FrancophonIA/ELRC3.0 huggingface dataset:
English: 0.180/0.215/0.250 mg is recommended with Daklinza.
Slovak: 0,180/0,215/0,250 mg. Iné perorálne kontraceptíva sa neskúmali.
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Slovak: Očakáva sa z dôvodu inhibície CYP3A4 a P-gp verapamilom:
English: It is used to treat adults with hepatitis C, an infectious disease that affects the liver, caused by the hepatitis C virus.
Slovak: C, infekčným ochorením, ktoré postihuje pečeň, vyvolané vírusom hepatitídy C.
English: In case of non-response to therapy with daclatasvir + peginterferon alfa + ribavirin, NS5A RAVs generally emerged at failure (139/153 genotype 1a and 49/57 genotype 1b).
Slovak: + peginterferónom alfa + ribavirínom sa NS5A RAVs spravidla objavili pri zlyhaní (139/153 s genotypom 1a a 49/57 s genotypom 1b).
English: No dose adjustment of Daklinza, peginterferon alfa, or ribavirin is required.
Slovak: Nie je potrebná úprava dávky Daklinzy, peginterferónu alfa ani ribavirínu.
English: SVR rates were >94% across combination antiretroviral therapy (cART) regimens, including boosted-PI-, NNRTI-, and integrase inhibitor (INSTI)-based therapies.
Slovak: % v režime kombinovanej antiretrovírusovej liečby (cART) vrátane terapií založených na PI so zosilneným účinkom, NNRTI a inhibítorom integrázy (INSTI).
English: Caution should be used when Daklinza is coadministered with rosuvastatin or other substrates of OATP 1B1 or BCRP.
Slovak: Daklinza súbežne podáva s rosuvastatínom alebo s inými substrátmi OATP1B1 alebo BCRP.
English: Atazanavir/cobicistat
Slovak: Atazanavir/kobicistát
English: Important information about some of the ingredients in Daklinza Daklinza contains lactose.
Slovak: Dôležité informácie o niektorých zložkách v Daklinze
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.
Slovak: [pacienti, ktorí neboli bielej pleti, čiernej pleti alebo Aziati] a “čierna pleť”) ako štatisticky významný kovariant na zdanlivý perorálny klírens daklatasviru (CL/F) a zdanlivý distribučný objem (Vc/F), čo má za následok mierne vyššie expozície v porovnaní s pacientmi s bielou pleťou, no veľkosť účinku na expozíciu daklatasviru nie je klinický významná.
English: Daklinza has not yet been studied in children and adolescents.
Slovak: U detí a dospievajúcich sa Daklinza ešte neskúmala.
English: Each film-coated tablet contains 30 mg, 60 mg or 90 mg daclatasvir (as dihydrochloride) The other ingredients are - Tablet core: anhydrous lactose (see section 2), microcrystalline cellulose, croscarmellose sodium, silicon dioxide (E551) and magnesium stearate - Film-coating: hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172)
Slovak: - Jadro tablety: bezvodá laktóza (pozri časť 2), mikrokryštalická celulóza, sodná soľ kroskarmelózy, oxid kremičitý (E551) a magnéziumstearát - Filmový obal: hypromelóza, oxid titaničitý (E171), makrogol 400, hliníkový lak indigokarmínu (E132), žltý oxid železitý (E172)
English: The AUC associated with this dose in males is 19-fold the clinical AUC exposure.
Slovak: AUC súvisiaca s touto dávkou u samcov je 19-násobok klinickej expozície AUC.
English: Daklinza + sofosbuvir for 12 weeks
Slovak: Daklinza + sofosbuvir počas 12 týždňov
English: Atorvastatin Fluvastatin Simvastatin Pitavastatin Pravastatin
Slovak: Atorvastatín Fluvastatín Simvastatín Pitavastatín Pravastatín
English: How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Slovak: Ubezpečte sa, že Daklinzu užívate tak dlho, ako vám lekár povedal, že ju máte užívať.
English: For 11 patients, cirrhosis status was missing or inconclusive (FibroTest score >0.48 to
Slovak: U 11 pacientov chýbal stav cirhózy alebo bol nepreukázaný (test FibroTest so skóre >0,48 až <0,75 alebo index APRI >1 až
English: Contraindications of concomitant use (see section 4.3) Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A4 and P-gp, e.g. phenytoin, carbamazepine, oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum), and thus may lead to lower exposure and loss of efficacy of Daklinza.
