FrancophonIA/ELRC3.0 huggingface dataset:
English: Daclatasvir is an inhibitor of P-gp, OATP 1B1 and BCRP.
Croatian: Daklatazvir je inhibitor P-gp-a, OATP 1B2 i BCRP-a.
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets
Croatian: OBLIK I SADRŽAJ 28 filmom obloženih tableta 28 x 1 filmom obložena tableta
English: Advanced cirrhosis and post-liver transplant (ALLY-1) In study ALLY-1, the regimen of daclatasvir, sofosbuvir, and ribavirin administered for 12 weeks was evaluated in 113 adults with chronic hepatitis C and Child-Pugh A, B or C cirrhosis (n=60) or HCV recurrence after liver transplantation (n=53).
Croatian: U ispitivanju ALLY-1 ocjenjivao se 12-tjedni režim liječenja daklatazvirom, sofosbuvirom i ribavirinom u 113 odraslih bolesnika s kroničnim hepatitisom C i cirozom Child-Pugh stadija A, B ili C (n=60) ili povratom HCV-a nakon presađivanja jetre (n=53).
English: The AUC value associated with this dose is 4-fold the clinical AUC exposure.
Croatian: Vrijednost AUC-a nakon primjene te doze je 4 puta veća od AUC-a nakon kliničke izloženosti u ljudi.
English: No cirrhosis With cirrhosis** Genotype 1 1a 1b Genotype 2 Genotype 3 Genotype 4 Virologic failure Detectable HCV RNA at end of treatment Relapse Missing post-treatment data
Croatian: Nemjerljiva razina HCV RNK SVR12 Bez ciroze** S cirozom** Genotip 1 1a 1b Genotip 2 Genotip 3 Genotip 4 Virološki neuspjeh Mjerljive razine HCV
English: Pack size of 28 film-coated tablets in perforated unit dose blisters.
Croatian: Veličina pakiranja: 28 filmom obloženih tableta u perforiranim blisterima djeljivima na jedinične doze.
English: Genotype 3
Croatian: Genotip 3
English: There was no Y93H RAV present at baseline for genotype-3 infected patients treated for 12-weeks with sofosbuvir + daclatasvir + ribavirin, and thus SVR outcomes cannot be assessed.
Croatian: Varijanta Y93H nije bila prisutna na početku liječenja u bolesnika s infekcijom genotipom 3 koji su se liječili sofosbuvirom + daklatazvirom + ribavirinom tijekom 12 tjedana i stoga se ne mogu ocijeniti ishodi s obzirom na SVR.
English: Available pharmacokinetic and toxicological data in animals have shown excretion of daclatasvir and metabolites in milk (see section 5.3).
Croatian: Dostupni farmakokinetički i toksikološki podaci iz istraživanja na životinjama pokazali su da se daklatazvir i metaboliti izlučuju u mlijeko
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Croatian: Daklinza + sofosbuvir +/- ribavirin tijekom 24 tjedna (vidjeti dijelove 4.4 i 5.1)
English: No evidence of mutagenic or clastogenic activity was observed in in vitro mutagenesis (Ames) tests, mammalian mutation assays in Chinese hamster ovary cells, or in an in vivo oral micronucleus study in rats.
Croatian: U in vitro testovima reverzne mutacije (Amesov test), testovima genskih mutacija stanica sisavaca na stanicama jajnika kineskog hrčka te in vivo mikronukleusnom testu nakon peroralne primjene u štakora, nisu opaženi dokazi mutagenih ni klastogenih učinaka.
English: Response was rapid (viral load at Week 4 showed that more than 97% of patients responded to therapy), and was not influenced by HCV subtype (1a/1b), IL28B genotype, or use of ribavirin.
