FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders common rash, alopecia, pruritus, dry skin Musculoskeletal and connective tissue disorders common arthralgia, myalgia arthralgia, myalgia
Lithuanian: sausa oda, alopecija, karščiavimas, mialgija, irzlumas, kosulys, viduriavimas, dusulysir artralgija.
English: Coadministration of Daklinza with systemic dexamethasone or other strong inducers of CYP3A4 is contraindicated (see section 4.3).
Lithuanian: Daklinza negalima vartoti kartu su sisteminio veikimo deksametazonu ir kitais vaistiniais preparatais, kurie stipriai indukuoja CYP3A4 (žr.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/939/003 28 tablets (calendar pack) EU/1/14/939/004 28 x 1 tablet
Lithuanian: EU/1/14/939/003 28 tabletės (kalendorinė pakuotė) EU/1/14/939/004 28 x 1 tabletės
English: HCV genotype:
Lithuanian: HCV GT 3
English: Relapse
Lithuanian: Terminas
English: ANTIBACTERIALS Clarithromycin Telithromycin
Lithuanian: Tabletės šerdis Bevandenė laktozė Mikrokristalinė celiuliozė
English: ↔ Darunavir AUC: 0.90 (0.73, 1.11) Cmax: 0.97 (0.80, 1.17) Cmin: 0.98 (0.67, 1.44)
Lithuanian: AUC - 0,90 (nuo 0,73 iki 1,11) Cmax - 0,97 (nuo 0,80 iki 1,17) Cmin - 0,98 (nuo 0,67 iki 1,44)
English: ↔ Midazolam AUC: 0.87 (0.83, 0.92) Cmax: 0.95 (0.88, 1.04)
Lithuanian: AUC - 0,87 (nuo 0,83 iki 0,92) Cmax - 0,95 (nuo 0,88 iki 1,04)
English: Ribavirin Dosing Guidelines The dose of ribavirin, when combined with Daklinza, is weight-based (1,000 or 1,200 mg in patients
Lithuanian: Ribavirino, vartojamo kartu su Daklinza, dozė priklauso nuo kūno svorio (pacientams sveriantiems < 75 kg - 1000 mg, sveriantiems ≥ 75 kg - 1200 mg).
English: Daclatasvir administered as a tablet was readily absorbed following multiple oral doses with peak plasma concentrations occurring between 1 and 2 hours.
Lithuanian: Jo kartotinai vartojant per burną, didžiausia koncentracija plazmoje susidaro po 1-2 val.
English: Each 30-mg film-coated tablet contains 58 mg of lactose (as anhydrous).
Lithuanian: Kiekvienoje 30 mg plėvele dengtoje tabletėje yra 58 mg bevandenės laktozės.
English: Table 12: Treatment outcomes, daclatasvir in combination with sofosbuvir for 12 weeks, patients with HCV genotype 3 in Study ALLY-3
Lithuanian: 3 genotipo HCV infekcija sirgusių pacientų 12 savaičių trukmės gydymo daklatasviro ir sofosbuviro deriniu rezultatai ALLY-3 tyrimo metu
English: Table 11: Treatment outcomes, daclatasvir in combination with sofosbuvir in patients with HCV/HIV co-infection in Study ALLY-2
Lithuanian: HCV ir kartu ŽIV infekuotų pacientų gydymo daklatasviro ir sofosbuviro deriniu rezultatai ALLY-2 tyrimo metu
English: Grade 3/4 increases in total bilirubin were observed in 5% of patients (all in patients with HIV coinfection who were receiving concomitant atazanavir, with Child-Pugh A, B, or C cirrhosis, or who were post-liver transplant).
Lithuanian: (visiems šiems pacientams buvo ir ŽIV infekcija, kartu vartota atazanaviro, buvo Child-Pugh A, B
English: Maternal toxicity including mortality, abortions, adverse clinical signs, decreases in body weight and food consumption was noted in both species at exposures 25-fold (rat) and 72-fold (rabbit) the clinical AUC exposure.
Lithuanian: Kai žiurkių ekspozicija (AUC) 25 kartus, o triušių 72 kartus viršijo klinikinę, nustatytas toksinis poveikis šių abejų rūšių vaikingoms patelėms - jų žuvimai, abortai, kenksmingi klinikiniai požymiai, sumažėjęs kūno svoris ir sumažėjęs maisto suvartojimas.
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).
