FrancophonIA/ELRC3.0 huggingface dataset:
English: Respiratory, thoracic and mediastinal disorders common dyspnoea, dyspnoea exertional, cough, nasal congestion
Slovak: Poruchy dýchacej sústavy, hrudníka a mediastína časté dyspnoe, exercionálne dyspnoe, kašeľ, kongescia nosa
English: CYP3A4 inhibition by ritonavir
Slovak: Inhibícia CYP3A4 ritonavirom
English: Coadministration of Daklinza with carbamazepine, oxcarbazepine, phenobarbital, phenytoin or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Slovak: Súbežné podávanie Daklinzy s karbamazepínom, oxkarbazepínom, fenobarbitalom, fenytoínom alebo s inými silnými induktormi CYP3A4 je kontraindikované (pozri časť
English: 30 months
Slovak: 12 týždňov
English: Inhibition of OATP 1B1 and BCRP by daclatasvir
Slovak: Inhibícia OATP1B1 a BCRP daklatasvirom
English: ANTICONVULSANTS
Slovak: ANTIKONVULZÍVA
English: Daklinza is given for 24 weeks, in combination with 24-48 weeks of peginterferon alfa and ribavirin: - If HCV RNA is undetectable at both treatment weeks 4 and 12, all 3 components of the regimen should be continued for a total duration of 24 weeks.
Slovak: Daklinza sa podáva počas 24 týždňov v kombinácii s peginterferónom alfa a ribavirínom, ktoré sa podávajú 24-48 týždňov: - Ak je HCV RNA nedetekovateľná v oboch
English: No dose adjustment of Daklinza or rilpivirine is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani rilpivirínu.
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.
Slovak: Na zaradenie boli vhodní pacienti s infekciou HCV s genotypom 1, 2, 3, 4, 5 alebo 6. Pacienti dostali daklatasvir 60 mg jedenkrát denne, sofosbuvir 400 mg jedenkrát denne a ribavirín (600 mg začiatočná dávka) počas 12 týždňov a po liečbe boli sledovaní počas 24 týždňov.
English: CYP3A4 inhibition by ketoconazole
Slovak: Inhibícia CYP3A4 ketokonazolom
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.
Slovak: % 1a a 20 % 1b) a 8 % malo HCV s genotypom 4; 65 % pacientov malo genotypy IL-28B rs12979860 non-CC.
English: Darunavir 800 mg/ritonavir 100 mg once daily (daclatasvir 30 mg once daily)
Slovak: Darunavir 800 mg/ritonavir 100 mg jedenkrát denne (daklatasvir 30 mg jedenkrát denne)
English: No dose adjustment of Daklinza or tenofovir is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani tenofoviru.
English: 400 mg daily
Slovak: 400 mg denne
English: In 9 phase 2/3 studies with daclatasvir in combination with peginterferon alfa + ribavirin or in combination with sofosbuvir +/- ribavirin, the following frequencies of such RAVs were seen at baseline: 7% in genotype 1a infection (M28T, Q30, L31, and/or Y93), 11% in genotype 1b infection (L31 and/or Y93H), 51% in genotype 2 infection (L31M), 8% in genotype 3 infection (Y93H) and 64% in genotype 4 infection (L28 and/or L30).
Slovak: V 9 štúdiách 2./3. fázy s daklatasvirom v kombinácii s peginterferónom alfa + ribavirínom alebo v kombinácii so sofosbuvirom +/- ribavirínom sa na začiatku pozorovali nasledovné frekvencie týchto RAVs: 7 % s infekciou s genotypom 1a (M28T, Q30, L31 a/alebo Y93), 11
English: ANTIDEPRESSANTS Selective serotonin reuptake inhibitors Escitalopram 10 mg once daily (daclatasvir 60 mg once daily)
Slovak: Selektívne inhibítory spätného vychytávania sérotonínu Escitalopram 10 mg jedenkrát denne (daklatasvir 60 mg jedenkrát denne)
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.