Croatian: Odgovor je bio brz (virusno opterećenje u 4. tjednu pokazalo je da je više od 97% bolesnika odgovorilo na liječenje), a na njega nisu utjecali podtip HCV-a (1a/1b),
English: 4.4 Special warnings and precautions for use
Croatian: Upozorenja i mjere opreza
English: ↑ Daclatasvir
Croatian: ↑ daklatazvir
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Daklinza 30 mg film-coated tablets
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Daklinza 30 mg filmom obložene tablete
English: The pharmacokinetics of daclatasvir following a single 30 mg oral dose were studied in non-HCV infected subjects with mild (Child-Pugh A), moderate (Child-Pugh B), and severe (Child-Pugh C) hepatic impairment compared with unimpaired subjects.
Croatian: Farmakokinetika daklatazvira nakon primjene jednokratne peroralne doze od 30 mg ispitivana je u bolesnika bez infekcije HCV-om s blagim (Child-Pugh A), umjerenim (Child-Pugh B) i teškim
English: AI444042: Patients received daclatasvir 60 mg once daily (n=82) or placebo (n=42) plus pegIFN/RBV for 24 weeks.
Croatian: AI444042: Bolesnici su primali daklatazvir u dozi od 60 mg jedanput na dan (n=82) ili placebo (n=42)
English: Daklinza + sofosbuvir for 12 weeks
Croatian: Daklinza + sofosbuvir tijekom 12 tjedana
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Croatian: Tablica 1: Preporučen režim liječenja lijekom Daklinza u kombiniranoj terapiji bez interferona Populacija bolesnika*
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000)
Croatian: Nuspojave su u Tablici 5 popisane prema režimu, organskim sustavima i učestalosti: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Croatian: Učestalost početnih varijanti proteina NS5A koje su povezane srezistencijom Početne varijante NS5A koje su povezane s rezistencijom često su primijećene u kliničkim ispitivanjima daklatazvira.
English: No dose adjustment of Daklinza or azithromycin or ciprofloxacin is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza, azitromicina ni ciprofloksacina.
English: Do not take Daklinza if you are taking any of the following medicines: phenytoin, carbamazepine, oxcarbazepine or phenobarbital, used to treat epileptic seizures rifampicin, rifabutin or rifapentine, antibiotics used to treat tuberculosis dexamethasone, a steroid used to treat allergic and inflammatory diseases medicines containing St. John's wort (Hypericum perforatum, a herbal preparation).
Croatian: Ne uzimajte lijek Daklinza ako uzimate neki od sljedećih lijekova: fenitoin, karbamazepin, okskabazepin ili fenobarbital, koji se koriste za liječenje epileptičkih napadaja rifampicin, rifabutin ili rifapentin, antibiotike koji se koriste za liječenje tuberkuloze deksametazon, kortikosteroid koji se koristi za liječenje alergijskih i upalnih bolesti lijekove koji sadrže gospinu travu (Hypericum perforatum, biljni lijek)
English: How to take Daklinza
Croatian: Kako uzimati lijek Daklinza
English: HCV RNA undetectable SVR12*
Croatian: HCV RNK nemjerljive razine SVR12*
English: Table 9: Treatment outcomes, daclatasvir in combination with sofosbuvir and ribavirin for 12 weeks, patients with cirrhosis or HCV recurrence after liver transplantation, Study ALLY-1
Croatian: Tablica 9: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom i ribavirinom tijekom 12 tjedana, bolesnici s cirozom i povratom HCV-a nakon presađivanja jetre, ispitivanje ALLY-1
English: Mainly interferon-based therapy +/-NS3/4 PI.
Croatian: Pretežno terapija utemeljena na interferonu +/- inhibitoru proteaze NS3/4.
English: Since Daklinza must always be used with other medicines against hepatitis C infection, please read the package leaflets for these medicines.
Croatian: Budući da se Daklinza uvijek mora uzimati u kombinaciji s drugim lijekovima za liječenje infekcije hepatitisom C, pročitajte Upute o lijeku tih lijekova.
English: Patient demographics and baseline disease characteristics are summarised in Table 10.
Croatian: Demografske značajke bolesnika i početne značajke bolesti sažeto su prikazane u Tablici 10.
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza u bolesnika s bilo kojim stupnjem oštećenja bubrežne funkcije (vidjeti dio 5.2).
