeks or 
Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana ili
ANTIDEPRESSANTS Selective serotonin reuptake inhibitors Escitalopram 10 mg once daily (daclatasvir 60 mg once daily) 
Selektivni inhibitori ponovne pohrane serotonina escitalopram 10 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
You should not breastfeed during treatment with Daklinza. 
Ne smijete dojiti tijekom liječenja lijekom
No dose adjustment of Daklinza or sofosbuvir is required. 
Nije potrebno prilagođavati dozu lijeka Daklinza ni sofosbuvira.
Among patients who achieved SVR12 with daclatasvir + pegIFN/RBV with a median duration of post-SVR12 follow-up of 22 months, 1% of patients relapsed. 
Među bolesnicima koji su postigli SVR12 uz primjenu daklatazvira + pegIFN-a/RBV-a, uz medijan trajanja praćenja nakon SVR12 od 22 mjeseca, u
Refer to the Summary of Product Characteristics of ribavirin. 
Vidjeti Sažetak opisa svojstava lijeka za ribavirin.
No clinically relevant antiviral activity was observed against a variety of RNA and DNA viruses, including HIV, confirming that daclatasvir, which inhibits a HCV-specific target, is highly selective for HCV. 
uključujući HIV, što potvrđuje da je daklatazvir, koji inhibira ciljno mjesto specifično za HCV, visoko selektivan za HCV.
0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily) 
etinilestradiol 35 μg jedanput na dan tijekom 21 dana + norgestimat 0,180/0,215/0,250 mg jedanput na dan tijekom 7/7/7 dana (daklatazvir 60 mg jedanput na dan)
Population pharmacokinetic analysis of data from clinical studies identified race (categories “other” [patients who are not white, black or Asian] and “black”) as a statistically significant covariate on daclatasvir apparent oral clearance (CL/F) and apparent volume of distribution (Vc/F) resulting in slightly higher exposures compared to white patients, but the magnitude of the effect on daclatasvir exposure is not clinically important. 
(kategorija „drugi“[bolesnici koje nisu bijele rase, crne rase ili Azijati] i „crna rasa“) predstavlja statistički značajnu kovarijantu za prividni oralni klirens (CL/F) i prividni volumen distribucije (Vc/F)
Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir: 
OATP 1B1 i/ili BCRP, očekuje se:
The safety and efficacy of Daklinza in the treatment of HCV infection in patients with Child-Pugh C liver disease have been established in the clinical study ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin for 12 weeks); however, SVR rates were lower than in patients with Child-Pugh A and B. Therefore, a conservative treatment regimen of Daklinza + sofosbuvir +/- ribavirin for 24 weeks is proposed for patients with Child-Pugh C (see sections 4.2 and 5.1). 
Child-Pugh stadija C ustanovljene su u kliničkom ispitivanju ALLY-1 (AI444215, Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana); međutim, stope SVR-a bile su niže nego u bolesnika s bolešću Child-Pugh stadija A i B.
How to store Daklinza 
Kako čuvati lijek Daklinza
INFORMATION IN BRAILLE Daklinza 30 mg 
16. PODACI NA BRAILLEOVOM PISMU Daklinza 30 mg
Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes. 
Deset posto bolesnika imalo je kompenziranu cirozu, a 75% bolesnika imalo je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
Median age was 55 years (range: 24 to 73); 90% of patients were white; 4% were black/African-American; 5% were Asian; 16% were Hispanic or Latino. 
Medijan dobi bio je 55 godina (raspon: 24 do 73); 90% bolesnika su bili bijelci; 4% crnci/Afroamerikanci; 5% Azijati; 16% su bili hispano ili latino porijekla.
ANTIVIRALS, HCV Nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg once daily (daclatasvir 60 mg once daily) Study conducted in patients with chronic HCV infection 
ANTIVIROTICI, HCV Nukleotidni analogni inhibitor polimeraze sofosbuvir 400 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
The 211 patients had a median age of 54 years (range: 20 to 70); 83% were white; 12% were black/African-American; 2% were Asian; 20% were Hispanic or Latino. 
Tih 211 bolesnika imalo je medijan dobi od 54 godine (raspon: 20 do 70); 83% bolesnika bili su bijelci, 12% crnci/Afroamerikanci, 2% Azijati, a njih 20%
Coadministration with strong inducers of CYP3A4 and P-gp is contraindicated while dose adjustment of Daklinza is recommended when coadministered with moderate inducers of CYP3A4 and P-gp (see Table 4). 
Istodobna primjena sa snažnim induktorima CYP3A4 i P-gp je kontraindicirana, a pri istodobnoj primjeni s umjerenim induktorima ili snažnim inhibitorima CYP3A4 i P-gp preporučuje se prilagoditi dozu lijeka Daklinza (vidjeti Tablicu 4).