Lithuanian: Jų metu vertintas daklatasviro derinio su peginterferonu alfa ir ribavirinu (pegIFN/RBV) veiksmingumas ir saugumas lėtine HCV infekcija sergantiems anksčiau negydytiems suaugusiesiems, dar sergantiems kompensuota kepenų liga (įskaitant cirozę). Į AI444042 tyrimą įtraukti 4 genotipo, o į AI444010 - 1 arba 4 HCV genotipo infekcija sirgę pacientai.
English: In clinical studies of daclatasvir in combination with sofosbuvir or with peginterferon alfa and ribavirin, plasma HCV RNA values were measured using the COBAS TaqMan HCV test (version 2.0), for use with the High Pure System, with a lower limit of quantification (LLOQ) of 25 IU/ ml.
Lithuanian: RNR koncentracija plazmoje tirta naudojant COBAS TaqMan HCV testo, skirto naudoti su High Pure
English: daclatasvir + sofosbuvir N=17
Lithuanian: Daklatasvira s ir sofosbuviras N = 17
English: Expected due to CYP3A4 induction by dexamethasone:
Lithuanian: Tikėtina deksametazono sukeliamos CYP3A4 indukcijos pasekmė:
English: Caution should be used if the medicinal product has a narrow therapeutic range (see Table 4).
Lithuanian: Jeigu tokių vaistinių preparatų terapinė platuma siaura, kartu jų reikia vartoti atsargiai (žr.
English: IMMUNOSUPPRESSANTS Cyclosporine 400 mg single dose (daclatasvir 60 mg once daily)
Lithuanian: IMUNOSUPRESANTAI Ciklosporinas viena 400 mg dozė (daklatasviras
English: B. PACKAGE LEAFLET
Lithuanian: DALOMŲJŲ (PERFORUOTŲ) LIZDINIŲ PLOKŠTELIŲ TEKSTAS
English: ↔ Alprazolam
Lithuanian: ↓ daklatasviro
English: *Comparison for daclatasvir was to a historical reference (data from 3 studies of daclatasvir 60 mg once daily with peginterferon alfa and ribavirin).
Lithuanian: * Daklatasviro palyginamieji duomenys ištirti anksčiau 3 tyrimų metu vartojus 60 mg daklatasviro 1
English: ↔ GS-331007** AUC: 1.0 (0.95, 1.08) Cmax: 0.8 (0.77, 0.90) Cmin: 1.4 (1.35, 1.53)
Lithuanian: AUC - 1,0 (nuo 0,95 iki 1,08) Cmax - 0,8 (nuo 0,77 iki 0,90) Cmin - 1,4 (nuo 1,35 iki 1,53)
English: daclatasvir + sofosbuvir N=13
Lithuanian: Daklatasvira s ir sofosbuviras N = 13
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.
Lithuanian: 5B (NS5B) ne nukleozidiniais inhibitoriais ir HCV NS5B nukleozidų analogais.
English: These medicines lower the effect of Daklinza so your treatment will not work.
Lithuanian: Šie vaistai silpnina Daklinza poveikį, todėl gydymas neveiks. Jeigu vartojate kurio nors iš jų, nedelsdami pasakykite gydytojui.
English: A third treatment group in study ALLY-2 included 50 HCV treatment-naïve HIV co-infected patients who received daclatasvir and sofosbuvir for 8 weeks.
Lithuanian: HCV infekcija ir kartu ŽIV infekcija, tokie pacientai 8 savaites vartojo daklatasvirą ir sofosbuvirą.
English: Table 6: Treatment outcomes, daclatasvir in combination with sofosbuvir, HCV genotype 1 in Study AI444040
Lithuanian: 1 HCV genotipo HCV infekcija sergančių pacientų gydymo daklatasviro ir sofosbuviro deriniu AI444040 tyrimo metu rezultatai
English: Methadone, 40-120 mg once daily individualized dose* (daclatasvir 60 mg once daily)
Lithuanian: 40-120 mg 1 kartą per parą individualiomis dozėmis *
English: No cirrhosis**
Lithuanian: Be cirozės**
English: 79% of patients were white; 13% were black/African-American; 1% were Asian; 9% were Hispanic or Latino.
Lithuanian: 83 % buvo baltieji, 12 % - juodieji afroamerikiečiai, 2 % - azijiečiai, 20 % - Lotynų amerikiečiai arba kilę iš ispaniškai kalbančių šalių už Ispanijos ribų (angl.