Slovak: Údaje z programov na použitie lieku v nevyhnutných prípadoch (compassionate use), v ktorých sú zaradení pacienti s infekciou s genotypom 3 a s cirhózou, podporujú používanie Daklinzy +
English: Coadministration of Daklinza with rifampicin, rifabutin, rifapentine or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Slovak: Súbežné podávanie Daklinzy s rifampicínom, rifabutínom, rifapentínom alebo s inými silnými induktormi CYP3A4 je kontraindikované (pozri časť
English: SVR12 rates were lower among patients with cirrhosis (see Table 12).
Slovak: Miery SVR12 boli nižšie u pacientov s cirhózou
English: Daklinza 90 mg: the film-coated tablet is light green, biconvex, round shape with "BMS" embossed on one side and "011" on the other side
Slovak: Daklinza 90 mg: filmom obalená tableta je svetlozelená, obojstranne vypuklá, okrúhleho tvaru s vyrazeným “BMS” na jednej strane a “011” na druhej strane.
English: Most patients (71%, including 98% of prior PI failures) had IL-28B rs12979860 non-CC genotypes.
Slovak: %, vrátane 98 % s predchádzajúcim zlyhaním PI) malo genotypy IL-28B rs12979860 non-CC.
English: 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.
Slovak: [13C,15N]-daklatasviru mali odhadovaný distribučný objem v rovnovážnom stave 47 l. In vitro štúdie naznačujú, že daklatasvir sa aktívne a pasívne transportuje do hepatocytov.
English: Expected due to CYP3A4 induction by etravirine or nevirapine:
Slovak: CYP3A4 etravirínom alebo nevirapínom:
English: Data from study ALLY-3 (AI444218) support a 12-week treatment duration of Daklinza + sofosbuvir for treatment-naïve and -experienced patients with genotype 3 infection without cirrhosis.
Slovak: Údaje zo štúdie ALLY-3 (AI444218) podporujú 12-týždňové trvanie liečby Daklinzou +
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.
Slovak: % vyššia u jedincov s hodnotami klírensu kreatinínu (CLcr) 60, 30 a 15 ml/min, v uvedenom poradí, v porovnaní s jedincami s normálnou funkciou obličiek.
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1) HCV GT 3
Slovak: +/- ribavirín počas 24 týždňov (pozri časti 4.4 a 5.1)
English: Tell your doctor if you take any of the following medicines: amiodarone or digoxin, used to treat irregular heart beats atazanavir/ritonavir, atazanavir/cobicistat, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate combination tablet, etravirine, nevirapine or efavirenz, used to treat HIV infection boceprevir or telaprevir, used to treat hepatitis C infection clarithromycin, telithromycin or erythromycin, used to treat bacterial infections dabigatran etexilate, used to to prevent blood clots ketoconazole, itraconazole, posaconazole or voriconazole, used to treat fungal infections verapamil, diltiazem, nifedipine or amlodipine, used to decrease blood pressure rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin, used to lower blood cholesterol oral contraceptives
Slovak: C klaritromycín, telitromycín alebo erytromycín, používané na liečbu bakteriálnych infekcií dabigatranetexilát, používaný na zabránenie vzniku krvných zrazenín ketokonazol, itrakonazol, posakonazol alebo vorikonazol, používané na liečbu plesňových infekcií verapamil, diltiazem, nifedipín alebo amlodipín, používané na zníženie krvného tlaku rosuvastatín, atorvastatín, fluvastatín, simvastatín, pitavastatín alebo pravastatín, používané na zníženie cholesterolu v krvi perorálne kontraceptíva
English: Lopinavir 400 mg/ritonavir 100 mg twice daily (daclatasvir 30 mg once daily)
Slovak: Lopinavir 400 mg/ritonavir 100 mg dvakrát denne (daklatasvir 30 mg jedenkrát denne)
English: daclatasvir + sofosbuvir N=21
Slovak: daklatasvir + sofosbuvir N=21
English: ANTIMYCOBACTERIALS Rifampicin 600 mg once daily (daclatasvir 60 mg single dose)
Slovak: Rifampicín 600 mg jedenkrát denne (daklatasvir 60 mg jednorazová dávka)
English: P-gp inhibition by daclatasvir
Slovak: Inhibícia P-gp daklatasvirom
English: Daclatasvir Cmax, AUC, and Cmin increased in a near dose-proportional manner.