Slovak: Daklinza je kontraindikovaná v kombinácii s liekmi, ktoré silne indukujú CYP3A4 a P-gp, napr. fenytoín, karbamazepín, oxkarbazepín, fenobarbital, rifampicín, rifabutín, rifapentín, systémový dexametazón a rastlinný liek s obsahom ľubovníka bodkovaného (Hypericum perforatum), a to môže viesť k nižšej expozícii a strate účinnosti Daklinzy.
English: All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Slovak: Všetci 44 pacienti s infekciou HCV s genotypom 2 (n=26) alebo 3
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose)
Slovak: Antagonisty H2-receptorov Famotidín 40 mg jednorazová dávka (daklatasvir 60 mg jednorazová dávka)
English: Cirrhotic cohort N = 60
Slovak: Kohorta s cirhózou N=60
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Slovak: Pravidlá ukončovania virologickej liečby, ktoré sa týkajú kombinácie Daklinzy so sofosbuvirom, nie sú dostupné.
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
Slovak: Tabuľka 9: Výsledky liečby, daklatasvir v kombinácii so sofosbuvirom a ribavirínom počas 12 týždňov, pacienti s cirhózou alebo opakujúcou sa infekciou HCV po transplantácii pečene, Štúdia ALLY-1
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Slovak: Tabuľka 11: Výsledky liečby, daklatasvir v kombinácii so sofosbuvirom u pacientov so súbežnou infekciou HCV/HIV v Štúdii ALLY-2
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.
Slovak: 211 pacientov malo medián veku 54 rokov (rozsah: 20 až 70); 83 % boli pacienti bielej pleti; 12 % boli pacienti čiernej pleti/Afroameričania; 2 % boli Ázijci; 20 % boli Hispánci alebo Latinoameričania.
English: Anhydrous lactose Microcrystalline cellulose Croscarmellose sodium Silicon dioxide (E551) Magnesium stearate
Slovak: Jadro tablety bezvodá laktóza mikrokryštalická celulóza sodná soľ kroskarmelózy oxid kremičitý (E551)
English: Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Slovak: Tabuľka 6: Výsledky liečby, daklatasvir v kombinácii so sofosbuvirom, HCV s genotypom 1 v štúdii AI444040
English: The highest AUC value in unaffected females was 18-fold the clinical AUC exposure.
Slovak: u neovplyvnených samíc bola 18-násobok klinickej expozície AUC.
English: L31V and Y93H were frequently observed resistance substitutions in genotype 1b, while M28T, L31V/M, Q30E/H/R, and Y93C/H/N were frequently observed resistance substitutions in genotype 1a.
Slovak: , zatiaľ čo M28T, L31V/M, Q30E/H/R a Y93C/H/N boli často pozorované substitúcie rezistencie pri genotype 1a.
English: Patients with CP A or B cirrhosis GT 1 or 4
Slovak: B s cirhózou GT 1 alebo 4
English: SVR12 rates were higher for patients with the IL-28B CC genotype than for those with non-CC genotypes and for patients with baseline HCV RNA less than 800,000 IU/ml but consistently higher in the daclatasvir-treated patients than for placebo-treated patients in all subgroups.
Slovak: CC a u pacientov s východiskovou hodnotou HCV RNA nižšou ako 800 000 IU/ml, no zhodne vyššie u pacientov liečených daklatasvirom než vo všetkých podskupinách pacientov liečených placebom.
English: Ten percent of patients had compensated cirrhosis, and 75% of patients had IL-28B rs12979860 non-CC genotypes.
Slovak: Desať percent pacientov malo kompenzovanú cirhózu a 75 % pacientov malo genotypy IL-28B rs12979860 non-CC.
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Slovak: Poruchy gastrointestinálneho traktu veľmi časté nauzea časté hnačka, vracanie, bolesť brucha, porucha gastroezofageálneho refluxu, zápcha, sucho v ústach, flatulencia nauzea, hnačka, bolesť brucha
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
Slovak: Tabuľka 7: Výsledky liečby, daklatasvir v kombinácii so sofosbuvirom počas 24. týždňov, liečba predtým neliečených pacientov s HCV s genotypom 2 alebo 3 v štúdii AI444040 Genotyp 2
English: Treatment week 24: ≥25 IU/ml
Slovak: ≥ 25 IU/ml
English: Detectable HCV RNA at end of treatment
Slovak: Detekovateľná HCV RNA na konci liečby
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).
Slovak: SVR12 sa dosiahlo u 83 % (50/60) pacientov v kohorte s cirhózou, s očividným rozdielom medzi pacientmi s Child-Pugh
English: In patients who received daclatasvir 60 mg tablet orally followed by 100 µg [13C,15N]-daclatasvir intravenous dose, the total clearance was
Slovak: U pacientov, ktorí dostali perorálne 60 mg tabletu daklatasviru, po ktorej nasledovalo intravenózne podanie 100 µg [13C,15N]-daklatasviru bol celkový klírens 4,24 l/h.