English: Expected due to CYP3A4 inhibition by atazanavir/cobicistat: ↑ Daclatasvir
Lithuanian: Tikėtina atazanaviro ir kobicistato sukeliamo CYP3A4 slopinimo pasekmė: ↑ daklatasviro
English: 200 mg daily
Lithuanian: 200 mg per parą
English: Expected due to CYP3A4 inhibition by boceprevir:
Lithuanian: Tikėtina bocepreviro sukeliamo CYP3A4 slopinimo pasekmė:
English: Retreatment with daclatasvir
Lithuanian: Daklatasviras (daclatasvirum)
English: daclatasvir + sofosbuvir N=21
Lithuanian: Daklatasvir as ir sofosbuviras N=21
English: Impact of baseline NS5A RAVs on cure rates
Lithuanian: Pradinių NS5A RAV įtaka pasveikimo dažniui
English: Daklinza 60 mg film-coated tablets
Lithuanian: Daklinza 60 mg tabletės
English: If you do miss a dose: and you notice within 20 hours of the time you usually take Daklinza, you must take the tablet as soon as possible.
Lithuanian: , tai užmirštą Daklinza tabletę išgerkite kuo greičiau, o kitą dozę gerkite įprastu laiku; jei po įprasto Daklinza vartojimo laiko praėjo 20 val.
English: With cirrhosis**
Lithuanian: Su ciroze*
English: All 44 patients with HCV genotype 2 (n=26) or 3 (n=18) infection were treatment-naïve.
Lithuanian: arba 3 (n = 18) genotipo HCV infekcija, anksčiau buvo negydyti.
English: Palpitations
Lithuanian: Rifampicinas
English: Potential for interaction with other medicinal products Daclatasvir is a substrate of CYP3A4, P-gp and organic cation transporter (OCT) 1.
Lithuanian: Daklatasviras yra CYP3A4, P-gp ir organinių katijonų nešiklio Nr.
English: Inhibition of P-gp and BCRP by daclatasvir
Lithuanian: Daklatasviras slopina P-gp ir BCRP.
English: Patients with Child-Pugh C liver disease
Lithuanian: (Child-Pugh C) sutrikusi, ir normalią kepenų funkciją turinčių žmonių organizme.
English: There are no virologic treatment stopping rules that apply to the combination of Daklinza with sofosbuvir.
Lithuanian: Priešvirusinio gydymo Daklinza ir sofosbuviro deriniu nutraukimo taisyklių nėra.
English: Table 13: Treatment outcomes, daclatasvir in combination with peginterferon alfa and ribavirin (pegIFN/RBV), treatment-naïve patients with HCV genotype 4
Lithuanian: Daklatasviro derinio su sofosbuviru arba peginterferonu alfa ir ribavirinu klinikinių tyrimų metu HCV
English: 600 mg daily
Lithuanian: 600 mg per parą
English: >2 for 7 patients.
Lithuanian: 6 ir 7 lenteles).
English: daclatasvir + sofosbuvir + ribavirin N=56
Lithuanian: Daklatasvir as, sofosbuviras ir ribavirinas N=56
English: daclatasvir + sofosbuvir + ribavirin N=20
Lithuanian: Daklatasvir as, sofosbuviras ir ribavirinas N=20
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).
Lithuanian: (53 % nepakitusio vaisto pavidalo) ir 6,6 % šlapime (daugiausia nepakitusio vaisto pavidalo).
English: Expected due to CYP3A4 and P-gp inhibition by verapamil:
Lithuanian: CYP3A4 ir P-gp slopinimo pasekmė: ↑ daklatasviro
English: These medicines lower the effect of Daklinza and may result in your treatment not working.
Lithuanian: Aukščiau išvardyti vaistai silpnina Daklinza poveikį, todėl jis gali neveikti. Jeigu vartojate kurio nors iš šių vaistų, apie tai nedelsdami pasakykite gydytojui.
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.
Lithuanian: AI444010 tyrimo metu pacientai 12 savaičių vartojo 60 mg daklatasviro 1 kartą per parą (n = 158) ar placebo (n = 78) ir pegIFN/RBV. Į daklatasviro 60 mg 1 kartą per parą grupę įtraukti pacientai, kuriems HCV RNR po 4 savaičių buvo < LLOQ, o po 10 savaičių nerasta, paskui buvo atsitiktinai atrinkti dar 12 savaičių vartoti 60 mg daklatasviro ar placebo kartu su pegIFN/RBV (bendra tyrimo trukmė sudarė 24 savaites).