Slovak: Cmin daklatasviru sa zvyšovali takmer proporčne k dávke.
English: No dose adjustment of Daklinza is required.
Slovak: Nie je potrebná úprava dávky Daklinzy.
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Slovak: Poruchy kostrovej a svalovej sústavy a spojivového tkaniva časté artralgia, myalgia artralgia, myalgia
English: General disorders and administration site conditions very common fatigue fatigue
Slovak: Celkové poruchy a reakcie v mieste podania veľmi časté únava únava
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Slovak: Podávanie Daklinzy so systémovým dexametazónom alebo s inými silnými induktormi CYP3A4 je kontraindikované (pozri časť
English: End of treatment
Slovak: LLOQ na konci liečby.
English: No dose adjustment of Daklinza or warfarin is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani warfarínu.
English: Daklinza + sofosbuvir (without ribavirin) for 24 weeks
Slovak: + sofosbuvir (bez ribavirínu) počas
English: If you have any questions, ask your doctor or pharmacist.
Slovak: Ak máte akékoľvek otázky, spýtajte sa svojho lekára lebo lekárnika.
English: Vascular disorders common hot flush
Slovak: Poruchy ciev časté návaly horúčavy
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Slovak: Inhibítory integrázy Dolutegravir 50 mg jedenkrát denne (daklatasvir 60 mg jedenkrát denne)
English: Some patients have reported dizziness, difficulty concentrating, and vision problems while taking Daklinza with other medicines for their hepatitis C infection.
Slovak: Niektorí pacienti počas užívania Daklinzy s inými liekmi na infekciu hepatitídy C hlásili závrat,
English: No dose adjustment of Daklinza or maraviroc is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani maraviroku.
English: Response was rapid (at Week 4 91% of daclatasvir-treated patients had HCV RNA <LLOQ).
Slovak: Výsledky liečby zo štúdie AI444042 sú uvedené v tabuľke 13. Odpoveď bola rýchla (v 4. týždni malo 91 % pacientov liečených daklatasvirom HCV RNA <LLOQ).
English: Daclatasvir in combination with sofosbuvir
Slovak: Daklatasvir v kombinácii so sofosbuvirom
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with atazanavir/ritonavir, atazanavir/cobicistat or other strong inhibitors of CYP3A4.
Slovak: 30 mg jedenkrát denne, ak sa súbežne podáva s atazanavirom/ritonavirom, atazanavirom/kobicistátom alebo s inými silnými inhibítormi CYP3A4.
English: Inhibition of P-gp and BCRP by daclatasvir
Slovak: Inhibícia P-gp a BCRP daklatasvirom
English: In vitro and in vivo studies showed that daclatasvir is a substrate of P-gp.
Slovak: In vitro a in vivo štúdie ukázali, že daklatasvir je substrátom P-gp. Absolútna biologická dostupnosť tabletovej formy je 67 %.
English: Benzodiazepines Midazolam 5 mg single dose (daclatasvir 60 mg once daily)
Slovak: Benzodiazepíny Midazolam 5 mg jednorazová dávka (daklatasvir 60 mg jedenkrát denne)
English: Patients with CP C cirrhosis
Slovak: Pacienti s cirhózou CP
English: CYP3A4 induction by rifampicin
Slovak: Indukcia CYP3A4 rifampicínom
English: If you are unsure of any information in the package leaflets, please contact your doctor or pharmacist.
Slovak: Ak si nie ste istý niektorou informáciou v tejto písomnej informácii pre používateľa, spýtajte sa svojho lekára alebo lekárnika.