English: Table 1: Recommended treatment for Daklinza interferon-free combination therapy
Slovak: Tabuľka 1: Odporúčaná liečba na kombinovanie terapie s Daklinzou bez interferónu Populácia pacientov*
English: INFORMATION IN BRAILLE Daklinza 30 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Daklinza 30 mg
English: Administration of Daklinza with verapamil may result in increased concentrations of daclatasvir.
Slovak: Podávanie Daklinzy s verapamilom môže viesť k zvýšeniu koncentrácií daklatasviru.
English: No dose adjustment of Daklinza is required for patients with any degree of renal impairment (see section 5.2).
Slovak: U pacientov s akýmkoľvek stupňom poškodenia obličiek nie je potrebná úprava dávky Daklinzy (pozri časť 5.2).
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).
Slovak: % ako nezmenené liečivo) a 6,6 % sa vylúčilo v moči (predovšetkým ako nezmenené liečivo).
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.
Slovak: +/- ribavirínom počas 12 alebo24 týždňov, kde sa v predbežnej analýze dlhšie trvanie liečby spájalo s nižším rizikom relapsu (asi 5 %).
English: INFORMATION IN BRAILLE Daklinza 60 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Daklinza 60 mg
English: Methadone, 40-120 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Slovak: Metadón, 40-120 mg jedenkrát denne individualizovaná dávka* (daklatasvir 60 mg jedenkrát denne)
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.
Slovak: Medián veku bol 55 rokov (rozsah: 24 až 73); 90 % pacientov bolo bielej pleti, 4 % boli čiernej pleti/Afroameričania; 5 % boli Ázijci; 16 % boli
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.
Slovak: a 12. týždni] ukončili liečbu po 24. týždni, zatiaľ čo pacienti, ktorí nedosiahli virologickú odpoveď dostali ďalších 24 týždňov liečby pegIFN/RBV na ukončenie celkových 48. týždňov študovanej liečby.
English: Administration of Daklinza with erythromycin may result in increased concentrations of daclatasvir.
Slovak: Podávanie Daklinzy s erytromycínom môže viesť k zvýšeniu koncentrácií daklatasviru.
English: INFORMATION IN BRAILLE Daklinza 90 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Daklinza 90 mg
English: Induction of CYP3A4 by efavirenz
Slovak: Indukcia CYP3A4 efavirenzom
English: 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.
Slovak: Počas liečby Daklinzou v kombinácii so sofosbuvirom sa hlásil závrat a počas liečby Daklinzou v kombinácii s peginterferónom alfa a ribavirínom sa hlásil závrat, porucha pozornosti, rozmazané videnie a znížená ostrosť zraku.
English: Protease inhibitors (PIs) Boceprevir
Slovak: Inhibítory proteázy (Protease inhibitors, PI)
English: AI444042: Patients received daclatasvir 60 mg once daily (n=82) or placebo (n=42) plus pegIFN/RBV for 24 weeks.
Slovak: Pacienti dostávali daklatasvir 60 mg jedenkrát denne (n=82) alebo placebo (n=42) plus pegIFN/RBV počas 24 týždňov.
English: HCV RNA undetectable SVR12*
Slovak: HCV RNA SVR12
English: Do not take Daklinza if you are allergic to daclatasvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet) if you are taking (by mouth or other ways that affect the whole body) 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).
Slovak: Daklinzu ak ste alergický na daklatasvir alebo na ktorúkoľvek z ďalších zložiek tohto lieku (uvedených v časti 6 tejto písomnej informácie) ak užívate (ústami alebo inými spôsobmi, ktoré pôsobia na celé telo) ktorýkoľvek z nasledovných liekov - fenytoín, karbamazepín, oxkarbazepín alebo fenobarbital, používané na liečbu epileptických záchvatov - rifampicín, rifabutín alebo rifapentín, antibiotiká používané na liečbu tuberkulózy - dexametazón, steroid používaný na liečbu alergických a zápalových ochorení
English: 28 x 1 film-coated tablet
Slovak: x 1 filmom obalená tableta
English: Treatmentexperienced*
Slovak: Predtým liečení*
English: Daklinza +sofosbuvir + ribavirin N=203
Slovak: Daklinza +sofosbuvir + ribavirín N=203
English: >2 for 7 patients.
Slovak: %] pacientov).