English: Treatment discontinuation in patients with inadequate on-treatment virologic response during treatment with Daklinza, peginterferon alfa and ribavirin It is unlikely that patients with inadequate on-treatment virologic response will achieve a sustained virologic response (SVR); therefore discontinuation of treatment is recommended in these patients.
Lithuanian: Daklinza, peginterferono alfa ir ribavirino vartojimo nutraukimas, kai virusologinis atsakas į gydymą nepakankamas
English: Emergent daclatasvir resistance-associated substitutions have been shown to persist for 2 years posttreatment and beyond for patients treated with other daclatasvir-based regimens.
Lithuanian: Nustatyta, kad pacientams, kuriems buvo skiriama kitokia daklatasviru paremto gydymo schema, išsivystę su atsparumu daklatasvirui susiję pakeitimai po gydymo išlieka
English: Among patients who achieved SVR12 with daclatasvir and sofosbuvir (± ribavirin) with a median duration of post-SVR12 follow-up of 15 months, no relapses have occurred.
Lithuanian: pasiekusius SVR12, vėliau stebėjus laikotarpį, kurio mediana 15 mėn., atkryčių nenustatyta.
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).
Lithuanian: Daklinza negalima vartoti kartu su šiais vaistais: fenitoinu, karbamazepinu, okskarbazepinu, fenobarbitaliu (jų skiriama norint išvengti traukulių dėl epilepsijos); rifampicinu, rifabutinu, rifapentinu (antibiotikais tuberkuliozei gydyti);
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.
Lithuanian: Daklinza derinys su peginterferonu alfa ir ribavirinu Dažniausiai praneštos nepageidaujamos reakcijos yra nuovargis, galvos skausmas, niežulys, anemija,
English: ACID REDUCING AGENTS H2-receptor antagonists Famotidine 40 mg single dose (daclatasvir 60 mg single dose)
Lithuanian: Famotidinas viena 40 mg dozė (daklatasviras viena 60 mg dozė)
English: Detectable HCV RNA at end of treatment
Lithuanian: Rasta HCV RNR gydymo pabaigoje
English: ↔ Daclatasvir ↔ Warfarin
Lithuanian: ↔ daklatasviro ↔ varfarino
English: Your doctor may need to adjust the dose of Daklinza or you may not be able to take Daklinza with certain medicines.
Lithuanian: Tai svarbu dėl to, kad Daklinza gali keisti kitų vaistų veikimą, o kai kurie kiti vaistai - Daklinza veikimą. Jeigu vartojate tam tikrų vaistų, gydytojui gali tekti pakoreguoti Daklinza dozę, o kartu su kai kuriais vaistais Daklinza vartoti negalima.
English: Table 2: Ribavirin dosing guidelines for coadministration with Daklinza regimen for patients with cirrhosis or post-transplant
Lithuanian: Kartu su Daklinza ir kitais vaistiniais preparatais vartojamo ribavirino dozavimo rekomendacijos pacientams, kuriems yra cirozė arba atliktas persodinimas
English: daclatasvir + sofosbuvir + ribavirin N=9
Lithuanian: Daklatasvira s, sofosbuviras ir ribavirinas N = 9
English: Patients with cirrhosis
Lithuanian: Pacientai, kuriems yra cirozė
English: daclatasvir + sofosbuvir + ribavirin N=5
Lithuanian: Daklatasvira s, sofosbuviras ir ribavirinas N = 5
English: Pregnancy
Lithuanian: Registruotojas
English: The Summary of Product Characteristics for the other medicinal products in the regimen should also be consulted before initiation of therapy with Daklinza.
Lithuanian: Prieš skiriant Daklinza, reikia susipažinti su kartu numatomų vartoti vaistinių preparatų charakteristikų santraukomis.
English: CYP3A4 inhibition by ketoconazole
Lithuanian: Ketokonazolas slopina CYP3A4.
English: No dose adjustment of Daklinza or escitalopram is required.
Lithuanian: Daklinza ir escitalopramo dozių koreguoti nereikia.
English: No dose adjustment of Daklinza or azithromycin or ciprofloxacin is required.
Lithuanian: Daklinza ir azitromicino dozių koreguoti nereikia.
English: 0.180/0.215/0.250 mg is recommended with Daklinza.
Lithuanian: Kartu su Daklinza rekomenduojama vartoti geriamojo kontraceptiko, kurio sudėtyje yra 35 μg etinilestradiolio ir 0,180/0,215/0,250 mg norgestimato.