English: Most patients (61%) had IL-28B rs12979860 non-CC genotypes.
Croatian: Većina bolesnika (61%) imala je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Croatian: Poremećaji probavnog sustava vrlo često mučnina često proljev, povraćanje, bol u abdomenu, gastroezofagealna refluksna bolest, konstipacija, suha usta, flatulencija mučnina, proljev, bol u abdomenu
English: 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.
Croatian: 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.
English: ANTICOAGULANTS Dabigatran etexilate
Croatian: ANTIKOAGULANSI dabigatran eteksilat
English: 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.
Croatian: 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.
English: Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Croatian: Tablica 6: Ishodi liječenja, daklatazvir u kombinaciji sa sofosbuvirom, HCV genotipa 1 u ispitivanju AI444040
English: Cirrhosis was determined by liver biopsy, FibroScan >14.6 kPa, or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI) >2.
Croatian: 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.
English: Patients without cirrhosis
Croatian: Bolesnici bez ciroze
English: Daclatasvir in combination with sofosbuvir
Croatian: Daklatazvir u kombinaciji sa sofosbuvirom
English: BRISTOL-MYERS SQUIBB POLSKA SP. Z O.O.
Croatian: SQUIBB POLSKA SP. Z O.O.
English: Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
Croatian: Bristol-Myers Squibb Belgium S.A. Tél/Tel: + 32 2 352 76 11
English: 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.
Croatian: 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
English: Table 10: Demographics and baseline characteristics in Study ALLY-2
Croatian: Tablica 10: Demografske značajke bolesnika i početne značajke bolesti u ispitivanju ALLY-2
English: 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.
Croatian: 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.
English: ↔ Daclatasvir ↔ Azithromycin or Ciprofloxacin
Croatian: ↔ azitromicin ili ciprofloksacin
English: Peginterferon alfa 180 µg once weekly and ribavirin 1000 mg or 1200 mg/day in two divided doses (daclatasvir 60 mg once daily)
Croatian: 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)
English: Pack size of 28 film-coated tablets in non-perforated calendar blisters.
Croatian: Veličina pakiranja: 28 filmom obloženih tableta u neperforiranim kalendarski označenim blisterima.
English: The pharmacokinetics of daclatasvir following a single 60 mg oral dose were studied in non-HCV infected subjects with renal impairment.
Croatian: Farmakokinetika daklatazvira nakon primjene jednokratne peroralne doze od 60 mg ocijenjena je u ispitanika s oštećenjem bubrežne funkcije koji nisu imali infekciju HCV-om.
English: ↔ Daclatasvir AUC: ↔∗ Cmax: ↔∗ Cmin: ↔∗
Croatian: ↔ daklatazvir AUC: ↔∗ Cmax: ↔∗
English: The most common of these side effects are listed below.
Croatian: U nastavku se navode najčešće od tih nuspojava.
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Croatian: Stope SVR-a bile su > 94% uz sve režime kombinirane antiretrovirusne terapije, uključujući terapije utemeljene na pojačanom inhibitoru proteaze,
English: Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1)
Croatian: Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana (vidjeti dio 5.1)
English: Treatment duration was 12 weeks for 82 treatment-naïve HCV genotype 1 patients, and 24 weeks for all other patients in the study.
Croatian: 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.
English: Daklinza contains the active ingredient daclatasvir.
Croatian: Daklinza sadrži djelatnu tvar daklatazvir.
English: Post-Liver Transplant N = 53
Croatian: Bolesnici kojima je presađena jetra N=53
English: Daklinza + sofosbuvir (without ribavirin) for 24 weeks
Croatian: Daklinza + sofosbuvir (bez ribavirina) tijekom 24 tjedna
English: 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.
Croatian: 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
English: 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.
Croatian: (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
English: No dose adjustment of Daklinza, peginterferon alfa, or ribavirin is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza, peginterferona alfa ni ribavirina.