↑ Digoxin 
↑ digoksin
Table 7: Treatment outcomes, daclatasvir in combination with sofosbuvir for 24 weeks, treatment-naïve patients with HCV genotype 2 or 3 in Study AI444040 Genotype 2 
Tablica 7: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 24 tjedna, prethodno neliječeni bolesnici s HCV-om genotipa 2 ili 3 u ispitivanju AI444040
↔ Raltegravir 
↔ daklatazvir ↔ raltegravir
Light green biconvex pentagonal of dimensions 9.1 mm x 8.9 mm, debossed tablet with "BMS" on one side and "215" on the other side. 
Svjetlozelena bikonveksna peterokutna tableta dimenzija 9,1 mm x 8,9 mm, s utisnutom oznakom "BMS" na jednoj i "215" na drugoj strani.
Genotype-specific activity 
Aktivnost protiv pojedinog genotipa
The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4. 
Dozu lijeka Daklinza treba povećati na 90 mg jedanput na dan kada se uzima istodobno s umjerenim induktorima CYP3A4.
No clinically relevant effects on the pharmacokinetics of either medicinal product are expected when daclatasvir is coadministered with any of the following: PDE-5 inhibitors, medicinal products in the ACE inhibitor class (e.g. enalapril), medicinal products in the angiotensin II receptor antagonist class (e.g. losartan, irbesartan, olmesartan, candesartan, valsartan), disopyramide, propafenone, flecainide, mexilitine, quinidine or antacids. 
inhibitora (npr. enalaprilom), lijekovima iz razreda antagonista receptora angiotenzina II (npr. losartanom, irbesartanom, olmesartanom, kandesartanom, valsartanom), dizopiramidom, propafenonom, flekainidom, meksilitinom, kinidinom ili antacidima.
In study ALLY-2, the combination of daclatasvir and sofosbuvir administered for 12 weeks was evaluated in 153 adults with chronic hepatitis C and HIV co-infection; 101 patients were HCV treatment-naïve and 52 patients had failed prior HCV therapy. 
U ispitivanju ALLY-2 ocjenjivalo se 12-tjedno liječenje kombinacijom daklatazvira i sofosbuvira u 153 odrasle osobe s istodobnim kroničnim hepatitisom C i infekcijom HIV-om; 101 bolesnik prethodno nije primao liječenje za HCV, a 52 bolesnika nisu uspješno odgovorila na prethodnu terapiju za HCV.
HCV Treatmentnaïve N=101 
Prethodno liječeni za HCV* N=52
↔ Daclatasvir ↔ Enfuvirtide 
↔ enfuvirtid
Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir. 
Primjena lijeka Daklinza s eritromicinom može povećati koncentracije daklatazvira.
In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was 
U bolesnika koji su nakon peroralne primjene tablete daklatazvira od 60 mg primili intravensku dozu [13C,15N]-daklatazvira od 100 µg, ukupni je klirens iznosio 4,24 l/h.
Daklinza in combination with peginterferon alfa and ribavirin The most frequently reported adverse reactions were fatigue, headache, pruritus, anaemia, influenzalike illness, nausea, insomnia, neutropenia, asthenia, rash, decreased appetite, dry skin, alopecia, pyrexia, myalgia, irritability, cough, diarrhoea, dyspnoea and arthralgia. 
Najčešće prijavljene nuspojave bile su umor, glavobolja, pruritus, anemija, bolest nalik gripi, mučnina, nesanica, neutropenija, astenija, osip, smanjen tek, suha koža, alopecija, pireksija, mialgija, razdražljivost, kašalj, proljev, dispneja i artralgija.
Daklinza can be taken with or without a meal. 
Daklinza se može uzimati neovisno o obrocima.
Treated patients had a median age of 49 years (range: 20 to 71); 77% of patients were white; 19% were black/African-American; 4% were Hispanic or Latino. 
Medijan dobi liječenih bolesnika bio je 49 godina (raspon: 20 do 71); 77% bolesnika bili su bijelci, 19% crnci/Afroamerikanci, a 4% hispanskog ili latinoameričkog podrijetla.
Table 14: Summary of noted newly emergent HCV NS5A substitutions on treatment or during follow-up in treated non-SVR12 subjects infected with HCV genotypes 1 through 3 
Tablica 14: Sažetak primijećenih novonastalih supstitucija u proteinu NS5A HCV-a koje su se razvile tijekom liječenja ili tijekom praćenja liječenih ispitanika s infekcijom
INFORMATION IN BRAILLE Daklinza 60 mg 
16. PODACI NA BRAILLEOVOM PISMU Daklinza 60 mg
Dizziness has been reported during treatment with Daklinza in combination with sofosbuvir, and dizziness, disturbance in attention, blurred vision and reduced visual acuity have been reported during treatment with Daklinza in combination with peginterferon alfa and ribavirin. 