English: Inhibition of OATP 1B1 and BCRP by daclatasvir
Lithuanian: Daklatasviras slopina OATP 1B1 ir BCRP.
English: Each film-coated tablet contains daclatasvir dihydrochloride equivalent to 90 mg daclatasvir.
Lithuanian: Daklinza 90 mg plėvele dengtos tabletės Kiekvienoje plėvele dengtoje tabletėje yra daklatasviro dihidrochlorido kiekis, atitinkantis 90 mg daklatasviro.
English: Daklinza + sofosbuvir +/- ribavirin for 24 weeks (see sections 4.4 and 5.1)
Lithuanian: Daklinza ir sofosbuviras su ribavirinu arba be jo 24 savaites (žr.
English: Daclatasvir is a very weak inducer of CYP3A4 and caused a 13% decrease in midazolam exposure.
Lithuanian: Jis sumažino midazolamo ekspoziciją 13 %.
English: Bristol-Myers Squibb GmbH & Co. KGaA Tel: + 49 89 121 42-0
Lithuanian: KGaA Tel: + 49 89 121 42-0
English: CP B
Lithuanian: CP A arba B klasė
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.
Lithuanian: - Po 4 ir 12 gydymo savaičių neradus HCV RNR, visi 3 derinio komponentai vartojami iš viso 24 savaites.
English: Expected due to CYP3A4 induction by the anticonvulsant:
Lithuanian: Tikėtina kobicistato sukeliamo CYP3A4 slopinimo pasekmė:
English: Expected due to CYP3A4 induction by St. John's wort:
Lithuanian: Tikėtina jonažolės sukeliamos CYP3A4 indukcijos pasekmė:
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).
Lithuanian: Daklinza negalima vartoti kartu su vaistiniais preparatais, kurie stipriai indukuoja CYP3A4 ir P-gp (pvz.
English: ↔ Daclatasvir AUC: ↔* Cmax: ↔* Cmin: ↔*
Lithuanian: ↔ Daklatasviro: AUC - ↔∗
English: SEDATIVES
Lithuanian: Escitalopramas
English: No dose adjustment of Daklinza 60 mg once daily, darunavir/ritonavir (800/100 mg once daily or 600/100 mg twice daily) or darunavir/cobicistat is required.
Lithuanian: 600 mg su 100 mg du kartus per parą) arba kartu su darunaviru ir kobicistatu, dozės koreguoti nereikia.
English: Steady state was achieved after 4 days of once-daily administration.
Lithuanian: pusiausvyros koncentracija susidaro po 4 dienų.
English: CARDIOVASCULAR AGENTS Antiarrhythmics
Lithuanian: Selektyvūs serotonino reabsorbcijos inhibitoriai
English: Bristol-Myers Squibb spol.
Lithuanian: Bristol-Myers Squibb B.
English: There is no known antidote for overdose of daclatasvir.
Lithuanian: Vis dėlto šis poveikis nėra tokio dydžio, kad turėtų klinikinės reikšmės daklatasviro ekspozicijai.
English: Amlodipine
Lithuanian: Efavirenzas
English: Recommended dose
Lithuanian: II PRIEDAS
English: No cirrhosis
Lithuanian: Ketokonazolas
English: If you forget to take Daklinza It is important not to miss a dose of this medicine.
Lithuanian: Svarbu nepraleisti šio vaisto dozių.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 30 mg tablets daclatasvir
Lithuanian: Daklinza 30 mg plėvele dengtos tabletės
English: HCV Treatmentexperienced*
Lithuanian: Anksčiau gydyti nuo HCV* N=52
English: Dose adjustment of Daklinza is recommended when coadministered with strong inhibitors of CYP3A4 (see Table 4).
Lithuanian: Daklinza negalima vartoti kartu su jonažolės ir kitais vaistiniais preparatais, kurie stipriai indukuoja CYP3A4 (žr.
English: Gastrointestinal disorders very common nausea common diarrhoea, vomiting, abdominal pain, gastrooesophageal reflux disease, constipation, dry mouth, flatulence nausea, diarrhoea, abdominal pain
Lithuanian: Odos ir poodinio audinio sutrikimai Dažni išbėrimas, alopecija, niežėjimas, sausa oda
English: Expected due to CYP3A4 inhibition by the antifungal:
Lithuanian: Tikėtina vaistinių preparatų nuo traukulių sukeliamo CYP3A4 slopinimo pasekmė:
English: NAME OF THE MEDICINAL PRODUCT Daklinza 90 mg tablets daclatasvir
Lithuanian: Daklinza 90 mg plėvele dengtos tabletės
English: Tablet core
Lithuanian: 1 lentelė.