English: ≤30 mL/min or haemodialysis
Slovak: ≤30 ml/min alebo hemodialýza ukončite liečbu ribavirínom
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
Slovak: ANTIVIROTIKÁ, HCV Nukleotidový analóg inhibítora polymerázy Sofosbuvir 400 mg jedenkrát denne (daklatasvir 60 mg jedenkrát denne)
English: SVR was the primary endpoint to determine the HCV cure rate, which was defined as HCV RNA less than LLOQ at 12 weeks after the end of treatment (SVR12) for studies AI444040, ALLY-1 (AI444215), ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 and AI444043 and as HCV RNA undetectable at 24 weeks after the end of treatment (SVR24) for study AI444010.
Slovak: ALLY-2 (AI444216), ALLY-3 (AI444218), AI444042 a AI444043 a ako nedetekovateľná HCV RNA v 24. týždni po ukončení liečby (SVR24) v štúdii AI444010.
English: Expected due to CYP3A4 induction by dexamethasone:
Slovak: Očakáva sa z dôvodu indukcie CYP3A4 dexametazónom:
English: Prior telaprevir or boceprevir failures daclatasvir + sofosbuvir N=70
Slovak: Predchádzajúce zlyhanie telapreviru alebo bocepreviru daklatasvir + sofosbuvir N=70
English: Cases of severe bradycardia and heart block have been observed when Daklinza is used in combination with sofosbuvir and concomitant amiodarone and/or other drugs that lower heart rate (see sections 4.4 and 4.5).
Slovak: Keď sa Daklinza používa v kombinácii so sofosbuvirom a pri súbežnom použití amiodarónu a/alebo iných liekov, ktoré znižujú srdcovú frekvenciu alebo bez nich, pozorovali sa prípady závažnej bradykardie a srdcovej blokády (pozri časť 4.4 a 4.5).
English: Frequency of baseline NS5A resistance-associated variants (RAVs) Baseline NS5A RAVs were frequently observed in clinical studies of daclatasvir.
Slovak: Východiskové NS5A RAVs sa často pozorovali v klinických štúdiách s daklatasvirom.
English: The median viral load was 6.42 log10 IU/ml, and 21% of patients had compensated cirrhosis.
Slovak: Medián vírusovej záťaže bol 6,42 log10 IU/ml a 21
English: 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).
Slovak: A, skóre 5-6), stredne ťažkým (Child-Pugh B, skóre 7-9) alebo ťažkým (Child-Pugh C, skóre ≥
English: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; therefore, extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients (see the Summary of Product Characteristics for ribavirin).
Slovak: Na všetkých druhoch zvierat, ktoré boli vystavené pôsobeniu ribavirínu, sa potvrdili významné teratogénne a/alebo embryocídne účinky; z tohto dôvodu je nutná mimoriadna opatrnosť,
English: ↔ Daclatasvir ↔ Azithromycin or Ciprofloxacin
Slovak: Azitromycín alebo ciprofloxacín
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Slovak: C navrhuje konzervatívny režim liečby Daklinza + sofosbuvir +/- ribavirín počas 24 týždňov (pozri časti 4.2 a 5.1).
English: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin
Slovak: Karbamazepín Oxkarbazepín Fenobarbital Fenytoín
English: Table 3: Treatment stopping rules in patients receiving Daklinza in combination with peginterferon alfa and ribavirin with inadequate on-treatment virologic response
Slovak: Tabuľka 3: Pravidlá ukončovania liečby u pacientov s nedostatočnou virologickou odpoveďou na liečbu, ktorí dostávajú Daklinzu v kombinácii s peginterferónom alfa a ribavirínom
English: NNRTI-based Other
Slovak: Na báze PI Na báze NNRTI
English: ↑ Digoxin
Slovak: Digoxín
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.
Slovak: Svetlozelená bikonvexná pentagonálna tableta s rozmermi 9,1 mm x 8,9 mm, s vyrazeným “BMS” na jednej strane a “215” na druhej strane.
English: The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Slovak: Pred začatím liečby Daklinzou si treba pozrieť aj Súhrn charakteristických vlastností iných liekov v režime.
English: Pack size of 28 film-coated tablets in perforated unit dose blisters.
Slovak: Vekosť balenia 28 filmom obalených tabliet v perforovaných blistroch umožňujúcich oddelenie jednotlivej dávky.
English: Daclatasvir in combination with peginterferon alfa and ribavirin Baseline NS5A RAVs (at M28T, Q30, L31, and Y93 for genotype 1a; at L31 and Y93 for genotype 1b) increase the risk for non-response in treatment-naive patients infected with genotype 1a and genotype 1b infection.