English: 12 weeks treatment duration
Slovak: 12 týždňová liečba predtým neliečená
English: Simeprevir 150 mg once daily (daclatasvir 60 mg once daily)
Slovak: Simeprevir 150 mg jedenkrát denne (daklatasvir 60 mg jedenkrát denne)
English: Most patients (61%) had IL-28B rs12979860 non-CC genotypes.
Slovak: %) mala genotypy IL-28B rs12979860 non-CC.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks Daklinza + sofosbuvir +/- ribavirin for 24 weeks
Slovak: + ribavirín počas 12 týždňov Daklinza + sofosbuvir
English: NAME OF THE MARKETING AUTHORISATION HOLDER Bristol-Myers Squibb Pharma EEIG
Slovak: Bristol-Myers Squibb Pharma EEIG
English: 24 weeks treatment duration
Slovak: 12. týždňová dĺžka liečby 24. týždňová dĺžka liečby Fibróza pečene
English: Daklinza 60 mg: the film-coated tablet is light green, biconvex, pentagonal shape with "BMS" debossed on one side and "215" on the other side.
Slovak: Daklinza 60 mg: filmom obalená tableta je svetlozelená, obojstranne vypuklá, päťuholníkového tvaru s vyrazeným “BMS” na jednej strane a “215” na druhej strane.
English: Daklinza 30 mg film-coated tablets Daklinza 60 mg film-coated tablets Daklinza 90 mg film-coated tablets daclatasvir
Slovak: Daklinza 60 mg filmom obalené tablety Daklinza 90 mg filmom obalené tablety daklatasvir
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.
Slovak: Daklatasvir je inhibítor replikácie genotypov 1a a 1b HCV v analýze replikónov na bunkovej báze s hodnotami účinnej koncentácie (50
English: No dose adjustment of Daklinza or escitalopram is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani escitalopramu.
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).
Slovak: gp je kontraindikované, zatiaľ čo pri súbežnom podávaní so stredne silnými induktormi CYP3A4 a Pgp sa odporúča úprava dávky Daklinzy (pozri Tabuľka 4).
English: CYP3A4 inhibition by telaprevir
Slovak: Inhibícia CYP3A4 telaprevirom
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Slovak: Dávka Daklinzy sa má zvýšiť na 90 mg jedenkrát denne, ak sa súbežne podáva so stredne silnými induktormi CYP3A4.
English: Treatment duration was 12 weeks for 82 treatment-naïve HCV genotype 1 patients, and 24 weeks for all other patients in the study.
Slovak: HCV s genotypom 1 a 24 týždňov u všetkých ostatných pacientov v štúdii.
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).
Slovak: 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 lieky s obsahom ľubovníka bodkovaného (Hypericum perforatum, rastlinný prípravok).
English: Expected due to CYP3A4 inhibition by the calcium channel blocker:
Slovak: Očakáva sa z dôvodu inhibície CYP3A4 blokátorom vápnikového kanálu:
English: Daklinza 30 mg and 60 mg film-coated tablets
Slovak: Daklinza 30 mg a 60 mg filmom obalené tablety 30 mesiacov
English: AUC*: 0.68 (0.60, 0.78) Cmax*: 0.83 (0.76, 0.92) Cmin*: 0.41 (0.34, 0.50)
Slovak: Cmax*: 0,83 (0,76; 0,92) Cmin*: 0,41 (0,34; 0,50)
English: Each 90-mg film-coated tablet contains 173 mg of lactose (as anhydrous).
Slovak: Každá 90-mg filmom obalená tableta obsahuje 173 mg laktózy (bezvodej).
English: Expected due to inhibition of P-gp by daclatasvir:
Slovak: Očakáva sa z dôvodu inhibície P-gp daklatasvirom: ↑
English: No dose adjustment of Daklinza or raltegravir is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani raltegraviru.
English: AUC: 0.82 (0.70, 0.96) Cmax: 0.56 (0.46, 0.67) Cmin: 0.89 (0.75, 1.06)
Slovak: AUC: 0,82 (0,70; 0,96) Cmax: 0,56 (0,46; 0,67)
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with efavirenz.