English: HCV Treatmentnaïve
Lithuanian: Pakartotinis gydymas daklatasviru
English: <75 kg or ≥75 kg, respectively).
Lithuanian: Telapreviras po 750 mg kas 8 val.
English: 11 patients or FibroTest score ≥0.75 and aspartate aminotransferase (AST): platelet ratio index (APRI)
Lithuanian: AST:platelet ratio index, APRI)
English: Otherwise the medicine may not work against the hepatitis C virus.
Lithuanian: Svarbu vartoti Daklinza visą nustatytą gydymo laikotarpį, nes kitaip jis gali nepaveikti hepatito C viruso.
English: Other HCV antivirals
Lithuanian: Kiti antivirusiniai vaistiniai preparatai nuo HCV Peginterferonas alfa
English: CP A
Lithuanian: CP A CP B CP C
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.
Lithuanian: Kartu vartojant atazanaviro su ritonaviru, atazanaviro su kobicistatu arba kitų vaistinių preparatų, kurie stipriai slopina
English: Expected due to CYP3A4 inhibition by the antibacterial:
Lithuanian: Tikėtina vaistinių preparatų nuo bakterijų sukeliamo CYP3A4 slopinimo pasekmė: ↑ daklatasviro
English: The dose of Daklinza should be increased to 90 mg once daily when coadministered with moderate inducers of CYP3A4.
Lithuanian: Kartu vartojant vaistinių preparatų, kurie vidutiniškai indukuoja CYP3A4, Daklinza dozę reikia padidinti iki 90 mg 1 kartą per parą.
English: Daklinza + sofosbuvir + ribavirin for 12 weeks (see section 5.1)
Lithuanian: Daklinza, sofosbuviras ir ribavirinas 12 savaičių (žr.
English: How long to take Daklinza Make sure you take Daklinza for as long as your doctor has told you to take it.
Lithuanian: Daklinza vartokite gydytojo nurodytą laiką.
English: ↔ Telaprevir
Lithuanian: ↔ Daklatasviras
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).
Lithuanian: amjodaroną - nuo širdies ritmo sutrikimo; atazanaviro su ritonaviru, ataranaviro su kobicistatu, elvitegraviro, kobicistato, emtricitabino, tenofoviro dizoproksilio fumarato derinio tablečių,etravirino, nevirapino, arba efavirenzo (jie skirti ŽIV infekcijai gydyti); bocepreviro arba telapreviro (jie skirti hepatito C infekcijai gydyti);
English: BRISTOL-MYERS SQUIBB A.E. Τηλ: + 30 210 6074300
Lithuanian: Τηλ: + 30 210 6074300
English: Integrase inhibitors Dolutegravir 50 mg once daily (daclatasvir 60 mg once daily)
Lithuanian: Dolutegraviras 50 mg 1 kartą per parą
English: CYP3A4 inhibition by ritonavir
Lithuanian: 2 - ciklofilino inhibitoriumi.
English: Daklinza is not recommended for patients below 18 years of age.
Lithuanian: Jaunesniems kaip 18 metų pacientams Daklinza vartoti nerekomenduojama, nes šio vaisto poveikis vaikams ir paaugliams dar neištirtas.
English: Discontinue ribavirin
Lithuanian: ↔ Ribavirino:
English: GT 3
Lithuanian: GT 1 arba 4 GT 3
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with ketoconazole or other strong inhibitors of CYP3A4.
Lithuanian: telitromicino arba kitų vaistinių preparatų, kurie stipriai slopina CYP3A4, Daklinza dozę reikia sumažinti iki 30 mg 1 kartą per parą.
English: NAME OF THE MEDICINAL PRODUCT Daklinza 60 mg tablets daclatasvir
Lithuanian: Daklinza 60 mg plėvele dengtos tabletės
English: The dose of Daklinza should be reduced to 30 mg once daily when coadministered with boceprevir or other strong inhibitors of CYP3A4.
Lithuanian: Kartu vartojant bocepreviro arba kitų vaistinių preparatų, stipriai slopinančių CYP3A4, Daklinza dozę reikia sumažinti iki 30 mg 1 kartą per parą.
English: ↔ Norelgestromin
Lithuanian: ↔ Norelgestromino:
English: Treatment week 24: ≥25 IU/ml
Lithuanian: P32-pašalinimas H58: D, P