Tijekom liječenja lijekom Daklinza u kombinaciji sa sofosbuvirom prijavljena je omaglica, dok su tijekom liječenja lijekom Daklinza u kombinaciji s peginterferonom alfa i ribavirinom prijavljeni omaglica, poremećaj pažnje, zamagljen vid i smanjena oštrina vida.
Green biconvex pentagonal of dimensions 7.2 mm x 7.0 mm, debossed tablet with "BMS" on one side and "213" on the other side. 
Zelena bikonveksna peterokutna tableta dimenzija 7,2 mm x 7,0 mm, s utisnutom oznakom "BMS" na jednoj i "213" na drugoj strani.
Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily) 
Inhibitor integraze dolutegravir 50 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, estimated volume of distribution at steady state was 47 l. In vitro studies indicate that daclatasvir is actively and passively transported into hepatocytes. 
U bolesnika koji su nakon peroralne primjene daklatazvir tablete od 60 mg primili intravensku dozu [13C,15N]-daklatazvira od 100 µg, procijenjeni volumen distribucije u stanju dinamičke ravnoteže iznosio je 47 l.
Following multiple oral doses of daclatasvir 60 mg once daily in combination with peginterferon alfa and ribavirin in treatment-naïve patients with genotype 1 chronic HCV, the geometric mean (CV%) daclatasvir Cmax was 1534 (58) ng/ml, AUC0-24h was 14122 (70) ng•h/ml, and Cmin was 232 (83) ng/ml. 
HCV-om genotipa 1, geometrijska srednja vrijednost (CV%) Cmax daklatazvira iznosila je 1534 (58) ng/ml, AUC0-24h je bio14122 (70) ng•h/ml, a Cmin 232 (83) ng/ml.
Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2 
Tablica 11: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom u bolesnika s istodobnom infekcijom HCV-om i HIV-om u ispitivanju ALLY-2
400 mg daily 
400 mg na dan
Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3 
Tablica 12: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom tijekom 12 tjedana, bolesnici s HCV-om genotipa 3 u ispitivanju ALLY-3
Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes. 
Većina bolesnika (71%, uključujući 98% bolesnika koji nisu odgovorili na prethodno liječenje inhibitorom proteaze) imala je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant 
Tablica 2: Smjernice za doziranje ribavirina pri njegovoj istodobnoj primjeni s režimom liječenja lijekom Daklinza u bolesnika s cirozom ili nakon presađivanja Laboratorijska vrijednost/Klinički kriteriji
Patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection were eligible to enroll, including patients with compenstated cirrhosis (ChildPugh A). 
4, 5 ili 6, uključujući bolesnike s kompenziranom cirozom (Child-Pugh stadij A).
Some other medicines can interact with Daklinza, affecting the levels of Daklinza in your body. 
Neki drugi lijekovi mogu djelovati na lijek Daklinza i tako utjecati na njegove koncentracije u organizmu.
Laboratory Value/Clinical Criteria 
Odstupanja laboratorijskih vrijednosti
↔ Daclatasvir AUC: 1.41 (1.32, 1.50) Cmax: 0.77 (0.70, 0.85) 
↔ daklatazvir AUC:: 1,41 (1,32, 1,50) Cmax:: 0,77 (0,70, 0,85)
Patients originally assigned to placebo and those in the daclatasvir group who did not achieve HCV RNA <LLOQ at Week 4 and undetectable at Week 10 continued pegIFN/RBV to complete 48 weeks of treatment. 
Bolesnici koji su izvorno randomizirani za primanje placeba i oni u skupini liječenoj daklatazvirom koji u 4. tjednu nisu imali HCV RNK < LLOQ, niti nemjerljive razine HCV RNK u 10. tjednu, nastavili su liječenje kombinacijom pegIFN/RBV do ukupno 48 tjedana liječenja.
If you have any questions, ask your doctor or pharmacist. 
Ako imate bilo kakvih pitanja, obratite se svom liječniku ili ljekarniku.
Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Istodobna primjena lijeka Daklinza s rifampicinom, rifabutinom, rifapentinom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).
No dose adjustment of Daklinza is required for patients with mild (Child-Pugh A, score 5-6), moderate (Child-Pugh B, score 7-9) or severe (Child-Pugh C, score ≥10) hepatic impairment (see sections 4.4 and 5.2). 
umjerenim (Child-Pugh stadij B, vrijednost: 7-9) ili teškim (Child-Pugh stadij C, vrijednost: ≥ 10)
Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous). 
Jedna filmom obložena tableta od 90 mg sadrži 173 mg laktoze (bezvodne).
Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side. 
Svijetlozelena bikonveksna okrugla tableta promjera 10,16 mm, s otisnutom oznakom "BMS"na jednoj i "011" na drugoj strani.
Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3). 
Istodobna primjena lijeka Daklinza s karbamazepinom, okskarbazepinom, fenobarbitalom, fenitoinom ili drugim snažnim induktorima CYP3A4 je kontraindicirana (vidjeti dio 4.3).