Slovak: 90 mg jedenkrát denne, ak sa súbežne podáva s efavirenzom.
English: ↔ Cyclosporine AUC: 1.03 (0.97, 1.09) Cmax: 0.96 (0.91, 1.02)
Slovak: Cyclosporín AUC: 1,03 (0,97; 1,09)
English: 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.
Slovak: Pacienti pôvodne zaradení na placebo a pacienti v skupine s daklatasvirom, ktorí nedosiahli v 4. týždni HCV RNA <
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.
Slovak: % pre 1a; 84 % pre 1b) u pacientov liečených daklatasvirom
English: Telaprevir 750 mg q8h (daclatasvir 20 mg once daily)
Slovak: Telaprevir 750 mg každých 8 hodín (daklatasvir 20 mg jedenkrát denne)
English: Expected due to CYP3A4 induction by the anticonvulsant:
Slovak: Očakáva sa z dôvodu indukcie CYP3A4 antikonvulzívom:
English: 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.
Slovak: Najčastejšie hlásené nežiaduce reakcie boli únava, bolesť hlavy, svrbenie, anémia, ochorenie podobné chrípke, nauzea, nespavosť, neutropénia, asténia, vyrážka, znížená chuť do jedla, suchá koža, alopécia,
English: No dose adjustment of Daklinza or enfuvirtide is required.
Slovak: Nie je potrebná úprava dávky Daklinzy ani enfuvirtidu.
English: Each 60-mg film-coated tablet contains 116 mg of lactose (as anhydrous).
Slovak: Každá 60-mg filmom obalená tableta obsahuje 116 mg laktózy (bezvodej).
English: AUC: 0.95 (0.82, 1.10) Cmax: 0.88 (0.78, 0.99) Cmin: 0.91 (0.71, 1.16)
Slovak: Cmax: 0,88 (0,78; 0,99) Cmin: 0,91 (0,71; 1,16)
English: N.V. Bristol-Myers Squibb Belgium S.A.
Slovak: Bristol-Myers Squibb Belgium S.A.
English: Discontinue ribavirin
Slovak: Pokyny podávania ribavirínu
English: Treatment outcomes in study AI444010 for patients with HCV genotype 4 are presented in Table 13.
Slovak: Výsledky liečby zo štúdie AI444010 u pacientov s HCV s genotypom 4 sú uvedené v tabuľke 13. Pre HCV s genotypom 1 boli pomery SVR12 64 % (54
English: All patients Cirrhosis
Slovak: Všetci pacienti Cirhóza
English: Telaprevir 500 mg q12h (daclatasvir 20 mg once daily)
Slovak: Telaprevir 500 mg každých 12 hodín (daklatasvir 20 mg jedenkrát denne)
English: LIST OF EXCIPIENTS Contains lactose.
Slovak: Daklinza obsahuje laktózu.
English: AI444043: 301 treatment-naïve patients with HCV genotype 1 infection and HIV co-infection (10% with compensated cirrhosis) were treated with daclatasvir in combination with pegIFN/RBV.
Slovak: AI444043: 301 predtým neliečených pacientov s infekciou HCV genotypu 1 a súbežne infikovaných HIV (10
English: 600 mg daily
Slovak: 600 mg denne
English: ↔ GS-331007** AUC: 1.0 (0.95, 1.08) Cmax: 0.8 (0.77, 0.90) Cmin: 1.4 (1.35, 1.53)
Slovak: GS-331007** AUC: 1,0 (0,95; 1,08)
English: Daklinza 90 mg film-coated tablets
Slovak: Daklinza 90 mg filmom obalené tablety
English: The safety and efficacy of Daklinza in children and adolescents aged <18 years have not yet been established.