English: Buprenorphine/naloxone, 8/2 mg to 24/6 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Croatian: buprenorfin/nalokson, individualizirana doza od 8/2 mg do 24/6 mg jedanput na dan* (daklatazvir 60 mg jedanput na dan)
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir
Croatian: Daklinza 30 mg filmom obložene tablete Daklinza 60 mg filmom obložene tablete Daklinza 90 mg filmom obložene tablete
English: Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir.
Croatian: Primjena lijeka Daklinza s verapamilom može dovesti do povećane koncentracije daklatazvira
English: How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Croatian: Lijek Daklinza morate uzimati onoliko dugo koliko Vam je rekao Vaš liječnik.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: 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).
Croatian: 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
English: INFORMATION IN BRAILLE Daklinza 90 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Daklinza 90 mg
English: Posology The recommended dose of Daklinza is 60 mg once daily, to be taken orally with or without meals.
Croatian: Preporučena doza lijeka Daklinza je 60 mg jedanput na dan, a uzima se peroralno neovisno o obrocima.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks or
Croatian: Daklinza + sofosbuvir + ribavirin tijekom 12 tjedana ili
English: ANTIDEPRESSANTS Selective serotonin reuptake inhibitors Escitalopram 10 mg once daily (daclatasvir 60 mg once daily)
Croatian: Selektivni inhibitori ponovne pohrane serotonina escitalopram 10 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
English: You should not breastfeed during treatment with Daklinza.
Croatian: Ne smijete dojiti tijekom liječenja lijekom
English: No dose adjustment of Daklinza or sofosbuvir is required.
Croatian: Nije potrebno prilagođavati dozu lijeka Daklinza ni sofosbuvira.
English: 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.
Croatian: Među bolesnicima koji su postigli SVR12 uz primjenu daklatazvira + pegIFN-a/RBV-a, uz medijan trajanja praćenja nakon SVR12 od 22 mjeseca, u
English: Refer to the Summary of Product Characteristics of ribavirin.
Croatian: Vidjeti Sažetak opisa svojstava lijeka za ribavirin.
English: 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.
Croatian: uključujući HIV, što potvrđuje da je daklatazvir, koji inhibira ciljno mjesto specifično za HCV, visoko selektivan za HCV.
English: 0.180/0.215/0.250 mg once daily for 7/7/7 days (daclatasvir 60 mg once daily)
Croatian: 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)
English: 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.
Croatian: (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)
English: Expected due to inhibition of OATP 1B1 and/or BCRP by daclatasvir:
Croatian: OATP 1B1 i/ili BCRP, očekuje se:
English: 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).
Croatian: 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.
English: How to store Daklinza
Croatian: Kako čuvati lijek Daklinza
English: INFORMATION IN BRAILLE Daklinza 30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Daklinza 30 mg
English: Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Croatian: Deset posto bolesnika imalo je kompenziranu cirozu, a 75% bolesnika imalo je polimorfizam IL-28B rs12979860 koji nije CC genotipa.
English: 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.
Croatian: 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.
English: ANTIVIRALS, HCV Nucleotide analogue polymerase inhibitor Sofosbuvir 400 mg once daily (daclatasvir 60 mg once daily) Study conducted in patients with chronic HCV infection
Croatian: ANTIVIROTICI, HCV Nukleotidni analogni inhibitor polimeraze sofosbuvir 400 mg jedanput na dan (daklatazvir 60 mg jedanput na dan)
English: 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.
Croatian: 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%
English: 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).
Croatian: 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).
English: ↑ Digoxin
Croatian: ↑ digoksin
English: 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
Croatian: 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
English: ↔ Raltegravir
Croatian: ↔ daklatazvir ↔ raltegravir
English: 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.
Croatian: Svjetlozelena bikonveksna peterokutna tableta dimenzija 9,1 mm x 8,9 mm, s utisnutom oznakom "BMS" na jednoj i "215" na drugoj strani.
English: Genotype-specific activity
Croatian: Aktivnost protiv pojedinog genotipa
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Croatian: Dozu lijeka Daklinza treba povećati na 90 mg jedanput na dan kada se uzima istodobno s umjerenim induktorima CYP3A4.