Slovak: Daklatasvir v kombinácii s peginterferónom alfa a ribavirínom Východiskové NS5A RAVs (M28T, Q30, L31 a Y93 pri genotype 1a; L31 a Y93 pri genotype 1b)
English: No dose adjustment of Daklinza or sofosbuvir is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani sofosbuviru.
English: Non-responders (non-SVR12) with baseline and postbaseline sequence with emergent NS5A RAVs M28: T Q30: H, K, R L31: I, M, V P32-deletion H58: D, P S62: L Y93: C, H, N Patient(s) lost to follow-up One patient considered a protocol failure (non-SVR) achieved SVR *** NS5A RAVs monitored at amino acid positions are 28, 29, 30, 31, 32, 58, 62, 92, and 93
Slovak: Jeden pacient považovaný v protokole za zlyhaného (bez-SVR) dosiahol SVR *** NS5A RAVs sledované na pozíciách aminokyselín sú 28, 29, 30, 31, 32, 58, 62, 92 a 93
English: Special populations Elderly
Slovak: Starší ľudia
English: Rilpivirine
Slovak: Rilpivirín
English: 79% of patients were white; 13% were black/African-American; 1% were Asian; 9% were Hispanic or Latino.
Slovak: bolo čiernej pleti/Afroameričania; 1 % boli Ázijci; 9 % boli Hispánci alebo Latinoameričania.
English: Digoxin 0.125 mg once daily (daclatasvir 60 mg once daily)
Slovak: Digoxín 0,125 mg jedenkrát denne (daklatasvir 60 mg jedenkrát denne)
English: 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.
Slovak: Zelená bikonvexná pentagonálna tableta s rozmermi 7,2 mm x 7,0 mm, s vyrazeným “BMS” na jednej strane a “213” na druhej strane.
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.
Slovak: AI444043 bola otvorená štúdia s jednou skupinou daklatasvir s pegIFN/RBV na liečbu predtým neliečených dospelých s chronickou infekciou
English: On-treatment virologic failure
Slovak: Virologické zlyhanie počas liečby
English: ANTIFUNGALS Ketoconazole 400 mg once daily (daclatasvir 10 mg single dose)
Slovak: Ketokonazol 400 mg jedenkrát denne (daklatasvir 10 mg jednorazová dávka)
English: Rifabutin Rifapentine
Slovak: Rifabutín Rifapentín
English: Calcium channel blockers Diltiazem
Slovak: Blokátory vápnikových kanálov
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.
Slovak: HCV, nenukleozidovými inhibítormi neštrukturálneho proteínu 5B (NS5B) HCV a nukleozidovými analógmi NS5B HCV.
English: Daklinza must always be used together with other medicines against hepatitis C infection and must never be used by itself.
Slovak: Daklinza sa musí vždy používať spolu s inými liekmi proti infekcii hepatitídy
English: Light green biconvex round of dimension 10.16 mm diameter, embossed tablet with "BMS" on one side and "011" on the other side.
Slovak: Svetlozelená bikonvexná okrúhla tableta s rozmerom 10,16 mm, s vyrazeným “BMS” na jednej strane a “011” na druhej strane.
English: Patients assigned to daclatasvir 60 mg once-daily treatment group who had HCV RNA <LLOQ at Week 4 and undetectable at Week 10 were then randomised to receive another 12 weeks of daclatasvir 60 mg + pegIFN/RBV or placebo + pegIFN/RBV for a total treatment duration of 24 weeks.
Slovak: LLOQ a v 10. týždni nedetekovateľnú boli potom randomizovaní na užívanie daklatasviru 60 mg + pegIFN/RBV na ďalších 12. týždňov alebo placeba + pegIFN/RBV s celkovou dĺžkou liečby 24. týždňov.
English: Potential for interaction with other medicinal products Daclatasvir is a substrate of CYP3A4, P-gp and organic cation transporter (OCT) 1.
Slovak: Daklatasvir je substrátom CYP3A4, P-gp a transportéra organických katiónov (OCT) 1 (organic cation transporter, OCT1).
English: AI444010: Patients received daclatasvir 60 mg once daily (n=158) or placebo (n=78) plus pegIFN/RBV through Week 12.
Slovak: Pacienti dostávali daklatasvir 60 mg jedenkrát denne (n=158) alebo placebo (n=78) plus pegIFN/RBV počas 12. týždňov.
English: Relapse was defined as HCV RNA ≥LLOQ during follow-up after HCV RNA <LLOQ at end of treatment.
Slovak: Relaps bol definovaný ako HCV RNA ≥