Slovak: Bezpečnosť a účinnosť Daklinzy u detí a dospievajúch vo veku <
English: Common (may affect up to 1 in 10 people): decreased appetite difficulty sleeping, irritability dizziness migraine shortness of breath, cough, nasal congestion (blocked nose) hot flush dry skin, unusual hair loss or thinning, rash, itching diarrhoea, vomiting, abdominal pain, constipation, heartburn, excessive gas in the stomach or bowel dry mouth joint pain, aching or tender muscles, not caused by exercise
Slovak: nával horúčavy suchá koža, nezvyčajné vypadávanie alebo rednutie vlasov, vyrážka, svrbenie hnačka, vracanie, bolesť brucha, zápcha, pálenie záhy, nadmerné množstvo plynu v žalúdku alebo v črevách sucho v ústach bolesť kĺbov, bolesť alebo oslabenie svalov, ktoré nie je spôsobené fyzickou námahou
English: Pregnancy
Slovak: Enfuvirtid
English: ↔ Daclatasvir*
Slovak: Daklatasvir* AUC:
English: AUC: 0.84 (0.73, 0.96) Cmax: 0.64 (0.54, 0.77) Cmin: 0.92 (0.80, 1.05)
Slovak: AUC: 0,84 (0,73; 0,96) Cmax: 0,64 (0,54; 0,77)
English: Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Slovak: Každá 30-mg filmom obalená tableta obsahuje 58 mg laktózy (bezvodej).
English: 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.
Slovak: %) Cmax daklatasviru 1534 (58) ng/ml, AUC0-24h bola 14122 (70) ng•h/ml a Cmin bola 232 (83) ng/ml.
English: Daklinza contains the active ingredient daclatasvir.
Slovak: Daklinza obsahuje liečivo daklatasvir.
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.
Slovak: U pacientov liečených daklatasvirom a sofosbuvirom s/bez ribavirínu nie sú dostupné žiadne údaje o pretrvávaní substitúcií súvisiacich s rezistenciou na daklatasvir 6 mesiacov po liečbe.
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.
Slovak: Farmakokinetika daklatasviru po jednorazovej perorálnej 30 mg dávke sa skúmala u jedincov s ľahkým (Child-Pugh
English: AUC: 0.94 (0.84, 1.04) Cmax: 1.01 (0.89, 1.14)
Slovak: AUC: 0,94 (0,84; 1,04)
English: oxcarbazepine, phenobarbital, rifampicin, rifabutin, rifapentine, systemic dexamethasone, and the herbal product St John's wort (Hypericum perforatum).
Slovak: Tieto liečivá zahŕňajú, no nie sú obmedzené len na fenytoín, karbamazepín, oxkarbazepín, fenobarbital, rifampicín, rifabutín, rifapentín, systémový dexametazón a rastlinný liek s obsahom ľubovníka bodkovaného (Hypericum perforatum).
English: Daklinza 30 mg film-coated tablets
Slovak: Daklinza 30 mg filmom obalené tablety
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 30 mg daclatasvir.
Slovak: Každá filmom obalená tableta obsahuje daklatasvíriumdichlorid zodpovedajúci 30 mg daklatasviru.
English: SEDATIVES
Slovak: mdloby.
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.
Slovak: Celková miera vyliečenia u pacientov infikovaných genotypom 3, ktorí sa liečili počas 12 týždňov sofosbuvirom + daclatasvirom (bez ribavirínu) v prítomnosti a v neprítomnosti
English: Discontinue Daklinza, peginterferon alfa and ribavirin
Slovak: Ukončenie liečby Daklinzou, peginterferónom alfa a ribavirínom
English: Common (may affect up to 1 in 10 people): difficulty sleeping dizziness migraine nausea (feeling sick), diarrhoea, abdominal pain joint pain, aching or tender muscles, not caused by exercise
Slovak: problémy so spánkom závrat migréna nevoľnosť (pocit na vracanie), hnačka, bolesť brucha bolesť kĺbov, bolesť alebo oslabenie svalov, ktoré nie je spôsobené fyzickou námahou
English: ↔ Daclatasvir
Slovak: Daklatasvir
English: Since Daklinza must always be used with other medicines against hepatitis C infection, please read the package leaflets for these medicines.
Slovak: Vzhľadom na to, že sa Daklinza musí vždy používať s inými liekmi proti infekcii hepatitídy C,